Synchronized robotic bone cutting

Abstract

To provide a system and a method robotically coordinated.SOLUTION: A robotic spinal surgery system is provided with at least three robotic arms 307, 308, 309 co-located on a single mobile base, wherein the movement of the robotic arms is coordinated by a central control unit on the base. The system further comprises tools 311 for spinal decompression, elements 312 for protection of nervous tissue and navigation cameras 310. The nerve protection elements are placed between bony anatomy structures and nervous structures to prevent contact of the spinal decompression tools with the nervous structures. The nerve protection elements further include safety components that can optionally close electrical circuits with the decompression tools and sense or stimulate the nervous structures. A method of deploying the inventive system in surgery is also provided.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] (Field of the Invention) The present invention relates to robotically controlled and adjusted surgical procedures. Specifically, the present invention relates to a robotic system comprising a plurality of bilateral robotic elements such as robotic arms, end effectors, surgical instruments, anatomical structure protection devices, cameras, imaging devices, tracking devices, or other devices useful for robotic surgery. The present invention also relates to a robotic system in which the installation and movement of robotic elements are controlled and adjusted by a single control unit, and all of the robotic elements are based on a single movable rigid chassis and are thus robotically adjusted at a single origin. Specifically, a plurality of robotic elements may be attached to and controlled by a single control unit and used to deploy and / or be associated with surgical instruments, trackers, cameras, and other surgical tools as part of a robotic surgical procedure in an adjusted manner. More specifically, in the context of robotic spinal surgery, a plurality of end effectors may be deployed bilaterally on a plurality of robotic arms and may be controlled by a single control unit and adjusted in a unified manner by a central control unit, and the relative movement of each robotic element may be used to perform a robotic surgical procedure. Most specifically, in the context of bone cutting (decompression) in robotic spinal surgery, instruments for cutting bone and protecting anatomical elements such as nerves may be deployed on a plurality of robotic arms and controlled to perform a safe and effective surgical procedure in a synchronized and adjusted manner.

Background Art

[0002] (Background of the Invention) Robotic surgery is well known in the art, as is the application of robotic techniques to spinal surgical procedures such as spinal decompression (bone cutting). Many robotic surgical systems, such as the da Vinci robotic surgical system from Intuitive Surgical, are remotely operated. For example, multi-arm robotic surgical systems, such as those offered by Cambridge Medical Robotics, are available in the art. These known systems are also often remotely operated and consist of a single arm deployed separately on a separate cart or chassis, with a level of adjustment provided by a remotely positioned control unit. Systems with multiple arms on multiple carts have significant drawbacks in terms of integration into the surgical workflow, in addition to occupying an undesirably large area in the operating room. Furthermore, the control of units remotely operated by a remotely positioned control unit does not provide the level of control required for the full range of surgical procedures, especially in the case of spinal surgery. The accuracy will inevitably be inferior to systems in which all robotic arms are fixed to a single chassis with a control unit and adjusted accordingly.

[0003] The full range of robotic spinal surgery procedures, including robotic spinal decompression, requires robotically coordinated navigation / sensing, which is not currently available. Typical procedures may require the operation of one or more end-effectors deployed by a robotic arm, the deployment of other instruments, the placement of multiple passive or active markers on bone and / or soft tissue, one or more robotically controlled and operated cameras / sensors that can be placed at various distances and angles from the surgical field, and one or more end-effectors deployed by a robotic arm. Such a bilateral multi-arm / multi-camera / sensor system mounted on and controlled by a single cart is not available in the current state of the art. There is a strong and long-recognized need for such a system, as it would enable the full range of spinal surgery procedures with robotically coordinated control and navigation at a level of precision not currently possible.

[0004] The need for a unified, multifaceted approach is strongly recognized in spinal decompression procedures. Spinal decompression presents the necessity of cutting bone in various ways, shapes, forms, and orientations. In many cases, the decompression process is performed to release the pressure that anatomical structures exert on sensitive nerves. In many such cases, nerves and / or spinal cords are practically touched (e.g., "scar tissue"), if not fully compressed and / or attached to by the anatomical structures of the spine. This demonstrates a fundamental problem and risk associated with bone cutting, whether performed robotically or by other techniques. That is, conventional robotic or non-robotic approaches, to some degree, involve cutting instruments directly adjacent to, or actually touching, delicate nerve or spinal cord structures when performing bone cutting. This poses an unacceptable risk of catastrophic injury.

[0005] In conventional procedures, whether robotically or non-robotically performed, protective surgical instruments can be placed between anatomical bone structures and nerve or spinal cord structures to protect those nervous system structures from cutting instruments and / or separate them. This approach is time-consuming, stressful, and extremely difficult for the surgeon. Existing robotic technology, while multi-arm, does not support the inherent need for separated but coordinated robotic movements. Therefore, attempting to use existing robotic technology will inevitably result in a lack of precision between the two surgical instruments. If there is a risk resulting from this lack of precision, there is a risk that the protective instruments will not completely protect the nerves or spinal cord, and thus there is a risk of damage to those structures. Furthermore, precise synchronization of protective instruments and cutting instruments by robots would enable automated robotic cutting, which would allow for prior planning of the required cutting and precise execution by the robotic system, which would inevitably improve clinical outcomes.

[0006] A system that robotically synchronizes the placement and movement of bone cutting instruments and anatomical protective devices would alleviate this concern to a considerable extent, as the instruments would be held by robotic arms whose movement is synchronized with each other, thus reducing the risk of injury. The holding and placement of instruments by synchronized robotic arms provides greater precision, and therefore greater safety. Such a system is provided in the context of the present invention. Furthermore, when utilizing such a system and autonomous robotic capabilities, the need for cutting instruments and protective devices to be robotically coordinated, in addition to being coordinated by conventional navigation techniques, becomes significantly higher and more important. [Overview of the Initiative] [Means for solving the problem]

[0007] (Summary of the invention) Provided herein is a robotically controlled surgical system. Specifically, the system of the present invention is a centrally coordinated and synchronized robotic system for bone cutting applications (e.g., spinal decompression, orthopedic applications, skull, ENT, etc.). The system comprises a plurality of robotic arms, each capable of holding at least one end effector, camera / sensor, or navigation element for relevant applications, e.g., use in spinal decompression procedures. The end effector may include cutting instruments and instruments for the purpose of protecting nerve or spinal cord elements of the spinal anatomical structure, e.g., anatomical protective instruments such as spatulas. The camera / sensor and navigation element are for guidance and / or tracking of the movement of the robotic arms and / or parts of the anatomical structure, and for providing deployment of the end effector and instruments.

[0008] The present invention comprises multiple robotic arms capable of cutting bone, protecting anatomical structures, and providing navigation support in an automatic and safe manner, such that they are robotically synchronized, through the holding and deployment of end effectors and / or cameras / sensors. In one embodiment, there may be three robotic arms, one holding a cutting instrument, one holding a protective instrument, and one holding a navigation / tracking sensor, e.g., a navigation camera. In such an embodiment, the first arm holds a protective instrument that can play a role in retracting, deflecting, protecting, or manipulating sensitive organs, e.g., nerves, spinal cord, etc., from the bone anatomical structure being cut. The second arm holds a cutting instrument (e.g., a high-speed bur) for cutting bone. The third arm holds a monitoring camera / sensor that provides images and / or other important data of the process from an optimal distance and angle portion. The camera is capable of operating from an optimal distance and angle portion, so that it is appropriately sized and deployed onto a robotic arm that is appropriately sized and positioned. Optionally, the robotic arm holding the cutting instrument or protective device may also hold an additional imaging or navigation camera to provide redundancy and diverse information.

[0009] The synchronized movement of the robotic arm is enabled by the interaction of a navigation camera and active or passive markers placed on anatomical structures at or during the procedure. The movement of the robotic arm is synchronized from a single movable base, which determines the arm's location based on navigation information provided by the markers and camera, via a central control unit.

[0010] Therefore, in various embodiments of the system of the present invention, passive or active markers may be placed on anatomical structures or additional surfaces, such as the patient's skin or operating table, and may be used to assist navigation / tracking during spinal decompression procedures or other cutting applications. These procedures may require the placement of one or more passive or active markers on the anatomical structures of one or more vertebrae. In certain embodiments, small markers may be preferred. Vertebrals are relatively small, and therefore, it may be advantageous to use relatively very small markers (1 cm or less in size) to place multiple markers on different vertebrae (in fact, on different components of the anatomical structure of the vertebrae). When using small markers, it may be advantageous to deploy one or more cameras / sensors very close to the surgical field, for example, at a distance of 30 cm or less from the surgical field, and at a favorable angle to the surgical field, so that the markers can be visualized. For example, if a small marker is deployed at an inconvenient angle inside the patient's body, positioning the camera / sensor at a close distance and appropriate angle would be advantageous. This arrangement can therefore provide appropriate navigation / sensing information to the central control unit and provide coordinated movement of cutting instruments and protective devices. In addition to the ability to bring the camera / sensor close to the organ or target and within the optimal angle, the centrally coordinated system can also calculate and determine the best position for the robotic arm to prevent collisions and enable a convenient workflow, in relation to each other, and especially to the ever-changing positions of the patient and clinical staff.

[0011] The approach of the present invention enables the synchronized operation of multiple robotic arms, and in many embodiments, three arms are selected. The cutting arm holding the cutting tool operates in sync with the arm holding the protective device and the sensor / navigation camera at all times.

[0012] Optionally, the three robotic arms can hold two cutting instruments and one protective device, in addition to any navigation elements present. In this embodiment, there is a synchronized operating pattern among the three arms. The two cutting arms operate in sync with the cutting instruments and protective device, with the bone being cut always at the center. Thus, both arms can always be aligned with each other in relation to the bone, while the bone is always protected. The third arm, which holds the camera, is also synchronized and therefore positioned optimally for viewing the bone markers and the bone being cut, while naturally, the surgical arms can also be equipped with an additional navigation camera, in addition to providing an additional sensing angle. Furthermore, the system allows for bilateral deployment of the arms from both sides of the patient, so the mass of the robotic arms is positioned primarily on both sides of the patient, so the surgical field is clear for surgical operation and for clear imaging / sensing by the third arm.

[0013] In alternative embodiments of the present invention, two end effectors (e.g., a cutting end effector and a protective end effector) have the ability to sense contact or near contact between them. This can be achieved using various techniques such as conductive, magnetically inductive, and capacitive sensing. Simply put, when a signal is generated indicating that the cutting tip is near or in contact with the protective device, the system controller can perform several actions, such as stopping the cutting action or continuing the cutting in a different direction. Robot synchronization of the system of the present invention provides perfect alignment between the cutting instrument and protective device and the anatomical and neural structures, achieving optimal bone cutting. The ability of the cutting instrument and protective device to sense each other by closing electrical circuits provides a crucial safety feature without risk or delay, preventing over-cutting and enabling the smooth continuation of spinal decompression procedures.

[0014] In various embodiments of the present invention, the protective end effector or protective device comprises at least two parts, most often positioned on either side of the device. One side is often made of metal so as to be able to close an electrical circuit when in contact with a bone cutting instrument, though this is not always the case. The other side of the protective device is constructed and configured to be capable of sensing nerve structures. It may be configured to detect the presence and / or proximity of nerve structures, and in addition, it may be configured to stimulate nerve structures.

[0015] In some alternative embodiments, the second part of the protective end effector or instrument that touches the nerve is made of a different material that acts as a sensor for nerve conditions. This can simply be a sensing part that senses nerve conditions or proximity (e.g., impedance measurement) and reports to the main controller, or it can also be a stimulator that provides the measured stimulus (e.g., 10 mA) to the nerve and receives a feedback signal. This capability can act as a second feedback loop for protecting delicate nerve structures while cutting bone. If the central controller receives a signal that can be interpreted, for example, as the end effector placing too much pressure on the nerve, the main controller can correct the relative cutting position between the two arms to generate a better cutting posture between the two arms that applies less pressure to the nerve.

[0016] Furthermore, another advantage arises from the fact that (for example) protective devices and cutting instruments are connected to different robotic arms and are not simply used together as a single device on one robotic arm. Moreover, naturally, by being on separate arms that are robotically connected and synchronized, the robotic controller can have several options for optimal cutting and safety measures through the algorithms built into it. For example, in some cases, as a safety measure, it is preferable to simply stop the high-speed bur from rotating, but this action is not always optimal in surgical procedures, as sometimes simply stopping the high-speed bur during cutting will cause it to stagnate in the bone. Sometimes, the optimal safety measure would be to move the high-speed bur backward so that it is a few millimeters away from the anatomical structure. Sometimes, from a clinical or convenience consideration, cutting instruments and / or protective devices should be close to their area from specific angles / locations, etc., i.e., separating the cutting instruments from the protective devices, but still allowing them to work together precisely, has significant value in robotic bone cutting procedures. Another embodiment of the benefits of separating cutting instruments from protective devices through different synchronized robotic arms would be that the method would allow, for example, one arm to move laterally and replace a cutting instrument while another arm remains holding and protecting the nerve. Furthermore, if two or more arms are busy with cutting, one can proceed and replace the instrument while the other remains operational. This has the potential to significantly improve the efficiency of the surgical process.

[0017] All these needs and elements greatly benefit from the centralized adjustment and synchronized control of the single-cart, multi-arm, bilateral, remotely operated robotic system of the present invention. Based on the placement of appropriately sized markers and navigation cameras at the appropriate distance and orientation to target anatomical structures and markers, the movement of the robotic arms carrying the end effectors and cameras can be adjusted to provide safe and precise robotic spinal decompression procedures. This specification also provides, for example, the following items: (Item 1) A system for safe surgical procedures, A robotic surgical apparatus comprising at least three robotic arms arranged on a single cart, and a central control unit located within the cart, A bone cutting instrument held by one of the at least three robot arms, A device for protecting a sensitive organ, held by another of the three robotic arms mentioned above, A camera or sensor is held by the third of the three robot arms mentioned above. Equipped with, The movement of the robotic arm is coordinated by the central control unit so that the protective device is positioned to provide protection to the critically sensitive structure. (Item 2) The aforementioned single cart is movable, as per the system described in item 1. (Item 3) The system according to item 1, wherein at least one of the three robotic arms is deployed on each side of the patient. (Item 4) The critically sensitive structure is a critical nervous system structure, as described in item 1. (Item 5) The aforementioned organ protection device for sensitive organs, A portion configured to close an electrical circuit when it comes into contact with the bone cutting instrument, A second portion configured to protect the critical nervous system structure, and The system according to item 4, comprising (Item 6) The system according to item 5, wherein the second portion is further configured to sense or stimulate the critical nervous system structure (Item 7) The system according to item 1, wherein the camera or sensor is selected from the group consisting of a navigation system, a tracking system, an X-ray, and an MRI (Item 8) The system according to any of the preceding items, wherein at least one small active or passive marker is placed on the bony anatomical structure of the patient's vertebrae as part of a spinal decompression procedure (Item 9) The system according to item 8, wherein at least two small active or passive small markers are placed on the bony anatomical structure of the patient's vertebrae (Item 10) The system according to item 9, wherein the camera or sensor is held in proximity to the bony anatomical structure of the patient's vertebrae (Item 11) The system according to item 10, wherein the small marker is less than 1 cm in size and the camera or sensor is held less than 50 cm from the bony anatomical structure of the patient's vertebrae (Item 12) The system according to any of the preceding items, wherein additional cameras or sensors are placed on the robotic arm holding the bone cutting instrument and on the robotic arm holding the sensitive organ protection instrument (Item 13) The system according to any of the preceding items, wherein the robotic arm holding the bone cutting instrument and the robotic arm holding the sensitive organ protection instrument are equipped with torque sensing capabilities (Item 14) A method of performing a safe spinal decompression surgery, comprising A robotic surgical apparatus comprising at least three robotic arms arranged on a single movable cart, and a central control unit located within the movable cart, A bone cutting instrument held by one of the at least three robot arms, A nerve protection device, held by another of the three robotic arms, A camera or sensor is held by the third of the three robot arms mentioned above. The robot arm moves within the surgical field, and the nerve protection device The central control unit adjusts the neuroprotective device so that it is positioned to provide protection to the critical nervous system structure, A portion configured to close an electrical circuit when it comes into contact with the bone cutting instrument, A second part configured to protect, sense, and / or stimulate nerve tissue To be equipped with, The bone cutting instrument is advanced until the electrical circuit is closed, or until the second part of the nerve protection device senses nerve activity consistent with the danger from the bone cutting instrument, thereby achieving the desired spinal decompression. Methods that include... (Item 15) The method according to item 14, wherein at least one of the three robotic arms is deployed on each side of the patient. (Item 16) The critical susceptible structure is a critical nervous system structure, as described in item 14. (Item 17) The aforementioned organ protection device for sensitive organs, A portion configured to close an electrical circuit when it comes into contact with or near contact with the bone cutting instrument, A second part configured to protect the critical nervous system structure and The method described in item 16, comprising: (Item 18) The method of item 17, wherein the second part is further configured to sense or stimulate the critical nervous system structure. (Item 19) The method described in any of the preceding items, wherein at least one small active or passive marker is placed on the osseoanatomical structure of the patient's vertebrae as part of a spinal decompression procedure. (Item 20) The method according to item 19, wherein the camera or sensor is held in close proximity to the anatomical structure of the patient's vertebrae. (Item 21) The method according to item 20, wherein the small marker is less than 1 cm in size, and the camera or sensor is held less than 50 cm from the bone anatomical structure of the patient's vertebrae. (Item 22) The method according to any of the preceding items, wherein an additional camera or sensor is installed on the robot arm holding the bone cutting instrument and on the robot arm holding the sensitive organ protection device. (Item 23) The robotic arm holding the bone cutting instrument and the robotic arm holding the sensitive organ protection instrument are equipped with torque sensing capability, according to any of the preceding items. [Brief explanation of the drawing]

[0018] [Figure 1a] Figures 1a, 1b, and 1c show various diagrams of vertebral anatomical structures, including bony portions that may require cutting, adjacent to nerve or spinal cord structures. [Figure 1b] Figures 1a, 1b, and 1c show various diagrams of vertebral anatomical structures, including bony portions that may require cutting, adjacent to nerve or spinal cord structures. [Figure 1c] Figures 1a, 1b, and 1c show various diagrams of vertebral anatomical structures, including bony portions that may require cutting, adjacent to nerve or spinal cord structures. [Figure 2] Figure 2 is a magnified view of a portion of the vertebra that is directly adjacent to the nerve structure and may require cutting. [Figure 3] Figure 3 shows a robot system according to a typical embodiment of the present invention, in which multiple centrally controlled robot arms hold cutting tools and protective devices. [Figure 4] Figure 4 shows a protective end effector according to a typical embodiment of the present invention, which includes a conductive sensing element. [Modes for carrying out the invention]

[0019] (Detailed description of the invention) A detailed description of the present invention is provided below with reference to the drawings and some representative embodiments.

[0020] In an example of the present invention illustrated by Figure 1, several diagrams of the vertebral anatomical structure are shown. In each of the three diagrams, a vertebra 104 is shown. In each case, a portion 101 of the vertebra 104 requires cutting, for example, because it is pressing against an adjacent nerve structure. In various parts of the diagram, a nerve root 102 and / or spinal cord 103 are shown. For example, the use of the system of the present invention with three adjustable robotic arms, accompanied by a cutting instrument deployed by three arms, a nerve protection device, and a camera, allows for precise cutting of a portion of the bone 101 while significantly minimizing the risk of catastrophic damage to the nerve root 102 or spinal cord 103 or other nerve structures.

[0021] Figure 2 shows a magnified view of a portion of the anatomical structure 201 directly adjacent to the nerve root 202 or other nerve structure. Given this arrangement of bone and nerve structures, bone cutting (i.e., decompression) would often be required as appropriate surgical treatment due to portions of the anatomical structure 201 pressing against or abutting the nerve root 202 or other nerve structure. This problem, requiring surgery, is often caused by stenosis or other compression, which can result from a variety of reasons, including age-related degeneration, congenital and non-congenital deformities, and trauma.

[0022] Figure 3 shows a robotic system for bone cutting according to one embodiment of the present invention. The robotic arm of the system of the present invention is mounted on a single movable rigid chassis equipped with a centralized control unit, enabling synchronized movement and control of the robotic arm. In the context of spinal decompression procedures, this synchronized control enables precise bone cutting at optimal angles and orientations.

[0023] The structure and form of this system enable bilateral optimal deployment of multiple robotic arms from both sides of the patient. This special deployment of the robotic arms keeps its main mass on both sides of the patient, so that the surgical field is clear for surgical procedures and imaging / sensing by the third arm and / or the surgeon. Furthermore, this method of deploying and positioning the robotic arms allows the arms to approach the surgical area, specifically, in most cases, the bone to be cut, while they are in a partially folded position. It is well known in the art that robots are more rigid and therefore more accurate when they are partially folded, i.e., not in a fully extended position. Unlike the system of the present invention, standard robotic systems known in the art today position their arms relatively far from each other and from the patient, which requires the arms to reach far distances, often in a fully extended configuration, and therefore lose accuracy.

[0024] In Figure 3, robot arms 307, 308, and 309 are shown mounted on a rigid chassis 301, which may be voluntarily movable. Robot arm 307 holds a cutting instrument 311. Robot arm 308 holds a neuroprotection device 312. Robot arm 309 holds a camera 310. In this embodiment, the “navigation camera” may consist of several alternative techniques such as visible light imaging, X-ray, MRI, magnetic tracking, laser sensing, and more, while being used as the primary method for robot / instrument / patient tracking. Also shown in Figure 3 are a surgical table 302 (which, if movable, may be voluntarily deployed under the table and / or removed before, during, and after surgical procedures) and a patient body 303, to which the robot system fits. Within the patient body, nerve structures 304 and parts of bone anatomical structures 305 requiring cutting are shown. The protective device 312 is placed between the nerve structure 304 and a portion of the anatomical bone structure 305 so that the cutting instrument 311 can perform precise cutting without risking damage to the nerve structure 304. The camera 310, with the help of a small marker 306 placed at the start of the surgical procedure, helps to position the robotic arms 307, 308, and 309 in the correct position relative to the surgical field. The camera 310 can then monitor the progress of the surgical procedure from an optimal angle.

[0025] Today, the common method for tracking organs to be operated on, such as anatomical structures and / or more specifically, vertebral bodies, is to place a marker on it. However, the marker must be conspicuously high above the open wound, for example, 5-25 cm, due to the fundamental reason that it needs to be visible to a camera / sensor passively positioned at a distance of 1-3 meters. Thus, the ability of this long, lightweight marker to maintain its position relative to the anatomical structure is limited, and therefore its accuracy is very low. For this reason, to date, this tracking technique has been rarely used for delicate and precise tasks such as spinal decompression. In this invention, thanks to an active proximity range and operating robotic arm capable of holding a camera / sensor and bringing it within close range to the open wound, the marker can be very small (e.g., 1 cm or less), thereby being rigidly connected to the bone being cut and in a very precise position. The markers can be passive or active and can support several tracking / sensing technologies, such as different color combinations and contrasts of visible light, infrared reflection, magnetic resonance, lasers, and more. Also, thanks to their small size, i.e., small size and weight of a few grams, they can be screwed directly into the bone (e.g., 3-6 mm threads) and fixed in place, thereby providing unprecedented accuracy. Those skilled in the art will understand that, using these small-sized markers and a navigation camera held close to the surgical field to achieve the optimal angle, multiple small active or passive markers can be placed on several sides of a single vertebra for optimal visualization.

[0026] In an alternative embodiment of the present invention, an additional navigation camera may be mounted on a robotic arm that holds a cutting instrument. In another alternative, the additional navigation camera may be mounted on an end effector that is also held by the robotic arm that holds the cutting instrument. The mounting of an additional camera on a surgical arm can further improve the view of the surgical field and provide additional information for small markers. Those skilled in the art will understand that the cameras can be mounted with excellent precision due to the coordinated movement of the robotic arm, each mounted on a single movable chassis with a central control unit, and can provide an improved view of the surgical field.

[0027] Figure 4 provides an enlarged view of a nerve protection device 400 according to one embodiment of the present invention. The protection device 400 has a metal part 401 and a sensing part 402. The device can have several sizes and shapes to suit various decompression and bone cutting techniques. Some have a small spoon-shaped outline, starting from a width of 1-2 mm and becoming long, curved or flat spatula-like. Also, today, hundreds of high-speed bone cutting burs and dozens of devices used manually by surgeons as "protective devices" are commonly available on the market. The specific design of cutting burs and protective devices depends not only on the application but also on the specific surgeon's personal preferences, tastes, surgical philosophy, and training, etc. The robotic arm can adjust its robotic movement and cutting technique according to the surgeon's planned and selected techniques and devices.

[0028] The metal part 401 can be seated adjacent to the anatomical bone structure 404 and can interact with the cutting instrument during the procedure. In one embodiment, when the cutting instrument comes into contact with the metal part, the circuit is closed and a signal is sent to a control unit in the rigid chassis of the robot system, which can then send feedback to stop the cutting instrument, reverse the cutting instrument, or take some other action to ensure precision and safety in the surgical procedure. Several material combinations may exist that can facilitate this requirement, and this is not limited to one specific material. An electrically closed circuit between the cutting instrument and the protective device can be largely achieved by any biocompatible metallic material (e.g., steel, titanium, aluminum, etc.). Additional related techniques may consist of the use of magnetic induction, capacitive sensing, and further. All are based on the proximity of the cutting instrument and protective device, which are centrally controlled. The sensing part 402 of the protective device 400 can either sense or stimulate the nerve structure 403 during the surgical procedure, again ensuring precision and safety in performing the procedure.

[0029] The protective device acts as a barrier between the cutting instrument and the sensitive organ, requiring active, dynamic, and continuously changing protection. The device has several functions. On the one hand, it physically separates the sensitive organ from the bone so that it is not immediately cut (sometimes the organ is compressed against the bone and physically attached). The device may consist of at least two different materials with at least two different functions. The upper portion facing the bone and the cutting instrument consists of a material suitable for the technique selected to close the circuit using the cutting instrument. The lower portion that touches the sensitive organ, e.g., nerves, can also consist of several materials. It can be passive, from a soft material, e.g., plastic, silicon, etc.; it can be made from a non-conductive insulating material, e.g., plastic, ceramic, etc., that prevents any electrical flow to the nerve; it can also be made from a sensing / electrode material that has the ability to unilaterally sense chemical and / or electrical signals from the nerve (nervous system). This can also be active by transmitting low currents, e.g., 10mA, and by having the ability to sense nerve responses. While this sensing technology is well established in the art, it is not so well established when combined with a multi-arm robotic system. This system, instrument, and technique can provide multiple tools and methods for cutting bone, protecting sensitive organs, and passively or actively sensing at any given step of the procedure. This sensing can be performed at specific cycles or for each action, by the surgeon's selection, by the robot's algorithm, or randomly. This combination of robot, sensing, and intelligent instrument can enable a multi-layered system with several safety layers.

[0030] All embodiments shown in Figures 1-4 can be used in the methods of the present invention for performing spinal decompression procedures. In one such embodiment, the robotic system shown in Figure 3 can deploy a cutting instrument 311 on robotic arm 307, a protective device 312 on robotic arm 308, and a camera 310 on robotic arm 309. The camera 310 and end effector are partially deployed to optimal positions for the procedure by navigation, which is enabled by the placement of a marker 306. Once robotic arms 307, 308, and 309 are in the optimal position and angle portion, the protective device 312 can be deployed between the portion of the anatomical bone structure 305 requiring cutting and the nerve structure 304 requiring protection, and the cutting can proceed. The use of the systems and methods of the present invention enables precise and safe cutting to be performed with appropriate safety protection to stop or reverse the cutting as required.

[0031] In an alternative embodiment of the present invention, the surgical robotic arm (which holds surgical instruments for decompression / cutting or other tasks) is also equipped with torque sensing capabilities. It is known that the skeletal anatomical structure of the spine moves during spinal surgery due to patient movement and the forces applied during the surgical procedure. Therefore, if the robotic arm is capable of sensing torque feedback, this can be useful in tracking the skeletal anatomical structure (in addition to information provided by a navigation camera that tracks markers placed on the skeletal anatomical structure). Again, since the robotic arm is robotically adjusted on a single movable chassis by a central control unit, torque information can be taken into account by the central control unit (in addition to, for example, navigation information) to more accurately track the anatomical structure and the robotic arm. This, in turn, leads to more accurate results in delicate procedures such as bone cutting.

[0032] Those skilled in the art will understand that several modifications of the disclosed embodiments are possible while remaining within the scope of the invention. Simply as examples, different variations of the number of navigation cameras, robotic arms, markers, and end effectors can be used without departing from the invention. In another embodiment, markers of various sizes can be used. The embodiments provided are essentially representative.

Claims

1. A system for safe surgical procedures on target anatomical structures adjacent to critically sensitive structures in a patient, A robotic surgical apparatus comprising at least three robotic arms arranged on a single cart, and a central control unit located within the cart, An end effector held by one of the at least three robot arms, A susceptible organ protection device held by another of the at least three robotic arms, the susceptible organ protection device comprising a barrier, the barrier configured to be positioned between the target anatomical structure and the critical susceptible structure, and configured to physically separate the critical susceptible structure from the target anatomical structure, A camera or sensor held by the third of the three robot arms mentioned above Equipped with, The central control unit is configured to automatically adjust the movement of the robotic arm so that the barrier of the sensitive organ protection device is positioned between the end effector and the critically sensitive structure, and remains positioned between the target anatomical structure and the critically sensitive structure during the surgical procedure, thereby minimizing the risk of damage to the critically sensitive structure during the surgical procedure.

2. The system according to claim 1, wherein the single cart is movable.

3. The system according to claim 1, wherein at least one of the three robotic arms is deployed on each side of the patient.

4. The system according to claim 1, wherein the critically sensitive structure is a critical nervous system structure.

5. The aforementioned organ protection device for sensitive organs, A portion configured to close an electrical circuit when it comes into contact with the end effector, A second portion configured to protect the critical nervous system structure and The system according to claim 4, comprising:

6. The system according to claim 5, wherein the second part is further configured to sense or stimulate the critical nervous system structure.

7. The system according to claim 1, wherein the camera or sensor is selected from the group consisting of a navigation system, a tracking system, X-rays, and MRI.

8. The system according to any one of claims 1 to 7, wherein at least one small active or passive marker is placed on the anatomical structure of the patient's vertebrae as part of a spinal decompression procedure.

9. The system according to claim 8, wherein at least two small active or passive small markers are placed on the bone anatomical structure of the patient's vertebrae.

10. The system according to claim 9, wherein the camera or sensor is held in close proximity to the anatomical structure of the patient's vertebrae.

11. The system according to claim 10, wherein the small marker is less than 1 cm in size, and the camera or sensor is held less than 50 cm from the anatomical structure of the patient's vertebrae.

12. The system according to any one of claims 1 to 11, wherein an additional camera or sensor is installed on the robot arm holding the end effector and on the robot arm holding the sensitive organ protection device.

13. The system according to any one of claims 1 to 12, wherein the robotic arm holding the end effector and the robotic arm holding the sensitive organ protection device are equipped with torque sensing capability.

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