CN110114021B

CN110114021B - Robotic surgical system

Info

Publication number: CN110114021B
Application number: CN201780080500.2A
Authority: CN
Inventors: 皮特·L·波诺; 詹姆斯·D·拉克; 约翰·S·斯卡尔斯; 托马斯·J·罗德
Original assignee: Globus Medical Inc
Current assignee: Globus Medical Inc
Priority date: 2016-11-17
Filing date: 2017-11-17
Publication date: 2022-12-23
Anticipated expiration: 2037-11-17
Also published as: EP3541303A1; CN110114021A; WO2018094240A1; CA3044255A1; AU2017362480A1

Abstract

Devices, systems, and methods for providing robotically-assisted surgery are provided that involve the removal of bone or non-fibrous tissue during a surgical procedure. The system utilizes a multi-axis robot having a reciprocating tool constructed and arranged to remove hard or non-fibrous tissue while keeping soft tissue intact. The multi-axis robot may be controlled by a computer or telemanipulator, which allows the surgeon to complete the procedure from an area proximate to the patient to thousands of miles away.

Description

Robotic surgical system

Technical Field

The present invention relates to surgical systems, and more particularly, to a multi-axis robotic device having an end effector configured to remove bone and non-fibrous tissue while minimizing damage to soft tissue.

Background

The central nervous system is an important component of human physiology that coordinates human activities. It is mainly composed of the brain and spinal cord. The spinal cord is composed of a bundle of nervous tissue that originates in the brain and branches to various parts of the body, acting as a conduit for the transmission of neural signals from the brain to other parts of the body, including motor control and sensation. It is the spine or vertebral column that protects the spinal cord. Anatomically, the spine is composed of several regions, including the cervical, thoracic, lumbar and sacral regions. The cervical spine is composed of seven vertebrae and functions to support the weight of the head. The thoracic vertebrae consist of twelve vertebrae and function to protect the organs in the thoracic cavity. Five vertebrae make up the lumbar spine. The lumbar spine contains the largest vertebrae and serves as the primary weight bearing portion of the spine. Located at the bottom of the spinal column are five fused vertebrae, known as the sacrum. The coccyx is located at the base of the spine and is composed of four fused vertebrae.

Each vertebra associated with various spinal cord regions consists of a vertebral body, a posterior arch, and a transverse process. Vertebral bodies, generally described as having a drum-like shape, are designed to bear weight and to bear compression or loads. Between the vertebral bodies are intervertebral discs. The intervertebral discs are filled with a soft, gelatinous substance that helps to cushion various movements of the spine and may be the source of various diseases. The posterior arch of the vertebra consists of the lamina, pedicle and facet joints. The transverse processes extend outwardly from the vertebrae and provide a means for muscle and ligament attachment that facilitates movement and stabilization of the vertebrae.

While most people have a fully functional spinal cord, it is not uncommon for an individual to have some type of spinal disease including lumbar spondylolisthesis, scoliosis, or spinal fracture. One of the more common diseases associated with the spinal cord is spinal cord injury. Intervertebral disc damage is caused by physical injury, disease, genetic predisposition, or part of the natural aging process. Disc damage often results in failure to maintain the disc space, resulting in compression of nerve roots between the discs, which can lead to pain. For example, a disc herniation is a condition in which disc material bulges out of the disc space between two vertebral bodies. This is a bulge of intervertebral disc material that causes an impact on the nerve and, for the patient, presents pain. For most patients, rest and the application of analgesic and anti-inflammatory drugs alleviate this problem. However, in severe cases, which have developed into cases of spinal instability or severe disc degeneration, damaged disc material between the vertebral bodies is removed and replaced with a spinal stabilization implant. Restoration to normal height can relieve pressure on the nerve root.

There are many different approaches to alleviate or alleviate severe spinal disorders. One surgical procedure commonly used is spinal fusion. Several surgical approaches have been developed over the years, including Posterior Lumbar Interbody Fusion (PLIF) procedures that utilize a posterior approach to access a patient's vertebrae or intervertebral disc space, transforaminal Lumbar Interbody Fusion (TLIF) procedures that utilize a posterior and lateral approach to access a patient's vertebrae or intervertebral disc space, and Anterior Lumbar Interbody Fusion (ALIF) procedures that utilize an anterior approach to access a patient's vertebrae or intervertebral disc space. Using any of these surgical procedures, the patient undergoes a spinal fusion procedure in which two or more vertebrae are connected or fused together by using a bone spacer and/or using bone grafting. The resulting surgery eliminates any motion between the fused spinal column portions.

In addition to spinal implants or the use of bone grafts, spinal fusion procedures typically utilize spinal instrumentation or surgical hardware, such as pedicle screws, plates, or spinal rods. Once the spinal spacer and/or bone graft is inserted, the surgeon places pedicle screws into a portion of the spine and attaches rods or plates to the screws as a means of stabilization while the bones fuse. Currently available systems for inserting rods into pedicle screws can be difficult, especially in view of the fact that the surgeons installing these rods often work in a narrow surgical field. Furthermore, since the internal anatomy of the patient may vary, resulting in a change in the curvature of the spine, the surgeon may not always have a linear path or may have an anatomy that must be manipulated around in order to properly insert the surgical rod into the pedicle screw assembly. In addition to requiring surgical skill, the difficulty in properly placing the rod in the pedicle screw may result in unnecessarily increasing the time it takes for the surgeon to complete the surgical procedure. Prolonged surgery increases the risk to the patient. More importantly, improper alignment of the rod and pedicle screw assembly often leads to patient complications and the need for corrective surgery.

Robotic surgery, computer-assisted surgery, and robot-assisted surgery are terms of technical development that use robotic systems to assist in surgical procedures. Robotically-assisted surgery has been developed to overcome the limitations of pre-existing minimally invasive surgical procedures and to enhance the surgeon's ability to perform open surgery.

In the case of robot-assisted minimally invasive surgery, the surgeon uses one of two methods to control the instrument, rather than moving the instrument directly; either directly from a remote manipulator or through computer control. A telemanipulator is a telemanipulator that allows the surgeon to perform normal movements associated with the procedure while the robotic arm performs these movements using the end effector and manipulator to perform the actual procedure on the patient. In computer controlled systems, the surgeon uses a computer to control the robotic arm and its end effector, although these systems may still use telemanipulators for input. One advantage of using a computerized method is that the surgeon does not have to be present, but can be anywhere in the world, leading to the possibility of telesurgery. One drawback relates to the lack of tactile feedback to the surgeon. Another disadvantage relates to visualization of the surgical site. Because the surgeon may be remote or the procedure may be percutaneous, it is difficult for the surgeon to accurately visualize the procedure as desired.

In the case of enhanced open surgery, autonomous instruments (in familiar configurations) replace traditional steel tools, performing certain actions (such as rib expansion) with smoother, feedback controlled motion than can be achieved by a human hand. The primary purpose of such smart instruments is to reduce or eliminate tissue trauma traditionally associated with open surgery. The method aims to improve open surgery, especially orthopaedic surgery, which has not heretofore benefited from robotics, by providing a tool capable of distinguishing between soft and hard or non-fibrous tissue for removal or modification.

Accordingly, there is a need for a robotic system that can be used by a surgeon to easily and safely remove or alter bone, cartilage, and intervertebral disc material, particularly but not limited to the spine, for orthopedic surgery. The robotic surgical system should provide ultrasound functionality to provide the surgeon with the ability to visualize the surgical field and/or visualize it in real time.

The prior art provides rotating bone, cartilage and disc removal tool assemblies. A problem with rotating bone, cartilage and disc removal tool assemblies is caused by the encounter with fibrous material that may become entangled with the rotating cutting tool and cause undesirable damage. The prior art also provides rotary vibrating bone, cartilage and disc removal tool assemblies. However, surgical procedures assisted or completed by the use of multi-axis robots in combination with rotating bone or non-fibrous tissue removal tools remain unused due to the high risk of damage to the patient.

Disclosure of Invention

Devices, systems and methods for providing robotically-assisted surgery are provided that involve the removal of bone or non-fibrous tissue during a surgical procedure. The system utilizes a multi-axis robot with a reciprocating tool constructed and arranged to remove hard or non-fibrous tissue while keeping soft tissue intact. The multi-axis robot may be controlled by a computer or telemanipulator, which allows the surgeon to complete the procedure from an area proximate to the patient to thousands of miles away. The system also provides ultrasound, also known as sonography, to develop a real-time image of the surgical area to help the surgeon successfully complete the procedure.

It is therefore an object of the present invention to provide a vibration tool that can be used in conjunction with a multi-axis robot to remove bone.

It is another object of the present invention to provide a vibrating tool that can be used in conjunction with a multi-axis robot to remove non-fibrous tissue.

It is another object of the present invention to provide a vibrating tool that can be removably secured to the distal arm of a multi-axis robot to allow the vibrating tool to be interchanged with other tools.

It is another object of the present invention to provide a vibration tool that can be used on robots having various structures.

It is a further object of the present invention to provide a vibratory tool that utilizes removable and replaceable cutters.

It is yet another object of the present invention to provide a robotic surgical system that utilizes ultrasound to provide real-time images to a surgeon to complete or control a robotic surgery.

It is a further object of the present invention to provide a robotic surgical system wherein the robot includes an automatic tool changer allowing the surgeon to quickly exchange tools on the robot arm.

It is another object of the present invention to provide a robotic surgical system that utilizes two robotic arms acting in tandem such that one robotic arm provides an ultrasound image to allow the second robotic arm to complete the desired surgical procedure.

Other objects and advantages of the present invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of the present invention. Any drawings contained herein form a part of the specification, include exemplary embodiments of the present invention, and illustrate various objects and features thereof.

Drawings

FIG. 1 illustrates one embodiment of a multi-axis robot and operator station;

FIG. 2 illustrates a side view of one embodiment of a multi-axis robot;

FIG. 3 illustrates an isometric view of one embodiment of a vibrating tool secured to a distal arm of a multi-axis robot;

FIG. 4 is an isometric end view of the embodiment shown in FIG. 3;

FIG. 5 is a side isometric view of the embodiment shown in FIG. 3;

FIG. 6 is a front perspective view of the embodiment shown in FIG. 3;

FIG. 7 is an isometric view of another embodiment of a vibrating tool secured to a distal arm of a multi-axis robot;

FIG. 8 is a front perspective view of another embodiment of an oscillating tool secured to the distal arm of a multi-axis robot;

FIG. 9 is a front perspective view of another embodiment of a vibrating tool secured to a distal arm of a multi-axis robot;

FIG. 10 is a partial cross-sectional view illustrating one embodiment of a vibrating tool;

FIG. 11 is a partial cross-sectional view of the embodiment of FIG. 10;

FIG. 12 is a partial isometric view of the embodiment of FIG. 10 showing a Scotch yoke mechanism for producing the oscillating motion;

FIG. 13 is an isometric view of another vibratory mechanism without a housing;

FIG. 14 is a partial isometric view of the embodiment shown in FIG. 13;

FIG. 15 is a partial isometric cross-sectional view of the embodiment shown in FIG. 13;

FIG. 16 is an isometric view of another vibratory mechanism without a housing;

FIG. 17 is a partial cross-sectional view showing a cam mechanism for generating oscillating motion of the cutting tool;

FIG. 18 is a partial cross-sectional view showing a cam mechanism for generating an oscillating motion of the cutting tool;

FIG. 19 is a side view showing a robotic arm with an ultrasound probe and a display of the resulting image;

FIG. 20 is a partial view of the embodiment shown in FIG. 19;

FIG. 21 is a side view illustrating one embodiment of a tool change system for use with a robotic arm;

FIG. 22 is an isometric view of one embodiment of a robotic arm including an ultrasonic probe and a vibrating tool; and

FIG. 23 is a side view of one embodiment of the present system utilizing two robotic arms.

Detailed Description

While the present invention may be embodied in various forms, there is shown in the drawings and will hereinafter be described a presently preferred, but not limiting, embodiment, with the understanding that the present disclosure is to be considered an exemplification of the invention and is not intended to limit the invention to the specific embodiment illustrated.

Referring to fig. 1-23, a robotic surgical system 100 is shown. The robotic surgical system 100 generally includes a multi-axis robot 2, a tool 4 (e.g., a vibrating tool assembly) having an effector 5 at its distal end, and an operator station 6. The tool 4 is preferably a vibrating tool, as described more fully below. The multi-axis robot 2 includes multiple axes about which the vibrating tool 4 can be precisely manipulated and oriented for surgical procedures. In a preferred but non-limiting embodiment, the multi-axis robot includes seven axes of movement. The movement axis includes a substrate axis 202, the substrate axis 202 is generally centered on the substrate 200 and the first arm 204 rotates about the substrate axis 202. The second axis 206 is substantially perpendicular to the first axis 202 and the second arm 208 rotates about the second axis 206. The second arm 208 includes a third axis 210, and the third arm 212 rotates about the third axis 210. The third arm 212 comprises a fourth rotation axis 214, the fourth rotation axis 214 being oriented substantially perpendicular with respect to the first axis 202 and substantially parallel to the second axis 206. The fourth arm 216 rotates about the fourth axis 214. Fourth arm 216 includes a fifth shaft 218 and fifth arm 220 rotates about fifth shaft 218. The fifth arm 220 comprises a sixth axis 222, the sixth axis 222 comprising the most efficient rotation around the sixth axis 222 for the wrist 224 of the robot. The wrist 224 carries the tool 4 and the effector 5 and has a seventh axis of rotation 228 for cutting the tool. A wrist 224 is located at the distal end of the fifth arm 220. It should be noted that each axis of rotation provides an additional degree of freedom of movement for the manipulation and orientation of the tool 4. It should also be noted that while the multi-axis robot 2 is shown with only the tool 4, the preferred embodiment is capable of changing the effector to various tools needed to complete a particular procedure. Actuators, not shown, are used to move the arms to their desired positions. The actuator may be electric, hydraulic or pneumatic without departing from the scope of the invention. The rotational position may be signaled to the computer 230 as an encoder (not shown) associated with each

arm

206, 208, 212, 216, 220 and other components having an axis of rotation. In the preferred embodiment, the drive is in electrical communication with the computer 230, and may also be remoteA control manipulator or suspension (not shown) combination. The computer 230 is programmed to control the movement and operation of the robot 2 via the controller portion 231 and may utilize excelsiusGPS such as from Globus ^TM The software package of (1). Alternatively, other software programming may be provided without departing from the scope of the invention. Computer 230 may have a primary storage device (often referred to as memory) and/or a secondary storage device that may be used to store digital information such as images described herein. The primary and secondary storage are collectively referred to herein as storage and may include one or both of the primary and secondary storage. The system 100 may also include sensors positioned along various locations on the multi-axis robot 2 that provide tactile feedback to the operator or surgeon 232. The computer 230 is electrically connected or coupled to the multi-axis robot 2 in a manner that allows operation of the multi-axis robot 2 ranging from a location proximate to the robot to thousands of miles away. The computer 230 is preferably capable of accepting, holding and executing programmed motions of the multi-axis robot 2 in a precise manner. In this way, a skilled surgeon may provide surgical care in an area such as a battlefield while the surgeon may be safely protected from injury. The controller 231 may comprise a movement control input device 233, such as a joystick, keyboard, mouse or electronic screen 306, see fig. 19, which may be touch activated. The screen 306 may be part of the monitor 234. Tool change commands may be entered using screen 306.

Referring to fig. 3-12, various embodiments of a vibration tool 4 for use as an effector are shown. The vibrating tool assembly 4 may be used in surgical procedures, such as spinal surgery, in which bone, cartilage, intervertebral discs, and other non-fibrous body material may be removed from the spine, for example. The oscillating tool assembly 4 has an output spindle 36 that drives the output spindle 36 to rotate in two directions, or oscillate rotationally about its axis 228. The spindle 36 supports a cutting tool 38, which cutting tool 38 is driven by the spindle 36 to rotate partially in both directions with a limited range of rotation. Such vibratory cutting is effective for removing bone, cartilage and intervertebral discs by a shearing operation while effectively minimizing damage to any fibrous material. If the cutting tool 38 inadvertently contacts fibrous material, such as nerves, during the cutting operation, the fibrous material may vibrate with minimal shear due to the flexibility of the fibrous material, thereby minimizing damage to the fibrous material.

Fig. 10 shows some of the internal components of the vibrating tool assembly 4. The power may be provided by a battery power source 46 oriented in the housing 32. The battery power source 46 may be charged or recharged by the multi-axis robot 2. Electronics 48 are provided in the housing 32 for controlling the operation of the tool assembly 4. The power switch (not shown) may be remotely operated by the computer 230, a remote operator, or a suspension device. A plurality of indicator lights 50 may be provided on the housing 32 and illuminated by the LEDs for indicating operating characteristics of the tool assembly 4, such as the state of charge of the battery power source 46. Alternatively, the tool 4 may communicate wirelessly to the computer 230 via bluetooth, zigbee chips, etc., whereby signals are visible on the local and/or remote monitor 234.

A motor 52 is mounted in the housing 32 for providing a rotational input. When controlled by the electronics 48, the motor 52 is powered by the battery power source 46. The motor 52 drives a transmission 54 for converting continuous rotational motion from the motor 52 into rotational vibration of the main shaft 36. The main shaft 36 is journalled in the housing 32 and driven by a transmission 54. The spindle 36 is preferably straight, but may be angled relative to the housing 32, as shown in fig. 10-12, for certain operations. Cooling fins or cooling fans (not shown) may be attached to or near the motor 52 for cooling the motor 52 and/or the tool assembly 4.

Referring now to fig. 11-12, the motor 52 drives an eccentric drive 56. The eccentric drive 56 includes a roller 58 supported for rotation on the drive 56, which is offset from a shaft 60 of the motor 52. Thus, rotation of the eccentric drive 56 causes the roller 58 to rotate about the shaft 60. The eccentric drive 56 also includes a balance member 62 offset from the shaft 60 opposite the roller 58 to balance the variator 54 and minimize unwanted vibrations. According to at least one embodiment, the counterbalance 62 may be integrally formed with the eccentric drive 56. According to another embodiment, the balance 62 may include additional weight. Alternatively, the roller 58 may be a pin. A guide, shown here as a pair of

pins

64, 65, is supported in the housing 32 generally perpendicular to the motor shaft 61. Alternatively, a single guide rail (not shown) may be used without departing from the scope of the invention. A shuttle 68 is disposed on guide 64 for reciprocal translation on guide 64. Shuttle 68 includes a channel 70, channel 70 being generally perpendicular to guide 64. The channel 70 receives the roller 58 of the eccentric drive 56. The channel 70 cooperates as a follower for allowing the roller 58 to translate along the length of the channel 70 while driving the shuttle 68 along the guide 64. The guide 64 may utilize bearings and/or rollers or the like to reduce friction.

Referring again to fig. 10-12, a rack 72 is formed on shuttle 68. The rack 72 is formed generally parallel to the spindle 36. A planetary or spur gear 74 is mounted to the spindle 36 to engage the rack 72 to provide a rack-and-pinion mechanism for converting reciprocating translation of the shuttle 68 into rotational vibration of the spindle 36. A pair of bearing assemblies 76 may also be provided in the housing for providing bearing support for the spindle 36. The transmission 54 may include any additional gear sets known in the art to vary speed or torque. According to one embodiment, spur gears may be added to the motor output shaft to multiply the speed of the rollers 58.

The eccentric drive 56 and shuttle 68 cooperate as a Scotch-yoke mechanism for converting continuous rotary motion to linear reciprocating motion. Although a scotch yoke mechanism is shown, any mechanism that converts rotary motion to reciprocating motion may be used, such as a crank and slider mechanism. It should also be noted that in some embodiments, the spindle 36 and spindle tube 37 (fig. 6, 7) are removable and replaceable from the remainder of the housing. In this way, the cutter or gear ratio providing more or less vibration can be easily changed to suit specific needs.

Referring to fig. 8 and 9, an alternative embodiment of the vibrating tool assembly 4 is shown. In these embodiments, the motor 52 and transmission assembly 54 are oriented at approximately a right angle relative to the main shaft 36. This configuration may provide an advantage for the type of operation by shortening the distance from the end of wrist 224 to the end of spindle 36.

Referring to fig. 13-15, an alternative embodiment of the vibration tool 104 is shown with the housing omitted for clarity. A transmission 154 is positioned in housing 132 and operatively couples shaft 136 to motor 152 and is operable to convert continuous rotary motion of a motor shaft 163 (fig. 15) of motor 152 into oscillating rotary motion of shaft 136. By oscillating rotational movement, it is meant that the shaft 136 will first rotate a portion of a full revolution in one rotational direction and then rotate in the other rotational direction; first counterclockwise, then clockwise, then counterclockwise, and so on. To accomplish this movement, the transmission 154 includes two portions. A first portion is generally indicated at 161 and is operable to convert the rotary motion of the shaft 163 of the motor 152 into a reciprocating linear motion of a portion thereof, and a second portion is generally indicated at 162 and is operable to convert the reciprocating motion into an oscillating rotary motion.

In the illustrated embodiment, the transmission portion 154 takes the form of a universal mechanism that utilizes an internally-toothed ring gear 164 and externally-toothed planet gears 165, with the planet gears 165 being located internally thereof and having their external gear teeth engaged with the internal gear teeth of the ring gear 164. The gear ratio of the ring gear 164 to the planet gears 165 is 2:1. the ring gear 164 is suitably secured within the housing 32 to prevent movement thereof relative to the housing 32. The planet gears 165 are suitably mounted to crank arms 166, which crank arms 166 are in turn fixed to the shaft 163 of the motor 152 and offset from the axis of rotation of the shaft 163, so that the planet gears 165 rotate within the ring gear 164 about the axis of rotation of the shaft 163. Preferably, the crank arm 166 has a weight 167, the weight 167 being opposite the position where the planetary gear 165 is mounted to the crank arm 166. In a universal mechanism, a tip on a planet gear will move substantially linearly in a reciprocating manner within its associated ring gear. In the illustrated embodiment, the path of movement of the toe is timed to move in a generally transverse plane relative to a portion of the variator 154. Preferably, secured to the planet gears 165, in an integral manner, are driver arms 169 that extend forward of the ring gear 164 for receipt in the follower 170 to effect movement of the follower 170 in response to movement of the arms 169. Follower 170 is suitably mounted in housing 32 in a manner that allows pivotal movement thereof about axis 171. The transverse linear motion of the point on the planet gear 165 is generally transverse to the longitudinal axis of the elongated slot 174 in the follower 170. The shaft 171 is suitably mounted in a bearing support 173, the bearing support 173 in turn being suitably mounted to the housing 32. Although only one bearing support 173 is shown, it is preferred that each end of the shaft 171 have a bearing support 173 associated therewith. It should be appreciated that shaft 171 may utilize follower 170 as a bearing for rotation of follower 170 about shaft 171 and have shaft 171 fixedly mounted to housing 32. Driver arms 169 are received within elongated slots 174 for effecting movement of follower 170 in a rotationally oscillating manner. Follower 170 moves in oscillating rotation about axis 186 of shaft 171. As a portion of the driver arm 169 moves along its linear path, a portion of the arm 169 engages the sides of the slot 174 to effect movement of the follower 170 in response to movement of the driver arm 169. In the illustrated construction, the actuator arm 169 is offset outside the outer diameter of the planet gears 165 so that its central axis does not move in a linear path, but rather moves in a series of arcs elongated in the horizontal direction and decreasing in the vertical direction. This back and forth and up and down movement is accommodated by configuring the slot 174 to be elongated, as best shown in FIG. 4. As the driver arm 169 moves in its path, it effects an oscillating rotational motion of the follower 170 about the shaft 171. Two counterclockwise and two clockwise oscillations of cutter 38 are achieved and four elliptical paths of a portion of drive 169 are traversed for each rotation of planet gear 165 in ring gear 164. The follower 170 is provided with a sector gear 176 that is operatively coupled to a gear 177 fixed to the shaft 136. As follower 170 moves, shaft 136 responds to it by engaging between gears 176 and 177. Because the follower 170 moves in a rotationally oscillating manner, the shaft 136 also moves in a rotationally oscillating manner. The components of the

transmission portions

161, 162 are configured relative to each other such that when the rotational vibratory motion changes direction at the shaft 136, the torque applied by the motor 152 will be high; when in the center of a vibration, the torque applied by the motor 152 will be lower. This helps provide a high starting torque for cutter 38 to reverse rotational direction.

Referring to fig. 16-18, another alternative embodiment of a vibrating tool for use with robotic surgical system 100 is shown. An alternative vibration tool assembly 200 includes a motor 202 mounted in a housing 204. The motor 202 drives a cam mechanism 206 for continuous rotation. The cam mechanism 206 has four

different cam profiles

208, 210, 212, 214 stacked axially from the motor 202. Each of the cam profiles 208, 210, 212, 214 is schematically illustrated in fig. 17-18. A follower mechanism 216 is mounted for rotation in the housing 204. The follower mechanism 216 has four

follower profiles

218, 220, 222, 224, each for mating with one of the cam profiles 208, 210, 212, 214, as shown in fig. 16-18. A main shaft 226 is disposed in the housing 204 with bearing support. The cam mechanism 206 and the follower mechanism 216 cooperate as a transmission 228 for converting one rotation of the cam mechanism into two rotational vibrations of the follower mechanism 216.

The motor 202 continuously rotates the cam mechanism 206 in one direction, which is clockwise as viewed in fig. 17-18. The cam profiles 208, 210, 212, 214 always engage the follower profiles 218, 220, 222, 224 at two contact points. At one point of contact, the cam mechanism 206 urges the follower mechanism 216 to rotate. At the other point of contact, the cam mechanism 206 prevents over-rotation of the follower mechanism 216. The

profiles

208, 210, 212, 214 on the cam mechanism 206 work together to rotationally vibrate the follower mechanism 216 in both directions. For the depicted embodiment, each of the four

cam profiles

208, 210, 212, 214 is comprised of two symmetrical lobes, which causes the follower mechanism 216 to make two complete oscillations (two back and forth) for each complete rotation of the motor 202. The cam mechanism 206 may also be designed to be asymmetric and/or such that the follower mechanism 216 produces any number of vibrations, such as one or more than two, per motor rotation.

In fig. 17, the second cam profile 210 contacts the second follower profile 220 for preventing over-rotation of the follower mechanism 216, while the fourth cam profile 214 drives the fourth follower profile 224. In fig. 18, the second cam profile 210 contacts the second follower profile 220 for driving the follower mechanism 216, while the third cam profile 212 engages the third follower profile 222 to prevent over-rotation of the follower mechanism. In fig. 17, the first cam profile 208 contacts the first follower profile 218 for preventing over-rotation of the follower mechanism, while the third cam profile 212 drives the third follower profile 222, reversing direction. In fig. 18, the first cam profile 208 contacts the first follower profile to prevent over-rotation of the follower mechanism 216, while the fourth cam profile 214 drives the fourth follower profile 224. This process is repeated in fig. 17.

Referring to fig. 1 and 19-23, an alternative embodiment is shown. In this embodiment, the robotic surgical system 100 generally includes one or two multi-axis robots 2, an ultrasound imaging system 300, effectors, such as a vibrating tool 4, and an operator station 6. Typically, the surgeon will utilize fluoroscopy, or fluoroscopy in conjunction with a Computed Tomography (CT) scan, or the like, in order to perform the procedure on the spine or other bone portions. A CT scan is performed preoperatively so the surgeon can identify landmarks within the patient 308 and attempt to align the fluoroscopic image with the CT scan image for the procedure. However, fluoroscopic images are often difficult to align because the patient is in different positions, resulting in distortion of fluoroscopic imaging and the like. Thus, to provide real-time images to the surgeon 232, one of the robots 2 may be equipped with an ultrasound imaging probe 302. The ultrasound imaging probe 302 is electrically connected to an imaging system electronic controller 304 disposed in the computer 230, which allows the operator to project real-time images onto the monitor 234 and ensure proper coverage of the ultrasound images with the CT scan. The CT scan images and ultrasound images may be stored in and recalled from computer 230 memory and displayed on monitor 234. Monitors 234 may be located in operator station 6 and/or within operating room 310. This configuration allows the operator 232 to take fluoroscopic images without exposing him or herself to radiation, while still allowing landmarks within the patient 308 to be closely identified and located for storage within the operator station for surgery. Thus, the operator may calibrate the robot positioning to correspond to the real-time ultrasound image for completing the procedure. The operator may then replace the ultrasound probe 302 as needed for the surgical instrument tool 4 with the effector 5 during the procedure so that the tool may be precisely manipulated and oriented for the surgical procedure. Springs or the like may also be used to control the amount of force used to urge the probe against the patient, e.g., probe 302 may be spring loaded to reduce the risk of hard contact with the patient during probe movement.

Referring to fig. 20, the wrist 223 portion of the robot carries an ultrasound probe 302. Ultrasound probe 302 is removably secured to wrist 223 to allow probes or tools of different configurations to be interchanged by the robot by operator 232 through instructions of computer 230 and to couple operator input control 231 allowing the computer to know the length 312 and diameter 314 of probe or tool 4 and effector 5. Thus, the robot can quickly approach the patient and slow down as the probe 302 or tool 4 approaches the patient, and still contact the patient in a soft controlled manner. In this manner, the computer 230 may also alter the three-dimensional positioning of the robot to correspond to the tool or probe size relative to the real-time image.

Basing point device 351 may be used to help determine the position of tool 4 relative to patient 308 and to help overlay various images, such as CT scans and ultrasound images. Typically, for orthopedic surgery, basepoint device 351 is attached to the bone along with a screw. Such basepoint equipment is available from Northern Digital, inc.

Fig. 21 shows one embodiment of the present apparatus, which includes an automatic tool changer 316. The automatic tool changer 316 is constructed and arranged to allow a tool 4 having an effector 5 to be changed by the robot 2 in response to commands from the computer 230, preferably input by the operator 232. In operation, the wrist 224 of the robot 2 is located at a predetermined position. Tool arm 318 is raised or rotated to engage the released tool in wrist 224. The tool arm 318 is then lowered to remove the tool 4 and rotated to position a replacement tool below the wrist 224. The tool arm 318 is raised to position the new tool within the wrist 224, with the wrist engaging the tool 4. The tool arm 318 may then retain the removed tool or place it on a carousel or conveyor 320, and the carousel or conveyor 320 may include any number of tools. Each tool 4 is provided with a tapered or otherwise shaped shank 322, the shank 322 being shaped to mate with a cavity in the wrist 224 to provide repeatable positioning. In at least one embodiment, each tool is also provided with a tang 324, the tang 324 cooperating with a drawbar or traction mechanism (not shown) within the wrist 224 to draw the tool into the wrist in a controlled and repeatable manner. Instead of the drawbar type just described, tool changers manufactured by ATI, such as MC-16941, QC-11 and QC-21, may also be used. As previously described, the length and diameter of each tool is retained within the computer 230 in the operator station 6 so that the positioning of the robot 2 arm is changed to correspond to each tool. In this way, one tool can be utilized and quickly changed to the next desired tool while still utilizing the calibration and positioning provided by ultrasound imaging. In at least one embodiment, the robot may be configured to rotate the robot's wrist 223 to measure the moment of the tool as a second check to insert the appropriate tool into the wrist.

Referring to fig. 22, an alternative embodiment is shown. In this embodiment, ultrasound probe 302 is secured to a side or other face of wrist 223. This configuration allows wrist 223 to be simply rotated to contact ultrasound imaging probe 302 onto patient 308 to provide imaging and/or repositioning of wrist 223 relative to the image. Once the image and positioning is checked or re-checked, the wrist 223 may be rotated to use the tool carried by the wrist. In this embodiment, the computer 230 tracks the length 312 and diameter 314 of the ultrasound probe 302 and tool 4 to maintain a precise position when switching from probe to tool or between tools.

Referring to fig. 23, an alternative embodiment is shown. In this embodiment, the system is provided with two or more robots 2 that work in unison and are positioned in communication with the operator station 6 and each other to prevent collisions and coordinate actions. As shown, one robot 2 utilizes an ultrasound imaging probe 302, while the other robot utilizes a tool 4. In this manner, images may be taken simultaneously with the operation of the cutting, drilling or other tool 4. This configuration allows for alignment correction or other manipulation of the tool while the procedure is taking place. It should be noted that an automatic tool changer may be used in conjunction with this or any of the other embodiments disclosed herein to increase the versatility of the system. It should also be noted that although the ultrasonic tool is shown as having a different trajectory than the robot with the tool, the second robot will preferably direct the ultrasound on a cross trajectory with the cutting tool.

The invention will be better understood by further description of its operation. The patient 308 is scheduled for surgery. In preparation, a first image of the surgical field of view is created, for example by a CT scan. Preferably, the first image is three-dimensional. The first image is digitally stored in the computer 230. At least one and preferably a plurality of fiduciary points devices 351 are fixed to patient 308 and included in the first image. The patient 308 is ready for surgery and moved to the operating room 310. At least one robot 2 is located in the operating room and an automatic tool changer 316 is located near the robot 2. The surgical field of the patient is exposed to the robot 2. An ultrasound probe 302 is mounted to the robot 2 and a second digital image of the surgical field is created and stored in the computer 230. The first and second images are overlaid by a computer 230, the computer 230 using a punctuation device 351 as a co-ordinate reference. At least a second image of the surgical field is displayed on the screen 306 of the monitor 234, the surgical field being displayed in real time at least at the start of the procedure. Preferably, both the first and second images are displayed simultaneously on the monitor 234, and are preferably three-dimensional images. If two robots 2 are used, a continuous second image may be displayed in real time, or if one robot 2 is used, the ultrasound probe may be used intermittently as selected by the operator 232, for example, between tool 4 changes. In a preferred embodiment, when the ultrasound probe is operated during use of the tool 4, the ultrasound probe 302 is pointed in a direction to sense and display the effector 5 of the tool 4 in the second image.

The computer 230, operator controls 231, monitor 234, screen 306, ultrasound probe 302, and robot 2 are operatively coupled together to effect various operations of each. Although a single computer 230 is shown, it should be understood that multiple computers may communicate with each other to form computer 230. For example, a remote computer may be coupled to a local computer through an Internet server to form computer 230. The operation control system includes an imaging control system 304, a controller 231 and possibly a screen 306, depending on its structure.

All patents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.

It is to be understood that while a certain form of the invention is shown, the invention is not to be limited to the specific form or arrangement of parts herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification.

It will be readily understood by those skilled in the art that the present invention is well adapted to carry out the objects and attain the ends and advantages mentioned, as well as those inherent therein. Any compounds, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary, and are not intended as limitations on the scope. Variations thereof and other uses will occur to those skilled in the art and are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the present invention has been described in connection with the specified preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.

Claims

1. A robotic surgical system, the system comprising:

a first multi-axis robot having a plurality of interconnected first arms, one of which is mounted to a base, the first arms being movable relative to each other, one of the first arms being a distal first arm and having an automated tool holder configured to releasably retain a surgical tool;

a computer coupled to the first robot and operable to control movement of the first arm in response to commands issued to the computer from a controller coupled to the computer, the computer operable to receive a first image of a portion of a patient and at least one second image of at least the portion of the patient during surgery and overlay the first and second images for viewing by a controller operator;

a monitor coupled to a computer and operable to view the first and second images;

a tool changer adjacent to the first robot and operable to hold a plurality of surgical tools configured to be mounted to an automated tool rack in response to commands from the controller, wherein the computer is programmed to know the length and diameter of each surgical tool such that the positioning of the plurality of interconnected first arms is changed to correspond to each of the surgical tools; and

at least one radix point device secured to the patient adjacent the surgical field, the radix point device operable to be displayed in the first and second images, the computer operable to adjust the overlay of the first image to the second image using the radix point device.

2. The surgical system of claim 1, wherein there is a plurality of said at least one base point device.

3. The surgical system of claim 2, wherein the first and second images are three-dimensional images.

4. The surgical system of claim 3, wherein the controller comprises an electronic screen.

5. The surgical system of claim 3, comprising a second multi-axis robot having a plurality of interconnected second arms, one of the second arms mounted to a second base, the second arms movable relative to each other, one of the second arms being a distal second arm, and having a second robotic tool holder configured to hold an ultrasound probe, the second multi-axis robot coupled to a computer, wherein the computer is operable to control movement of the second arms in response to commands to the computer from the controller, the ultrasound probe operable to provide the at least one second image in real time.

6. The surgical system of claim 3, wherein the robotic tool holder is configured to hold a surgical tool and an ultrasound probe simultaneously.

7. The surgical system of claim 6, wherein the computer is operable to control movement of the surgical tool and the ultrasound probe and to select which of the surgical tool and the ultrasound probe is used in a surgical procedure.

8. The surgical system of claim 5, wherein the first and second multi-axis robots are operable to work in unison with one multi-axis robot utilizing an ultrasound probe and the other multi-axis robot utilizing the surgical tool to allow a second image to be taken while operating the surgical tool.

9. The surgical system of claim 5, wherein the computer is operable to effect pointing the ultrasound probe in a direction to sense an effector of the tool, and to display the effector in the second image.