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, or other devices useful for robotic surgery, and in particular for robotic spinal surgery. The invention also relates to robotic systems wherein the placement and movement of the robotic elements are controlled and coordinated by a single control unit, and wherein all of the robotic elements are based on a mobile single rigid chassis and, thus, are robotically coordinated at a single origin point. Specifically, 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, 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 a robotic spinal surgery procedure requiring high accuracy, repetitive tasks and multiple tool sets, the invention relates to a robotic system wherein tool carts adjacent to the central robotic chassis may be interchanged during the surgery and the robotic system may select and feed itself tools and deploy them efficiently and accurately during the surgical procedure.

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 control unit. This is particularly important in the context of spinal surgery procedures involving complex, repetitive tasks with multiple different tool sets. A single, large robotic arm is invariably less able to perform complex tasks demanding high accuracy than is a smaller, lighter robotic arm. Thus, a single robotic system with multiple, smaller arms that can be positioned to approach the surgical field from multiple sides of the patient would be highly desirable.

Performance of a full range of spinal surgery procedures, including complex procedures demanding high accuracy, requires robotically coordinated system which may also in certain a portion and aspects utilize robotically coordinated navigation 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 a wide range of varied and versatile instruments and tools, placement 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 multi-arm/multi-camera system mounted on, and controlled by, one mobile cart, is not available in the current state of the art. There is a strong and long-felt need for such a system as it will enable the performance of safe and precise spinal surgery procedures with robotically coordinated control and navigation at a level of accuracy not currently possible.

There is a widely shared goal in the field of robotic spinal surgery to have the robotic system take a more active, independent and even dominant role in the surgical procedure. It is thought in the abstract that a pure robotic approach would improve accuracy and, therefore, the surgical result and patient safety. However, the goal of greater robotic control over the surgical procedure has not yet been met, largely due to the aforementioned drawbacks of currently available robotic systems. Robotic systems with large, cumbersome arms are inherently less accurate than systems with smaller robotic arms. Also, teleoperated systems are not designed to be accurate by themselves rather by human operator who closes the loop and for that reason accurate and reliable centrally coordinated and controlled robotic systems have an inherent advantage.

There are also barriers to adoption with conventional robotic systems due to their large footprint and interference with surgical workflow. Even in the situation where the surgical robotic system can take substantially more control over a spinal surgical procedure, there is still the need for multiple medical staff to be present in the surgical field. Therefore, a system with a high degree of automation with respect to tasks like tool selection and performance of repetitive tasks must still be relatively compact and take up relatively little floor space in the operating room. Even the most accurate spinal surgical robot will not be adopted by clinicians if it significantly blocks human access to the surgical field.

The requirement in the marketplace for a more active and independent surgical robot is enhanced in use cases that require complicated, multi-step tasks that require the input of multiple medical professionals in the surgical field. The need is also enhanced when repetitive tasks are required during a surgical procedure - even the best surgeons are prone to error when performing repetitive, complex tasks. One such example is the placement of multiple pedicle screws during a robotic spinal surgery procedure. Pedicle screw placement can be repetitive - drill, tap, screw actions are performed for each instance of placing the screw. A robotic system that can perform this task accurately and more autonomously would thus be highly desirable.

Spinal surgery procedures are also made more complicated by the fact that multiple different tool sets may be required as the procedure progresses. For example, even the placement of multiple pedicle screws in the spine of a patient may require the use of different types of screws in each vertebra and those of skill in the art will understand that each different pedicle screw is often configured to be used with its own unique tool set. This in turn creates the need for tool changes during the surgical procedure. Certainly, a centrally coordinated and controlled surgical robotic system that is able to select and deploy tools from interchangeable adjacent carts while not being too big and cumbersome to interrupt he medical staff normal space would be highly desirable.

A system that robotically synchronizes the selection and deployment of varied tool sets during surgery would be greatly beneficial in the performance of repetitive and complex tasks requiring high accuracy. The actions of the robotic system and its multiple arms would be coordinated and controlled from a central chassis, thus achieving the aims of a high degree of independence and accuracy, with the added benefit of visualization and navigation capabilities being deployed from the same central chassis. Such a system is provided in the context of the present invention.

SUMMARY OF THE INVENTION

Provided herein is a mobile robotically controlled surgical system. Specifically, the inventive system is a centrally coordinated and synchronized robotic system for spinal robotic surgery procedures, optionally for bilateral approach in spinal robotic surgery procedures. The system comprises multiple robotic arms that each can hold, place and/or manipulate at least one end effector, camera or navigation element for use in a spinal surgery procedure. The end effectors may include any surgical tools useful for performing spinal surgical procedures and are interchangeable. The cameras and navigation elements are for another layer of accuracy and confidence providing guidance for the movement of the robotic arms and deployment of the end effectors and tools.

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 two robotic arms, one of which place, guide and/or hold end effectors and/or tools and one holding a navigation and imaging camera. In another embodiment, there are three arms in which two are using different surgical tools and different end effectors. In such an embodiment, the arms holding the tools may, after the tools have been placed, bring and manipulate other end effectors or tools in the surgical field. In such an embodiment, the first arm may optionally position and then control the use of, for example, a drilling tool. The second arm may optionally position and then control the placement of an element such as a screwdriver. A third arm may optionally hold a camera 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 its deployment 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, the robotic arms and/or the tools or end effectors may have active or passive markers placed on them that may assist the robotic system in positioning the robotic arms, the tools and/or the end effectors.

In one embodiment, the already robotically synchronized movement of the robotic arms is enhanced by the interaction of the navigation cameras with active or passive markers that are placed during or at the beginning of the procedure on portions of the patient’s anatomy. 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. The additional navigation information provided by the various markers and the one or more cameras can improve that accuracy in some cases or add another layer of protection and verification.

In some embodiments of the present invention, carts with robotic tool sets may be brought into the surgical field and optionally attached and detached from the central chassis of the robotic surgical system using a robust, accurate and repeatable mechanical and electrical connection. Once rigidly mechanically attached to the central chassis, the tool carts are essentially robotically synchronized with the robotic surgical system. In this regard, the multiple robotic arms are able to accurately select and deploy tools from the tool carts into the surgical field in a centrally coordinated manner. In alternative embodiments, tool carts containing tool sets that are no longer needed during the surgical procedure may be detached from the central chassis and alternative tool carts with alternative tool sets may be brought into the surgical field and may be rigidly mechanically attached to the central robotic chassis. Again, once attached, the new tool carts are robotically synchronized with the robotic surgical system and the multiple robotic arms are able to select and deploy the tools in a centrally coordinated manner. In these representative embodiments of the present invention, multiple mobile, portable, variable and versatile tool sets can be brought into the surgical field and subsequently removed without impacting operating room floor space or surgical workflow too dramatically.

In an alternative embodiment of the present invention, the central robotic single chassis system can be equipped with a barcode or RFID scanner that is configured to be able to read appropriate RFID codes on surgical tools or tool carts. This allows the robotic system to keep an inventory of available tools and implants that have been used in the surgical procedure and also to prevent mistakes of using wrong tools. In this embodiment, the centrally coordinated robotic system is able to check that the desired tools were selected and used and, thus, provide a safety and accuracy check with respect to the surgical procedure. In the example of complex spinal surgical procedures involving repetitive tasks with multiple different tool sets, this functionality can only be said to enhance accuracy, surgeon performance and patient safety. This functionality is enabled by the scanner device and tool carts being optionally connected to the central robotic chassis, which in turn can then centrally coordinate the progress of the surgical procedure.

The inventive embodiments take advantage of multiple feedback loops to ensure precision and safety in the performance of a bilateral robotic spinal surgical procedure. The movement of the robotic arms is robotically synchronized to the greatest possible level of precision because the relatively small robotic arms are all co-mounted on a single rigid chassis that has a central control unit.

The robotic arms bases are also mounted on the central chassis relatively far from each other, for example at least one meter apart - thus providing for greater reachability, maneuverability and moments application. This advantage is significant in this invention since being able to have several robotic arms which are not very big e.g., up to one meter reach but their bases are relatively far from each other enables high reachability and area coverage of f the surgical room with relatively small arms while being highly accurate and without notable interference for the surgical staff. Robotic navigation is provided by one or more cameras/sensors that are deployed by one or more robotic arms that are also co-mounted on the same single chassis and are also controlled by the same central control unit. All of these needs and elements benefit tremendously from the central coordination and synchronized control of the inventive mobile 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 further coordinated to provide for a safe and precise robotic spinal surgical procedure. Rigid mechanical attachment of interchangeable tool carts to the central chassis, along with the use of scanning tool inventory elements allows for an unprecedented level of accuracy and diversity in the performance of repetitive tasks in spinal robotic surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows an end view of a robotic spinal surgery system with multiple tool cart elements being available and interchangeably connected according to an embodiment of the present invention.

Figure 2 is an alternative overhead view of a robotic spinal surgery system with interchangeable tool carts 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.

In a working example of the invention exemplified by Figure 1, a mobile, bilateral robotic spinal surgery system is shown. The system comprises a mobile central chassis 101 that can be deployed under a surgical table 102. In a representative application, the body of a patient 103 is placed in on the surgical table. Shown in Figure 1 is a vertebra 104 of the patient 103, wherein a surgical marker 105 may optionally be placed on the vertebra 104 of the patient 103. The optional surgical marker 105 may be used in conjunction with a navigation camera 112 to register the position of the patient 103 so that it will be known by a central control unit found in the central chassis 101 of the robotic surgical system. Another and alternative method to register the robotic arms to the patient anatomy does not require the navigation marker but another radiopaque marker placed on the robotic arm and being scanned together with the bony anatomy.

The robotic surgical system further comprises three robotic arms 106, 107 and 108 that are all deployed on the central chassis 101 . One of skill in the art will realize that more or less robotic arms can be deployed on the central chassis 101 (e.g. two arms from both sides both holding cameras bi-laterally) but that three arms may be suitable for many robotic spinal surgical procedures since two arms may hold robotic tools and one may hold a navigation camera. This three-arm configuration may be especially useful to those of skill in the art as it may optionally enable a bilateral approach to robotic spinal surgery. This bilateral approach is particularly enabled by the present robotic surgical system that positions a central chassis 101 under the surgical table allowing for relatively small and maneuverable robotic arms to approach the patient from either side of the table, all with a small operating room footprint.

Figure 1 also shows several tool carts 113, 114, 115 and 116 as being aspects of an embodiment of the present invention. The tool carts 113, 114, 115 and 116 may optionally be mechanically rigidly connected to each other and to the central chassis 101 by connection elements 117. The connection elements 117 may optionally include electronic communication means so that, among other things, the central control unit found in the central chassis 101 can identify the tool carts that are connected 113, 114, and 115, know their position, and guide the robotic arms 106, 107, 108 to select tools from the tool carts.

In the representative embodiment of Figure 1, robotic arm 106 is holding a navigation camera 112, robotic arm 107 is positioned to select a tool from a tool cart 113 and robotic arm 108 is holding a tool 109. A representative alternative tool set 111 is positioned on tool cart 113. In addition, tool carts according to embodiments of the present invention may comprise an additional robotic arm 110 that may be used for the positioning, exchange and deployment of surgical tools. Figure 2 provides a top view of a similar inventive embodiment to that found in Figure 1. Figure 2 provides one of skill in the art with a more comprehensive view of a representative layout of the inventive system in an operating room. Specifically, Figure 2 shows areas of operating room floor 118 that are unoccupied by the present inventive system. The areas of unoccupied operating room floor 118 are thus available for medical staff and other surgical equipment, such as intraoperative imaging equipment. Moreover, since this is a mobile system in its essence, all carts can be quickly deployed in any surgical room and later quickly taken out and clearing the room for other types of surgery. Figure 2 thus demonstrates that the current inventive system provides significant advantages in terms of minimal footprint and minimal disruption of surgical workflow.

The inventive system demonstrated in Figures 1 and 2 allows for the performance of novel and versatile robotic spinal surgical procedures. Solely by way of example, robotic spinal surgery often requires the placement of multiple pedicle screws or other hardware elements in multiple vertebrae of a patient. These are complex, repetitive tasks that can challenge even the best spine surgeon. Repetition and fatigue are factors in the performance of these types of procedures, as are the natural limits of human precision and accuracy. Surgical tasks such as these are further complicated by the fact that different areas of patient anatomy may require different surgical tools and different surgical approaches, thus necessitating the use of different tool sets. As the surgeon progresses through the patient’s spinal column and places pedicle screws, they may wish to use different hardware types and may also wish to take different surgical approaches, thus necessitating the use of different tool sets. This type of surgical task may be greatly facilitated by a robotic system that can easily incorporate the use of different tool sets and also automates tool, thus providing accuracy beyond the limits of human performance.

One of skill in the art reading the present disclosure and viewing Figures 1 and 2 will understand that the surgical team may sequentially bring tool carts 113, 114, 115 and 116 into the surgical field, each bearing different tool sets. The surgical robotic system may then deploy the tool sets in a centrally coordinated manner that increases accuracy. 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 and end effectors can be used without departing from the invention. As another example, markers of varying sizes can be used. As yet another example, numerous variations of surgical tools and surgical approaches to unilateral or bilateral spinal surgical can be employed without departing from the invention described herein. The embodiments provided are representative in nature.