On-Bone Robotic System for Computer-Assisted Surgery
Patent Information
- Application Number
- JP2024525694
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-11-02
- Filing Date
- 2022-11-02
- Publication Date
- 2025-10-09
AI Technical Summary
Robotic systems in surgical procedures have a significant footprint and require bulky tracking devices, limiting space management and movement in the operating room.
An on-bone robotic system with a bone anchor device that houses sensors for tracking orientation, a robotic tool unit with actuators for surgical tool movement, and a processor for actuation, allowing for reduced footprint and improved space management by integrating the robotic components within the bone.
The system provides accurate and efficient surgical tool guidance with reduced spatial requirements, enabling precise bone modifications and implant positioning while minimizing the operational footprint in the operating room.
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Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 63 / 274,554, filed November 2, 2021, which is incorporated by reference herein.
[0002] This application relates to computer assisted surgery, and more particularly to robotic tools, robotized tools and implantable electronic devices used in surgical procedures. [Background technology]
[0003] In orthopedic surgery, robots are increasingly used in conjunction with computer-assisted surgery to perform bone resections and guide the positioning of implants, among other actions. Whether the robots are collaborative or autonomous, the use of robots can contribute to increasing the precision and accuracy of bone modification procedures. Robotic arms are tracked to navigate their various tools relative to the bone, i.e., to obtain position and / or orientation data relating the robotic tools to bony landmarks.
[0004] However, robots have a significant footprint in the operating room. A robotic system typically has its own stand and / or station, which can result in obstacles that limit the movement of people around the patient. Moreover, in some cases, robotic systems are used with bulky tracking systems, such as optical tracking devices, which also increase space management concerns in the operating room. It is desirable to reduce the footprint of robots used in surgical procedures. Summary of the Invention
[0005] In a first aspect, there is provided an on-bone robotic system comprising: a bone anchor device configured to be housed within a bone, the bone anchor device including at least one sensor for tracking an orientation of the bone; and a robotic tool unit detachably coupled to the bone anchor device, the robotic tool unit including at least one actuator for displacing a surgical tool of the robotic tool unit relative to the bone when the robotic tool unit is coupled to the bone anchor device, the on-bone robotic system including at least one joint enabling at least one degree of freedom of movement of the surgical tool relative to the bone anchor device, and a processor for actuating the at least one actuator in response to tracking of the bone by the sensor.
[0006] Further according to the first aspect, for example, the bone anchor device has a receptacle configured to be received within a bone, the receptacle housing at least one sensor.
[0007] Further according to the first embodiment, for example, the front end of the bone anchor device is flared.
[0008] Further according to the first aspect, for example, the anti-rotation feature protrudes laterally from the receptacle.
[0009] Further according to the first aspect, for example, the anti-rotation feature includes at least one fin.
[0010] Further according to the first aspect, for example, the at least one sensor includes an inertial sensor.
[0011] Further according to the first aspect, for example, the bone anchor device includes a battery.
[0012] Further according to the first aspect, for example, the bone anchor device is configured for use as an implant for tracking bone movement post-operatively.
[0013] Further according to the first aspect, for example, the at least one actuator includes at least one motor.
[0014] Further according to the first aspect, for example, there may be two motors and the robotic tool unit displaces the surgical tool in at least two rotational degrees of freedom.
[0015] Further according to the first aspect, for example, the at least one actuator includes at least one linear actuator.
[0016] Further according to the first aspect, for example, the surgical tool has a cut slot.
[0017] Further according to the first aspect, for example, the robotic tool unit includes at least one sensor for tracking an orientation of the surgical tool.
[0018] Further according to the first aspect, for example, the robotic tool unit includes at least one camera oriented towards the bone and configured to capture images of the bone.
[0019] Further according to the first aspect, for example, a communications device may be coupled to the processor and configured for wireless communications.
[0020] According to a second aspect of the present disclosure, there is provided a method for performing an orthopedic surgical procedure, comprising anchoring an on-bone robotic system to a bone via a bone anchor device inserted within the bone, the bone anchor device including at least one sensor for tracking an orientation of the bone, actuating the on-bone robotic system to displace a surgical tool operably coupled to the bone anchor device, the movement of the surgical tool being guided in response to the tracking of the bone by the sensor, and removing at least the surgical tool from the bone anchor device to leave the bone anchor device as an implant post-operatively, the bone anchor device configured to track the bone post-operatively.
[0021] Further according to the second aspect, for example, anchoring the on-bone robotic system to a bone includes drilling a hole in the bone for inserting a bone anchor device in the hole.
[0022] Further according to the second aspect, for example, inserting the bone anchor device into the hole includes penetrating the anti-rotation feature into the bone.
[0023] Further according to the second aspect, for example, moving during actuation includes moving the surgical implement in at least one rotational degree of freedom.
[0024] Further according to the second aspect, for example, moving the surgical implement includes activating a rotational motor to move the surgical implement in at least one rotational degree of freedom.
[0025] Further according to the second aspect, for example, the movement during actuation includes moving the surgical implement in two rotational degrees of freedom.
[0026] Further according to the second aspect, for example, the movement during actuation includes moving the surgical implement in one translational degree of freedom.
[0027] Further according to the second aspect, for example, the method may include imaging the bone from an on-bone robotic system.
[0028] Further according to the second aspect, for example, the method may include aligning imaging of the bone from an on-bone robotic system with a pre-operative virtual model of the bone to navigate the position and orientation of a surgical tool relative to the bone.
[0029] Further according to the second aspect, for example, the method may further include wirelessly communicating data from the at least one sensor.
[0030] According to a third aspect, there is provided a system for intra-operative and post-operative tracking of bone in a surgical procedure, the system comprising: a processing unit; and a non-transitory computer readable memory communicatively coupled to the processing unit and comprising computer readable program instructions executable by the processing unit to activate at least one actuator to obtain, intra-operatively, orientation data of at least one sensor in a bone anchor device anchored to the bone, to displace a surgical tool operably coupled to the bone anchor device as part of an on-bone robotic system as a function of the orientation data, and to obtain, post-operatively, orientation data of at least one sensor in the bone anchor device that remains anchored to the bone after the surgical procedure.
[0031] Further according to the third aspect, for example, activating the at least one actuator includes activating at least one rotational motor to orient the surgical tool relative to the bone in one rotational degree of freedom.
[0032] Further according to the third aspect, for example, activating the at least one actuator includes activating a second rotational motor to orient the surgical tool relative to the bone in a second rotational degree of freedom.
[0033] Further according to the third aspect, for example, actuating the at least one actuator includes actuating at least one linear actuator to displace the surgical tool relative to the bone in one translational degree of freedom.
[0034] Further according to the third aspect, for example, the method may further include imaging the bone from an on-bone robotic system.
[0035] Further according to the third aspect, for example, the method may further include aligning imaging of the bone from the on-bone robot with a pre-operative virtual model of the bone to navigate the position and orientation of the surgical tool relative to the bone. [Brief description of the drawings]
[0036] Reference is made below to the accompanying drawings.
[0037] [Figure 1] FIG. 1 is a schematic diagram of an on-bone robotic system according to one embodiment of the present disclosure. [Figure 2A-2B] 2A and 2B are schematic diagrams illustrating the on-bone robotic system of FIG. 1 for the distal femur. [Figure 3A-3C] 3A, 3B, and 3C are schematic diagrams of the on-bone robotic system of FIG. 1 along with an alignment plate tool. [Figure 4A] FIG. 4A is a schematic diagram of an alignment plate tool with bone contacting actuators according to one embodiment of the present disclosure. [Figure 4B] FIG. 4B is a schematic diagram of an alignment plate tool with bone contacting actuators according to one embodiment of the present disclosure. [Figure 5A-5B] 5A and 5B are schematic illustrations of the robotic system of FIG. 1 with a cutting guide tool. [Fig. 5C-5D] 5C and 5D are schematic illustrations of the robotic system of FIG. 1 with a cutting guide tool. [Figures 6A-6C]6A, 6B, and 6C are a series of views illustrating the on-bone robotic system of FIG. 1 being used on a tibia, according to one embodiment. [Figure 7A-7C] 7A, 7B, and 7C are a series of views showing the on-bone robotic system of FIG. 1 being used on a tibia according to another embodiment. [Figure 8A-8B] 8A and 8B are schematic diagrams of the on-bone robotic system of FIG. 1 using a temporary implant surgical tool. [Fig. 8C-8E] 8C, 8D and 8E are schematic diagrams of the on-bone robotic system of FIG. 1 using a temporary implant surgical tool. [Figure 9] 9 is a perspective view of one variation of the cutting block surgical tool of the on-bone robotic system of FIG. [Figure 10] FIG. 10 is a schematic perspective view of another variation of a cutting block surgical tool of the on-bone robotic system of FIG. [Figure 11] FIG. 11 is a schematic side view of another variation of the cutting block surgical tool of the on-bone robotic system of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0038] Referring to the drawings, and more particularly to FIG. 1, an on-bone robotic system is illustrated as reference numeral 10. The on-bone robotic system 10 is of a type used as part of computer-assisted surgery to provide guidance to the surgeon in performing orthopedic surgical procedures. The on-bone robotic system 10 may therefore have electronic components and actuators to perform some of the automated functions described herein and / or to guide the surgeon in making modifications to the bone and placing implants (on-board electronics). Moreover, the on-bone robotic system 10 may include implantable (sometimes called wearable) components within the patient's body that can provide navigation data during and, optionally, after surgery. In the following figures, the robotic system 10 is shown in a knee replacement surgical procedure involving the resection of bone on the distal femur and at the tibial plateau to define the cut planes. However, it is also contemplated to use the on-bone robotic system 10 for other types of surgical procedures.
[0039] In FIG. 1, the on-bone robotic system 10 is shown generally as having a bone anchor device 20 and a robotic tool unit connectable to the bone anchor device 20. The robotic tool unit may include a robot base 30 and an exemplary surgical tool 40, which may be integrally or detachably connected to each other. Other surgical tools that may be part of the robotic tool unit are shown as 50, 60, 70, and 80 and are described below. Although the robot base 30 and the surgical tool 40 are shown as separate and interconnectable, they may be one part that may be connected to the bone anchor device 20. For simplicity, the parts of the bone anchor device 20 are numbered in the 20 series, such as 21, for example. The same nomenclature is used for the robot base 30 and the surgical tools 40, 50, 60, 70, and 80. The bone anchor device 20 serves different functions. The bone anchor device can serve as an anchor or attachment for other parts of the on-bone robotic system 10. It may also be configured to track the bone to which it is connected, for example by providing orientation data for the bone. For example, the bone anchor device 20 may generate data indicative of the location of the functional axis of the bone. The bone anchor device 20 may also be used as an implanted electronic device to post-operatively provide bone-related data, for example movements associated with gait, such as range of motion, flexion / extension, force, stride count, stride length, among others. The robotic tool unit is attached to the bone anchor device 20 by its robot base 30 and is used during surgery to perform various functions associated with, for example, a surgical tool 40 coupled to the robot base 30. The robotic base 30 may be separate from the bone anchor device 20 for embodiments in which the bone anchor device 20 is a post-operative implanted electronic device.
[0040] 1, 2A and 2B simultaneously, the bone anchor device 20 is of the type that penetrates into the bone. In the embodiment of FIG. 2A and FIG. 2B, the bone anchor device 20 is anchored to the distal femur F and may be used to track bony landmarks of the femur F, such as a functional axis, in three-dimensional space. Values such as varus / valgus and flexion / extension may be derived from the functional axis, making tracking of the functional axis via the bone anchor device 20 useful for this purpose.
[0041] The bone anchor device 20 is configured to be received within a cavity in a bone. For example, as shown in Figures 2A and 2B, the bone anchor device 20 is received within a cavity formed within the intercondylar notch of the distal femur F as one possible location for receiving the bone anchor device 20. Figures 6A-6C and 7A-7C show the bone anchor device 20 within the proximal tibia. The bone anchor device 20 defines a receptacle 21 or similar body for enclosing and thus housing the electronic components. The receptacle 21 in Figure 1 is shown generally as being cylindrical in shape, but may have other shapes. In one embodiment, it is contemplated to introduce the bone anchor device 20 into a bone by drilling a hole therein, where the cylindrical shape of the receptacle 21 is suitable for receiving within the drilled hole. The receptacle 21 is configured to be coupled to a robot base 30 and may thus have a connector 21A. In the illustrated embodiment, the connector 21A is shown as being a hole (e.g., a threaded hole), but it may have other forms, such as a protruding member like a shaft, a rod, or may integrate a quick-connect system feature, etc. The connector 21A is selected to be complementary to the connector of the robot base 30, such that the connection between the bone anchor device 20 and the robot base 30 is geometrically determined. That is, once the bone anchor device 20 and the robot base 30 are connected to each other, some geometric data is known, such as the distance between the bone anchor device 20 and the robot base 30, the orientation between the coordinate systems xyz1 and xyz2 associated with the bone anchor device 20 and the robot base 30, respectively, if a movement between the bone anchor device 20 and the robot base 30 is possible after the mutual connection. In fact, the connector 21A may be part of a joint that allows a relative movement between the bone anchor device 20 and the robot base 30. The joint may include, for example, a spherical joint, a universal joint, an expansion joint, etc.
[0042] The electronics 22 are housed in a receptacle 21 of the bone anchor device 20. In one embodiment, the bone anchor device 20 is autonomous in that it can operate to generate signals by itself. Thus, as part of the electronics 22, there may be a processor / memory to perform certain functions. The memory may include non-transient instructions that the processor can execute to perform a given function, as detailed below. Since the bone anchor device 20 may remain implanted in the bone after surgery, a power source such as a battery may be part of the electronics 22. The bone anchor device 20 described above is tasked with tracking the bone in space. Thus, an inertial sensor is part of the electronics. The inertial sensor may be known as a power-free sensor, a micro-electromechanical sensor unit (MEMS unit), and has any suitable set of inertial sensors (e.g. accelerometers, gyroscopes) to produce tracking data in at least three degrees of rotation (i.e. orientation about a set of three axes is tracked). The inertial sensor may include a processor including a printed circuit board, and non-transitory computer readable memory communicatively coupled to the processor and including computer readable program instructions executable by the processor, or may use the processor / memory described above. Moreover, the inertial sensor may be self-contained in that it may be pre-calibrated for operation, may have its own power supply or may be connected to a power source, and may have an interface thereon, for example in the form of a display (e.g., an LED indicator).
[0043] Additionally, as part of the electronics, there may be a communication device for the bone anchor device 20 to emit a signal indicative of the bone orientation. The communication device may be a wireless device that may use any suitable wireless communication protocol, such as Bluetooth, Wi-Fi, etc.
[0044] It is desirable for the bone anchor device 20 to remain anchored in a fixed position and orientation relative to the bone. In a variant, it may be possible to drive the bone anchor device 20 into the bone. Thus, a spike 23A or similar flared end (frustoconical end) may protrude from the front end of the bone anchor device 20 as it protrudes from the receptacle 21, the flared shape being from the tip to the rear end. The spike 23A is shown as having a triangular fin that may facilitate the driving of the bone anchor device 20 into the bone. However, the spike 23A may be optional if the bone anchor device is received in a drilled hole in the bone. Furthermore, considering the penetration of the bone anchor device 20 into the bone, the spike 23A may be received in cancellous bone, which may or may not provide sufficient foothold. Thus, one or more fins 23B or similar anchoring features may be at or near the rear end of the receptacle 21 for the fins 23B to gain foothold in the cortical bone. The fins 23B may have a smaller cross-sectional shape than the spikes 23A that may be sufficient to prevent rotation of the receptacle 21 within the bone, ensuring that the bone anchor device 20 does not move relative to the bone. Other anti-rotation features may be present as well. The fins 23B may have a cross-sectional shape that widens from the front to the rear end to promote interaction with the surrounding bone.
[0045] Appropriate calibration techniques can be used to ensure that the inertial sensor in the electronics 22 tracks the axis of the bone that houses the bone anchor device 20. In one variation, calibration is performed to create an axis or other landmark. For example, the method described in U.S. Pat. No. 9,901,405, which is incorporated herein by reference, can be used to determine the functional axis. Other data that can be tracked by the bone anchor device 20 include, for the femur, other axes such as the femoral medial lateral axis, the femoral anterior face, a femoral bone model, etc. From a pre-calibration perspective, the position and orientation of the inertial sensor in the receptacle 21 may be known, thus allowing the inertial sensor to be tied to a given landmark of the bone at the time of insertion. For example, the bone anchor device may be calibrated to the functional axis entry point (e.g., tibia) by its positioning in a drilled hole at the entry point of the tibia.
[0046] The receptacle 21 has a given volume size in order to accommodate the electronic component 22 and limit its invasiveness. In one embodiment, the diameter of the receptacle 21 is 8 mm to 10 mm, although other dimensions may be possible. The height of the receptacle 21 may be 8 mm to 15 mm, but may be smaller or larger.
[0047] With reference to FIG. 1 , the robotic base 30 and the surgical tool 40 may form part of a robotic tool unit that is used together with the bone anchor device 20 to perform a given task on the bone. The robotic tool unit may be available as a whole, i.e. with the robotic base 30 and the surgical tool 40 integrated together, but may also be made up of removable parts, i.e. the robotic base 30 and the surgical tool 40 are detachably connected. The detachable connection may allow the use of different surgical tools 40 with the same robotic base 30, thus reducing the cost of the robotic tool unit since the surgical tools 40 can share a common robotic base 30 with its electronic and mechanical components. During a surgical procedure, the robotic tool unit may be moved relative to the bone and used by the user as a physical interface to perform functions on the bone, while the bone anchor device 20 is anchored to the bone and serves as a base for the robotic tool unit.
[0048] In FIG. 1 , the robot base 30 is in an assembly-disassembly relationship with the bone anchor device 20. The robot base 30 may be detachably coupled to the bone anchor device 20. The robot base 30 may also define a receptacle 31 for receiving therein electronic, mechanical and / or electromechanical components 32, 42. The electronic, mechanical and / or electromechanical components 32, 42 may also be internal to the surgical tool 40, hence the reference number 42. In other words, the electronic and / or mechanical components 32, 42 may be part of a robot tool unit, i.e., the combination of the robot base 30 and the surgical tool 40. The receptacle 31 has a connector 31A configured to be coupled to the connector 21A of the bone anchor device 20. For example, the connector 31A is shown as being a shaft as one possible means for being coupled to the connector 21A of the bone anchor device 20. In one embodiment, the connectors 21A and 31A together define one or more joints to allow a given movement of the robotic tool unit relative to the bone anchor device 20. For example, referring to xyz1 in FIG. 1, i.e., the reference system of the bone anchor device 20 fixed to the bone, the robotic tool unit including the robot base 30 and / or the surgical tool 40 may translate towards and away from the bone anchor device 20, for example in a direction generally parallel to the functional axis of the femur F. The translational movement may be limited to one degree of freedom (DOF). The robotic tool unit including the robot base 30 and / or the surgical tool 40 may also rotate relative to the bone anchor device 20 with two or three DOFs. For the purpose of adjusting the flexion-extension plane, one rotational DOF of the joint between the robotic tool unit and the bone anchor device 20 may be aligned with the femur for rotation about the medial lateral axis of the femur F. Another rotational DOF of the joint between the robotic tool unit and the bone anchor device 20 may be aligned with the femur for rotation about the anterior-posterior axis of the femur F for purposes of varus-varus adjustment. A third rotational DOF may be aligned with the axis of the bone anchor device 20 to allow rotational adjustment about the posterior or epicondyles of the femur.This may allow for adjustment using the condyle abutment members described below.
[0049] A connector 31B may be provided on the receptacle 31 for connection of the surgical tool 40 to the robot base 30 when not connected as one. The connector 31B is shown as a threaded hole, but other connection parts may be present, such as quick connection features such as clips, tongues, or other types of complementary connections. In one variation, the robot base 30 is fixed in movement relative to the bone anchor device 20, while the surgical tool 40 may move relative to the robot base 30 and thus the bone anchor device 20, by one or more joints between the robot base 30 and the surgical tool 40. The robot base 30 and the surgical tool 40 may be removably connected, as shown in FIG. 1, with one possibility being that the holes 31B in the robot base 30 and the holes 41B of the connector are aligned for fastener connection. The movement may be as described above for the joints between the bone anchor device 20 and the robot base 30, i.e. one translational DOF and two or more rotational DOFs. 3A, 3B, and 3C show an example spherical joint 33 and translational joint 34 between the surgical tool 40 and the robot base 30, illustrating one contemplated method for moving the surgical tool 40 relative to the femur F with two or more rotational degrees of freedom. Other joint arrangements are possible to provide any suitable or desired degrees of freedom of movement. By way of example, the surgical tool 40 has a cut slot 41A, but may have different and / or other guidance features (e.g., drill guides, abutment features, etc.).
[0050] Among the electronic and / or mechanical components 32, 42, the robot base 30 may include a processor / memory with non-transient instructions for the processor to perform a given function associated with surgery. Rotational motors may be included in the electronic and / or mechanical components 32, 42 and may be used to control the rotation of the robot base 30 relative to the bone anchor device 20 or the robot base 30 relative to the surgical tool 40. The movement of the robot base 30 may also be controlled using micro gears, linear actuators or fluids (air, oil, water), an example of which is provided below. In one embodiment, the rotational motor is controllable to cause the movement of the receptacle 31 relative to the connector 31A, which is part of the joint between the bone anchor device 20 and the robot base 30. Thus, with the surgical tool 40 coupled to the robot base 30, the movement of the robot base 30 may cause the movement of the surgical tool 40 relative to the bone. A linear actuator may be present as part of the parts 32, 42 to actuate translational movement between the robot base 30 and the bone anchor device 20. In other words, the robot base 30 may move closer or farther from the bone anchor device 20. A force sensor may be present as part of the parts 32, 42 in the robot base 30 or may be in the surgical tool 40. A rotational encoder may be present to determine the orientation of the robot base 30 relative to the bone anchor device 20 when they are movable relative to each other using one or more joints. Alternatively, a rotational encoder may determine the orientation of the surgical tool 40 relative to the robot base 30 when they may rotate relative to each other. Any suitable power source is part of the parts 32, 42. For example, the robot tool unit may be wired to a power source or may have a battery. A communication device may also be present for communication between the robot tool unit and the bone anchor device 20 or for communication with a processor separate from the on-bone robotic system 10.While the rotational encoders can determine the relative orientation between the robot base 30 and the bone anchor device 20, there may be inertial sensors in the robot base 30 or in the surgical tool 40 to monitor the orientation of the robot tool unit. Similarly, it is also possible to use optical tracking technology to observe the rotation of the robot base 30 relative to the bone and / or the bone anchor device. For example, the optical tracking technology may include a laser range finder that is part of the robot base 30 and projects light onto the bone, for example. One or more cameras may also be provided as part of the parts 32, 42, the term "camera" encompassing various hardware and software components necessary to perform imaging (e.g. lenses, apertures, image sensors, e.g. CCD, image processors). The cameras may take the form of a set to operate as a depth camera system. The camera may be on the robot base 30 and / or on the surgical tool 40, with a suitable distance given to the camera lens to view the bone on which the on-bone robotic system 10 is assembled and / or to view the bone environment, such as the lens shown at 42A in FIG. 1. For example, the camera may be used to image the bone surface, which is then used to match the imaged bone surface to a bone model (e.g., a 3D virtual bone model) obtained through different pre-operative or intra-operative imaging (e.g., CT scans, various forms of X-ray photography), programmed into the memory of the on-bone robotic system 10 or accessible by the on-bone robotic system 10. Thus, the presence of the camera 32, 42 on the on-bone robotic system 10 can contribute to the calibration and subsequent navigation of the system relative to the bone. The camera 32, 42 may have a unique perspective of, for example, gaps, recesses on the bone. Another possibility is that, as described below, a cutter actuator may be present as part of the robotic tool unit if the surgical tool 40 is configured to perform cuts. The cutter actuator may be a motor, an ultrasonic oscillator, a linear actuator, or the like.
[0051] Now that the general configuration of the on-bone robotic system 10 has been described, surgical procedures involving the system 10 and which may use different types of surgical tools 40 will be described. The surgical procedure is a knee replacement procedure in which a tibial plateau implant is placed on the tibia and a femoral component is implanted on the distal femur. The on-bone robotic system 10 may also be used in other types of procedures, such as partial proximal tibial procedures, distal femur only, proximal tibia only, hip joint surgery (e.g., partial hip replacement, total hip replacement), hip surface replacement, shoulder surgery, etc.
[0052] As a starting point, the bone anchor device 20 is placed in the bone. For example, the bone anchor device 20 is in the intercondylar notch (e.g., the intramedullary cavity or medullary canal) and is tasked with tracking landmarks of the femur F, such as a frame of reference that includes a functional axis. Other locations on the femur F are possible for the bone anchor device 20 as well.
[0053] With reference to Figures 3A, 3B and 3C, anterior and lateral views of a femur with an on-bone robotic system 10 are provided. The surgical tool 40 is shown as an alignment plate displaceable to contact the distal surface of the condyle. The alignment plate thus has an abutment plane 40A, and a joint in the robotic tool unit or between the robotic tool unit and the bone anchor device 20 may enable the abutment plane 40A to be brought into contact with the condyle by translation and / or rotation. Although Figures 3A and 3B show a single plane for abutment with the distal surface of the condyle, the surgical tool 40 may also have another abutment surface for abutment with the posterior surface of the condyle, as shown in Figure 3B. In Figure 3B, the condyle abutment member 40B may be connected to the abutment plane 40A, but alternatively, it may be possible for the condyle abutment member 40B to be entirely part of the abutment plane 40A. In one embodiment, translation between the abutment plane 40A and the condyle abutment member 40B is made possible using a translation joint. In one embodiment, the bone contacting surfaces of the abutment plane 40A and the condyle abutment member 40B are orthogonal to each other. The abutment contact may be automated by the on-bone robotic system 10, and a force sensor determines if contact is achieved. By using parts 22 and 32, 42 to share orientation data, the orientation of the surgical tool 40 relative to the bone anchor device 20 can be known, and thus additional bone landmarks can be tracked. In one variation, an alignment plate is used to locate the mid-lateral axis, the plane of the posterior surface of the condyle, and / or the plane aligned with the distal surface of the condyle and / or both epicondyles. Once the functional axis is known, the robot base 30 can align itself parallel to the functional axis and, using the actuation means described herein, can touch the most distal part of the condyle with the abutment surface 40 and record that landmark (the most distal point of the femur). A bone cut can then be made relative to this landmark, e.g., resection plane 9 mm from the most distal point of the femur. Similarly, orientation of the cutting plane for the distal cut may include palpating the distal condyle at, e.g., a 3 degree flexion angle relative to the functional axis.
[0054] 4A, one variation of the abutment surface surgical tool 40 is illustrated in which bone-contacting actuators 43 are provided at the corners or sides of the abutment plane 40A. The bone-contacting actuators 43 each have a piston or similar moving part 43A that protrudes outward from the abutment plane 40A. The moving part 43A is configured to contact a given landmark of the bone, such as a distal feature of a condyle. For example, the bone-contacting actuators 43 are stepper motors, ball screw motors, or equivalents, having an output rod that defines the moving part 43A. Rotation of the bone-contacting actuators 43 can result in protruding movement of the moving part 43A, and thus may be performed to adjust the orientation of the surgical tool 40 relative to the bone, for example, via a spherical joint 33. Concurrent rotation of the bone-contacting actuators 43 may also be performed via a translation joint 34 to move the abutment plane 40A away from the bone.
[0055] For example, there may be four such bone contacting actuators 43, although only two are visible from the perspective of FIG. 4A. Thus, since the adjacent plate surgical tool 40 may have a known orientation relative to the bone axis via the bone anchor device 20 (e.g., an inertial sensor in the electronics 22), the bone contacting actuators 43 may be controlled to orient the adjacent plate surgical tool 40 in a desired direction relative to an anatomical feature of the femur, such as the functional axis, and / or to move the adjacent plate surgical tool 40 away from the femur F. Thus, the degrees of freedom present, particularly within the robotic tool unit or between the bone anchor device 20 and the robotic base 30, may allow for varus and / or flexion / extension gradient adjustment of the final resection plane via the orientation of the surgical tool 40 relative to the femur F. Control of the bone contacting actuators 43 may be used to set the adjacent plate surgical tool 40 in a desired orientation and / or position and to hold the adjacent plate surgical tool 40 in a desired orientation. If the bone-contacting actuator 43 is simultaneously actuated, it is likewise possible to move the surgical tool 40 axially relative to the bone, provided that there is a translational degree of freedom within the robotic tool unit or between the bone anchor device 20 and the robotic base 30. The bone-contacting actuator 43 may be self-locking in that it may hold its length except when actuated. Thus, once the bone-contacting actuator 43 holds its length and abuts the bone, the adjacent plate surgical tool 40 may be in a fixed position and orientation relative to the bone, e.g., hovering over the bone, and may serve as a structure to support additional components. The desired position and / or orientation may be automated and / or effected on-bone, with the robotic system 10 actuated to achieve the desired position and / or orientation for the adjacent plate surgical tool 40.
[0056] 4B, another embodiment is shown in which the adjacent plate surgical tool 40 has a movable part 43A that is displaceable using a cylinder, also known as a piston, shown as 43B, whether there is more than one cylinder 43B. The cylinders 43B may be hydraulic or pneumatic cylinders, etc. Each cylinder may have its own valve to control the length of the cylinder 43B, as described in U.S. Patent Application Publication No. 2009 / 0018544 to Zimmer Inc, which is incorporated herein by reference. The pressure source may be built-in or may be separate from the on-bone robotic system 10.
[0057] 5A and 5B, once a desired position and / or orientation of the adjacent plate surgical tool 40 relative to the femur is achieved, another tool, such as a cutting guide 50, may be secured to the adjacent plate surgical tool 40. The cutting guide 50 may have one or more cut slots 51 and pin holes 52 for securing the cutting guide 50 to the bone. Although the exemplary embodiment is configured to create a distal cut, there may be other cut slots for other cuts, such as an anterior cut, an anterior chamfer, a posterior chamfer, and / or a posterior cut. The cut created using the cut slot 51 may be a provisional cut, for example, to support a provisional implant.
[0058] The cutting guide 50 is in a known geometric relationship to the adjacent plate surgical tool 40 when attached, such that the cut surface made through the cut slot 51 is in a desired position and orientation relative to the bone. Taking into account the geometry of the cutting guide 50 and the geometric relationship between the cutting guide 50 and the surgical tool 40 when displacing the surgical tool 40, the on-bone robotic system 10 may be operated to guide the resection of the cut surface in a navigated orientation relative to a bony landmark tracked by the bone anchor device 20, such as the functional axis of the femur F. Thus, according to Figures 4A and 4B, where the orientation of the abutment plate of the surgical tool 40 is adjusted via the electronic components 22 and 32, and Figures 5A and 5B, where the cutting guide 50 is fixedly fixed to the surgical tool 40 with the cut slot 51 at the desired position, the cutting guide 50 can be pinned to the bone with a pin 53 as in Figure 5B, or attached to the bone in another manner. The camera 32 can be used to provide video imaging that allows the cutting guide 50 to be positioned and oriented relative to the bone. The robotic tool unit (i.e., including the robot base 30 and surgical tool 40) can be removed to allow for the distal cut. The bone anchor device 20 can remain in the bone after the cutting guide 50 is attached to the bone and can be used to track the movement of the bone as described above.
[0059] As a result, the on-bone robotic system 10 featuring the surgical tools 40 and / or 50 (cutting guide 50 and alignment plate surgical tool 40 may be a single device) may self-align to the femur F by performing its femoral registration to guide the femoral cut. Self-alignment may also involve imaging using the camera 32, for example with a 3D model of the bone. Additionally, imaging from the camera or lasers from the components 32, 42 may be used to determine the resection depth relative to a landmark (e.g., the ankle for the tibia), thus allowing the virtual implant geometry to be used to calculate relaxation values. If the bone anchor device 20 is an implanted electronic device used post-operatively, the coordinates of the various planes resulting from the femoral registration may be transferred to the electronic components 22 of the bone anchor device 20 as data to be used in post-operative tracking.
[0060] 6A to 6C, an on-bone robotic system 10 may be used to create a cutting surface on the proximal tibia T in order to define a tibial plateau for receiving an implant. The on-bone robotic system 10 may thus comprise a bone anchor device 20, a robotic tool unit including a robotic base 30 and different types of surgical tools. In FIGS. 6A to 6C, the cutting tool is defined by a cutting guide 60 having a cut slot 61 and a pin hole 62 for fixing the cutting guide 60 to the tibia T. The pin hole 62 is one of several solutions for fixing the cutting guide 60 to the tibia T. An articulating mechanism 63 mechanically couples the cutting guide 60 to the robotic base 30. Suitable joints, such as a slip or expansion joint 63A, a first rotary joint 63B (e.g., a swivel joint) and a second rotary joint 63C (e.g., a swivel joint), may be present in the articulated mechanism 63 to allow movement of the cutting guide 60 relative to the robot base 30. Although joints 63A, 63B and 63C are shown in a series arrangement, other arrangements are contemplated, such as by combining joints 63B and 63C into a single rotary joint (e.g., a spherical joint, a universal joint) having two rotational degrees of freedom.
[0061] The movement of the cutting guide 60 may be navigated for position and / or orientation through suitable electronics 22, 32 that are part of the robotic system 10 to provide a desired orientation relative to the tibial plateau relative to tibial landmarks such as the functional axis, the highest point of the tibial plateau, or the deepest point of the tibial plateau. If present, the camera 32 may be optionally used to provide video imaging, which allows the cutting guide 60 to be positioned and oriented relative to the bone. A 3D virtual model of the tibial plateau may be used to overlay the camera 32 image as a reference. Thus, in one variation, the positioning of the cutting guide 60 may be based on imaging, for example, which is used to determine the deepest point on the tibial plateau. Moreover, some or all of the various degrees of freedom of the articulated mechanism 63 between the cutting guide 60 and the bone anchor device 20 may be actuated by actuators internal to the robotic tool unit to automate or control the position and / or orientation of the cut slot 61 relative to the tibia T. The bone anchor device 20 used in Figures 6A-6C may navigate the functional axis of the tibia. To calibrate the bone anchor device 20 and enable tracking of tibial landmarks, various techniques and tools may be used, such as those described in U.S. Patent No. 10,729,452, incorporated herein by reference, that allow the functional axis of the tibia T to be digitized and tracked by inertial sensors such as those present in the bone anchor device 20. Thus, the orientation of the cut slot 61 may be adjusted for valgus (e.g., joint 63B) and / or cant (e.g., joint 63C).
[0062] Once the cutting guide 60 is properly positioned relative to the tibia T, it may be anchored to the bone, such as by pins in the pin holes 62. Components of the robotic tool unit, such as the robot base 30 and the articulating mechanism 63, may be removed. The bone anchor device 20 may likewise be removed or left in the tibia T deep enough so as not to intersect the cut plane of the cut slot 61. If left in the tibia T, the bone anchor device 20 may be used to track post-operative movement. Additionally, the bone anchor device 20 may be coupled to the tibial plateau implant to receive force sensing data from a force sensor in the implant.
[0063] 7A-7C, another approach to creating a proximal tibia plane is shown. The surgical tools of the robotic system 10 include a milling tool or similar cutting tool 70 that is translated onto the surface of the bone by an articulated mechanism 63. Thus, as part of FIG. 7A, the orientation of the cutting tool 70 is adjusted to achieve a desired orientation between the cutting tool 70 and the tibia, for example. Again, to calibrate the bone anchor device 20 and enable tracking of tibial landmarks, various techniques and tools can be used, such as those described in U.S. Pat. No. 10,874,405, incorporated herein by reference, that allow the functional axis of the tibia T to be digitized and tracked, for example, by inertial sensors present within the bone anchor device 20. Thus, the orientation of the cutting tool 70 may be adjusted for varus (e.g., joint 63B) and / or cant (e.g., joint 63C). At this time, after the tibial plateau is properly oriented to be resurfaced, the cutting tool 70 may be translated by joint 63A onto the top surface of the tibial plateau. The robotic system 10 may control the translational movement to achieve the desired resection depth of the tibial plateau. Thus, the articulated mechanism 63 may drive the movement of the cutting tool 70, although manual assistance may also be used.
[0064] The on-bone robotic system 10 featuring surgical tools 60 and / or 70 can self-align to the tibia T by performing its tibial registration and can guide or perform the tibial cut itself. If the bone anchor device 20 is an implanted electronic device used post-operatively, the coordinates of the plane resulting from the tibial registration can be transferred to the electronics 22 of the bone anchor device 20 as data to be used in post-operative tracking.
[0065] 8A-8E, the on-bone robotic system 10 is shown using a temporary implant 80 as a surgical tool for the robotic tool unit in conjunction with the robot base 30 to operate with the bone anchor device 20 described above. The temporary implant surgical tool 80 may be used intraoperatively after the preliminary cut of the distal femur has been made. The temporary implant surgical tool 80 is used to assist in determining the desired location and / or orientation of the femoral implant relative to the femur F by providing data coupled with the balance of the soft tissue of the bone. Thus, the temporary implant surgical tool 80 may have a geometry that emulates the shape of a femoral implant with a distal surface 80A and a posterior surface 80B, the posterior surface 80B having a condyle-like formation. The temporary implant surgical tool 80 may have suitable force sensors as part of the electronics / mechanics 42 to collect force data for various flexion-extension and / or varus-varus angles at the knee. Therefore, to allow for soft tissue balance, the temporary implant surgical tool 80 must be adjustable and movable relative to the femur F, as described in U.S. Patent Nos. 7,442,196, 10,555,822, and 10,485,554, which are incorporated herein by reference. Thus, preliminary cuts made in the distal femur, such as posterior cuts and / or distal cuts, must take into account the size of the temporary implant surgical tool 80 to allow for movement of the temporary implant surgical tool 80. Additionally, the preliminary cuts must be minimal to allow for additional bone removal for the final cuts to be made for the femoral implant to be placed.
[0066] In one embodiment, the temporary implant surgical tool 80 is coupled to the robot base 30 by a spherical joint 33 and / or a translation joint 34 (FIGS. 3A, 3B and 3C), allowing actuators within the on-bone robotic system 10 to lock the temporary implant surgical tool 80 in a given position and orientation relative to the femur F, whose landmarks are tracked by the bone anchor device 20. The position and / or orientation of the temporary implant surgical tool 80 is tracked relative to the femur F via various possible electronic / mechanical components 32, 42, such as encoders, motors, linear actuators and / or inertial sensors. These components may be used in conjunction with data provided by inertial sensors in the bone anchor device 20. With the temporary implant surgical tool 80 in a fixed position and orientation relative to the femur, various knee manipulations may be performed to collect force sensor data, which is related to the instantaneous position and orientation of the temporary implant surgical tool 80. If the force sensor data is above a given threshold, which may indicate soft tissue imbalance, dynamic adjustments may be performed by the on-bone robotic system 10. Dynamic adjustments may be accomplished by adjusting the position and / or orientation of the temporary implant surgical tool 80, for example, to replicate a given varus-valgus angle, flexion / extension angle, femoral flexion rotation, and / or femoral length. Once sufficient data has been acquired by the force sensors of the temporary implant surgical tool 80 to select a target femoral implant position and orientation, the temporary implant surgical tool 80 may be removed. A cutting guide tool, such as the one shown as 40 in FIG. 4A or FIG. 4B, may be attached to the robot base 30, or in another embodiment, to the temporary implant surgical tool 80, to position the cut slots in a position and orientation that corresponds to the target femoral implant position and orientation, taking into account the geometrical relationship and size of the cutting guide tool 40.
[0067] As part of the surgical workflow involving the temporary implant surgical tool 80, a preliminary cut may be made to the distal femur F to remove enough bone to secure the temporary implant cutting tool 80 to the femur. Resection of the tibial plateau as shown in Figures 6A-6C and 7A-7C may be accomplished before or after the preliminary cut to the distal femur F. Thus, the surgical workflow may conclude with resection of the femur to create a suitable planar cut after balancing the soft tissue with the temporary implant surgical tool 80.
[0068] Still referring to FIGS. 8A-8E, an alternative to the use of joints 33 and 34 is shown in which a distal surface 80A of the temporary implant surgical tool 80 has an actuated pad 81A. Similarly, a posterior surface 80B of the temporary implant surgical tool 80 can have an actuated pad 81B. Each of the actuated pads 81A, 81B can be translationally displaceable relative to the remainder of the temporary implant surgical tool 80 and can hold a set position relative to the remainder of the temporary implant surgical tool 80. Any suitable motor or linear actuator from part 42 can be used to actuate the displacement. Movement to a set position can be used to emulate an adjusted position and orientation of the temporary implant surgical tool 80 relative to the femur F. Thus, as shown in FIGS. 8A and 8B, the flexion angle can be adjusted. As shown in FIG. 8B, the rotation of the femur in the AP plane can be adjusted for balance. As shown in FIGS. 8C and 8D, the varus-varus angle can be adjusted. Force sensors as described in U.S. Pat. No. 10,485,554 can be integrated into actuated pads 81A and / or 81B to measure forces in dynamic soft tissue balance procedures for various degrees of valgus and flexion-extension. In FIG. 8E, an optional cutting guide tool 82 can be positioned against actuated pad 81A via abutment surface 82A to transfer their combined contact plane to cut slot 82B. The cutting guide tool 82 can then be pinned to the bone and the robot base 30 can be removed so that the cut surface can be resected. In the embodiment of FIGS. 8A-8E, the robot base 30 can be optional, but can be used to interface the bone anchor device 20 to the temporary implant surgical tool 80.
[0069] The electronics 42 mounted on the temporary implant surgical tool 80 may include a range finder, such as an optical sensor, that can be used to determine the distance between the activated pads 81A and 81B and the rest of the temporary implant surgical tool 80, or from the temporary implant surgical tool 80 to the bone to determine position and / or orientation. For example, this may be an alternative to having inertial sensors. These sensors may be used to determine the distance between the temporary implant surgical tool 80 and the tibial plateau during range of motion and laxity testing. The surgeon will then be shown pressure readings as well as distance readings.
[0070] Referring to Figure 9, another surgical tool is shown at 90. The surgical tool is a cutting block 90 that can be used in a variety of ways. For example, the cutting block 90 can be used to prepare a flat bone surface, such as may be used in machining the distal planar surface of the femur in the embodiment of Figure 4, or the tibial plateau in the embodiment of Figures 7A-7C.
[0071] The housing 91 may contain multiple cutting heads 92 within a milling tool arrangement, i.e., mill head. In the example of FIG. 9, the housing 91 is shown as having a generally trapezoidal perimeter around the multiple cutting heads 92. The perimeter may be shaped to complement the shape of the bone surface (e.g., femur, tibia) to be machined. Other perimeter shapes may be provided, including generally triangular, parallelogram, rectangular, or irregular shapes. The multiple cutting heads 92 may be disposed within the housing 91 and may be exposable through the attack surface of the cutting block 90.
[0072] The cutting block 90 may be fitted with a number of cutting heads 92 arranged to machine a flat surface. Together, the cutting heads 92 may form a two-dimensional cutting surface. In some embodiments, the cutting heads 92 may be telescopic relative to the housing 91, thus exposing the two-dimensional cutting surface outside the housing 91. The cutting heads 92 may be actuated by a motor from the electronic / mechanical components 42. Additional structures that may be oscillated or rotated together as a whole may be present to oscillate or rotate the cutting heads 92. The oscillation or rotation of the cutting heads 92 (e.g. as a whole) may be in addition to the rotation or oscillation movement provided to each of the multiple cutting heads 92. For example, ultrasonic actuation may be used to drive the oscillation of the cutting block 90 and / or its displacement towards the bone. Irrigation and suction of bone fragments are also planned within the cutting block 90, as shown by suction holes 93A, coupled to a suction source S and irrigation jets 93B for the purpose of facilitating the milling operation. Only one suction hole 93A is shown, but others may be present in various locations.Similarly, only one cleaning jet 93B is shown, but others may be present in various locations.
[0073] Referring to Figure 10, another surgical tool is shown at 100. Surgical tool 100 is another cutting block that may be used in a variety of ways. For example, cutting block 100 may be used to prepare flat bone surfaces, and thus may be used to prepare the distal flat of the femur in the embodiment of Figure 4A or 4B, or the tibial plateau in the embodiment of Figures 7A-7C.
[0074] The cutting block 100 may include a cutting band 101. The cutting block 100 may also include a first cylindrical drive member 102A and a second cylindrical drive member 102B arranged in a housing 103. The cutting band 101 may extend (e.g., be stretched) between the first cylindrical drive member 102A and the second cylindrical drive member 102B. As another possibility, one of the members 102A and 102B may be driven. The cutting band 101 may form a closed loop (e.g., a flexible eternal band). The cutting band 101 may be rotated upon activation of a motor from the part 42. In some embodiments, a rotor may reside inside the first and / or second cylindrical drive members 102A and / or 102B. In some embodiments, instead of or in addition to rotating the cutting band, the cutting band may be vibrated upon activation by an oscillator. The cutting band 101 may also be rotated by a transmission. Examples of transmissions include tandem pulleys, chain and sprockets, gear drives, and the like. The cutting band 101 may include an abrasive element. In some embodiments, the abrasive element is a series of blades. Irrigation and suction of bone debris is also contemplated within the cutting block 100, as shown by suction hole 104A, coupled to a suction source and irrigation jets 104 to facilitate the milling operation. Only one suction hole 104A is shown, but other holes may be present in various locations. Similarly, only one irrigation jet 104B is shown, but other jets may be present in various locations.
[0075] In Figure 11, another surgical tool is shown as 110. Surgical tool 110 is another cutting block that can be used in a variety of ways. For example, cutting block 110 can be used to prepare flat bone surfaces, and thus may be used in preparing the distal flat of the femur in the embodiment of Figure 4, or the tibial plateau in the embodiment of Figures 7A-7C.
[0076] The cutting block 110 may feature multiple blades 111 that may vibrate when placed against a bone surface to prepare the flat bone surface. In one embodiment, vertical vibration of the blade 111, i.e., vibration in the axial direction of the blade 111, is generated to perform the cutting action. Ultrasonic actuation may be used to generate the vibration, i.e., its displacement toward the bone. Irrigation and suction of bone debris is also contemplated within the cutting block 110, as shown by suction holes 112A connected to a suction source S and irrigation jets 112B to facilitate the milling operation. Although a pair of suction holes 112A are shown, other holes (or fewer holes) may be present in various locations. Similarly, although only one irrigation jet 112B is shown, other jets may be present in various locations.
[0077] The above description is intended to be merely illustrative, and one skilled in the art will recognize that modifications may be made to the described embodiments without departing from the scope of the disclosed invention. Moreover, other modifications falling within the scope of the present invention will be apparent to those skilled in the art in light of a review of this disclosure, and such modifications are intended to fall within the scope of the appended claims. Although the on-bone robotic system 10 has been described as being used for knee surgery, femoral and / or tibial resection, similar procedures may be used for other bones, such as the humerus, spine, etc. For the tibia, the assembly described in U.S. Pat. No. 10,729,452 may be used, the contents of which are incorporated herein by reference. EXAMPLES
[0078] Claim-related Examples Example 1 is an on-bone robotic system including a bone anchor device configured to be housed within a bone, the bone anchor device including at least one sensor for tracking an orientation of the bone, and a robotic tool unit detachably coupled to the bone anchor device, the robotic tool unit including at least one actuator for displacing a surgical tool of the robotic tool unit relative to the bone when coupled to the bone anchor device, the on-bone robotic system including at least one joint enabling at least one degree of freedom of movement of the surgical tool relative to the bone anchor device, and including a processor for actuating the at least one actuator in response to tracking of the bone by the sensor.
[0079] Example 2 is a bone anchor device having a receptacle configured to be received within a bone, the receptacle housing at least one sensor, which may include or optionally combine with the subject matter of Example 1.
[0080] Example 3 has a flared front end of the bone anchor device and may include or optionally combine the subject matter of Example 2.
[0081] Example 4, in which the anti-rotation feature protrudes laterally from the receptacle, may include or optionally combine the subject matter of examples 2 and 3.
[0082] Example 5, in which the anti-rotation feature includes at least one fin, can include the subject matter of example 4, or can optionally be combined therewith.
[0083] Example 6, in which at least one sensor includes an inertial sensor, may include or optionally combine with the subject matter of examples 1 to 5.
[0084] Example 7 is a bone anchor device that includes a battery and can include the subject matter of Examples 1 to 6, or can optionally be combined therewith.
[0085] Example 8 is a bone anchor device configured to be used as an implant for tracking bone movement post-operatively and may include or optionally combine with the subject matter of Example 7.
[0086] In a ninth embodiment, the at least one actuator includes at least one motor and may include or optionally combine with the subject matter of the first to eighth embodiments.
[0087] Example 10 includes two motors and the robotic tool unit displaces the surgical tool in at least two rotational degrees of freedom and can include or optionally combine with the subject matter of example 9.
[0088] In an eleventh embodiment, the at least one actuator comprises at least one linear actuator and may comprise or optionally combine with the subject matter of embodiments one to ten.
[0089] Example 12 is a surgical tool having a cut slot, which may include the subject matter of Examples 1 to 11, or may be optionally combined therewith.
[0090] Example 13 is a robotic tool unit including at least one sensor for tracking the orientation of a surgical tool and may include the subject matter of Examples 1 to 12 or may optionally be combined therewith.
[0091] Example 14 includes a robotic tool unit including at least one camera oriented toward the bone and configured to capture images of the bone, and may include or optionally combine with the subject matter of Examples 1 to 13.
[0092] Example 15 includes a communication device coupled to the processor and configured for wireless communication, and may include or optionally combine with the subject matter of Examples 1 to 14.
[0093] Example 16 is a method for performing an orthopedic surgical procedure, comprising: anchoring an on-bone robotic system to a bone via a bone anchor device inserted into the bone, the bone anchor device including at least one sensor for tracking an orientation of the bone; operating the on-bone robotic system to displace a surgical tool operably connected to the bone anchor device, the movement of the surgical tool being guided in response to tracking of the bone by the sensor; and removing at least the surgical tool from the bone anchor device to leave the bone anchor device as an implant post-operatively, the bone anchor device being configured to track the bone post-operatively.
[0094] Example 17, in which anchoring the on-bone robotic system to the bone includes drilling a hole in the bone for inserting a bone anchor device into the hole, can include the subject matter of Example 16, or can optionally be combined therewith.
[0095] Example 18, in which inserting the bone anchor device into the hole includes penetrating the anti-rotation feature into the bone, can include the subject matter of Example 17, or can optionally be combined therewith.
[0096] Example 19, in which the movement during actuation includes moving the surgical tool in at least one rotational degree of freedom, can include the subject matter of Examples 16 to 18, or can optionally be combined therewith.
[0097] Example 20, in which moving the surgical tool includes activating a rotational motor to move the surgical tool in at least one rotational degree of freedom, can include the subject matter of Example 19, or can optionally be combined therewith.
[0098] Example 21, in which the movement upon actuation includes moving the surgical tool in two rotational degrees of freedom, can include the subject matter of Examples 19 to 20, or can optionally be combined therewith.
[0099] Example 22, in which the movement during actuation includes moving the surgical tool in one translational degree of freedom, can include the subject matter of Examples 19 to 21 or can optionally be combined therewith.
[0100] Example 23 further includes imaging bone from an on-bone robotic system and may include or optionally combine with the subject matter of Examples 16 to 22.
[0101] Example 24 further includes aligning imaging of the bone from an on-bone robotic system with a pre-operative virtual model of the bone to navigate the position and orientation of surgical tools relative to the bone, and may include or optionally combine with the subject matter of Example 23.
[0102] Example 25 further includes wirelessly communicating data from at least one sensor and may include or optionally combine with the subject matter of Examples 16 to 24.
[0103] Example 26 is a system for tracking bone intraoperatively and postoperatively in a surgical procedure, the system including a processing unit and a non-transitory computer readable memory communicatively coupled to the processing unit and including computer readable program instructions executable by the processing unit to perform the following: intraoperatively acquiring orientation data of at least one sensor in a bone anchor device anchored to the bone; activating at least one actuator to displace a surgical tool operably coupled to the bone anchor device as part of an on-bone robot in response to the orientation data; and post-operatively acquiring orientation data of at least one sensor in the bone anchor device that remains anchored to the bone after the surgical procedure.
[0104] Example 27, in which activating at least one actuator includes activating at least one rotational motor to orient a surgical tool relative to the bone in one rotational degree of freedom, can include the subject matter of Example 26 or can optionally be combined therewith.
[0105] Example 28, in which activating at least one actuator includes activating a second rotational motor to orient the surgical tool relative to the bone in a second rotational degree of freedom, can include the subject matter of Example 26 or can optionally be combined therewith.
[0106] Example 29, in which actuating at least one actuator includes actuating at least one linear actuator to displace the surgical tool relative to the bone in one translational degree of freedom, can include or optionally combine with the subject matter of Examples 26 to 28.
[0107] Example 30 further includes imaging bones from an on-bone robot and may include or optionally combine with the subject matter of Examples 26 to 29.
[0108] Example 31 further includes aligning imaging of the bone from an on-bone robot with a pre-operative virtual model of the bone to navigate the position and orientation of surgical tools relative to the bone, and may include or optionally combine with the subject matter of Example 30.
[0109] These non-limiting examples may stand alone or may be combined with one or more of the other examples in various permutations or combinations.
Claims
1. An on-born robotic system, a bone anchor device configured to be received within a bone, the bone anchor device including at least one sensor for tracking an orientation of the bone; a robotic tool unit detachably coupled to the bone anchor device, the robotic tool unit including at least one actuator for displacing a surgical tool of the robotic tool unit relative to the bone when the robotic tool unit is coupled to the bone anchor device; and An on-born robot system comprising: at least one joint that allows at least one degree of freedom of movement of the surgical tool relative to the bone anchor device; a processor for actuating the at least one actuator in response to the tracking of the bone by the sensor. On-Bone Robot System.
2. The on-bone robotic system of claim 1 , wherein the bone anchor device has a receptacle configured to be received within the bone, the receptacle housing the at least one sensor.
3. The on-bone robotic system of claim 2 , wherein the front end of the bone anchor device is flared.
4. The on-bone robotic system of claim 2 or claim 3, wherein an anti-rotation feature projects laterally from the receptacle.
5. The on-bone robotic system of claim 4 , wherein the anti-rotation feature comprises at least one fin.
6. The on-born robotic system of claim 1 , wherein the at least one sensor includes an inertial sensor.
7. The on-bone robotic system of claim 1 , wherein the bone anchor device includes a battery.
8. The on-bone robotic system of claim 7 , wherein the bone anchor device is configured to be used as an implant to track movement of the bone post-operatively.
9. The on-bone robotic system of claim 1 , wherein the at least one actuator includes at least one motor.
10. The on-bone robotic system of claim 9 , including two of the motors, wherein the robotic tool unit displaces the surgical tool with at least two rotational degrees of freedom.
11. The on-bone robotic system of claim 1 , wherein the at least one actuator includes at least one linear actuator.
12. The on-bone robotic system of claim 1 , wherein the surgical tool has a cut slot.
13. The on-bone robotic system of claim 1 , wherein the robotic tool unit includes at least one sensor for tracking an orientation of the surgical tool.
14. The on-bone robotic system of claim 1 , wherein the robotic tool unit includes at least one camera oriented toward the bone and configured to capture images of the bone.
15. The on-born robotic system of claim 1 including a communication device coupled to the processor and configured for wireless communication.
16. 1. A system for intraoperative and postoperative bone tracking in a surgical procedure, comprising: a processing unit; a non-transitory computer-readable memory communicatively coupled to the processing unit and containing computer-readable program instructions executable by the processing unit, the processing unit comprising: acquiring orientation data of at least one sensor in a bone anchor device secured to the bone during surgery; activating at least one actuator to displace a surgical tool operatively coupled to the bone anchor device as part of an on-bone robot in response to the orientation data; and and post-operatively obtaining orientation data of at least one sensor within the bone anchor device that remains anchored to the bone after the surgical procedure. a non-transitory computer-readable memory; A system including:
17. 17. The system of claim 16, wherein activating the at least one actuator comprises activating at least one rotational motor to orient the surgical tool relative to the bone in one rotational degree of freedom.
18. 17. The system of claim 16, wherein activating the at least one actuator includes activating a second rotational motor to orient the surgical tool relative to the bone in a second rotational degree of freedom.
19. 19. The system of claim 16, wherein activating the at least one actuator comprises activating at least one linear actuator to displace the surgical tool relative to the bone in one translational degree of freedom.
20. 19. The system of any one of claims 16 to 18, further comprising imaging the bone from the on-bone robot.
21. 21. The system of claim 20, further comprising aligning the imaging of the bone from the on-bone robot with a pre-operative virtual model of the bone to navigate a position and orientation of the surgical tool relative to the bone.