Robotic system for use through a natural orifice and for suturing within the gastrointestinal tract - Patent Application 20070122999

Abstract

A flexible robotic system is provided for guidance and to facilitate secure suturing within the gastrointestinal tract, providing assistance, assurance, and verification to compensate for the operator's skill and experience level and to expedite the completion of intragastric bariatric procedures.

Description

[Technical Field]

[0001] The present disclosure relates to treatment systems for treating mammalian bodies through natural orifices, and more particularly, to robotic systems adapted to facilitate operation of such treatment systems and treatment methods. [Background technology]

[0002] The condition of obesity means that an individual has a large amount of body fat and weighs more than is considered healthy for the individual's height. While biology plays a large role in why people become obese, not getting enough exercise, eating more food than the body can utilize, and drinking too much alcohol also contribute to people becoming obese. Obesity is a major health threat because excess weight puts more stress on all parts of the body and puts people at risk for a variety of health problems, such as diabetes, heart disease, and stroke.

[0003] For some people, lifestyle changes such as maintaining a healthy diet and exercising regularly can help reduce body fat and halt obesity. However, for others, reducing body fat and maintaining consistent weight loss can be extremely difficult. Weight-loss medications are available on the market, but some medications have serious side effects, may not be effective, and patient compliance with regular use can be low. For obese individuals who are unable to reduce body fat mass through lifestyle changes or medication, various surgical options are available.

[0004] Gastric bypass surgery was the first commonly performed procedure to make the stomach smaller. This procedure involves stapling together portions of the stomach wall and then repositioning a small portion of the small intestine into the newly formed gastric pouch. By reducing the size of the stomach, the stomach holds less food, the individual feels full more quickly, fewer calories are ingested, fewer calories are absorbed, and weight loss results. However, this procedure has drawbacks. It is an open surgical procedure that carries its own risks, including the possibility of complications and infection, and can have a lengthy post-operative recovery period. It is also relatively complex and requires restructuring of the small intestine. Furthermore, the staples may release over time, causing the stomach to expand again, or the stomach's volume may naturally expand over time, reducing the effectiveness of the procedure.

[0005] Another procedure is "gastric banding," primarily using the LAP-BAND® system, which involves inserting an inflatable band around the stomach through a laparoscopic procedure. The band is wrapped around the upper part of the stomach to form a stoma, or ring. A thin tube connected to an access port implanted under the skin is attached to the ring. A balloon attached to the band contacts the stomach and can be inflated (or deflated) with saline through the access port using a needle. Adding saline tightens the stoma around the stomach, causing a feeling of fullness more quickly. If the band is too tight, the saline can be withdrawn. The advantage of gastric banding is that the procedure can be performed minimally invasively through a small laparoscopic incision in the abdomen, resulting in a reduced recovery period and no small bowel remodeling. Nevertheless, the procedure still requires an incision, which can result in infection and uncomfortable recovery. Additionally, a permanent port is left beneath the patient's skin, which may be undesirable for some patients.

[0006] These types of procedures can be effective if all goes well, but as mentioned above, they carry the risks associated with open or laparoscopic surgery and are therefore only prescribed in cases of extreme obesity.

[0007] Incision-free, fully endoscopic methods for reducing gastric volume have been developed for surgically treating obesity. Generally, such methods involve endoluminal approximation of tissue in a portion of the stomach, including at least a portion of the greater curvature of the stomach. The method involves creating an endoscopic stitch pattern, which closes most of the stomach. The resulting gastric reduction procedure can provide a 70-75 percent reduction in available stomach volume. Because this procedure does not involve an incision, it is safer for the patient and allows for a faster recovery.

[0008] Although this procedure has been shown to be an effective method for reducing gastric volume, producing faster satiety, and resulting in weight loss in obese patients, obstacles remain in its application. Bariatric procedures are traditionally performed by bariatric surgeons who approach gastric reduction from the outside of the stomach and are unfamiliar with operating on the anatomy of the gastrointestinal tract as viewed from the inside. Meanwhile, gastroenterologists, who are more familiar with manipulating the stomach from the inside, are unfamiliar with bariatric procedures and surgical suturing, resulting in reduced comfort with such procedures. Summary of the Invention

[0009] This Summary is provided to introduce a selection of concepts in a simplified form that are described in more detail below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. Those skilled in the art will understand that each of the various aspects and features of the disclosure, whether described in this Summary or not, can be advantageously used separately in some instances, or in other instances in combination with other aspects and features of the disclosure. No limitation on the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary.

[0010] A flexible robotic system is provided for guidance and to facilitate secure suturing within the gastrointestinal tract, providing assistance, assurance, and verification to compensate for the operator's skill and experience level and to expedite the completion of intragastric bariatric procedures.

[0011] In accordance with various principles of the present disclosure, a robotic suturing system is configured for use in the gastrointestinal tract of a human patient, the human patient having a natural orifice communicating with the gastrointestinal tract. In some aspects, the system includes a flexible, deformable endoluminal robot adapted to be inserted into the gastrointestinal tract through the natural orifice, the endoluminal robot having a proximal end and a distal end, a suturing tool removably coupled to the distal end of the flexible endoluminal robot, the suturing tool adapted to grasp tissue and advance a needle with a suture through the grasped tissue, a robotic control system configured to control movement of the endoluminal robot and the needle on the suturing tool, an imaging system for acquiring real-time images of the gastrointestinal tract, and a display for presenting the real-time images to an operator.

[0012] In some aspects, the robotic control system includes an actuator for operating the endoluminal robot and an actuator for operating the suturing tool, and an operator interface for controlling the actuators.

[0013] In some aspects, the system further includes a sensor adapted to map at least a portion of the gastrointestinal tract. In some embodiments, the imaging system includes at least one of an optical sensor, a laser scanning sensor, a distance sensor, an ultrasonic sensor, a CT scanning device, and a LIDAR sensor.

[0014] In some aspects, the system further includes a mapping system for defining a virtual map of a portion of the gastrointestinal tract. In some aspects, the system further includes a modeling system for proposing a pre-operative plan for a procedure in the gastrointestinal tract. In some aspects, the modeling system is adapted to project aspects of the pre-operative plan onto the real-time image.

[0015] In some embodiments, the system further includes one or more sensors adapted to determine whether the needle has been inserted through the full thickness of the tissue. In some aspects, the display is also adapted to present a virtual image to guide the operator. In some aspects, the virtual image includes suggested suture locations. In some aspects, the virtual image includes warning zones for non-suturing. In some aspects, the virtual image includes suggested suture locations. In some aspects, the virtual image includes suggested suture orientations. In some aspects, the virtual image includes anatomical landmarks. In some aspects, the virtual image includes fiducials.

[0016] In accordance with various principles of the present disclosure, a method for suturing tissue of a portion of a patient's gastrointestinal tract includes mapping at least a portion of the gastrointestinal tract, acquiring imaging data of the patient, constructing a digital twin of the portion of the gastrointestinal tract, identifying suggested locations for suturing within the digital twin, providing a suturing system having an imaging system capable of acquiring real-time video images, inserting the suturing system into the gastrointestinal tract through a natural orifice, virtually overlaying the suggested locations on the real-time video images, and suturing the portion of the gastrointestinal tract system.

[0017] In some embodiments, the portion of the gastrointestinal tract is the stomach. In some embodiments, the sutures reshape the stomach. In some variations, the sutures are placed at the proposed locations.

[0018] In some aspects, the method further includes updating the suggested locations for suturing as the portion of the gastrointestinal tract is sutured. In some aspects, the method further includes providing a virtual overlay of the warning zone on the real-time video image.

[0019] In some aspects, the method further includes updating the virtual overlay for the warning zone as the gastrointestinal tract is sutured. In some embodiments, the method further comprises providing an overlay of an estimated current volume reduction of the portion of the gastrointestinal tract caused by the suturing.

[0020] In some embodiments, the method further includes providing an overlay of anatomical landmarks on the real-time video image. In some aspects, the method further includes providing fiducials on landmarks of the gastrointestinal tract to guide the human operator. In some aspects, the fiducials are virtual and are overlaid on the real-time image. In some aspects, the fiducials are physical. In some aspects, the fiducials can be sensed by a sensor of the system.

[0021] In some embodiments, the method further includes monitoring whether the needle passes through the full thickness of the tissue. In some embodiments, the method further includes determining whether the needle has passed through the full thickness of the tissue by using a force sensor, hi some embodiments, the determining comprises analyzing at least one signal from the force sensor to determine whether the needle has passed through the full thickness of the tissue.

[0022] In some embodiments, the method further includes providing insufflation gas within the gastrointestinal tract and adjusting the amount of insufflation gas as the gastrointestinal space is sutured. In some aspects, the method further includes grasping the tissue before suturing, monitoring the force on the grasped tissue, and releasing the grasped tissue if the force exceeds a threshold.

[0023] In some embodiments, the needle is coupled to a suture that is detectable by a robotic system. In some embodiments, the suture includes a surface texture. In some embodiments, the suture includes a surface pattern.

[0024] In some embodiments, the method further includes monitoring tension in the suture. In some variations, the method further comprises controlling the tension of the suture. In accordance with various principles of the present disclosure, a method for suturing tissue in a portion of a patient's stomach includes providing a suturing system having an imaging system capable of acquiring real-time video images, inserting the suturing system into the stomach through a natural orifice, overlaying a virtual image on the real-time video image on a display, and suturing the portion of the stomach.

[0025] In some embodiments, the virtual image includes proposed suture locations. In some embodiments, the virtual image includes a warning zone for non-sutures. In some embodiments, the virtual image includes proposed suture locations.

[0026] In some embodiments, the virtual image includes a proposed suture orientation. In some embodiments, the virtual image includes anatomical landmarks. In some embodiments, the virtual image includes a fiducial.

[0027] In accordance with various principles of the present disclosure, an integrated needle and suture includes a needle having a shaft defining a sharp tissue-piercing end and an opening, and a length of suture having first and second ends secured to the needle, the suture having at least one barb along its length, the second end of the suture adapted to be withdrawn through the opening and to be self-retained therethrough upon passage of the at least one barb through the opening. These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be understood that individual aspects may be claimed separately or in combination with aspects and features of that embodiment or any other embodiment. [Brief explanation of the drawings]

[0028] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected therein may vary. For example, devices may be enlarged so that their details can be appreciated, but are intended to be scaled down, for example, to fit within the working channel of a delivery catheter or endoscope. For clarity and conciseness, not every element is labeled in every figure, and not every element of each embodiment is shown unless the illustration is necessary for one of ordinary skill in the art to understand the disclosure.

[0029] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference numerals represent like elements, and in which: [Figure 1] FIG. 1 is a schematic diagram of a robotic suturing system. [Figure 2] FIG. 1 illustrates a distal end perspective view of an embodiment of a robotic suturing system. [Figure 3] FIG. 3 is an exploded view of the embodiment of the robotic suturing system of FIG. 2. [Figure 4] FIG. 13 is a perspective view of the distal end of another embodiment of a robotic suturing system. [Figure 5] FIG. 1 is a schematic side view of a first cartridge end cap suturing system for a robotic suturing system. [Figure 6] FIG. 6 is a rear perspective view of the distal end of the system of FIG. 5. [Figure 7] FIG. 6 is a front perspective view of the distal end of the system of FIG. 5. [Figure 8] FIG. 1 is a schematic diagram of a second cartridge end cap suturing system for a robotic suturing system. [Figure 9] FIG. 12 is a schematic diagram of a third cartridge suturing system for a robotic suturing system. [Figure 10] FIG. 1 is a flow diagram of the process before and during the suturing procedure. [Figure 11] 1A-1C are schematic diagrams of the display of the robotic suturing system at various steps in a procedure and in various situations. [Figure 12] 1A-1C are schematic diagrams of the display of the robotic suturing system at various steps in a procedure and in various situations. [Figure 13A] FIG. 1 is a perspective view of the distal end of a robotic suturing system within the gastrointestinal tract, illustrating the orientation of the suturing system relative to the tissue for optimal performance. [Figure 13B] FIG. 1 is a perspective view of the distal end of a robotic suturing system within the gastrointestinal tract, illustrating the orientation of the suturing system relative to the tissue for optimal performance. [Figure 13C] FIG. 1 is a perspective view of the distal end of a robotic suturing system within the gastrointestinal tract, illustrating the orientation of the suturing system relative to the tissue for optimal performance. [Figure 14] 1A-1C are schematic diagrams of the display of the robotic suturing system at various steps in a procedure and in various situations. [Figure 15] 1A-1C are schematic diagrams of the display of the robotic suturing system at various steps in a procedure and in various situations. [Figure 16] 1A-1C are schematic diagrams of the display of the robotic suturing system at various steps in a procedure and in various situations. [Figure 17A] 13 shows the force feedback signal in the "accept" situation of the bite through tissue. [Figure 17B] 13 shows the force feedback signal in a "warning" situation of a bite through tissue. [Figure 18] 1A-1C are schematic diagrams of the display of the robotic suturing system at various steps in a procedure and in various situations. [Figure 19] 1A-1C are schematic diagrams of the display of the robotic suturing system at various steps in a procedure and in various situations. [Figure 20] 1 is an embodiment of a needle and suture for use in suturing the gastrointestinal tract. DETAILED DESCRIPTION OF THE INVENTION

[0030] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It will be understood that the present disclosure is not limited to the particular embodiments described, as such may vary. All devices, systems, and methods discussed herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of the present disclosure. Each example embodiment is provided for illustrative purposes and is merely exemplary, not the only way to implement those principles. Thus, references to elements, structures, or features in the drawings should be understood as references to example embodiments of the present disclosure, and not as limiting to the particular element, structure, or feature described. Those skilled in the art will likely recognize other examples of how to implement the disclosed principles upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope and spirit of the present subject matter. For example, features illustrated or described as part of one embodiment can be used with other embodiments to yield still further embodiments. Accordingly, the present subject matter is intended to cover such modifications and variations as come within the scope of the appended claims and their equivalents.

[0031] It will be understood that the present disclosure is described in this application at various levels of detail. In some instances, details that are not necessary for those skilled in the art to understand the present disclosure or that make it difficult for those skilled in the art to perceive other details may be omitted. The terminology used herein is used to describe particular embodiments only and is not intended to limit the scope beyond the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0032] As used herein, "proximal" refers to a direction or location closest to a user (such as a medical professional, clinician, technician, operator, or physician, such terms may be used interchangeably herein without limitation, and include automated controllers, etc.), such as, for example, when using the device (e.g., during introduction, positioning, or delivery of the device / system within a patient) and / or when closest to a delivery device; and "distal" refers to a direction or location furthest from a user, such as, for example, when using the device (e.g., during introduction, positioning, or delivery of the device / system within a patient) and / or when closest to a delivery device. "Longitudinal" means extending along the longer or greater dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight when the element is flexed or bent, and does not necessarily maintain a fixed configuration; "axial" refers generally to along the longitudinal axis. It will be understood, however, that references to axial or longitudinal movement with respect to the above-described systems or elements thereof need not be strictly limited to axial and / or longitudinal movement along the longitudinal or central axis of the referenced elements. "Central" means at least approximately bisecting the center point and / or being approximately equidistant from the periphery or boundary, and "central axis," with respect to an opening, means a line that at least approximately bisects the center point of the opening and extends longitudinally along its length when the opening comprises, for example, a tubular element, channel, cavity, or hole. Finally, references to a position or location "at" are intended to include at such position or location and / or near (e.g., along, adjacent, proximate, etc.). As understood herein, corresponding is intended to convey a relationship between members, parts, elements, etc., that are configured to interact with each other or have other intended relationships to each other.

[0033] Various embodiments of apparatus, systems, and methods according to various principles of the present disclosure will be described with reference to examples illustrated in the accompanying drawings. The use of "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. herein suggests that one or more particular features, structures, concepts, and / or characteristics according to the principles of the present disclosure may be included in connection with the embodiments. However, such references do not necessarily imply that all embodiments include the particular feature, structure, concept, and / or characteristic, or that an embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations thereof. It should be understood that one or more features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more features, structures, concepts, and / or characteristics of any embodiment provided herein. That is, any feature, structure, concept, and / or characteristic described herein may be combined to create a hybrid embodiment, and such hybrid embodiments are within the scope of the present disclosure. Furthermore, references in various places herein to “one embodiment,” “an embodiment,” “some embodiments,” “other embodiments,” etc., do not necessarily all refer to similar embodiments, and separate or alternative embodiments do not necessarily exclude other embodiments from one another. It is understood that the various features, structures, concepts, and / or properties of the disclosed embodiments are independent and distinct from one another and can be used or presented individually or in various combinations with one another to create alternative embodiments that are considered part of this disclosure. Accordingly, the disclosure is not limited to only the embodiments specifically set forth herein, and the example embodiments disclosed herein are not intended to limit the broader aspects of the disclosure, as it would be tedious to describe all of the many possible combinations and subcombinations of features, structures, concepts, and / or properties. It will be understood that the various dimensions provided herein are exemplary, and that one of ordinary skill in the art can readily determine the appropriate ranges of standard deviations and allowable variations from the present disclosure and the portions encompassed by the claims associated therewith.The following description is merely illustrative of embodiments and is not intended as limiting the broader aspects of the present disclosure.

[0034] 1 and 2, a robotic suturing system 10 includes an endoluminal robot 12 and a suturing system 14 attached to the distal end 16 of the robot. The endoluminal robot 12 includes a robotically controllable, deformable insertion tube 18 that is advanceable into a natural orifice of a patient. The robotic system 12 knows the shape of the insertion tube and its position in space.

[0035] 2 and 3, the suturing system 14 includes an end cap 20 removably attached to the distal end 16 of an insertion tube 18. A needle holder arm 22 is mounted on the end cap 20 for rotation about an axis 24 and carries a removable needle 26 with a length of suture 28. The axis 24 is oriented transverse to the longitudinal axis AL of the insertion tube 18.

[0036] In one embodiment, the suturing system includes a flexible transmission member 30, a gear train 32 coupled to a distal end portion of the flexible transmission member 30, and a connecting member 34 pivotally coupled to a mounting bracket 35 at a pivot pin 36 and extending to the needle holder arm 22. A removable needle 26 is connected to the needle holder arm 22 and adapted to pierce tissue. When the transmission member 30 is actuated, the connecting member 34 moves the needle 26 and the needle holder arm 22 in a direction to pierce the tissue or to remove the needle 26 and the needle holder arm 22 from the tissue. In one embodiment, the end cap 20 of the suturing system is operable substantially as described in U.S. Patent No. 9,867,610, which is incorporated herein in its entirety (Appendix A).

[0037] In one embodiment, the end cap 20 of the suturing system is adapted to be removably attached to the distal end 16 of the deformable insertion tube 18. Any suitable method of attaching the end cap to the insertion tube may be used. With reference to FIG. 3 , the end cap 20 may be attached to the distal end face 40 of the insertion tube 18 via a resilient, partially tubular spring clamp 42 that extends proximally from the end cap and is inserted into the first instrument channel 44 of the insertion tube 18. During use, the outward force from the spring clamp 42 against the walls of the first instrument channel 44 secures the end cap 20 to the insertion tube 18. The end cap 20 may alternatively be attached to the insertion tube via an external clamp extending around a portion of the insertion tube, via a bayonet lock, via a band or tape, or via other suitable structure.

[0038] When the end cap 20 is installed, one or more actuators from the robotic system 10 are coupled to the transmission member 30 so that the robotic system can control the movement of the needle arm 22 and, consequently, the needle 26 when the robotic system is activated.

[0039] In one embodiment, the insertion tube 18 includes a first instrument channel 44 for passage of a needle changing device (not shown) and preferably a second instrument channel 48 for passage of a tissue grasper 50 ( FIG. 2 ). The needle changing device is adapted to extend through the first instrument channel 44 and has a distal end adapted to receive, grasp, and release a needle 26 located at the distal end of the first instrument channel. Exemplary needle changing structures and operations are disclosed in detail in previously incorporated U.S. Pat. No. 9,867,610. Referring to FIG. 2 , the illustrated example embodiment of a tissue grasper 50 includes a helical coil with a sharp distal tip that can be advanced and rotated into tissue to grasp the tissue, longitudinally retracted to retract the grasped tissue, and counter-rotated to release the tissue. Such a tissue grasper 50 is disclosed in previously incorporated U.S. Pat. No. 9,867,610. Other tissue graspers may also be used, including, but not limited to, forceps, vacuum-assisted devices, and the like.

[0040] While the above description of the flexible robotic surgical system suggests that the end cap 20 is substantially similar to that described in U.S. Pat. No. 9,867,610, it should be understood that the robotic insertion tube 18 may include fewer or additional features than a conventional endoscope having two instrument channels, and the configuration of the end cap may be modified and coupled to the insertion tube in a suitable mating manner. For example, with reference to FIG. 4 , one or both of the first and second instrument channels 44 a and 48 b for needle exchange and tissue grasping operations and instruments may be provided external to the robotic insertion tube 18. By way of example, a similar structure is described in detail in previously incorporated U.S. Pat. No. 11,051,800. The end cap 20 a may be coupled in a suitable manner at and along the distal end of the robotic insertion tube, as shown.

[0041] The suturing system 16 includes an end cap 20 (20a) operable via a flexible transmission member 30 extending along the exterior of the robotic insertion tube 18 for proximal operation.

[0042] In other embodiments, the robotic suturing system may include an end cap integrated into the cartridge and adapted to interface with a suitably configured robotic suturing system. Referring to Figures 5 through 7, by way of example, end cap 20b may be integrated into cartridge 60b. Cartridge 60b includes a base 62b for seating on the distal end 16 of insertion tube 18 and a connecting member 34b extending from needle holder arm 22 through an opening 64b in base 62b. Connecting member 34b has a free end 66b and structure at or near free end 66b for engaging an actuator in the distal end 16 of robotic insertion tube 18. In one embodiment, free end 66b is adapted to fit within opening 67 in the distal end 16 of the insertion tube. In one embodiment, the free end 66b has a hole 68b, and the distal end 16 of the insertion tube has a pin 70 that can be actuated to laterally advance through the opening 68b in the free end 66b and securely engage the free end 66b. The pin 70 is attached to a mechanism within the insertion tube 18 adapted to affect longitudinal displacement of the connecting member 34b and, consequently, movement of the needle holder arm 22. The connecting member 34b may alternatively be configured by other methods for attachment to one or more actuators to affect longitudinal displacement of the connecting member 34b. The base 62b also includes a tab 72b that is adapted for insertion into a recess 74 in the distal end 16 of the insertion tube 18 and provides releasable attachment between the base 62b of the cartridge 60b and the distal end 16 of the insertion tube 18 in a manner that prevents rotation of the end cap 20b on the insertion tube 18. Other methods suitable for providing attachment between the cartridge 60b and the insertion tube 18 may be used.

[0043] Referring to FIG. 8 , another embodiment of a cartridge 60c is shown. The cartridge 60c is mechanically connected to the needle holder arm 22 and includes a rotatable tissue grasper 50c having a first connector 82c at its proximal end adapted to interface with a first actuator (not shown) of the robotic insertion tube at the distal end of the robotic insertion tube and a second connector 84c at its proximal end adapted to interface with a second actuator (not shown) of the robotic insertion tube. The first connector 82c is adapted to allow for the transmission of longitudinal force. The first connector 82c may utilize, for example, a bayonet connection, a threaded connection, a collet, a rare earth magnet, an electromagnet interface, a snap interface, a solenoid release pin, a dovetail interface, a keyway, a friction fit, a clip, a set screw, a gear interface, and / or other suitable connectors to interface with the respective actuators on the robotic insertion tube. The second connector 84c is adapted to allow for the application of torque from the respective actuators on the robotic insertion tube to the second connector. The second connector 84c may utilize, for example, a collet, a rare earth magnet, an electromagnet interface, a snap interface, a solenoid release pin, a dovetail interface, a keyway, a friction fit, a C-clip, a set screw, a gear interface, and / or other suitable connectors. Additionally, the needle change system 46c may similarly be provided to align with the distal end of the needle holder arm 22 when the arm is in the closed position, and may be operated by a suitable connector integrated with the arm and manipulated via a robotic insertion tube. Thus, the cartridge 60c may integrate all components that operate on tissue with a needle. After a surgical procedure, the entire cartridge may be removed for cleaning, reprocessing, sterilization, and reuse. Alternatively, or additionally, the cartridge may be discarded and replaced after a determined number of surgical procedures.

[0044] In the example embodiment shown in Figure 9, the cartridge 60d has a first connector 82d in the form of a rack. The rack 82d is adapted to interface with a rotatable worm gear 90d operable from within the insertion tube 18d. Rotation of the worm gear 90d longitudinally displaces the rack 82d, affecting the opening and closing of the needle holder arm 22d. The second connector 84d includes a bevel gear that interacts with a rotatable bevel gear 92d operable from within the insertion tube 18d.

[0045] 1 and 2 , the robotic surgical system 10 also includes a mechanized system 51 for controlling the movement of the insertion tube 18 and needle holder arm 22 via mechanical actuators, such as push-pull and / or rotatable actuators, or gear-driven mechanisms, such as worm gears. The robotic surgical system 10 includes a robotic control system 52 for controlling the movement of the mechanized system 51 based on input from a surgical system. A human interface 54 is coupled to the robotic control system 10 to translate human manual input into movement of the insertion tube 18. The interface 54 may include, but is not limited to, a joystick 55, a trackball, a keyboard, buttons, knobs, a haptic glove, or any other suitable interface that accepts input from an operator. The robotic surgical system 10 also includes a first sensor 56, including load cells and strain gauges, coupled to actuators within the mechanized system 51 to monitor forces applied by the mechanized system and actuators. The first sensor 56 may be located within the insertion tube or may be coupled to a sensor external to the insertion tube via mechanical, optical, or electrical components. The robotic surgical system also includes a light source, a camera 58, a second sensor 59 for sensing and identifying the patient's environment and optionally the needle and / or suture, and a visual display 60 for displaying images from the camera optionally augmented by input from the first and second sensors and / or patient data. The robotic surgical system also includes a processing system 62 that includes a microprocessor that runs robotic system software, memory for storing the software, and an interface for accessing patient data, and that integrates inputs from the subsystems together.

[0046] The robotic system 10 is adapted to map at least a portion of the gastrointestinal anatomy, preferably at least the stomach, and generate a usable model thereof for use in pre-operative planning and / or real-time aspects of the procedure. Referring to FIG. 10 , according to aspects of the present disclosure, a robotic surgical system enables mapping and imaging of the gastric environment in a planning step 100 prior to a surgical procedure. Patient imaging data, including but not limited to weight and height, and / or patient scanning and visualization techniques, including but not limited to MRI, CAT scan, stereoscopic imaging, and / or other visualization and scanning techniques, are acquired at 102. Next, at 104, a three-dimensional (3D) map of the patient's stomach shape is constructed based on the patient imaging data. The 3D map is preferably a digital twin of the patient's anatomy. On the digital twin, the robotic system identifies placement locations for sutures within the tissue and the sequence for suturing based on the patient, patient orientation, procedure, and intended outcome. The physician can digitally evaluate the proposed location and intended reconstructed anatomy before performing the procedure on the display 60. At 106, the virtual procedure can be evaluated, including suture placement and intended anatomical reconstruction. The proposed positions can be approved or modified. And, at 108, the procedure can be performed.

[0047] Referring to FIG. 11 , during the procedure, the robotic system displays a real-time video image 110 as seen through an endoscopic camera. This image is combined with one or more optional overlays: a digitized or virtual image of the mapped anatomical structures, a reference line 112, a first recommended location 114 for suturing with a suture needle, subsequent recommended suture locations 116 for influencing the proposed gastric remodeling and the sequential placement of such sutures, and warning zones 118a, 118b of tissue to avoid grasping or suturing (e.g., because such tissue overlies sensitive tissue) (described below with reference to FIG. 18 ). The overlay images are displayed on the display screen 60 and / or augmented reality glasses. By way of example, the system 10 may map and display a course of sutures, e.g., projected stitches "1" through "6," starting with a highlighted suggested stitch "1" at 114 to provide the intended gastric reduction. Preferably, all overlay images can be switched "on" and "off" according to operator preference.

[0048] According to one aspect of the present disclosure, the robotic surgical system 10 is adapted to use real-time image acquisition from an optical system 58 connected to the insertion tube 18 and first and second sensors 56, 59. The optical system 58 and sensors 56, 59 may include, but are not limited to, stereoscopic imaging optical sensors, laser scanning sensors, distance sensors, ultrasound sensors, CT scanning devices, LIDAR sensors, or other sensors for displaying real-time images of the stomach or other gastrointestinal structures on the display 60 as they are reconstructed via a suturing procedure, i.e., as the tissue is reshaped through suture tension and suture restraint via clamping, ligation, etc. As the gastrointestinal tract 124 is reconstructed, the system 10 displays updated suggested locations for tissue suturing, patterns for suturing, the proposed procedure and the suggested number of ideal sutures for gastric reduction, locations of sensitive structures, stomach size information such as residual volume, volume reduction 126 ( FIG. 19 ), estimated remaining procedure time, and current intraluminal pressure due to insufflation. Other useful parameters may also be displayed. Thus, as anatomical structures are reconfigured during endoluminal suturing, the system assists the operator in navigating and maintaining optimal technique to optimize results, reduce procedure time, reduce the risk of suture tangles or other problems that may require troubleshooting and delay the procedure, and reduce the amount of training required to master a procedure. As an example, during an endoluminal sleeve gastroplasty procedure, the stomach is reconfigured to a narrower and shorter shape that may be disorienting to a human operator but can be managed by a robotic visualization system to guide the operator.

[0049] Referring to FIG. 12 , the real-time imaging system identifies landmarks on the stomach 124 or other parts of the gastrointestinal tract as at least a portion of the gastrointestinal tract is reconstructed. A visualized compass 128 and virtual markers of important anatomical locations, such as the posterior wall, anterior wall, base, and pylorus, assist the operator. In addition, the robotic system can be designed to deploy or display fiducials in any form, including, but not limited to, physical markers, such as dye markers sprayed on the tissue, laser or argon plasma burned markers on the tissue, colored or patterned physical marks attached to the tissue, radiopaque markers attached to the tissue, active signal-generating markers, or virtual indicia. To facilitate sensing the shape of the portion of the gastrointestinal tract as it is reconstructed, the physical fiducials can be sensed by an image sensor or other sensor at the distal end of the insertion tube. A virtual fiducial 130 can indicate where the system is currently instructed to pass a suture needle, while other fiducials 132 can indicate preferred locations for passing a suture needle through the entire thickness of the tissue. This facilitates orienting the operator during the procedure. The virtual markers may be overlaid on the camera image 110 of the stomach anatomy 124 and used to guide the human operator to move the end of the insertion tube relative to the tissue so that the suturing needle extends through the grasped tissue 134 and the appropriate amount (total thickness) of tissue in the intended orientation relative to the grasped tissue. Alternatively, the overlaid information to augment the real-time image may also be transmitted and displayed on a special headset or glasses that the system operator may wear during the procedure where system input and guidance is desired.

[0050] Referring to FIG. 12 , an illustrative example of a system embodiment is shown with tissue grasper 50 engaged with stomach tissue 134. However, as indicated by the offset positions of datums 130, 132, the grasped tissue 134 is not optimally positioned for needle 26 to extend through the full thickness of the tissue, as preferably described below. This is also illustrated in FIG. 13A , which shows needle path 136 laterally offset from path 138 extending through the full thickness of the grasped tissue 134. In order for needle 26 to pass through the full thickness (along path 138) through the tissue, path 136 of needle 26 must be displaced laterally toward marker 132. Control 54 operably connected to robotic insertion tube 18 is manipulated to move the insertion tube in the direction of arrow 140 to align needle path 136 with full thickness path 138, as shown in FIG. 13B . Additionally, as shown in FIG. 14 , the robotic system monitors the rotational orientation of the suturing system and can guide the operator with markers or actively rotate the end cap and suturing needle as needed to provide a path for the needle 26 so that the tissue is properly positioned and sutured and / or the suture is properly positioned to extend between the suture locations. The intended tissue should be centered on the needle trajectory as the needle is rotated about its axis of rotation on the needle holder arm. Image analysis is used to detect tissue within the optical sensor's field of view and to detect and confirm that the tissue is properly centered and at the appropriate distance from the tissue location. Additionally, as shown in FIG. 14 , the system identifies whether the end cap 20 supporting the needle 22 should be rotated to provide a proper needle trajectory through the tissue to maximize tissue thickness through the needle. Once the system and operator determine that the needle 26 is properly oriented relative to the tissue, the system can be activated, advancing the needle 26 through the retracted tissue 134. The system may include a lockout with an override feature to prevent unintentional advancement of the needle 26 into tissue unless the needle is oriented in a desired manner.

[0051] The insertion tube 18 may optionally include endoscopic ultrasound (EUS) capabilities. Such capabilities may extend to the distal end of the suturing system. Such endoscopic ultrasound capabilities allow the operator to visualize anatomical structures outside the gastrointestinal tract during intraluminal suturing. This allows identification and monitoring of sensitive structures outside the gastrointestinal tract, mitigating the risk of suturing through the gastrointestinal tract and unintentionally engaging external anatomical structures. By way of example, endoscopic ultrasound may provide feedback to optimize the penetration depth of the tissue grasper or needle (or other fastener). The fastener depth and the degree of tissue traction by the tissue grasper 50 may be optimized based on the location and potentially underlying tissue and organs. Ultrasound readings may also be used to optimize insufflation of the gastrointestinal tract based on tissue thickness, with thinner tissue being infused at higher pressures and thicker tissue being infused at lower pressures. Ultrasound may also be used to verify whether the suturing needle 26 has extended through the entire thickness of the tissue.

[0052] In other aspects of the system, the system analyzes a first sensor 56 coupled to the tissue grasper 50 to obtain a force "fingerprint" and verify that the grasper 50 has properly engaged or moved through the tissue. The system utilizes force feedback from a torque gauge coupled to the tissue grasper's 50 actuator to determine when the tissue is properly engaged. For example, when a helical coil tissue grasper 50 is rotated in a first direction (e.g., clockwise), the sensed torque is related to the tissue depth engaged by the coil. The system includes a feedback function optimized to engage the tissue until a determined torque is sensed to ensure consistent tissue engagement depth and optimal holding force between the grasper and the tissue. Similarly, in other aspects, if the sensed torque decreases and then increases, the system can be configured to identify that the coil tissue grasper has rotated through the stomach wall and then engaged a structure outside the stomach, triggering an alarm condition.

[0053] Additionally, the first sensors 56, 59 are used to identify whether an unintended structure has engaged outside the stomach wall. For example, when retracting the tissue grasping instrument with the grasped stomach wall, an expected sensed force is present on the tissue grasper. If a significantly high force is sensed, this may indicate that the tissue grasper is grasping an organ or other tissue outside the stomach. A warning or alarm indicator may also be presented under such conditions, with appropriate identification of the trigger. In such cases, the tissue should be released and re-grasped at a more appropriate depth and / or anatomical location.

[0054] Further, the sensor 56 may be coupled to the tissue grasper 50 and operated to indicate on the display 146 the force experienced by the grasped stomach tissue 134. FIG. 14 provides an example embodiment of a force meter display 146 with an indication 148 of a lower force applied by the tissue grasper (which may indicate a failure to deliver a full-thickness suture), while FIG. 15 shows a greater force applied by the tissue grasper 50 on the meter, indicating that the grasper 50 has grasped and retracted the stomach tissue for a full-thickness suture passage. Additionally, FIG. 15 illustrates the alignment of the virtual markers 130, 132 for suture passage with the recommended suture path 132. Thus, FIG. 15 illustrates an ideal state prior to advancing the needle 26 through the tissue 134. The system is then ready to advance the suture needle 26 through the retracted tissue 134.

[0055] 13C and 16, the system 10 is then operated to move the needle 26 through the retracted tissue 134, and preferably through the entire thickness of the tissue. The system may use various feedback mechanisms to confirm such full-thickness tissue suturing. In one embodiment, force feedback from a strain gauge attached to the needle holder arm 22, or a strain gauge / load cell hanging pulley, or a linear slider driving the needle holder arm actuation cable, is used to confirm that the suturing needle has moved through the intended tissue thickness. When performing an endoluminal sleeve gastrectomy, to ensure long-term stability of the tissue approximation, it is preferable that the two sections of the stomach wall be sutured together through the entire thickness of the stomach wall, i.e., from the inner wall of a first section of the stomach to the outer wall of the first section, and then from the outer side of a second section of the stomach to the inner wall of the second section. This is in contrast to partial-thickness suturing, in which the needle and suture pass through the stomach wall and do not completely exit and return. The intended full-thickness occlusion of the suture path is verified in real time by monitoring the forces acting on the tissue-penetrating portion of the suturing mechanism with a force sensor. The monitored forces are characteristic of the needle's interaction with different soft tissue types, such as mucosa, submucosa, muscle, and serosa, due to differences in penetration, expansion, and friction forces. Referring to FIG. 17A, during a full-thickness needle path through tissue, the first sensor 56 identifies a signal 150 having two distinct peaks 152a, 152b and a distinct drop 154 ​​between the two peaks 152a, 152b, indicating that the needle 26 passes through two distinct serosa membranes as it traverses through the rumen portion and returns through the reticulum portion. This signal indicates a full-thickness suturing by the needle, providing a high degree of confidence in its durability. In contrast, referring to FIG. 17B, a differently shaped force signal 160 is shown, having only a single peak 162. The system may identify the difference and provide an acknowledgement indicator to the operator when signal 150 is identified and / or a warning or alarm indicator to the operator when signal 160 is identified. In the event of a warning event, system 10 may recommend that a suture bite be placed over the tissue portion.The display 60 may include a digital gauge 170 and a display for operator alerts, patient monitoring, and recommendations for subsequent steps of the procedure that update and change depending on the stage of the procedure and active components (FIG. 16). Such force monitoring may also be used to detect inadvertent puncture of structures outside the gastrointestinal tract during intraluminal suturing and subsequent retraction of the suture needle to prevent the structures from engaging the outside of the gastrointestinal tract during full thickness suturing.

[0056] The system 10 includes a pressure gauge in one of the insertion tube or suturing system to maintain optimal insufflation of the gastrointestinal space. If the pressure falls below a first predetermined level, the system automatically operates a valve or pump to add insufflation gas through a port in the insertion tube. If the pressure exceeds a second predetermined level, the system automatically operates a vent or actively expels insufflation fluid from the gastrointestinal space. The level of insufflation can be automatically controlled by the robotic control system to ensure a continuous optimal insufflation level for visualization, taking into account where the robotic system is in the tissue approximation sequence, for example, a higher level of insufflation for initial visualization of the working space pre-procedure and for initial spatial mapping by the robotic system, a lower level of insufflation during tissue acquisition to limit tissue grasper penetration depth and reduce the risk of capturing extraneous structures, and a lower level of insufflation to reduce forces on the sutures and tissue during final tissue approximation.

[0057] 18, the system displays progress after stitches "1," "2," and "3" have been performed, with approaching stitch "4" being recommended next. Additionally, as referenced above, the system identifies regions 118a, 118b, e.g., near the base, that are overlaid with a "warning" symbol. One region 118a may be displayed in a first color and may indicate a first type of warning (tissue thickness with a first caution), while the second region 118b may be displayed in a second color and may indicate a second type of warning (underlying organs and / or tissue thickness with a second caution).

[0058] Once the sutures have passed through the intended area, they are tensioned to pull the sutured portions of the stomach (or other gastrointestinal system) toward each other. The tissues may be pulled to appose various areas so that they contact each other, or may be pulled to otherwise move and reposition areas of the stomach depending on the intended procedure and outcome. With reference to FIG. 19, after the sutures are properly tensioned, they are tightened by application of a tightening device, ligation, integrated fixation elements, or via other devices or methods. The system indicates the current changes to the stomach shape at 124, including a volume reduction indicated at 126. Additional sutures may be applied as needed to complete the procedure.

[0059] According to aspects of the present disclosure, sutures can be managed by a robotic system. In management, the sutures can be better visualized, accessed, controlled, and manipulated. For visualization within anatomical space, lengths of suture attached to needles are marked with aids to facilitate robotic suturing. In some embodiments, the sutures can be a high-contrast color, and the display system is color filtered to enhance visualization of the sutures in the surgical field. By using a distinct, high-contrast suture color, the sutures are easily distinguished by the robotic system from other parts of the endoluminal suturing system, tissue, and blood. Additionally, in some embodiments, the tissue contains a fluorescent dye, and the fluorescent wavelength of the robotic imaging system is tuned to a staining frequency to visualize and locate all sutures within the gastric tract. In some embodiments, the sutures are radiopaque to facilitate visualization under a fluorescent microscope during and / or after the surgical procedure is completed. In this manner, the durability of the sutures can be determined over time. In some embodiments, for example, the suture may have a textured surface and / or structural suture that provides high contrast under ultrasound imaging, allowing the location of the suture to be automatically detected by the system. The suture material may also be selected to provide high ultrasound signal strength. In some embodiments, the suture may be provided with a surface pattern recognizable by the robotic system to indicate the end of the suture attached to the needle, the free end of the suture, and locations in between. Such a pattern or patterns may be similar to a barcode that can be visually read by the robotic system to accurately identify which portion of the suture is currently under direct visualization and to determine if any portions of the suture are crossing in an undesired way. Managing needle path and location is one valuable advantage of robotic systems.In certain embodiments, the robotic system may use visual information from the sutures to verify the number of sutures placed and their correct location, as well as the length of suture used; such information may be used, for example, to update a computer-generated rendering of the treatment space and to update recommended suture locations shown or superimposed on the real-time image viewed by the operator.

[0060] In another aspect of administration, suture tension is controlled. A predetermined suture tension (within an upper limit) or slack is actively maintained on the suture throughout the procedure. Optimal slack allows for smooth running of the suture within the tissue, maneuverability of the suturing system, and reduced suture pull resistance during suturing, but should not be so loose as to prevent optimal suture tension during final tissue approximation or increase the likelihood of suture entanglement. The ideal tension during final tissue approximation is below the tension of the knot tied on the suture or the strength of the suture to mitigate suture breakage and below the force required to tear the suture through the tissue, but high enough to achieve proper tissue apposition. Additionally, because loose sutures can wrap around and become entangled in the device, it is desirable to maintain slight tension on the suture as it passes through the device channels with the suture. To provide the proper tension on the suture, the suture may be fed through a mechanism such as, for example, a roller system, pulleys, or a spool mounted on a strain gauge. If the tension is too high, the roller, pulley, or spool may then be unwound or moved to release more suture into the surgical field. Then, if the tension is too low, the roller, pulley, or spool may be wound or moved to capture the suture from the surgical field and increase the tension. The process may be controlled manually or automatically based on current parameters.

[0061] Other aspects of management monitor and prevent sutures from crossing over one another in ways that can cause inadvertent clamping, twisting, or knotting of the sutures, unnecessary pulling resistance on the suture, and entanglement. The position of the sutures is monitored to detect crossing and provide a warning signal to the operator that a crossing situation has occurred, or the current suture position is prone to crossing and automatically suggest or adjust the movement of the robotic system in a manner that prevents suture crossing. For example, the end cap 20 can be automatically rotated by the insertion tube 18, or the insertion tube 18 can be rotated to mitigate suture crossing.

[0062] In other aspects of suture management, the overall use of endoscopic suturing procedures is reduced in complexity by the robotic platform. For example, in manually operable endoscopic suturing systems similar in configuration to robotic suturing systems, the suture needle is advanced through tissue, after which the trailing end is tensioned and terminated, for example, by cinching, knotting, or crimping. However, in robotic systems, the trailing end of the suture can be utilized in a different manner. For example, once suturing of the tissue is complete, the trailing end of the suture can be terminated, and excess suture can be cut and removed, after which the needle end of the suture can be tensioned, terminated, and cut. Furthermore, the trailing end of short sutures for a procedure can be pre-installed with a permanent anchor, such as a pivoting bar-shaped T-tag, a polypropylene disc, or a curled nickel-titanium suture tail, which does not require termination and cutting after suturing.

[0063] In the example embodiment shown in FIG. 20 , a needle 180 having one or more openings 182 a, 182 b may be used that interlocks with a barbed suture 184 to form a one-way, self-locking tensioning mechanism. When tension is applied to the suture 184, the suture is pulled against the needle 180 and tissue is approximated in a needle-side, locking manner. The remaining portion of the barbed suture 184 is then severed from the locked needle 180 and suture 184. As can be seen with reference to FIG. 20 , the barbs of the barbed suture 184 may be angled relative to the body of the suture to allow the barbs to pass through one or more openings 182 a, 182 b of the needle 180 in one direction but not in the opposite direction, thereby locking movement in the opposite direction.

[0064] In other aspects of suture management, suturing may be performed in a different direction than that performed in a similarly configured manually operable endoscopic suturing system. In manually operable systems, suturing is performed in a right-to-left, top-to-bottom, or distal-to-proximal direction. This is intended to maintain the suture within the field of view and prevent tangling or crossing of the suture. However, a robotic system with enhanced suture recognition and maneuverability capabilities may enable more natural left-to-right, bottom-to-top, or proximal-to-distal suturing, eliminating the need for the operator to carefully pre-plan the suture path and pattern. The robotic system is programmed to analyze the anatomy of the surgical field, identify the optimal suture pattern for a given procedure given the anatomy, highlight the optimal suture pattern for the surgical procedure, and highlight the optimal suture direction for the suture pattern. The highlighted patterns and directions are preferably displayed on a real-time image of the surgical site as captured by an optical sensor, for example, using augmented reality and / or a virtual three-dimensional image constructed from the anatomical structure of the surgical site constructed from real-time or pre-acquired imaging data.

[0065] Embodiments of a robotic suturing system for bariatric treatment and methods of robotically assisted robotic suturing and bariatric treatment are described and illustrated herein. While embodiments of the present disclosure may be described with specific reference to medical devices, systems, and procedures for treating the gastrointestinal system, it should be understood that such medical devices, systems, and methods may be used to treat tissues in the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, and the like. Furthermore, while specific embodiments of the present invention have been described, it is not intended that the present invention be limited to specific embodiments, as the present invention is as broad as the art will permit, and the specification is intended to be read in the same manner. Accordingly, it will be understood by those skilled in the art that yet other modifications may be made to the present invention as provided without departing from the scope of the claims. Accordingly, references to elements or structures or features in the drawings should be understood as references to example embodiments of the present disclosure, and not as limiting to the specific elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will occur to those skilled in the art reading this disclosure. It will be apparent to those skilled in the art that modifications may be applied to the disclosed apparatus, systems, and / or methods and / or to the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the present disclosure. It will be understood that various features described with respect to one embodiment, whether explicitly shown or not, may be applied to other embodiments, either alone or in any combination thereof. Furthermore, elements shown as integrally formed may be constructed from multiple pieces, or elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or otherwise changed, and sizes or dimensions of elements may be changed. Similarly, although operations, actions, or procedures are described in a particular order, this should not be construed as requiring such a specific order to achieve desired results, or that all operations, actions, or procedures must be performed.Accordingly, the embodiments disclosed herein are to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims and not limited to the foregoing description herein or to the specific embodiments or arrangements described or illustrated. In view of the foregoing, individual features of any embodiment may be used and claimed separately or in combination with features of that or any other embodiment, and the scope of the subject matter being indicated by the appended claims and not limited to the foregoing description.

[0066] In the foregoing description and in the claims that follow, it will be understood that the phrases "at least one," "one or more," and "and / or," as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. Terms such as "a," "an," "the," "first," and "second" do not exclude a plurality. For example, the term "a" or "one" entity as used herein refers to one or more of that entity. Thus, the terms "a" (or "one"), "one or more," and "at least one" can be used interchangeably herein. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise. As used herein, the conjunction "and" includes each of the connected structures, components, features, etc., unless the context clearly dictates otherwise, and the conjunction "or" includes one or more of the connected structures, components, features, etc., alone and in any combination and number, unless the context clearly dictates otherwise. All directional references (e.g., proximal, distal, superior, inferior, upward, downward, left, right, lateral, longitudinal, front, rear, above, below, top, bottom, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or serve to distinguish regions of related elements from one another and do not limit the related elements, particularly with respect to position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, engaged, joined, etc.) should be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements, unless otherwise indicated. Thus, connection references do not necessarily mean that two elements are directly connected or in fixed relationship to one another. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0067] The following claims are incorporated into this detailed description by this reference, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the terms "comprises," "comprising," "including," and "comprising" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. In addition, although individual features may be included in different claims, they may sometimes be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. In addition, a reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. 1. A robotic suturing system for use in the gastrointestinal tract of a human patient, the human patient having a natural orifice in communication with the gastrointestinal tract; a) a flexible, deformable endoluminal robot adapted to be inserted into the gastrointestinal tract through the natural orifice, the endoluminal robot having a proximal end and a distal end; b) a suturing tool removably coupled to the distal end of the flexible endoluminal robot, the suturing tool adapted to grasp tissue and advance a needle with a suture through the grasped tissue; c) a robotic control system configured to control movement of the endoluminal robot and the needle on the suturing tool; d) an imaging system for acquiring real-time images of the gastrointestinal tract; and e) a display for presenting said real-time image to an operator; A robotic suturing system comprising:

2. The robotic suturing system of claim 1 , wherein the robotic control system includes an actuator for operating the endoluminal robot and an actuator for operating the suturing tool, and an operator interface for controlling the actuators.

3. The robotic suturing system of claim 1 or 2, further comprising a sensor adapted to map at least a portion of the gastrointestinal tract.

4. The robotic suturing system of any one of claims 1 to 3, wherein the imaging system includes at least one of an optical sensor, a laser scanning sensor, a distance sensor, an ultrasonic sensor, a CT scanning device, and a LIDAR sensor.

5. The robotic suturing system of any one of claims 1 to 4, further comprising a mapping system for defining a virtual map of the portion of the gastrointestinal tract.

6. The robotic control system of claim 5 , further comprising a modeling system for proposing preoperative planning of procedures in the gastrointestinal tract.

7. The robotic control system of claim 5 , wherein the modeling system is adapted to project aspects of the pre-operative plan onto the real-time image.

8. 8. The robotic suturing system of claim 1, further comprising one or more sensors adapted to determine whether the needle has been inserted through the full thickness of the tissue.

9. The robotic suturing system of any one of claims 1 to 8, wherein the display is also adapted to present virtual images to guide the operator.

10. The robotic suturing system of claim 9 , wherein the virtual image includes proposed suture locations.

11. The robotic suturing system of claim 9 , wherein the virtual image includes a warning zone for non-suturing.

12. The robotic suturing system of claim 9 , wherein the virtual image includes proposed suture locations.

13. The robotic suturing system of claim 9 , wherein the virtual image includes a proposed suture orientation.

14. The robotic suturing system of claim 9 , wherein the virtual image includes anatomical landmarks.

15. The robotic suturing system of claim 9 , wherein the virtual image includes a fiducial.

Images