Robotically assisted endoluminal surgical procedures

Abstract

Systems, methods and devices for endoluminal surgical procedures include a robotic surgical systems adapted and configured to perform lower and upper gastrointestinal endoluminal submucosal dissection (ESD), endoluminal ‎sleeve gastroplasty (ESG), trans-oral endoluminal fundoplication, bariatric endoluminal antral myotomy (BEAM), peroral endoluminal myotomy (POEM), gastroplasty with endoscopic myotomy (GEM), trans-vaginal hysterectomy, trans-vaginal oophorectomy, and trans-vaginal oophoro-salpingectomy. The systems include a physician console, a patient cart and a system controller. The system controller is adapted and configured to receive a plurality of control inputs from ‎each of a plurality of hand control input devices, to process the plurality of control inputs and to ‎transmit a plurality of control outputs to an axial translation actuator, a roll actuator, ‎a steerable overtube controller, a plurality of instrument controllers and a videoscope ‎controller.

Description

ROBOTICALLY ASSISTED ENDOLUMINAL SURGICAL PROCEDURESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 641,114, filed May 1, 2024, the entire contents of which are incorporated herein by reference in their entirety.TECHNICAL FIELD

[0002] This disclosure is directed to surgical robotic systems and to related methods utilizing a flexible steerable overtube or access port, which are particularly suited for use in single-site and endoluminal (endolumenal) surgical procedures. More particularly, this disclosure is directed to robotically assisted transoral, transesophageal, transumbilical, intragastric, transanal and transvaginal endoscopic surgical procedures, techniques, and treatments, sometimes referred to as Natural Orifice Transluminal (Translumenal) Endoscopic Surgery (NOTES), as well as in Single Incision Laparoscopic Surgery (SILS), Single Port Access (SPA) surgery, Natural Orifice Trans-Umbilical Surgery (NOTUS), Laparo-Endoscopic Single-site Surgery (LESS), One Port Umbilical Surgery (OPUS), Single Port Incisionless Conventional Equipment-utilizing Surgery (SPICES), Single Access Site Surgical Endoscope (SASSE) procedures.BACKGROUND OF THE INVENTION

[0003] Minimally invasive surgical procedures such as endoluminal surgery and singlesite laparoscopic surgery are known in the art and provide many benefits over traditional open or multi-port laparoscopic surgical procedures. Endoluminal surgical procedures are performed endoscopically within hollow organs using typical surgical techniques, such as dissection, suturing, cutting, and stapling. These procedures may be performed trans- orally within the upper gastrointestinal (GI) tract, transanally within the lower GI tract, or transvaginally within the abdominal or pelvic cavity. Endoluminal surgery is beneficial in that no skin incision is required to gain access to the surgical site within a patient’s natural lumen. This can dramatically reduce patient recovery time and can improveprocedural safety. Single-site or single-incision surgical procedures are typically performed within a patient’s abdominal cavity or thoracic cavity through a single incision. This too can reduce patient recovery time and trauma since multiple incisions are not required to access the patient’s abdominal or thoracic cavity and incisional location is more flexible. Single-incision abdominal surgical procedures are often performed through a patient's umbilicus or navel, also beneficially minimizing the visual appearance of any subsequent scarring.

[0004] Robotic surgical systems are also known in the art and have been used to perform both endoluminal and single-site surgical procedures. An example of such a system is disclosed, for example, in commonly assigned U.S. Patent 12,138,001, which is incorporated herein by reference in its entirety. This flexible robotic system includes a patient cart with a multi-axis positioning system and employs a steerable overtube assembly having a plurality of working channels for introducing surgical devices to a surgical site. The overtube assembly is also described in detail in commonly assigned U.S. Patent 11,963,730, which is also incorporated herein by reference in its entirety. Exemplary surgical devices and end effectors or tools that can be introduced to a surgical site through a working channel of the steerable overtube assemblies are disclosed in commonly assigned U.S. Patent 12,186,007, the disclosure of which is incorporated herein by reference in its entirety.

[0005] Systems, devices and methods in accordance with the invention can incorporate or utilize aspects of devices, systems and methods disclosed in the following patent applications or publications, each of which is incorporated herein by reference in its entirety: Master Control Systems for Robotic Surgical Systems, as described in U.S. Patent 12,064,196 and U.S. Patent Application Publication 2024 / 0374325, Patient Console 5 -Degree of Freedom Positioning Systems, as described in U.S. Patent 12,138,001, User Interfaces for Surgical Robotic Systems, as described in U.S. Patent Application Publication 2025 / 0041011, Position Control for Patient Console, as described in U.S. Patent Application Publication 2023 / 0363842, Safety Hand Sensor for Robotic Surgical System, as described in U.S. Patent Application Publication 2023 / 0210621, Display Systems for Robotic Surgical Systems, as described in U.S. Patent Application Publication 2023 / 0248450, Disposable End Effectors as described inU.S. Patent 12,186,007 and U.S. Patent Application Publication 2025 / 0082393, Wire Elongation Compensation System, as described in U.S. Patent Application Publication 2023 / 0285099 and U.S. Patent Application Publication 2025 / 0090255, Steerable Overtube Assemblies for Robotic Surgical Systems, as described in U.S. Patent 11,963,730 and U.S. Patent Application Publication 2024 / 0268907, Controller Arrangements for Robotic Surgical Systems, as described in U.S. Patent Application Publication 2023 / 0248457, Barrier Drape Adapters for Robotic Surgical Systems, as described in U.S. Patent Application Publication 2023 / 0363847, Force Transmission Systems for Robotically Controlled Medical Devices, as described in U.S. Patent 12,144,571, Robotic Systems and Instruments, as described in U.S. Patent Application Publication 2025 / 0057610, Systems And Method for Trans-Luminal Introduction Of A Medical Device, as described in U.S. Patent Application Publication 2023 / 0355221, Robotic Medical System Drape Adapter Assemblies, as described in U.S. Patent Application 18 / 415,502, fded January 17, 2024, Valve Assembly for Sealing an Instrument Channel on a Robotic Surgical System, as described in U.S. Patent Application 18 / 535,425, fded December 11, 2023, Support Assembly for Holding a Videoscope on a Robotic Surgical System, as described in U.S. Patent Application 18 / 596,171, fded March 5, 2024, Robotically Assisted Endoluminal Surgical Procedures, as described in U.S. Patent Application 63 / 641,114, fded May 1, 2024, Robotically Assisted Single-Incision Surgical Procedures, as described in U.S. Patent Application 63 / 641,165, fded May 1, 2024, Posable Patient Cart for a Robotic Surgical System, as described in U.S. Patent Application 63 / 677,557, fried July 31, 2024, Roll and Pitch Module for a Modular Patient Cart of a Robotic Surgical System, as described in U.S. Patent Application 63 / 677,576, fded July 31, 2024, Central Drive Unit and Translation Module for a Modular Patient Cart of a Robotic Surgical System, as described in U.S. Patent Application 63 / 677,614, fded July 31, 2024, Cart and Tower Module for a Modular Patient Cart of a Robotic Surgical System, as described in U.S. Patent Application 63 / 677,648, fded July 31, 2024, Bipolar End Effector Assembly for Robotic Surgical Instrument, as described in U.S. Patent Application 18 / 790,627, fried July 31, 2024, Robotic Surgical Systems with Steerable Overtube Controller, Sterile Drape Adapter and Presence Detection, as described in U.S. Patent Application 63 / 751,912,filed January 31, 2025, Robotic Surgical Systems with Steerable Overtube Controller, Sterile Drape Adapter and Presence Detection, as described in U.S. Patent Application 63 / 751,927, filed January 31, 2025, Robotic Surgical Systems with Steerable Overtube Controller, Sterile Drape Adapter and Presence Detection as described in U.S. Patent Application 63 / 751,953, filed January 31, 2025, Surgical Apparatus, as described in U.S. Patent 11,504,144, Surgical Apparatus, as described in U.S. Patent Publication Number 2020 / 0107898, End Effector and End Effector Drive Apparatus, as described in U.S. Patent 10,881,422, and / or Seven Degree of Freedom Positioning Device for Robotic Surgery, as described in U.S. Patent 12,193,770.

[0006] Applicant recognizes a need in the art to provide systems, devices and methods to provide improved surgical outcomes in robotically assisted endoluminal surgical procedures including, but not limited to, endoluminal submucosal dissection (ESD) procedures, endoluminal sleeve gastroplasty (ESG) procedures, bariatric endoluminal antral myotomy (BEAM) procedures, endoluminal sleeve gastroplasty with endoscopic myotomy (GEM) procedures, peroral endoluminal myotomy (POEM) procedures, trans- vaginal hysterectomy and oophorectomy procedures, and trans-oral endoluminal fundopli cation procedures. The present disclosure provides systems, devices and methods that address these needs.SUMMARY OF THE INVENTION

[0007] The purposes and advantages of the below-described illustrated embodiments will be set forth in and apparent from the description that follows. Additional advantages of the illustrated embodiments will be realized and attained by the devices, systems and methods particularly pointed out in the written description and claims hereof, as well as from the appended drawings.

[0008] In accordance with the present invention, systems, devices, methods and computer program products, or computer software are provided for robotically-assisted endoluminal surgical procedures.

[0009] In accordance with one embodiment of the invention, a method of performing a robotically assisted endoluminal submucosal dissection (ESD) procedure on a patient comprises the steps of: a) advancing a steerable overtube assembly to a site of a lesionwithin a gastrointestinal (GI) tract of the patient, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) marking boundaries of the lesion using the one or more robotically controlled surgical instruments; c) injecting a fluid into a submucosal plane associated with the lesion to lift and separate the lesion from adjacent muscle tissue; d) dissecting tissue surrounding the lesion using the one or more robotically controlled surgical instruments; e) retrieving the resected lesion from the site using the one or more robotically controlled surgical instruments; and f) closing a defect created by resecting the lesion using the one or more robotically controlled surgical instruments.

[0010] The method can further comprise the step of: g) introducing the steerable overtube assembly into the GI tract before the advancing step. The introducing step can be effected under robotic control. The introducing step can be effected manually. The method can further comprise the step of: h) docking the steerable overtube assembly to a steerable overtube controller of a surgical robot after the introducing step.

[0011] The method can be a robotically assisted ESD procedure performed within an upper GI tract of the patient. The method can further comprise the step of positioning the patient in a supine position with the patient's head tilted left or right or in a sword swallower position. The method can be a robotically assisted ESD procedure performed within a lower GI tract of the patient. The method can comprise the step of positioning the patient in a supine position with the patient's legs separated, flexed, and supported in stirrups, or in a lateral position. The step of marking boundaries of the lesion can involve cauterizing the mucosal tissue surrounding the lesion at a plurality of locations using an end effector of the one or more robotically controlled surgical instruments. The step of injecting a fluid into the submucosal plane associated with the lesion can involve introducing a needle through a working channel of the steerable overtube assembly to inject the fluid into the submucosal plane. The step of injecting a fluid into the submucosal plane associated with the lesion can involve using the one or more robotically controlled surgical instruments to retract tissue as the fluid is injected into the submucosal plane, and / or to direct the needle into tissue as the fluid is injected into the submucosa.

[0012] The step of dissecting tissue surrounding the lesion can involve using an end effector of a first one of the one or more robotically controlled surgical instruments to retract tissue and using an end effector of a second one of the one or more robotically controlled surgical instruments to dissect the tissue surrounding the lesion. The step of retrieving the resected lesion can involve using an end effector of the one or more robotically controlled surgical instruments to place the resected lesion into a specimen retriever introduced though the steerable overtube assembly. The step of closing the defect created by the resection of the lesion can involve using end effectors of first and second ones of the one or more robotically controlled surgical instruments to suture the defect closed.

[0013] In another aspect, a robotic surgical system adapted and configured to perform a robotically assisted endoluminal submucosal dissection (ESD) procedure includes a physician console, a patient cart and a system controller. The physician console comprises: i) a plurality of hand control input devices adapted to receive 3-dimensional hand gesture inputs from an operator; and ii) a plurality of foot pedals configurable to perform system functions adapted to receive a foot pedal input from the operator. The patient cart is adapted and configured for bidirectional data communication with the physician console, having a spatially configurable supporting frame having a plurality of degrees of freedom and configured to support a unitary drive unit comprising: i) an axial translation actuator associated therewith for actuating axial translation along a central axis of the unitary drive unit; ii) a roll actuator associated therewith for actuating roll movement of the unitary drive unit about the central axis of the unitary drive unit; iii) a steerable overtube controller adapted and configured to operatively engage and actuate bidirectional steering of a steerable overtube in two degrees of freedom; iv) a plurality of instrument controllers adapted and configured to operatively engage and actuate each of a plurality of elongate flexible surgical instruments deployable through first and second working channels of the steerable overtube; and v) a videoscope controller adapted and configured to operatively engage and actuate a videoscope deployable through a third working channel of the steerable overtube. The system controller is adapted and configured to receive a plurality of control inputs from each of the plurality of hand control input devices, to process the plurality of control inputs and to transmit a pluralityof control outputs to each of the axial translation actuator, the roll actuator, the steerable overtube controller, the plurality of instrument controllers and the videoscope controller, the control outputs causing the system to: i) advance a steerable overtube assembly to a site of a lesion within a gastrointestinal (GI) tract of a patient, wherein the steerable overtube assembly is insertable into the GI tract and configured for advancing into and for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; ii) mark boundaries of the lesion using the one or more robotically controlled surgical instruments; iii) inject a fluid into a submucosal plane associated with the lesion to lift and separate the lesion from adjacent muscle tissue; iv) dissect tissue surrounding the lesion using the one or more robotically controlled surgical instruments; v) retrieve the resected lesion from the site using the one or more robotically controlled surgical instruments; and vi) close a defect created by resecting the lesion using the one or more robotically controlled surgical instruments.

[0014] The control outputs can further cause the system to: vii) introduce the steerable overtube assembly into the GI tract. The steerable overtube assembly can be manually introducible into the GI tract. The steerable overtube assembly can be adapted and configured to be docked to the steerable overtube controller following manual introduction into the GI tract.

[0015] In a further aspect, a computer program product adapted and configured to enable a robotically assisted endoluminal submucosal dissection (ESD) procedure is provided. The computer program product comprises computer-readable program code capable of being executed by one or more processors when retrieved from a non-transitory computer-readable medium, the program code comprising instructions configurable to effect: a) advancement of a steerable overtube assembly to a site of a lesion within a gastrointestinal (GI) tract of a patient, wherein the steerable overtube assembly is insertable into the GI tract and configured for advancing into and for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) marking of boundaries of the lesion using the one or more robotically controlled surgical instruments; c) injection of a fluid into a submucosal plane associated with the lesion to lift and separate the lesion from adjacent muscle tissue; d) dissection of tissue surrounding the lesion using the one or more robotically controlled surgicalinstruments; e) removal of the resected lesion from the site using the one or more robotically controlled surgical instruments; and f) closure of a defect created by resecting the lesion using the one or more robotically controlled surgical instruments. The program code can further comprise instructions configurable to effect: g) introduction of the steerable overtube assembly into the GI tract.

[0016] The steerable overtube assembly can be manually introducible into the GI tract, and the steerable overtube assembly can be adapted and configured to be docked to a steerable overtube controller following manual introduction into the GI tract, and the program code can further comprise instructions configurable to robotically steer the steerable overtube following docking with the robotic controller.

[0017] In accordance with another embodiment of the invention, a method of performing a robotically assisted endoluminal sleeve gastroplasty (ESG) procedure on a patient, comprises the steps of a) advancing a steerable overtube assembly into a stomach of the patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) marking guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement using the one or more robotically controlled surgical instruments; c) stitching a suture through the marked gastric walls or though the mucosectomies in the stomach in a predefined pattern to acquire tissue using the one or more robotically controlled surgical instruments; and d) pulling opposite ends of the suture to appose the acquired tissue and thus forming a first distal suture plication, using a pair of the one or more robotically controlled surgical instruments.

[0018] The method can further comprise the step of: e) introducing the steerable overtube assembly into an upper gastrointestinal (GI) tract before the advancing step. The introducing step can be effected under robotic control. The introducing step can be effected manually. The method can further comprise the step of: f) docking the steerable overtube assembly to a steerable overtube controller of a surgical robot after the introducing step.

[0019] The method can further comprise the step of forming one or more subsequent suture plications proximal to the first suture plication by continually repeating steps (c)and (d) until a stomach volume and stomach length have been reduced by a predetermined amount. The method can further comprise the step of positioning the patient in a supine position with the patient's head tilted left or right or in a sword swallower position. The step of marking guidelines and / or forming mucosectomies on the anterior and posterior gastric walls of the stomach can involve cauterizing the gastric walls using an end effector of the one or more robotically controlled surgical instruments.

[0020] The step of stitching a suture through the marked gastric walls can involve using end effectors of first and second ones of the one or more robotically controlled surgical instruments to place the suture. The step of pulling opposite ends of the suture to appose the acquired tissue can involve using end effectors of first and second ones of the one or more robotically controlled surgical instruments to grasp and tighten the suture.

[0021] In another aspect, a robotic surgical system adapted and configured to perform a robotically assisted endoluminal sleeve gastroplasty (ESG) procedure comprises: a physician console, a patient cart and a system controller. The physician console comprises i) a plurality of hand control input devices adapted to receive 3 -dimensional hand gesture inputs from an operator; and ii) a plurality of foot pedals configurable to perform system functions adapted to receive a foot pedal input from the operator. The patient cart is adapted and configured for bidirectional data communication with the physician console, having a spatially configurable supporting frame having a plurality of degrees of freedom and configured to support a unitary drive unit comprising: i) an axial translation actuator associated therewith for actuating axial translation along a central axis of the unitary drive unit; ii) a roll actuator associated therewith for actuating roll movement of the unitary drive unit about the central axis of the unitary drive unit; iii) a steerable overtube controller adapted and configured to operatively engage and actuate bidirectional steering of a steerable overtube in two degrees of freedom; iv) a plurality of instrument controllers adapted and configured to operatively engage and actuate each of a plurality of elongate flexible surgical instruments deployable through first and second working channels of the steerable overtube; and v) a videoscope controller adapted and configured to operatively engage and actuate a videoscope deployable through a third working channel of the steerable overtube. The system controller is adapted and configured to receive a plurality of control inputs from each of the plurality of handcontrol input devices, to process the plurality of control inputs and to transmit a plurality of control outputs to each of the axial translation actuator, the roll actuator, the steerable overtube controller, the plurality of instrument controllers and the videoscope controller, the control outputs causing the system to: i) advance a steerable overtube assembly into a stomach of a patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; ii) mark guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement using the one or more robotically controlled surgical instruments; iii) stitch a suture through the marked gastric walls or though the mucosectomies in the stomach in a predefined pattern to acquire tissue using the one or more robotically controlled surgical instruments; and iv) pull opposite ends of the suture to appose the acquired tissue and thus forming a first distal suture plication, using a pair of the one or more robotically controlled surgical instruments.

[0022] The control outputs can further cause the system to: vii) introduce the steerable overtube assembly into an upper GI tract of the patient. The steerable overtube assembly can be manually introducible into an upper GI tract of the patient. The steerable overtube assembly can be adapted and configured to be docked to the steerable overtube controller following manual introduction into the upper GI tract.

[0023] In accordance with a further aspect, a computer program product adapted and configured to enable an endoluminal sleeve gastroplasty (ESG) procedure is provided. The computer program product comprises computer-readable program code capable of being executed by one or more processors when retrieved from a non-transitory computer-readable medium, the program code comprising instructions configurable to effect: a) advancement of a steerable overtube assembly into a stomach of a patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) marking of guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement using the one or more robotically controlled surgical instruments; c) stitching of a suture through the marked gastric walls or though the mucosectomies in thestomach in a predefined pattern to acquire tissue using the one or more robotically controlled surgical instruments; and d) pulling on opposite ends of the suture to appose the acquired tissue and thus forming a first distal suture plication, using a pair of the one or more robotically controlled surgical instruments. The program code can further comprise instructions configurable to effect: g) introduction of the steerable overtube assembly into an upper GI tract of the patient.

[0024] The steerable overtube assembly can be manually introducible into the upper GI tract, the steerable overtube assembly can be adapted and configured to be docked to a steerable overtube controller following manual introduction into the upper GI tract, and the program code can further comprise instructions configurable to robotically steer the steerable overtube following docking with the robotic controller.

[0025] In accordance with a further embodiment of the invention, a method of performing a robotically assisted bariatric endoluminal antral myotomy (BEAM) procedure on a patient comprises the steps of: a) advancing a steerable overtube assembly into a stomach of the patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injecting a fluid into a submucosal plane of the stomach at the site, to lift and separate a mucosal tissue layer from a muscle layer; c) creating a mucosal incision at the site along the greater curvature of the stomach using at least one robotically controlled surgical instrument deployed from a distal end of the steerable overtube assembly; d) tunneling through the mucosal incision, under the mucosa layer to a submucosal plane, and to a location proximal to a pylorus using the one or more robotically controlled surgical instruments; e) forming two parallel lines of partial thickness myotomy from a distal to proximal antrum of the stomach using the one or more robotically controlled surgical instruments; and f) closing the mucosal incision using the one or more robotically controlled surgical instruments.

[0026] The method can further comprise the step of: g) introducing the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient, before the advancing step. The introducing step can be effected under robotic control. The introducing step can be effected manually, without robotic control. The method can further comprise the stepof: h) docking the steerable overtube assembly to a steerable overtube controller of a surgical robot after the introducing step.

[0027] The method can further comprise a step of positioning the patient in a supine or prone position with the patient's head tilted left or right. The step of injecting the fluid into the submucosal plane can involve introducing a needle through a working channel of the steerable overtube assembly to inject the fluid into the submucosal plane. The step of injecting a fluid into the submucosal plane can involve using the one or more robotically controlled surgical instruments to retract the mucosal tissue layer as the fluid is injected into the submucosal plane, and / or to direct the needle into tissue as the fluid is injected into the submucosa. The step of creating a mucosal incision can involve using an end effector of a first one of the one or more robotically controlled surgical instruments to retract the mucosa layer and using an end effector of a second one of the one or more robotically controlled surgical instruments to form the incision.

[0028] The step of tunneling under the mucosa layer of the stomach to the submucosal plane can involve using an end effector of a robotically controlled surgical instrument to retract the mucosa and using an end effector of the one or more robotically controlled surgical instruments to tunnel below the mucosal tissue layer. The step of forming the two parallel lines of partial thickness myotomy can involve using an end effector of a first one of the one or more robotically controlled surgical instruments to retract the mucosa layer and using an end effector of a second one of the one or more robotically controlled surgical instruments to form the two parallel lines of partial thickness myotomy. The step of closing the mucosal incision can involve using end effectors of first and second ones of the one or more robotically controlled surgical instruments to suture the mucosal incision closed.

[0029] In another aspect, a robotic surgical system adapted and configured to perform a robotically assisted bariatric endoluminal antral myotomy (BEAM) procedure comprises: a physician console, a patient cart and a system controller. The physician console comprises: i) a plurality of hand control input devices adapted to receive 3-dimensional hand gesture inputs from an operator; and ii) a plurality of foot pedals configurable to perform system functions adapted to receive a foot pedal input from the operator. The patient cart is adapted and configured for bidirectional data communication with thephysician console, having a spatially configurable supporting frame having a plurality of degrees of freedom and configured to support a unitary drive unit comprising: i) an axial translation actuator associated therewith for actuating axial translation along a central axis of the unitary drive unit; ii) a roll actuator associated therewith for actuating roll movement of the unitary drive unit about the central axis of the unitary drive unit; iii) a steerable overtube controller adapted and configured to operatively engage and actuate bidirectional steering of a steerable overtube in two degrees of freedom; iv) a plurality of instrument controllers adapted and configured to operatively engage and actuate each of a plurality of elongate flexible surgical instruments deployable through first and second working channels of the steerable overtube; and v) a videoscope controller adapted and configured to operatively engage and actuate a videoscope deployable through a third working channel of the steerable overtube. The system controller is adapted and configured to receive a plurality of control inputs from each of the plurality of hand control input devices, to process the plurality of control inputs and to transmit a plurality of control outputs to each of the axial translation actuator, the roll actuator, the steerable overtube controller, the plurality of instrument controllers and the videoscope controller, the control outputs causing the system to: i) advance a steerable overtube assembly into a stomach of a patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; ii) inject a fluid into a submucosal plane of the stomach at the site, to lift and separate a mucosal tissue layer from a muscle layer; iii) create a mucosal incision at the site along the greater curvature of the stomach using at least one robotically controlled surgical instrument deployed from a distal end of the steerable overtube assembly; iv) tunnel through the mucosal incision, under the mucosa layer to a submucosal plane, and to a location proximal to a pylorus using the one or more robotically controlled surgical instruments; v) form two parallel lines of partial thickness myotomy from a distal to proximal antrum of the stomach using the one or more robotically controlled surgical instruments; and vi) close the mucosal incision using the one or more robotically controlled surgical instruments.

[0030] The control outputs can further cause the system to: vii) introduce the steerable overtube assembly into an upper GI tract of the patient. The steerable overtube assemblycan be manually introducible into an upper GI tract of the patient. The steerable overtube assembly can be adapted and configured to be docked to the steerable overtube controller following manual introduction into the upper GI tract.

[0031] In accordance with a further aspect, a computer program product adapted and configured to enable a bariatric endoluminal antral myotomy (BEAM) procedure is provided. The computer program product comprises computer-readable program code capable of being executed by one or more processors when retrieved from a non- transitory computer-readable medium, the program code comprising instructions configurable to effect: a) advancement of a steerable overtube assembly into a stomach of a patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injection of a fluid into a submucosal plane of the stomach at the site, to lift and separate a mucosal tissue layer from a muscle layer; c) creation of a mucosal incision at the site along the greater curvature of the stomach using at least one robotically controlled surgical instrument deployed from a distal end of the steerable overtube assembly; d) tunneling through the mucosal incision, under the mucosa layer to a submucosal plane, and to a location proximal to a pylorus using the one or more robotically controlled surgical instruments; e) formation of two parallel lines of partial thickness myotomy from a distal to proximal antrum of the stomach using the one or more robotically controlled surgical instruments; and f) closure of the mucosal incision using the one or more robotically controlled surgical instruments. The program code can further comprise instructions configurable to effect: g) introduction of the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient.

[0032] The steerable overtube assembly can be manually introducible into the upper GI tract, the steerable overtube assembly can be adapted and configured to be docked to a steerable overtube controller following manual introduction into the upper GI tract, and the program code can further comprise instructions configurable to robotically steer the steerable overtube following docking with the robotic controller.

[0033] In accordance with still a further embodiment of the invention, a method of performing a robotically assisted peroral endoluminal myotomy (POEM) procedure on a patient is provided and comprises the steps of: a) advancing a steerable overtubeassembly into an esophagus or stomach of the patient to a site adjacent a lower esophageal sphincter or a pyloric sphincter, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injecting a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a muscle layer; c) creating a mucosal incision at the site using the one or more robotically controlled surgical instruments; d) tunneling under the mucosa layer to the submucosal plane through the mucosal incision, to a location immediately proximal to the lower esophageal sphincter or the pyloric sphincter, using the one or more robotically controlled surgical instruments; e) forming a linear myotomy of an anterior portion of the lower esophageal sphincter or the pyloric sphincter using the one or more robotically controlled surgical instruments; and f) closing the mucosal incision using the one or more robotically controlled surgical instruments.

[0034] The method can further comprise the step of: g) introducing the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient before the advancing step. The introducing step can be effected under robotic control. The introducing step can be effected manually, without robotic control. The method can further comprise the step of: h) docking the steerable overtube assembly to a steerable overtube controller of a surgical robot after the introducing step. The method can further comprise the step of positioning the patient in a supine or prone position with the patient's head tilted left or right.

[0035] The step of injecting a fluid into the submucosal plane can involve introducing a needle through a working channel of the overtube assembly to inject the fluid into the submucosal plane. The step of injecting a fluid into the submucosal plane can involve using an end effector of the one or more robotically controlled surgical instruments to retract the mucosal tissue layer as the fluid is injected into the submucosal plane, and / or to direct the needle into tissue as the fluid is injected into the submucosa. The step of creating a mucosal incision can involve using an end effector of a first one of the one or more robotically controlled surgical instruments to retract the mucosal tissue layer and using an end effector of a second one of the one or more robotically controlled surgical instruments to form the incision.

[0036] The step of tunneling under the mucosal tissue layer to the submucosal plane can involve using an end effector of a first one of the one or more robotically controlledsurgical instruments to retract the mucosal tissue layer and using an end effector of a second one of the one or more robotically controlled surgical instruments to tunnel below the mucosal tissue layer. The step of forming the linear myotomy can involve using an end effector of a first one of the one or more robotically controlled surgical instruments to retract the mucosal tissue layer and using an end effector of a second one of the one or more robotically controlled surgical instruments to form the myotomy. The step of closing the mucosal incision can involve using end effectors of first and second one of the one or more robotically controlled surgical instruments to suture the mucosal incision closed.

[0037] In another aspect, a robotic surgical system adapted and configured to perform a robotically assisted peroral endoluminal myotomy (POEM) procedure comprises: a physician console, a patient cart and a system controller. The physician console comprises: i) a plurality of hand control input devices adapted to receive 3-dimensional hand gesture inputs from an operator; and ii) a plurality of foot pedals configurable to perform system functions adapted to receive a foot pedal input from the operator. The patient cart is adapted and configured for bidirectional data communication with the physician console, having a spatially configurable supporting frame having a plurality of degrees of freedom and configured to support a unitary drive unit comprising: i) an axial translation actuator associated therewith for actuating axial translation along a central axis of the unitary drive unit; ii) a roll actuator associated therewith for actuating roll movement of the unitary drive unit about the central axis of the unitary drive unit; iii) a steerable overtube controller adapted and configured to operatively engage and actuate bidirectional steering of a steerable overtube in two degrees of freedom; iv) a plurality of instrument controllers adapted and configured to operatively engage and actuate each of a plurality of elongate flexible surgical instruments deployable through first and second working channels of the steerable overtube; and v) a videoscope controller adapted and configured to operatively engage and actuate a videoscope deployable through a third working channel of the steerable overtube. The system controller is adapted and configured to receive a plurality of control inputs from each of the plurality of hand control input devices, to process the plurality of control inputs and to transmit a plurality of control outputs to each of the axial translation actuator, the roll actuator, the steerableovertube controller, the plurality of instrument controllers and the videoscope controller, the control outputs causing the system to: i) advance a steerable overtube assembly into an esophagus or stomach of a patient to a site adjacent a lower esophageal sphincter or a pyloric sphincter, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; ii) inject a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a muscle layer; iii) create a mucosal incision at the site using the one or more robotically controlled surgical instruments; iv) tunnel under the mucosa layer to the submucosal plane through the mucosal incision, to a location immediately proximal to the lower esophageal sphincter or the pyloric sphincter, using the one or more robotically controlled surgical instruments; v) form a linear myotomy of an anterior portion of the lower esophageal sphincter or the pyloric sphincter using the one or more robotically controlled surgical instruments; and vi) close the mucosal incision using the one or more robotically controlled surgical instruments.

[0038] The control outputs can further cause the system to: vii) introduce the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient. The steerable overtube assembly can be manually introducible into the upper GI tract. The steerable overtube assembly can be adapted and configured to be docked to the steerable overtube controller following manual introduction into the upper GI tract.

[0039] In accordance with a further aspect, a computer program product adapted and configured to enable a peroral endoluminal myotomy (POEM) procedure is provided. The computer program product comprises computer-readable program code capable of being executed by one or more processors when retrieved from a non-transitory computer-readable medium, the program code comprising instructions configurable to effect: a) advancement of a steerable overtube assembly into an esophagus or stomach of the patient to a site adjacent a lower esophageal sphincter or a pyloric sphincter, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injection of a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a muscle layer; c) creation of a mucosal incision at the site using the one or more robotically controlled surgical instruments; d) tunneling under the mucosa layer to the submucosalplane through the mucosal incision, to a location immediately proximal to the lower esophageal sphincter or the pyloric sphincter, using the one or more robotically controlled surgical instruments; e) formation of a linear myotomy of an anterior portion of the lower esophageal sphincter or the pyloric sphincter using the one or more robotically controlled surgical instruments; and f) closure of the mucosal incision using the one or more robotically controlled surgical instruments. The program code can further comprise instructions configurable to effect: g) introduction of the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient.

[0040] The steerable overtube assembly can be manually introducible into the upper GI tract, the steerable overtube assembly can be adapted and configured to be docked to a steerable overtube controller following manual introduction into the upper GI tract, and the program code can further comprise instructions configurable to robotically steer the steerable overtube following docking with the robotic controller.

[0041] In accordance with a further embodiment of the invention, a method of performing a robotically assisted gastroplasty with endoscopic myotomy (GEM) on a patient, comprises the steps of: a) advancing a steerable overtube assembly toward an antrum of a stomach of the patient to a site at or near an inci sura, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injecting a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a stomach muscle layer; c) creating a mucosal incision at the site using the one or more robotically controlled surgical instruments; d) tunneling under the mucosal tissue layer to a submucosa, through the mucosal incision, to a location proximal to a pyloric sphincter using the one or more robotically controlled surgical instruments; e) forming an antral myotomy of the stomach muscle layer using the one or more robotically controlled surgical instruments; f) closing the mucosal incision using the one or more robotically controlled surgical instruments; and g) performing an endoluminal sleeve gastroplasty proximal to the antral myotomy using the one or more robotically controlled surgical instruments.

[0042] The step of performing an endoluminal sleeve gastroplasty can involve the steps of: h) placing a running stitch at the incisura, perpendicular to and proximal the antral myotomy; i) marking guidelines or forming mucosectomies on anterior and posteriorgastric walls of the stomach to guide subsequent suture placement, using the one or more robotically controlled surgical instruments; j) stitching a suture through marked gastric walls or though mucosectomies in the stomach in a predefined pattern to acquire tissue, using the one or more robotically controlled surgical instruments; and k) pulling opposite ends of the suture to appose the acquired tissue and thus form a first suture plication, using first and second ones of the one or more robotically controlled surgical instruments.

[0043] The method can further comprise the step of forming one or more subsequent suture plications proximal to the first suture plication by continually repeating steps (k) and (1) until a stomach volume and a stomach length have been reduced by a predetermined amount. The method can further comprise the step of: h) introducing the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient before the advancing step.

[0044] The introducing step can be effected under robotic control. The introducing step can be effected manually, without robotic control. The method can further comprise the step of: i) docking the steerable overtube assembly to a steerable overtube controller of a surgical robot after the introducing step. The method can further comprise the step of positioning the patient in a supine position with the patient's head tilted left or right or in a sword swallower position.

[0045] In another aspect, a robotic surgical system adapted and configured to perform a robotically assisted gastroplasty with endoscopic myotomy (GEM) procedure comprises a physician console, a patient cart and a system controller. The physician console comprises: i) a plurality of hand control input devices adapted to receive 3-dimensional hand gesture inputs from an operator; and ii) a plurality of foot pedals configurable to perform system functions adapted to receive a foot pedal input from the operator. The patient cart is adapted and configured for bidirectional data communication with the physician console, having a spatially configurable supporting frame having a plurality of degrees of freedom and configured to support a unitary drive unit comprising: i) an axial translation actuator associated therewith for actuating axial translation along a central axis of the unitary drive unit; ii) a roll actuator associated therewith for actuating roll movement of the unitary drive unit about the central axis of the unitary drive unit; iii) a steerable overtube controller adapted and configured to operatively engage and actuatebidirectional steering of a steerable overtube in two degrees of freedom; iv) a plurality of instrument controllers adapted and configured to operatively engage and actuate each of a plurality of elongate flexible surgical instruments deployable through first and second working channels of the steerable overtube; and v) a videoscope controller adapted and configured to operatively engage and actuate a videoscope deployable through a third working channel of the steerable overtube. The system controller is adapted and configured to receive a plurality of control inputs from each of the plurality of hand control input devices, to process the plurality of control inputs and to transmit a plurality of control outputs to each of the axial translation actuator, the roll actuator, the steerable overtube controller, the plurality of instrument controllers and the videoscope controller, the control outputs causing the system to: i) advance a steerable overtube assembly toward an antrum of a stomach of the patient to a site at or near an incisura, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; ii) inject a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a stomach muscle layer; iii) create a mucosal incision at the site using the one or more robotically controlled surgical instruments; iv) tunnel under the mucosal tissue layer to a submucosa, through the mucosal incision, to a location proximal to a pyloric sphincter using the one or more robotically controlled surgical instruments; v) form an antral myotomy of the stomach muscle layer using the one or more robotically controlled surgical instruments; vi) close the mucosal incision using the one or more robotically controlled surgical instruments; and vii) perform an endoluminal sleeve gastroplasty proximal to the antral myotomy using the one or more robotically controlled surgical instruments.

[0046] The control outputs can further cause the system to: viii) place a running stitch at the incisura, perpendicular to and proximal the antral myotomy; ix) mark guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement, using the one or more robotically controlled surgical instruments; x) stitch a suture through marked gastric walls or though mucosectomies in the stomach in a predefined pattern to acquire tissue, using the one or more robotically controlled surgical instruments; and xi) pull opposite ends of the suture to appose theacquired tissue and thus form a first suture plication, using first and second ones of the one or more robotically controlled surgical instruments.

[0047] The control outputs can further cause the system to: introduce the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient. The steerable overtube assembly can be manually introducible into an upper gastrointestinal (GI) tract of the patient. The steerable overtube assembly can be adapted and configured to be docked to the steerable overtube controller following manual introduction into the upper GI tract.

[0048] In accordance with a further aspect, a computer program product adapted and configured to enable a robotically assisted gastroplasty with endoscopic myotomy (GEM) procedure is provided. The computer program product comprises computer-readable program code capable of being executed by one or more processors when retrieved from a non-transitory computer-readable medium, the program code comprising instructions configurable to effect: a) advancement of a steerable overtube assembly toward an antrum of a stomach of a patient to a site at or near an incisura, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injection of a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a stomach muscle layer; c) creation of a mucosal incision at the site using the one or more robotically controlled surgical instruments; d) tunneling under the mucosal tissue layer to a submucosa, through the mucosal incision, to a location proximal to a pyloric sphincter using the one or more robotically controlled surgical instruments; e) formation of an antral myotomy of the stomach muscle layer using the one or more robotically controlled surgical instruments; f) closure of the mucosal incision using the one or more robotically controlled surgical instruments; and g) performance of an endoluminal sleeve gastroplasty proximal to the antral myotomy using the one or more robotically controlled surgical instruments.

[0049] The program code can further comprise instructions configurable to effect: h) placing of a running stitch at the incisura, perpendicular to and proximal the antral myotomy; i) marking of guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement, using the one or more robotically controlled surgical instruments; j) stitching of a suture through marked gastricwalls or though mucosectomies in the stomach in a predefined pattern to acquire tissue, using the one or more robotically controlled surgical instruments; and k) pulling of opposite ends of the suture to appose the acquired tissue and thus form a first suture plication, using first and second ones of the one or more robotically controlled surgical instruments. The program code can further comprise instructions configurable to effect: g) introduction of the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient.

[0050] The steerable overtube assembly can be manually introducible into the upper GI tract, the steerable overtube assembly can be adapted and configured to be docked to a steerable overtube controller following manual introduction into the upper GI tract, and the program code can further comprise instructions configurable to robotically steer the steerable overtube following docking with the robotic controller.

[0051] All optional features described above and below can be additionally included with the subject systems, devices, methods, and program code.BRIEF DESCRIPTION OF DRAWINGS

[0052] So that those skilled in the art to which the subject disclosure appertains will readily understand how to make and use the devices, systems and methods of the subject disclosure without undue experimentation, embodiments thereof will be described in detail herein below with reference to certain figures, wherein:

[0053] Fig. l is a schematic plan view of an example embodiment of a robotic surgical system in accordance with the invention;

[0054] Fig. 2A is an isometric view of an example embodiment of a physician console of robotic surgical systems in accordance with the invention;

[0055] Figs. 2B & 2C are detail views of a hand control device for use in controlling surgical instruments, overtube and videoscope of the subject invention;

[0056] Fig. 3A is an isometric view of a first example embodiment of a patient cart of robotic surgical systems in accordance with the invention;

[0057] Fig. 3B is an isometric view of a second example embodiment of a patient cart of robotic surgical systems in accordance with the invention;

[0058] Fig. 4A illustrates a central drive unit in accordance with the invention, including instrument controllers, a videoscope controller and an overtube controller, illustrated with a protective casing;

[0059] Fig. 4B is an isometric view of an instrument controller in accordance with the present invention;

[0060] Fig. 4C is an isometric view of one embodiment of a robotic overtube controller for a steerable overtube, in accordance with the present invention;

[0061] Fig. 5A is an isometric view of an example embodiment of a steerable overtube of robotic surgical systems in accordance with the invention in a straight or neutral conformation;

[0062] Fig. 5B is an isometric view illustrating the steerable overtube of Fig. 5 A showing a bent steerable distal end;

[0063] Fig. 5C is a cross-sectional view of a shaft of the steerable overtube of Fig. 5 A illustrating working channels and other construction features;

[0064] Fig. 5D is a bottom view of a hub portion of the steerable overtube of Fig. 5A;

[0065] Fig. 6A is an isometric view of the instrument controller of Fig. 4B, illustrated aligned with flexible robotically-controlled surgical instrument in accordance with the invention (the instrument shown in partial cutaway view exposing an internal forcereversal mechanism);

[0066] Fig. 6B is a cutaway side view of a robotically-controlled surgical instrument of Fig. 6A, illustrating force reversal mechanisms in a neutral state;

[0067] Fig. 6C is a cutaway side view of the robotically-controlled surgical instrument of Fig. 6A illustrating force reversal mechanisms in flexed state of second (wrist) joint;

[0068] Fig. 6D is a detailed cutaway side view of the robotically-controlled surgical instrument of Fig. 6A illustrating a force reversal mechanism in a force-applied state;

[0069] Fig. 6E is a side view illustrating a variety of end effectors for robotically controlled surgical instruments in accordance with the invention;

[0070] Fig. 7 is a distal isometric view of a distal end portion of a steerable overtube in accordance with the invention, including a plurality of instruments extending through the distal end of working channels thereof, as well as a videoscope deployed therefrom;

[0071] Fig. 8 is a block diagram illustrating example control flow between a surgeon console and an instrument in accordance with the systems of the present invention;

[0072] Figs. 9 through 15 illustrate the operative steps of a robotically assisted endoluminal submucosal dissection (ESD) in the lower gastrointestinal (GI) tract of a patient;

[0073] Figs. 16 through 22 illustrate the operative steps of a robotically assisted endoluminal submucosal dissection (ESD) in the upper GI tract of a patient;

[0074] Figs. 23 through 29 illustrate the operative steps of a robotically assisted endoluminal sleeve gastroplasty (ESG) procedure;

[0075] Fig. 30 illustrates the performance of a robotically assisted trans-oral endoluminal fundopli cation or endoluminal GERD procedure;

[0076] Figs. 31 through 37 illustrate the operative steps of a robotically assisted bariatric endoluminal antral myotomy (BEAM) procedure;

[0077] Figs. 38 through 43 illustrate the operative steps of a robotically assisted peroral endoluminal myotomy (POEM) procedure;

[0078] Figs. 45 through 57 illustrate the operative steps of a robotically assisted endoluminal gastroplasty with endoscopic myotomy (GEM) procedure;

[0079] Fig. 58 illustrates a robotically assisted trans-vaginal hysterectomy in accordance with the subject disclosure; and

[0080] Fig. 59 illustrates a robotically assisted trans-vaginal oophorectomy in accordance with the subject disclosure.DETAILED DESCRIPTION OF THE INVENTION

[0081] Reference will now be made to the drawings wherein like reference numerals identify similar structural features or aspects of the subject disclosure.

[0082] Robotic Surgical Systems

[0083] For purposes of explanation and illustration, and not limitation, a schematic diagram of an exemplary embodiment of a robotic surgical system 100 in accordance with the invention is illustrated in Figure 1, along with certain ancillary devices, as will be described below. Included with the system 100 are a patient cart 110, including asteerable overtube 140 attached thereto, a physician console 120. The patient cart 110 includes two hand control devices 121a, 121b, one or more foot controls such as foot pedals 123, 124 and a display screen 125. A patient bed 180 and one or more optional ancillary equipment carts, such as vision tower 190 are also illustrated.

[0084] In accordance with the illustrated embodiment, a system cable 1 is provided to connect and facilitate data transfer between the physician console 120 and patient cart 110, while electrical power is provided separately by respective power cables 10 and 6. The system cable 1 enables bidirectional communication by transferring control signals to and from the patient cart 110 and video data to the physician console, as well as other feedback signals, including position feedback signals of system components, and status and error messages. One or more video cable(s) 2 can be provided for one or more accessory display(s), if desired. Image data is transferred from a videoscope (726, Fig. 7) by videoscope cable 7 to the patient cart 110 for encoding and transmission to the physician console 120. A camera control unit can also be provided if needed to support operation of the videoscope and signal transmission therefrom.

[0085] Ancillary surgical equipment can be provided, including a vision tower 190, which may include components such as a surgical insufflator 3, and an electrosurgical unit 4, which may interface with one or more ports on the steerable overtube 140 by insufflation tubing 8, and connect to robotic electrosurgical instruments through appropriate cabling, respectively. Further, the electrosurgical unit 4 can be provided and controlled by way of an energy activation cable 5 to the patient cart 110 for pass-through control from the physician console 120, the electrosurgical unit 4 also connecting to a robotic electrosurgical instrument by way of an instrument cable 9. Additional items, including anesthesia equipment 11 and one or more sterile tables 12 can be provided. The sterile table(s) 12 can hold accessories, components or instruments for the subject system 100 that may be needed during a procedure, as well as other supplies.

[0086] Additionally illustrated are a physician or operator 21 (which terms are used interchangeably herein) seated at the physician console 120, an assistant 22, which can be a sterile assistant tasked primarily with monitoring the patient cart 110, handling accessories and removing and installing instruments, as needed, and a circulatingassistant 23. Further medical professionals, such as an anesthesiologist, can also be present and interact with the system 100.

[0087] Physician Console and Patient Cart

[0088] With reference now to Figure 2A, an isometric view of an example embodiment of a physician console 120 is shown. The hand control devices 121a, 121b, and display screen 125 are clearly shown, along with foot controls 123, 124. The foot controls (e.g., foot pedals 123, 124 and 126) are provided for control of system functions, including selecting system components to be controlled by the respective hand control devices 121a, 121b, and / or for control of ancillary equipment, such as the electrosurgical unit 4.

[0089] Figures 2B and 2C illustrate detailed views of the hand control devices 121a, 121b for the physician console 120. An operator or physician (e.g., surgeon) uses the hand control devices 121a, 121b of the physician console 120 to control various aspects of the system, including a manipulable videoscope, surgical instruments, and a steerable overtube 140. The steerable overtube 140 is an access port through which robotic surgical instruments and the videoscope of the subject systems pass to reach a surgical site, and which will be described in more detail below. A physician 21 or operator grips handle portions 226 of each of the left and right hand control devices 121a, 121b. The handle portions 226 include finger grip controls 229 which pivot with respect to a body of the handle portion 226. Under normal operation, the finger grip controls 229 control operation of end effectors of corresponding surgical instruments. A finger clutch button 227 is also provided, which allows a user to temporarily disengage the functionality of the respective hand control device to allow repositioning of the hand control devices 121a, 121b, without causing movement of a corresponding instrument itself. The handle portions 226 are rotatable about their own axes, which movement during normal operation causes rotation of a corresponding surgical instrument about its own axis. The handle portions 226 are translatable and in 3 dimensions — vertically (up, down), laterally (left, right), forward (distally), backward (proximally), or combinations thereof. The handle portions 226 are also bendable vertically (e.g., about the y-axis) and laterally (e.g., about the z-axis), and rotatable about their own axis 228. These movements are interpreted by the subject systems as corresponding movements of surgical instruments orother system components, such as the steerable overtube or videoscope, depending on the mode selected, and as will be described in further detail below. In some embodiments, the subject system can include a mode selection mechanism that allows the physician to toggle between different control targets, such as surgical instruments, the steerable overtube 140, and the videoscope 726. Mode switching can be accomplished via dedicated buttons or foot controls, enabling intuitive hands-free operation. Upon mode selection, the system can reconfigure input interpretation from the hand control devices 121a, 121b to control the selected subsystem. For example, in "videoscope mode," hand controller movements are interpreted as camera orientation commands, whereas in "instrument mode," the same motions control the associated instruments and end effectors. Visual or auditory feedback may be provided to confirm mode transitions.

[0090] Figure 3 A and Figure 3B are isometric views of an example embodiments of patient carts 110 and 310 of robotic surgical systems in accordance with the invention. Among various features, the patient cart 110, 310 can house one or more controllers, such as a system controller 150 for coordinating all the functions of the system, including receipt of instructions, signal processing and commanding actuators to operate. System controller functions can be distributed across multiple controllers housed respectively in different components, including in the physician console 120. The patient carts 110, 310 are positionable and adjustable in 3-dimensions in order to allow orientation in a position suitable for the particular access route for the surgery being performed. For example, a transesophageal approach requires a position slightly above the patient, and angled downwardly, while other surgical approaches require different positioning of the patient cart 110, 310.

[0091] With reference to Figure 3A, a steerable overtube axis 396 is defined by the steerable overtube 140, and thus also with respect to the central drive unit 413. The central drive unit 413 includes various robotic actuators and is described in more detail below in connection with Figures 4A-4C. The steerable overtube 140 is connectable to and detachable from a robotic overtube controller 170, and thus is translatable along the steerable overtube axis 396 through motorized adjustment of a translation stage 385. The steerable overtube 140 is also rotatable about the same axis 396 through adjustment of a motorized roll joint 386. A vertical axis 398 is defined through the patient cart 110.Vertical translation along the vertical axis 398 is effected through adjustment of a motorized elevation stage 382, while rotation about the vertical axis 398 is effected through adjustment of a motorized yaw joint 383. Pitch adjustment about pitch axis 392 is effected through adjustment of a motorized pitch joint 384. Further horizontal adjustments can also be made by movement of the base 380 and therefore the entire patient cart 110. Such movements can include motorized assistance or be purely manual.

[0092] With reference to Figure 3B, a steerable overtube axis 396b is defined by the steerable overtube 140, and thus also with respect to the central drive unit 413. The steerable overtube 140 is connectable to a robotic overtube controller 170, and thus is translatable along the steerable overtube axis 396b through motorized adjustment of a translation stage 385b. The steerable overtube 140 is also rotatable about the same axis 396b through adjustment of a motorized roll joint 386b. A vertical axis 398b is defined through the patient cart 310. Vertical translation along the vertical axis 398b is effected through adjustment of a motorized elevation stage 382b, while rotation about the vertical axis 398b is effected through adjustment of the cart base 380b by casters 381. Pitch adjustment about pitch axis 392b is effected through adjustment of a motorized pitch joint 384b.

[0093] Central Drive Unit

[0094] Figure 4A illustrates an example embodiment of a central drive unit 413 in accordance with the invention. The central drive unit 413 includes instrument controllers 420, each illustrated with respective sanitary drape adapters 424. Also illustrated is a videoscope controller 430 with its respective drape adapter 434. The drape adapters 424, 434 are detachable from their respective controllers to facilitate sterilization and the placement for draping material over the central drive unit 413. An overtube arm 480 extends distally from the central drive unit 413 and provides a point to attach the steerable overtube 140, thereby enabling control of its robotic steering functions. The robotic steering functions are accomplished through actuators of an overtube controller 170 housed in the overtube arm 480. In certain embodiments, the overtube arm 480 is static relative to the central drive unit 413. Rotation, translation and other spatialpositioning thereof can therefore be accomplished by movement of the entire central drive unit 413.

[0095] The overtube arm 480, along with its corresponding robotic controller 170, serves as the attachment interface and driver of bending or flexural motion of the overtube 140. The flexural motion is controlled by the physician or operator at the physician console 120 with two degrees of freedom (left / right and up / down) via the system controller 150 and robotic overtube controller 170. Docking of the overtube 140 to the overtube controller is achieved by aligning and engaging the overtube hub 510 (the proximal control end and connection interface, Fig. 5 A) with the overtube controller 170. When the overtube 140 engages with the overtube controller 170, the user may observe feedback, such as a change in visual indicator 482 on the overtube arm 480 to a green color for confirmation of complete connection, if so embodied.

[0096] Instrument Controllers and Videoscope Controller

[0097] Figure 4B is an isometric view of one example of an instrument controller 420 in accordance with the present invention. The instrument controller has a plurality of linear actuators 454, corresponding to each of a plurality of pushing couplings 474. However, for simplicity, only one linear actuator 454 is illustrated. A drape adapter 424 is also illustrated on the distal end of the instrument controller 420 and interfaces between the instrument controller 420 and an instrument, allowing for mechanical passthrough of linear driving force of each of the linear actuators while maintaining a sterile barrier by virtue of being removable and sterilizable, and also by being adapted and configured to secure a sterile drape to the patient cart 110.

[0098] Each of the plurality of linear actuators 454 (by way of the pushing couplings 474 of the drape adapter 424, if so embodied) actuates respective pushing actuators 601 of a reverse motion mechanism 609 of a transmission system 600 of a respective surgical instrument 690 (e.g., Fig. 6D). Such linear actuators 454 can include lead screw mechanisms or other linear motion devices.

[0099] In accordance with one example, in order to actuate individual reverse motion mechanisms 609, and corresponding control wires 603 coupled to instrument bending joints 673, 675 or an end effector 671 (e.g., Figs 6B-6D), individual linear actuators 454dedicated respectively thereto are arranged in connection with a supportive structure and / or housing 456. In one example embodiment, each linear actuator 454 includes a lead screw housing physically connected to and grounded against rotation and axial movement by the supportive structure or housing, a motor, a threaded shaft configured with outer threads thereon, and a connecting bracket having a first connector portion and / or other ancillary components. The first connector portion can have internal threads into which the threaded shaft extends. An extension member can be provided and can extend distally therefrom in a direction away from a corresponding motor. Thus, linear pushing force is output from each linear actuator 454 through pushing couplings 474 to respective pushing actuators 601 of a reverse motion mechanism 609 of an instrument 690. As illustrated, ten linear push couplings 474 are provided on the drape adapter 424, corresponding, respectively, to ten linear actuators 454. Each actuator 454 is adapted to impart pushing force on a respective pushing actuator 601 of a corresponding reverse motion mechanism 600 (e.g., Fig. 6D), and is controlled to do so in response to system commands generated by the system controller 150.

[0100] Additionally, the instrument controller 420 imparts axial translation 410 and rotation 402, 404 about a central axis 444 on instruments (e.g., 690) by way of additional, respective actuators. Such actuators move the linear actuators 454, the drape adapter 424 and instruments (e.g., 690) in unison, when controlled to do so in response to system commands generated by the system controller 150.

[0101] Similarly to the instrument controller 420, the videoscope controller 430 includes a plurality of individual linear actuators (e.g., 454) dedicated respectively to actuate individual reverse motion mechanisms (e.g., 609) and corresponding control wires (e.g., 603), coupled to instrument bending joints. With reference to Figure 7, the videoscope 726 can be embodied to include two degrees of freedom in bending, as well as freedom in axial translation and rotation about that axis, imparted by the videoscope controller 430. The bending allows the videoscope 726 to deploy from its respective channel and extend radially outward, and away from a central axis to illuminate and facilitate a wider viewing angle of the operative site with improved perspective. In the illustrated embodiment, each of the two bending sections of the videoscope 726 utilizes two control wires, two respective reverse motion mechanisms and two linear actuators 454, therebyrequiring four linear actuators and other corresponding components. In an alternate embodiments, additional degrees of freedom in bending can be provided to the videoscope (as with the instruments), thereby requiring additional linear actuators 454, reverse motion mechanisms 609 and control wires 603. The subject systems can be embodied to provide a videoscope controller 430 that is mechanically identical to the instrument controllers but configured or controlled only to actuate the linear actuators 454 required. Such embodiments can advantageously be adapted to interface with a third surgical instrument (e.g., 690), in place of a videoscope, providing visualization by alternative means, as through a separate endoscope.

[0102] As with the instrument controller 420, the videoscope controller 430 imparts axial translation and rotation on the videoscope (e.g., 726) by way of additional, respective actuators. Such actuators move the linear actuators 454, the drape adapter 434 and videoscope in unison, when controlled to do so in response to system commands generated by the system controller 150.

[0103] As described in connection with an overtube control mode, in accordance with one embodiment, movements of the videoscope 726 are controlled by a physician or operator through one or both hand control devices 121a, 121b. In accordance with one embodiment, the movements of the videoscope 726 are controlled by the right hand control device 121b following activation of a mode control switch. In accordance with one embodiment, a videoscope control mode switch can be provided among the foot pedals 123 of the physician console 120, or elsewhere on the physician console 120, and can be included in a GUI thereof.

[0104] Steerable Overtube Controller

[0105] Figure 4C is a detailed view illustrating the overtube arm 480 including the robotic overtube controller 170, which, is embodied as a component of the central drive unit 413, in accordance with an exemplary aspect of the present invention. The robotic overtube controller 170 is adapted to engage and robotically steer the steerable overtube 140 in response to system commands generated by the system controller 150. A sterile drape adapter (not shown), along with a drape material affixed thereto can be provided to ensure a sterile operating environment. The robotic overtube controller 170 includes aplurality of couplers or “drive dogs” 484a, 484b for securely engaging an interfacing portion of the steerable overtube 140. The drive dogs 484a, 484b are operably connected to and driven by respective mechanical actuators housed with in the overtube controller 170. The actuators, in turn, receive instructions from the physician console 120 by way of one or more controllers, such as system controller 150. The actuators for the drive dogs 484a, 484b can be servomotors or alternative actuators that allow for precise control. The drive dogs 484a, 484b interface with first and second robotic actuator interfaces 584a, 584b provided on the hub 510 (Fig. 5D). In this manner, actuators within the robotic overtube controller 170 become operably connected to mechanical steering portions of the steerable overtube 140.

[0106] Steerable Overtube

[0107] With reference to Figure 5A, an isometric view of the steerable overtube 140 of the subject robotic surgical systems is illustrated. The steerable overtube 140 includes a hub 510 for interfacing the steerable overtube 140 with a patient cart 110 of a robotic surgical system 100. The hub 510 also provides access to working channels (e.g., for inserting instruments and other accessories), as well as manual control handles 511 for operating the bending of the steerable portion 541 thereof when not engaged with the patient cart 121 of the robotic surgical system 100. As illustrated in this exemplary embodiment, a flexible portion 543 is provided between the hub 510 at the proximal end portion of the steerable overtube 140 and the distal end of the steerable portion 541 thereof.

[0108] In accordance with the illustrated embodiment, the hub 510 includes multiple ports for introducing or connecting surgical instruments and other functional surgical devices, such as insufflation, irrigation, suction, smoke removal equipment, introduction and / or removal of suture material and needles, specimen retrieval tools, and the like. On its lower surface, various functional features are included for engaging with a robotic overtube controller 170 (which itself will be described in more detail below in connection with subsequent figures). Among these features are first and second robotic actuator interfaces 584a, 584b for engaging corresponding drive dogs 484a, 484b of the robotic overtube controller 170.

[0109] As illustrated, the steerable overtube 140 is steerable in two planes (e.g., pitch (up / down plane) and yaw (left / right plane), and combination of motion in these planes). A manual actuator 511 is provided in the illustrated embodiment and includes coaxial dual knob manual control. The first and second robotic actuator interfaces 584a, 584b are configured to mate with drive dogs 484a, 484b of the overtube controller 170 of the patient cart 120. Therefore, both manual and robotic steering control are possible. The hub 510 can include access channels connected to each working channel 591a, 591b, 592, 593a, 593b, 595 (Fig. 5C) to allow insertion of instruments, materials or supplies into each working channel. Figure 5B illustrates a distal end portion of the steerable overtube 140 in a flexed state, bent toward the left (in x-y plane) by angle cp (phi). Although illustrated as approximately a 90-degree bend, it is to be understood that the distal steerable portion 541 of the steerable overtube 140 can bend up, down, left, right or combinations of such bends to a degree up to and beyond 180-degrees.

[0110] With reference to Figure 5C, there is illustrated cross-sectional view of a flexible shaft 543 of the steerable overtube of Fig. 5 A illustrating various working channels, including primary instrument channels 591a, 591b. All working channels can advantageously be used for more than one function. For example, the primary instrument channels 591a, 591b can be used for robotically controlled surgical instruments (e.g., 690, Fig. 6A), and also repurposed for manual instruments and specimen retrieval, for example. A videoscope channel 592 is provided in an upper middle portion of the body of the steerable overtube 140 for a videoscope (e.g., videoscope 726, Fig. 7), which similarly can be repurposed for manual instruments, additional robotic instruments, or for other purposes. Additionally, insufflation channels 593a, 593b are provided to permit fluid communication between the insufflator 3 (Fig. 1) and the operative space. One or more channels can be used for irrigation, suction and / or smoke removal, if desired. An accessory channel 595 is also provided, which can permit introduction of additional surgical instruments or materials (e.g., needle, suture material) while the primary instrument channels 591a, 591b are utilized, typically each by robotic surgical instruments 690.

[0111] Also illustrated in the cross-sectional view of Figure 5C are control wires 594a, 594b, 594c, 594d operably connected between the distal steerable portion 541 and thesteering mechanism in the hub 510. The steering mechanism applies tension to the control wires 594a-d to manipulate the bendable portion 541. In accordance with a preferred embodiment, the steering mechanism is operable both manually by way of handles 511 and by way of the robotic actuator interfaces 584a, 584b, best seen in the bottom view of Figure 5D. In that manner, robotic control of overtube bending can be initiated at the physician console 120, commands being processed by the controller 150 and sent to the overtube controller 170.

[0112] Robotic Assisted Control

[0113] Gross Positioning

[0114] Gross positioning of the steerable overtube 140 is accomplished by movements of the patient cart (e.g., 110) itself and adjustable elements thereof for supporting and positioning the central drive unit 413, while smaller adjustments of bending of the distal end portion of the steerable overtube 140 is accomplished through actuation of the overtube controller 170, which interfaces with the steering mechanism of the steerable overtube 140. In accordance with one embodiment, the steerable overtube 140 is advanced to a surgical site manually, under visualization (using manual knobs 511), and docked with the overtube controller 170 when at or near the surgical site. Compatible surgical instruments, as will be described in more detail below, are adapted to extend through working channels of the steerable overtube 140. Therefore, gross positioning (including translation, rotation and bending) of the distal end portions of the surgical instruments can be achieved by positioning the distal end of the steerable overtube 140. Fine control of instruments (axial and radial translation, rotation joint bending, end effector actuation) is controlled by the respective instrument controller 420, or in the case of a videoscope 726, by the videoscope controller 430.

[0115] Scaling

[0116] In all cases of gross and fine movement control of system components, processing of control signals by the system controller 150 can determine the scaling of control input to actuator output, which scaling can be preprogrammed, and / or input or adjusted by thephysician. For example, a scaling ratio of 1 : 1 (input : output) can account for an input across the full mechanical range of the hand control devices 121a, 121b, and map movements across the full mechanical range of each degree of freedom (joint bending, translation, rotation, end effector operational range). To reduce operator fatigue, the ratio can be increased (e.g., 1:2), whereby one unit of travel of a hand controller 121a, 121b results in more (e.g., 2) units of movement for each function of the instrument.Conversely, to allow for finer control, the ratio can be decreased (e.g., 2: 1), whereby two units of travel of a hand controller 121a, 121b results in fewer (e.g., 1) units of movement for each function of the instrument. Scaling ratios can be globally selected or independently selected for each degree of freedom. For example, rotational scaling can be increased to reduce stress on an operator's wrist, while maintaining or reducing scaling for other functions, such as lateral movement to enhance precision when required or desired.

[0117] Patient Cart Positioning

[0118] With reference to Fig. 3 A, the patient cart 110 is spatially positioned and adjusted so that the central drive unit 413 is in a location such that the robotic overtube controller 170 can engage the hub 510 of the steerable overtube 140 following initial placement of the steerable overtube 140, e.g., under manual control. The illustrated embodiment of a patient cart 110 includes multiple degrees of freedom to permit flexibility in positioning. That is, horizontal positioning, yaw, elevation, pitch, axial translation, and roll can all be adjusted through positioning of the patient cart 110, by movement of the patient cart base 380 and by adjustment of positioning actuators thereof, as described above in connection with Figure 3 A. Similar functions are facilitated by the patient cart 310 described above in connection with Figure 3B.

[0119] In accordance with certain embodiments, during a procedure, rotation about and axial translation along the overtube axis 396 can be controlled from the physician console 120. Accordingly, a translation stage (e.g., 385, 385b) actuator and roll joint (e.g., 386, 386b) actuator will be operable from the physician console 120 and effect corresponding movements of the entire steerable overtube 140, videoscope, any surgical instruments inserted therethrough, and the corresponding instrument controllers 420 and videoscopecontroller 430. Optionally, movements of other joints of the patient cart 110, 310 can be entirely blocked by the controller 150, such as when attachment of a steerable overtube 140 to the overtube controller 170 is detected.

[0120] Insertion of Overtube and Docking

[0121] In accordance with one aspect of the invention, during use, the steerable overtube 140 is manually navigated to an operative site (or a "working site" in non-medical applications) using manual control handles 511 to operate the bending portion 541 of the steerable overtube 140. The steerable overtube 140 is advanced under visualization, in conjunction with the videoscope 726 or separate endoscope, for example. Once the distal portion of the steerable overtube is positioned at the operative site, the hub 510 is connected to the robotic overtube controller 170 and the surgical procedure can continue under robotic control. One or more surgical instruments are inserted through the steerable overtube 140 and may be removed or exchanged during a procedure.

[0122] In accordance with one aspect of the invention, the first and second robotic actuator interface portions 584a, 584b of the hub 510 of the steerable overtube 140 are directly connected to the manual control handles 511 of the hub 510, and through the internal mechanism thereof also to the steering elements of the steerable overtube 140, such as control wires (e.g., 594a-594d).

[0123] Overtube Positioning

[0124] Following the above-described engagement, the steerable overtube 140 can be used under robotic control of the system 100 by way of the robotic overtube controller 170. More specifically, flexural motions (e.g., up, down, left, right) of the steerable portion 541 of the steerable overtube 140 are controlled by the robotic overtube controller 170, while translational movements (along longitudinal axis 396) and roll movements (about longitudinal axis 396) are facilitated by corresponding actuated joints of the patient cart 110, as described above. In certain embodiments, the robotic overtube controller 170, to which the steerable overtube 140 is securely engaged, is translated, or rotated in its entirety to effect translation or roll movements of the steerable overtube140. In certain embodiments, all instrument controllers and videoscope, also rotate or translate in unison, as enabled by the patient cart 110.

[0125] In accordance with one embodiment, movements of the steerable overtube 140 are controlled by a physician or operator through one or both hand control devices 121a, 121b. In accordance with one embodiment, the movements of the steerable overtube 140 are controlled by the left hand control device 121a following activation of a mode control switch. In accordance with one embodiment, an overtube control mode switch 126 is provided among the foot pedals 123 and 124 of the physician console 120.

[0126] In accordance with the illustrated embodiment, the overtube control mode switch 126 is depressed, and movements of a hand control device 121a, 121b (e.g., left hand control device 121a) are received by a controller, such as the system controller 150, processed and then output to respective actuators of the system 100 in order to effect the commanded movements. In accordance with one embodiment, forward (distal) / backward (proximal) movements of the hand control device 121a, 121b are interpreted by the controller 150 as axial translation commands. In accordance with one embodiment, rotation movements of the hand control device 121a, 121b are interpreted by the controller 150 as roll commands. In accordance with one embodiment, lateral (sideways - left / right) translation motions of the hand control device 121a, 121b are interpreted by the controller 150 as left / right flexural commands. Alternatively, in accordance with one embodiment, lateral (sideways- left / right) bending motions of the hand control device 121a, 121b (e.g., by flexion / extension of a user's wrist) are interpreted by the controller 150 as lateral (left / right) flexural commands. In accordance with one embodiment, vertical translation motions (up / down) of the hand control device 121a, 121b are interpreted by the controller 150 as up / down flexural commands. Alternatively, in accordance with one embodiment, vertical bending motions (up / down) of the hand control device 121a, 121b are interpreted by the controller 150 as up / down flexural commands.

[0127] Upon receipt of a flexural command from the hand control device 121a, 121b, the controller 150 determines the corresponding actuator action. It then commands the actuator operably connected to the drive dogs 484a, 484b to rotate either clockwise or counterclockwise. This in turn rotates the corresponding engagement portion 584a, 584bof the hub 510 of the steerable overtube 140. Internally to the hub 510, each engagement portion operates a mechanism corresponding to one of lateral (left / right) or vertical (up / down) flexural motion. Such mechanisms are configured to apply tension to control wires corresponding to their respective movements, such as by applying asymmetric tension to a bending joint by one or more control wires. A first engagement portion (e.g., 584a) and corresponding drive dog (e.g., 484a) therefore operate one of lateral (left / right) bending and vertical (up / down) bending, while a second engagement portion (e.g., 584b) and corresponding drive dog (e.g., 484b) operate bending in the remaining direction or plane. Accordingly, if all elements of the system 100, including the steerable overtube 140, its hub 510, and programming of the controller 150, are configured consistently, either drive dog 484a, 484b can be configured to operate bending in either plane.

[0128] In accordance with certain embodiments, bending inputs at the hand control devices 121a, 121b can be processed by the controller 150 prior to generating an output control signal. Among the processing functions that can be applied is a scaling process, as described above, by which a magnitude of input motion is correlated to a magnitude of output motion. Such scaling can be set to a default amount, or alternatively can be increased or decreased by the user to control more precisely corresponding movements of the steerable portion 541 of the steerable overtube 140.

[0129] Examples of System Control

[0130] The following nonlimiting examples are provided to illustrate control of bending of the steerable overtube 140 through interaction with the robotic overtube controller 170 and other elements of the system 100. For example, to bend the steerable portion 541 of the steerable overtube 140 left, an operator translates the left hand control device 121a to the left, which is output by the hand control device 121a as a control signal to the controller 150. The signal is processed to determine a corresponding direction and degree of rotation of the corresponding drive dog to achieve a determined amount of left bending of the steerable portion 541. The controller 150 signals the corresponding actuator to advance in the prescribed direction. Similarly, right translation of the hand control device 121a causes rotation of the drive dog and the actuator in the opposite direction, effecting right bending of the steerable portion 541. Upward and downward bending issimilarly achieved using the other drive dog and its corresponding actuator, responding to upward and downward translation of the hand control device 121a.

[0131] Instrument Fine Positioning

[0132] Instrument Fine Rotation

[0133] With reference to Figure 6A, in accordance with one embodiment, the instrument controller 420 and thus the surgical instrument 690 connected thereto are moveable in the axial direction 610 by movement of the housing 456 in the axial direction 610, by actuation of a designated actuator, which can be held in a further housing, of the central drive unit 413, for example. The instrument controller 420 is also rotatable about its central axis 444 by a designated actuator, such as one rotating a ring gear connected thereto. This allows controllable rotation of the surgical instrument 690, in either of opposed rotational directions 402, 404. The larger assembly of the central drive unit 413 is also controllably translated along or rotated about the overtube axis 396, such that housing 456 held therein will move about axis 396, along with any attached instrument 690.

[0134] With reference to Figs. 6B & 6C, cutaway views of a robotic instrument 690, incorporating a force transmission system 600 are illustrated and demonstrate movement of the reverse linkage 625 and control wires 603 in relation to articulation in one plane of a second (bending) joint 675 at the distal end of an elongate shaft 670 thereof. Also illustrated are a first bending joint 673 and an end effector 671. Although bending in one plane is illustrated in connection with one pair of antagonistic actuators, their respective reverse motion mechanisms and control wires, it is to be understood that bending at each joint, in each plane, and actuation of an end effector 671 (e.g., graspers, needle driver, scissors) also utilize respective pairs of antagonistic actuators, their respective reverse motion mechanisms and control wires. For example, the second bending joint 675 can be bent downward as illustrated, and also upward, by actuating the opposed control wire, or into or out of the page (not illustrated here), or a combination of those motions, which configuration uses four independent control wires and corresponding reverse motion mechanisms 609 (including reverse linkages 625 and pushing actuators 601) of the forcetransmission system 600. The first bending joint 673 is preferably provided with the capability of bending in two orthogonal planes, or a combination thereof (i.e., in 3- dimensions), which configuration uses an additional four independent control wires and reverse motion mechanisms 609 of the force transmission system 600. Likewise, opening and closing actuation of an end effector 671 utilizes two additional, respective independent control wires and reverse motion mechanisms 609 operating antagonistically to control precise positioning.

[0135] With reference to Figure 6D, a force transmission system 600 for a robotic instrument 690, which can be a surgical instrument or medical device, can include a pushing actuator 601 configured to be pushed by a linear actuator (e.g., 454) of a robotic instrument controller (e.g., 420 described in further detail herein in connection with Figs. 4B and 6A) and a control wire 603. The control wire 603 can include a first end 603a attached to a location 605a that moves with movement of the pushing actuator 601. The control wire 603 can include a second end 603b attached to a distal location 607 of the robotic instrument 690 (e.g., anchored within a steerable assembly to cause bending of a joint of the robotic instrument, or actuation of an end effector thereof).

[0136] The force transmission system 600 can include a reverse motion device or mechanism 609 that can be interfaced with the control wire 603 between the first end 603a and the second end 603b. The reverse motion device or mechanism 609 can be configured to cause a proximal pulling action on the second end 603b of the control wire 603 in response to distal pushing by the pushing actuator 601 on the first end 627 of the reverse linkage 625. The reverse motion device 609 can be configured to maintain a point of contact 611 with the control wire 603 in the same spatial location (e.g., a fixed point relative to the base 613 of the instrument adapter 680 of the robotic instrument) to prevent lateral (radial) wire motion due to actuation.

[0137] The reverse motion device 609 can be a reverse linkage 625 attached to the pushing actuator 601 on a first end 627 (e.g., at a first pin 629) and interfaced with a control wire 603 on the second end 631. The reverse linkage 625 can be rotatably mounted and axially fixed to a base 613 (e.g., at a pivot 643, such as by second pin 634, via frame 633). The second end 631 of the reverse linkage 625 can be or can include a curved contact surface 63 la to maintain the point of contact 611 with the control wire603 in the same spatial location (i.e., radial position, with respect to a central axis 444 of the robotic instrument 690) to prevent control wire motion due to actuation. Other configurations of a reverse actuation mechanism may also advantageously be utilized, in accordance with the invention.

[0138] In the illustrated embodiment, when urged by movement of a respective linear actuator 454, the pushing actuator 601 moves linearly (e.g., parallel to the central axis 444 of the instrument 290), while the portion of the reverse linkage 625 between the pivot 634 and the pin 629 rotates. Accordingly, devices of the present invention can be equipped with a sliding joint 660 to compensate for a changing radius between the pivot 643 and the pin 629 at the pushing actuator 601.

[0139] With reference to Fig 6E, various end effectors 671 are illustrated for use in connection with the subject surgical instruments 690. Among these end effectors 671 are pinching forceps 671a, monopolar cautery knife 671b, needle driver 671c, monopolar curved scissors 67 Id, rat tooth forceps 67 le, and Cadiere forceps 67 If Optionally, bipolar scissors, surgical staplers and suturing devices can also advantageously be provided in accordance with the systems of the present invention. Fine positioning of spatial orientation of the end effectors 671a-671f is accomplished by bending of the first joint 673 and second joint 675, while actuation of end effectors is also accomplished by a pair of designated reverse linkages 625 and control wires 603. Optionally, manual endoscopic surgical instruments can be utilized in connection with the present invention, alone or in combination with robotically controlled surgical instruments if required or desired.

[0140] Instrument Fine Axial Rotation

[0141] With reference to the flow diagram of Figure 8, in accordance with one embodiment, fine instrument rotation is achieved by a physician or operator rotating either of the hand control devices 121a or 121b corresponding to the instrument 690 either clockwise or counter-clockwise. The hand control device 121a or 121b generates a control input signal 810, which is input to the controller 150. The controller 150 processes the control input signal 810 and outputs a control output signal 820 directed to one or more rotation actuators of the instrument controller (e.g., a drive motor). In thismanner, rotation of the instrument controller 420 clockwise / counter-clockwise results in rotation of the instrument 690 correspondingly, relative to steerable overtube 140.

[0142] Instrument fine axial translation

[0143] In accordance with one embodiment, fine instrument translation of each instrument 690 is achieved by a physician or operator moving a corresponding hand control device 121a or 121b forward (distally from the operator) or backward (proximally toward the operator). The hand control device 121a or 121b generates a control input signal 810, which is input to the controller 150. The controller 150 processes the signal 810 and outputs a control output signal 820 directed to one or more axial translation actuators of the instrument controller. In one embodiment, the axial translation actuator includes a motor effecting translation of the instrument controller 420, as described above. In this manner, translation of instrument controller 420 moves the attached instrument 690 correspondingly relative to the steerable overtube 140.

[0144] Instrument fine bending

[0145] In accordance with one embodiment, fine instrument bending of one or more joints 673, 675 is achieved by a physician or operator rotating a corresponding hand control device 121a or 121b laterally, vertically or a combination thereof (left and up, right and up, right and down, left and down), such as by the operator flexing their wrist. The hand control device 121a or 121b generates a control input signal 810, which is input to the controller 150. The controller 150 processes the signal 810 and outputs a control output signal 820 directed to the one or more linear actuators (e.g., a lead screw mechanism) of the instrument controller 420. For a bend of one joint in one plane, one corresponding actuator is driven distally to provide pushing force to a corresponding reverse motion device 609 and its control wire 603, corresponding to the desired directional bend of the desired joint. Optionally, an antagonistic control wire 603 is additionally similarly tensioned to a predetermined complementary degree to stabilize the joint position. Similarly, for a bend of one joint in two planes, two corresponding actuators are driven distally, corresponding to the desired directional bend of the desiredjoint. Optionally, antagonistic control wires 603 are additionally similarly tensioned to a predetermined complementary degree to stabilize the joint position in two planes.

[0146] In accordance with some embodiments, the controller 150 programmatically interprets the above-described rotational input to effect corresponding bending at the instrument second (distal) joint 675. Alternatively, in accordance with some embodiments, this rotational input is programmatically interpreted by the controller 150 so as to effect corresponding bending at the instrument first (proximal) j oint 673. Alternatively still, in accordance with some embodiments, this rotational input is programmatically interpreted by the controller 150 so as to effect corresponding bending at the instrument first (proximal) j oint 673 and second (distal) joint 675. Optionally, such extreme bending can be undertaken when a large degree of bending input is sensed by the hand control device 121a, 121b. Alternatively, such additional bending can be triggered by the operator, such as through operator input, which can be offered through a user interface such as a mechanical button or a graphical user interface and / or in a settings menu.

[0147] Example of Instrument Bending

[0148] To bend the end effector 671 to the left, a first (proximal) joint 673 is controlled to bend left. If so embodied, a second (distal) joint 675 can alternatively or additionally be controlled to bend left. Accordingly, either one control wire 603 corresponding to a single joint action, or two control wires 603 corresponding respectively to two joint actions, are placed under tension, as described above. Optionally tensioning of antagonistic control wires 603 can be implemented, as described above.

[0149] Instrument fine radial translation

[0150] As illustrated in Figure 7, the surgical instruments 690a, 690b are deployable from the steerable overtube 140, at which point they can be controlled to translate laterally to work more easily in the operative space. To provide a useful working arrangement of the end effectors 671 of the subject instruments 690, the first joint 673 and second joint 675 can be actuated in unison to displace the end effector 671 radially outwardly. Such configuration allows multiple instruments 690 to work jointly on a task(e.g., grasping by one instrument and cutting by the other instrument), all while viewed through a videoscope 726.

[0151] Therefore, and in accordance with one embodiment, the foregoing is achieved by translation by an operator of the hand control devices 121a or 121b corresponding to the instrument 690 (e.g., left, right, up, down). Optionally, a combination bend (e.g., left and up, right and up, right and down, left and down) can also be accommodated by the subject devices. Alternatively, lateral deployment can be implemented by the subject systems automatically as the instruments are advanced axially.

[0152] With reference to Figure 8, as illustrated in the block diagram 800 of an example control system in accordance with the invention, the hand control devices 121a and 121b generate control input signals 810, which are input to the controller 150. The controller 150 processes the control input signal 810 and outputs a control output signal 820 directed to the corresponding linear actuators, causing the linear actuators to drive distally. Linear pushing force is transferred to the respective reverse motion mechanism 609, which converts pushing force into tensile force in the corresponding control wire 603. In turn, this force effects the prescribed bends required by the desired translation- either two control wires 603 are actuated, corresponding to bending of each of the first joint 673 and second joint 675 in one plane, or four wires 603 are actuated, corresponding to bending of each of the first joint 673 and second joint 675 in two planes. As described above, antagonistic wires 603 for each degree of freedom can additionally be tensioned to stabilize that joint. In this latter case, this means that eight wires 603, reverse motion mechanisms 609 and actuators 454 are employed for the complex movement. Additionally, bending of each joint in one plane can be coupled with axial rotation and translation (i.e., about axis 444, described above).

[0153] With continued reference to Fig. 7, a distal isometric view of a distal end portion of a steerable overtube 140 in accordance with the invention is illustrated. An outer sheath 722 encloses two instruments 690a, 690b and a videoscope 726, each of which is extendable from a cap 724 having openings defined therein through which the instruments 690a, 690b and videoscope 726 are selectively extendable. As illustrated, the distal ends of the instruments 690a, 690b extend outwardly of the cap 724, and thus the first joint 673 and second joint 675 of each instrument 690a, 690b are positionedoutwardly of the outer sheath 722. The end of the videoscope 726 is likewise extended outwardly of the cap 724 and thus of the sheath 722.

[0154] If the instrument controller 420 is rotated in the directions 402, 404 (Fig. 4B) about its centerline 444, the distal ends of the instruments 690a, 690b likewise rotate at the cap 724 in directions 702, 704. If the first joint 673 and second joint 675 are straight (not bent) and the end effector 671 is therefore colinear with the whole instrument 690a, 690b, it will likewise rotate about its own centerline of the axial direction 644 (Fig. 7) in directions 702, 704. However, as the first joint 673 and second joint 675 of each instrument 690a, 690b are bendable by selective pulling of control wires 603, the centerline 728 of the end effector 671 and the centerline of the distal end of the instruments 690a, 690b can be controllably offset from each other by a single angle when one of the first joint 673 and second joint 675 bend, or a compound double angle when both the first joint 673 and second joint 675 bend.

[0155] Instrument Control in General

[0156] Additionally, as discussed above, the overtube 140 and thus the instruments 690a, 690b and the videoscope 726 therein can be advanced or retracted along and rotated about axis 396 (Fig. 3A) and thus rotate in directions 730, 732. Additionally, each instrument 690a, 690b, and thus the end effector 671 attached thereto, is independently moveable in the axial direction 644 by independent movement of the instrument controller 420 to which it is coupled, in translation directions 410. Accordingly, a physician can position the distal end (i.e., the cap 724 end) of the steerable overtube 140 in a desired working area or operative space (e.g., a location in a body lumen), and then with the videoscope 726 view the operative space, including the end effectors 671. Because each of the first joint 673 and second joint 675 are independently bendable in two orthogonal planes, and the overtube 140 is rotatable about axis 396, the end effector 671 can be positioned in a multitude of orientations in the operative space.

[0157] That is, each of the instruments 690a, 690b, benefit from many degrees of freedom, including translation (along the axis of the axial direction 644), rotation (about the axis of the axial direction 644 in opposing directions 702, 704) and 4-way-bending at each of two joints 673 and 675. In combination with gross positioning afforded by thesteerable overtube 140, this allows the physician or operator to reach difficult locations to successfully complete delicate and complex tasks. The large degree of freedom afforded to the end effectors 671 by way of the first joint 673 and second joint 675 allow triangulation of the end effectors 671 in order to perform tasks in a natural fashion while monitoring progress through the videoscope 726, the image of which is transmitted through the system 100 (e.g., by system cable 1) to the display 125.

[0158] Each of the four bending directions at each of the joints 673, 675, along with each of an open and close motion of the end effectors 671 is designated a control wire 603, which is actuated through applied tension via the above-described reverse motion mechanisms 609 as part of a force transmission system 600. In turn, each reverse motion mechanism 609 is actuated by a designated linear actuator 454 of an instrument controller 420. Optionally, one or more adapters, such as sterile drape adapters 424 or other interface can be applied between the instrument controller 420 and the instrument 690.

[0159] The linear actuators 454 are selectively controlled by the control output signals 820 from a controller 150 to effect the desired motion of the instrument 690. The controller 150 generates the control output signals 820 in response to control input signals 810 from the physician console 120. The control input signals 810 are processed by the controller 150 to interpret command inputs, including change of position of a corresponding hand control device 121a, 121b of the console 120. Processing of the control input signal 810 can include a scaling function, which can be adjustable by the physician. If desired the processing can also include filtering or smoothing of a control input signal 810 to remove unintentional or undesired motion, such as small involuntary movements e.g., shaking), or sudden and / or large movements, which may indicate an error (e.g., accidental bumping of a controller).

[0160] The controller 150 may be embodied as hardware and / or software, but regardless is referred to herein as a controller, control module and / or system controller. A single physical or software controller can be provided to control all aspects or the system, or alternatively multiple physical or software controllers, such as master controllers and slave controllers can be provided, for example. Accordingly, computer executable code performing the functions of the block diagram 800 of Figure 8, and / or other system functions is also encompassed by the present disclosure.

[0161] As discussed above, gross positioning of the steerable overtube 140 is accomplished by movements of the patient cart 110 itself and adjustable elements thereof for supporting and positioning the central drive unit 413, particularly axial translation and axial rotation (roll). Smaller adjustments of bending of the distal end portion of the steerable overtube 140 are accomplished through actuation of the overtube controller 170, which interfaces with the bending mechanism of the steerable overtube 140. The subject instruments 690a, 690b are adapted to extend through working channels of the steerable overtube 140 and therefore gross positioning (including translation, rotation and bending) of the distal end portions of the surgical instruments 690a, 690b is achieved by positioning the distal end of the steerable overtube 140.

[0162] In all cases, processing of control signals by the controller 150 can include scaling of control input to actuator output, which scaling can be preprogrammed, and / or input or adjusted by an operator.

[0163] In all cases of the described antagonistic control mechanisms, even though one actuator may be activated to perform a bending or actuation function, an opposed actuator can be driven to a position in order to maintain force applied to the opposing reverse motion device 609 and cable 603 in order to stabilize a desired degree of bending (of a joint) or actuation (of an end effector).

[0164] Examples of Radial Translation

[0165] To translate left, a first (proximal) joint 673 is controlled to bend left, while the second (distal) joint 675 is controlled to bend right, to compensate for the bending of the first joint while allowing the end effector 671 to shift left. Accordingly, at least two control wires 603 - one corresponding to each of the actions of the respective joint are placed under tension, as described above. Opposing antagonistic control wires 603 can also be placed under a degree of tension to stabilize the joint.

[0166] To translate to the upper right, a first (proximal) j oint 673 is controlled to bend up and to the right, while the second (distal) joint 675 is controlled to bend down and to the left, thereby counteracting the directional change of the end effector 671 by the bending of the first joint 673 and resulting only in a translation of the end effector 671. In this example, at least four control wires 603 - one corresponding to each of the actions of therespective joints are placed under tension, as described above - that is, in the case of a compound movement (e.g., up & right or down and left), two control wires 603 are used- one for bending in each plane.

[0167] Instrument End Effector Actuation

[0168] Not every instrument 690 is necessarily embodied with an active (i.e., operable) end effector 671, such as a forceps, grasper, needle driver or scissors, but may instead include an end effector including a hook or static blade, for example. In accordance with one embodiment, if the end effector 671 is operable (e.g., operable grasper jaws), actuation is accomplished by way of actuation of a handpiece gripper 226 by a physician's or operator's fingers, as best seen in Figure 2B. A finger or grip control 229 of the hand control device 121a, 121b is moved to a position corresponding to open or closed position of end effectors 671, or a point therebetween. The hand control device 121a or 121b generates a control input signal 810, which is input to the controller 150. The controller 150 processes the input signal 810 and outputs a control output signal 820 directed to the corresponding linear actuator 454 either corresponding to an opening direction or a closing direction of the end effector 671.

[0169] Thereafter, the respective linear actuator 454 of the instrument controller 420 drives distally. Linear pushing force is transferred to the respective reverse motion mechanism 609 of the connected instrument 690, which converts pushing force into tensile force in the corresponding control wire 603. In turn, this force is transferred to the end effector 671 where the end effector mechanism is operably engaged with the control wire 603.

[0170] Alternatively, if the end effector 671 is static, the control wires 603 that would have been utilized to operate the end effector can instead be utilized to effect movement of an additional degree of freedom, such as an extra bending joint to impart additional flexibility and versatility. In accordance with certain embodiments, the controller 150 is adapted to recognize the presence of an instrument's specific functionality, and then map control for those functions programmatically to respective linear actuators 454 for those functions. In cases of such alternative or additional functions, control inputs from a physician or operator can be prompted through an existing mechanical / tactile interfaceby a mode switching input (button, pedal, GUI), or can be provided with alternate inputs, such as voice recognition.

[0171] Superposition of Commands and Movements

[0172] Control inputs can be interpreted by the subject systems and superimposed to effect complex movements simultaneously. For example, as described above, a radially outward translation command actuates bending of multiple joints from a neutral home position to a laterally displaced home position, at which position further bending commands can be instructed. As such, the commanded positioning of respective linear actuators 454 due to bending commands can be superimposed on the already-commanded linear actuator positions to accomplish the outward translation command. That is, although joints 673, 675 are bent due to outward translation of the end effector 671, further reorientation of the end effector 671 may require additional bending. Similarly, an initial orientation (e.g., pointed distally) of the end effector 671 can be maintained when translating end effector to radially outward location.

[0173] Instrument Identification & Control Mapping

[0174] When connecting an instrument 690 to the robotic instrument controller 420, an instrument identification process can be initiated by the controller 150 upon connection of the instrument 690 with the instrument controller 420. Alternatively, instrument identification can be performed manually by a physician or other user.

[0175] Such information can include an identifier, instrument type, calibration data, prior use data or the like. Alternatively or additionally, the information can be simply a unique identifier for which the controller 150 searches a local or remote database to retrieve relevant data. Subsequently the controller 150 can map an individual linear actuator 454 to corresponding reverse motion mechanism 609, and in that manner, by control wire 603 to the specific function thereof (bending joint e.g., 673, 675 and bend direction (e.g., up, down, left, right) or end effector 671 movement (e.g., open / close)). The controller 150, also mapping the input control signals from a hand control device 121a, 121b to a function (e.g., bend up, close end effector) therefore can map the input command to the appropriate linear actuator 454 to achieve the desired function.

[0176] Surgical MethodsThe above-described systems, devices and methods, including control methods, are advantageously applied to various surgical procedures and methods, as described below. It should be understood that procedural steps described in connection with one method below can be performed in the same way as similar procedural steps in other methods described below, including the particular instrumentation and materials used.

[0177] Lower Gastrointestinal Endoluminal Submucosal Dissection

[0178] Referring now to the drawings, Figs. 9 through 15 illustrate a new and useful method of performing a robotically assisted endoluminal submucosal dissection (ESD) procedure on a patient 910. More particularly, this robotically assisted ESD procedure is performed within the lower gastrointestinal (GI) tract of the patient 910, up to the reach of the endoluminal robot. This procedure targets benign lesions and early superficial cancers that involve the mucosa and / or submucosa of the GI tract. These lesions can be close to muscle tissue and can be difficult to remove completely intact with other methods.

[0179] With reference to Fig. 9, this method of the subject disclosure includes the initial step of positioning the patient for lower gastrointestinal lesions in a supine position with the patient's legs separated, flexed and supported in stirrups (patient could also be in a lateral decubitus position). The patient cart 110 is oriented at an end of the patient bed 180, and directed cranially with respect to the patient for a favorable anatomical approach. The steerable overtube assembly 140 is introduced into the lower (GI) tract 1011 of the patient and advanced to the site of a lesion 1025 within the GI tract. The flexible and steerable overtube assembly 140 is of the type disclosed above in connection with Figures 5A-5D, and the robotic surgical device or patient cart 110, 310 is a patient cart with a multi-axis positioning system of the type disclosed above in connection with Figures 3A & 3B.

[0180] In one embodiment, the steerable overtube 140 is manually introduced into the lower (GI) tract 1011 (z.e., transanally) and advanced into the operative site under visualization by the videoscope 726 or endoscope inserted in a respective workingchannel of the steerable overtube 140. The steerable overtube 140 may either be inserted directly into the anus or through a transanal access device intermediary placed in the patient’s anus or anorectal canal. Thereafter, the steerable overtube 140 is docked to the overtube controller 170 of the patient cart 110 to enable robotic control of steering, axial translation and rotation as needed. In another embodiment, the steerable overtube 140 is docked to the overtube controller 170 prior to introduction into the lower (GI) tract 1011, and is advanced to the operative site under robotic control and visualization by the videoscope 726. Advancement of the steerable overtube 140 is carried out through operation of the translation stage 385, 385b, and controlled by a hand controller 121a, 121b after switching the system to an overtube control mode, which in one aspect can be accomplished by depressing a designated foot pedal (e. ., 124). Similarly, roll (axial rotation) is effected with movement of the roll joint 386, 386b, and steering is effected by the overtube controller 170, and controlled by a hand controller 121a, 121b when in overtube control mode.

[0181] When at least the distal portion of the steerable overtube 140 is within the lower (GI) tract 1011, insufflation can be applied through one or more of the insufflation channels 593a, 593b (Fig. 5C) of the steerable overtube 140. During the procedure, the insufflation channels 593a, 593b and accessory channel 595 can be used for irrigation, suction, insufflation and / or smoke evacuation, as needed. If a transanal access device is used, insufflation and / or smoke evacuation may be performed through the transanal access device as an alternative to insufflating through the steerable overtube.

[0182] As illustrated in Fig. 10, in accordance with one aspect, the method includes the step of marking boundaries of the lesion 1025 using at least one robotically controlled surgical instrument (e.g., 690b) deployed from a distal end of the overtube assembly 140. In accordance with certain embodiments, the step of marking the boundaries of the lesion 1025 involves cauterizing the mucosal tissue surrounding the lesion 1025 at a plurality of locations 1017 using an end effector 671 (e.g., a unipolar or bipolar electrocautery tool) of a robotically controlled surgical instrument 690a, 690b.

[0183] Subsequently, injection of a fluid into the submucosal plane associated with the lesion 1025 to lift and separate the lesion 1025 from the muscle tissue is performed, and is shown in Fig. 11. The submucosa is a layer of loose connective tissue that lies beneaththe mucosa and above muscle. This layer also contains blood vessels, lymphatic vessels, and nerves. The fluid injection provides a lifting effect of the lesion 1025, separating it from the muscular layer of the intestinal wall 1013, thereby reducing the risk of thermal injury, perforation and bleeding. In one embodiment, injection of fluid into the submucosa associated with the lesion 1025 involves introducing a needle 1150 through a working channel of the overtube assembly 140, such as the accessory channel 595, to inject the fluid into the submucosa. In one embodiment, the injection of a fluid into the plane of the submucosa associated with the lesion involves using an end effector 671 of a robotically controlled surgical instrument 690a, 690b (e.g., having a forceps end effector) to retract the mucosa as the fluid is injected into the submucosal plane. In one embodiment, the injection of a fluid into the plane of the submucosa associated with the lesion involves using an end effector 671 of a robotically controlled surgical instrument 690a, 690b to direct the needle into the tissue as the fluid is injected into the submucosal plane. The fluid may consist of a sterile aqueous sodium chloride solution or other solution such as hyaluronic acid, hydroxyethyl starch, dextrose water, hydroxypropyl methylcellulose, Eleview®, or other lifting agent, and may include a biocompatible dye to enhance visualization of the lesion 1025 and / or tissue planes for dissection.

[0184] A mucosal incision is performed distal to the lesion 1025, which may be continued circumferentially surrounding the lesion 1025 using at least one robotically controlled surgical instrument 690a, 690b deployed from the distal end of the overtube assembly 140, Next, as shown in Fig. 12, the tissue surrounding the lesion 1025 is dissected using at least one robotically controlled surgical instrument 690a, 690b deployed from the distal end of the overtube assembly 140. The step of dissecting the tissue surrounding the lesion, which is shown in Fig. 12, preferably involves using an end effector 671 of one robotically controlled surgical instrument 690a to retract tissue while using an end effector 671 e.g., a hook knife or scissor) of another robotically controlled surgical instrument 690b to dissect the tissue surrounding the lesion 1025.

[0185] With reference to Figure 13, the resected lesion 1025 is retrieved from the operative site using at least one instrument deployed from the distal end of the overtube assembly 140. One robotically controlled surgical instrument (e.g., 690a) can be used to place the resected lesion 1025 into a specimen retriever 1360, which is delivered to thesite through the overtube assembly, such as by the instrument channel 591a, 591b or accessory channel 595 thereof, and then withdrawn from the overtube assembly with the specimen.

[0186] With reference to Fig. 14, closure of the defect created by the resection of the lesion 1025 is accomplished using at least one robotically controlled surgical instrument 690a, 690b deployed from the distal end of the overtube assembly 140. In accordance with one preferred embodiment, closure of the defect created by the resection of the lesion 1025, involves using end effectors 671 of a pair of robotically controlled surgical instruments 690a, 690b to suture the defect closed (e.g., needle drivers or the like). Exemplary end effectors for use with the robotic surgical devices 690a, 690b and systems (e.g., 100) described and illustrated herein, are shown in Figures 6A-6E & 7, for example. In accordance with one example, one instrument (e.g., 690a) is used to stabilize or hold tissue or the suture, and the second instrument 690b is used to pass a needle 1440 through the tissue, pulling a suture material 1441. The needle 1440 can be passed between end effectors of different instruments (e.g., 690a, 690b) to allow for reorientation of the needle 1440 during suturing. The closed defect is illustrated in Fig. 15, for reference.

[0187] Upon completion of the foregoing procedure steps, the surgical site can be inspected by the physician 21 through images on the display screen 125 provided by the endoscope 726. The surgical instruments 690a, 690b can be used to manipulate the anatomy for inspection. If the specimen was not retrieved in the previous step described above, a robotically controlled surgical instrument (e.g., 690a) deployed from the distal end of the overtube assembly 140 may be used to grasp the lesion 1025 and place the resected lesion 1025 into a specimen retriever 1360, which is delivered to the site through the overtube assembly, such as by the instrument channel 591a, 591b or accessory channel 595 thereof. Subsequently, the surgical instruments 690a, 690b are withdrawn into their respective instrument channels 591a, 591b. If the robotic surgical instruments 690a, 690b are not to be used further, they can be removed from the steerable overtube 140 entirely. The steerable overtube is then removed from the lower GI tract 1011 under visualization of the videoscope, along with the lesion 1025 and specimen retriever 1360, if applicable.

[0188] Upper Gastrointestinal Endoluminal Submucosal Dissection (ESP)

[0189] With reference to Figs. 16 through 22, there is illustrated a new and useful method of performing a robotically assisted ESD procedure within the upper GI tract of a patient 1610. Barret's esophagus presents as a change in the cells lining the esophagus 1713 and can occur in patients with gastroesophageal reflux disease (GERD), and is known as a precursor to esophageal cancer. Additionally, other benign lesions and superficial cancers throughout the esophagus, stomach, and duodenum are targeted by this procedure.

[0190] This method of the subject disclosure includes an initial step of positioning the patient 1610 in a supine position with the patient's head tilted left or right (or in a sword swallower position). In one example, the sword swallower position as used herein refers to a patient posture wherein the neck is extended and the head tilted backward such that the oral, pharyngeal, and esophageal axes are aligned to facilitate endoscopic overtube insertion. The patient cart 110 is oriented beside the patient bed 180, and directed toward the patient 1610. The assembly of the steerable overtube 140 is introduced into the upper GI tract 1711 of the patient 1610 and advanced to the site of a lesion 1725 within the upper GI tract 1711 as shown in Figs. 16-17.

[0191] In one embodiment, the steerable overtube 140 is manually introduced into the upper GI tract 1711 (i.e., trans-orally) and advanced to the operative site under visualization by the videoscope 726 or endoscope inserted in a respective working channel of the steerable overtube 140. Thereafter, the steerable overtube 140 is docked to the overtube controller 170 of the patient cart 110 to enable robotic control of steering, axial translation and rotation as needed. In another embodiment, the steerable overtube 140 is docked to the overtube controller 170 prior to introduction into the upper GI tract 1711, and is advanced to the operative site under robotic control and visualization by the videoscope 726, with robotic manipulation of advancement, roll and steering of the steerable overtube 140.

[0192] When at least the distal portion of the steerable overtube 140 is within the upper GI tract 1711, insufflation can be applied through one or more of the insufflation channels 593a, 593b (Fig. 5C) of the steerable overtube 140. During the procedure, the insufflation channels 593a, 593b and accessory channel 595 can be used for irrigation, suction, insufflation and / or smoke evacuation, as needed.

[0193] As illustrated in Fig. 17, the method further includes the step of marking boundaries of the lesion 1725 using at least one robotically controlled surgical instrument (e.g., 690b) deployed from a distal end of the steerable overtube assembly 140. In accordance with certain embodiments, the step of marking the boundaries of the lesion 1725 involves cauterizing the mucosal tissue surrounding the lesion 1725 at a plurality of locations 1717 using an end effector 671 (e.g., a unipolar or bipolar electrocautery tool) of a robotically controlled surgical instrument 690a, 690b.

[0194] Subsequently, injection of a fluid into the submucosal plane associated with the lesion 1725 to lift and separate the lesion 1725 from the muscle tissue is performed, and is shown in Fig. 18, which reduces the risk of thermal injury, perforation, and bleeding, while also aiding in visualization of the submucosal plane and edges of the lesion 1725. In one embodiment, injection of fluid into the submucosa associated with the lesion 1725 involves introducing a needle 1150 through a working channel of the overtube assembly 140, such as the accessory channel 595, to inject the fluid into the submucosa. In one embodiment, the injection of a fluid into the plane of the submucosa associated with the lesion involves using an end effector 671 of a robotically controlled surgical instrument 690a, 690b (e.g., having a forceps end effector) to retract the mucosa as the fluid is injected into the submucosal plane. In one embodiment, the injection of a fluid into the plane of the submucosa associated with the lesion involves using an end effector 671 of a robotically controlled surgical instrument 690a, 690b to direct the needle into the tissue as the fluid is injected into the submucosal plane. The fluid may consist of a sterile aqueous sodium chloride solution or other solution such as hyaluronic acid, hydroxyethyl starch, dextrose water, hydroxypropyl methylcellulose, Eleview®, or other lifting agent, and may include a biocompatible dye to enhance visualization of the lesion 1725 and / or tissue planes for dissection.

[0195] With reference to Fig. 19, the resected lesion 1725 is retrieved from the operative site 1711 using at least one robotically controlled surgical instrument (e.g., 690a) deployed from the distal end of the overtube 140. Appropriate end effectors 671 for the dissection can include grasping and cutting end effectors, such as forceps, scissors and / or other cutting end effectors, including electrosurgical instruments. One robotically controlled surgical instrument (e.g., 690a) can be used to place the resected lesion 1725into a specimen retriever 1360, which is delivered to the site through the overtube assembly 140, such as through the instrument channel 591a, 591b or accessory channel 595 thereof, and then removed from the overtube assembly with the specimen. A mucosal incision is performed distal to the lesion 1725, which may be continued circumferentially surrounding the lesion 1725 using at least one robotically controlled surgical instrument 690a, 690b deployed from the distal end of the overtube 140. Next, as shown in Fig. 19, the tissue surrounding the lesion 1725 is dissected using at least one robotically controlled surgical instrument 690a, 690b deployed from the distal end of the overtube 140. The step of dissecting the tissue surrounding the lesion, which is shown in Fig. 19, preferably involves using an end effector 671 of one robotically controlled surgical instrument 690a to retract tissue while using an end effector 671 (e.g., a hook knife or scissor) of another robotically controlled surgical instrument 690b to dissect the tissue surrounding the lesion 1725. With reference to Figure 20, the resected lesion 1725 is retrieved from the operative site using at least one instrument deployed from the distal end of the overtube 140. One robotically controlled surgical instrument (e.g., 690a) can be used to place the resected lesion 1725 into a specimen retriever 1360, which is delivered to the site through the overtube assembly, such as by the instrument channel 591a, 591b or accessory channel 595 thereof, and then withdrawn from the overtube assembly with the specimen.

[0196] With reference to Fig. 21, in accordance with one preferred embodiment, closure of the defect created by resection of the lesion 1725, involves using end effectors 671 of a pair of robotically controlled surgical instruments 690a, 690b to suture the defect closed (e.g., needle drivers or the like). In accordance with one example, one instrument (e.g., 690a) is used to stabilize or hold tissue or the suture, and the second instrument 690b is used to pass a needle 1440 through the tissue, pulling a suture material 1441. The needle 1440 can be passed between end effectors of different instruments (690a, 690b) to allow for reorientation of the needle 1440 during suturing. The closed defect is illustrated in Fig. 22, for reference.

[0197] Upon completion of the foregoing procedure steps, the surgical site of the upper GI tract 1711 can be inspected by the physician 21 through images on the display screen 125 provided by the endoscope 726. The surgical instruments 690a, 690b can be used tomanipulate the anatomy for inspection. If the specimen was not retrieved in the previous step described above, a robotically controlled surgical instrument (e.g., 690a) deployed from the distal end of the overtube 140 may be used to grasp the lesion 1725 and place the resected lesion 1725 into a specimen retriever 1360, which is delivered to the site through the overtube assembly, such as by the instrument channel 591a, 591b or accessory channel 595 thereof. Subsequently, the surgical instruments 690a, 690b are withdrawn into their respective instrument channels 591a, 591b. If the robotic surgical instruments 690a, 690b are not to be used further, they can be removed from the steerable overtube 140 entirely. The steerable overtube is then removed from the upper GI tract under visualization of the videoscope, along with the lesion 1725 and specimen retriever 1360 if applicable. Additional subject matter relating to the robotically assisted ESD procedures of the subject disclosure is provided in the following examples.

[0198] Example 1

[0199] In one example, a study was performed comparing robot-assisted versus conventional endoscopic submucosal dissection for colonic lesions in order to evaluate the efficacy, viability, and safety of robot-assisted vs conventional ESD performed by endoscopists with no prior ESD experience.

[0200] A randomized, controlled study was performed comparing conventional ESD procedure with robot-assisted ESD using the system 100 described hereinabove utilizing an ex-vivo bovine colon model. Ten endoscopists with similar endoscopic experience ranging from 2 to 4 years, and with no prior ESD or robotic experience, were randomized into two groups. Group 1 first performed one conventional ESD, then one robot-assisted ESD, while Group 2 started with robot-assisted and then conventional ESD. All participants underwent a standardized teaching and practice session on both conventional and robotic-assisted ESD.

[0201] A standard, circular, 2-cm lesion was made and placed at the 6 o'clock position for each procedure. The primary outcome was completion of en bloc resection.Secondary outcomes included procedure time, perforation rate, muscle injury rate, and National Aeronautical and Space Administration Task Load Index (NASA-TLX), a validated, quantitative survey of physical and mental workload.

[0202] Ten endoscopists each performed 2 ESDs (one conventional and one robot- assisted) for a total of 20 procedures. Complete en bloc resection was successful in 40% of conventional and 100% of robot-assisted ESDs (P = 0.011). Mean procedure time was lower for robot-assisted procedures (32.3 vs 85.1 min; P < 0.001). Complications including muscle injury (40% vs 90%; P = 0.018) and perforations (0% vs 30%; P = 0.065) were also lower with robot-assisted procedures. NASA-TLX scores showed more physical and mental workload when endoscopists performed conventional ESD, 109.5, versus robot-assisted ESD, 54.1, (P < 0.001).

[0203] The study concluded that robot-assisted ESD was more effective, faster, safer, and easier than conventional ESD among gastroenterologists without prior ESD experience. These findings suggest that robot-assisted ESD could help facilitate wider adoption of the technique beyond highly trained endoscopists.

[0204] Example 2

[0205] In another example, an endoscopic submucosal dissection (ESD) and suture closure for large gastric lesion in an ex vivo porcine model was conducted using the above described system 100.

[0206] ESD was performed using a novel master-slave robotic platform. The platform consisted of an 18 mm large, 45 cm long flexible shaft, and two 6 mm robotic effector arms with 7 degrees of freedom and a full suite of surgical instruments. The triangulation achieved by the system allows for efficient traction and countertraction, making endoscopic resection and tissue approximation as easy as standard surgical manipulation. A cobra configuration of the camera allows for changing the viewing angle (from 0-45 degrees) independent of the instruments, allowing dynamic adjustment of the operating field. A novice to ESD and surgical suturing underwent one day of training for familiarization with the platform and interface. Subsequently, a large gastric lesion was created via a mucosal marking in the posterior wall of an ex-vivo porcine model. After mucosal lifting using a conventional injection needle, the mucosal incision and submucosal dissection were performed with robotic surgical scissors using monopolar cautery. Traction and countertraction were provided with an articulated grasper. The mucosal defect was closed using a running 3 / 0 barbed suture. Procedure time (fromsubmucosal injection to the end of dissection), specimen dimension and area (largest diameter x smallest diameter x 0.25 x 7c), quality of dissection (en-bloc or piecemeal), ESD speed (cm2 / min), perforation, and muscle layer injury together with suturing time were recorded.

[0207] A 9.5 by 7.5 cm (52.23 cm2) lesion was resected en-bloc in 97 minutes (0.538 cm2 / min) with no perforation or muscular injury. Suture closure of the defect was achieved in 60 minutes.

[0208] The study concluded that the feasibility of a novel robot-assisted endoscopic platform to facilitate a safe, complete ESD of a large gastric lesion was demonstrated in a novice with minimal training, and that the use of such a platform could well represent a major turning point in training the next generation of endoscopists and allow to democratize the treatment of superficial gastrointestinal lesions.

[0209] Endoluminal Sleeve Gastroplasty (ESG)

[0210] Referring now to Figs. 23 through 29, a method of performing a robotically assisted endoluminal sleeve gastroplasty (ESG) procedure on a patient is illustrated. ESG is a type of minimally invasive weight-loss procedure wherein sutures are placed in locations to make the stomach volume and length smaller. The sutures change the structure of the stomach, leaving it shaped like a tube, which limits the amount of food that can be consumed, while the patient feels fuller sooner.

[0211] This method of the subject disclosure initially includes the steps of positioning the patient 2310 in a supine position with the patient's head tilted left or right (or in a sword swallower position), while the patient cart 110 is oriented beside the patient bed 180, toward the patient's mouth, as seen in Fig. 23. The steerable overtube assembly 140 is introduced into the upper GI tract of the patient (i.e., trans-orally), and advanced into the stomach 2313 of the patient 2310 to a site adjacent the distal greater curvature of the stomach, also as shown in Fig. 23. Introduction and advancement of the steerable overtube 140 can be manual or robotic, as described in connection with above-described methods. When at least the distal portion of the steerable overtube 140 is within the upper GI tract 1711, insufflation can be applied through one or more of the insufflation channels 593a, 593b (Fig. 5C) of the steerable overtube 140. During the procedure, theinsufflation channels 593a, 593b and accessory channel 595 can be used for irrigation, suction, insufflation and / or smoke evacuation, as needed.

[0212] With reference to Fig. 24, the method further includes the step of marking guidelines 2314 on the anterior and posterior gastric walls of the stomach 2313 using at least one robotically controlled surgical instrument (e.g., 690b) deployed from a distal end of the assembly of the overtube 140 to guide subsequent suture placement. In accordance with one preferred embodiment, the step of marking guidelines 2314 involves cauterizing the gastric walls using an end effector 671 of a robotically controlled surgical instrument (e.g., a unipolar or bipolar electrocautery tool). Those skilled in the art will readily appreciate that mucosectomies can be made in lieu of marking guidelines so that when the sutured tissue is apposed, the apposing mucosectomies will fuse together, providing potentially longer lasting plications.

[0213] Subsequently, sutures are stitched through the marked gastric walls 2312 in a predefined pattern to acquire tissue. Sutures 2314 are placed with at least one robotically controlled surgical instrument 690a, 690b deployed from the distal end of the overtube 140 as shown in Fig. 25. In accordance with one example, one instrument (e.g., 690a) is used to stabilize or hold tissue or the suture and a second instrument 690b is used to pass a needle through the tissue, pulling a suture material 1441. The needle can be passed between end effectors of different instruments 690a, 690b to allow for reorientation of the needle during suturing. Using the instruments 690a, 690b, opposite ends of the suture 1441 are pulled in order to appose or approximate the acquired tissue and thus form a first distal suture plication 2615, as shown in Fig. 26. The method further includes the step of forming one or more subsequent suture plications 2715 proximal to the first suture plication 2615, as shown in Fig. 27.

[0214] The physician 21 can then check, through images on the display screen 125 provided by the endoscope 726, and add additional suture plications until the stomach volume and length have been reduced as required. Fig. 28 is a cross-sectional view of the stomach 2313 showing a gastric wall 2312 having multiple plications 2615, 2715, 2815. Subsequently, the surgical instruments 690a, 690b are withdrawn into their respective instrument channels 591a, 591b. If the robotic surgical instruments 690a, 690b are not to be used further, they can be removed from the steerable overtube 140 entirely; finally, thesteerable overtube 140 is withdrawn. Fig. 29 illustrates a before and after comparison, illustrating the reduction in stomach volume and length as a result of the disclosed robotically assisted ESG procedure. Additional subject matter relating to the robotically assisted ESG procedure of the subject disclosure is provided in the following example

[0215] Example 3

[0216] In one example, a study was performed to evaluate technical feasibility and develop a procedure for robotic endoluminal sleeve gastroplasty using the abovedescribed systems, which preclinical work was in preparation for a bariatric clinical trial. A novel approach to ESG using a fully-robotic endoscopic system, as described above, in a porcine stomach model was demonstrated. The system included an 18 mm robotic overtube with 6 channels, including two 7 mm channels for the major articulating instruments, and channels for optics, insufflation, and accessory devices. The first suture was placed at the level of the incisura using a running suture. The suture was started on the posterior wall, moving to the greater curvature, then to the anterior wall. Following this a running suture was placed using a continuous 'v' pattern moving from posterior, along the greater curvature, to the anterior surface and back. This suture served to reduce both the width and length of the stomach, similar to the 'u' suture pattern in conventional ESG. Lastly, the procedure was finished with a continuous reinforcing suture from the distal to proximal stomach, opposing the anterior and posterior surfaces, medial to the existing plications in a "zigzag" configuration. This reinforcement aimed to help reduce tension on the underlying running sutures, and also further narrow the stomach lumen. At the end of the procedure, the gastric lumen was reduced by over 50% compared to the pre-procedural state. The study concluded that such procedures are feasible and have potential to enhance procedural performance, allowing a broader range of endoscopists to offer the technique.

[0217] Transoral Endoluminal Fundoplication

[0218] Transoral endoluminal fundoplication, as shown in Fig. 30, is a minimally invasive procedure to treat acid reflux, also known as heartbum, and other symptoms associated with chronic gastroesophageal reflux disease (GERD). These symptoms arecaused by a malfunctioning valve that allows acid from the stomach 3018 into the esophagus 3017. By folding the fundus around the opening between the stomach and esophagus, the area is reinforced to prevent stomach acid from coming up into the esophagus. Fundoplication helps create a new barrier to reflux from the stomach.

[0219] With reference to Fig. 30, there is shown the performance of a robotically assisted trans-oral endoluminal fundoplication or endoluminal GERD procedure, which involves positioning the patient 3010 in a supine position with the patient's head tilted left or right (or in a sword swallower position). The steerable overtube 140 is introduced into the upper GI tract 3015 of the patient 3010, and advanced to a site adjacent the lower esophageal sphincter 3016. Advancement of the steerable overtube 140 is as described above, and can proceed under manual technique or robotic control. Following docking of the steerable overtube 140 to the overtube controller 170 of the patient cart 110, robotically controlled instruments 690a, 690b, are deployed from the assembly of the overtube 140 and are used to remodel the lower esophageal sphincter, with visualization provided through the videoscope 726.

[0220] Following introduction and orientation of the overtube 140 in the operative space (e.g., lumen 3019 of the stomach 3018), procedure steps are consistent with other endoluminal fundoplication procedures, such as transoral incisionless fundoplication (TIF) approaches for fundoplication, but utilizing the robotic surgical instruments 690a, 690b and system 100 described above. The procedure involves folding tissue at the top of the stomach 3018 towards the esophagus 3017, and securing the folded tissue with fasteners or sutures to prevent reflux or stomach acid back into the esophagus. Bimanual manipulation of tissue using instruments 690a, 690b each with grasping end effectors 671 can be advantageously employed. Sutures, staples and / or other surgical fasteners can be placed with the instruments 690a, 690b. Alternatively or additionally, sutures, staples and / or other surgical fasteners can be placed with a separate manual or robotically controlled instrument inserted through the accessory channel 595 of the overtube 140 or the instrument channel 591a, 591b, for example.

[0221] In one embodiment, the steerable overtube 140 is advanced in the esophagus 3017 to a point just proximal the lower esophageal sphincter 3016. The instruments 690a, 690band videoscope 726 are deployed from the distal end of the overtube 140 to access the tissues in the area surrounding and including the lower esophageal sphincter 3016.

[0222] In another embodiment, the steerable overtube 140 is advanced in the lumen 3019 of the stomach 3018 to a point just distal the lower esophageal sphincter 3016, at which point the instruments 690a, 690b and videoscope 726 are deployed from the distal end of the overtube 140 to access the tissues in the area surrounding and including the lower esophageal sphincter 3016.

[0223] In a further alternate embodiment, the steerable overtube 140 is advanced into the stomach 3018 and steered back toward the esophagus 3017 — that is, approaching or exceeding 180-degrees to orient the distal end of the overtube 140 toward the operative site from within the lumen 3019 of the stomach 3018. That is, the overtube 140 is steered at least 90-degrees, to orient the surgical instruments 690a, 690b and endoscope 726 toward the upper portion of the stomach 3018, to the area surrounding and including the lower esophageal (gastroesophageal) sphincter 3016. The overtube 140 can be steered by the overtube controller 170 to operate in carrying out this method at a steering angle cp (phi) (see Fig. 5B) between 90-degrees and 225-degrees in one implementation. The overtube 140 can be steered by the overtube controller 170 to operate at a steering angle cp (phi) between 135-degrees and 225-degrees in another implementation. The overtube 140 can be steered by the overtube controller 170 to operate at a steering angle cp (phi) between 160-degrees and 200-degrees in further implementation. The overtube 140 can be steered by the overtube controller 170 to operate at a steering angle (p (phi) between 160-degrees and 180-degrees in still further implementation. Moreover, the overtube 140, the surgical instruments 690a, 690b and endoscope 726 can be rotated (roll) about the overtube axis 396. Therefore, a steering angle cp (phi) of less than 180-degrees can provide complete access to the upper portion of the stomach 3018, and the area surrounding and including the lower esophageal sphincter 3016 by activating the actuator of the roll joint 386, 386b of the patient cart 110 for the physician console 120.Thereafter, the dexterity afforded by axial translation and rotation, and the bending of the first 673 and second 675 bending joints of the robotic surgical instruments 690a, 690b allow for complete access to, and manipulation of, the operative site with end effectors 671.

[0224] During the procedure, insufflation can be applied through one or more of the insufflation channels 593 a, 593b (Fig. 5C) of the steerable overtube 140. Additionally or alternatively, the insufflation channels 593a, 593b and accessory channel 595 can be used for irrigation, suction and / or smoke evacuation, as needed. Upon completion of the foregoing procedure steps, the operative site can be inspected by the physician 21 through images on the display screen 125 provided by the endoscope 726. Subsequently, the surgical instruments 690a, 690b are withdrawn into their respective instrument channels 591a, 591b. If the robotic surgical instruments 690a, 690b are not to be used further, then they can be removed from the steerable overtube 140 entirely, and the steerable overtube 140 withdrawn from the esophagus 3017.

[0225] Bariatric Endoluminal Antral Myotomy (BEAM)

[0226] Referring now to Figs. 31 through 37, the operative steps of a method of performing a robotically assisted bariatric endoluminal antral myotomy (BEAM) procedure on a patient 3110 are illustrated. This procedure is intended to produce a consistent delay in gastric emptying, which can advantageously lead to reproducible and durable weight loss.

[0227] With reference to Fig. 31, the method includes the steps of positioning a patient3110 in a supine position with the patient's head tilted left or right (or in a sword swallower position). The patient cart 110 is oriented toward the patient 3110, and the steerable overtube assembly 140 is introduced into the upper gastrointestinal (GI) tract3111 of the patient 3110 under visualization, either manually or robotically, as described above in connection with other procedures. The overtube 140 is advanced into the stomach 3113 of the patient 3110 to a site adjacent the distal greater curvature of the stomach. The overtube 140 is docked to the overtube controller 170, if not previously connected, thereby allowing robotic control of axial advancement, axial rotation and steering (bending) of the distal portion thereof.

[0228] The method further includes injecting a fluid into the submucosal plane of the stomach 3113 to lift and separate the mucosal tissue 3218 from the muscle 3419 as shown in Fig. 32. In accordance with one preferred embodiment, the step of injecting a fluid into the submucosal plane includes introducing a needle 1150 through a workingchannel (e.g., accessory channel 595) of the assembly of the overtube 140 to inject the fluid into the submucosa 3218. The step of injecting a fluid into the submucosal plane can involve using an end effector 671 of a robotically controlled surgical instrument 690a, 690b to retract the mucosa 3218 as the fluid is injected into the submucosa, and / or to direct the needle into the tissue as the fluid is injected into the submucosa.

[0229] With reference to Fig. 33, a mucosal incision 3317 is created along the greater curvature of the stomach using at least one robotically controlled surgical instrument 690a, 690b deployed from a distal end of the assembly of the overtube 140. The instruments 690a, 690b can be equipped with grasping and / or cutting end effectors 671, with one being used to retract the mucosa 3218, and with the other being used to form the incision 3317.

[0230] As shown in Fig. 34, the method can further include tunneling through the mucosal incision 3317 and under the mucosa 3218 of the stomach 3113 to a location proximal to the pylorus, using at least one robotically controlled surgical instrument 690a, 690b deployed from a distal end of the assembly of the overtube 140.

[0231] The step of tunneling under the mucosa 3218 of the stomach 3113 to the submucosa shown in Fig. 34 preferably involves using an end effector of a robotically controlled surgical instrument to retract the mucosa 3218 and using an end effector of another robotically controlled surgical instrument to tunnel below the mucosa 3218.

[0232] The method further includes forming two parallel lines of partial-thickness myotomy 3514 from the distal to proximal antrum of the stomach 3113 using at least one robotically controlled surgical instrument 690a, 690b deployed from a distal end of the overtube 140, as shown in Fig. 35.

[0233] Preferably, the step of forming the two parallel lines of myotomy 3514 shown in Fig. 35 involves using an end effector 671 (e.g., forceps or graspers) of a robotically controlled surgical instrument e.g., 690a) to retract the mucosa 3218 and using an end effector 671 (e.g., hook knife or scissor) of another robotically controlled surgical instrument (e.g., 690b) to form the two parallel lines of myotomy 3514.

[0234] With reference to figures 36 and 37, the defect created by the mucosal incision 3317 is closed using at least one robotically controlled surgical instrument, preferably using end effectors 671 of a pair of robotically controlled surgical instruments 690a, 690bto grasp the mucosal tissue 3218 and needle 1440 with suture material 1441 to suture the defect closed, as shown completed in Fig. 37.

[0235] During the procedure, insufflation can be applied through one or more of the insufflation channels 593a, 593b (Fig. 5C) of the steerable overtube 140. Additionally or alternatively, the insufflation channels 593a, 593b and accessory channel 595 can be used for irrigation, suction and / or smoke evacuation, as needed. Upon completion of the foregoing procedure steps, the operative site can be inspected by the physician 21 through images on the display screen 125 provided by the endoscope 726. Subsequently, the surgical instruments 690a, 690b are withdrawn into their respective instrument channels 591a, 591b. If the robotic surgical instruments 690a, 690b are not to be used further, then they can be removed from the steerable overtube 140 entirely, and the steerable overtube 140 withdrawn from the upper GI tract 3111 of the patient 3110.

[0236] Peroral Endoluminal Myotomy (POEM)

[0237] Referring now to Figs. 38 through 44, the operative steps of a method of performing a robotically assisted peroral endoluminal myotomy (POEM) procedure on a patient 3810 are illustrated. This procedure is performed in the esophagus 3841 to treat swallowing disorders caused by muscle problems, such as achalasia and spasms in the esophagus. This procedure is performed in the stomach 3843 to treat gastric emptying disorders such as gastroparesis.

[0238] The method initially includes positioning the patient 3810 in a supine (illustrated) or prone position with the patient's head tilted left or right. With reference to Fig. 38, the patient cart 110 is oriented toward the patient 3810, and the steerable overtube 140 is introduced into the upper gastrointestinal (GI) tract of the patient 3810 under visualization, either manually or robotically, as described above in connection with other procedures. The steerable overtube 140 is advanced into the esophagus 3841 of the patient 3810 to a site adjacent the lower esophageal sphincter, if performed in the esophagus 3841. In an alternate embodiment, the overtube 140 is advanced into the stomach 3843 of the patient 3810 to a site adjacent the pyloric sphincter.

[0239] With reference to Fig. 39, fluid is injected into the submucosal plane at the site to lift and separate the mucosal tissue from the muscle. In accordance with a preferredembodiment, this step involves introducing a needle 1150 through a working channel (e.g., 595) of the overtube 140 which can further involve using an end effector 671 of a robotically controlled surgical instrument (690a, 690b) to retract the mucosa 3943 as the fluid is injected into the submucosa, or to direct the needle into the tissue as the fluid is injected into the submucosa. Subsequently, a mucosal incision 4044 is made at the site using at least one robotically controlled surgical instrument 690a, 690b deployed from a distal end of the overtube 140 as shown in Fig. 40. In accordance with a preferred embodiment, this step includes using an end effector of one robotically controlled surgical instrument 690a to retract the mucosa 3943 and using an end effector of another robotically controlled surgical instrument 690b to form the incision 4044.

[0240] Thereafter, as shown in Fig. 41, tunneling under the mucosa 3943 to the submucosa is performed through the mucosal incision 4044, to a location immediately proximal to the lower esophageal sphincter in one embodiment, or to a location immediately proximal to the pyloric sphincter in another embodiment — in either case with one or more of the robotically controlled surgical instruments 690a, 690b. This process is, in one embodiment, advantageously accomplished by using an end effector 671 of one robotically controlled surgical instrument 690a to retract the mucosa 3943 while using an end effector 671 of the other robotically controlled surgical instrument 690b to tunnel below the mucosa 3943.

[0241] Next, as shown in Fig. 42, one or more of the robotically controlled surgical instruments 690a, 690b are used to form a myotomy 4245. In accordance with preferred embodiments, the myotomy 4245 is a linear myotomy of the lower esophageal sphincter muscle, or pyloric sphincter muscle, depending on the embodiment. In one embodiment, the step of forming the myotomy 4245 shown in Fig. 42 involves using an end effector of one robotically controlled surgical instrument 690a to retract the mucosa 3943 and using an end effector of another robotically controlled surgical instrument 690b to form the myotomy 3943. As shown in Fig. 43, closing the defect created by the mucosal incision 4044 using at least one robotically controlled surgical instrument 690a, 690b. In accordance with a preferred embodiment, end effectors 671 of a pair of robotically controlled surgical instruments 690a, 690b are used to grasp the mucosal tissue 3943 andneedle 1440 with suture material 1441 to suture the defect closed, as shown completed in Fig. 44.

[0242] During the procedure, insufflation can be applied through one or more of the insufflation channels 593a, 593b (Fig. 5C) of the steerable overtube 140. Additionally or alternatively, the insufflation channels 593a, 593b and accessory channel 595 can be used for irrigation, suction and / or smoke evacuation, as needed. Upon completion of the foregoing procedure steps, the operative site can be inspected by the physician 21 through images on the display screen 125 provided by the endoscope 726. Subsequently, the surgical instruments 690a, 690b are withdrawn into their respective instrument channels 591a, 591b. If the robotic surgical instruments 690a, 690b are not to be used further, then they can be removed from the steerable overtube 140 entirely, and the steerable overtube 140 withdrawn from the esophagus 3841.

[0243] Gastroplasty with Endoscopic Myotomy (GEM)

[0244] Referring now to Figs. 45 through 57, the operative steps of a method of performing a robotically assisted endoluminal gastroplasty with endoscopic myotomy (GEM) procedure on a patient are illustrated. The GEM procedure described herein combines steps of performing antral myotomy (AM) and endoluminal sleeve gastroplasty (ESG) into a single endoluminal procedure intended for weight management and improved gastric function. In essence, this procedure is intended to delay antral pump activity to slow gastric emptying in combination with achieving a reduced stomach volume and length.

[0245] The method includes an initial step of positioning a patient 4510 in a supine or prone position on the patient bed 180 with the patient's head tilted left or right, ensuring unobstructed assess to the upper GI tract for the robotic device, as shown in Fig. 45, and orienting the patient cart 110 toward the patient 4510. The steerable overtube 140 is introduced into the upper GI tract of the patient 4510, which may be performed manually or robotically, as described above in connection with other procedures.

[0246] In a first part of the method, an antral myotomy is formed by advancing or otherwise navigating, either manually under visualization or robotically under visualization, the overtube assembly 140 toward the antrum 4514 of the patient's stomach4513 to a site at or near the incisura. If not previously docked, the overtube 140 is then docked to the overtube controller 170. The steerable overtube 140 is operated robotically through the overtube controller 170 to orient the distal portion of the steerable overtube 140 toward the operative site at or near the inci sura.

[0247] With reference to Fig. 46, the first part of the method further includes the step of injecting a fluid (e.g., saline) into the submucosal plane at the site to lift and separate the mucosal tissue from the stomach muscle forming a cushion-like elevation that separates the mucosa from the underlying stomach muscle to delineate a plane for a mucosal incision. This step can be carried out through a needle 1150 inserted through the accessory lumen 595 of the steerable overtube 140.

[0248] As shown in Fig. 47, a mucosal incision 4717 is created at the incisura using at least one robotically controlled surgical instrument 690a, 690b deployed from a distal end of the overtube 140. Thereafter, as seen in Fig. 48, the robotically controlled surgical instruments 690a, 690b are used to tunnel through the incision 4717, under the mucosa 4615, to the submucosa and to a location proximal to the pyloric sphincter 4612.

[0249] Thereafter, as illustrated in Fig. 49, an antral myotomy 4919 is performed of the stomach muscle, using at least one of the robotically controlled surgical instruments (e.g., 690b), while the other instrument e.g., 690a) can be used to retract the mucosa 4615. Closure of the defect created by the mucosal incision 4717 is illustrated in Fig. 50, and is performed using at least one robotically controlled surgical instrument. Preferably end effectors 671 of a pair of robotically controlled surgical instruments 690a, 690b are used to grasp the mucosal tissue 4615 and needle 1440 to suture the defect closed with suture material 1441. Completed closure of the defect is shown in Fig. 51, which completes the first part of the GEM procedure.

[0250] The second part of the GEM procedure involves performing a gastroplasty using robotically controlled surgical instruments 690a, 690b, as shown in Figs. 52 through 57. More particularly, the method involves placing a running suture 5241 at the incisura, perpendicular to, and proximal of, the myotomy 4717. Needle driver end effectors 671, or the like, as shown in Fig. 52 can be used. This suture 5241 can then be tightened by pulling a free end. Then, starting distally, a suture 5342 is placed in an angular pattern as illustrated in Fig. 53, and proximal to the running stitch at the incisura. That suture 5342is subsequently tightened, as shown in Fig. 54, thus forming a first suture plication 5551 illustrated in Fig. 55.

[0251] With reference to Fig. 56, a second suture plication 5651 is preferably formed proximal to the first suture plication 5551. At such a time, the physician will assess whether it is necessary to add additional suture plications 5652, and those plications 5652 are sequentially added and tightened as needed, moving proximally along the greater curvature of the stomach 4513 to achieve a tubular gastric configuration with structural integrity.

[0252] Fig. 57 shows the reduction in stomach volume and length resulting from the second part of the GEM procedure. The GEM procedure is thus completed, with the patient's stomach now reconfigured to both restrict food intake and delay gastric emptying, advancing the therapeutic goals for weight management and improved gastrointestinal function.

[0253] During the procedure, insufflation can be applied through one or more of the insufflation channels 593a, 593b (Fig. 5C) of the steerable overtube 140. Additionally or alternatively, the insufflation channels 593a, 593b and accessory channel 595 can be used for irrigation, suction and / or smoke evacuation, as needed. Upon completion of the foregoing procedure steps, the operative site can be inspected by the physician 21 through images on the display screen 125 provided by the endoscope 726. Subsequently, the surgical instruments 690a, 690b are withdrawn into their respective instrument channels 591a, 591b. If the robotic surgical instruments 690a, 690b are not to be used further, then they can be removed from the steerable overtube 140 entirely, and the steerable overtube 140 withdrawn.

[0254] Trans-vaginal Hysterectomy

[0255] Fig. 58 illustrates a robotically assisted trans-vaginal hysterectomy in accordance with the subject disclosure, which involves positioning a patient in dorsal lithotomy position. The patient cart 110 is oriented toward the patient, and the steerable overtube assembly 140 is introduced into the vagina 5870 of the patient 3110 under visualization, either manually or robotically, as described above in connection with other procedures. The overtube 140 is advanced through the vagina 5870 of the patient.

[0256] A colpotomy 5875 is formed either manually prior to overtube 140 introduction, or robotically with the surgical instruments 690a, 690b, under visualization through the videoscope 726. At least one of the robotically controlled surgical instruments (e.g., 690b) with cutting or electrosurgical end effector can be used, while the other instrument (e.g., 690a) can used to retract adjacent tissue. Thereafter, the overtube 140 is advanced through the colpotomy 5875 into the pelvic cavity 5880, and to a site superior the fundus of the uterus 5860, for example. The overtube 140 is docked to the overtube controller 170, if not previously connected, thereby allowing robotic control of axial advancement, axial rotation and steering (bending) of the distal portion thereof.

[0257] The overtube assembly 140 is retroflexed about 180-degrees to orient the distal end toward the uterus 5860. Alternative ranges of retroflex are described above.Following introduction and orientation of the overtube 140 in the operative space (i.e., pelvic cavity 5880), procedure steps are consistent with other endoscopic or trans-vaginal approaches for hysterectomy, but utilizing the robotic surgical instruments 690a, 690b and system 100 described above. The robotically controlled instruments 690a, 690b, and videoscope 726 are deployed from the overtube assembly 140, permitting marking structures with electrosurgical end effectors, manipulation of tissue with grasping end effectors 671, dissection and excision with cutting or electrosurgical end effectors 671, specimen removal with grasping end effectors 671 or specialized tools, suturing with needle-driving and grasping end-effectors 671, stapling with surgical stapler end effectors or separate instruments inserted through the accessory channel 595 or instrument channel 591a, 591b of the steerable overtube 140.

[0258] During the procedure, insufflation can be applied through one or more of the insufflation channels 593 a, 593b (Fig. 5C) of the steerable overtube 140. Additionally or alternatively, the insufflation channels 593a, 593b and accessory channel 595 can be used for irrigation, suction and / or smoke evacuation, as needed. Upon completion of the foregoing procedure steps, the operative site can be inspected by the physician 21 through images on the display screen 125 provided by the endoscope 726. Subsequently, the surgical instruments 690a, 690b are withdrawn into their respective instrument channels 591a, 591b. If the robotic surgical instruments 690a, 690b are not to be used further, thenthey can be removed from the steerable overtube 140 entirely, and the steerable overtube 140 withdrawn from the pelvic cavity 5880 of the patient.

[0259] Closure of the defect created by the colpotomy 5875 is performed using at least one robotically controlled surgical instrument 690a, 690b, preferably using end effectors 671 of a pair of robotically controlled surgical instruments 690a, 690b to grasp and stabilize the vaginal wall, and needle to suture the defect closed with suture material. Thereafter the overtube 140 is withdrawn from the vagina 5870. Alternatively, repair can be performed manually.

[0260] Trans-vaginal Oophorectomy

[0261] Fig. 59 illustrates a robotically assisted trans-vaginal oophorectomy in accordance with the subject disclosure. An ovarian cyst is the most common reason an oophorectomy is needed. It is also performed to treat problems such as a twisted ovary and to remove the risk of developing ovarian cancer.

[0262] This procedure involves first positioning a patient in dorsal lithotomy position. The patient cart 110 is oriented toward the patient, and the steerable overtube assembly 140 is introduced into the vagina 5870 of the patient 3110 under visualization, either manually or robotically, as described above in connection with other procedures. The overtube 140 is advanced through the vagina 5870 of the patient. A colpotomy 5875 is formed either manually prior to overtube 140 introduction, or robotically with the surgical instruments 690a, 690b, under visualization through the videoscope 726. At least one of the robotically controlled surgical instruments (e.g., 690b) with cutting or electrosurgical end effector can be used, while the other instrument (e.g., 690a) can used to retract adjacent tissue. Thereafter, the overtube 140 is advanced through the colpotomy 5875 into the pelvic cavity 5880 to a site superior the fundus of the uterus 5860 and ovaries 5960 for example. The overtube 140 is docked to the overtube controller 170, if not previously connected, thereby allowing robotic control of axial advancement, axial rotation and steering (bending) of the distal portion thereof.

[0263] The assembly of the steerable overtube 140 is retroflexed 180-degrees to orient the distal end toward an ovary 5960. Following introduction and orientation of the overtube 140 in the operative space (i.e., pelvic cavity), procedure steps are consistentwith other endoscopic or trans-vaginal approaches for oophorectomy, but utilizing the robotic surgical instruments 690a, 690b and system 100 described above. The robotically controlled instruments 690a, 690b, and videoscope 726 are deployed from the overtube 140, permitting marking structures with electrosurgical end effectors, manipulation of tissue with grasping end effectors 671, dissection and excision with cutting or electrosurgical end effectors, specimen removal with grasping end effectors or specialized tools, suturing with needle-driving and grasping end-effectors, stapling with surgical stapler end effectors or separate instruments inserted through the accessory channel 595 of the steerable overtube 140.

[0264] During the procedure, insufflation can be applied through one or more of the insufflation channels 593 a, 593b (Fig. 5C) of the steerable overtube 140. Additionally or alternatively, the insufflation channels 593a, 593b and accessory channel 595 can be used for irrigation, suction and / or smoke evacuation, as needed. Upon completion of the foregoing procedure steps, the operative site can be inspected by the physician 21 through images on the display screen 125 provided by the endoscope 726. Subsequently, the surgical instruments 690a, 690b are withdrawn into their respective instrument channels 591a, 591b. If the robotic surgical instruments 690a, 690b are not to be used further, then they can be removed from the steerable overtube 140 entirely, and the steerable overtube 140 withdrawn from the pelvic cavity 5880 of the patient.

[0265] Closure of the defect created by the colpotomy 5875 is performed using at least one robotically controlled surgical instrument 690a, 690b, preferably using end effectors 671 of a pair of robotically controlled surgical instruments 690a, 690b to grasp and stabilize the vaginal wall, and grab a needle to suture the colpotomy 5875 closed with suture material. Thereafter the overtube 140 is withdrawn from the vagina 5870. Alternatively, repair of the colpotomy 5875 can be performed manually.

[0266] A robotically assisted Salpingo-oophorectomy (i.e., the removal of an ovary 5960 and its fallopian tube 5965) is also envisioned and well within the scope of the subject disclosure, and can include the procedure steps set forth above in connection with trans- vaginal hysterectomy and trans-vaginal oophorectomy.

[0267] While the methods, procedures, techniques and treatments of the subject disclosure have been shown and described with reference to preferred embodiments,those skilled in the art will readily appreciate that changes and / or modifications may be made thereto without departing from the spirit or scope of the subject disclosure. Moreover, it will be apparent to those skilled in the art that variations of the precise implementation of the subject systems can also be made without departing from the spirit or scope of the invention.

[0268] In light of the various illustrated embodiments of the subject systems, devices and methods described above, it is to be appreciated that such various non -limiting embodiments, or elements thereof, may be used separately, combined, or selectively combined for specific applications. Further, any of the various features of the above nonlimiting embodiments can be used without the corresponding use of other described features. The foregoing description should therefore be considered as merely illustrative of the principles, teachings, and exemplary embodiments of this invention, and not in limitation thereof.

[0269] Any module(s) disclosed herein can include any suitable hardware and / or software module(s) configured to perform any suitable function(s) (e.g., as disclosed herein, e.g., as described above). As will be appreciated by those skilled in the art, aspects of the present disclosure may be embodied as a system, method or computer program product. Accordingly, aspects of this disclosure may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc ), or an embodiment combining software and hardware aspects, all possibilities of which can be referred to herein as a “circuit,” “module,” or “controller.” A “circuit,” “module,” or “controller” can include one or more portions of one or more separate physical hardware and / or software components that can together perform the disclosed function of the “circuit,” “module,” or “controller”, or a “circuit,” “module,” or “controller” can be a single self-contained unit (e.g., of hardware and / or software). Furthermore, aspects of this disclosure may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon.

[0270] Any combination of one or more computer readable medium(s) may be utilized. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium may be, forexample, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0271] A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0272] Program code embodied on a computer readable medium may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

[0273] Computer program code for carrying out operations for aspects of this disclosure may be written in any combination of one or more programming languages, including an object-oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a widearea network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).

[0274] Aspects of this disclosure may be described above with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of this disclosure. It will be understood that each block of any flowchart illustrations and / or block diagrams, and combinations of blocks in any flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / acts specified in any flowchart and / or block diagram block or blocks.

[0275] These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function / act specified in the above-described flowchart and / or block diagram block or blocks.

[0276] The computer program instructions may also be loaded onto a computer, controller other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions / acts specified herein.

[0277] Those having ordinary skill in the art understand that any numerical values disclosed herein can be exact values or can be values within a range. Further, any terms of approximation (e.g., “about,” “approximately,” “around”) used in this disclosure can mean the stated value within a range. For example, in certain embodiments, the range can be within (plus or minus) 20%, or within 10%, or within 5%, or within 2%, or within 1%or within any other suitable percentage or number as appreciated by those having ordinary skill in the art (e.g., for known tolerance limits or error ranges).

[0278] The use of the term “substantially” in the Specification and Claims means largely but not wholly that which is specified. The term “substantially” can also mean “consisting essentially of.”

[0279] With regard to degree, the term “substantially” in one aspect means greater than 50%, up to and including 100%. The term “substantially” in another aspect means 90% to 100%, inclusive. The term “substantially” in another aspect means 95% to 100%, inclusive. The term “substantially” in another aspect means 97% to 100%, inclusive. The term “substantially” in another aspect means 98% to 100%, inclusive. The term “substantially” in another aspect means 99% to 100%, inclusive. The term “substantially” in another aspect means 99.5% to 100%, inclusive. The term “substantially” in another aspect means 99.6% to 100%, inclusive. The term “substantially” in another aspect means 99.7% to 100%, inclusive. The term “substantially” in another aspect means 99.8% to 100%, inclusive. The term “substantially” in another aspect means 99.9% to 100%, inclusive.

[0280] With regard to function and corresponding functional language, the term “substantially” in the Specification and the Claims means sufficiently to such a degree of being precise such that performance of the prescribed action or task, from the perspective of one with ordinary skill in the art, is the same as though the object, element or step were exactly precise.

[0281] The term “predetermined” as used herein, including in the Specification and Claims, means an element, quantity or value, for example, which is selected in advance, where precise details, quantities or values can vary, but which nevertheless is relevant to the claimed invention.

[0282] The articles “a,” “an,” and “the” as used herein and in the appended claims are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article unless the context clearly indicates otherwise. By way of example, “an element” means one element or more than one element.

[0283] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements thatare conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0284] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, ”or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.”

[0285] With regard to positioning in space and relative positional terms, as used herein, have conventional meaning and are to be interpreted as such, unless explicitly indicated otherwise. For example, the terms distal and proximal mean farther / farthest or nearer / nearest from a reference point. Where represented there may be illustrated axes shown in phantom line or otherwise, and / or a reference legend oriented with respect to one or more figures to visually guide understanding of use of such relative positional terms. As such translation along or rotation about such axes and / or movement within planes defined thereby can be easily understood.

[0286] The embodiments of the present disclosure, as described above and shown in the drawings, provide for improvement in the art to which they pertain. While the systems, devices / apparatus and methods of the subject disclosure have been shown and described, those skilled in the art will readily appreciate that changes and / or modifications may bemade thereto without departing from the scope of the subject disclosure. For example, those skilled in the art will readily appreciate that the various aspects of the invention described and illustrated throughout the specification, and components thereof, can be readily interchanged with one another and utilized alone or in any combination, without limitation, which is explicitly contemplated herein.

[0287] It is to be appreciated that the concepts, systems, circuits and techniques sought to be protected herein are not limited to use in the example applications described herein (e.g., medical, surgical or industrial applications), but rather may be useful in substantially any application where the subject devices, systems and methods find advantageous applications. While particular embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that embodiments of the disclosure are not limited to the precise construction and compositions disclosed herein and that various modifications, changes, and variations can be apparent from the foregoing descriptions without departing from the spirit and scope of the disclosure as defined in the appended claims. Accordingly, it is submitted that that scope of the patent should not be limited to the described embodiments but rather should be limited only by the spirit and scope of the following claims.

Claims

Claims1. A method of performing a robotically assisted endoluminal submucosal dissection (ESD) procedure on a patient, comprising the steps of: a) advancing a steerable overtube assembly to a site of a lesion within a gastrointestinal (GI) tract of the patient, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) marking boundaries of the lesion using the one or more robotically controlled surgical instruments; c) injecting a fluid into a submucosal plane associated with the lesion to lift and separate the lesion from adjacent muscle tissue; d) dissecting tissue surrounding the lesion using the one or more robotically controlled surgical instruments; e) retrieving the resected lesion from the site using the one or more robotically controlled surgical instruments; and f) closing a defect created by resecting the lesion using the one or more robotically controlled surgical instruments.

2. The method of Claim 1, further comprising the step of: g) introducing the steerable overtube assembly into the GI tract before the advancing step.

3. The method of Claim 2, wherein the introducing step is effected under robotic control.

4. The method of Claim 2, wherein the introducing step is effected manually.

5. The method of Claim 4, further comprising the step of: h) docking the steerable overtube assembly to a steerable overtube controller of a surgical robot after the introducing step.

6. The method of Claim 1, wherein the method is a robotically assisted BSD procedure performed within an upper GI tract of the patient.

7. The method of Claim 6, further comprising the step of positioning the patient in a supine position with the patient's head tilted left or right or in a sword swallower position.

8. The method of Claim 1, wherein the method is a robotically assisted ESD procedure performed within a lower GI tract of the patient.

9. The method of Claim 8, further comprising the step of positioning the patient in a supine position with the patient's legs separated, flexed, and supported in stirrups, or in a lateral position.

10. The method of Claim 1, wherein the step of marking boundaries of the lesion involves cauterizing the mucosal tissue surrounding the lesion at a plurality of locations using an end effector of the one or more robotically controlled surgical instruments.

11. The method of Claim 1, wherein the step of injecting a fluid into the submucosal plane associated with the lesion involves introducing a needle through a working channel of the steerable overtube assembly to inject the fluid into the submucosal plane.

12. The method of Claim 11, wherein the step of injecting a fluid into the submucosal plane associated with the lesion involves using the one or more robotically controlled surgical instruments to retract tissue as the fluid is injected into the submucosal plane, or to direct the needle into tissue as the fluid is injected into the submucosa.

13. The method of Claim 1, wherein the step of dissecting tissue surrounding the lesion involves using an end effector of a first one of the one or more robotically controlled surgical instruments to retract tissue and using an end effector of a second one of the one or more robotically controlled surgical instruments to dissect the tissue surrounding the lesion.

14. The method of Claim 1, wherein the step of retrieving the resected lesion involves using an end effector of the one or more robotically controlled surgical instruments to place the resected lesion into a specimen retriever introduced though the steerable overtube assembly.

15. The method of Claim 1, wherein the step of closing the defect created by the resection of the lesion involves using end effectors of first and second ones of the one or more robotically controlled surgical instruments to suture the defect closed.

16. A robotic surgical system adapted and configured to perform a robotically assisted endoluminal submucosal dissection (ESD) procedure, the system comprising: a) a physician console comprising: i) a plurality of hand control input devices adapted to receive 3 -dimensional hand gesture inputs from an operator; and ii) a plurality of foot pedals configurable to perform system functions adapted to receive a foot pedal input from the operator; b) a patient cart adapted and configured for bidirectional data communication with the physician console, having a spatially configurable supporting frame having a plurality of degrees of freedom and configured to support a unitary drive unit comprising: i) an axial translation actuator associated therewith for actuating axial translation along a central axis of the unitary drive unit; ii) a roll actuator associated therewith for actuating roll movement of the unitary drive unit about the central axis of the unitary drive unit; iii) a steerable overtube controller adapted and configured to operatively engage and actuate bidirectional steering of a steerable overtube in two degrees of freedom; iv) a plurality of instrument controllers adapted and configured to operatively engage and actuate each of a plurality of elongate flexible surgical instruments deployable through first and second working channels of the steerable overtube; and v) a videoscope controller adapted and configured to operatively engage and actuate a videoscope deployable through a third working channel of the steerable overtube; andc) a system controller adapted and configured to receive a plurality of control inputs from each of the plurality of hand control input devices, to process the plurality of control inputs and to transmit a plurality of control outputs to each of the axial translation actuator, the roll actuator, the steerable overtube controller, the plurality of instrument controllers and the videoscope controller, the control outputs causing the system to: i) advance a steerable overtube assembly to a site of a lesion within a gastrointestinal (GI) tract of a patient, wherein the steerable overtube assembly is insertable into the GI tract and configured for advancing into and for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; ii) mark boundaries of the lesion using the one or more robotically controlled surgical instruments; iii) inject a fluid into a submucosal plane associated with the lesion to lift and separate the lesion from adjacent muscle tissue; iv) dissect tissue surrounding the lesion using the one or more robotically controlled surgical instruments; v) retrieve the resected lesion from the site using the one or more robotically controlled surgical instruments; and vi) close a defect created by resecting the lesion using the one or more robotically controlled surgical instruments.

17. The robotic surgical system of Claim 16, the control outputs further causing the system to: vii) introduce the steerable overtube assembly into the GI tract.

18. The robotic surgical system of Claim 16, wherein the steerable overtube assembly is manually introducible into the GI tract.

19. The robotic surgical system of Claim 18, wherein the steerable overtube assembly is adapted and configured to be docked to the steerable overtube controller following manual introduction into the GI tract.

20. A computer program product adapted and configured to enable a robotically assisted endoluminal submucosal dissection (ESD) procedure, the computer program product comprising computer-readable program code capable of being executed by one or more processors when retrieved from a non-transitory computer-readable medium, the program code comprising instructions configurable to effect: a) advancement of a steerable overtube assembly to a site of a lesion within a gastrointestinal (GI) tract of a patient, wherein the steerable overtube assembly is insertable into the GI tract and configured for advancing into and for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) marking of boundaries of the lesion using the one or more robotically controlled surgical instruments; c) injection of a fluid into a submucosal plane associated with the lesion to lift and separate the lesion from adjacent muscle tissue; d) dissection of tissue surrounding the lesion using the one or more robotically controlled surgical instruments; e) removal of the resected lesion from the site using the one or more robotically controlled surgical instruments; and f) closure of a defect created by resecting the lesion using the one or more robotically controlled surgical instruments.

21. The computer program product of Claim 20, wherein the program code further comprises instructions configurable to effect: g) introduction of the steerable overtube assembly into the GI tract.

22. The computer program product of Claim 20, wherein the steerable overtube assembly is manually introducible into the GI tract, wherein the steerable overtube assembly is adapted and configured to be docked to a steerable overtube controller following manual introduction into the GI tract, and wherein the program code further comprises instructions configurable to robotically steer the steerable overtube following docking with the robotic controller.

23. A method of performing a robotically assisted endoluminal sleeve gastroplasty (ESG) procedure on a patient, comprising the steps of: a) advancing a steerable overtube assembly into a stomach of the patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) marking guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement using the one or more robotically controlled surgical instruments; c) stitching a suture through the marked gastric walls or though the mucosectomies in the stomach in a predefined pattern to acquire tissue using the one or more robotically controlled surgical instruments; and d) pulling opposite ends of the suture to appose the acquired tissue and thus forming a first distal suture plication, using a pair of the one or more robotically controlled surgical instruments.

24. The method of Claim 23, further comprising the step of: e) introducing the steerable overtube assembly into an upper gastrointestinal (GI) tract before the advancing step.

25. The method of Claim 24, wherein the introducing step is effected under robotic control.

26. The method of Claim 24, wherein the introducing step is effected manually.

27. The method of Claim 26, further comprising the step of: f) docking the steerable overtube assembly to a steerable overtube controller of a surgical robot after the introducing step.

28. The method of Claim 23, further comprising the step of forming one or more subsequent suture plications proximal to the first suture plication by continually repeating steps (c) and (d) until a stomach volume and stomach length have been reduced by a predetermined amount.

29. The method of Claim 23, further comprising the step of positioning the patient in a supine position with the patient's head tilted left or right or in a sword swallower position.

30. The method of Claim 23, wherein the step of marking guidelines and / or forming mucosectomies on the anterior and posterior gastric walls of the stomach involves cauterizing the gastric walls using an end effector of the one or more robotically controlled surgical instruments.

31. The method of Claim 23, wherein the step of stitching a suture through the marked gastric walls involves using end effectors of first and second ones of the one or more robotically controlled surgical instruments to place the suture.

32. The method of Claim 23, wherein the step of pulling opposite ends of the suture to appose the acquired tissue involves using end effectors of first and second ones of the one or more robotically controlled surgical instruments to grasp and tighten the suture.

33. A robotic surgical system adapted and configured to perform a robotically assisted endoluminal sleeve gastroplasty (ESG) procedure, the system comprising: a) a physician console comprising: i) a plurality of hand control input devices adapted to receive 3 -dimensional hand gesture inputs from an operator; and ii) a plurality of foot pedals configurable to perform system functions adapted to receive a foot pedal input from the operator; b) a patient cart adapted and configured for bidirectional data communication with the physician console, having a spatially configurable supporting frame having a plurality of degrees of freedom and configured to support a unitary drive unit comprising: i) an axial translation actuator associated therewith for actuating axial translation along a central axis of the unitary drive unit; ii) a roll actuator associated therewith for actuating roll movement of the unitary drive unit about the central axis of the unitary drive unit;iii) a steerable overtube controller adapted and configured to operatively engage and actuate bidirectional steering of a steerable overtube in two degrees of freedom; iv) a plurality of instrument controllers adapted and configured to operatively engage and actuate each of a plurality of elongate flexible surgical instruments deployable through first and second working channels of the steerable overtube; and v) a videoscope controller adapted and configured to operatively engage and actuate a videoscope deployable through a third working channel of the steerable overtube; and c) a system controller adapted and configured to receive a plurality of control inputs from each of the plurality of hand control input devices, to process the plurality of control inputs and to transmit a plurality of control outputs to each of the axial translation actuator, the roll actuator, the steerable overtube controller, the plurality of instrument controllers and the videoscope controller, the control outputs causing the system to: i) advance a steerable overtube assembly into a stomach of a patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; ii) mark guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement using the one or more robotically controlled surgical instruments; iii) stitch a suture through the marked gastric walls or though the mucosectomies in the stomach in a predefined pattern to acquire tissue using the one or more robotically controlled surgical instruments; and iv) pull opposite ends of the suture to appose the acquired tissue and thus forming a first distal suture plication, using a pair of the one or more robotically controlled surgical instruments.

34. The robotic surgical system of Claim 33, the control outputs further causing the system to: vii) introduce the steerable overtube assembly into an upper GI tract of the patient.

35. The robotic surgical system of Claim 33, wherein the steerable overtube assembly is manually introducible into an upper GI tract of the patient.

36. The robotic surgical system of Claim 35, wherein the steerable overtube assembly is adapted and configured to be docked to the steerable overtube controller following manual introduction into the upper GI tract.

37. A computer program product adapted and configured to enable an endoluminal sleeve gastroplasty (ESG) procedure, the computer program product comprising computer-readable program code capable of being executed by one or more processors when retrieved from a non- transitory computer-readable medium, the program code comprising instructions configurable to effect: a) advancement of a steerable overtube assembly into a stomach of a patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) marking of guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement using the one or more robotically controlled surgical instruments; c) stitching of a suture through the marked gastric walls or though the mucosectomies in the stomach in a predefined pattern to acquire tissue using the one or more robotically controlled surgical instruments; and d) pulling on opposite ends of the suture to appose the acquired tissue and thus forming a first distal suture plication, using a pair of the one or more robotically controlled surgical instruments.

38. The computer program product of Claim 37, wherein the program code further comprises instructions configurable to effect: g) introduction of the steerable overtube assembly into an upper GI tract of the patient.

39. The computer program product of Claim 37, wherein the steerable overtube assembly is manually introducible into the upper GI tract, wherein the steerable overtube assembly is adapted and configured to be docked to a steerable overtube controller following manual introduction into the upper GI tract, and wherein the program code further comprises instructions configurable to robotically steer the steerable overtube following docking with the robotic controller.

40. A method of performing a robotically assisted bariatric endoluminal antral myotomy (BEAM) procedure on a patient, comprising the steps of: a) advancing a steerable overtube assembly into a stomach of the patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injecting a fluid into a submucosal plane of the stomach at the site, to lift and separate a mucosal tissue layer from a muscle layer; c) creating a mucosal incision at the site along the greater curvature of the stomach using at least one robotically controlled surgical instrument deployed from a distal end of the steerable overtube assembly; d) tunneling through the mucosal incision, under the mucosa layer to a submucosal plane, and to a location proximal to a pylorus using the one or more robotically controlled surgical instruments; e) forming two parallel lines of partial thickness myotomy from a distal to proximal antrum of the stomach using the one or more robotically controlled surgical instruments; and f) closing the mucosal incision using the one or more robotically controlled surgical instruments.

41. The method of Claim 40, further comprising the step of: g) introducing the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient, before the advancing step.

42. The method of Claim 41, wherein the introducing step is effected under robotic control.

43. The method of Claim 41, wherein the introducing step is effected manually.

44. The method of Claim 43, further comprising the step of: h) docking the steerable overtube assembly to a steerable overtube controller of a surgical robot after the introducing step.

45. The method of Claim 40, further comprising a step of positioning the patient in a supine or prone position with the patient's head tilted left or right.

46. The method of Claim 40, wherein the step of injecting the fluid into the submucosal plane involves introducing a needle through a working channel of the steerable overtube assembly to inject the fluid into the submucosal plane.

47. The method of Claim 46, wherein the step of injecting a fluid into the submucosal plane involves using the one or more robotically controlled surgical instruments to retract the mucosal tissue layer as the fluid is injected into the submucosal plane, or to direct the needle into tissue as the fluid is injected into the submucosa.

48. The method of Claim 40, wherein the step of creating a mucosal incision involves using an end effector of a first one of the one or more robotically controlled surgical instruments to retract the mucosa layer and using an end effector of a second one of the one or more robotically controlled surgical instruments to form the incision.

49. The method of Claim 40, wherein the step of tunneling under the mucosa layer of the stomach to the submucosal plane involves using an end effector of a robotically controlled surgical instrument to retract the mucosa and using an end effector of the one or more robotically controlled surgical instruments to tunnel below the mucosal tissue layer.

50. The method of Claim 40, wherein the step of forming the two parallel lines of partial thickness myotomy involves using an end effector of a first one of the one or more roboticallycontrolled surgical instruments to retract the mucosa layer and using an end effector of a second one of the one or more robotically controlled surgical instruments to form the two parallel lines of partial thickness myotomy.

51. The method of Claim 40, wherein the step of closing the mucosal incision involves using end effectors of first and second ones of the one or more robotically controlled surgical instruments to suture the mucosal incision closed.

52. A robotic surgical system adapted and configured to perform a robotically assisted bariatric endoluminal antral myotomy (BEAM) procedure, the system comprising: a) a physician console comprising: i) a plurality of hand control input devices adapted to receive 3 -dimensional hand gesture inputs from an operator; and ii) a plurality of foot pedals configurable to perform system functions adapted to receive a foot pedal input from the operator; b) a patient cart adapted and configured for bidirectional data communication with the physician console, having a spatially configurable supporting frame having a plurality of degrees of freedom and configured to support a unitary drive unit comprising: i) an axial translation actuator associated therewith for actuating axial translation along a central axis of the unitary drive unit; ii) a roll actuator associated therewith for actuating roll movement of the unitary drive unit about the central axis of the unitary drive unit; iii) a steerable overtube controller adapted and configured to operatively engage and actuate bidirectional steering of a steerable overtube in two degrees of freedom; iv) a plurality of instrument controllers adapted and configured to operatively engage and actuate each of a plurality of elongate flexible surgical instruments deployable through first and second working channels of the steerable overtube; and v) a videoscope controller adapted and configured to operatively engage and actuate a videoscope deployable through a third working channel of the steerable overtube; andc) a system controller adapted and configured to receive a plurality of control inputs from each of the plurality of hand control input devices, to process the plurality of control inputs and to transmit a plurality of control outputs to each of the axial translation actuator, the roll actuator, the steerable overtube controller, the plurality of instrument controllers and the videoscope controller, the control outputs causing the system to: i) advance a steerable overtube assembly into a stomach of a patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; ii) inject a fluid into a submucosal plane of the stomach at the site, to lift and separate a mucosal tissue layer from a muscle layer; iii) create a mucosal incision at the site along the greater curvature of the stomach using at least one robotically controlled surgical instrument deployed from a distal end of the steerable overtube assembly; iv) tunnel through the mucosal incision, under the mucosa layer to a submucosal plane, and to a location proximal to a pylorus using the one or more robotically controlled surgical instruments; v) form two parallel lines of partial thickness myotomy from a distal to proximal antrum of the stomach using the one or more robotically controlled surgical instruments; and vi) close the mucosal incision using the one or more robotically controlled surgical instruments.

53. The robotic surgical system of Claim 52, the control outputs further causing the system to: vii) introduce the steerable overtube assembly into an upper GI tract of the patient.

54. The robotic surgical system of Claim 52, wherein the steerable overtube assembly is manually introducible into an upper GI tract of the patient.

55. The robotic surgical system of Claim 54, wherein the steerable overtube assembly is adapted and configured to be docked to the steerable overtube controller following manual introduction into the upper GI tract.

56. A computer program product adapted and configured to enable a bariatric endoluminal antral myotomy (BEAM) procedure, the computer program product comprising computer- readable program code capable of being executed by one or more processors when retrieved from a non-transitory computer-readable medium, the program code comprising instructions configurable to effect: a) advancement of a steerable overtube assembly into a stomach of a patient to a site adjacent a distal greater curvature of the stomach, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injection of a fluid into a submucosal plane of the stomach at the site, to lift and separate a mucosal tissue layer from a muscle layer; c) creation of a mucosal incision at the site along the greater curvature of the stomach using at least one robotically controlled surgical instrument deployed from a distal end of the steerable overtube assembly; d) tunneling through the mucosal incision, under the mucosa layer to a submucosal plane, and to a location proximal to a pylorus using the one or more robotically controlled surgical instruments; e) formation of two parallel lines of partial thickness myotomy from a distal to proximal antrum of the stomach using the one or more robotically controlled surgical instruments; and f) closure of the mucosal incision using the one or more robotically controlled surgical instruments.

57. The computer program product of Claim 56, wherein the program code further comprises instructions configurable to effect: g) introduction of the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient.

58. The computer program product of Claim 56, wherein the steerable overtube assembly is manually introducible into the upper GI tract, wherein the steerable overtube assembly is adapted and configured to be docked to a steerable overtube controller following manual introduction into the upper GI tract, and wherein the program code further comprises instructions configurable to robotically steer the steerable overtube following docking with the robotic controller.

59. A method of performing a robotically assisted peroral endoluminal myotomy (POEM) procedure on a patient, comprising the steps of: a) advancing a steerable overtube assembly into an esophagus or stomach of the patient to a site adjacent a lower esophageal sphincter or a pyloric sphincter, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injecting a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a muscle layer; c) creating a mucosal incision at the site using the one or more robotically controlled surgical instruments; d) tunneling under the mucosa layer to the submucosal plane through the mucosal incision, to a location immediately proximal to the lower esophageal sphincter or the pyloric sphincter, using the one or more robotically controlled surgical instruments; e) forming a linear myotomy of an anterior portion of the lower esophageal sphincter or the pyloric sphincter using the one or more robotically controlled surgical instruments; and f) closing the mucosal incision using the one or more robotically controlled surgical instruments.

60. The method of Claim 59, further comprising the step of: g) introducing the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient before the advancing step.61 . The method of Claim 60, wherein the introducing step is effected under robotic control.

62. The method of Claim 60, wherein the introducing step is effected manually.

63. The method of Claim 62, further comprising the step of: h) docking the steerable overtube assembly to a steerable overtube controller of a surgical robot after the introducing step.

64. The method of Claim 59, further comprising the step of positioning the patient in a supine or prone position with the patient's head tilted left or right.

65. The method of Claim 59, wherein the step of injecting a fluid into the submucosal plane involves introducing a needle through a working channel of the overtube assembly to inject the fluid into the submucosal plane.

66. The method of Claim 59, wherein the step of injecting a fluid into the submucosal plane involves using an end effector of the one or more robotically controlled surgical instruments to retract the mucosal tissue layer as the fluid is injected into the submucosal plane, or to direct the needle into tissue as the fluid is injected into the submucosa.

67. The method of Claim 59, wherein the step of creating a mucosal incision involves using an end effector of a first one of the one or more robotically controlled surgical instruments to retract the mucosal tissue layer and using an end effector of a second one of the one or more robotically controlled surgical instruments to form the incision.

68. The method of Claim 59, wherein the step of tunneling under the mucosal tissue layer to the submucosal plane involves using an end effector of a first one of the one or more robotically controlled surgical instruments to retract the mucosal tissue layer and using an end effector of a second one of the one or more robotically controlled surgical instruments to tunnel below the mucosal tissue layer.

69. The method of Claim 59, wherein the step of forming the linear myotomy involves using an end effector of a first one of the one or more robotically controlled surgical instruments to retract the mucosal tissue layer and using an end effector of a second one of the one or more robotically controlled surgical instruments to form the myotomy.

70. The method of Claim 59, wherein the step of closing the mucosal incision involves using end effectors of first and second one of the one or more robotically controlled surgical instruments to suture the mucosal incision closed.

71. A robotic surgical system adapted and configured to perform a robotically assisted peroral endoluminal myotomy (POEM) procedure, the system comprising: a) a physician console comprising: i) a plurality of hand control input devices adapted to receive 3 -dimensional hand gesture inputs from an operator; and ii) a plurality of foot pedals configurable to perform system functions adapted to receive a foot pedal input from the operator; b) a patient cart adapted and configured for bidirectional data communication with the physician console, having a spatially configurable supporting frame having a plurality of degrees of freedom and configured to support a unitary drive unit comprising: i) an axial translation actuator associated therewith for actuating axial translation along a central axis of the unitary drive unit; ii) a roll actuator associated therewith for actuating roll movement of the unitary drive unit about the central axis of the unitary drive unit; iii) a steerable overtube controller adapted and configured to operatively engage and actuate bidirectional steering of a steerable overtube in two degrees of freedom; iv) a plurality of instrument controllers adapted and configured to operatively engage and actuate each of a plurality of elongate flexible surgical instruments deployable through first and second working channels of the steerable overtube; andv) a videoscope controller adapted and configured to operatively engage and actuate a videoscope deployable through a third working channel of the steerable overtube; and c) a system controller adapted and configured to receive a plurality of control inputs from each of the plurality of hand control input devices, to process the plurality of control inputs and to transmit a plurality of control outputs to each of the axial translation actuator, the roll actuator, the steerable overtube controller, the plurality of instrument controllers and the videoscope controller, the control outputs causing the system to: i) advance a steerable overtube assembly into an esophagus or stomach of a patient to a site adjacent a lower esophageal sphincter or a pyloric sphincter, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; ii) inject a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a muscle layer; iii) create a mucosal incision at the site using the one or more robotically controlled surgical instruments; iv) tunnel under the mucosa layer to the submucosal plane through the mucosal incision, to a location immediately proximal to the lower esophageal sphincter or the pyloric sphincter, using the one or more robotically controlled surgical instruments; v) form a linear myotomy of an anterior portion of the lower esophageal sphincter or the pyloric sphincter using the one or more robotically controlled surgical instruments; and vi) close the mucosal incision using the one or more robotically controlled surgical instruments.

72. The robotic surgical system of Claim 71, the control outputs further causing the system to: vii) introduce the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient.

73. The robotic surgical system of Claim 71, wherein the steerable overtube assembly is manually introducible into the upper GI tract.

74. The robotic surgical system of Claim 73, wherein the steerable overtube assembly is adapted and configured to be docked to the steerable overtube controller following manual introduction into the upper GI tract.

75. A computer program product adapted and configured to enable a peroral endoluminal myotomy (POEM) procedure, the computer program product comprising computer-readable program code capable of being executed by one or more processors when retrieved from a non- transitory computer-readable medium, the program code comprising instructions configurable to effect: a) advancement of a steerable overtube assembly into an esophagus or stomach of the patient to a site adjacent a lower esophageal sphincter or a pyloric sphincter, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injection of a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a muscle layer; c) creation of a mucosal incision at the site using the one or more robotically controlled surgical instruments; d) tunneling under the mucosa layer to the submucosal plane through the mucosal incision, to a location immediately proximal to the lower esophageal sphincter or the pyloric sphincter, using the one or more robotically controlled surgical instruments; e) formation of a linear myotomy of an anterior portion of the lower esophageal sphincter or the pyloric sphincter using the one or more robotically controlled surgical instruments; and f) closure of the mucosal incision using the one or more robotically controlled surgical instruments.

76. The computer program product of Claim 75, wherein the program code further comprises instructions configurable to effect: g) introduction of the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient.

77. The computer program product of Claim 75, wherein the steerable overtube assembly is manually introducible into the upper GI tract, wherein the steerable overtube assembly is adapted and configured to be docked to a steerable overtube controller following manual introduction into the upper GI tract, and wherein the program code further comprises instructions configurable to robotically steer the steerable overtube following docking with the robotic controller.

78. A method of performing a robotically assisted gastroplasty with endoscopic myotomy (GEM) on a patient, comprising the steps of: a) advancing a steerable overtube assembly toward an antrum of a stomach of the patient to a site at or near an incisura, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injecting a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a stomach muscle layer; c) creating a mucosal incision at the site using the one or more robotically controlled surgical instruments; d) tunneling under the mucosal tissue layer to a submucosa, through the mucosal incision, to a location proximal to a pyloric sphincter using the one or more robotically controlled surgical instruments; e) forming an antral myotomy of the stomach muscle layer using the one or more robotically controlled surgical instruments; f) closing the mucosal incision using the one or more robotically controlled surgical instruments; and g) performing an endoluminal sleeve gastroplasty proximal to the antral myotomy using the one or more robotically controlled surgical instruments.

79. The method of Claim 78, wherein the step of performing an endoluminal sleeve gastroplasty involves the steps of: h) placing a running stitch at the incisura, perpendicular to and proximal the antral myotomy;i) marking guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement, using the one or more robotically controlled surgical instruments; j) stitching a suture through marked gastric walls or though mucosectomies in the stomach in a predefined pattern to acquire tissue, using the one or more robotically controlled surgical instruments; and k) pulling opposite ends of the suture to appose the acquired tissue and thus form a first suture plication, using first and second ones of the one or more robotically controlled surgical instruments.

80. The method of Claim 79, further comprising the step of forming one or more subsequent suture plications proximal to the first suture plication by continually repeating steps (k) and (1) until a stomach volume and a stomach length have been reduced by a predetermined amount.

81. The method of Claim 78, further comprising the step of: h) introducing the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient before the advancing step.

82. The method of Claim 81, wherein the introducing step is effected under robotic control.

83. The method of Claim 81, wherein the introducing step is effected manually.

84. The method of Claim 83, further comprising the step of: i) docking the steerable overtube assembly to a steerable overtube controller of a surgical robot after the introducing step.

85. The method of Claim 78, further comprising the step of positioning the patient in a supine position with the patient's head tilted left or right or in a sword swallower position.

86. A robotic surgical system adapted and configured to perform a robotically assisted gastroplasty with endoscopic myotomy (GEM) procedure, the system comprising:a) a physician console comprising: i) a plurality of hand control input devices adapted to receive 3 -dimensional hand gesture inputs from an operator; and ii) a plurality of foot pedals configurable to perform system functions adapted to receive a foot pedal input from the operator; b) a patient cart adapted and configured for bidirectional data communication with the physician console, having a spatially configurable supporting frame having a plurality of degrees of freedom and configured to support a unitary drive unit comprising: i) an axial translation actuator associated therewith for actuating axial translation along a central axis of the unitary drive unit; ii) a roll actuator associated therewith for actuating roll movement of the unitary drive unit about the central axis of the unitary drive unit; iii) a steerable overtube controller adapted and configured to operatively engage and actuate bidirectional steering of a steerable overtube in two degrees of freedom; iv) a plurality of instrument controllers adapted and configured to operatively engage and actuate each of a plurality of elongate flexible surgical instruments deployable through first and second working channels of the steerable overtube; and v) a videoscope controller adapted and configured to operatively engage and actuate a videoscope deployable through a third working channel of the steerable overtube; and c) a system controller adapted and configured to receive a plurality of control inputs from each of the plurality of hand control input devices, to process the plurality of control inputs and to transmit a plurality of control outputs to each of the axial translation actuator, the roll actuator, the steerable overtube controller, the plurality of instrument controllers and the videoscope controller, the control outputs causing the system to: i) advance a steerable overtube assembly toward an antrum of a stomach of the patient to a site at or near an incisura, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; ii) inject a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a stomach muscle layer;iii) create a mucosal incision at the site using the one or more robotically controlled surgical instruments; iv) tunnel under the mucosal tissue layer to a submucosa, through the mucosal incision, to a location proximal to a pyloric sphincter using the one or more robotically controlled surgical instruments; v) form an antral myotomy of the stomach muscle layer using the one or more robotically controlled surgical instruments; vi) close the mucosal incision using the one or more robotically controlled surgical instruments; and vii) perform an endoluminal sleeve gastroplasty proximal to the antral myotomy using the one or more robotically controlled surgical instruments.

87. The robotic surgical system of Claim 86, the control outputs further causing the system to: viii) place a running stitch at the incisura, perpendicular to and proximal the antral myotomy; ix) mark guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement, using the one or more robotically controlled surgical instruments; x) stitch a suture through marked gastric walls or though mucosectomies in the stomach in a predefined pattern to acquire tissue, using the one or more robotically controlled surgical instruments; and xi) pull opposite ends of the suture to appose the acquired tissue and thus form a first suture plication, using first and second ones of the one or more robotically controlled surgical instruments.

88. The robotic surgical system of Claim 86, the control outputs further causing the system to: vii) introduce the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient.

89. The robotic surgical system of Claim 86, wherein the steerable overtube assembly is manually introducible into an upper gastrointestinal (GI) tract of the patient.

90. The robotic surgical system of Claim 89, wherein the steerable overtube assembly is adapted and configured to be docked to the steerable overtube controller following manual introduction into the upper GI tract.

91. A computer program product adapted and configured to enable a robotically assisted gastroplasty with endoscopic myotomy (GEM) procedure, the computer program product comprising computer-readable program code capable of being executed by one or more processors when retrieved from a non-transitory computer-readable medium, the program code comprising instructions configurable to effect: a) advancement of a steerable overtube assembly toward an antrum of a stomach of a patient to a site at or near an incisura, the steerable overtube assembly configured for introducing and deploying from a distal end thereof one or more robotically controlled surgical instruments; b) injection of a fluid into a submucosal plane at the site to lift and separate a mucosal tissue layer from a stomach muscle layer; c) creation of a mucosal incision at the site using the one or more robotically controlled surgical instruments; d) tunneling under the mucosal tissue layer to a submucosa, through the mucosal incision, to a location proximal to a pyloric sphincter using the one or more robotically controlled surgical instruments; e) formation of an antral myotomy of the stomach muscle layer using the one or more robotically controlled surgical instruments; f) closure of the mucosal incision using the one or more robotically controlled surgical instruments; and g) performance of an endoluminal sleeve gastroplasty proximal to the antral myotomy using the one or more robotically controlled surgical instruments.

92. The computer program product of Claim 91 , wherein the program code further comprises instructions configurable to effect: h) placing of a running stitch at the incisura, perpendicular to and proximal the antral myotomy; i) marking of guidelines or forming mucosectomies on anterior and posterior gastric walls of the stomach to guide subsequent suture placement, using the one or more robotically controlled surgical instruments; j) stitching of a suture through marked gastric walls or though mucosectomies in the stomach in a predefined pattern to acquire tissue, using the one or more robotically controlled surgical instruments; and k) pulling of opposite ends of the suture to appose the acquired tissue and thus form a first suture plication, using first and second ones of the one or more robotically controlled surgical instruments.

93. The computer program product of Claim 91, wherein the program code further comprises instructions configurable to effect: g) introduction of the steerable overtube assembly into an upper gastrointestinal (GI) tract of the patient.

94. The computer program product of Claim 91, wherein the steerable overtube assembly is manually introducible into the upper GI tract, wherein the steerable overtube assembly is adapted and configured to be docked to a steerable overtube controller following manual introduction into the upper GI tract, and wherein the program code further comprises instructions configurable to robotically steer the steerable overtube following docking with the robotic controller.

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