Robot Hand-Held Surgical Instrument System and Method

Abstract

A system is provided that includes a surgical robot system for use with a tool. In some forms, the robotic instrument includes a handheld portion for being held by a user and a tool support movably coupled to the handheld portion for supporting the tool. The robotic system further includes an actuator assembly operably attached to the tool support and the handheld portion and configured to move the tool support relative to the handheld portion with multiple degrees of freedom. The robotic system may include a handle alignment member extending from the handheld portion. At least a portion of the handle alignment member is aligned with a tool plane defined by the tool when the tool support has an optimal range of motion relative to the handheld portion.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority and all its benefits to U.S. Provisional Patent Application No. 63 / 390,856, filed on July 20, 2022, the entire content of which is hereby expressly incorporated by reference herein.

[0002] Technical Field The present disclosure generally relates to surgical robot hand - held instrument systems and methods of use.

Background Art

[0003] Physical cutting guides are used to constrain surgical tools when excising tissue from a patient. In some cases, physical cutting guides constrain such surgical tools for preparing joints to receive replacement implants. The time required to position and secure a physical cutting guide on a patient can account for a significant portion of the overall time required to perform a surgical procedure.

[0004] Navigation systems (also referred to as tracking systems) can be used to properly align and fix jigs and to track the position and / or orientation of surgical tools used to excise tissue from a patient. Tracking systems typically employ one or more trackers associated with the tool and the tissue being excised. The display can then be viewed by a user to determine the current position of the tool relative to the desired cutting path of the tissue being excised. The display can be arranged in a format that requires the user to look away from the tissue and the surgical site to visualize the progress of the tool. This can distract the user from focusing on the surgical site. Also, it can be difficult for the user to position the tool in the desired format.

[0005] Surgery assisted by a robot typically relies on a large robot equipped with a robotic arm that can move in six degrees of freedom (DOF). These large robots are cumbersome to operate and maneuver in an operating room.

[0006] Furthermore, robotic hand-held surgical instruments that use actuators to align the tool with a desired target object have a limited range of adjustability. Thus, the operator is required to hold these instruments within a certain distance and / or angle of the desired target object in order to align the tool with the desired target object. However, it is difficult for the operator to know how much adjustability the instrument has at any given moment during the procedure.

[0007] Accordingly, there is a need for a system and method for solving one or more of these problems. SUMMARY OF THE INVENTION

[0008] One aspect of the present disclosure includes a handheld surgical robot system. The handheld surgical robot system includes a handheld portion, a blade support including a blade mount movably coupled to the handheld portion and defining a blade plane, and a saw blade removably coupled to the blade support and disposed in the blade plane. The saw blade defines a longitudinal axis and a transverse axis. The handheld surgical robot system also includes an actuator assembly operably attached to the blade support and the handheld portion. The actuator assembly is configured to move the blade support relative to the handheld portion with multiple degrees of freedom. The handheld surgical robot system further includes a handle alignment member extending from the handheld portion. The handle alignment member includes a handle alignment protrusion extending toward the blade mount, at least a part of the handle alignment protrusion is oblique to the longitudinal axis and the transverse axis of the saw blade, and a part of the handle alignment protrusion and the blade plane are aligned when the blade support has an optimal range of motion (range of movement) relative to the handheld portion.

[0009] The actuator assembly includes a plurality of actuators, and each of the plurality of actuators is configured to move between a first position and a second position to move the blade support relative to the handheld portion. The home position may be an intermediate point between the first position and the second position of each of the plurality of actuators, and the blade support has an optimal range of motion when at least two of the plurality of actuators are in the home position.

[0010] When the handheld portion is in a posture that does not provide an optimal range of motion, the blade plane and the handle alignment protrusion may be misaligned, providing a visual indication that the handheld portion is in a posture that does not provide an optimal range of motion for the blade support.

[0011] The actuator assembly is configured to adjust at least one of the pitch, height, and roll of the blade support relative to the handheld portion. The first spatial arrangement of the handle alignment protrusion relative to the blade plane can provide a visual indication of at least one of a first pitch relationship, a first height relationship, and a first roll relationship of the blade support relative to the handheld portion. Thus, the first spatial arrangement provides a visual indication that the handle alignment protrusion and the blade plane are aligned and that the blade support has an optimal range of motion relative to the handheld portion. The second spatial arrangement of the handle alignment protrusion relative to the blade plane provides a visual indication of at least one of a second pitch relationship, a second height relationship, and a second roll relationship of the blade support relative to the handheld portion. Thus, the second spatial arrangement provides a visual indication that the handheld portion is in a posture relative to the blade support that does not provide an optimal range of motion for the blade support.

[0012] The first spatial arrangement may provide a visual indication of the first pitch relationship of the blade support relative to the handheld portion, and the second spatial arrangement may provide a visual indication of the second pitch relationship of the blade support relative to the handheld portion. When the actuator pitches the blade support relative to the handheld portion, the second pitch relationship provides a visual indication of the pitch of the blade support relative to the handheld portion, where a first portion of the handle alignment protrusion is farther from the blade plane along the longitudinal axis in the pitch direction than a second portion of the handle alignment protrusion.

[0013] The first spatial arrangement may also provide a visual indication of the first height relationship of the blade support relative to the handheld portion, and the second spatial arrangement may also provide a visual indication of the second height relationship of the blade support relative to the handheld portion. Thus, the second height relationship provides a visual indication of the height of the blade support relative to the handheld portion, where the handle alignment protrusion is at least partially above or below the blade plane in the height direction.

[0014] The first spatial arrangement may further provide a visual indication of a first roll relationship of the blade support relative to the handheld portion, and the second spatial arrangement may further provide a visual indication of a second roll relationship of the blade support relative to the handheld portion. Thus, the second roll relationship provides a visual indication of the roll of the blade support relative to the handheld portion, where the handle alignment protrusion is farther from the blade plane than the middle portion of the handle alignment protrusion in the roll direction.

[0015] The handheld surgical robot system may further include a second handle alignment member extending from the handheld portion at a location separate from the first handle alignment member. The second handle alignment member includes a second handle alignment protrusion extending toward the blade mount, and at least a portion of the second handle alignment protrusion is oblique to the longitudinal axis and the transverse axis of the saw blade. Similarly to the above, the first handle alignment protrusion and the second handle alignment protrusion are aligned with the blade plane when the blade support has an optimal range of motion relative to the handheld portion.

[0016] The handheld surgical robot system may further include a tool alignment member extending from the blade support. The tool alignment member includes a tool alignment protrusion extending toward the blade mount, and at least a portion of the tool alignment protrusion is oblique to the longitudinal axis and the transverse axis of the saw blade. The tool alignment protrusion may define a tool alignment edge, and the handle alignment member defines a handle alignment edge oblique to the longitudinal axis and the transverse axis of the saw blade. The tool alignment edge may be defined such that when the blade support is aligned relative to the handheld portion, the tool alignment edge is offset from and parallel to the handle alignment edge. When the handheld portion is in a posture that does not provide an optimal range of motion, the tool alignment protrusion and the handle alignment protrusion may be misaligned, providing a visual indication that the handheld portion is in a posture that does not provide an optimal range of motion for the blade support.

[0017] The handle alignment protrusion and the tool alignment protrusion include a first mark and a second mark. The first mark is visually distinguishable from the second mark. The first mark of the handle alignment protrusion and the first mark of the tool alignment protrusion may be aligned when the tool alignment protrusion and the handle alignment protrusion are aligned, providing a visual indication that the blade support has an optimal range of motion relative to the handheld portion. The first mark of the handle alignment protrusion and the first mark of the tool alignment protrusion may be misaligned when the tool alignment protrusion and the handle alignment protrusion are misaligned, providing a visual indication that the handheld portion is in a posture that does not provide an optimal range of motion to the blade support. The first mark may be a first color and the second mark may be a second color.

[0018] Another aspect of the present disclosure includes a handheld surgical robot system for supporting a surgical blade. The handheld surgical robot system includes a handheld portion, a tool support movably coupled to the handheld portion and defining a tool support plane, and an actuator assembly operably attached to the tool support and the handheld portion. The actuator assembly is configured to move the tool support relative to the handheld portion with multiple degrees of freedom. The handheld surgical robot system further includes a handle alignment member extending from the handheld portion, and the handle alignment member includes a handle hook-shaped portion. The handle hook-shaped portion and the tool support plane are aligned when the tool support has an optimal range of motion relative to the handheld portion.

[0019] Yet another aspect of the present disclosure includes a handheld surgical robot system. The handheld surgical robot system includes a handheld portion, a tool support movably coupled to the handheld portion and defining a tool support plane, and a tool removably coupled to the tool support. The tool defines a longitudinal axis and a transverse axis. The handheld surgical robot system also includes an actuator assembly operably attached to the tool support and the handheld portion. The actuator assembly is configured to move the tool support relative to the handheld portion with multiple degrees of freedom. The handheld surgical robot system further includes a handle alignment member extending from the handheld portion, the handle alignment member including a handle alignment protrusion extending toward the tool support, at least a portion of the handle alignment protrusion being disposed at an angle greater than 0 degrees and less than 90 degrees relative to the longitudinal axis, and a portion of the handle alignment protrusion and the tool support plane being aligned when the tool support has an optimal range of motion relative to the handheld portion.

[0020] Yet another aspect of the present disclosure includes a handheld surgical robot system for supporting a tool. The handheld surgical robot system includes a handheld portion and a tool support movably coupled to the handheld portion. The tool support is configured to support a tool that defines a tool plane. The handheld surgical robot system also includes an actuator assembly operably attached to the tool support and the handheld portion. The actuator assembly is configured to move the tool support relative to the handheld portion with multiple degrees of freedom. The handheld surgical robot system further includes a handle alignment member extending from the handheld portion. The handle alignment member includes a handle support arm extending between a first handle support arm end and a second handle support arm end. The handle support arm includes a handle coupling portion coupled to the first handle support arm end and removably coupled to the handheld portion. The handle alignment member also includes an alignment member mount coupled to the second handle support arm end and an alignment indicating member coupled to the alignment member mount. The handle coupling portion may include a handle coupling member configured to couple to a corresponding coupling member disposed on the handheld portion to couple the handle alignment member to the handheld portion.

[0021] A further aspect of the present disclosure includes a mechanical alignment device configured to be used with a handheld surgical robot system to provide a visual indication of the orientation of the handheld portion of the handheld surgical robot system relative to the tool support of the handheld surgical robot system. The mechanical alignment device includes a support arm extending between a first support arm end and a second support arm end. The support arm includes a coupling portion coupled to the first support arm end and configured to be removably coupled to one of the handheld portion and the tool support of the handheld surgical robot system. The mechanical alignment device also includes an alignment member mount coupled to the second support arm end and an alignment indicating member coupled to the alignment member mount.

[0022] Additional aspects of the present disclosure include a handheld surgical robot system for supporting a saw blade. The handheld surgical robot system also includes a handheld portion. The system also includes a blade support movably coupled to the handheld portion. The blade support is configured to support the saw blade. The system also includes an actuator assembly operably attached to the blade support and the handheld portion. The actuator assembly is configured to move the blade support relative to the handheld portion with multiple degrees of freedom. The system also includes a tool alignment member coupled to and extending from the blade support, and a handle alignment member coupled to and extending from the handheld portion, wherein at least a portion of the tool alignment member and at least a portion of the handle alignment member are aligned when the blade support has a desired range of motion relative to the handheld portion.

[0023] Another aspect of the present disclosure includes a handheld robot system for supporting a saw blade. The handheld robot system also includes a handheld portion. The system also includes a blade support movably coupled to the handheld portion for supporting the saw blade. The system also includes an actuator assembly operably attached to the blade support and the handheld portion. The actuator assembly is configured to move the blade support relative to the handheld portion with multiple degrees of freedom. The system also includes a first tool alignment member and a second tool alignment member coupled to and extending from the blade support on both sides. The system also includes a first handle alignment member and a second handle alignment member coupled to and extending from the handheld portion, wherein the first tool alignment member and the second tool alignment member are respectively aligned with the first handle alignment member and the second handle alignment member when the blade support has a desired range of motion relative to the handheld portion.

[0024] Yet another aspect of the present disclosure includes a visual indication system for use with a handheld robotic system. The visual indication system includes a shroud coupled to and extending between a blade support and a handheld portion such that the shroud surrounds at least one of a plurality of actuators. The shroud defines at least two shroud landmarks configured to displace relative to one another when the blade support and the handheld portion are misaligned with respect to each other to provide a visual indication of the orientation of the blade support relative to the handheld portion.

[0025] A further aspect of the present disclosure includes a handheld robotic system for supporting a saw blade. The handheld robotic system includes a handheld portion and a blade support movably coupled to the handheld portion for supporting the saw blade. The system also includes a plurality of actuators configured to operably interconnect the blade support and the handheld portion and to move the blade support relative to the handheld portion in a plurality of degrees of freedom. The system also includes a light source in the blade support. The system also includes a first tool alignment member and a second tool alignment member coupled to the blade support and extending from opposite sides of the blade support. The system also includes a first handle alignment member and a second handle alignment member coupled to the handheld portion and extending from the handheld portion. When the blade support has a desired range of motion relative to the handheld portion, the first tool alignment member and the second tool alignment member are aligned with the first handle alignment member and the second handle alignment member, respectively. The light source is illuminated when the blade support has the desired range of motion to indicate that the blade support and the handheld portion are within a specified alignment range with respect to a cutting plane.

[0026] Another further aspect of the present disclosure includes a handheld surgical robot system for supporting a saw blade. The handheld surgical robot system includes a handheld portion. The system also includes a blade support movably coupled to the handheld portion. The blade support is configured to support a saw blade. The system also includes a plurality of actuators operably interconnecting the blade support and the handheld portion, the plurality of actuators being configured to move the blade support relative to the handheld portion in a plurality of degrees of freedom. The system further includes a tool alignment member coupled to and extending from the blade support and a handle alignment member coupled to and extending from the handheld portion, the handle alignment member being removably connected to the handheld portion.

[0027] An additional aspect of the present disclosure includes a surgical system for treating an anatomical structure according to a plurality of target planes. The surgical system includes an instrument including a saw blade and a handheld portion, the actuator system may include a plurality of actuators, and includes a blade support for supporting and moving the saw. The plurality of actuators extend between the blade support and the handheld portion, and the blade support may include a saw drive motor coupled to a saw mount. The system also includes a navigation system and a tracker for being coupled to the blade support, the tracker being configured to determine a current tool plane and including a tracker frame, with at least six optical markers coupled to the tracker frame. The tracker frame includes at least two surfaces, the at least two surfaces being non-planar with respect to each other, and at least three of the at least three to six optical markers being coupled to each of the at least two surfaces. The system also includes a control system in communication with the navigation system and the tracker, the control system being configured to control the actuator system to align the current tool plane with at least one of the plurality of target planes.

[0028] Another additional aspect of the present disclosure includes a surgical method for controlling a surgical system that includes a handheld robotic instrument, a saw blade, a handheld portion, an actuator system including a plurality of actuators, and a blade support for supporting and moving the saw. The surgical method includes determining a current tool plane by a tool tracker and a navigation system, selecting one of a plurality of target planes by an input device on the tracker, and adjusting the tool support by the plurality of actuators to align the current plane with the selected target plane. The control also includes selecting a different target plane of the plurality of target planes by the input device.

[0029] A final aspect of the present disclosure includes a surgical instrument tracker for tracking a surgical saw. The surgical instrument tracker includes a tracker frame defining an instrument engagement opening for receiving a proximal portion of the saw, and the saw tracker frame includes a mount. The tracker also includes at least six optical markers coupled to the tracker frame, the tracker frame includes at least two surfaces, the at least two surfaces are non-planar with respect to each other, and at least three of the at least three to six optical markers are coupled to each of the at least two surfaces. When the mount of the saw tracker is coupled to an accessory mount, the tracker frame at least partially surrounds the accessory mount.

[0030] The advantages of the present disclosure will be readily appreciated by referring to the following detailed description when considered in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0031]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

Figure 25

Figure 26

Figure 27

Figure 28

Figure 29

Figure 30

Figure 31

Figure 32

Figure 33

Figure 34

Figure 35

Figure 36

Figure 37

Figure 38

Figure 39

Figure 40

Figure 41

Figure 42

Figure 43

Figure 44

Figure 45

Figure 46

Figure 47

Figure 48

Figure 49

Figure 50

Figure 51

Figure 52

Figure 53

Figure 54

Figure 55

Figure 56

Figure 57

Figure 58

Figure 59

Figure 60

Figure 61

Figure 62

Figure 63

Figure 64

Figure 65

Figure 66

Figure 67

Figure 68

Figure 69

Figure 70

Figure 71

Figure 72

Figure 73

Figure 74

Figure 75

Figure 76

Figure 77

Figure 78

Figure 79

Figure 80

Figure 81

Figure 82

Figure 83

Figure 84

Figure 85

Figure 86

Figure 87

Figure 88

Figure 89

Figure 90

Figure 91

Figure 92

Figure 93

Figure 94

Figure 95

Figure 96

Figure 97

Figure 98

Figure 99

Figure 100

Figure 101

Figure 102

DETAILED DESCRIPTION OF THE INVENTION

[0032] Overview Referring to FIG. 1, a robot system 10 is shown. A robot system 10 is shown for performing an artificial knee joint procedure on a patient 12 to remove a portion of the femur F and tibia T of the patient 12 so that the patient 12 can receive an artificial knee joint implant IM. The robot system 10 can be used to perform other types of surgical procedures, including surgeries involving hard tissue / soft tissue resection or other treatment modalities. For example, the treatment can include removing tissue, coagulating tissue, removing tissue, stapling tissue, suturing tissue, and the like. In some examples, the surgical procedure includes knee surgery, hip surgery, shoulder surgery, spinal surgery, and / or ankle surgery, and may involve removing tissue to be replaced by a surgical implant such as a knee implant, hip implant, shoulder implant, spinal implant, and / or ankle implant. The robot system 10 and the techniques disclosed herein may be used to perform other surgical or non-surgical procedures and may be used in industrial applications or other applications where a robot system is utilized.

[0033] Referring to FIGS. 1 and 2, the robotic system 10 includes an instrument 14. In some examples, the user holds and supports the instrument 14 by hand (as shown in FIG. 1). In some examples, the user may hold the instrument 14 by hand while the instrument is at least partially or fully supported by an auxiliary device such as a passive arm (e.g., a connecting arm with a locking joint, a weight balancing arm), an active arm, and / or the like. As best shown in FIGS. 1 and 2, the instrument 14 includes a handheld portion 16 for being grasped and / or supported by hand by the user and / or an auxiliary device.

[0034] Instrument 14 may be freely moved and supported by a user without the assistance of a guide arm, e.g., configured to be held by a human user while physically removing material such that the weight of the tool is supported only by the user's hand during surgery. In other words, instrument 14 may be configured to be held such that the user's hand supports instrument 14 against gravity. Instrument 14 may weigh 8 lbs. or less, 6 lbs. or less, 5 lbs. or less, or even 3 lbs. or less. Instrument 14 may have a weight corresponding to ANSI / AAMI HE75:2009. Instrument 14 also includes a tool support 18 for housing tool 20. In some examples, when tool 20 is a saw blade 380, tool support 18 may be referred to as a blade support. A method for operating instrument 14 may include a user suspending the weight of instrument 14 without any assistance from a passive arm or robotic arm. Alternatively, the weight of instrument 14 may be supported by the use of a counterbalanced passive arm, an assist device, or an active robotic arm, whereby the user need not support the full weight of the instrument. In such cases, the user may still grasp the handheld portion 16 to interact with and / or guide instrument 14. The contents of the passive arm and Kang et al., U.S. Patent No. 9,060,794 are incorporated herein by reference. Further, robotic system 10 may not have a robotic arm with two or more joints in series in some examples.

[0035] Tool 20 is coupled to tool support 18 to interact with anatomical structures in certain operations of robotic system 10, which will be further described below. Tool 20 is also referred to as an end effector. Tool 20 may be removable from tool support 18 so that a new / different tool 20 can be attached when needed. Tool 20 may be permanently fixed to tool support 18. Tool 20 may include an energy applicator designed to contact the tissue of patient 12. In some examples, tool 20 may be a saw blade as shown in FIGS. 1 and 2, or other types of resection accessories. In such examples, tool support 18 may be referred to as a blade support. Of course, in any example referred to as a blade support, the term "tool support" may be substituted, or vice versa. However, other tools are possible, such as the content of Bozung's U.S. Patent No. 9,707,043 incorporated herein by reference. In some examples, tool 20 may be a drill bit, an ultrasonic vibration tip, a bur, a stapler, etc. Tool 20 may include a blade assembly and a drive motor for causing vibration of the blade, as shown in Walen et al.'s U.S. Patent No. 9,820,753, or U.S. Patent No. 10,687,823, which are incorporated herein by reference. Such drive components may include a transmission TM coupled to drive motor M to convert the rotational motion from drive motor M into vibration of tool 20.

[0036] The systems and methods described in PCT / US2020 / 04128, titled "Robotic Handheld Surgical Instrument Systems and Methods", filed on July 15, 2020, are also incorporated herein by reference.

[0037] An actuator assembly 400 including one or more actuators 21, 22, 23 moves the tool support 18 relative to the handheld portion 16 in three degrees of freedom, thereby providing a robotic motion that assists the user in positioning the tool 20 in a desired position and / or orientation (e.g., in a desired pose relative to the femur F and / or tibia T during surgery) while holding the handheld portion 16. The actuator assembly 400 may include actuators 21, 22, 23 arranged in parallel, in series, or a combination thereof. In some examples, the actuators 21, 22, 23 move the tool support 18 relative to the handheld portion 16 in more than three degrees of freedom. In some examples, the actuator assembly 400 is configured to move the tool support 18 relative to the handheld portion 16 in at least two degrees of freedom, such as pitch and z-axis translation. In some examples, as shown herein, the actuators 21, 22, 23 move the tool support 18 and its associated tool support coordinate system TCS relative to the handheld portion 16 and its associated base coordinate system BCS in only three degrees of freedom. For example, the tool support 18 and its tool support coordinate system TCS can rotate about the y-axis to provide a pitch motion, rotate about the x-axis to provide a roll motion, and translate along an axis Z that coincides with the z-axis of the base coordinate system BCS to provide a z-axis translation motion. The allowable motions in pitch, roll, and z-axis translation are indicated by arrows in each of the schematic diagrams of FIGS. 2 and 3A-3C, FIGS. 4A-4C, and FIGS. 5A-5C. FIG. 6 provides an example of the pose of the tool support 18 and the pose of the handheld portion 16 within the range of motion of the instrument 14. In some examples not shown, the actuator may move the tool support 18 relative to the handheld portion 16 in four or more degrees of freedom.

[0038] Referring again to FIG. 2, a constraint assembly 24 having a passive link mechanism 26 can be used to constrain the movement of the tool support 18 relative to the handheld portion 16 in the remaining three degrees of freedom. The constraint assembly 24 can include any suitable link mechanism (e.g., one or more links having any suitable shape or configuration) for constraining movement as described herein. In the example shown in FIG. 2, the constraint assembly 24 constrains rotation about the z-axis of the base coordinate system BCS to constrain yaw movement, constrains translation in the x-axis direction of the base coordinate system BCS to constrain x-axis translation, and constrains translation in the y-axis direction of the base coordinate system BCS to constrain y-axis translation, thereby serving to limit the movement of the tool support coordinate system TCS. The actuators 21, 22, 23 and the constraint assembly 24 are controlled to effectively mimic the function of a physical cutting guide, such as a physical saw cutting guide, in the situations further described below.

[0039] Referring to FIG. 7, an appliance control device 28 or other type of control unit is provided to control the appliance 14. The appliance control device 28 can include one or more computers, or any other suitable form of control device that manages the operation of the appliance 14 and the movement of the tool support 18 (and tool 20) relative to the handheld portion 16. The appliance control device 28 can have a central processing unit (CPU) and / or other processor, memory, and storage (not shown). The appliance control device 28 has software loaded as described below. The processor can include one or more processors to control the operation of the appliance 14. The processor can be any type of microprocessor, multiprocessor, and / or multi-core processing system. The appliance control device 28 can additionally or alternatively include one or more microcontrollers, field programmable gate arrays, system-on-chips, discrete circuits and / or other suitable hardware, software, or firmware that can perform the functions described herein. The term processor is not intended to limit any embodiment to one processor. The appliance 14 can also include one or more displays and / or input devices (e.g., trigger, push button, foot switch, keyboard, mouse, microphone (voice activated), gesture control device, touch screen, etc.).

[0040] The control system 60 further includes one or more software programs and software modules. The software modules can be part of one or more programs operating in the navigation control device 36, the instrument control device 28, or both, to process data for assisting in the control of the robotic system 10. The software programs and / or modules include computer-readable instructions stored in the non-transitory memory 64 in the navigation control device 36, the instrument control device 28, or both, and executed by one or more processors 70 of the control devices 28, 36. The memory 64 can be any suitable configured memory such as RAM, non-volatile memory, and can be executed from a local or remote database. Additionally, software modules for instructing and / or communicating with the user can form part of one or more programs and can include instructions stored in the memory 64 in the navigation control device 36, the instrument control device 28, or both. The user can interact with either the navigation user interface UI or the input device of other user interface UI to communicate with the software module. The user interface software can operate in a device separate from the navigation control device 36 and / or the instrument control device 28.

[0041] The instrument control device 28 controls the operation of the tool 20, such as power control to the tool 20 (e.g., the drive motor M of the tool 20 that controls the cutting movement) and control of the movement of the tool support 18 relative to the handheld portion 16 (e.g., by controlling the actuators 21, 22, 23). The instrument control device 28 controls the state (e.g., position and / or orientation) of the tool support 18 and the tool 20 relative to the handheld portion 16. The instrument control device 28 can control the speed (linear or angular velocity), acceleration, or other derivatives of the movement of the tool 20 relative to the handheld portion 16 and / or relative to the anatomical structure, caused by the actuators 21, 22, 23.

[0042] As shown in FIG. 2, the instrument control device 28 may include a control housing 29 attached to the tool support 18 and / or the handheld portion 16 or a combination thereof, and one or more control boards 31 (e.g., one or more printed circuit boards and associated electronic components) are disposed within the control housing 29. The control board 31 may include actuators 21, 22, 23 and a microcontroller, a field programmable gate array (FPGA), a driver, a memory, a sensor, or other electronic components for controlling the drive motor M (e.g., via a motor control device). The instrument control device 28 may also include an off-board control console 33 that communicates with the control board 31 for data and power. The sensors S, actuators 21, 22, 23, and / or drive motor M described herein may supply signals to the control board 31, and the control board 31 transmits data signals to the console 33 for processing. The console 33 feeds back control commands (e.g., current commands, torque commands, speed commands, angle commands, position commands, or combinations thereof, and various control and configuration parameters) to the control board 31, supplies power to the actuators 21, 22, 23 and / or drive motor M, and controls them. It is contemplated that the processing may be performed on the control board within the control housing. In some examples, the processing of the control algorithm may be distributed between the console and the control housing. In one example, position control and speed control calculations may be performed on the console, and current control may be performed on a field programmable gate array disposed in the control housing. Of course, a separate control housing is not required and / or it is contemplated that the processing can be performed at any number of different locations.

[0043] In some forms, the console 33 may include one console for powering and controlling the actuators 21, 22, 23 and the drive motor M. In some forms, the console 33 may include one console for powering and controlling the actuators 21, 22, 23 and a separate console for powering and controlling the drive motor M. One such console for powering and controlling the drive motor M may be as described in U.S. Patent No. 7,422,582, filed September 30, 2004, entitled "Control Console to which Powered Surgical Handpieces are Connected, the Console Configured to Simultaneously Energize more than one and less than all of the Handpieces", which is incorporated herein by reference. A flexible circuit FC, also known as a flex circuit, may interconnect the actuators 21, 22, 23 and / or other components with the instrument control device 28. For example, the flexible circuit FC may be provided between the actuators 21, 22, 23 and the control board 31. Other forms of wired or wireless connections may additionally or alternatively exist between components.

[0044] Referring again briefly to FIG. 1, the robotic system 10 further includes a navigation system 32. One example of the navigation system 32 is described in U.S. Patent No. 9,008,757, filed Sep. 24, 2013, entitled “Navigation System Including Optical and Non-Optical Sensors,” which is incorporated herein by reference. The navigation system 32 tracks the movement of various objects. Such objects include, for example, the instrument 14, the tool 20, and anatomical structures, such as the femur F and the tibia T. The navigation system 32 tracks these objects to collect state information of each object with respect to the (navigation) localizer coordinate system LCLZ. As used herein, the state of an object includes, but is not limited to, data (e.g., its coordinate system) defining the position and / or orientation of the object being tracked or an equivalent / derivative of the position and / or orientation. For example, the state may be the pose of the object and / or may include linear velocity data, angular velocity data, etc.

[0045] The navigation system 32 may include a cart assembly 34 that houses a navigation control device 36 and / or other types of control units. The navigation user interface UI is operatively communicating with the navigation control device 36. The navigation user interface UI includes one or more displays 38. The navigation system 32 can display a graphical representation of the relative state of the object being tracked to the user using one or more displays 38. The navigation user interface UI further includes one or more input devices for inputting information to the navigation control device 36 or for otherwise selecting / controlling certain aspects of the navigation control device 36. Such input devices include interactive touch screen displays. However, the input devices can include any one or more of push buttons, pointers, foot switches, keyboards, mice, microphones (voice-activated), gesture control devices, etc. In some examples, the user can make selections, configure the robotic surgery system 10, and / or advance the workflow by using buttons located on the pointer to search for icons and menus of the user interface UI.

[0046] The navigation system 32 also includes a localizer 44 coupled to the navigation control device 36. In one example, the localizer 44 is an optical localizer and includes a camera unit 46. The camera unit 46 has an outer casing 48 that houses one or more optical sensors 50. The localizer 44 may include its own localizer control device 49 and may further include a video camera VC.

[0047] The navigation system 32 includes one or more trackers. In some examples, the tracker includes a pointer tracker PT, a tool tracker 52, a first patient tracker 54, and a second patient tracker 56. In the example shown in FIG. 1, the tool tracker 52 is firmly attached to the instrument 14, the first patient tracker 54 is firmly attached to the femur F of the patient 12, and the second patient tracker 56 is firmly attached to the tibia T of the patient 12. In this example, the patient trackers 54, 56 are firmly attached to sections of bone. The trackers 52, 54, 56 and the pointer tracker are aligned with their respective objects (e.g., bone, tool) and the navigation system 32 manually, automatically, or a combination thereof. In some examples, the pointer tracker PT is firmly attached to the pointer 57 and is used to register an anatomical structure with respect to one or more coordinate systems including the localizer coordinate system LCLZ and / or for other calibration and / or registration functions. In one example, the pointer 57 can be used to align the patient trackers 54, 56 with respect to the bones to which the trackers 54, 56 are attached, and to align the tool tracker 52 (and optionally 53) with respect to the tool support 18, the tool 20, the hand-held portion 16, or a combination thereof. In some examples, the pointer tracker PT can be used to align the TCP of the instrument 14 with respect to the tracker 52 with respect to the tracker coordinate system. Thus, when the localizer 44 is moved from position to position, the alignment of the instrument 14 is determined with respect to the tool tracker 52. However, other means of aligning the trackers 52, 54, 56 are contemplated and can be implemented with or separate from the pointer tracker PT. Other tracker locations are also contemplated.

[0048] Throughout this description, various variations are described with respect to a "bone-to-tracker" or "instrument TCP-to-tracker", i.e., with respect to a "tracker coordinate system" rather than with respect to the LCTZ coordinate system. The localizer coordinate system can be used as an intermediate coordinate system during alignment and bone preparation since all tracked objects are measured with respect to the LCTZ. During alignment, various localizer reference poses are ultimately mathematically combined and the alignment result is stored "with respect to the tracker", such that the alignment remains valid if the camera (i.e., the LCTZ) is moved.

[0049] The tool tracker 52 may be attached to any suitable component of the instrument 14 and in some forms may be attached to the handheld portion 16, to the tool support 18, directly to the tool 20, or combinations thereof. The trackers 52, 54, 56, PT may be fixed to their respective components in any suitable manner by fasteners, clamps, etc. For example, the trackers 52, 54, 56, PT may be rigidly fixed, flexibly connected (fiber optic), or not physically connected at all (ultrasonic) as long as there is a suitable (supplementary) method for determining the relationship (measurement) of each tracker to the associated object. Any one or more of the trackers 52, 54, 56, PT may include an active marker 58. The active marker 58 may include a light emitting diode (LED). Alternatively, the trackers 52, 54, 56, PT may have a passive marker such as a reflector that reflects light emitted from the camera unit 46. Printed markers or other suitable markers not specifically described herein may also be utilized.

[0050] Various coordinate systems can be used to track an object. For example, the coordinate systems can include a localizer coordinate system LCLZ, a tool support coordinate system TCS, a base coordinate system BCS, coordinate systems associated with respective trackers 52, 54, 56, PT, one or more coordinate systems associated with an anatomical structure, one or more coordinate systems associated with preoperative and / or intraoperative images (e.g., CT images, MRI images, etc.) and / or models (e.g., 2D or 3D models) of an anatomical structure, e.g., an implant coordinate system, and a TCP (tool center point) coordinate system. In some examples, the robotic system 10 does not rely on preoperative and / or intraoperative imaging to generate a 2D or 3D model of the target bone. Rather, the robotic system may be used in an image-free system that uses a pointer tracker PT to align the target anatomical structure and capture various anatomical landmarks, which are then processed by a control system 60 to morph a nominal bone model to match the captured data. In other examples, preoperative and intraoperative imaging is used to image the patient's target region and then convert the 2D and / or 3D images to a 3D model of the target bone. It is also contemplated that the robotic surgical system 10 may use a combination of imaging processing and image-free processing when generating a 3D model of the target surgical area. One exemplary system is described in U.S. Patent No. 8,617,174, which is incorporated herein by reference. Coordinates in various coordinate systems can be converted to other coordinate systems using transformations when establishing relationships between coordinate systems, e.g., through alignment, calibration, geometric relationships, measurements, etc.

[0051] As shown in FIG. 2, in some examples, the TCP is a predetermined reference point or origin of a TCP coordinate system defined at the distal end of the tool 20. The geometric shape of the tool 20 may be defined with respect to the TCP coordinate system and / or with respect to the tool support coordinate system TCS. The tool 20 may include one or more geometric features, and the one or more geometric features are defined, for example, with respect to the TCP coordinate system and / or with respect to the tool support coordinate system TCS and stored in the non-volatile memory of the control board 31 in the control housing 29 of the instrument 14, the navigation system 32, the instrument control device 28, or a combination thereof, such as the outer circumference, circumference, radius, diameter, width, length, height, volume, area, surface / plane, the range of the motion envelope (along any one or more axes), and the like. For example, the tool 20 may define a longitudinal axis 910 (see FIG. 68) extending the length of the tool and a transverse axis 912 extending across the width of the tool. The tool center point (TCP) is, in another example, a predetermined reference point defined on the tool 20 and a corresponding coordinate system. The TCP has a known or calculable (i.e., not necessarily static) posture with respect to other coordinate systems. The TCP coordinate system includes an origin and a set of axes (e.g., x-axis, y-axis, z-axis) that define the posture of the TCP. By tracking the TCP (or knowing the posture of the TCP), the system 10 can calculate the position and orientation of the instrument 14 based on the posture of the TCP and the known positional relationship between the TCP and the features of the instrument 14. In some examples, the tool 20 has a tool plane (e.g., for a saw blade) for purposes of illustration and simplicity but is not intended to limit the tool 20 to any particular form. For example, the tool support 18 may include a tool mount 18a that defines a blade plane BP. Points, other primitives, meshes, other 3D models, etc. can be used to virtually represent the tool 20. The origin of the TCP coordinate system may be located at the center of the sphere of the bar of the tool 20 or at the distal end of the saw blade 27, whereby the TCP coordinate system is tracked relative to the origin at the distal tip of the tool 20.Alternatively, the TCP can be tracked using multiple tracked points. The TCP can be defined in various ways depending on the configuration of the tool 20. The instrument may employ joint / motor encoders, or any other non-encoder position sensing method, whereby the control system 60 can determine the pose and / or position of the TCP relative to the hand-held portion 16 and the BCS. The tool support 18 may use joint measurements to determine the TCP pose and / or may employ techniques for directly measuring the TCP pose. The control of the tool 20 is not limited to the center point. For example, any suitable primitive, mesh, etc. can be used to represent the tool 20. Of course, the TCP can alternatively be defined as a point rather than a coordinate system. With the TCP coordinate system, when determining the pose of a saw blade or other tool, it becomes possible to calculate any required reference points or geometric aspects of the tool.

[0052] The TCP coordinate system, the tool support coordinate system TCS, and the coordinate system of the tool tracker 52 can be defined in various ways depending on the configuration of the tool 20. For example, the pointer 57 can be used with the calibration divot CD in the tool support 18 and / or the tool 20 to align (calibrate) the pose of the tool support coordinate system TCS relative to the coordinate system of the tool tracker 52, to determine the pose of the TCP coordinate system relative to the coordinate system of the tool tracker 52, and / or to determine the pose of the TCP coordinate system relative to the tool support coordinate system TCS. For example, other techniques can be used to directly measure the pose of the TCP coordinate system by directly attaching and fixing one or more additional trackers / markers to the tool 20. In some forms, the tracker / marker can be attached and fixed to the hand-held portion 16, the tool support 18, or both. In an example where the hand-held portion includes a tracker, the pose of the hand-held portion relative to the localizer coordinate system LCTZ can be directly measured. In yet other alternative examples, the TCP can be defined relative to the tool tracker using an intermediate tool support coordinate system TCS.

[0053] Since the tool support 18 is movable with a number of degrees of freedom relative to the handheld portion 16 by the actuators 21, 22, 23, the instrument 14 may employ encoders, Hall effect sensors (having analog or digital outputs), and / or any other position sensing method to measure the posture of the TCP coordinate system and / or the tool support coordinate system TCS relative to the base coordinate system BCS. In one example, the instrument 14 may use measurements from sensors that measure the actuation of the actuators 21, 22, 23 to determine the posture of the TCP coordinate system and / or the tool support coordinate system TCS relative to the base coordinate system BCS, as further described below.

[0054] The localizer 44 monitors the trackers 52, 54, 56, PT (e.g., their coordinate systems) to determine the respective states of the trackers 52, 54, 56, PT corresponding to the states of the objects to which they are respectively attached. The localizer 44 may perform known techniques to determine the states of the trackers 52, 54, 56, PT and the associated objects (such as tools, patients, tool supports, and handheld portions). The localizer 44 provides the states of the trackers 52, 54, 56, PT to the navigation control device 36. In some examples, the navigation control device 36 determines the states of the trackers 52, 54, 56, PT and communicates this to the instrument control device 28.

[0055] The navigation control device 36 may include one or more computers, or any other suitable form of control device. The navigation control device 36 has a central processing unit (CPU) and / or other processors, memory, and storage (not shown). The processor can be any type of processor, microprocessor, or multiprocessor system. Software is loaded into the navigation control device 36. The software converts, for example, a signal received from the localizer 44 into data representing the position and / or orientation of the object being tracked. The navigation control device 36 may additionally or alternatively include one or more microcontrollers, field programmable gate arrays, system-on-chips, discrete circuits, and / or other suitable hardware, software, or firmware that can perform the functions described herein. The term processor is not intended to limit any embodiment to a single processor.

[0056] An example of the navigation system 32 is shown for determining the state of an object, but the navigation system 32 may have any other suitable configuration for tracking the instrument 14, the tool 20, and / or the patient 12. In another example, the navigation system 32 and / or the localizer 44 are ultrasonic. For example, the navigation system 32 may include an ultrasonic imaging device coupled to the navigation control device 36. The ultrasonic imaging device images any of the aforementioned objects, such as the instrument 14, the tool 20, and / or the patient 12, and generates a status signal to the navigation control device 36 based on the ultrasonic image. The ultrasonic image may be 2D, 3D, or a combination of both. The navigation control device 36 may process the image in near real-time to determine the state of the object. The ultrasonic imaging device may have any suitable configuration and may differ from the camera unit 46 shown in FIG. 1.

[0057] In another example, the navigation system 32 and / or the localizer 44 are radio frequency (RF) based. For example, the navigation system 32 may include an RF transceiver coupled to the navigation control device 36. The instrument 14, the tool 20, and / or the patient 12 may include an RF emitter or transponder attached thereto. The RF emitter or transponder can be excited passively or actively. The RF transceiver transmits an RF tracking signal and generates a status signal to the navigation control device 36 based on the RF signal received from the RF emitter. The navigation control device 36 may analyze the received RF signal and associate a relative status therewith. The RF signal may be of any suitable frequency. The RF transceiver may be placed at any suitable location to effectively track an object using the RF signal. Further, the RF emitter or transponder may have any suitable structural configuration that may be significantly different from the trackers 52, 54, 56, PT shown in FIG. 1.

[0058] In yet another example, the navigation system 32 and / or the localizer 44 are electromagnetic. For example, the navigation system 32 may include an electromagnetic (EM) transceiver coupled to the navigation control device 36. The instrument 14, the tool 20, and / or the patient 12 may include EM components attached thereto, such as any suitable magnetic tracker, electromagnetic tracker, inductive tracker, etc. The tracker can be excited passively or actively. The EM transceiver generates an EM field and generates a status signal to the navigation control device 36 based on the EM signal received from the tracker. The navigation control device 36 may analyze the received EM signal and associate a relative status therewith. Again, such an example of the navigation system 32 may have a structural configuration different from that of the navigation system 32 shown in FIG. 1.

[0059] The navigation system 32 may have any other suitable components or structures not specifically described herein. Further, any of the techniques, methods, and / or components described above with respect to the illustrated navigation system 32 may be implemented or provided for any of the other examples of the navigation system 32 described herein. For example, the navigation system 32 may utilize simply any combination of inertial tracking or tracking techniques, and additionally or alternatively, may include fiber optic tracking, machine vision tracking, etc.

[0060] Referring to FIG. 7, the robot system 10 includes a control system 60 that includes, among other components, in particular an instrument control device 28 and a navigation control device 36. The control system 60 further includes one or more software programs and software methods. The software module may be part of one or more programs operating in the instrument control device 28, the navigation control device 36, or a combination thereof to process data and assist in controlling the robot system 10. The software program and / or module includes computer-readable instructions stored in the memory 64 in the instrument control device 28, the navigation control device 36, or a combination thereof for execution by one or more processors 70 of the control device 28. The memory 64 may be any suitable configured memory such as non-temporary memory, RAM, non-volatile memory, etc., and may be executed from a local or remote database. In addition, the software module for prompting and / or communicating with the user may form part of one or more programs and may include instructions stored in the memory 64 in the instrument control device 28, the navigation control device 36, or a combination thereof. The user may interact with either the navigation user interface UI or the input device of another user interface UI to communicate with the software module. The user interface software may operate in a device separate from the instrument control device 28 and / or the navigation control device 36. The instrument 14 may communicate with the instrument control device 28 via a power / data connection. The power / data connection provides a path for input and output, as shown as the BUSS / COMM connection 37 in FIG. 7, and is used to control the instrument 14 based on the position and orientation data generated by the navigation system 32 and transmitted to the instrument control device 28.

[0061] The control system 60 may include any suitable configuration of input, output, and processing devices suitable for performing the functions and methods described herein. The control system 60 may include the appliance control device 28, the navigation control device 36, or a combination thereof, and / or may include only one of these control devices, or additional control devices. The control device may communicate via a wired bus or communication network, via wireless communication, or otherwise, as shown as the BUSS / COMM connection 37 in FIG. 7 in one example. The control system 60 may be referred to as a control device. The control system 60 may include one or more microcontrollers, field programmable gate arrays, system-on-chips, discrete circuits, sensors, displays, user interfaces, indicators, and / or other suitable hardware, software, or firmware capable of performing the functions described herein.

[0062] Appliance In an exemplary configuration, the appliance 14 is most preferably shown in FIGS. 8 and 9. The appliance 14 includes a handheld portion 16 held by a user, a tool support 18 movably coupled to the handheld portion 16 to support the tool 20, and an actuator assembly 400 including a plurality of actuators 21, 22, 23 operably interconnecting the tool support 18 and the handheld portion 16 to move the tool support 18 relative to the handheld portion 16 with at least three degrees of freedom, and a constraint assembly 24 having a passive link mechanism 26 operably interconnecting the tool support 18 and the handheld portion 16.

[0063] The handheld portion 16 includes a grip 72 for being grasped by a user so that the user can operate, guide, and / or grasp the instrument 14. The handheld portion 16 can be configured with ergonomic features such as a grip for holding by the user's hand, and a textured or composite material coating to prevent the user's hand from slipping when wet and / or when blood is adhered. The handheld portion 16 may include a taper for accommodating users with different hand sizes and is formed to conform to the contour of the user's hand and / or fingers. The handheld portion 16 also includes a base 74, to which the grip 72 is attached by one or more fasteners, adhesives, welding, etc. In the illustrated form, the base 74 includes a sleeve 76 having generally a hollow cylindrical shape. Joint supports 77, 78, 79 extend from the sleeve 76. Actuators 21, 22, 23 can be movably coupled to the base 74 at the joint supports 77, 78, 79 via joints that will be further described below.

[0064] The tool support 18 includes a tool support body 80, and a tracker 52 can be fixed or movably attached to the tool support body 80 via one or more tracker mounts fixed to the tool support 18 at one or more attachment positions 82. In one example, the tool tracker 52 is integrated with the tool support 18. In another example, the tool tracker 52 is removably attached at one or more attachment positions 82. The tool 20 is removably coupled to the tool support 18 in the form shown. In particular, the tool support 18 includes a tool coupler such as a head 84 to which the tool 20 is attached, as described in Walen et al.'s U.S. Patent No. 9,820,753, which is incorporated herein by reference. The head 84 can be configured to utilize a vibratory mode saw blade and a sagittal mode saw blade. A drive motor M that drives the operation of the tool 20 is disposed on the tool support body 80 (e.g., to drive the vibration of the saw blade in some embodiments). The tool 20 can be attached to and released from the head 84 in the form disclosed in Walen et al.'s U.S. Patent No. 9,820,753, which is incorporated herein by reference. As best shown in FIG. 9, the tool support 18 also includes a plurality of actuator mounts 86, 88, 90, to which actuators 21, 22, 23 are movably coupled to the tool support 18 via joints, as will be further described below. The actuator mounts 86, 88, 90 may include brackets or the like suitable for attaching the actuators 21, 22, 23 such that the tool support 18 can move relative to the hand-held portion 16 with at least three degrees of freedom.

[0065] In the illustrated form, the actuators 21, 22, 23 include electrical linear actuators that extend between the base 74 and the tool support body 80. When actuated, the effective lengths of the actuators 21, 22, 23 change, varying the distance between the tool support body 80 and the base 74 along the corresponding axes of the actuators 21, 22, 23. Thus, the control system 60 commands the actuators 21, 22, 23 to operate in harmony in response to the individual inputs respectively provided to each of the actuators 21, 22, 23 by the control system 60, thereby changing the effective lengths and moving the tool support 18 relative to the handheld portion 16 with at least three degrees of freedom to a target posture. In the illustrated form, three actuators 21, 22, 23 are provided and may be referred to as the first, second, and third actuators 21, 22, 23 or the front actuators 21, 22 and the rear actuator 23. The effective lengths of the first, second, and third actuators 21, 22, 23 are adjustable along the first active axis AA1, the second active axis AA2, and the third active axis AA3 (see FIG. 9). The first, second, and third actuators 21, 22, 23 have independently adjustable effective lengths to adjust the pitch orientation, roll orientation, and z-axis translation position of the tool support 18 relative to the handheld portion 16, as previously described. In some examples, more actuators may be provided. In some examples, the actuators may include rotary actuators. The actuators 21, 22, 23 may include a linkage mechanism having one or more links of any suitable size or shape. The actuators 21, 22, 23 may have any configuration suitable for enabling movement of the tool support 18 relative to the handheld portion 16 with at least three degrees of freedom. For example, in some forms, there may be one front actuator and two rear actuators, or some other arrangement of the actuators.

[0066] In this configuration, the actuators 21, 22, 23 are coupled to the base 74 and the tool support body 80 via a plurality of active joints. The active joints include a set of first active joints 92 that couple the actuators 21, 22, 23 to the tool support body 80 at actuator mounts 86, 88, 90. In one configuration, as shown in FIG. 9, the first active joints 92 include active U-joints. The U-joints include a first pivot pin 94 and a joint block 96. The first pivot pin 94 pivotally connects the joint block 96 to the actuator mounts 86, 88, 90 through a through hole 98 in the joint block 96. A set screw 100 may fix the first pivot pin 94 to the actuator mounts 86, 88, 90. The U-joints may also include a second pivot pin 104. The joint block 96 has a lateral hole 102 for receiving the second pivot pin 104. The second pivot pin 104 has a through hole 103 for receiving the first pivot pin 94, whereby the first pivot pin 94, the joint block 96, and the second pivot pin 104 form the cross of the U-joint. The first pivot pin 94 and the second pivot pin 104 of each U-joint define intersecting drive axes PA. The second pivot pin 104 pivotally connects the pivot yokes 106 of the actuators 21, 22, 23 to the joint block 96. As a result, the actuators 21, 22, 23 can move with two degrees of freedom relative to the tool support body 80. Other types of active joints are also contemplated, such as active spherical joints that include balls with slots for receiving pins.

[0067] Referring to FIG. 9, the active joint also includes a set of second active joints 108 that couple two front actuators 21, 22 to the base 74 of the hand-held portion 16. In the form shown, the second active joints 108 are supported by joint supports 77, 78. Each of the second active joints 108 includes a swivel yoke 110 arranged to pivot about a swivel axis SA with respect to the base 74 of the hand-held portion 16. Each swivel yoke 110 has a swivel head 112 and a post 114 extending from the swivel head 112 to pivotally engage the base 74 in one of the joint supports 77, 78. A nut 115 is threadedly connected to one end of the post 114 to capture the post 114 at the base 74 while allowing free rotation of the respective swivel yoke 110 within each joint support 77, 78.

[0068] Each of the second active joints 108 includes a carrier 116 pivotally coupled to one of the swivel yokes 110. The carrier 116 has a threaded through-hole 117 for receiving the lead screws 150 of the two front actuators 21, 22, as will be further described below. Each carrier 116 also includes opposed trunnions 118 that are fixed in pockets in the swivel yoke 110 to allow the carrier 116 to pivot with respect to the swivel yoke 110 about a drive axis PA (see FIG. 9). In some forms, for each of the second active joints 108, the swivel axis SA intersects the drive axis PA to define a single vertex about which the actuators 21, 22 move in two degrees of freedom.

[0069] The cover is attached to the swivel head 112 and defines one of the pockets, while the swivel head 112 defines the other pocket. During assembly, the carrier is first positioned such that one of the trunnions is placed in the pocket in the swivel head 112, and then the carrier is captured between the cover and the swivel head 112, and the cover is attached over the other trunnion so that it can pivot relative to the swivel yoke 110 via the trunnions and the pockets. The configuration of the swivel yoke 110 and the associated carrier, i.e., the ability of the carrier to pivot about the swivel axis SA and rotate about the drive axis PA, allows the second active joint 108 to accommodate two degrees of freedom of movement of the two front actuators 21, 22 relative to the base 74. Other joint arrangements between the two front actuators 21, 22 and the base 74 are also possible.

[0070] The active joint also includes a third active joint 124 that couples the rear (third) actuator 23 to the base 74 of the hand-held portion 16. In the illustrated form, the third active joint 124 is supported by a joint support 79. The third active joint 124 includes a pivot housing 126 fixed to the joint support 79 of the base 74.

[0071] The third active joint 124 includes a carrier pivotally coupled to a pivot housing 126 via a trunnion. Fasteners having pockets are attached to both sides of the pivot housing 126 through through-holes so as to engage the trunnion. The fasteners are arranged such that the carrier can pivot via the trunnion disposed in the pocket after assembly. The carrier has a threaded through-hole for receiving the lead screw 150 of the rear actuator 23 as will be further described below. Due to the configuration of the pivot housing 126 and the associated carrier, i.e., the ability of the associated carrier to pivot only about the drive axis PA (e.g., not swivel), the third active joint 124 allows only one degree of freedom of movement of the rear actuator 23 relative to the base 74. Other joint arrangements between the rear actuator 23 and the base 74 are possible.

[0072] Each of the actuators 21, 22, 23 includes a housing. The housing includes a canister and a cap threadedly connected to the canister. A pivot yoke 106 forming part of the first active joint 92 is fixed to the housing such that the housing and the pivot yoke 106 can move together relative to the tool support 18 via the first active joint 92. The cap captures the annular shoulder of the pivot yoke 106 to fix the pivot yoke 106 to the canister.

[0073] In some forms, the pivot yoke 106 and the canister include one or more alignment features for aligning each pivot yoke 106 in a predetermined orientation relative to its respective canister. Such alignment features may include coupling portions or key / keyway, etc. During assembly, the pivot yoke 106 may first be fixed to the canister in a predetermined orientation, and then the cap may be screwed (e.g., via mating male and female threads) onto the canister to capture the pivot yoke 106 in a predetermined orientation relative to the canister. This predetermined relationship may be useful when routing and / or aligning the flex circuit FC, when preventing rolling of the pivot yoke 106 relative to the canister, and / or for other purposes.

[0074] Each actuator 21, 22, 23 also includes a motor disposed in each housing. The motor has a casing disposed in the housing and a motor winding assembly disposed within the casing. The motor winding assembly may be aligned in a predetermined orientation relative to the canister via set screws or other alignment features such as those described above. Each motor also has a rotor fixed to the lead screw 150. The lead screw 150 is supported for rotation within the housing by one or more bushings and / or bearings. The rotor and associated lead screw 150 are configured to rotate relative to the housing upon selective energization of the motor. The lead screw 150 has a fine pitch and lead angle (i.e., the lead screw is self-locking) to prevent backdriving. As a result, a load applied to the tool 20 will not easily backdrive the motor. In some examples, the lead screw 150 has 8 - 36 class 3 threads that produce a lead of 0.02 - 0.03 inches (0.508 mm - 0.762 mm) / revolution. Other screw types / sizes may also be employed.

[0075] Each of the actuators 21, 22, 23 may be controlled by a separate motor control device. The motor control devices are individually wired to the actuators 21, 22, 23, respectively, to direct each of the actuators 21, 22, 23 to a predetermined target position. In some examples, the motor control device is a proportional integral derivative (PID) control device. In some examples, the motor control device may include a series of control loops related to position, speed, and torque (current). Additionally and / or alternatively, the motor control device may include only a torque (current) control loop. In another example, the position control loop may feed directly into the torque (current) control loop. Each of these control stages may be implemented as a PID control device, as a state space control device, and / or may utilize alternative or additional control techniques (e.g., speed feedforward, torque feedforward, etc.). In some cases, the torque (current) control loop is implemented using field oriented control and space vector modulation. The stages of the control loop can be distributed among various components of the system. In some examples, the position loop and the speed loop are implemented in the appliance control device, and the torque control loop is implemented directly in the control board 31 as part of the control housing 29 in the appliance 14, reducing the impact of data communication latency from the appliance 14 through the connection to the console 33. This is because the current control loop does not require any data feedback via the console 33. The position control loop and the speed control loop are not as sensitive to communication latency and can be implemented in the console 33. In some examples, the motor control device may be integrated with or form part of the appliance control device 28. For ease of explanation, the motor control device is described herein as part of the appliance control device 28.

[0076] The power supply provides a 32 VDC power signal to the motor, for example, via the console 33. The 32 VDC signal is supplied to the motor through the appliance control device 28. The appliance control device 28 selectively provides a power signal to each motor to selectively operate the motor. This selective operation of the motor positions the tool 20. The motor may be any suitable type of motor, including a brushless DC servo motor, a permanent magnet synchronous motor, other forms of DC motors, etc. The power supply also supplies power to the appliance control device 28 to energize the components inside the appliance control device 28. In some examples, the actuator motor may be a three-phase brushless motor. The actuator motor may be a DC motor. The actuator motor may be a permanent magnet synchronous motor. Each of the actuator motors may be configured to have a sine wave back electromotive force to achieve limited mechanical cogging, enable smooth and specific movement, and limit torque ripple. However, other motor types are conceivable. Naturally, the power supply can provide other types of power signals, for example, 12 VDC, 24 VDC, 40 VDC, etc. The appliance may use an electronic switch, for example, a MOSFET or a GaN FET, to pulse-width modulate the voltage signal to turn the three-phase motor on / off at a high frequency, for example, typically at least 16 kHz and up to a maximum of 256 kHz or more.

[0077] In one possible embodiment, one or more sensors S (see also FIG. 7) transmit signals back to the appliance control device 28 such that the appliance control device 28 can determine the current position and / or angle (i.e., the measured position) of the associated actuators 21, 22, 23. The levels of these signals can vary as a function of the rotational position of the associated rotor. In one embodiment, the sensors S can resolve the rotational position of the rotor within a given rotation with high resolution. These sensors S can be Hall effect sensors that output analog and / or digital signals based on the sensed magnetic field from the rotor or from other magnets placed on the lead screw 150 (e.g., a two-pole magnet low voltage signal, such as 5 VDC, for exciting the Hall effect sensor can be supplied from a motor control device associated with the motor with which the Hall effect sensor is associated. In some examples, two Hall effect sensors are placed within the housing, spaced 90 degrees apart from each other around the rotor, to sense the joint position such that the appliance control device 28 can determine the position of the rotor and count the increasing rotations. In some forms, the Hall effect sensor outputs a digital signal representing an increasing number. Various types of motors and sensor arrangements are possible. In some examples, the motor is a brushless DC servo motor, and two or more internal Hall effect sensors may be arranged spaced 90 degrees, 120 degrees, or any other suitable interval from each other around the rotor. The sensors S may include an absolute encoder or an incremental encoder that can be used to detect the rotational position of the rotor and count the rotations of the rotor. Other types of encoders may be used as one or more sensors. The sensors can be placed at any suitable position on the actuator and its surrounding components, suitable for determining the position of each actuator when the actuator is adjusted, such as on the housing, on the nut, on the screw, etc. In yet another configuration, sensorless motor control may be utilized. In such an embodiment, the position of each rotor can be determined by measuring the back EMF and / or inductance of the motor.Other suitable examples can be found in U.S. Patent No. 7,422,582, which is hereby incorporated by reference in its entirety.

[0078] In some examples, the sensors and / or encoders may measure position feedback for joint position control and / or to determine the position of the tool support 18 relative to the handheld portion 16 when used in connection with the motion model of the instrument 14. In some examples, the sensors and / or encoders rely on multi-turn measurements, which accumulate from one rotation to the next and are used to determine the absolute position of the actuators 21, 22, 23 along their axes and are used in relation to a known pitch (i.e., the number of rotations per inch of the lead screw). Additionally, or alternatively, the sensors and / or encoders may be used to determine the "electrical angle of the rotor" for use in the electronic commutation of the motor. For example, the sensors and / or encoders may be used to determine the rotor position and apply an appropriate excitation signal to achieve optimal (efficient) torque generation. In this example, the sensors and / or encoders may utilize single-turn or sub-turns (within one electrical rotation) that roll over each electrical rotation. The number of electrical rotations is equal to the number of mechanical rotations divided by the number of poles of the motor (e.g., the number of pole pairs). However, a sensorless method may be implemented.

[0079] In some examples, the output signal from the Hall effect sensor is sent to the appliance control device 28. The appliance control device 28 monitors the received signal for changes in those levels. Based on these signals, the appliance control device 28 determines the joint position. The joint position can be considered as the number of degrees of rotation of the rotor from the initial position or the home position. The rotor can make a plurality of 360° rotations. Thus, the joint position can exceed 360°. A scalar value called a count represents the joint position from the home position. The rotor rotates in both clockwise and counterclockwise directions. Each time the signal levels of a plurality of signals (analog or digital) undergo a predetermined state change, the appliance control device 28 increases or decreases the count to indicate a change in the joint position. Each time a 360° rotation of the rotor is completed, the appliance control device 28 increases or decreases the value of the count by a fixed number of counts. In some examples, the count is increased or decreased by 100 to 3000 for each 360-degree rotation of the rotor. In some examples, when an incremental encoder is used to monitor the joint position, there are 1024 positions (counts) for each 360-degree rotation of the rotor. Inside the appliance control device 28, there are counters associated with each actuator 21, 22, 23. The counters record a value equal to the cumulative number of counts that have been increased or decreased. The count value can be positive, zero, or negative. In some forms, the count value defines the increasing movement of the rotor. Thus, the rotors of the actuators 21, 22, 23 may first be moved to a known position called the home position (further described below), and then the count value is used to define the current position of the rotor.

[0080] As described above, the carrier has a through-hole with an internal thread for receiving the slide screw 150 by screwing, and each of the slide screws 150 rotates relative to a corresponding one of the carriers to adjust the effective length of a corresponding one of the plurality of actuators 21, 22, 23, thereby changing the count measured by the instrument control device 28. Each of the housings and the corresponding carrier is restricted in relative movement in at least one degree of freedom to allow the slide screw 150 to rotate relative to the carrier. More specifically, the pivot yoke 106 cannot rotate about the associated active axes AA1, AA2, AA3 (i.e., the configuration of the first active joint 92 restricts such rotational movement of the pivot yoke 106), and the carrier cannot rotate about the associated active axes AA1, AA2, AA3 (i.e., the configuration of the second active joint 108 and the third active joint 124 restricts such rotational movement of the carrier), whereby the slide screw 150 can rotate relative to the carrier.

[0081] A stopper 152, such as a threaded fastener and a shoulder formed on the slide screw 150, is fixed to the slide screw 150. The stopper 152 is sized to abut against the carrier 116 at the end of the travel distance of each slide screw 150.

[0082] As described above, the actuators 21, 22, 23 are such that the effective length is actively adjustable to enable movement of the tool support 18 relative to the hand-held portion 16. One example of this effective length is indicated by the reference sign "EL" in the case of the third actuator. In this case, the effective length EL is measured from the pivot axis PA to the center of the associated first active joint 92. When each of the actuators 21, 22, 23 is adjusted, the lead screw 150 is changed as to how much it is screwed into or out of the associated carrier, thereby changing the distance from the center of the associated carrier to the center of the associated first active joint 92, and the effective length EL changes. The actuators 21, 22, 23 are adjustable between a minimum value and a maximum value of the effective length EL. The effective length EL of each of the actuators 21, 22, 23 can be represented / measured in any suitable form to indicate the distance between the tool support 18 and the hand-held portion 16 along the active axes AA1, AA2, AA3, which distance varies to effect various movements of the tool support 18 relative to the hand-held portion 16.

[0083] The restraint assembly 24 operates in synchronism with the actuators 21, 22, 23 to constrain the movement provided by the actuators 21, 22, 23. The actuators 21, 22, 23 provide movement in three degrees of freedom, whereas the restraint assembly 24 constrains movement in three degrees of freedom. In the form shown, the restraint assembly 24 includes a passive link mechanism 26 and a passive link mechanism joint 156 that couples the passive link mechanism 26 to the tool support 18.

[0084] In one form, as shown in FIG. 9, the passive link mechanism joint 156 includes a passive link mechanism U-joint. The U-joint includes a first pivot pin 158 and a joint block 160. The first pivot pin 158 pivotally connects the joint block 160 to the passive link mechanism mount 162 of the tool support body 80 through a through hole 164 in the joint block 160. A set screw 166 can fix the first pivot pin 158 to the passive link mechanism mount 162. The U-joint also includes a second pivot pin 170. The joint block 160 has a lateral hole 168 for receiving the second pivot pin 170. The second pivot pin 170 pivotally connects the passive link mechanism pivot yoke 172 of the passive link mechanism 26 to the joint block 160. The second pivot pin 170 has a through hole 171 for receiving the first pivot pin 158, whereby the first pivot pin 158, the joint block 160, and the second pivot pin 170 form the cross of the U-joint. The first pivot pin 158 and the second pivot pin 170 define intersecting pivot axes PA. As a result, the passive link mechanism 26 can move with two degrees of freedom relative to the tool support body 80. Other types of passive link mechanism joints are also conceivable, such as a passive link mechanism spherical joint including a ball with a slot for receiving a pin.

[0085] The passive link mechanism 26 includes a shaft 174 fixed to the passive link mechanism pivot yoke 172. The passive link mechanism 26 also includes a sleeve 76 of the base 74 configured to receive the shaft 174 along a constraint axis CA. The passive link mechanism 26 is configured to allow the shaft 174 to axially slide along the constraint axis CA relative to the sleeve 76 and to constrain radial movement of the shaft 174 relative to the axis CA of the shaft 174 during operation of one or more of the actuators 21, 22, 23.

[0086] The passive link mechanism 26 further includes a key for restricting rotation of the shaft 174 relative to the sleeve 76 about the constraint axis CA. The key fits into mating keyways in the shaft 174 and the sleeve 76 to lock the shaft 174 to the sleeve 76 in the rotational direction. Other arrangements for preventing relative rotation of the shaft 174 and the sleeve 76, such as an integral key / slot arrangement, are also contemplated. The passive link mechanism 26 operably interconnects the tool support 18 and the handheld portion 16 independently of the actuators 21, 22, 23. The passive link mechanism is passively adjustable in effective length EL along the constraint axis CA during operation of one or more of the actuators 21, 22, 23. The sleeve 76, the shaft 174, and the key 176 represent one combination of links for the passive link mechanism 26. Other sizes, shapes, and numbers of links connected in any suitable form may be employed for the passive link mechanism 26.

[0087] In the illustrated form, the passive link mechanism joint 156 can pivot about two pivot axes PA with respect to the tool support 18. Other configurations are possible.

[0088] Also, in the illustrated form, the first active joint 92 and the passive link mechanism joint 156 define a pivot axis PA disposed on a common plane. Non-parallel pivot axes PA, parallel pivot axes PA disposed in different planes, combinations thereof, and / or other configurations are also contemplated.

[0089] In some forms, the head 84 of the tool support 18 is arranged such that when the tool 20 is coupled to the tool support 18, the tool 20 is disposed on a tool plane BP (e.g., a blade plane) parallel to a common plane. In some examples, the tool plane BP is spaced from the common plane CP by 2.0 inches or less, 1.0 inch or less, 0.8 inch or less, or 0.5 inch or less.

[0090] In the illustrated form, the actuators 21, 22, 23 are arranged such that the active axes AA1, AA2, AA3 are oblique to the constraint axis CA at all positions of the actuators 21, 22, 23, including when they are in their home positions. By angling the axes AA1, AA2, AA3, the actuators are generally arranged in a tapered shape so that a thinner and more compact base 74 and associated grip 72 are possible. Other configurations are conceivable, including configurations where the active axes AA1, AA2, AA3 are not oblique to the constraint axis CA. Such configurations may include configurations where the actuator axes AA1, AA2, AA3 are parallel to each other in the home position.

[0091] Further configurations of the actuators, active joints, and constraint assemblies are possible. The control techniques described may be applied to other mechanical configurations not mentioned, particularly configurations for controlling a tool or a surgical blade relative to a handheld portion with one or more degrees of freedom. In some forms, the constraint assembly may be absent and the tool support 18 of the instrument 14 may be able to move relative to the handheld portion 16 with additional degrees of freedom. For example, the instrument may include a linear actuator, a rotary actuator, or a combination thereof. The instrument may include two, three, four, five, six, or more different actuators arranged in parallel or in series.

[0092] Virtual boundary The software employed by the control system 60 to control the operation of the instrument 14 includes a boundary generator 182 (FIG. 7). The boundary generator 182 can be implemented in other components such as the instrument control device 28, the navigation control device 36, and / or a separate control device. The boundary generator 182 may be part of a separate system that operates remotely from the instrument 14. Referring to FIG. 7, the boundary generator 182 is a software program or module that generates one or more virtual boundaries 184 for constraining the movement and / or operation of the instrument 14. In some examples, the boundary generator 182 provides virtual boundaries 184 that define virtual cutting guides (e.g., virtual saw cutting guides). The virtual boundaries 184 may be provided to delineate the contours of various operation / control regions as described below. The virtual boundaries 184 can be one-dimensional (1D), two-dimensional (2D), or three-dimensional (3D), and can include points, lines, axes, trajectories, planes (infinite planes or plane segments bounded by anatomical structures or other boundaries), volumes or other shapes including complex geometric shapes. The virtual boundaries 184 can be represented by pixels, point clouds, voxels, triangular meshes, other 2D or 3D models, combinations thereof, etc. U.S. Patent Application Publication No. 2018 / 0333207 and U.S. Patent No. 8,898,043 are incorporated by reference, and any of their features can be used to facilitate the planning or execution of a surgical procedure.

[0093] The virtual boundary 184 can be used in various forms. For example, the control system 60 may control a predetermined movement of the tool 20 to stay within the boundary, may control a predetermined movement of the tool 20 to stay outside the boundary, may control a predetermined movement of the tool 20 to stay on the boundary (e.g., stay at a point, stay on an orbit, and / or stay on a plane), may control a predetermined movement of the tool 20 to approach the boundary (attractive boundary) or move away from the boundary (repulsive boundary), and / or may control a predetermined operation / function of the instrument 14 based on the relationship (e.g., spatial, speed, etc.) of the instrument 14 to the boundary. Other uses of the boundary 184 are also conceivable.

[0094] In some examples, one of the virtual boundaries 184 is a desired cutting plane, as shown in FIG. 2. The control system 60 ultimately functions to hold the tool 20 in the desired cutting plane in some form. The virtual boundary 184 that controls the positioning of the tool 20 may be a volumetric boundary. For example, as shown in FIG. 2, it may have a thickness slightly larger than the blade thickness to constrain the saw blade to stay on the desired cutting plane within the boundary. Thus, the desired cutting plane can be defined by a virtual plane boundary, a virtual volume boundary, or other forms of virtual boundaries. The virtual boundary 184 may be referred to as a virtual object. The virtual boundary 184 may be defined with respect to an anatomical model AM such as a 3D bone model (see FIG. 2 where the anatomical model AM is virtually superimposed on the actual femur F by alignment). In other words, points, lines, axes, orbits, planes, volumes, etc. related to the virtual boundary 184 are defined within a coordinate system fixed with respect to the coordinate system of the anatomical model AM so that the virtual boundary 184 can be tracked by tracking the anatomical model AM (e.g., via tracking of the associated anatomical structures to which the anatomical model AM is aligned).

[0095] By aligning the anatomical model AM with the first patient tracker 54, the virtual boundary 184 is associated with the anatomical model AM and the associated coordinate system. The virtual boundary 184 may be implant-specific, for example, defined based on the size, shape, volume, etc. of the implant, and / or patient-specific, for example, defined based on the patient's anatomical structure. The virtual boundary 184 can be a boundary generated preoperatively, intraoperatively, or a combination thereof. In other words, the virtual boundary 184 can be defined before the surgery begins, during the surgery (including during tissue resection), or a combination thereof. The virtual boundary 184 can be provided in many forms, such as the control system 60 generating the virtual boundary or receiving the virtual boundary from other sources / systems. The virtual boundary 184 may be stored in memory for retrieval and / or update.

[0096] In some cases, such as when preparing the femur F to receive the artificial knee joint implant IM (see Figure 1), the virtual boundary 184 can be used to delineate the contours of a number of cutting planes (e.g., five cutting planes) and includes a number of planar boundaries associated with the 3D model of the distal end of the femur F. These multiple virtual boundaries 184 can be actuated one at a time by the control system 60 to constrain the cutting to one plane at a time.

[0097] The instrument control device 28 and / or the navigation control device 36 track the state of the tool 20 relative to the virtual boundary 184. In one example, the state of the TCP coordinate system (e.g., the posture of the saw blade) is measured relative to the virtual boundary 184 to determine the target positions for the actuators 21, 22, 23 so that the tool 20 remains in the desired state. In some cases, the control system 60 controls / positions the instrument 14 in a manner that mimics the response of the physical handpiece when a physical boundary / barrier is present.

[0098] Referring again to FIG. 7, two additional software programs or modules operate in the instrument control device 28 and / or the navigation control device 36. One software module executes behavior control 186. Behavior control 186 is a process that calculates data indicating the next commanded / desired position and / or orientation (e.g., desired pose) for the tool 20. In some cases, only the desired position of the TCP is output from the behavior control 186, while in some cases, the commanded pose of the tool 20 is output. The output from the boundary generator 182 (e.g., the current position and / or orientation of the virtual boundary 184 in one or more coordinate systems) can be supplied as an input to the behavior control 186 to determine the next commanded position of the actuators 21, 22, 23 and / or the orientation for the tool 20. The behavior control 186 can process this input together with one or more other inputs, which will be further described below, to determine the commanded pose.

[0099] The instrument control device 28 can control one or more of the actuators 21, 22, 23 by sending command signals to each of the actuators 21, 22, 23 to adjust the tool 20 towards the desired pose. The instrument control device 28 may know the full length that the actuators 21, 22, 23 can adjust the tool support 18 relative to the hand-held portion 16. In some examples, the instrument control device 28 knows the full length that the actuators 21, 22, 23 can adjust and can send command signals to the actuators 21, 22, 23 to move only by the distance measured from position to position. The measured position can be a known position or the distance between the current position of the actuators 21, 22, 23 and the actuator limits. Each position at which the actuators 21, 22, 23 move can be the measured distance between the positive and negative limits of the actuator movement distance (i.e., the position between the two ends of the lead screw). The instrument control device 28 can command the actuators 21, 22, 23 to and from the measured position, as will be described below.

[0100] The instrument control device 28 can send command signals to each of the actuators 21, 22, 23 to move the actuators 21, 22, 23 from the first position to the commanded position where the tool 20 is arranged in the desired posture. In some examples, the commanded position may be determined by the instrument control device 28 together with the navigation system 32, thereby determining the positions of the tool 20 and the tool support 18 relative to virtual objects such as the handheld portion 16, the patient trackers PT, 54, 56, the desired cutting plane, or combinations thereof, and sending signals to the actuators 21, 22, 23 to adjust a predetermined distance or the commanded position to arrange the tool 20 in the desired posture. The instrument control device can command the actuators 21, 22, 23 to a predetermined position to achieve the desired adjustment of the tool 20. The instrument control device 28 can control the actuators 21, 22, 23 to move linearly by the calculated distance to adjust the tool 20 toward the desired posture. In other examples, such as when an absolute encoder is used, the instrument control device can send signals to the actuators 21, 22, 23 to arrange each of the actuators 21, 22, 23 at the commanded position based on the known position of the tool support 18 relative to the handheld portion determined by the absolute encoder.

[0101] The instrument control device 28 may know the full length that the actuators 21, 22, 23 can adjust the tool support 18 relative to the hand-held portion 16. In some examples, the instrument control device 28 knows the full length that the actuators 21, 22, 23 can adjust, and can send command signals to the actuators 21, 22, 23 to move the measured distance from position to position (e.g., by commanding a desired amount of linear movement via a commanded rotation). The measured position may be a known position or the distance between the current position of the actuators 21, 22, 23 and the actuator limits. Each position where the actuators 21, 22, 23 move may be the measured distance between the positive and negative limits of the actuator movement distance (i.e., the position between the two ends of the lead screw). The instrument control device 28 can command the actuators 21, 22, 23 to positions as described below and from positions as described below. The instrument control device can command the actuators 21, 22, 23 to a predetermined position to achieve a desired adjustment of the tool 20. The instrument control device 28 can control the actuators 21, 22, 23 to linearly move by a calculated distance to adjust the tool 20 toward a desired orientation. In other examples, such as when an absolute encoder is used, the instrument control device can send signals to the actuators 21, 22, 23 to position each actuator 21, 22, 23 at the commanded position based on the known position of the actuators 21, 22, 23 between their respective actuator movement limits determined by the absolute encoder. Alternatively, in one example, an incremental encoder can be used in combination with a homing operation performed during system setup, as described in U.S. Patent Application Publication No. 2017 / 0156799, which is incorporated herein by reference. The homing operation can be used to position the actuators 21, 22, 23 and joints at their center positions, and subsequently, the absolute offset of the incremental encoder can be determined. By determining the offset of the incremental encoder, the incremental encoder can function as a forward absolute encoder.

[0102] In some examples, when a homing position is used, the homing process establishes the initial rotor positions (zero positions) of actuators 21, 22, 23. The home position is substantially the position of rotor 148 that provides the maximum possible amount of movement in each direction along the respective active axes AA1, AA2, AA3. In some examples, the home position is generally arranged such that the home point HP of the lead screw 150, which is centered midway between the stoppers 152, is centered in the associated carrier 116 (see FIG. 12 showing two actuators 22, 23 in their respective home positions). Even when a homing operation is not used, such as when an absolute encoder is used, setting actuators 21, 22, 23 to the home point HP before or after executing other modes (such as the approach mode described further below) may be included. The appliance control device 28 may be configured to control actuators 21, 22, 23 to their home positions between the minimum and maximum effective lengths EL of actuators 21, 22, 23.

[0103] When in the home position, the adjustability of actuators 21, 22, 23 is maximized to hold tool 20 in a desired orientation. Depending on the specific geometry and configuration of instrument 14, various adjustment levels are possible. In some examples, when all actuators 21, 22, 23 are in the home position, assuming that the roll orientation and non-z-axis translation are zero changes, the pitch orientation may be adjusted by approximately ±18° relative to the home position for tool 20. In some examples, when all actuators 21, 22, 23 are in the home position, assuming that the pitch orientation and non-z-axis translation are zero changes, the roll orientation may be adjusted by approximately ±33° relative to the home position for tool 20. In some examples, when all actuators 21, 22, 23 are in the home position, assuming that the pitch orientation and roll orientation are zero changes, the z-axis translation may be adjusted by approximately ±0.37 inches relative to the home position for tool 20. Of course, tool 20 can be adjusted during operation simultaneously, sequentially, or in combinations thereof for pitch, roll, and z-axis translation.

[0104] In some examples, when one or more of the actuators 21, 22, 23 reach their limits, the instrument control device 28 may request adjustment of the handheld portion 16 in order to return the tool 20 to a range in which the actuator can adjust the tool 20 towards the desired orientation. In such cases, simulated commanded positions may be used to show the user how to move the handheld portion 16 to return the tool 20 and the actuators 21, 22, 23 to match the desired orientation. The simulated commanded position may be a position determined by the instrument control device 28 using navigation data from the navigation system 32, and the handheld portion 16 must be moved so as to adjust the tool 20 towards the desired orientation without adjusting the actuators 21, 22, 23. The simulated commanded position cooperates with one or more displays 38 to communicate to the user that the handheld portion 16 needs to be moved in a particular way to place the tool 20 in the desired orientation. In some examples, the guidance array 500 communicates to the user to move the handheld portion 16 in the same way as if the actuators 21, 22, 23 were adjusting the tool 20, but depends on the user to correct the orientation of the tool 20 by operating the handheld portion 16 while the actuators remain in place.

[0105] The second software module executes motion control 188. One aspect of motion control 188 is the control of the instrument 14. Motion control 188 receives data from behavior control 186 that defines the next commanded posture. Based on these data, motion control 188 determines the next rotor position of the rotor 148 of each actuator 21, 22, 23 (e.g., using inverse kinematics) so that the instrument 14 can position the tool 20 as commanded by behavior control 186, e.g., in the commanded posture. In other words, motion control 188 processes the commanded posture defined in the Cartesian coordinate space into the actuator position (such as the rotor position) of the instrument 14 so that the instrument control device 28 can command the motor 142 to move the actuators 21, 22, 23 of the instrument 14 to the commanded rotor position corresponding to the commanded position of the tool 20, e.g., the commanded posture. In one form, in order to ensure as precisely as possible that the motor 142 drives the associated actuators 21, 22, 23 to the commanded rotor position, motion control 188 regulates the rotor position of each motor 142 and continuously adjusts the torque output by each motor 142.

[0106] In some forms, the instrument control device 28 determines the difference between the measured position and the commanded position of the rotor 148 for each actuator 21, 22, 23. The instrument control device 28 outputs a target current (proportional to the torque of the rotor) and changes the voltage to adjust the current in the actuator from the initial current to the target current. The target current causes the actuators 21, 22, 23 to move and moves the tool 20 from the measured posture to the commanded posture. This can occur after the commanded posture has been converted to joint positions. In one example, the measured position of each rotor 148 may be obtained from the above-described sensor S such as an encoder.

[0107] The boundary generator 182, behavior control 186, and motion control 188 may be subsets of a software program. Alternatively, each may be a software program that operates separately and / or independently in any combination thereof. The term "software program" is used herein to represent computer-executable instructions configured to perform the various capabilities of the described technical solutions. For the sake of simplicity, the term "software program" is intended to include at least any one or more of the boundary generator 182, behavior control 186, and / or motion control 188. The software program can be executed in the instrument control device 28, the navigation control device 36, or any combination thereof, or can be executed in any suitable form by the control system 60.

[0108] A clinical application 190 may be provided to handle user interactions. The clinical application 190 handles user interactions in many aspects and adjusts the surgical workflow, including preoperative planning, implant placement, alignment, visualization of bone preparation, and postoperative evaluation of implant fit. The clinical application 190 is configured to output to the display 38. The clinical application 190 may operate in its own separate processor or may operate in parallel with the instrument control device 28 and / or the navigation control device 36. In one example, the clinical application 190 interacts with the boundary generator 182 after the implant placement is set by the user and then sends the virtual boundary 184 returned by the boundary generator 182 to the instrument control device 28 for execution.

[0109] The initial position of the base coordinate system BCS can be determined based on the known geometric relationship between the tool support coordinate system TCS and the base coordinate system BCS when the actuators 21, 22, 23 are in the home position or other predetermined positions. This relationship changes when the actuators 21, 22, 23 are adjusted, and the associated changes can be determined based on the kinematics of the robot system 10 (e.g., establishing the dynamic transformation between these coordinate systems). Alternatively, or in addition, another tracker can be attached and fixed with respect to the base coordinate system BCS to directly track the orientation of the base coordinate system BCS with respect to the tool support coordinate system TCS. Thereby, the robot system 10 recognizes the position of the tool 20 and its relationship to the orientation of the handheld portion 16 at the home position and the like. Thus, when the tool 20 is moved by the user and its orientation is tracked using the tool tracker 52, the robot system 10 also tracks the orientation of the handheld portion 16 and its base coordinate system BCS. In some examples, it is assumed that the position of the tool 20 with respect to the tool support 18 is known as a result of a previous calibration process.

[0110] In some forms, the home position is determined by first determining the orientation of the handheld portion 16 (e.g., in the base coordinate system BCS) relative to the tool support 18 in a common coordinate system (e.g., relative to the tool support coordinate system TCS) by employing a separate tracker fixed to the handheld portion 16. This spatial relationship between the handheld portion 16 and the tool support 18 can also be determined by alignment using the pointer 57 and known calibration divots in the handheld portion 16, or via other navigation methods. Subsequently, the current rotor positions of each of the actuators 21, 22, 23 can be derived from this spatial relationship based on the kinematics of the instrument 14. Knowing the current rotor positions and measuring the changes from the current rotor positions using encoders (and corresponding encoder signals), the instrument control device 28 can then operate each of the actuators 21, 22, 23 until they reach the home position. The home position can be stored in the memory of the instrument control device 28.

[0111] Basically, the instrument control device 28 determines the positions of the actuators 21, 22, 23 using tracking data obtained by the navigation system 32 from trackers 52 coupled to the tool support 18 and the handheld portion 16 on the instrument 14. Thereby, the incremental encoders can subsequently operate as absolute encoders.

[0112] Command data packets are sent to the motor control device from, for example, the console 33 of the appliance control device 28 or another component. These command data packets include the target position for the roller 148 of the motor (or the target position of the actuator). Here, each target position can be a positive or negative number representing the target cumulative count for the associated roller 148. The console 33 of the appliance control device 28 or other components generate these command data packets and send them to each motor control device at a rate of one packet every 0.05 to 4 milliseconds. In some examples, each motor control device receives the command data packets at least once every 0.125 milliseconds.

[0113] In use, with the tracker 52 disposed on the tool support 18, the navigation system 32 is used to determine the posture (current posture) of the tool 20. The instrument control device 28 may also determine the current position of each of the actuators 21, 22, 23 based on the output encoder signals from one or more encoders disposed on each of the actuators 21, 22, 23. When the current position of each of the actuators 21, 22, 23 is received, the instrument control device 28 may calculate the current posture of the handheld portion 16 (for example, the current posture of the base coordinate system BCS with respect to a desired coordinate system such as the TCP coordinate system using forward kinematics for converting from the actuator position to the posture (TCP with respect to the BCS)). When the instrument control device 28 has the current relative postures of the tool support 18 and the handheld portion 16 in the desired coordinate system, the instrument control device 28 may then determine the commanded posture of the tool 20 based on the current posture of the tool 20 determined by the navigation system 32, the current posture of the handheld portion 16 calculated based on the current positions of each of the actuators 21, 22, 23, and the position and / or orientation of the planned virtual object that is the target as the desired cutting plane. The instrument calculates the posture (commanded posture) of the TCP with respect to the BCS, and as a result, the TCP is positioned on the desired plane or aligned with the planned virtual object. The instrument control device 28 may send command commands to the actuators 21, 22, 23 to move to the commanded position, thereby changing the postures of the tool support 18 and the tool 20. In one example, since the commanded posture of the tool 20 is further based on the target cutting plane, the instrument control device 28 calculates the current posture of the tool support 18 and the current positions of the actuators 21, 22, 23 to determine the current posture of the handheld portion 16. When the current posture of the tool support 18, the current positions of the actuators 21, 22, 23, and the current posture of the handheld portion 16 are known, the instrument control device 28 can send command signals to the actuators 21, 22, 23 to adjust the tool support 18 and the tool 20 based on the desired plane.The control device calculates the commanded pose assuming that the pose of the handheld portion (BCS) is instantaneously (during a single iteration) stationary with respect to the patient's anatomy. By updating the corresponding pose each time, the actual movement of the BCS is adjusted.

[0114] Referring to FIG. 11, exemplary control is described with respect to various variations. The TCP is determined by the tracker 52 tracking the tool 20 in the LCLZ (LCLZ-TT) and using the alignment data to determine the transformation between the tool tracker 52 and the TCP (TT-TCP) of the tool 20 such as a saw. Similarly, the patient is tracked using the patient tracker PT (shown as 54) in the LCLZ (LCLZ-PT). The transformation (PT-TP) is determined between the patient tracker PT and each of the planned virtual objects 184 (TP) using the alignment data and the planning information. As described above, the transformation between the BCS and the TCP (BCS-TCP) is calculated based on the current position of each actuator (described above). The transformation between the BCS and the TCP is utilized to re-associate the various coordinate systems to the handheld portion 16. Because the commanded pose can be determined with respect to the BCS. Conceptually, the commanded pose is an update to the transformation from the BCS to the TCP, such that the TCP is aligned in this example with the planned virtual object 184 (target plane TP).

[0115] Of course, the expression "TCP of the instrument" is used interchangeably with the expression "position of the saw blade". Thus, in any example where the TCP of the instrument / tool is used, this expression may be substituted by the position of the saw blade, or vice versa. Of course, it is also contemplated that the position of the "saw blade" can be the position of any suitable configured tool such as a drill, bar, guide tube, screw driver, tap, pin, etc.

[0116] Throughout this description, unless otherwise specified, any instance of a pose may be a commanded pose, a current pose, a past pose, or a past commanded pose. Each of these poses may be different from one another by the frequency of control, but the differences in position and / or orientation between these poses may be minimal in each control iteration.

[0117] It should also be understood that a combination of the position and orientation of an object is referred to as the pose of the object. Throughout this disclosure, the term "pose" may be replaced by position and / or orientation to achieve an appropriate alternative of the concepts described herein, and vice versa. In other words, any use of the term "pose" can be replaced with "position", and any use of the term "position" can be replaced with "pose".

[0118] Operation During operation, the power of the robot system 10 is first turned on, and a software application for operating the system is launched. The trackers 52, 54, 56, PT are initialized, and the trackers 52, 54, 56 are placed on the instrument 14 and the target anatomical structure (e.g., the femur F and the tibia T). When the trackers 54, 56 are attached to the anatomical structure, the anatomical structure and / or the associated image / model are aligned with the trackers 54, 56 using known alignment techniques. This may require the user to touch a predetermined surface or landmark on the anatomical structure with the pointer 57. For example, this may require the user to touch several points on the surface of the anatomical structure while pressing a select button on the pointer 57 or while pressing a foot switch of the navigation system 32. This "paints" points on the surface in the navigation system 32 for matching with the preoperative and / or intraoperative image / model of the anatomical structure. The preoperative image and / or intraoperative image / model of the anatomical structure are loaded into the navigation system 32. The tracked portion of the anatomical structure is aligned with the preoperative / intraoperative image / model. Consequently, this enables the robot system 10 to represent a graphical display of the actual position and orientation of the anatomical structure on the display 38 when the anatomical structure moves.

[0119] In the calibration / alignment procedure, the orientation and position of the tracker 52 are calibrated / aligned with respect to the tool support 18 by referring to a fixed known position of the calibration divot CD or other reference point. In some examples, one or more trackers 52 may be placed on the tool support 18, the hand-held portion 16, or both such that the position of the tool support 18 and / or the hand-held portion 16 is tracked by the navigation system 32. In an example where the tracker 52 is integrated into the instrument 14, such calibration is unnecessary because the relative position of the tracker 52 with respect to the tool support 18 is known.

[0120] Virtual objects (e.g., virtual boundary 184) used to control the operation of the instrument 14 are also defined / acquired. Software (e.g., boundary generator 182) operating in the instrument control device 28 generates / acquires an initial definition of the virtual object. The user may have the ability and option to adjust the properties / arrangement of the virtual object as needed.

[0121] In one exemplary configuration, the control system 60 defines various regions at a predetermined distance and / or position from the target site and / or anatomical structure. Each of these regions can be defined in a coordinate system related to the anatomical structure and / or the virtual boundary 184. In some cases, these regions are defined as spheres or other geometric primitives for the target site and / or anatomical structure. In other examples, the regions (and others described below) can be defined with respect to the instrument 14, the tool support 18, the handheld portion 16, the tool 20, the target site / anatomical structure, or combinations thereof. The control system 60 can control the instrument 14 when the regions defined by the handheld portion 16, the tool support 18, the tool 20, the target site / anatomical structure, or combinations thereof approach a particular virtual boundary / virtual cut guide feature.

[0122] In particular, the instrument control device 28 generates a set of target rotor positions that the rotor 148, which is integral with the motor 142, must rotate to maintain the tool 20 in a desired orientation. In other words, if the user moves the handheld portion 16 so as to move the tool 20 away from the desired orientation, this is detected by the navigation system 32. In response to this movement, the instrument control device 28 determines how far the tool 20 has moved away from the desired position and, based on data from the navigation system 32, counteracts such movement by driving the actuators 21, 22, 23 as necessary to return the tool 20 to the desired orientation. Of course, since the instrument control device 28 operates at a high frequency (e.g., frame rate) to continuously counteract such deviations substantially in real time, such deviations from the desired orientation are typically small.

[0123] The target rotor position is determined based on the operation of the actuators 21, 22, 23 and the resulting movement (e.g., kinematics). For example, if the desired posture requires a z-axis translation relative to the handheld portion 16, there is a linear relationship between the range in which the tool 20 moves along the z-axis and the amount of rotation of each roller 148 (e.g., how many counts are associated with such a z-axis movement). Also, there is a relationship between the degree to which the tool 20 changes its pitch orientation in response to the operation of only the third actuator 23 or in combination with one or both of the first and second actuators 21, 22. Finally, there is also a relationship between the degree to which the tool 20 changes its roll orientation in response to the operation of one or both of the first and second actuators 21, 22 with or without the operation of the third actuator 23. Based on these relationships, the instrument control device 28 determines the target rotor position for each roller 148 required to maintain the desired posture of the tool 20. The instrument control device 28 operates the motor 142 based on the target rotor position. For example, the console 33 may send a packet to the motor control device including these target rotor positions, and each motor control device may apply an appropriate energization signal to the associated motor 142. These energization signals cause the rotation of the rotor 148, and the rotation of the rotor 148 causes the repositioning of the lead screw 150 that moves the tool support 18 / tool 20 as required to maintain the tool 20 in the desired posture.

[0124] As described above, when the user aligns the handheld portion 16 toward a desired plane while being guided by the alignment members 502, 504, the actuators 21, 22, 23 are held at the home position or other predetermined positions. By holding the actuators 21, 22, 23 at the home position or other predetermined positions, the user may feel it easier to adjust or align the tool 20 with the desired plane and instrument posture relative to the target. However, when the tool reaches the desired posture, the visual guidance is intended to guide the user on how to move the handheld portion 16 in order to provide sufficient adjustability to the instrument 14 by holding the actuators 21, 22, 23 near the home position or other predetermined positions. For example, the user may need to move the handheld portion 16 upward in the z-axis direction to move all the actuators 21, 22, 23 closer to the home position while holding the tool 20 in the desired posture. In other words, the actuators 21, 22, 23 can be extended almost completely. To achieve this, the directional indication from the guidance array 500 is upward. In this case, the guidance array 500 is actually guiding the user to move the handheld portion 16 upward so that the actuators 21, 22, 23 operate toward the home position to maximize the adjustability of the actuators 21, 22, 23. When the user moves the handheld portion 16 upward, the actuators 21, 22, 23 continue to operate to hold the tool 20 in the desired posture (e.g., on the virtual boundary 184). As a result, the actuators 21, 22, 23 contract, for example, contract toward the home position. Ideally, when the user starts cutting the bone, the maximum movement amount is available in each direction for each of the actuators 21, 22, 23.Otherwise, if one or more of the actuators 21, 22, 23 are almost reaching the available movement distance in their respective directions, even a slight movement of the handheld portion 16 may result in the instrument control device 28 being unable to hold the tool 20 in the desired posture, and inaccurate cutting may occur.

[0125] In addition and / or alternatively, in some forms, the tool 20 may move to the desired posture, and then the user may adjust the handheld portion 16 to a more comfortable position within the available movement distance threshold of the actuators 21, 22, 23 while the tool 20 is maintained in the desired position. The user can then select to move to a freehand mode where the posture of the handheld portion 16 relative to the posture of the tool 20 is held or stopped in the current spatial relationship by activating an input device such as a button and / or a foot switch or by selecting on a touch screen. The held posture of the handheld portion 16 relative to the posture of the tool 20 may change the virtual threshold of the actuators 21, 22, 23, and it is also conceivable to restrict the movement of the actuators to maintain the held posture when the user selects an operating mode.

[0126] Visual guidance As shown in FIGS. 12 - 28, instrument 14 also includes a guidance array 500. The guidance array 500 provides a visual indication to the operator of the orientation of blade support 18 relative to the handheld portion 16 of instrument 14 during operation of the instrument 14. Thus, the guidance array 500 provides a visual indication of the necessary changes in pitch orientation, roll orientation, and z - axis translation of the handheld portion 16 to achieve the desired orientation of tool 20 while providing maximum adjustability to the plurality of actuators 21, 22, 23 to maintain tool 20 on the target plane TP. The guidance array 500 includes a tool alignment member 502 coupled to blade support 18 and a handle alignment member 504 coupled to handheld portion 16 to guide the user regarding how to move the handheld portion 16 to provide sufficient adjustability to instrument 14 by holding actuators 21, 22, 23 in a home position or other predetermined position. In some configurations, at least a portion of tool alignment member 502 and at least a portion of handle alignment member 504 can be aligned when actuators 21, 22, 23 are in their respective home positions. For example, in the configuration shown in FIGS. 12 - 17, the upper surface 503 of tool alignment member 502 and the upper surface 505 of handle alignment member 504 are aligned when actuators 21, 22, 23 are in their respective home positions.

[0127] In one configuration, the term "aligned" is defined as at least a portion of the tool alignment member 502 and at least a portion of the handle alignment member 504 being substantially in the same plane or intersecting within appropriate tolerances. For example, when at least a portion of the tool alignment member 502 and at least a portion of the handle alignment member 504 are aligned, the tool alignment member 502 and the handle alignment member 504 provide a visual indication to the operator of the instrument 14 that the blade support 18 has a desired range of motion with respect to the hand-held portion 16. In particular, when in the home position, the adjustability of the actuators 21, 22, 23 is maximized to hold the tool 20 in the desired orientation. In some examples, the alignment percentage between the tool alignment member and the handle alignment member can be 99 percent or more aligned, 90 percent or more aligned, 70 percent or more aligned, or even 60 percent or more aligned. In other examples, proper alignment can be within a specified proximity to the target orientation, such as a 1 percent deviation from the target orientation, a 5 percent deviation from the target orientation, a 10 percent deviation from the target orientation, or even a 20 percent deviation from the target orientation, in each individual degree of freedom. Similarly, proper alignment can be within 1 mm of the target orientation, within 2 mm of the target orientation, or even within 5 mm of the target orientation, in each individual degree of freedom. Additionally, proper alignment can be within a deviation of 1 degree or more from the target orientation, a deviation of 5 degrees or more from the target orientation, a deviation of 15 degrees or more from the target orientation, or even a deviation of 30 degrees or more from the target orientation, in roll and / or pitch.

[0128] In one configuration, referring to FIGS. 12 - 28, the tool alignment member 502 can be a member that extends away from the blade support 18. For example, the tool alignment member 502 includes a tool alignment portion 510 that defines a tool alignment plane 512 (shown in FIG. 17), and the tool alignment plane 512 is parallel or coplanar with the blade plane BP, providing a visual indication of the orientation of the blade plane BP to the operator of the instrument 14. The terms tool plane and blade plane BP can be used interchangeably. The tool alignment member 502 can have any shape or structure that can provide a visual indication of the orientation of the blade plane BP relative to the handle alignment member 504. In one example, as shown in FIGS. 12 - 28, the tool alignment portion 510 of the tool alignment member 502 can define a "U" shape. In this example, the tool alignment portion 510 includes an elongated body and two protrusions that allow the tool alignment portion to surround the handle alignment portion 524 when the tool alignment member 502 and the handle alignment member 504 are aligned when the actuators 21, 22, 23 are in their respective home positions. Each portion of the tool alignment portion 510 can be generally flat and have a length, width, and height that define a three - dimensional shape to provide a visual indication of alignment and misalignment with the handle alignment member. The "U" - shaped contour of the tool alignment member 502 can allow the operator to view the orientation of the handle alignment portion relative to the elongated member and the protrusions, and further assist in providing a visual indication of the orientation of the blade support 18 relative to the hand - held portion 16.

[0129] For example, referring to FIGS. 15 and 16, the tool alignment member 502 may also include an attachment portion 506 configured to be attached to the blade support 18. The attachment portion 506 can be attached to the blade support 18 using any suitable means (e.g., fasteners, magnets, adhesives, etc.) at any suitable location to facilitate the function of the tool alignment member 502 (described in more detail below). The tool alignment member 502 may further include a support portion 508. The support portion 508 may extend from the attachment portion 506 to support the tool alignment portion 510. In some examples, the tool alignment member 502 may be rigid with respect to the blade support 18 to facilitate the function of the tool alignment member 502. The tool alignment member 502 can be formed from any suitable material such as plastic, aluminum, steel, composites, etc., or combinations thereof. Further, the tool alignment member can be formed using any suitable manufacturing method including 3D printing, casting, machining, injection molding, stamping, etc., or combinations thereof. The tool alignment portion 510 can be formed in other shapes (described in more detail below). In other configurations, the tool alignment member 502 can be the tool 20 itself. For example, the tool 20 and the handle alignment member 504 can be aligned when the actuators 21, 22, 23 are in their respective home positions.

[0130] As shown in FIGS. 12 - 28, in one example, the handle alignment member 504 may extend from the handle portion 16. The handle alignment member 504 may include a handle alignment portion 524 that defines a handle alignment plane 526 (shown in FIG. 17) that provides a visual indication of the orientation of the handle portion 16 to an operator of the instrument 14. In particular, the handle alignment plane 526 is aligned with the tool alignment plane 512 when the actuators 21, 22, 23 are in their respective home positions. The handle alignment member 504 can be of any suitable shape or configuration that provides a visual indication to the user that one or more of the actuators 21, 22, 23 has moved from its respective home position. In some examples, such as those shown in FIGS. 12 - 28, the handle alignment portion 524 of the handle alignment member 504 defines a planar rectangular member having a length, height, and width that define a three - dimensional shape. The relative shape and dimensions of the handle alignment member 504 provide a visual indication when the actuators 21, 22, 23 are moved from their respective home positions by exposing certain features of the handle alignment member relative to the tool alignment member 502.

[0131] Referring to FIGS. 15 and 16, the handle alignment member 504 includes a mounting collar 516 that includes a first portion 518 and a second portion 520. Collectively, the first and second portions 518, 520 are configured to be coupled to each other to form the mounting collar 516 and attach the handle alignment member 504 to the grip 72 of the handheld portion 16. The first and second portions 518, 520 can be coupled using any suitable means. In some examples, fasteners such as screws, bolts, clamps, etc., or combinations thereof can be used. The mounting collar 516 can be attached to the handheld portion 16 at any suitable location to facilitate the function of the handle alignment member 504 (described in more detail below). Also, as shown most clearly in FIG. 16, the handle alignment member 504 can be removably coupled to the mounting collar 516 of the handheld portion 16. For example, the handle alignment member 504 can be magnetically coupled to the handheld portion 16 such that the handle alignment member 504 can be separated on demand or when the operator's hand is pinched between the tool alignment member 502 and the handle alignment member 504. Any suitable means (magnets, latches, clips, fasteners, hooks and loops, etc., and combinations thereof) for removably coupling the handle alignment member 504 to the handheld portion are contemplated.

[0132] The handle alignment member 504 may also include a support arm 522. The support arm 522 may extend from the mounting collar 516 to support the handle alignment portion 524. In particular, as most clearly shown in FIGS. 12-17, the support arm 522 extends upwardly from the grip 72 of the handheld portion 16 such that when the actuators 21, 22, 23 are in their respective home positions, the handle alignment portion 524 of the handle alignment member 504 is aligned with the tool alignment portion 510 of the tool alignment member 502. In some examples, the handle alignment member 504 is rigid with respect to the handheld portion 16 to facilitate the function of the handle alignment member 504. The handle alignment member 504 may be formed from any suitable material such as plastic, aluminum, steel, composites, etc., or combinations thereof. Further, the handle alignment member 504 may be formed using any suitable manufacturing method including 3D printing, casting, machining, injection molding, stamping, etc., or combinations thereof.

[0133] In some configurations, the guidance array 500 may include two or more tool alignment members and two or more handle alignment members. In some examples, the guidance array 500 may include a first tool alignment member 502 and a second tool alignment member 528. Similarly, in some examples, the guidance array 500 may include a first handle alignment member 504 and a second handle alignment member 530. In some examples, it is contemplated that there may be four or more, or six or more, or even a plurality of tool alignment members and handle alignment members, respectively. For example, referring to FIGS. 12-28, in some configurations, the first alignment members 502, 504 and the second alignment members 528, 530 extend from opposite sides of the hand-held portion 16 and have a mirror-image arrangement with respect to each other. As shown in FIG. 17, when the actuators 21, 22, 23 are in their respective home positions, both the first tool alignment member 502 and the first handle alignment member 504, and the second tool alignment member 528 and the second handle alignment member 530 are aligned with each other, respectively, providing a visual indication that the blade support 18 has a desired range of motion with respect to the hand-held portion 16. In particular, the alignment members 502, 504, 528, 530 can be of any suitable shape to provide an indication of the alignment of the tool alignment members 502, 528 with respect to the handle alignment members 504, 530, respectively. For example, the alignment members 502, 504, 528, 530 may be generally planar, prismatic, defining protrusions that assist in the visual indication (e.g., defining an "X"-shaped cross-section, defining an "L"-shaped cross-section), cylindrical, spherical, etc., or combinations thereof.

[0134] In addition, the first and second tool alignment members 502, 528, and the first and second handle alignment members 504, 530 (collectively may be referred to as the guidance array 500) are disposed about the blade support 18 and the handheld portion 16, such that the first and second tool alignment members 502, 528 and the first and second handle alignment members 504, 530 are visible from the proximal end 560 of the blade support 18 throughout the entire range of motion of the blade support 18 relative to the handheld portion 16. In other words, the first and second tool alignment members 502, 528 and the first and second handle alignment members 504, 530 are configured to be visible to an operator holding the instrument 14, such that the operator has a line of sight to the first and second tool alignment members 502, 528 and the first and second handle alignment members 504, 530 throughout the entire range of motion of the blade support 18 relative to the handheld portion 16. Further, the guidance array 500 may be arranged such that the guidance array 500 provides a visual indication of the orientation of the blade support 18 relative to the handheld portion 16 in all cutting postures of the instrument 14 (e.g., during a distal thigh resection or a posterior bevel resection).

[0135] During operation of the instrument 14, at least one of the target plane TP of the instrument 14, the tool alignment members 502, 528, and at least one of the handle alignment members 504, 530 can be arranged such that they are aligned in a first spatial relationship when the tool 20 is in the target plane TP and the actuators 21, 22, 23 are in their respective home positions. For example, as shown in the configuration shown in FIG. 17, the target plane TP, the tool alignment members 502, 528, and the handle alignment members 504, 530 are arranged in a first spatial relationship when the tool alignment plane 512, the handle alignment plane 526, and the target plane TP are in the same plane. For example, referring to FIG. 17, when the tool alignment members 502, 528 and the handle alignment members 504, 530 are arranged in a first spatial relationship, the "U"-shaped tool alignment portion 510 surrounds the rectangular handle alignment portion 524, and the upper surfaces 503, 505 of the tool alignment portion 510 and the handle alignment member portion 524 are in the same plane, indicating that the actuators 21, 22, 23 are in their respective home positions. The first spatial relationship provides a visual indication that the tool 20 is aligned with the target plane TP and the actuators 21, 22, 23 are in their respective home positions, whereby the actuators 21, 22, 23 have the maximum amount of adjustability for holding the tool 20 in the desired posture and provide the maximum adjustment of pitch, roll, and z-axis translation (i.e., height) to maintain the tool 20 in the target plane TP to the handheld surgical robot system.

[0136] In particular, to facilitate visual indication throughout the movement ranges of actuators 21, 22, 23, tool alignment members 502, 528 and handle alignment members 504, 530 are arranged and sized relative to each other such that tool alignment members 502, 528 and handle alignment members 504, 530 do not collide at any point between the respective first and second positions of the plurality of actuators 21, 22, 23. Collectively, the respective first and second positions of the plurality of actuators 21, 22, 23 define a potential movement range of blade support 18 relative to hand-held portion 16. The potential movement range may define a space within which blade support 18 can move relative to hand-held portion 16. For example, FIGS. 52 and 53 show potential positions of blade support 18 relative to a hand-held portion stacked on top of each other. In one configuration, for example, blade support 18 can move relative to hand-held portion 16 within a space having a height of approximately 150 mm and a width of approximately 115 mm. The height and width of the space are considered to be variable based on the geometry of instrument 14 and the limitations of actuators 21, 22, 23.

[0137] Also, during operation of instrument 14, at least one of tool alignment members 502, 528 and at least one of handle alignment members 504, 530 can be arranged to be offset from each other in a second spatial relationship when blade support 18 is in a posture that does not provide a desired movement range relative to hand-held portion 16 (shown in FIGS. 18-28). The second spatial relationship provides a visual indication that blade support 18 is in a posture relative to hand-held portion 16 that does not provide a desired movement range for instrument 14, indicating that the operator must adjust the posture of hand-held portion 16 such that tool alignment members 502, 528 and handle alignment members 504, 530 are aligned in the first spatial relationship to provide maximum adjustability for instrument 14. In particular, the addition of second tool alignment member 528 and second handle alignment member 530 functions to further assist in providing a visual indication of the posture of blade support 18 relative to hand-held portion 16.

[0138] In a second spatial relationship, there are various scenarios in which the tool alignment members 502, 528 can be displaced from the handle alignment members 504, 530. For example, the blade support 18 can pitch relative to the handheld portion 16 about a transverse axis 558 (shown in FIGS. 18-21), the blade support 18 can roll relative to the handheld portion 16 about a longitudinal axis 552 (shown in FIGS. 22-24), and / or the blade support 18 can move (i.e., rise) along a vertical axis 554 relative to the handheld portion 16 (shown in FIGS. 25-28). Of course, other displacements resulting from the movement of the blade support 18 relative to the handheld portion 16 in other degrees of freedom are conceivable, and combinations of the above displacements can occur simultaneously. For example, the blade support 18 can be pitched and rolled simultaneously relative to the handheld portion 16. When the tool alignment member 502 is displaced relative to the handle alignment member 504, the resulting second spatial relationship provides a visual indication of the orientation of the blade support 18 relative to the handheld portion 16, even if the displacement occurs in multiple degrees of freedom.

[0139] In some configurations, the first spatial relationship may provide a visual indication that the blade support 18 is aligned with respect to the handheld portion 16 with a pitch degree of freedom about the transverse axis 558. However, as described above, the plurality of actuators 21, 22, 23 may be configured to adjust at least the pitch of the blade support 18 with respect to the handheld portion 16 to maintain the tool 20 in the target plane TP. For example, FIGS. 18-21 show a blade support 18 that has been pitched a predetermined amount with respect to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability. When the blade support 18 is pitched with respect to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, at least one of the tool alignment members 502, 528 may be displaced with respect to at least one of the handle alignment members 504, 530, respectively, in a second spatial arrangement. The second spatial arrangement may include a pitch relationship. The pitch relationship may provide a visual indication of the magnitude of the pitch of the blade support 18 with respect to the handheld portion 16 about the transverse axis.

[0140] For example, as shown in FIGS. 18 - 21, the tool alignment member 502 and the handle alignment member 504 can be arranged in a pitch relationship when the distal portion 542 of the handle alignment member 504 is further away from the blade plane BP (shown as D1) than the proximal portion 544 of the handle alignment member 504 along the longitudinal axis 552 of the handle alignment member 504 in the pitch direction (shown as D2). Also, for example, as most clearly shown in FIG. 21, when the second tool alignment member 528 is pitched relative to the second handle alignment member 530 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, the longitudinal distal portion 542 of the second handle alignment member 530 is further away from the blade plane BP than the longitudinal proximal portion 544 of the second handle alignment member 530 along the longitudinal axis 552 of the second handle alignment member 530 in the pitch direction (shown as distance D4). In other words, when the blade support 18 is pitched relative to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, one end of the handle alignment members 504, 528 is further away from the blade plane BP than the other end along the longitudinal axis of the tool 20 in the moving direction. Thus, the arrangement of the alignment members 502, 504, 528, 530 in the pitch relationship can provide a visual indication to the operator that the blade support 18 does not have a desired range of motion relative to the handheld portion 16, and that the tool alignment members 502, 528 and the handle alignment members 504, 530 are aligned in a first spatial relationship, providing maximum adjustability to the instrument 14, and the operator must adjust the posture of the handheld portion 16.

[0141] In other configurations, the first spatial relationship may provide a visual indication that the blade support 18 is aligned with the handheld portion 16 with a roll degree of freedom about the longitudinal axis 552. The plurality of actuators 21, 22, 23 may be configured to adjust at least the roll of the blade support 18 relative to the handheld portion 16 to maintain the tool 20 in the target plane TP. For example, FIGS. 22-24 show the blade support 18 rolled relative to the handheld portion 16 by a predetermined amount such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability. When the blade support 18 is rolled relative to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, at least one of the tool alignment members 502, 528 may be displaced from the handle alignment members 504, 530, respectively, in a second spatial arrangement. The second spatial arrangement may include a roll relationship. The roll relationship may provide a visual indication of the magnitude of the roll of the blade support 18 relative to the handheld portion 16 about the longitudinal axis 552.

[0142] For example, as shown in FIGS. 22-24, when the distal portion 546 of the handle alignment member 504 is further away from the blade plane BP than the proximal portion 548 of the handle alignment member 504 along the transverse axis 558 of the handle alignment member 504 in the direction of the roll (shown as distance D2), it can be arranged in a roll relationship. Also, for example, FIG. 24 shows the transverse distal portion 546 of the second handle alignment member 530 (shown as distance D3) that is farther from the blade plane BP than the transverse proximal portion 548 of the second handle alignment member 530 along the transverse axis 558 in the direction of the roll (shown as D4). Further referring to FIG. 24, the combination of the second spatial relationship of the first tool alignment member 502 with respect to the first handle alignment member 504 and the second spatial relationship of the second tool alignment member 528 with respect to the second handle alignment member 530 can provide an additional visual indication of the orientation of the blade support 18 with respect to the hand-held portion 16, simply more so than the first tool alignment member 502 with respect to the first handle alignment member 504. In particular, the first handle alignment member 504 and the second handle alignment member 530 can cumulatively define a handle alignment plane 426 (shown in FIG. 24) that can be rolled with respect to the tool alignment plane 512 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, providing a visual indication of the orientation of the blade support 18 with respect to the hand-held portion. Thus, the operator is provided with another visual indication that the blade support 18 does not have an optimal range of motion with respect to the hand-held portion 16. In other words, when the blade support 18 is rolled with respect to the hand-held portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, one side of the handle alignment members 504, 528 is further displaced from the blade plane BP in the direction of deviation than the other side of the handle alignment members 504, 528.Accordingly, the arrangement of the alignment members 502, 504, 528, 530 in the roll relationship can provide a visual indication that the blade support 18 does not have a desired range of motion relative to the handheld portion 16 and that the operator must adjust the posture of the handheld portion 16 so that the tool alignment member 502 and the handle alignment member 504 are aligned in a first spatial relationship to provide maximum adjustability to the instrument 14.

[0143] In an additional configuration, the first spatial relationship can provide a visual indication that the blade support 18 does not undergo any vertical movement (i.e., upward movement) relative to the handheld portion 16 along the vertical axis 554. The plurality of actuators 21, 22, 23 can be configured to adjust at least the upward movement of the blade support 18 relative to the handheld portion 16 to maintain the tool 20 in the target plane TP. For example, FIGS. 25-28 show the blade support 18 that has been raised by a predetermined amount relative to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability. When the blade support 18 is raised relative to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, at least one of the tool alignment members 502, 528 can be displaced from at least one of the handle alignment members 504, 530, respectively, in a second spatial arrangement. The second spatial arrangement can include an elevation relationship. The elevation relationship can provide a visual indication of the magnitude of the upward movement of the blade support 18 relative to the handheld portion 16. For example, as shown in FIGS. 25-28, the tool alignment member 502 and the handle alignment member 504 can be arranged in an elevation relationship when the tool alignment member 502 is moved upward a predetermined distance D1 in the upward direction relative to the handle alignment member 504. Also, for example, FIGS. 26 and 28 show a second handle alignment member 530 that has been moved upward a predetermined distance D3 relative to the second tool alignment member 528. Thus, the arrangement of the alignment members 502, 504, 528, 530 in the elevation relationship can provide a visual indication that the operator must adjust the posture of the handheld portion 16 such that the blade support 18 does not have a desired range of motion relative to the handheld portion 16 and the tool alignment members 502, 528 and the handle alignment members 504, 530 are aligned in the first spatial relationship, providing maximum adjustability to the instrument 14.

[0144] In view of the above description, it should be recognized that the guidance array 500 provides many advantages for the operation of the instrument 14. For example, the guidance array 500 reduces the amount of focus shift required for the operator to confirm the orientation of the blade support 18 relative to the hand-held portion 16. In other words, since the guidance array 500 is positioned relative to the tool 20 such that the guidance array 500 is substantially within the operator's line of sight, the operator does not need to substantially shift focus (e.g., rotate the head) to receive a visual indication of the orientation of the blade support 18 relative to the hand-held portion 16. At the same time, while the guidance array 500 is substantially within the operator's line of sight, the guidance array 500 is positioned toward the proximal portion 560 of the tool support, so the user can see the guidance array 500 and the distal end of the tool 20, and the user can simultaneously focus on cutting and alignment. In other words, the guidance array 500 is positioned at a specific distance from the distal tip of the tool 20 such that the user has an unobstructed view of the surgical site and the tool 20. Additionally, the guidance array 500 provides the operator with an easily recognizable visual indication of the orientation of the blade support 18 relative to the hand-held portion 16, reducing the need for auxiliary components (e.g., an auxiliary navigation display) to provide the visual indication. Also, the guidance array 500 produces minimal parallax. Further, since the guidance array 500 provides a visual indication primarily by a mechanical structure, there is no time lag in providing an operative visual indication as compared to electronic navigation.

[0145] In FIGS. 29 - 32, another configuration of the guidance array 600 is shown. In the shown configuration of the guidance array 600, the tool alignment member 602 may include a tool alignment portion 610 that defines a cylindrical shape. Similarly, the handle alignment member 604 may include a handle alignment portion 624 that defines a cylindrical shape. As shown in the configuration shown in FIG. 32, for example, the target plane TP, the tool alignment member 602, and the handle alignment member 604 are arranged in a first spatial relationship when the tool alignment portion 610 and the handle alignment portion 624 intersect the target plane TP, providing a visual indication that the tool 20 is aligned with the target plane TP and the actuators 21, 22, 23 are in their respective home positions. In one configuration, the term "intersect" is defined such that at least a portion of the tool alignment member 602 and at least a portion of the handle alignment member 604 are (as described above) substantially aligned within an appropriate tolerance when viewed from the proximal end 560 of the handheld surgical system 10. Referring to FIG. 32, the tool alignment portion 610 and the handle alignment portion 624 may each include marks in the form of a first color 666 and a second color 668. The marks 666, 668 in the tool alignment portion 610 and the handle alignment portion 624 function to provide a visual indication of the alignment of the blade support 18 with respect to the handheld portion 16. For example, when the marks 666, 668 are aligned such that (as shown in FIG. 32) the marks 666, 668 overlap when viewed by the operator from the proximal end 560 of the handheld instrument 14, the operator is provided with a visual indication that the blade support 18 has maximum adjustability with respect to the handheld portion 16. In particular, the marks 666, 668 each have a length that defines an appropriate overlap tolerance such that the blade support 18 has an optimal range of motion with respect to the handheld portion 16. The tool alignment member 602 and the handle alignment member 604 may be arranged such that they are not aligned in a second spatial relationship when the blade support 18 is in a posture that does not provide the desired range of motion with respect to the handheld portion 16 (as described above).Also, as shown most clearly in FIGS. 30 and 31, the handle alignment member 604 can be removably coupled to the handheld portion 16. For example, the handle alignment member 604 can be magnetically coupled to the handheld portion 16 such that the handle alignment member 604 can be separated as required. However, any suitable means for removably coupling the handle alignment member 604 to the handheld portion (e.g., latches, clips, fasteners, hooks and loops, etc., and combinations thereof) are contemplated.

[0146] In particular, the guidance array 600 can include a second tool alignment member 628 and a second handle alignment member 630 to provide further indication of the orientation of the blade support 18 relative to the handheld portion 16. For example, if the blade support 18 is rolled a predetermined amount in a predetermined direction relative to the handheld portion 16 away from the configuration shown in FIG. 32 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, one side of the handle alignment members 604, 628 will be moved further from the blade plane BP than the other side of the handle alignment members 604, 628 in the direction of deviation. In other words, the mark 668 in the handle alignment portion 624 moves away from the mark 666 in the tool alignment portion 610 in the direction of deviation, shifting the handle alignment portion 624 relative to the tool alignment portion 610 and providing a visual indication that the blade support 18 does not have the desired range of motion relative to the handheld portion 16 and that the tool alignment members 602, 628 and the handle alignment members 604, 630 are misaligned in a first spatial relationship and the operator must adjust the orientation of the handheld portion 16 so that the instrument 14 provides maximum adjustability. Similarly, the second tool alignment member 628 and the second handle alignment member 630 provide further indication of the orientation of the blade support 18 relative to the handheld portion 16 in terms of pitch and elevation degrees of freedom.

[0147] Figures 33 and 34 show yet another configuration of the guidance array 600'. In the shown configuration of the guidance array 600', the tool alignment member 602' may include a tool alignment portion 610' that defines a sphere. Similarly, the handle alignment member 604' may include a handle alignment portion 624' that defines a sphere. In some configurations as shown in FIG. 34, the tool alignment portion 610' is disposed on the blade plane BP. As shown in the configuration shown in FIG. 34, for example, the target plane TP, the tool alignment member 602', and the handle alignment member 604' are arranged in a first spatial relationship when the tool alignment portion 610', the handle alignment portion 624', and the target plane TP intersect, providing a visual indication that the tool 20 is aligned with the target plane TP and the actuators 21, 22, 23 are in their respective home positions. Referring particularly to FIG. 34, the tool alignment portion 610' and the handle alignment portion 624' may be sized such that an operator can easily recognize that they are aligned when viewing the guidance array 600' from the proximal end 560 of the instrument 14, providing a visual indication that the blade support 18 has an optimal momentum with respect to the handheld portion 16. Also, the tool alignment member 602' and the handle alignment member 604' may be arranged such that they are shifted in a second spatial relationship when the blade support 18 is in a posture that does not provide the desired range of motion with respect to the handheld portion 16 (as described above). In particular, the guidance array 600' may include a second tool alignment member 628' and a second handle alignment member 630' to provide further indication of the posture of the blade support 18 with respect to the handheld portion 16.

[0148] In particular, the guidance array 600’ may include a second tool alignment member 628’ and a second handle alignment member 630’ to provide further indication of the orientation of the blade support 18 relative to the handheld portion 16. For example, if the blade support 18 is rolled a predetermined amount relative to the handheld portion 16 away from the configuration shown in FIG. 34 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, one side of the handle alignment members 604’, 628’ is moved further from the blade plane BP than the other side of the handle alignment members 604’, 628’ in the deviation direction. In other words, the spherical handle alignment portion 624’ moves away from the spherical tool alignment portion 610’ in the deviation direction, shifting the spherical handle alignment portion 624’ relative to the spherical tool alignment portion 610’, providing a visual indication that the blade support 18 does not have the desired range of motion relative to the handheld portion 16 and that the operator must adjust the orientation of the handheld portion 16 so that the tool alignment members 602’, 628’ and the handle alignment members 604’, 630’ are aligned in a first spatial relationship, providing maximum adjustability to the instrument 14. Similarly, the second tool alignment member 628’ and the second handle alignment member 630’ provide further indication of the orientation of the blade support 18 relative to the handheld portion 16 in pitch and elevation degrees of freedom.

[0149] Figures 35 - 37 show another example of the guidance array 600''. In the illustrated example of the guidance array 600'', the tool alignment member 602'' includes a tool alignment portion 610'', and the handle alignment member 604'' includes a handle alignment portion 624''. However, in particular, as shown in the configuration shown in FIG. 36, the tool alignment member 602'' and the handle alignment member 604'' are arranged such that they do not obstruct the line of sight of the surgical navigation system 32 to any tracking marker 584 (described below). When this is the case, the tool alignment portion 610'' and the handle alignment portion 624'' can be offset from the blade plane BP. For example, as shown in FIG. 36, the tool alignment portion 610' and the handle alignment portion 624' are aligned along a plane defined between the blade plane BP and the grip 72 of the handheld portion 16. In other words, in the configuration shown in FIGS. 35 - 37, when the tool alignment member 602'' and the handle alignment member 604'' are arranged in a first spatial relationship such that they are aligned (i.e., substantially parallel), the tool alignment portion 610'' and the handle alignment portion 624'' are not on the same plane. However, when the tool alignment member 602'' and the handle alignment member 604'' are arranged in the first spatial relationship, the tool alignment portion 610'' and the handle alignment portion 624'' are parallel to the blade plane BP and provide a visual indication that the tool 20 is aligned with the target plane TP and the actuators 21, 22, 23 are in their respective home positions. Also, when the blade support 18 is in a posture that does not provide the desired range of motion with respect to the handheld portion 16 (as described above), the tool alignment member 602'' and the handle alignment member 604'' can be arranged to be displaced in a second spatial relationship. In particular, the guidance array 600'' can include a second tool alignment member 628'' and a second handle alignment member 630'' to provide further indication of the blade support 18 with respect to the handheld portion 16.

[0150] In particular, the guidance array 600’’ may include a second tool alignment member 628’’ and a second handle alignment member 630’’ to provide further indication of the orientation of the blade support 18 relative to the handheld portion 16. For example, if the blade support 18 is rolled a predetermined amount relative to the handheld portion 16 away from the configuration shown in FIG. 37 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, one side of the handle alignment members 604’’, 628’’ is moved further from the tool alignment plane 512 than the other side of the handle alignment members 604’’, 628’’ in the deviation direction. In other words, the handle alignment portion 624’’ moves away from the tool alignment portion 610’’ in the deviation direction, shifting the handle alignment portion 624’’ relative to the tool alignment portion 610’’, such that the blade support 18 does not have the desired range of motion relative to the handheld portion 16, and the tool alignment members 602’’, 628’’ and the handle alignment members 604’’, 630’’ are aligned in a first spatial relationship, providing a visual indication that the operator must adjust the orientation of the handheld portion 16 to provide maximum adjustability to the instrument 14. Similarly, the second tool alignment member 628’’ and the second handle alignment member 630’’ provide further indication of the orientation of the blade support 18 relative to the handheld portion 16 in pitch and elevation degrees of freedom.

[0151] Figures 38 and 39 show further configurations of the guidance array 600'''. In the illustrated example of the guidance array 600''', the tool alignment member 602''' includes a tool alignment portion 610''', and the handle alignment member 604''' includes a handle alignment portion 624'''. In particular, however, unlike the configurations shown in FIGS. 12-28 and 35-37, only the tool alignment member 602''' is aligned with one side of the handle alignment member 604''', whereas in the configurations in FIGS. 12-28 and 39-42, the tool alignment member 502 is aligned with both the distal and proximal ends of the handle alignment member 504. As shown in the configuration shown in FIG. 39, for example, the target plane TP, the tool alignment member 602''', and the handle alignment member 604''' are arranged in a first spatial relationship when the tool alignment portion 610''', the handle alignment portion 624''', and the target plane TP are aligned, providing a visual indication that the tool 20 is aligned with the target plane TP and the actuators 21, 22, 23 are in their respective home positions. Also, the tool alignment member 602''' and the handle alignment member 604''' can be arranged to be displaced in a second spatial relationship when the blade support 18 is in a posture that does not provide the desired range of motion with respect to the handheld portion 16 (as described above). In particular, the guidance array 600''' can include a second tool alignment member 628''' and a second handle alignment member 630''' to provide further indication of the posture of the blade support 18 with respect to the handheld portion 16.

[0152] In particular, the guidance array 600’’’ may include a second tool alignment member 628’’’ and a second handle alignment member 630’’’ to provide further indication of the orientation of the blade support 18 relative to the handheld portion 16. For example, if the blade support 18 is rolled by a predetermined amount relative to the handheld portion 16 such that the plurality of actuators 21, 22, 23 are no longer at maximum adjustability as shown in FIG. 39, one side of the handle alignment members 604’’’, 628’’’ will be moved further from the blade plane BP than the other side of the handle alignment members 604’’’, 628’’’ in the deviation direction. In other words, the handle alignment portion 624’’’ moves away from the tool alignment portion 610’’’ in the deviation direction, shifting the handle alignment portion 624’’’ relative to the tool alignment portion 610’’’, such that the blade support 18 does not have the desired range of motion relative to the handheld portion 16, and the tool alignment members 602’’’, 628’’’ and the handle alignment members 604’’’, 630’’’ are aligned in a first spatial relationship, providing a visual indication that the operator must adjust the orientation of the handheld portion 16 to provide maximum adjustability to the instrument 14. Similarly, the second tool alignment member 628’’’ and the second handle alignment member 630’’’ provide further indication of the orientation of the blade support 18 relative to the handheld portion 16 in pitch and elevation degrees of freedom.

[0153] In particular, as shown in the configurations illustrated in FIGS. 29-39 and 51, the tool alignment members 602, 602', 602'', 602''' can be integrally formed with the tool tracker 574 of a surgical navigation system that can be removably coupled to the blade support 18. Forming the tool alignment members 602, 602', 602'', 602''' integrally with the tool tracker 574 reduces the mounting space required on the blade support 18, allows the tool tracker to be closer to the tip of the tool 20, and facilitates more accurate surgical navigation. The tool tracker 574 may include side walls 580 attached to a cross member 582, and each side wall 580 may include one or more of a plurality of markers 584. In some configurations, the plurality of markers may be arranged in a mirror image configuration on each side wall 580. The side walls 580 may have a contour that matches the profile of the blade support 18. Additionally, in some configurations, the markers 584 may be active, passive, or a combination thereof. In other configurations, the markers 584 may be disposed on the tool alignment members 602, 602', 602'', 602''' to improve the line of sight with the surgical navigation system 32. To attach the tool tracker 574 to the blade support 18, the tool tracker 574 may include a guide slot 576, and the blade support 18 may include a guide rail 578 (shown in FIG. 35) at the distal end of the blade support 18. The guide slot 576 of the tool tracker 574 is sized to receive the guide rail 578 of the blade support 18, allowing the tool tracker 574 to be connected to the distal end of the blade support 18.

[0154] In addition, the tool alignment member 602 and / or the handle alignment member 604 may include one or more marks. For example, in some configurations such as those shown in FIGS. 32 and 34, the tool alignment member 602 includes at least a first mark 562, and the handle alignment member 604 includes at least a second mark 564. In particular, the first mark 562 is visually distinguishable from the second mark 564. For example, in the form shown in FIGS. 32 and 34, the first mark 562 may be arranged to be visible from the proximal end 560 of the handheld portion 16 when the tool alignment member 602 and the handle alignment member 604 are misaligned (i.e., in a second spatial arrangement). Conversely, the second mark 564 is arranged to be visible from the proximal end of the handheld portion 16 when the tool alignment member 602 and the handle alignment member 604 are aligned (i.e., in a first spatial arrangement). Thus, the first visual indicator 562 and the second visual indicator 564 provide the operator with an easily distinguishable visual indication of the alignment of the tool alignment member 602 relative to the handle alignment member 604. In some forms, the mark includes one or more visual cues (e.g., patterns, lights, colors, combinations thereof, etc.). For example, referring to FIG. 32, the mark may include colored marks 666, 668.

[0155] For example, in another configuration as shown in FIGS. 47-48, the tool alignment member 502 and the handle alignment member 504 each have a first mark 562 and a second mark 564. For example, the first mark 562 may be a first color 566, and the second mark 564 may be a second color 568. In this configuration, the first color 566 is visible along the edge where the tool alignment member 504 and the handle alignment member 504 are adjacent when the tool alignment member and the handle alignment member are aligned (shown in most detail in FIGS. 35, 37, and 40). Conversely, at least one of the second marks 564 is visible along the edge where the tool alignment member 504 and the handle alignment member 504 are adjacent when the tool alignment member 504 and the handle alignment member 504 are misaligned (shown in most detail in FIG. 40). To facilitate this configuration, the upper surface 503 of the tool alignment member 502 and the upper surface 505 of the handle alignment member 504 may include the first mark 562. Similarly, the side surface 570 of the tool alignment member 502 and the side surface 572 of the handle alignment member 504 may include the second mark 564, whereby when the tool alignment member 502 and the handle alignment member 504 are misaligned with respect to each other, the second mark 564 appears, providing an indication that one or more of the plurality of actuators 21, 22, 23 has moved from the home position. The marks 562, 564 enable the operator to quickly distinguish between the surface of the tool alignment member 502 and the surface of the handle alignment member 504 in order to quickly determine whether the tool alignment member 502 and the handle alignment member 504 are misaligned. For example, as shown in FIG. 40, at least one of the second marks 564 (in the form of the second color 568 and provided on the side surface 572) is visible when the tool alignment member 502 and the handle alignment member 504 are misaligned, providing an indication that one or more of the plurality of actuators 21, 22, 23 has moved from the home position.

[0156] Referring to FIGS. 42 and 43, the instrument 14 may include a light emitter such as an LED 586 at any suitable position within the operator's line of sight, such as a tool alignment member 502, a handle alignment member 504, or a blade support 18. The light emitter 586 may be configured to be lit when the blade support 18 has a desired range of motion, providing a visual indication that the blade support 18 and the handheld portion 16 are within a specified alignment range with respect to the target plane TP. For example, the light emitter 586 may be configured to indicate that the actuators 21, 22, 23 are in a first spatial arrangement (i.e., have a desired range of motion). Alternatively, the light emitter 586 may be configured to light when the blade support 18 is in a second spatial arrangement. For example, when a first visual indicator 201 is actuated to indicate that movement of the handheld portion 16 is required, the visual indicator 201 represents that one or more of the actuators 21, 22, 23 have moved too far from the home position, shifting the tool alignment member and the handle alignment member, and indicating that the handheld portion 16 needs to be moved.

[0157] In some examples, the control device may control the light emitter 586 based on the commanded positions of the actuators 21, 22, 23 and the available movement distances of the actuators 21, 22, 23. For example, the first color may be based on a first range of movement distances within the operating range of the actuators 21, 22, 23 and the commanded positions of the actuators 21, 22, 23, and the second color may be based on a second range of movement distances within the operating range of the actuators 21, 22, 23 and the commanded positions of the actuators 21, 22, 23, which may be different from the first range of movement distances. A third color representing a third range of movement distances of the actuators 21, 22, 23 within the available movement distance may be included, and the third range of movement distances may be different from the second range of movement distances. For example, the first color is red and is associated with the commanded positions of the actuators 21, 22, 23 that are closest to the outer limit of the available movement distance, the second color is yellow and is associated with the commanded positions of the actuators 21, 22, 23 that are further away from the outer limit of the available movement distance, and the third color is green and indicates that the commanded positions of the actuators 21, 22, 23 are far from the limits of the available movement distance range.

[0158] In a further example, the color associated with the illuminator 586 may represent a plurality of actuator parameters, whereby the illuminator 586 conveys to the user a first color representing the amount of movement distance required to bring at least one of the actuators 21, 22, 23 to the commanded position, and a second color representing the direction required to move the handheld portion 16 so as to bring the tool 20 within the operating range of the actuator. As described above, the third color may correspond to the outermost range of the available movement distance (i.e., the least amount of movement distance available with respect to the commanded position), the second color may correspond to the intermediate range of the available movement distance, and the first color may correspond to the innermost range of the available movement distance (i.e., the greatest amount of movement distance available with respect to the commanded position). In some examples, the illuminator 586 is configured to be divided into two or more portions. Each portion may be lit in a different state to indicate the desired direction of movement of the handheld portion 16. In some forms, the lighting of the upper and lower portions of the illuminator 586 may be actuated in the same state based on the commanded position and the available movement distance of the handheld portion 16.

[0159] Alternatively, the illuminator 586 or other marker may be controlled based on one or more components of the commanded posture and one or more ranges of motion in a particular degree of freedom. More specifically, the illuminator 586 or other marker may be controlled based on the pitch component of the commanded posture and the pitch range of motion. Alternatively, or in combination, the illuminator 586 may be controlled based on the roll component of the commanded posture and the roll range of motion. The pitch and roll ranges of motion may be defined by a series of overlapping ranges. The control system 60 may control the illuminator to emit a first color when the pitch component of the commanded posture is within the innermost range of the pitch range of motion and the roll component of the commanded posture is within the innermost range of the roll range of motion. Alternatively, the control system 60 may control the illuminator to emit light of a second color or may prevent power to the illuminator when the pitch component of the commanded posture is in a relatively outer range of the pitch range of motion or the roll component of the commanded posture is in a relatively outer range of the roll range of motion. By controlling the illuminator 586 in this way, the visual marker can indicate that the user is in a good posture with respect to pitch and roll or that the user needs to adjust one of pitch and roll. Similarly, the control system 60 may further emit the first color only when additional conditions exist, such as when the elevation component of the commanded posture is also within the innermost range of the elevation range of motion. Further, the control system 60 may control the illuminator 586 to emit light of a second color or may prevent power to the illuminator 586 when any of the pitch component, roll component, or elevation component is outside the innermost range of its respective motion. Although elevation, pitch, and roll are mentioned here, the illuminator 586 can be controlled based on the components of the commanded posture in other relative degrees of freedom and their respective ranges of motion.

[0160] Referring to FIGS. 44 - 50, in another configuration, the instrument 14 may include a shroud 700 coupled to the blade support 18 and the handheld portion 16 and extending between the blade support 18 and the handheld portion 16. In particular, as shown in FIGS. 29 - 39, the shroud 700 may be included in the instrument 14 simultaneously with the tool alignment member 502 and the handle alignment member 504. The shroud 700 may be formed from any suitable material such as plastic, rubber, composite, etc., or combinations thereof, that is compatible with a sterilization process such as an autoclave sterilization process or a hydrogen peroxide sterilization process. The shroud 700 may be coupled to the blade support 18 and the handheld portion 16 using any suitable means such as clamps, fasteners, adhesives, etc., or combinations thereof. In some configurations, the shroud 700 may surround at least one of the plurality of actuators 21, 22, 23. The shroud 700 may include an accordion fold that can extend and bend when the blade support 18 moves relative to the handheld portion 16. Also, in some configurations, the shroud 700 defines at least two shroud landmarks 702 (described in more detail below). In some configurations, there may be two or more, five or more, ten or more, or even a plurality of shroud landmarks 702. When the blade support 18 moves relative to the handheld portion 16, the relative movement of the shroud landmarks 702 provides a visual indication of the orientation of the blade support 18 relative to the handheld portion 16. In particular, referring to FIG. 45, the instrument 14 may include one or more shroud alignment members 706 removably coupled to the handheld portion 16. For example, in some configurations, the instrument 14 may include at least two shroud alignment members 706. The shroud alignment members 706 may be transparent and may include shroud alignment marks 708. For example, referring to FIG. 47, the shroud alignment marks 708 may indicate when the plurality of actuators 21, 22, 23 are in their respective home positions and thus when the instrument 14 has an optimal range of motion.In some configurations, there may be two or more, four or more, or even a plurality of shroud alignment members 706. For example, FIGS. 47-50 show a handheld surgical robot system that includes a second shroud alignment member 714 to provide further visual indication of the orientation of the blade support 18 relative to the handheld portion 16.

[0161] In some configurations, at least two shroud landmarks 702 include at least two creases 704. In some configurations, the creases 704 may be defined by accordion-like folds. The creases 704 may define a plane 716 (shown in FIG. 46) that provides a visual indication of the orientation of the blade support 18 relative to the handheld portion 16. The creases 704, for example, the plane 716, are substantially parallel and offset by a distance corresponding to the shroud alignment mark 708, such that the plane 716 is aligned with the shroud alignment mark 708 at the first position 710, with the plurality of actuators 21, 22, 23 in their respective home positions, and thus provides a visual indication that the instrument 14 has an optimal range of motion. However, also, the plane 716 may be displaced in the vertical and angular directions when the blade support 18 and the handheld portion 16 are moved to the second position 712, providing a visual indication that the blade support 18 does not have an optimal range of motion relative to the handheld portion 16.

[0162] Figures 47 to 50 show that, similar to the tool alignment member 502 and the handle alignment member 504, the shroud 700 can be configured to provide a visual indication of the attitude of the blade support 18 relative to the handheld portion 16 to the operator. For example, FIG. 48 shows the shroud 700 when the blade support 18 is pitched relative to the handheld portion. FIG. 49 shows the shroud 700 when the blade support 18 is rolled relative to the handheld portion 16. FIG. 50 shows the shroud 700 when the blade support 18 is raised relative to the handheld portion. In each of FIGS. 48 to 50, the attitude of the crease 704 relative to the shroud alignment mark 708 provides a visual indication of the attitude of the blade support 18 relative to the handheld portion 16 to the operator.

[0163] In some configurations, similar to the tool alignment member 502 and the handle alignment member 504, at least two shroud landmarks 702 may include a first mark 562 and a second mark 564. Also, similarly, the first mark 562 may be visually distinguishable from the second mark 564, thereby providing the operator with an easily distinguishable visual indication of the attitude of the blade support 18 relative to the handheld portion. For example, the first mark 562 may be of a first color and the second mark 564 may be of a second color. In this configuration, the first color is visible when the blade support 18 is in the first position (i.e., when the plurality of actuators 21, 22, 23 are in their respective home positions), and the second color is visible when the blade support 18 is in the second position (i.e., when the blade support 18 does not have an optimal range of motion relative to the handheld portion 16).

[0164] In another configuration shown in FIGS. 54-77, the instrument 14 also includes a guidance array 900. The guidance array 900 provides a visual indication of the orientation of the tool support 18 relative to the handheld portion 16 during operation of the instrument 14, and provides the operator with a visual indication of the necessary changes in pitch orientation, roll orientation, and z-axis translation relative to the handheld portion 16 to achieve the desired orientation of the tool 20 while providing maximum adjustability to the actuator assembly 400 (described above) to maintain the tool 20 in the target plane TP. The guidance array 900 includes a handle alignment member 904 extending from the handheld portion 16, and the handle alignment member 904 is for guiding the operator as to how to move the handheld portion 16 to provide sufficient adjustability to the instrument 14 by holding the actuators 21, 22, 23 of the actuator assembly 400 near the home position or other predetermined position, and provides the operator with a visual indication for this purpose.

[0165] The handle alignment member 904 can be of any suitable shape or configuration that provides a visual indication to the operator user that one or more of the actuators 21, 22, 23 of the actuator assembly 400 have moved from their respective home positions. For example, referring to FIGS. 54-77, the handle alignment member 904 may include a handle alignment protrusion 906. The handle alignment protrusion 906 may extend toward the tool mount 18a. In particular, referring to FIGS. 54-77, the handle alignment protrusion 906 may be shaped such that at least a portion 908 of the handle alignment protrusion 906 is disposed at an oblique angle with respect to the longitudinal axis 910 and the transverse axis 912 of the tool 20 / tool support 18. For example, the handle alignment protrusion 906 may define a handle alignment edge 914 that is disposed at an oblique angle with respect to the longitudinal axis 910 and the transverse axis 912 of the tool 20 / tool support 18. The "oblique" angle of the handle alignment protrusion 906 with respect to the longitudinal axis 910 and the transverse axis 912 may include, for example, an arrangement of the handle alignment protrusion 906 at an angle greater than 0 degrees and less than 90 degrees with respect to both the longitudinal axis 910 and the transverse axis 912. For example, the tool alignment protrusion 906 may define a tool alignment edge 914 that has an angle of 45 degrees with respect to the longitudinal axis and the transverse axes 910, 912.

[0166] For example, in one configuration, such as that shown in FIGS. 54-77, the handle alignment member 904 may define a hook-shaped handle alignment protrusion 906. The hook-shaped handle alignment protrusion 906 may define a curved handle alignment edge 914 that curves inwardly toward the tool support 18 to define the aforementioned oblique angle. The configuration in FIGS. 54-77 shows a hook-shaped handle alignment protrusion 906, but any suitable edge that defines an oblique angle, such as a polygonal edge, a stepped edge, etc. (but not limited to these), is conceivable. In particular, as will be explained in more detail below, the oblique angle of the handle alignment protrusion 906 with respect to the longitudinal axis 910 and the transverse axis 912 of the tool 20 / tool support 18 may provide the user with the ability to more accurately distinguish the posture of the tool support 18 with respect to the hand-held portion 16 with multiple degrees of freedom simultaneously.

[0167] In some configurations as shown in the configurations of FIGS. 54-57, at least a portion of the handle alignment protrusion 906 and the tool plane BP may be aligned when the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions, providing a visual indication to the operator that the tool support 18 has an optimal range of motion with respect to the handheld portion 16. In one configuration, the term "aligned" is defined as at least a portion of the handle alignment protrusion 906 being substantially coplanar with or intersecting the tool plane BP within appropriate tolerances. In particular, when in the home position, the amount of adjustability of the actuators 21, 22, 23 of the actuator assembly 400 is maximized to hold the tool 20 in the desired orientation. In some examples, the alignment of at least a portion of the handle alignment protrusion 906 with the tool plane BP can be aligned by 99% or more, 90% or more, 70% or more, or even 60% or more. In other examples, proper alignment can be within 1% deviation from the target orientation, within 5% deviation from the target orientation, within 10% deviation from the target orientation, or even within 20% deviation from the target orientation, etc., within the specified proximity to the target orientation in each respective degree of freedom. Similarly, proper alignment can be within 1 mm, within 2 mm, or even within 5 mm of the target orientation in each respective degree of freedom. Additionally, proper alignment can be within 1 degree or more deviation from the target orientation in roll and / or pitch, within 5 degrees or more deviation from the target orientation, within 15 degrees or more deviation from the target orientation, or even within 30 degrees or more deviation from the target orientation.

[0168] Conversely, the tool plane BP and the handle alignment protrusion 906 are configured to be displaced when the handheld portion 16 is in a posture that does not provide an optimal range of motion, and the handheld portion 16 is in a posture that does not provide an optimal range of motion to the tool support 18, thus providing a visual indication that it needs to be adjusted by the operator (described in more detail below). In some configurations, the guidance array 900 may also include a tool alignment member 902. In one configuration, for example, referring to FIGS. 54-77, the tool alignment member 902 may extend from the tool support 18. The tool alignment member 902 may have any shape or structure that can provide a visual indication of the posture of the tool plane BP relative to the handle alignment member 902. For example, the tool alignment member 902 may include a tool alignment protrusion 916 that extends toward the tool mount 18a. Referring to FIGS. 54-77, for example, similar to the handle alignment protrusion 906, the tool alignment protrusion 916 may include at least a portion 920 disposed at an oblique angle with respect to the longitudinal axis 910 and the transverse axis 912 of the tool 20 / tool support 18. In some configurations, for example, the tool alignment protrusion 916 may define a tool alignment edge 918 that is oblique with respect to the longitudinal axis 910 and the transverse axis 912 of the tool 20.

[0169] The optimal range of motion can be considered to be the maximum range of motion in one, two, three or more degrees of freedom. The optimal range of motion does not necessarily have to be the maximum range of motion, but rather can be the range of motion desired for a preferred posture of the tool support or other pre-planned virtual object such as a specific cut by the saw or a planned cut or planned axis. The optimal range of motion does not have to be at the center of the range of motion in one or more degrees of freedom, and in some configurations can be at the center of the range of motion in one, two or three degrees of freedom.

[0170] For example, in one configuration such as FIGS. 54-77, the tool alignment member 902 may define a hook-shaped tool alignment projection 916. The hook-shaped tool alignment projection 916 may define a curved tool alignment edge 918 that bends inwardly toward the tool support 18 to define the aforementioned oblique angle. The configuration in FIGS. 54-77 shows the hook-shaped tool alignment projection 916, but any suitable edge that defines an oblique angle, such as a polygonal edge, a stepped edge, etc. (but not limited thereto), is conceivable. In particular, the hook-shaped tool alignment projection 916 and the hook-shaped handle alignment projection 906 may be configured to be aligned when the tool support 18 has an optimal range of motion with respect to the handheld portion 16, and further, when the handheld portion 16 is in a posture that does not provide an optimal range of motion to the tool support 18, it may be configured to be displaced, providing a visual indication that the handheld portion 16 is in a posture that does not provide an optimal range of motion to the tool support 18.

[0171] In some examples, when the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions, the tool alignment edge may be offset from and parallel to the handle alignment edge, providing the operator with a visual indication that the tool support 18 has a desired range of motion with respect to the handheld portion 16. Also, in some examples, the tool alignment member 916 is disposed closer to the tool support 18 than the handle alignment member 906.

[0172] In some configurations, the tool alignment protrusion 916 is substantially aligned with the tool plane BP. For example, the tool alignment protrusion 916 may be in the same plane as the tool plane BP. Thereby, the tool alignment protrusion 916 can function as a visual indication of the orientation of the tool plane BP to facilitate providing a visual indication of the orientation of the handheld portion 16 relative to the tool support 18. However, it is important to note that the handle alignment member 904 can function to provide a visual indication of the orientation of the handheld portion 16 relative to the tool support 18 without the addition of the tool alignment member 902. In particular, the user can further understand the relationship of the tool support 18 to the handheld portion 16 by considering the relationship between the handle alignment member 904 and the tool 20.

[0173] The handle alignment member 904 can be removably coupled to the handheld portion 16. For example, the handle alignment member 904 can include a handle coupling portion 922 configured to be coupled to the handheld portion 16. As shown most clearly in FIG. 58, the handle coupling portion 922 of the handle alignment member 904 can be removably coupled to the handheld portion 16. For example, the handle coupling portion 922 can be magnetically coupled to the handheld portion 16 such that the handle alignment member 904 can be separated if required or if an operator's hand is pinched between the handle alignment member 904 and the tool alignment member 902 and / or the tool support 18. Any suitable means for removably coupling the handle alignment member 904 to the handheld portion 16 (e.g., magnets, latches, clips, fasteners, hooks and loops, etc., as well as combinations thereof) are contemplated.

[0174] The handle alignment member 904 may also include a support arm 924. The support arm 924 may extend from the handle coupling portion 922 to support the handle alignment member 904. In particular, as most clearly shown in FIGS. 54-58, the support arm 924 extends upward from the grip 72 of the handheld portion 16, whereby the handle alignment member 904 is aligned with the tool plane BP when the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions. In some examples, the handle alignment member 904 is rigid with respect to the handheld portion 16 to facilitate the function of the handle alignment member 904. The handle alignment member 904 may be formed from any suitable material such as plastic, aluminum, steel, composite materials, or combinations thereof. Further, the handle alignment member 904 may be formed using any suitable manufacturing method including 3D printing, casting, machining, injection molding, stamping, or combinations thereof.

[0175] Similarly, referring to FIG. 58, the tool alignment member 902 may also include a tool coupling portion 926 configured to be coupled to the tool support 18. The tool coupling portion 926 may be attached to the tool support 18 using any suitable means (e.g., fasteners, magnets, adhesives, etc.) at any suitable location to facilitate the function of the tool alignment member 802. For example, the tool support 18 may include a tool mounting rail 928 that extends laterally from the tool support 18. The tool coupling portion 926 of the tool alignment member 902 may define a tool mounting channel 930 configured to engage the tool mounting rail 928 to removably secure the tool alignment member 902 to the tool support 18.

[0176] The tool alignment member 902 may further include a support portion 932. The support portion 932 may extend from the tool coupling portion 926 to support the tool alignment member 902. In some examples, the tool alignment member 902 may be rigid with respect to the tool support 18 to facilitate the function of the tool alignment member 902. The tool alignment member 902 may be formed from any suitable material such as plastic, aluminum, steel, composite materials, etc., or combinations thereof. Further, the tool alignment member may be formed using any suitable manufacturing method including 3D printing, casting, machining, injection molding, stamping, etc., or combinations thereof.

[0177] In some configurations, the guidance array 900 may include two or more handle alignment members and two or more tool alignment members. Any number of corresponding tool alignment members and handle alignment members are contemplated. For example, the guidance array 900 may include a first handle alignment member 904 and a second handle alignment member 934 that extends from the handheld portion 16 at a location different from the first handle alignment member 904. Similarly, the second handle alignment member 934 includes a second handle alignment protrusion 936. The second handle alignment protrusion 936 may extend towards the tool mount 18a. In particular, referring to FIGS. 54-77, the second handle alignment protrusion 936 may be shaped such that at least a portion 938 of the second handle alignment protrusion 936 is disposed at an angle oblique to the longitudinal axis 910 and the transverse axis 912 of the tool 20 / tool support 18. For example, the second handle alignment protrusion 936 may include a second handle alignment edge portion 940 that is disposed at an angle oblique to the longitudinal axis 910 and the transverse axis 912 of the tool 20 / tool support 18.

[0178] In some examples, the guidance array 900 can include a first tool alignment member 902 and a second tool alignment member 942 extending from the handheld portion 16 at a location different from the first tool alignment member 902. For example, referring to FIGS. 54-77, in some configurations, the first alignment members 902, 904 and the second alignment members 934, 942 extend from opposite sides of the handheld portion 16 and have a mirror image arrangement with respect to each other.

[0179] The second tool alignment member 942 can include a second tool alignment protrusion 944 extending toward the tool mount 18. The second tool alignment protrusion 944 can have at least a portion 946 disposed at an angle oblique to the longitudinal axis 910 and the transverse axis 912 of the tool 20 / tool support 18. In some configurations, for example, the second tool alignment protrusion 944 can define a second tool alignment edge 948 that is oblique to the longitudinal axis 910 and the transverse axis 912 of the tool 20 / tool support 18. In some examples, the second tool alignment edge 948 can be offset and parallel to the second handle alignment edge 940 when the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions, providing a visual indication to the operator that the tool support 18 has an optimal range of motion with respect to the handheld portion 16. For example, referring to FIGS. 54 and 56, the handle alignment edges 914, 940 and the tool alignment edges 918, 948 are offset and parallel to each other when the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions. In particular, the alignment members 902, 904, 934, 942 can be of any suitable shape for providing an indication of the alignment of the alignment members 902, 934 with respect to the handle alignment members 904, 942, respectively. In some examples, there can be four or more, or six or more, or even a plurality of tool alignment members and handle alignment members, respectively.

[0180] As shown in FIGS. 54 to 57, both the first tool alignment protrusion 916 and the first handle alignment protrusion 906, and the second tool alignment protrusion 942 and the second handle alignment protrusion 936 are aligned with each other when the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions, providing a visual indication that the tool support 18 has an optimal range of motion with respect to the hand-held portion 16. Conversely, both the first tool alignment protrusion 916 and the first handle alignment protrusion 906, and the second tool alignment protrusion 944 and the second handle alignment protrusion 936 are configured to be offset from each other when the hand-held portion 16 is in a posture that does not provide an optimal range of motion, providing a visual indication that the hand-held portion 16 is in a posture that does not provide an optimal range of motion to the tool support 18 and thus needs to be adjusted by the operator.

[0181] During operation of the instrument 14, the handle alignment protrusions 906, 936 and the tool plane BP can be arranged to be aligned in a first spatial relationship 950 when the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions. For example, referring to FIGS. 54 to 57, when the handle alignment protrusions 906, 936 and the tool plane BP are arranged in the first spatial relationship 950, the handle alignment protrusions 906, 936 and the tool plane BP are aligned, providing a visual indication that the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions.

[0182] In addition, referring to FIG. 57, when the instrument 14 holds the tool support 18 such that the tool 20 remains in the target plane TP, the target plane TP, the handle alignment protrusions 906, 936, and the tool plane BP are configured to be arranged in a first spatial relationship 950 when the handle alignment protrusions 906, 936, the tool plane BP, and the target plane TP are aligned. The tool 20 is aligned with the target plane TP and the actuators 21, 22, 23 provide a visual indication that they are in their respective home positions such that the tool 20 has the maximum amount of adjustability to hold the tool 20 in the desired orientation. To maintain the tool 20 in the target plane TP, the instrument 14 is provided with maximum adjustment of pitch, roll, and z-axis translation (i.e., elevation).

[0183] During operation of the instrument 14, the handle alignment protrusions 906, 936 can be arranged to be displaced from the tool plane BP in a second spatial relationship 952 when the tool support 18 is in a position that does not provide the desired range of motion with respect to the handheld portion 16 (shown in FIGS. 59 - 75). The second spatial relationship 952 provides a visual indication that the tool support 18 is in a position that does not provide the desired range of motion with respect to the handheld portion 16, and thus indicates that the operator must adjust the orientation of the handheld portion 16 so that the handle alignment protrusions 906, 936 are aligned with the tool plane BP in the first spatial relationship 950 in order to provide the instrument 14 with maximum adjustability.

[0184] Similarly, during operation of the instrument 14 further including at least one of the tool alignment members 902, 942 having the tool alignment protrusions 916, 944, the handle alignment protrusions 906, 936 and the tool alignment protrusions 916, 944 can be arranged to be aligned in a first spatial relationship 950 when the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions. For example, referring to FIGS. 54-57, when the handle alignment protrusions 906, 936 and the tool alignment protrusions 916, 944 are arranged in the first spatial relationship 950, the handle alignment protrusions 906, 936 and the tool alignment protrusions 916, 944 are aligned respectively, providing a visual indication that the actuators 21, 22, 23 are in their respective home positions.

[0185] Also, referring to FIG. 57, when the instrument 14 holds the tool support 18 such that the tool 20 remains on the target plane TP, the target plane TP, the handle alignment protrusions 906, 936, and the tool alignment protrusions 916, 944 are configured to be arranged in a first spatial relationship when the handle alignment protrusions 906, 936, the tool alignment protrusions 916, 944, and the target plane TP are aligned, providing a visual indication that the actuators 21, 22, 23 are in their respective home positions so that the tool 20 is aligned with the target plane TP and the actuators 21, 22, 23 have the maximum amount of adjustability to hold the tool 20 in the desired orientation, and providing the instrument 14 with the maximum adjustment of pitch, roll, and z-axis translation (i.e., elevation) to maintain the tool 20 on the target plane TP.

[0186] In addition, during operation of the instrument 14 further including at least one of the tool alignment members 902, 942, the tool alignment protrusions 916, 944 and the handle alignment protrusions 902, 942 may be arranged to be offset from each other in a second spatial relationship 952 when the tool support 18 is in a posture that does not provide a desired range of motion with respect to the handheld portion 16. The second spatial relationship 952 provides a visual indication that the tool support 18 is in a posture that does not provide a desired range of motion for the instrument 14 with respect to the handheld portion 16, and indicates that the operator must adjust the posture of the handheld portion 16 so that the tool alignment protrusions 916, 944 and the handle alignment protrusions 906, 936 are aligned in the first spatial relationship 950 to provide maximum adjustability for the instrument 14. In particular, the addition of the second tool alignment member 942 and the second handle alignment member 934 functions to further assist in providing a visual indication of the posture of the tool support 18 with respect to the handheld portion 16. In particular, the tool alignment members 902, 942 and the handle alignment members 904, 934 are arranged and sized relative to each other so that the tool alignment members 902, 942 and the handle alignment members 904, 932 do not collide at any point between the respective first and second positions of the plurality of actuators 21, 22, 23 of the actuator assembly 400 to facilitate the visual indication throughout the range of motion of the actuators 21, 22, 23.

[0187] There are various scenarios in which the handle alignment protrusions 906, 936 can be displaced from the tool plane BP and / or the tool alignment protrusions 916, 944 in the second spatial relationship 952. For example, the tool support 18 can pitch with respect to the handheld portion 16 about the lateral axis 912 (shown in FIGS. 59-62), the tool support 18 can roll with respect to the handheld portion 16 about the longitudinal axis 910 (shown in FIGS. 63-66), and / or the tool support 18 can move (i.e., rise) along the vertical axis 954 with respect to the handheld portion 16 (shown in FIGS. 67-70). It should be recognized that other displacements resulting from the movement of the tool support 18 with respect to the handheld portion 16 in other degrees of freedom are conceivable. It should also be recognized that combinations of the displacements mentioned above can occur simultaneously. For example, the tool support 18 can be pitched and rolled simultaneously with respect to the handheld portion 16. When the handle alignment protrusions 916, 936 are displaced with respect to the tool plane BP and / or the tool alignment protrusions 916, 944, the resulting second spatial relationship 952 provides a visual indication of the orientation of the tool support 18 with respect to the handheld portion 16 even when displacements occur in multiple degrees of freedom.

[0188] In some configurations, the first spatial relationship 950 may include a first pitch relationship 956 that provides a visual indication that the tool support 18 is aligned with respect to the handheld portion 16 in a pitch degree of freedom about the lateral axis 912. However, as described above, the plurality of actuators 21, 22, 23 of the actuator assembly 400 may be configured to adjust at least the pitch of the tool support 18 with respect to the handheld portion 16 to maintain the tool 20 in the target plane TP. For example, FIGS. 59-62 show the tool support 18 pitched by a predetermined amount with respect to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability. When the tool support 18 is pitched with respect to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, the handle alignment protrusions 906, 936 may be displaced with respect to the tool plane BP and / or the tool alignment protrusions 916, 944, respectively, in the second spatial arrangement 952. The second spatial arrangement 952 may include a second pitch relationship 958. The second pitch relationship 958 may provide a visual indication of the magnitude and direction of the pitch of the tool support 18 with respect to the handheld portion 16 about the lateral axis 912.

[0189] For example, as shown in FIGS. 59 - 62, when a first portion 960 of the handle alignment protrusions 906, 936 is further from the tool plane BP and / or the tool alignment protrusions 916, 944 in the pitch direction than a second portion 962 of the handle alignment protrusions 906, 936, the handle alignment protrusions 906, 936 and the tool plane BP and / or the tool alignment protrusions 916, 944 can be arranged in a second pitch relationship 958. Referring to FIGS. 59 - 62, for example, a distal portion 964 of the handle alignment protrusions 906, 936 is further from the tool plane BP and / or the tool alignment protrusions 916, 944 than a proximal portion 966 of the handle alignment members protrusions 906, 936 along the longitudinal axis 910. For example, as shown in FIGS. 59 - 62, the handle alignment protrusions 906, 936 are pitched downward relative to the tool alignment protrusions 916, 944 such that the distal ends of the handle alignment protrusions 906, 936 are below the distal ends of the tool alignment protrusions 916, 944, providing a visual indication to the user that the grip 72 should be rotated to eliminate the pitch condition.

[0190] In other words, when the tool support 18 is pitched relative to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, one end of the handle alignment protrusions 906, 936 is further from the tool plane BP and / or the tool alignment protrusions 916, 944 than the other end along the longitudinal axis 910 in the pitch direction. Thus, the second pitch relationship 958 can provide a visual indication that the operator must adjust the attitude of the handheld portion 16 such that the tool support 18 does not have a desired range of motion relative to the handheld portion 16 and the handle alignment protrusions 906, 936 are aligned with the tool plane BP and / or the tool alignment protrusions 906, 936 in a first spatial relationship 950, providing maximum adjustability to the instrument 14.

[0191] In other configurations, the first spatial relationship 950 may include a first roll relationship 968 that provides a visual indication that the tool support 18 is aligned with the handheld portion 16 with roll freedom. The plurality of actuators 21, 22, 23 may be configured to adjust at least the roll of the tool support 18 about the longitudinal axis 910 relative to the handheld portion 16 to maintain the tool 20 in the target plane TP. For example, FIGS. 63-66 show the tool support 18 rolled relative to the handheld portion 16 by a predetermined amount such that the plurality of actuators 21, 22, 22 no longer have maximum adjustability. When the tool support 18 is rolled relative to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, the handle alignment protrusions 906, 936 may be displaced from the tool plane BP and / or the tool alignment protrusions 916, 944, respectively, in the second spatial arrangement 952. The second spatial arrangement 952 may include a second roll relationship 970. The second roll relationship 970 may provide a visual indication of the magnitude and direction of the roll of the tool support 18 relative to the handheld portion 16 about the longitudinal axis 910.

[0192] For example, as shown in FIGS. 63 to 66, the handle alignment protrusions 906, 936 and the tool plane BP and / or the tool alignment protrusions 916, 944 may be arranged in a second roll relationship 970 when the lateral portions 972 of the handle alignment protrusions 906, 936 are further away from the tool plane BP and / or the tool alignment protrusions 916, 944 than the intermediate portions 974 of the handle protrusions 906, 936 in the roll direction. In particular, referring to FIG. 66, the second spatial relationship 952 of the first handle alignment protrusion 906 with respect to the tool plane BP and / or the tool alignment protrusion 916, combined with the second spatial relationship 952 of the second handle alignment protrusion 936 with respect to the tool plane BP and / or the second tool alignment protrusion 944, may provide a further visual indication of the posture of the tool support 18 with respect to the handheld portion 16 than simply the second spatial relationship 952 of the first handle alignment protrusion 906 with respect to the tool plane BP and / or the tool alignment protrusion 916.

[0193] In particular, the addition of the second tool alignment member 942 and the second handle alignment member 934 provides the operator with another visual indication that the tool support 18 does not have an optimal range of motion with respect to the hand-held portion 16. In other words, referring to FIGS. 63-66, when the tool support 18 is rolled relative to the hand-held portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, one side of the handle alignment protrusions 906, 936 is moved further away from the tool plane BP and / or the tool alignment protrusions 916, 944 than the other side of the handle alignment protrusions 906, 936 in the rolling direction. For example, as shown in FIGS. 63-66, the lateral portion 972 of the first handle alignment protrusion 906 is below the first tool alignment protrusion 916, while the lateral portion 972 of the second handle alignment protrusion 916 is above the second tool alignment protrusion 944, indicating that the hand-held portion 16 is being rolled clockwise relative to the tool support 18. Thus, feedback is provided to the operator that the hand-held portion 16 should be adjusted in the clockwise direction to return the instrument 14 to a position with maximum adjustability. Thus, the second roll relationship 970 can provide a visual indication that the tool support 18 does not have the desired range of motion with respect to the hand-held portion 16, and that the handle alignment protrusions 906, 936 and the tool plane BP and / or the tool alignment protrusions 916, 944 are aligned in the first spatial relationship 950, and that the operator must adjust the posture of the hand-held portion 16 to provide maximum adjustability to the instrument 14.

[0194] In an additional configuration, the first spatial relationship 950 can include a first height relationship 978 that provides a visual indication that the tool support 18 does not undergo any vertical movement (i.e., upward movement) relative to the handheld portion 16 about the vertical axis 954. The plurality of actuators 21, 22, 23 of the actuator assembly 400 are configured to adjust at least the height of the tool support 18 relative to the handheld portion 16 to maintain the tool 20 in the target plane TP. For example, FIGS. 67-70 show the tool support 18 raised by a predetermined amount relative to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability. When the tool support 18 is raised relative to the handheld portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, the handle alignment protrusions 906, 936 can be displaced from the tool plane BP and / or the tool alignment protrusions 916, 944, respectively, in the second spatial arrangement 952. The second spatial arrangement 952 can include a second height relationship 980. The second height relationship 980 can provide a visual indication of the magnitude of the upward movement of the tool support 18 relative to the handheld portion 16.

[0195] For example, as shown in FIGS. 67 to 70, the handle alignment protrusions 906, 936 and the tool plane BP and / or the tool alignment protrusions 916, 944 can be arranged in a second height relationship 980 when the handle alignment protrusions 906, 936 are moved downward in the height direction relative to the tool plane BP and / or the tool alignment protrusions 916, 944. In other words, when the tool support 10 is raised relative to the hand-held portion 16 such that the plurality of actuators 21, 22, 23 no longer have maximum adjustability, the handle alignment protrusions 906, 936 are located in the space above or below the tool plane BP and / or the tool alignment protrusions 916, 944 along the vertical axis 954 in the height direction. Thus, the arrangement of the handle alignment protrusions 906, 936 relative to the tool alignment protrusions 916, 944 in the second height relationship 980 provides a visual indication that the tool support 18 does not have an optimal range of motion relative to the hand-held portion 16 and that the operator must adjust the posture of the hand-held portion 16 so that the handle alignment protrusions 906, 936 are aligned with the tool plane BP and / or the tool alignment protrusions 916, 944 in the first spatial relationship 950 to provide maximum adjustability to the instrument 14. For example, the tool alignment protrusions 916, 944 are shown above the handle alignment protrusions 906, 936 on respective sides of the instrument 14 in FIGS. 67 to 70, providing a visual indication that the hand-held portion 16 needs to be moved upward to align the hand-held portion 16 with the tool support 18 in order to position the instrument 14 in a position having maximum adjustability.

[0196] In light of the above description, it should be recognized that the guidance array 900 provides many advantages to the operation of the instrument 14. For example, the handle alignment protrusions 906, 936 (and the handle alignment edges 914, 940 defined thereby) can be arranged at an angle oblique to the longitudinal axis 910 and the transverse axis 912 of the tool 20 / tool support 18. The arrangement of the portions 908, 938 of the handle alignment protrusions 906, 936 at an angle oblique to the longitudinal axis 910 and the transverse axis 912 provides the advantage of enabling the operator to grasp the alignment of the handle alignment protrusions 906, 936 with respect to the tool plane BP and / or the tool alignment protrusions 916, 944 in multiple degrees of freedom simultaneously.

[0197] For example, as shown in FIGS. 71-75, in some configurations, the actuator assembly 400 is configured to simultaneously adjust at least the pitch and roll of the tool support 18 relative to the handheld portion 16. Referring to FIGS. 71-75, for example, where the tool support 18 is simultaneously moved in both pitch and roll degrees of freedom, the arrangement of the oblique portions 908, 938 of the handle alignment protrusions 906, 936 with respect to the tool plane BP and / or the tool alignment protrusions 916, 944 provides a visual indication of the orientation of the handheld portion 16 relative to the tool support in at least two degrees of freedom. In particular, a second spatial arrangement 952 of the handle alignment protrusions 906, 936 with respect to the tool plane BP and / or the tool alignment protrusions 916, 944 respectively provides a visual indication of at least a second pitch relationship 958 and a second roll relationship 970 of the tool support BP relative to the handheld portion 16, and provides a visual indication that the handheld portion 16 is in an orientation that does not provide an optimal range of motion for the tool support 18 relative to the tool support 18. Thus, the operator is warned that the handle alignment protrusions 906, 936 and the tool plane BP and / or the tool alignment protrusions 916, 944 are aligned in a first spatial relationship 944 and that the orientation of the handheld portion 16 must be adjusted to provide maximum adjustability to the instrument 14.

[0198] As an example of this feedback in multiple degrees of freedom, FIGS. 71-75 show that one end of the handle alignment protrusions 906, 936 is further away from the tool plane BP and / or the tool alignment protrusions 916, 944 than the other end along the longitudinal axis 910 in the pitch direction, and one side of the handle alignment protrusions 906, 936 is further displaced from the tool plane BP and / or the tool alignment protrusions 916, 944 than the other side of the handle alignment protrusions 906, 936 in the roll direction. Thus, the diagonal arrangement of the handle alignment protrusions 906, 936 (and in some configurations the tool alignment protrusions 916, 944) provides a first visual reference towards the lateral portion 972 of the handle alignment protrusions 906, 936 that provides a visual indication in the roll degree of freedom and a second visual reference towards the first portion 960 of the handle alignment protrusions 906, 936 that provides a visual indication in the pitch degree of freedom, thereby facilitating a visual indication of the attitude of the tool support 18 with respect to the handheld portion 16. Thus, cumulatively, the diagonal portions 908, 938 of the handle alignment protrusions 906, 936 provide increased functionality for visual indication compared to the orthogonal arrangement of the handle alignment protrusions.

[0199] In addition, as shown in FIGS. 76 and 77, the tool alignment member 902 and / or the handle alignment member 904 may include one or more markings to facilitate the user's visual perception of the alignment of the handle alignment protrusions 906, 936 with respect to the tool alignment protrusions 916, 944. For example, each of the handle alignment protrusions 906, 936 and / or the tool alignment protrusions 916, 944 may include at least one of a first marking 986 and a second marking 988, and the first marking 986 is visually distinguishable from the second marking 988. The first marking 986 and / or the second marking 988 may be disposed on the handle alignment protrusions 906, 936 and / or the tool alignment protrusions 916, 944, for example, on the slopes 990 and / or the sides 992 of the handle alignment protrusions 906, 936 and / or the tool alignment protrusions 916, 944. However, any suitable surface of the handle alignment protrusions 906, 936 and / or the tool alignment protrusions 916, 944 is considered to facilitate the operator's visual perception of the alignment of the handle alignment protrusions 906, 936 with respect to the tool alignment protrusions 916, 944. Thus, the first marking 986 and / or the second marking 988 provide the operator with an easily distinguishable visual indication of the alignment of the tool alignment protrusion 916 with respect to the handle alignment protrusion 906. In some forms, the marking includes one or more separate visual cues (e.g., patterns, lights, colors, combinations thereof, etc.). For example, referring to FIGS. 76 and 77, the marking may include a colored mark.

[0200] In the configurations shown in FIGS. 76 and 77, for example, the markings may be arranged to provide a visual indication that when the tool alignment protrusion 916 and the handle alignment protrusion 906 are aligned, the first marking 986 of the handle alignment protrusion 906 and the first marking 986 of the tool alignment protrusion 916 are aligned, and the tool support 18 has an optimal range of motion with respect to the handheld portion 16. Conversely, the first marking 986 of the handle alignment protrusion 906 and the first marking 986 of the tool alignment protrusion may be offset when the tool alignment protrusion 916 and the handle alignment protrusion 906 are misaligned, and may be configured to provide a visual indication that the handheld portion 16 is in a posture that does not provide an optimal range of motion to the tool support 18.

[0201] FIGS. 78-85 show yet another configuration of the guidance array 1000 for use with the handheld surgical robot system 10. Similar to the configuration described above, the guidance array 1000 provides a visual indication of the posture of the tool support 18 with respect to the handheld portion 16 during operation of the instrument 14 to the operator, and provides a visual indication of the required changes in the pitch orientation, roll orientation, and z-axis translation of the handheld portion 16 to achieve the desired posture of the tool 20 while providing maximum adjustability to the actuator assembly 400 (described above) to maintain the tool 20 in the target plane TP. The guidance array 1000 includes a handle alignment member 104 extending from the handheld portion 16 to provide a visual indication to the operator as to how to move the handheld portion 16 to provide sufficient adjustability to the instrument 14 by holding the actuators 21, 22, 23 of the actuator assembly 400 in the home position or other predetermined position.

[0202] Referring to FIGS. 80 - 83, for example, the handle alignment member 1004 includes a handle support arm 1106. The handle support arm 1106 extends between a first handle support arm end 1108 and a second handle support arm end 1110. The handle support arm 1106 includes a handle coupling portion 1112 coupled to the first handle support arm end 1108 (shown in greatest detail in FIGS. 81 and 82). The handle coupling portion is configured to couple the handle alignment member 1004 to the handle - held portion 16 of the instrument 14. For example, in some configurations, the handle coupling portion 1112 includes a handle coupling member 1114 configured to couple to a corresponding coupling member 1116 disposed on the handle - held portion 16.

[0203] Referring to FIGS. 80 - 82, in some configurations, the handle coupling portion 1112 of the handle alignment member 1004 is magnetically coupled to the handle - held portion of the instrument 14. Thus, the handle alignment member 1004 can be quickly magnetically attached to and removed from the handle - held portion 16. To facilitate this magnetic connection, one of the handle coupling member 1114 and the coupling member disposed on the handle - held portion 16 may include one or more magnets 1118, while the other of the handle coupling member 1114 and the coupling member disposed on the handle - held portion 16 may include one or more magnets 1118 and / or a ferromagnetic material 1120, whereby the handle coupling member 1114 and the coupling member disposed on the handle - held portion 16 are configured to magnetically couple to each other to couple the handle alignment member 1004 to the handle - held portion 16.

[0204] Referring to FIGS. 81 and 83, the handle alignment member 1004 further includes a handle alignment member mount 1122 coupled to the second handle support arm end 1110. Additionally, in the configuration shown in FIGS. 81 and 83, the handle alignment member 1004 also includes a handle alignment indicating member 1124 coupled to the handle alignment member mount 1122. The handle alignment indicating member 1124 can be of any suitable shape or configuration that provides a visual indication to the operator user that the plurality of actuators 21, 22, 23 of the actuator assembly 400 have moved from their respective home positions. For example, in one configuration, similar to the other configurations described above, the handle alignment member 1004 can define a hook-shaped protrusion. Also, similar to that described above, at least a portion of the handle alignment indicating member 1124 and the tool plane BP can be aligned when the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions, providing a visual indication to the operator that the tool support 18 has an optimal range of motion with respect to the hand-held portion 16. Conversely, the tool plane BP and the handle alignment indicating member 1124 are configured to be displaced when the hand-held portion 16 is in a posture that does not provide an optimal range of motion, providing a visual indication that the hand-held portion 16 is in a posture that does not provide an optimal range of motion to the tool support 18 and, thus, needs to be adjusted by the operator.

[0205] Referring further to FIGS. 81 and 83, the handle alignment indicating member 1124 can be removably coupled to the handle alignment member mount 1122 using one or more fasteners 1128. Additionally, the handle alignment indicating member 1124 may be made of a material suitable for autoclave sterilization. Suitable materials include, but are not limited to, stainless steel and autoclaveable polymers such as polyphenyl sulfone. Examples of methods for manufacturing the handle alignment indicating member 1124 include forming the handle alignment indicating member 1124 by stamping a stainless steel sheet, machining the handle alignment indicating member 1124 from a block of autoclaveable polymer such as polyphenyl sulfone, and molding the handle alignment indicating member 1124 from an autoclaveable polymer such as polyphenyl sulfone.

[0206] In some configurations, referring to FIGS. 78 - 86, the guidance array 1000 may also include a tool alignment member 1126. In one configuration, for example, the tool alignment member 1126 may extend from the tool support 18. Similar to what was described above for other configurations, when the tool support 18 has an optimal range of motion with respect to the hand-held portion 16, the handle alignment member 1004 and the tool alignment member 1126 are aligned. Also, similar to the handle alignment member 1004 described above, the tool alignment member 1126 may include a tool support arm 1130 that extends between a first tool support arm end 1132 and a second tool support arm end 1134. The tool support arm 1130 includes a tool coupling portion 1136 coupled to the first tool support arm end 1132 (shown in greatest detail in FIG. 81). The tool coupling portion 1136 is configured to couple the tool alignment member 1026 to the tool support 18 of the instrument 14. For example, in some configurations, the tool coupling portion 1136 includes a tool coupling member (not shown) configured to couple to a corresponding coupling member 1138 disposed on the tool support 18. Also, similar to what was described above, the tool alignment member 1126 can be magnetically coupled to the tool support 18.

[0207] The tool alignment member 1126 also includes a tool alignment member mount 1140 coupled to the second support arm end 1134. The tool alignment member 1126 further includes a tool alignment indicating member 1142. The tool alignment indicating member 1142 can be coupled to the tool alignment member mount 1140 using, for example, a fastener. The tool alignment indicating member 1142 may be made of the same material as the handle alignment indicating member 1124 and can be manufactured by the same method. In some configurations, the handle alignment indicating member 1124 and the tool alignment indicating member 1142 can have the same shape and size to improve manufacturing efficiency and cost.

[0208] In addition, referring to FIGS. 80 and 85, the handle alignment indicating member 1124 and / or the tool alignment indicating member 1142 can include laser marks 1144 to facilitate a visual indication of the orientation of the handle alignment indicating member 1124 and / or the tool alignment indicating member 1142 with respect to the tool alignment indicating member 1142 and / or the tool plane BP. Thus, if the tool support 18 does not have an optimal range of motion with respect to the handheld portion 16, the laser marks 1144 improve the visual indication provided to the operator that the orientation of the handheld portion needs to be adjusted. The laser marks can be formed using a laser, but are not limited thereto, and other methods of marking the handle alignment indicating member 1124 and / or the tool alignment indicating member 1142, such as printing, scoring, etching, etc., are contemplated. In another configuration, referring to FIG. 85, the polymer used to form the handle alignment indicating member 1124 and / or the tool alignment indicating member 1142 can be dyed to provide a color that contrasts with the surrounding components to improve the visual indication provided to the operator.

[0209] As briefly described above, instrument 14 may include a tracker that enables the posture of instrument 14 to be tracked by a surgical navigation system. For example, referring to FIGS. 78-86, instrument 14 may include a tracker 1150 coupled to blade support 18 or other tool support. Thus, tracker 1150 enables robotic surgical system 10 to determine the current position of tool plane BP or the axis of the tool within the space. Tracker 1150 includes a tracker frame 1152. Tracker frame 1152 includes at least two surfaces 1156. The at least two surfaces 1156 are not planar with respect to each other. For example, FIG. 78 shows at least two surfaces arranged in a wedge shape with respect to each other. Tracker 1150 also includes at least six optical markers 1154 coupled to the tracker frame. At least three of the six optical markers 1154 are attached to each of the at least two surfaces 1156. In some configurations, multiple markers 1154 are coupled at the at least two surfaces 1156 and arranged as mirror images of each other, whereas in other configurations, the multiple markers 1154 are arranged asymmetrically. In other configurations, the at least two surfaces 1156 may be on opposite sides of a plane that bisects instrument 14.

[0210] In addition, the tracker frame 1152 may define an instrument engagement opening 1170 for receiving the proximal portion of the instrument 14. Thus, the instrument 14 may include a mount 1172 for engaging the tracker frame 1152 and holding the tracker frame 1152 relative to the instrument 14. For example, the tracker frame 1152 may partially surround the mount 1172 when the tracker 1150 is coupled to the instrument 14. In some examples, the mount 1172 may be a slot. The tracker 1150 may further include a battery 1174 for powering the tracker 1150. For example, in some configurations, the optical marker 1154 may be an active marker having a light-emitting light source such as an infrared LED. The battery may also power the antenna 1162, which is described in more detail below. For example, one or more of at least six optical markers 1154 may be LED emitters, and one or more LED emitters are arranged to form at least two arrays, each array including at least one LED emitter.

[0211] As described previously above, the robotic surgery system 10 includes a control system 60. Referring to FIG. 86, the control system 60 includes, among other components, a navigation system 32 and an instrument control device 28. The control system 60 is configured to control the actuators 21, 22, 23 so as to align the tool plane BP of the instrument 14 with at least one target plane 184. Continuing to refer to FIG. 86, the tracker 1150 includes an input device 1160, an antenna 1162, and a tracker control device 1164. The tracker control device 1164 is coupled to the input device 1160 and the antenna 1162 to provide an input signal to the navigation system 32. Thus, the control system 60 detects an input signal from the input device 1160 and varies the position of the tool support 18 by the actuators 21, 22, 23 so as to align the tool support 18 with a different one of the plurality of target planes 184. In addition, the navigation system 32 may be configured to determine the tool plane BP of the saw blade 20 based on a target plane, the target plane being based on the selected target plane 184. Alternatively, the control system 60 may be configured to detect an input signal from an input device and align the tool support with a different one of a plurality of axes (as opposed to a plane), and / or the navigation system may be configured to determine the orientation of the tool support based on a target plane, the target plane being based on the selected target axis.

[0212] In another aspect, the robotic surgery system 10 may be configured to use the tool tracker 1150 and the navigation system 32 to determine the current tool plane BP. Thus, the robotic surgery system 10 may select one of the plurality of target planes 184 by the input device 1160 and adjust the tool support 18 by the plurality of actuators 21, 22, 23 so as to place the current plane BP in alignment with the selected target plane 184.

[0213] Referring now to FIGS. 87 - 90, the instrument 14 includes various support arms 1224, 1254 of the handle alignment member 1204 in addition to different types of connections between the tool alignment protrusions 1203, 1210 and the tool support 18. In FIGS. 87 and 88, the instrument 14 includes an integrated handle alignment member 1202 having a handle alignment protrusion 1203 projecting from the tool support 18. FIG. 87 shows the instrument in a separated state 1219 and includes a handle support arm 1224 configured as a deformable support. The handle alignment member 1204 includes a base 1208 connected to the support arm 1224, and the support arm 1224 is connected to the handle alignment protrusion 1206. The base 1208 of the handle alignment member 1204 includes a coupling feature 1213 configured to be received by a receiver 1214 in the attachment region 1216 in the handheld portion 16. In this example, the coupling feature 1213 is a pin, but other attachments such as magnets, fasteners, biasing members, or combinations thereof are contemplated as described above. In this example, the tool alignment member 1202 and the tool alignment protrusion 1203 are integral with the tool support 18.

[0214] Similar to FIG. 87, FIG. 88 includes an integral tool alignment member 1202 and a tool alignment protrusion 1203. However, in this example, the handle alignment member 1204 includes a non - deformable solid support arm 1254. Rather, if there is interference between the handle alignment member 1204 and the tool alignment member 1202, when a threshold force is applied to the handle alignment member 1204, the base 1208 separates from the attachment region 1216, shifting the handle alignment member 1204 from the engaged position 1218 to the separated position 1219.

[0215] Figures 89 and 90 show an instrument 14 having an obstacle 1260 between a tool alignment member 1202 and a handle alignment member 1204. In FIG. 89, the tool alignment member 1202 is a removable component having a base 1217 connected to a tool support at an attachment region 1220. The base 1217 of the tool alignment member 1202 is connected to a tool alignment protrusion 1210. The obstacle 1260 is sandwiched between the tool alignment protrusion 1210 and the handle alignment protrusion 1206. In this example, the tool alignment member 1202 is transitioning from a retained state to a separated state to prevent collision with the obstacle 1260 and avoid damage to the instrument 14. Similarly, FIG. 90 shows the obstacle 1260 between a tool alignment protrusion 1203 and the handle alignment protrusion 1206. In this example, a deformable support arm 1224 is biased away from the obstacle 1260 to prevent collision with the obstacle 1260 and avoid damage to the instrument 14.

[0216] In another configuration shown in FIGS. 91 - 98, the instrument 14 is shown with a guidance array 1300. The guidance array 1300 provides a visual indication of the orientation of the tool support 18 relative to the hand-held portion 16 during operation of the instrument 14 to the operator, and provides a visual indication of the required changes in the pitch orientation, roll orientation, and z-axis translation of the hand-held portion 16 to achieve the desired orientation of the tool 20 while providing maximum adjustability to the actuator assembly 400 (described above) to maintain the tool 20 in the target plane TP. The guidance array 1300 includes a handle alignment member 1304 extending from the hand-held portion 16 for providing a visual indication to the operator as to how to move the hand-held portion 16 to provide sufficient adjustability to the instrument 14 by holding the actuators 21, 22, 23 of the actuator assembly 400 near their home position or other predetermined position.

[0217] The handle alignment member 1304 can be of any suitable shape or configuration that provides a visual indication to the operator user that one or more of the actuators 21, 22, 23 of the actuator assembly 400 have moved from their respective home positions. For example, referring to FIGS. 91-98, the handle alignment member 1304 can include a handle alignment protrusion 1306. The handle alignment protrusion 1306 can extend towards the tool support 18. In particular, referring to FIGS. 91-98, the handle alignment protrusion 1306 can be shaped such that at least a portion 1324 of the handle alignment protrusion 1306 is disposed at an angle oblique to the longitudinal and transverse axes of the tool 20 / tool support 18 as described above.

[0218] In one example, the handle alignment member 1304 can define a hook-shaped handle alignment protrusion 1306. The hook-shaped handle alignment protrusion 1306 can define a curved handle alignment edge that bends inwardly towards the tool support 18 to define the aforementioned oblique angle. The configuration of FIGS. 91-98 shows a hook-shaped handle alignment protrusion 1306, but any suitable edge that defines an oblique angle, such as a polygonal edge, a stepped edge, etc. (but not limited to these), is contemplated.

[0219] In some configurations as shown in FIGS. 91 - 98, when the actuators 21, 22, 23 of the actuator assembly 400 are in their respective home positions, at least a portion of the handle alignment protrusion 1306 and the tool plane BP may be aligned, providing a visual indication to the operator that the tool support 18 has an optimal range of motion with respect to the hand-held portion 16. In one configuration, the term "aligned" is defined as at least a portion of the handle alignment protrusion 1306 being substantially in the same plane as or intersecting the tool plane BP within appropriate tolerances. In particular, when in the home position, the amount of adjustability of the actuators 21, 22, 23 of the actuator assembly 400 is maximized to hold the tool 20 in a desired orientation. In some examples, the alignment of at least a portion of the handle alignment protrusion 1306 with the tool plane BP can be 99 percent or more aligned, 90 percent or more aligned, 70 percent or more aligned, or even 60 percent or more aligned. In other examples, appropriate alignment can be within a specified proximity to the target orientation, such as within 1 percent deviation from the target orientation in each individual degree of freedom, within 5 percent deviation from the target orientation, within 10 percent deviation from the target orientation, or even within 20 percent deviation from the target orientation. Similarly, appropriate alignment can be within 1 mm of the target orientation, within 2 mm of the target orientation, or even within 5 mm of the target orientation in each individual degree of freedom. Additionally, appropriate alignment can be within 1 degree or more deviation from the target orientation in roll and / or pitch, within 5 degrees or more deviation from the target orientation, within 15 degrees or more deviation from the target orientation, or even within 30 degrees or more deviation from the target orientation.

[0220] Conversely, the tool plane BP and the handle alignment protrusion 1306 are configured to be displaced when the handheld portion 16 is in a posture that does not provide an optimal range of motion, and the handheld portion 16 is in a posture that does not provide an optimal range of motion for the tool 18, and thus provides a visual indication that it needs to be adjusted by the operator (further described below). In some configurations, the guidance array 1300 also includes a tool alignment member 1302. In one configuration, for example, referring to FIGS. 91-98, the tool alignment member 1302 can be a part of the tool support 18. The tool alignment member 1302 can have any shape or structure that can provide a visual indication of the posture of the tool plane BP relative to the handle alignment member 1304. In this example of FIGS. 91-96, the tool alignment member 1302 is a part of the tool support 18 that surrounds at least a portion of the actuator assembly 400. In another example, such as in FIGS. 97 and 98, the tool alignment member 1302 is a tool alignment protrusion 1303 configured as a shroud clamp that follows the shape of the tool support 18. In some examples, similar to the handle alignment protrusion 1306, the tool alignment members 1302, 1303 can have at least a portion that is disposed at an oblique angle with respect to the longitudinal and transverse axes of the tool 20 / tool support 18 as described above. In some examples, the oblique angle is a molded portion of the tool support. Although the handle alignment protrusion 1306 and the tool alignment protrusion 1303 are described as being oblique, other shapes are conceivable.

[0221] The optimal range of motion can be considered to be the maximum range of motion in one, two, three, or more degrees of freedom. The optimal range of motion need not necessarily be the maximum range of motion, but rather can also be considered to be the range of motion desired for a preferred posture of the tool support for a particular cut by the saw or other pre-planned virtual object, such as a planned cut or a planned axis. The optimal range of motion need not be at the center of the range of motion in one or more degrees of freedom, and in some configurations can be at the center of the range of motion in one, two, or three degrees of freedom.

[0222] In some configurations, the tool alignment member 1302 and / or the tool alignment protrusion 1303 can be substantially aligned with the tool plane BP. For example, the tool alignment member 1302 and / or the tool alignment protrusion 1303 can be in the same plane as the tool plane BP. Thereby, the tool alignment member 1302 and / or the tool alignment protrusion 1303 can function as a visual indication of the orientation of the tool plane BP to facilitate providing a visual indication of the posture of the handheld portion 16 with respect to the tool support 18. However, it is important to note that the handle alignment member 1304 can function to provide a visual indication of the posture of the handheld portion 16 with respect to the tool support 18 without the addition of the tool alignment protrusion 1303. In particular, the user can further understand the relationship of the tool support 18 with respect to the handheld portion 16 by considering the relationship between the handle alignment member 1304 and the tool support 18.

[0223] The handle alignment member 1304 can be removably coupled to the handheld portion 16. In the example shown in FIGS. 91-98, the handle alignment member 1304 is shown as an integral member including a first arm 1307 and a second arm 1309 connected by a retainer 1308. The first arm 1307, the second arm 1309, and the retainer 1308 together form a coupler that generates a biasing force on the handheld portion 16 at the attachment position 1316 (also called a mount). The handle alignment member 1304 has a complementary shape to at least a part of the handheld portion 16.

[0224] In some examples, the handle alignment member 1304 is removably coupled to the handle portion 16 such that the handle alignment member 1304 can be separated upon request or when the operator's hand is sandwiched between the tool support 18 and / or the tool alignment protrusion 1303 between the handle alignment member 1304 and the tool alignment member 1302. Any suitable means for removably coupling the handle alignment member 1304 to the handle portion 16 (e.g., magnets, latches, clips, fasteners, hooks and loops, etc., and combinations thereof) are contemplated.

[0225] In some examples, the handle alignment member 1304 is configured to transition between a retained state 1318 where the handle alignment member 1304 is connected to the handle portion 16 and a separated state 1319 where the handle alignment member 1304 is detached from the handle portion 16. In the retained state 1318, the first arm 1307, the second arm 1309, and the retainer 1308 of the handle alignment member 16 provide a biasing force to the handle portion 16. During operation or when the handle alignment member 1304 is desired to be removed, when a threshold force greater than the biasing force of the handle alignment member 1304 is applied to the handle alignment member 1304, the handle alignment member 1304 is caused to transition from the retained state 1318 to the separated state 1319, separating and / or breaking the handle alignment member 1304 from the handle portion 16. In some examples where the handle alignment member 1304 utilizes a biasing force to maintain connection with the handle portion 16, the retainer 1308, the first arm 1307, and the second arm 1309 may be formed from plastic. In other examples where the handle alignment member 1304 uses a biasing force to couple to the handle portion 16, the retainer 1308, the first arm 1307, and the second arm 1309 may be formed from a metal such as titanium.

[0226] In some examples, to fix the handle alignment member 1304 to the handle portion 16, the first arm 1307 and the second arm 1309 include protrusions 1313 for connecting to a mount 1316 in the handle portion 16. In this example, the mount 1316 has a complementary channel 1317 for receiving the protrusion 1313. In the examples specifically shown in FIGS. 93-96, the protrusion 1313 is an elongated protrusion with a rounded contour. Similarly, each channel 1317 of the attachment location 1316 has a rounded recessed shape for receiving the protrusion 1313 of the handle alignment member 1304. Similarly, in other examples such as shown in FIG. 99, the handle alignment member 1404 includes log-shaped protrusions 1413 on arms 1407, 1409 extending from a retainer 1408. In another example such as shown in FIG. 100, the handle alignment member 1504 includes two circular protrusions 1513 on arms 1507, 1509 extending from a retainer 1508. Additionally, it is contemplated that the handle portion 16 may have protrusions at the attachment location 1316 and the handle alignment member 1304 may include complementary channels for receiving the protrusions of the handle portion 16. Further, combinations of retention methods may be used in addition to biasing retention forces such as magnetic characteristics.

[0227] The handle alignment member 1304 may also include support arms 1324. Each support arm 1324 may extend from a first arm 1307 and a second arm 1309 respectively to support a handle alignment protrusion 1306. As seen in FIGS. 91-98, the support arms 1324 extend upwardly from the first arm 1307 and the second arm 1309 of the handle alignment member 1304 such that the handle alignment protrusion 1306 is aligned with the tool plane BP when the actuators 21, 22, 23 of the actuator assembly 40 are in their respective home positions. In some examples, the handle alignment member 1304 is rigid with respect to the hand-held portion 16 to facilitate the function of the handle alignment member 1304. The handle alignment member 1304 may be formed from any suitable material such as plastic, aluminum, steel, composite materials, etc., or combinations thereof. In some examples, the handle alignment member 1304 may be formed from titanium. In other examples, the handle alignment member 1304 may be formed from plastic. In other examples, a combination of materials may be used to form the handle alignment member 1304. Further, the handle alignment member 1304 may be formed using any suitable manufacturing method including 3D printing, casting, machining, injection molding, stamping, etc., or combinations thereof.

[0228] The handle alignment protrusion 1306 is connected to the first arm 1307 and the second arm 1309 of the handle alignment member 1304. The handle alignment member 1306 can function to assist the user in determining the optimal position for arranging the handheld portion 16 relative to the tool support 18 by providing a visual indication of the relative positions of the handheld portion 16 and the tool support 18. To assist with the visual indication, the handle alignment protrusion 1306 can include one or more markings to provide greater visibility of any discrepancy that moves the handheld portion 16 and the tool support 18 relative to each other away from the home position of the actuator assembly 400. In some examples, the handle alignment protrusion can include one or more colors. In other examples, a pattern or motif can be used. FIG. 96 shows an example of the handle alignment protrusion 1306 that includes a plurality of grooves 1314 extending along the upper length of the handle alignment protrusion 1306. Similarly, FIGS. 99-101 also include grooves 1414, 1514, 1614 that extend along the upper length of the handle alignment protrusions 1406, 1506, 1606. In other examples, the handle alignment protrusions 1306, 1406, 1506, 1606 can include ridges that extend on the surface of the handle alignment protrusions 1306, 1406, 1506, 1606. In further examples, adding one or more colors to the handle alignment protrusions 1306, 1406, 1506, 1606 provides additional visual guidance. In some examples, the color can be added to the handle alignment members 1304, 1404, 1504, 1606, particularly the handle alignment protrusions 1306, 1406, 1506, 1606, by injection molding, 3D printing, anodizing, or a combination thereof, depending on the materials and manufacturing methods used to form the handle alignment members 1304, 1404, 1504, 1604.

[0229] Referring to FIGS. 97 and 98, the tool alignment member 1302 may also include a tool alignment protrusion 1302 configured to be coupled to the tool support 18. In this example, the tool alignment protrusion 1302 is a clamp disposed around a portion of the tool support 18, and the clamp has a size and thickness that function as the tool alignment member 1302. The clamp is used as the tool alignment member 1302 and the tool alignment protrusion 1303, but any other suitable means for providing at least one mark at any suitable position to facilitate the function of the tool alignment member 1302 is conceivable. Similar to the handle alignment member 1304 described above, the tool alignment member 1302 may be formed from any suitable material such as plastic, aluminum, steel, composite materials, etc., or combinations thereof. Further, the tool alignment member may be formed using any suitable manufacturing method including 3D printing, casting, machining, injection molding, stamping, etc., or combinations thereof.

[0230] Similar to FIGS. 91 - 100, FIG. 101 is another example of a handle alignment member 1604. The handle alignment member 1604 includes a first arm 1607 and a second arm 1609 connected by a retainer 1608. The first arm 1607 and the second arm 1609 each include a protrusion 1613 for connecting to the handheld portion 16 in the held state 1318. The first arm 1607 and the second arm 1609 are each connected to a support arm 1624 coupled to a handle alignment protrusion 1606. In this example, the retainer 1608 includes a pocket 1610 for enhancing the elasticity of the handle alignment member 1604. In some examples, adding the pocket 1610 to the retainer 1608 increases the compliance of a stiffer material such as titanium and reduces the force required to connect the handle alignment member 1604 to the handheld portion 16 and to separate the handle alignment member 1604 from the handheld portion 16.

[0231] Referring to FIG. 102, in another configuration, the instrument 14 can include a shroud 1700 that is coupled to the tool support 18 and the handheld portion 16 and extends between the tool support 18 and the handheld portion 16. The shroud 1700 can be included in the instrument 14 simultaneously with the tool alignment member 1702. The shroud 1700 can be formed from any suitable material such as plastic, rubber, composite, etc., or combinations thereof, that is compatible with a sterilization process such as an autoclave sterilization process or a hydrogen peroxide sterilization process. The shroud 1700 can be coupled to the blade support 18 and the handheld portion 16 using any suitable means such as clamps, fasteners, adhesives, etc., or combinations thereof. In some configurations, the shroud 1700 can surround at least one of the plurality of actuators 21, 22, 23. The shroud 1700 can include accordion folds that can expand and curve when the blade support 18 moves relative to the handheld portion 16. Also, in some configurations, the shroud 1700 defines at least two shroud landmarks 1708 (described in further detail below). In some configurations, there can be two or more, five or more, ten or more, or even a plurality of shroud landmarks 1708. When the blade support 18 moves relative to the handheld portion 16, the movement of the shroud landmarks 1708 relative to each other and the movement of the shroud landmarks 1708 relative to the tool alignment member 1702 provide a visual indication of the orientation of the tool support 18 relative to the handheld portion 16. The shroud 1700 and the various landmarks can be used with the handle alignment member, the tool alignment member, or both.

[0232] In some configurations, at least two shroud landmarks 1708 include at least a first visual indicator and a second visual indicator. In one example as shown in FIG. 102, at least one of the shroud landmarks 1708 may be a crease 1704, and another shroud landmark may be a colored section 1705 of the shroud 1700. In some configurations, the crease 1704 may be defined by an accordion fold. The crease 1704 may define a plane that may assist in visually indicating the orientation of the tool support 18 relative to the handheld portion 16. In some examples, the colored section 1705 may be disposed in a portion of the crease 1704 to accentuate the plane defined by at least one crease 1704, and the plurality of actuators 21, 22, 23 are in their respective home positions, and thus provide a visual indication to the tool alignment member 1702 that the instrument 14 has an optimal range of motion.

[0233] Although not shown in the drawings, additional alternative configurations of the shroud 1700 including alternative configurations of the shroud landmarks 1704, 1705 are contemplated. For example, the shroud 1700 may include alternative configurations of the shroud landmarks 1704, 1705 that dispose the color section 1705 along one or more sections of the crease 1704.

[0234] Additional clauses of the present invention are included below. I. A handheld surgical robot system for supporting a saw blade, a handheld portion, a blade support movably coupled to the handheld portion and configured to support a saw blade, an actuator assembly operably attached to the blade support and the handheld portion and configured to move the blade support relative to the handheld portion in a plurality of degrees of freedom, A tool alignment member coupled to and extending from the blade support; and a handle alignment member coupled to and extending from the handheld portion, the handheld surgical robot system comprising: wherein at least a portion of the tool alignment member and at least a portion of the handle alignment member are aligned when the blade support has a desired range of motion relative to the handheld portion. II. The actuator assembly includes a plurality of actuators, each of the plurality of actuators being configured to move between a first position and a second position to move the blade support relative to the handheld portion, the home position being a midpoint between the first position and the second position of each of the plurality of actuators, the blade support having a desired range of motion when at least two of the plurality of actuators are in the home position, the handheld robot system according to clause I. III. When the handheld portion is in a posture that does not provide a desired range of motion, the tool alignment member and the handle alignment member are misaligned, and the handheld portion provides a visual indication that the blade support is in a posture that does not provide a desired range of motion, the handheld robot system according to clause II. IV. The tool alignment member and the handle alignment member are arranged and sized relative to each other such that they do not collide at any point between the first position and the second position of each of the plurality of actuators, the collective first and second positions of each of the plurality of actuators defining a potential range of motion of the blade support relative to the handheld portion, the potential range of motion defining a space having a height of about 150 mm and a width of about 115 mm, the handheld robot system according to any one of clauses I to III. V. When a plurality of actuators move the blade support relative to the handheld portion, the tool alignment member and a portion of the handle alignment member are positioned above the grip of the handheld portion and visible from the proximal end of the blade support, the tool alignment member is disposed on the blade support and the handle alignment member is disposed on the handheld portion, the handheld robotic system according to any one of clauses I to IV. VI. A plurality of actuators are configured to adjust at least the pitch of the blade support relative to the handheld portion, a first spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of a first pitch relationship of the blade support relative to the handheld portion, a second spatial arrangement of the tool alignment member relative to the handle alignment member provides a second pitch relationship of the blade support relative to the handheld portion, the first spatial arrangement provides a visual indication that the tool alignment member and the handle alignment member are aligned and the blade support has a desired range of motion relative to the handheld portion, a second spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of the pitch of the blade support relative to the handheld portion, the distal portion of the tool alignment member is further from the tool plane than the proximal portion of the tool alignment member along the longitudinal axis in the direction of pitch, the handheld robotic system according to any one of clauses I to V. VII. A plurality of actuators are configured to adjust at least the height of the blade support relative to the handheld portion, a first spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of a first height relationship of the blade support relative to the handheld portion, a second spatial arrangement of the tool alignment member relative to the handle alignment member provides a second height relationship of the blade support relative to the handheld portion, The first spatial arrangement provides a visual indication that the tool alignment member and the handle alignment member are aligned and that the blade support has a desired range of motion relative to the handheld portion. The second spatial arrangement provides a visual indication of the height of the blade support relative to the handheld portion. The tool alignment member is at least partially above or below the handle alignment member in the height direction. The handheld robot system according to any one of Clauses I to VI. VIII. The plurality of actuators are configured to adjust at least the roll of the blade support relative to the handheld portion. The first spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of the first roll relationship of the blade support relative to the handheld portion. The second spatial arrangement of the tool alignment member relative to the handle alignment member provides the second roll relationship of the blade support relative to the handheld portion. The spatial arrangement provides a visual indication that the tool alignment member and the handle alignment member are aligned and that the blade support has a desired range of motion relative to the handheld portion. The second spatial arrangement provides a visual indication of the roll of the blade support relative to the handheld portion. The distal portion of the tool alignment member is further away from the tool plane than the proximal portion of the tool alignment member along the transverse axis in the direction of the roll. The handheld robot system according to any one of Clauses I to VII. IX. The tool alignment member includes a first tool alignment member and a second tool alignment member. The first tool alignment member and the second tool alignment member extend from both sides of the blade support. The handle alignment member includes a first handle alignment member and a second handle alignment member. The first handle alignment member and the second handle alignment member extend from the handheld portion. When the blade support has a desired range of motion relative to the handheld portion, the first tool alignment member and the first handle alignment member, and the second tool alignment member and the second handle alignment member intersect each other. The first and second tool alignment members, and the first and second handle alignment members, are a handheld robotic system according to any one of clauses I to VIII, visible from the proximal end for the blade support over the entire range of motion of the blade support relative to the handheld portion. X. A plurality of actuators are configured to adjust at least the pitch of the blade support relative to the handheld portion, and a first spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of a first pitch relationship of the blade support relative to the handheld portion, and a second spatial arrangement of the tool alignment member relative to the handle alignment member provides a second pitch relationship of the blade support relative to the handheld portion, The first spatial arrangement provides a visual indication that the tool alignment member and the handle alignment member are aligned and that the blade support has a desired range of motion relative to the handheld portion, and a second spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of the pitch of the blade support relative to the handheld portion, and at least one distal portion of the tool alignment members is further from the tool plane along the longitudinal axis in the pitch direction than the proximal portion of the tool alignment member, a handheld robotic system according to clause IX. XI. A plurality of actuators are configured to adjust at least the height of the blade support relative to the handheld portion, and a first spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of a first height relationship of the blade support relative to the handheld portion, and a second spatial arrangement of the tool alignment member relative to the handle alignment member provides a second height relationship of the blade support relative to the handheld portion, The first spatial arrangement provides a visual indication that the tool alignment member and the handle alignment member are aligned and that the blade support has a desired range of motion relative to the handheld portion, and the second spatial arrangement provides a visual indication of the height of the blade support relative to the handheld portion, and the tool alignment member is at least partially above or below the handle alignment member in the height direction, a handheld robotic system according to any one of clauses IX or X. XII. The plurality of actuators are configured to adjust at least the roll of the blade support relative to the handheld portion, and the first spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of the first roll relationship of the blade support relative to the handheld portion, and the second spatial arrangement of the tool alignment member relative to the handle alignment member provides the second roll relationship of the blade support relative to the handheld portion. The spatial arrangement is such that the tool alignment member and the handle alignment member are aligned, providing a visual indication that the blade support has a desired range of motion relative to the handheld portion, and the second spatial arrangement provides a visual indication of the roll of the blade support relative to the handheld portion. At least one distal portion of the tool alignment member is further from the tool plane along a transverse axis in the roll direction than the proximal portion of the tool alignment member, according to any one of Clauses IX to XI of the hand robot system described above. XIII. When the blade support has a desired range of motion relative to the handheld portion, the first tool alignment member and the second tool alignment member are each aligned with the first handle alignment member and the second handle alignment member, according to any one of Clauses IX to XII of the handheld robot system described above. XIV. The tool alignment member and the handle alignment member include a first mark and a second mark, the first mark is visually distinguishable from the second mark, the first mark is visible from the proximal end of the handheld portion when the tool alignment portion and the handle alignment member are misaligned, and the second mark is visible from the proximal end of the handheld portion when the tool alignment member and the handle alignment member are aligned, according to the handheld robot system described in Clause III. XV. The tool alignment member and the handle alignment member each have a first mark and a second mark, according to the handheld robot system described in Clause XIV. XVI. The first mark is the first color, the second mark is the second color, the first color is visible when the tool alignment member and the handle alignment member are aligned, and at least one of the second marks is visible when the tool alignment member and the handle alignment member are misaligned. The handheld robot system according to clause XV. XVII. The tool alignment member and the handle alignment member further include an upper surface and a side surface, The upper surface includes the first mark, the side surface includes the second mark, when the tool alignment member and the handle alignment member are misaligned with each other, the second mark is exposed, and provides an indication that one or more of the plurality of actuators have moved from the home position. The handheld robot system according to clause XVI. XVIII. The tool alignment member is a saw blade. The handheld robot system according to any one of clauses I to XVII. XIX. Further includes a tracker for a surgical navigation system, the tracker is removably coupled to the blade support, the tracker includes a tracking element for localizing the tool alignment member, and the tracker is part of the tool alignment member. The handheld robot system according to any one of clauses I to XVIII. XX. A handheld robot system for supporting a saw blade, A handheld portion, A blade support movably coupled to the handheld portion for supporting the saw blade, An actuator assembly operably attached to the blade support and the handheld portion, configured to move the blade support relative to the handheld portion in a plurality of degrees of freedom. The actuator assembly, A first tool alignment member and a second tool alignment member coupled to the blade support and extending from both sides of the blade support, A first handle alignment member and a second handle alignment member coupled to the handheld portion and extending from the handheld portion. A handheld robotic system for supporting a saw blade, wherein when the blade support has a desired range of motion relative to the handheld portion, the first tool alignment member and the second tool alignment member are each aligned with the first handle alignment member and the second handle alignment member. XXI. The actuator assembly includes a plurality of actuators, each of the plurality of actuators configured to move between a first position and a second position and to move the blade support relative to the handheld portion within a range of motion. The home position is a midpoint between the first position and the second position of each of the plurality of actuators, and the blade support and the handheld portion have a desired range of motion when each of the plurality of actuators is in the home position, the handheld robotic system according to clause XX. XXII. When the blade support and the handheld portion are moved to a position other than the home position, the first tool alignment member and the second tool alignment member are each displaced from the first and second handle alignment members, providing a visual indication that the blade support and the handheld portion are in a position where they do not have a desired range of motion, the handheld robotic system according to clause XXI. XXIII. The tool alignment member and the handle alignment member further include an upper surface and a side surface. The upper surface includes a first mark and the side surface includes a second mark, the first mark being different from the second mark, such that when the tool alignment member and the handle alignment member are displaced from each other, the second mark is exposed in one of the tool alignment member, the handle alignment member, or both, providing an indication that one or more of the plurality of actuators has moved from the home position, the handheld robotic system according to clause XXII. XXIV. The plurality of actuators are configured to adjust at least the pitch of the blade support relative to the handheld portion, and the first spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of the first pitch relationship of the blade support relative to the handheld portion, and the second spatial arrangement of the tool alignment member relative to the handle alignment member provides a second pitch relationship of the blade support relative to the handheld portion. The first spatial arrangement provides a visual indication that the tool alignment member and the handle alignment member are aligned and that the blade support has a desired range of motion relative to the handheld portion, and the second spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of the pitch of the blade support relative to the handheld portion. At least one distal portion of the tool alignment member is further from the tool plane along the longitudinal axis in the pitch direction than the proximal portion of the tool alignment member. The handheld robotic system according to clause XXIII. XXV. The plurality of actuators are configured to adjust at least the height of the blade support relative to the handheld portion, and the first spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of the first height relationship of the blade support relative to the handheld portion, and the second spatial arrangement of the tool alignment member relative to the handle alignment member provides a second height relationship of the blade support relative to the handheld portion. The first spatial arrangement provides a visual indication that the tool alignment member and the handle alignment member are aligned and that the blade support has a desired range of motion relative to the handheld portion, and the second spatial arrangement provides a visual indication of the height of the blade support relative to the handheld portion. The tool alignment member is at least partially above or below the handle alignment member in the height direction. The handheld robotic system according to clause XXIII or XXIV. XXVI. A plurality of actuators are configured to adjust at least the roll of the blade support relative to the handheld portion, and a first spatial arrangement of the tool alignment member relative to the handle alignment member provides a visual indication of a first roll relationship of the blade support relative to the handheld portion, and a second spatial arrangement of the tool alignment member relative to the handle alignment member provides a second roll relationship of the blade support relative to the handheld portion. The spatial arrangement provides a visual indication that the tool alignment member and the handle alignment member are aligned and that the blade support has a desired range of motion relative to the handheld portion, and the second spatial arrangement provides a visual indication of the roll of the blade support relative to the handheld portion. At least one distal portion of the tool alignment member is further from the tool plane than the proximal portion of the tool alignment member along a transverse axis in the roll direction, the handheld robotic system according to any one of clauses XXIII to XXV. XXVII. A visual indication system for use with a handheld robotic system, the handheld robotic system including a tool, a handheld portion, a blade support movably coupled to the handheld portion for supporting the tool, and a plurality of actuators operatively interconnected between the blade support and the handheld portion and configured to move the blade support relative to the handheld portion with a plurality of degrees of freedom, the visual indication system including a shroud coupled to the blade support and the handheld portion and extending between the blade support and the handheld portion and enclosing at least one of the plurality of actuators. The shroud defines at least two shroud landmarks configured to move relative to each other when the blade support and the handheld portion are displaced relative to each other to provide a visual indication of the orientation of the blade support relative to the handheld portion. XXVIII. The visual indication system according to clause XXVII, wherein at least two shroud landmarks include at least two folds that define planes that are substantially parallel in a first position, the planes being offset from each other by a first distance when in the blade support and the handle portion, and when the blade support and the handle portion are moved to a second position, the at least two defined planes intersect. XXIX. The visual indication system according to clause XXVIII, wherein the blade support defines a blade plane and the at least two folds are substantially parallel to the blade plane when the blade support and the handle portion are in the first position. XXX. At least two shroud landmarks include a first mark and a second mark, the first mark being visually distinguishable from the second mark, the first mark being a first color and the second mark being a second color, such that the first color is visible when the blade support is in the first position and at least one of the second marks is visible when the blade support is in the second position, of the visual indication system according to clause XXIX. XXXI. A hand-held robotic system for supporting a saw blade, comprising a handle portion, a blade support movably coupled to the handle portion for supporting the saw blade, a plurality of actuators operatively interconnected between the blade support and the handle portion and configured to move the blade support relative to the handle portion with a plurality of degrees of freedom, a light source in the blade support, a first tool alignment member and a second tool alignment member coupled to the blade support and extending from the blade support on both sides, a first handle alignment member and a second handle alignment member coupled to the handle portion and extending from the handle portion, When the blade support has a desired range of motion relative to the handheld portion, the first tool alignment member and the second tool alignment member are each aligned with the first handle alignment member and the second handle alignment member, A handheld robotic system in which a light source is illuminated when the blade support has a desired range of motion to indicate that the blade support and the handheld portion are within an alignment range designated by a cutting plane. XXXII. A handheld surgical robotic system for supporting a saw blade, A handheld portion, A blade support movably coupled to the handheld portion and configured to support a saw blade, A plurality of actuators operably interconnecting the blade support and the handheld portion and configured to move the blade support relative to the handheld portion with a plurality of degrees of freedom, A tool alignment member coupled to and extending from the blade support, A handle alignment member coupled to and extending from the handheld portion, comprising, A handheld surgical robotic system, wherein the handle alignment member is removably connected to the handheld portion. XXXIII. The handheld surgical robotic system according to clause XXXII, wherein the handle alignment member is magnetically connected to the handheld portion such that the handle alignment member is removably connected to the handheld portion. XXXIV. A surgical system for treating an anatomical structure according to a plurality of target planes, Comprising an instrument, the instrument comprising, A saw blade, A handheld portion, An actuator system including a plurality of actuators, A blade support for supporting and moving a saw, wherein a plurality of actuators extend between the blade support and the handheld portion, and the blade support includes a saw drive device coupled to a saw mount, the blade support and, A navigation system, and A tracker for coupling to the blade support, configured to determine a current tool plane, A tracker frame, and At least six optical markers coupled to the tracker, wherein the tracker frame includes at least two faces, the at least two faces are non-planar with respect to each other, and at least three of the at least six optical markers are coupled to each of the at least two faces, the tracker including the at least six optical markers, A control system in communication with the navigation system and the tracker, configured to control the actuator system to align the current tool plane with at least one of a plurality of target planes, the control system, comprising a surgical system. XXXV. An input device, and An antenna, and A control device coupled to the input device and the antenna, configured to provide an input signal to the navigation system, the control device, further comprising the surgical system according to clause XXXIV. XXXVI. The control system further (a) Detecting an input signal from an input device of the tracking unit, (b) Changing the position change of the blade support by the actuator system to align the tool support with a different one of a plurality of target planes Is configured to The navigation system is configured to determine a tool plane of the saw blade based on a target plane, the target plane being based on a selected target plane, the surgical system according to clause XXXV. XXXVII. The surgical system according to any one of clauses XXXIV to XXXVI, wherein the plurality of optical markers are at least 6 optical markers, and at least 3 of the at least 6 optical markers are coupled to each of at least 2 surfaces. XXXVIII. The surgical system according to any one of clauses XXXIV to XXXVII, wherein a plurality of trackers coupled on at least 2 surfaces are arranged as mirror images of each other. XXXIX. The surgical system according to any one of clauses XXXIV to XXXVIII, wherein a plurality of trackers coupled on at least 2 surfaces are arranged asymmetrically. XL. A surgical method for controlling a surgical system, the surgical system comprising a hand-held robotic instrument, the hand-held robotic instrument inc...

Claims

1. A handheld surgical robot system, comprising: A handheld portion defining a mount; A tool support movably coupled to the handheld portion, the tool support including a tool mount defining a tool plane; A working tool removably coupled to the tool support; An actuator assembly operably attached to the tool support and the handheld portion, the actuator assembly being configured to move the tool support relative to the handheld portion with a plurality of degrees of freedom; A handle alignment member removably coupled to the handheld portion; The handle alignment member having a coupler shaped to releasably engage the mount, the coupler being operable between: A holding state in which a holding force is applied to one of the mount and the coupler to prevent relative movement between the handle alignment member and the handheld portion; A separated state in which the holding force is not applied to one of the mount and the coupler. A handheld surgical robot system.

2. The handle alignment member separates from the handheld portion by a threshold force greater than the holding force, according to Claim 1 of the handheld surgical robot system described above.

3. The coupler has a shape complementary to at least a part of the handheld portion, according to Claim 1 of the handheld surgical robot system described above.

4. The coupler of the handle alignment member has a first arm and a second arm connected by a retainer, the first arm, the second arm, and the retainer being biased against the mount in the holding state to apply the holding force to the handheld portion, according to Claim 3 of the handheld surgical robot system described above.

5. Each of the first arm and the second arm includes a protrusion, and the mount includes a receiving channel in the handheld portion complementary to the protrusions in the first arm and the second arm, according to Claim 4 of the handheld surgical robot system described above.

6. The protrusion has a rounded shape, and the receiving channel is rounded to receive the protrusion, according to Claim 5 of the handheld surgical robot system described above.

7. ​ Each of the first arm and the second arm includes a rounded channel, and the mount includes complementary-shaped protrusions on at least two sides of the handheld portion, the handheld surgical robot system according to claim 4.

8. The handheld surgical robot system according to claim 1, further comprising a tool alignment member extending from the tool support, the tool alignment member including a tool alignment protrusion extending at least partially toward the handle alignment member.

9. The handheld surgical robot system according to claim 8, wherein the tool alignment member is removably connected to the tool support.

10. The handheld surgical robot system according to claim 8, further comprising a shroud between the handheld portion and the tool support around the actuator assembly, the shroud being attached to the tool support by a clamp, the clamp being the tool alignment member.

11. The handheld surgical robot system according to claim 1, wherein the handle alignment member is formed of plastic.

12. The handheld surgical robot system according to claim 1, wherein the handle alignment member is formed of titanium.

13. The handheld surgical robot system according to claim 12, wherein the handle alignment member is manufactured by 3D printing.

14. The handheld surgical robot system according to claim 12, wherein the handle alignment member includes a mark, the mark being at least one groove along the handle alignment member.

15. The handheld surgical robot system according to claim 4, wherein the coupler includes a shield between the coupler and the handheld portion.

16. The handheld surgical robot system according to claim 1, wherein the handle alignment member includes one or more marks.

17. The handheld surgical robot system according to claim 8, wherein the handle alignment member includes a first mark and the tool alignment member includes a second mark.

18. The handheld surgical robot system according to claim 17, wherein the first mark is a first color and the second mark is a second color.

19. The handheld surgical robot system according to claim 18, wherein each of the handle alignment member and the tool alignment member further includes an inclined surface and a side surface.

20. The handheld surgical robot system according to claim 19, wherein the inclined surface includes the first mark and the side surface includes the second mark.

21. The handheld surgical robot system according to claim 17, wherein the first mark is a first color and the second mark is at least one groove.

22. The handheld surgical robot system according to claim 4, wherein the biasing member is formed of plastic.

23. The handheld surgical robot system according to claim 4, wherein the biasing member is formed of titanium.

24. The handle alignment member further includes two handle alignment protrusions, and each of the handle alignment protrusions is connected to the first arm and the second arm respectively. The handheld surgical robot system according to claim 4, wherein the handle alignment member is integral.

25. The retainer according to claim 4, includes a pocket for increasing the elasticity of the coupler.

26. A handheld surgical robot system, A handheld portion, A tool support movably coupled to the handheld portion and configured to support a working tool, A plurality of actuators operably interconnecting the tool support and the handheld portion and configured to move the tool support relative to the handheld portion with a plurality of degrees of freedom, A shroud between the handheld portion and the tool support around the plurality of actuators, A tool alignment member coupled to the tool support and extending from the tool support, A handle alignment member extending from the handheld portion and removably connected to the handheld portion by a first connector. A handheld surgical robot system comprising.

27. The tool alignment member is removably connected to the handheld portion and includes a second connector, and the first connector of the handle alignment member and the second connector of the tool alignment member are different, the handheld surgical robot system according to claim 26.

28. The tool alignment member is removably connected to the handheld portion and includes a second connector, and the first connector and the second connector are of the same type of connection, the handheld surgical robot system according to claim 26.

29. The shroud is connected to the tool support by a clamp, and the clamp is the tool alignment member, the handheld surgical robot system according to claim 26.

30. The shroud defines at least two shroud landmarks configured to move relative to each other when the tool support and the handheld portion are offset relative to each other such that the handheld portion is in a posture that does not provide an optimal range of motion, in order to provide a visual indication of the posture of the tool support relative to the handheld portion. The at least two shroud landmarks include at least two folds that define planes that are substantially parallel and offset from each other by a first distance, and the tool support has an optimal range of motion relative to the handheld portion. The at least one fold moves a second distance relative to each other when the tool support and the handheld portion are offset relative to each other such that the handheld portion is in a posture that does not provide an optimal range of motion, in order to provide a visual indication of the posture of the tool support relative to the handheld portion, the handheld surgical robot system according to claim 26.

31. The shroud is a first color and the tool alignment member is a second color, and the first color and the second color are different colors, the handheld surgical robot system according to claim 26.

32. The first connector is a protrusion in the handle alignment member that is received by complementary channels in the handheld portion, and the second connector is a clamp that connects the tool alignment member to the tool support across the shroud, the handheld surgical robot system of claim 27.

33. A handheld surgical robot system, a handheld portion, a tool support movably coupled to the handheld portion and configured to support a working tool, a plurality of actuators operably interconnecting the tool support and the handheld portion and configured to move the tool support relative to the handheld portion in a plurality of degrees of freedom, a tool alignment member removably coupled to the tool support and extending from the tool support, a handle alignment member removably coupled to the handheld portion and extending from the handheld portion comprising, wherein the handle alignment member is connected to the handheld portion by a first connector, and the tool alignment member is connected to the handheld portion by a second connector, the handheld surgical robot system.

34. The handle alignment member is in a holding state for preventing relative movement between the handle alignment member and the handheld portion, and in a separated state in which the handle alignment member is detached from the handheld portion and is operable therebetween, the handheld surgical robot of claim 33.

35. The tool alignment member is in a holding state for preventing relative movement between the tool alignment member and the tool support, and in a separated state in which the tool alignment member is detached from the tool support and is operable therebetween, the handheld surgical robot of claim 33.

36. The handle alignment guide includes a coupler shaped to releasably engage a mount in the handheld portion, and in the holding state, a holding force is applied to one of the mount and the coupler to prevent relative movement between the handle alignment member and the handheld portion, the handheld surgical robot of claim 34.

37. The handle alignment member of the handheld surgical robot according to claim 36 is separated from the handheld portion by a threshold force greater than the holding force. **Claim 38** The tool alignment guide includes a connector shaped to releasably engage a mount on the tool support, and a holding force is applied to one of the mount and the connector to prevent relative movement between the tool alignment member and the tool support in the held state. The handheld surgical robot according to claim 36. **Claim 39** The tool alignment member of the handheld surgical robot according to claim 38 is separated from the tool support by a threshold force greater than the holding force.

Images