WO2024089473A1

WO2024089473A1 - Multi-arm robotic sewing system and method

Info

Publication number: WO2024089473A1
Application number: PCT/IB2023/055439
Authority: WO
Inventors: Yossi Bar
Original assignee: Lem Surgical Ag
Priority date: 2022-10-24
Filing date: 2023-05-26
Publication date: 2024-05-02

Abstract

A robotically controlled surgical system is provided. In some embodiments, the inventive system is a centrally coordinated and synchronized robotic system for robotic sewing procedures, optionally for bilateral spinal robotic sewing procedures. The system comprises multiple robotic arms that each can hold, place and/or manipulate at least one end effector, tool, camera or navigation element, such as a marker or label, for use in a robotic sewing procedure. The markers or labels may be placed on different tissue portions, such as skin and muscle, to provide guidance information for the robotic navigation capabilities. The end effectors may include any surgical tools useful for performing robotic procedures. The cameras and navigation elements are for providing guidance for the movement of the robotic arms and deployment of the markers, end effectors and tools. The inventive system allows for safe, accurate, bilateral robotic sewing with the application of required forces and provision of automation for assisting surgeons in repetitive tasks.

Description

MULTI- ARM ROBOTIC SEWING SYSTEM AND METHOD

PRIOR RELATED APPLICATIONS

This application claims the benefit of priority of prior-filed United States Provisional Patent Application 63/418,675, filed October 24, 2022.

FIELD OF THE INVENTION

The invention relates to systems for robotically controlled and coordinated surgical procedures. In particular, the invention relates to robotic systems comprising multiple robotic elements, such as robotic arms, end effectors, surgical instruments, cameras, imaging devices, tracking devices, sensors or other devices useful for robotic surgery. The invention also relates to robotic systems that provide required stiffness, rigidity and accuracy in surgical application where high forces and torques are applied to the robotic arms, with examples found in spinal surgery and orthopedic surgery. Specifically, in these surgical contexts, multiple robotic elements may be attached to, and controlled by, a single control unit and may be used in a coordinated fashion to deploy and/or relate to surgical instruments, trackers, cameras, markers, and other surgical tools as part of a robotic surgical procedure. More particularly, in the context of robotic spinal surgery, multiple end effectors may be deployed on multiple robotic arms and controlled by a single control unit and may be used in a centrally coordinated fashion to perform a robotic surgical procedure, with the relative movements of each robotic element being coordinated by the central control unit. Most particularly, in the context of robotic spinal surgery procedures such as sewing of tissue layers, required application of force, torque and full robotic control may be enabled by deployment of a robotic system comprising multiple robotic arms with requisite stiffness and accuracy deployed on a single rigid chassis and wherein full robotic control is provided by a central control unit in the single chassis. The provided systems and methods are also applicable to soft tissue (e.g., abdominal) surgery where force and torque requirements are not as high, but the reachability and control of the disclosed robotic systems are highly desirable. BACKGROUND OF THE INVENTION

Robotic surgery is well known in the art, as is the application of robotic techniques to spinal surgery procedures. Many robotic surgery systems, such as the da Vinci robotic surgery system from Intuitive Surgical, are teleoperated. Multi-arm robotic surgical systems are available in the field, for example those provided by Cambridge Medical Robotics, but these known systems are often also teleoperated and are all comprised of single arms deployed separately on separate carts or chassis with some level of coordination provided by a remotely- positioned control unit. Systems comprising multiple arms on multiple carts have significant drawbacks regarding integration into surgical workflow, along with an undesirably large footprint in the operating room. Also, the control of teleoperated units by a remotely-positioned control unit does not provide the level of control required for a full range of surgical procedures, particularly in the case of spinal surgery. Accuracy will inevitably be inferior to a system where all robotic arms are fixed to, and coordinated by, a single chassis comprising a single control unit. Known multi-arm teleoperated systems are also often kinematically constrained in the case of systems such as da Vinci where all of the arms originate from the same point, thus constraining their first joints and, consequently, their maneuverability and reachability.

Performance of a full range of spinal surgery procedures requires robotically coordinated system which is not available today. A typical procedure may require the maneuvering of one or more end effectors deployed by robotic arms, the deployment of other instruments, placement and/or tracking of multiple passive or active markers on bone and/or on soft tissue or on instruments or robotic arms, and one or more robotically controlled and maneuvered cameras that can be placed at varying distances and angulations from the surgical field, and one or more end effectors deployed by robotic arms. Such a mobile bi-lateral multi-arm/multi-camera system mounted on, and controlled by, one cart, is not available in the current state of the art.

Robotic systems and techniques available today do not allow the completion of tasks such as robotic sewing that involve high forces and/or automatic capabilities. As already discussed herein, most robotic surgery systems available today, whether single arm or multi-arm, are teleoperated, meaning that the surgeon is positioned at a console and is remotely controlling the movement and operation of one or more robotic arms. Today, all robotic systems which have robotic sewing capabilities are ‘remote manipulators’ such as these in which the surgeon is in complete control (albeit remotely) and they are the one who sees with their eyes the position of the robotic arms/end-effectors. Accordingly, the surgeon relies on this on-line continuous visualization for closing the loop- i.e. complete hand-eye correlation with regards to closing the loop.

Remote manipulators have 2 main flaws which this invention is intended to solve. One is that remote manipulators require 100% human control which can be exhausting for humans and prone to human mistakes. Second is that these remote manipulators are uniformly designed to perform actions in the human abdomen or in other small and delicate internal spaces, so they are usually comprised of thin and delicate arms which can provide high manipulation and dexterity but not robotic automatic capabilities nor high stiffness and/or rigidity. As already discussed, even in abdominal applications, known teleoperated systems are often kinematically constrained if all of their arms are based at a single origin.

Many surgical operations, like spine and other orthopedic surgery, require cutting and sewing of skin and muscles not only in delicate internal spaces (e.g. abdominals). These procedures, like sewing a human back after spine surgery or a human leg after orthopedic surgery, involve working with big and strong muscles which requires significant push/pull forces (e.g. higher than 3 kgf). Remote manipulators are too weak to handle these forces. Moreover, remote manipulators require 100% human involvement which can be very exhausting for surgeons - sewing a human back after spine surgery can take 40 minutes and more of exhausting, repetitive work with application of high forces, all of which being required at the end of several hours of a taxing surgical procedure.

From these reasons, there is a strong felt need for a full robotic system and method which is capable of robotically sewing human tissue types (e.g. skin and muscle in back, legs, shoulders etc.) and to be able to handle the required high forces while providing fully robotic closed-loop operation for robotic full or partial control of the surgical procedure. Such a system is provided in the context of the present invention. SUMMARY OF THE INVENTION

Provided herein is a mobile bi-lateral robotically controlled surgical system. Specifically, the inventive system is a centrally coordinated and synchronized robotic system for robotic surgical procedures, optionally being optimized for robotic surgical procedures requiring the application of high forces while still providing excellent accuracy, such the sewing of multiple tissue layers in spinal surgery or other orthopedic surgery. The system comprises multiple robotic arms that each can hold, place and/or manipulate multiple end effectors, camera/sensor elements or navigation/tracking elements for use in robotic surgical procedures. The end effectors may include any surgical tools useful for performing robotic surgical procedures. The cameras/sensors and navigation/tracking elements (including, but not limited to, markers, force/torque sensing, CT, MRI, navigation cameras, endoscopic cameras etc.) are for providing guidance for the movement of the robotic arms and deployment of end effectors and tools.

In some embodiments, a bilateral robotically controlled surgical system according to the present invention may have two or more surgical arms capable of positioning end effectors and holding tools, along with one or more imaging, navigation or surveillance arms holding a navigation and/or endoscopic camera, with all of these arms being based on a single cart with a central control unit. The bilateral nature of the inventive systems means that the single cart fits under a surgical table and at least one of the surgical arms extends upwards from under the surgical table on one side of the table and at least one of the surgical arms extends upwards from under the table on the other side of the table. The surveillance, navigation or imaing arm holds the navigation camera or in another embodiment, an endoscopic camera in an advantageous position for viewing the surgical field and any associated navigation/endoscopic cameras.

In some embodiments, a bilateral robotically controlled surgical system according to the present invention may have four or more surgical arms capable of positioning end effectors and holding tools, along with two or more navigation or surveillance arms holding a navigation and/or endoscopic cameras. In these embodiments, at least two of the surgical arms and at least one of the surveillance arms are positioned on one mobile cart and at least two additional surgical arms and at least one additional surveillance arm are positioned on another mobile cart. The two carts may be joined together with appropriate mechanical and electrical connections such that one mobile unit is formed with a single control unit providing full robotic and navigation control. The joined mobile unit has at least four surgical arms and at least two surveillance arms and is capable of performing a wide range of surgical procedures while all the robotic arms are synchronized by the fact that they share the same mechanical chassis.

In the various provided embodiments of a bilateral robotically controlled surgical system according to the present invention, the origin of each of the surgical arms is positioned at least 80cm apart from the origin of any of the other surgical arms, and in some cases at least 1 meter apart. This provides for full reachability, maneuverability and control without kinematic constraint since the base of the arms are spaced far apart.

The present invention describes a mobile bi-lateral surgical robotic system which may involve navigational markers and sensors used to robotically utilize bi-lateral synchronized surgical techniques. More particularly, described is a surgical technique focused on a soft tissue sewing apparatus. In the present invention at least 2 robotic arms, which are robotically synchronized, assembled and calibrated on a single rigid chassis are cooperating with at least 1 additional robotic arm which comprises at least one camera/sensor to keep track of the surgical procedure and the various markers and sensors used to perform the procedure. Additional robotic arms deployed on the single rigid chassis can be used to position and operate additional surgical tools and camera/sensor elements as desired.

As described, the invention comprises multiple robotic arms which access and visualise the surgical field in an automatic and safe way because they are robotically synchronized. In one embodiment, there may be three robotic arms, two of which place, guide and/or hold robotic tools and one holding a navigation camera. In such an embodiment, the first arm may optionally position and then control the use of, for example, a sewing tool such as a suturing apparatus. The second arm may optionally position and then control the use of, for example, a forceps or grasping tool. A third arm may optionally hold a camera/sensor that provides an image of the process from an optimal distance and angulation. The camera is able to operate from optimal distance and angulation because it is sized appropriately and is deployed on an appropriately sized and positioned robotic arm. Optionally, the robotic arms may also hold additional imaging or navigation cameras to provide redundancy and diversity of information. Also optionally, active or passive markers may be placed on various tissue elements inside the body or outside on the skin surface for example to assist the robotic system in positioning the robotic arms and surgical tools. Also optionally, the robotic arms and/or the end effectors may have active or passive markers placed on them that may assist the robotic system in positioning the robotic arms and/or the end effectors.

In one embodiment, the synchronized movement of the robotic arms is enabled by the interaction of the navigation cameras with active or passive markers that are placed on portions of the patient’s anatomy and/or the robotic arms or end effectors. The movement of the robotic arms is synchronized by a central control unit from a single base that knows where the arms are based upon factory assembly and calibration, the navigation information provided by the various markers and the one or more cameras is supplementary and may assist during the procedure to add more information about the location of the arms in relation to the environment. The fact that all the robotic arms are assembled on a joined mechanical chassis and calibrated together frees the need to continuously monitor the markers on the robotic arms and tools and focus only on the markers placed on the tissue. This can contribute tremendously to the enablement of this robotic sewing procedure since it is practically impossible in many cases for the navigation/endoscopic camera to continuously track so many markers, especially when in many applications the end effectors are far from each other and their markers are obscured.

In one embodiment, the invention suggests putting on the outer surface of the muscles and/or skin and/or on the inner portion of the muscles and/or on certain internal organs markers with specific patterns (can be glued as stickers but can also be added in other manners such as sewed, stuck with a small needle etc.). The markers are seen and recognized by the camera/ sensor and can be deployed on both sides of an incision on the muscles and/or skin so during the swing procedure the camera recognizes them and can keep track of the changing relative positions between the various tissue components. In this way, while the robotic arms are sewing the patient, pushing the sewing needles inside and pulling the needle and wires and by that deflecting and manipulating the soft tissue, the camera/sensor can keep track over the changing soft tissue and react accordingly. The sewing patterns can be detected by the human doctor intraoperatively and to be executed partially or fully by the robotic system or can be fully automatic being calculated and decided by Al based SW.

In various embodiments, the surgical arms are robotically synchronized so that they can work in synchronization with each other and in relation to the marked soft tissue. The robotic arms are equipped with force and torque sensors so they can sense forces and moments applied by the soft tissue and or each other while working synchronously and exchanging tools etc. The robotic arms have the ability to be deployed bi-laterally to each side of the patient’s body or specific organ thus providing the advantage of working synchronously in relation to each other (similar to human work with 2 arms) and for providing appropriate reach and access to the surgical field for the desired application. The inventive robotic arms, being robotically coordinated and controlled arms and not remote manipulators, are strong and sturdy and so can push and pull the needle and wire with the required forces (e.g. above 3 kgf) to firmly tighten together the sewed muscles of the back or other area of multi-layered tissue. Moreover, in this invention, the robotic arm bases are located at distance from each other (e.g. at least 80cm or 1 meter apart) what provides superior reachability and application of force/moments.

Accordingly, in various embodiments of the inventive system and methods, passive or active markers may be used to assist in navigation during a robotic sewing procedure that may employ a bilateral approach. These procedures may require the placement of multiple passive or active markers on the patient’s anatomy (on various tissue layers) or on the robotic arms, end effectors or tools. In particular embodiments, miniature markers may be preferred. Portions of the patient’s anatomy, such as multiple skin layers, may be relatively small and positioned closely together, and so to place multiple markers on different anatomical portions, it may be advantageous to use relatively small markers (2 cm or less in size). When using small markers, it may be advantageous to have the one or more cameras be deployed quite close to the surgical field on multiple robotic arms, for example at a distance of 30cm or less from the surgical field, and also at an advantageous angulation relative to the surgical field so that the marker(s) can be visualized. It may also be advantageous to place smaller markers on the robotic arms, end effectors or tools so that they do not obscure each other or aspects of the surgical field. This arrangement can then provide appropriate navigation information to the central control unit and provide for coordinated movement of the robotic arms in their positioning and operation of end effectors and surgical tools. To further explain, from such disclosed close proximity between the camera/sensor and the miniature marker and the required large number of markers on the anatomy and the robots and its end effectors and tools it is extremely advantageous not be needing to observe all markers together but to be able to focus only on the anatomy markers. With the novel suggested robotic system this is achievable.

All of these needs and elements benefit tremendously from the central coordination and synchronized control of the inventive single-cart, multi-arm, non-teleoperated robotic system. Based on the placement of appropriately sized markers and the placement of navigation cameras at an appropriate distance and orientation to the target anatomy and the markers, movement of the robotic arms carrying end effectors and cameras can be coordinated to provide for a safe and accurate robotic sewing procedure that applies required forces for the chosen application. Robotic full or partial control is also provided to alleviate surgeon exhaustion and to provide enhanced accuracy beyond human capability.

Many of the embodiments herein are described in connection with robotically coordinated sewing in robotic spinal surgery. However, any complex sewing task will benefit from the system and methods of the present invention. The present inventive systems provide full bilateral reachability and robotic control without kinematic constraint and so accuracy will be enhanced in any sewing task when compared with teleoperated systems or single arm robotic systems.

BRIEF DESCRIPTION OF THE DRAWINGS

Figures 1 shows an example of a human back during a spinal surgical procedure, with the muscles dissected with a mid-line incision and deflected to the sides. Figure 2 shows an example of a human back during a spinal surgical procedure with a mid-line closure according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

With reference now to the figures and several representative embodiments of the invention, the following detailed description is provided.

With reference to the attached figures, inventive robotic systems are provided comprising two or more surgical arms and one or more surveillance arms holding a camera or sensor. The camera or sensor may be a navigation camera or other appropriate sensor for viewing the surgical field and any associated markers. All of the arms of the inventive robotic systems are positioned on a single cart or chassis that comprises a central control until providing full robotic control of the arms. The single cart or chassis can fit under the surgical table and the inventive robotic systems are bilateral - at least one surgical arm extends upwards on one side of the surgical table and at least one additional surgical arm extends upwards on the other side of the surgical table. The surveillance arm is capable of holding the camera or sensor (e.g., navigation camera) in an advantageous position where markers (e.g., navigation markers) can be visualized. In some embodiments, the navigation camera may be held close to the surgical field to view markers on patient internal anatomy (e.g., spine bony anatomy). However, in many sewing applications relevant to the present invention, the navigation camera may be held in a position to gain a view of a larger surgical field, such as for example a large section of a patient’s spine wherein the various layers of tissue need to be sewed shut.

In a working example of the invention exemplified by Figure 1, the anatomy of a human patient’s back is shown during spinal surgery with a typical mid-line incision. Various elements of the present invention are shown that, taken together, provide for an accurate, robotically coordinated mid-line closure of the incision.

In Figure 1, the following elements are shown. Displayed are the right side 101 of the patient’s soft tissue and the left side 102 while the back is open during surgery with a midline incision 103. In the inventive system and method, single markers 104 are placed on the anatomy, along with a right marker 105 and a left marker 106 attached to respective outer tissue surfaces (the patient’s skin)- markers 105 and 106 can be in a shape of a long flat sticker that can cover a relatively long area on the skin. Right marker 105 and left marker 106 may have a pattern of imaging-visible elements on them (e.g., 104), as shown in Figure 1, such that a camera/sensor can see whether the imaging visible elements are lined up or not. Sewing wire 107 is shown passing from one side of the patient’s soft tissue to the other, along with a sewing needle 108 and an already placed second sewing wire element 109. Also shown are single markers (e.g., 110) deployed to the inner portion (muscle) of the patient’s soft tissue. Placement of the various markers and labels allows for the navigation capabilities of the robotic system to track the relative position of the soft tissue layers to ensure an accurate and desired result (e.g., mid-line closure) by thus appropriately guiding the positioning and operation of surgical tools (e.g., needles and wires).

In Figure 2, the end result of a robotic sewing procedure with use of the present system and methods is shown. An accurate mid-line closure has been achieved, as demonstrated by the symmetrical lining up of the single markers (e.g., 204). This accurate result was achieved with the placement and tracking of the markers by the robotically coordinated system of the present invention, wherein sufficient forces can be applied to sew multiple layers of skin and muscle and automation can be provided for high accuracy that may exceed human capabilities.

In particular, the inventive embodiments demonstrate the benefits of a bilateral approach to robotically coordinated sewing in a spinal surgery procedure. The inventive system minimizes or removes altogether many of the disadvantages associated with currently available teleoperated surgical systems. Due to the fact that this system uses rigid robotic arms and that the bases of the arms are far from each other (e.g. at least 1 meter apart), the system allows for the application of more force and moment, thus allowing for the sewing of multiple tissue layers such as skin and muscle. Also, the use of markers that are seen by the robotic system allows for the alignment of the anatomy to achieve the desired mid-line closure. Full or partial automation of this task by the robotically coordinated system alleviates surgeon fatigue and may provide accuracy that exceeds the capabilities of the average surgeon. All of these needs and elements benefit tremendously from the central coordination and synchronized control of the inventive single-cart, multi-arm, non-teleoperated robotic system. Based on the placement of appropriately sized markers and the placement of navigation cameras at an appropriate distance and orientation to the target anatomy and the markers, movement of the robotic arms carrying end effectors and cameras can be coordinated to provide for a safe and accurate robotic sewing procedure. The centrally coordinated robotic navigation system provided by the applicants as part of the inventive system is premised on the notion of mounting multiple robotic arms on a single, central chassis, wherein the central chassis also comprises a central control unit. The central control unit coordinates the movements of the 3 or more robotic arms that deploy surgical instruments and navigation cameras and are guided by navigation information provided by the navigation cameras and active or passive markers and/or tissue labels. In the present invention, the central control unit typically coordinates the movement of two robotic arms deploying sewing tools and one robotic arm holding a navigation camera. The system is then able to guide the sewing tools to marked or labeled tissue of interest through navigation information provided by the navigation camera and apply the forces necessary to achieve the desired sewing result (e.g., mid-line closure).

One of skill in the art will realize that several variations on the disclosed embodiments are possible while staying within the bounds of the current invention. Solely by way of example, different variations in the number of navigation cameras, robotic arms, markers/labels and end effectors can be used without departing from the invention. As another example, markers and labels of varying sizes, shapes and patterns can be used. As yet another example, numerous variations of surgical tools and surgical approaches to bilateral robotic sewing can be employed without departing from the invention described herein. The embodiments provided are representative in nature.

Claims

WHAT IS CLAIMED IS:

1. A system for robotic sewing of patient tissue comprising: a robotic surgical system comprising at least two surgical arms and at least one surveillance arm based on a single mobile cart wherein the surgical arms extend bilaterally on either side of a surgical table; at least one sensor held by the surveillance arm wherein the sensor can provide images of a surgical field of a patient; a marker placed on a portion of anatomy of the patient, wherein the marker can be observed by the sensor; at least one pair of surface markers configured to be placed on either side of an incision in tissue of the patient, wherein each of the surface markers has pairs of elements that can be observed by the sensor and wherein the elements are configured to align with each other; and one or more sewing instruments; wherein the robotic surgical system is configured to control the at least two surgical arms incorporating information provided by the sensor, and wherein the at least two surgical arms are configured to move the one or more sewing instruments to sew the tissue of the patient so that the pairs of surface markers align.

2. The system for robotic sewing of claim 1, wherein the portion of anatomy is the patient’s bony anatomy.

3. The system for robotic sewing of claim 2, wherein the patient’s bony anatomy is the patient’s spine.

4. The system for robotic sewing of claim 1, wherein the portion of anatomy is the patient’s soft tissue.

5. The system for robotic sewing of claim 4, wherein the patient’s soft tissue is an internal organ of the patient.

6. The system for robotic sewing of any of claims 1 through 5, wherein the tissue is skin tissue or subcutaneous tissue.

7. A system for robotic sewing of patient tissue comprising: a robotic surgical system comprising at least two surgical arms and at least one imaging arm based on a single mobile cart wherein the surgical arms extend bilaterally on either side of a surgical table; at least one sensor held by the imaging arm wherein the sensor can provide images of a surgical field of a patient; a marker placed on a portion of anatomy of the patient, wherein the marker can be observed by the sensor; at least one pair of surface markers configured to be placed on either side of an incision in tissue of the patient, wherein each of the surface markers has pairs of elements that can be observed by the sensor and wherein the elements are configured to align with each other; and one or more sewing instruments; wherein the robotic surgical system is configured to control the at least two surgical arms incorporating information provided by the sensor, and wherein the at least two surgical arms are configured to move the one or more sewing instruments to sew the tissue of the patient so that the pairs of surface markers align.

8. The system for robotic sewing of claim 7, wherein the sensor is an endoscopic camera.

9. The system for robotic sewing of claim 7, comprising at least two imaging arms.

10. The system for robotic sewing of claim 9, wherein each of the at least two imaging arms holds at least one sensor that is an endoscopic camera.

11. The system for robotic sewing of claim 7, wherein the portion of anatomy is the patient’s bony anatomy.

12. The system for robotic sewing of claim 11, wherein the patient’s bony anatomy is the patient’s spine.

13. The system for robotic sewing of claim 7, wherein the portion of anatomy is the patient’s soft tissue.

14. The system for robotic sewing of claim 13, wherein the patient’s soft tissue is an internal organ of the patient.

15. The system for robotic sewing of any of claims 7-15, wherein the tissue is internal tissue of the patient and wherein the at least one sensor can be positioned advantageously to visualize the tissue during sewing.