Torque limiting device, system and method

Abstract

Various torque limiting surgical devices and methods are disclosed. A surgical driver can include a body, a motor configured to rotate a drill bit engaged with the surgical driver, and a processor configured to control operation of the surgical driver. The surgical driver can have a torque limiting function, such as by monitoring an amount of torque applied to the drill bit and reducing or stopping rotation of the drill bit when certain torque limiting criteria are met.

Description

[0001] This application is a divisional application of application number 201980052230.3, filed on February 5, 2021, with the subject matter of "torque limiting device, system and method".

[0002] Cross-reference to related applications

[0003] This application claims the benefit of U.S. Provisional Application 62 / 719,874 entitled “Torque-limited Drilling”, filed on August 20, 2018, the entire contents of which are incorporated herein by reference. Technical Field

[0004] This disclosure generally relates to torque-limiting surgical actuators, systems, and methods, such as torque-limiting surgical actuators for use in orthopedic surgery. Background Technology

[0005] In some surgical procedures, medical professionals (such as surgeons) use manually driven instruments to drill into a patient's bone. With the increasing prevalence of powered surgical instruments, medical professionals no longer use manual surgical drilling instruments and methods when drilling and driving into a patient's bone. Powered surgical instruments operate at much faster speeds than hand-actuated, manual surgical instruments. However, despite the many benefits offered by such powered instruments, it can be difficult for medical professionals to determine when the drill has transitioned through different layers of bone and / or when it has penetrated the entire cross-section of the bone. Summary of the Invention

[0006] This application discloses a torque-limiting surgical device, comprising: a body including a handle configured for gripping by a user; a motor positioned within the body; a drive head configured to be rotated by the motor and drive a screw or drill; and a processor positioned within the body; wherein, under the control of the processor, the torque-limiting surgical device is configured to: apply torque to the screw or drill to drill into bone; monitor current or voltage supplied to the motor; determine a torque value applied to the screw or drill based on the current or voltage supplied to the motor as the screw or drill drills through the bone; determine that a torque-limiting condition is satisfied, wherein determining that the torque-limiting condition is satisfied includes: determining that the screw or drill has drilled in or through a first cortical layer of the bone; and determining that the screw or drill has drilled through a second cortical layer of the bone; and stopping the application of torque to the drill in response to determining that the torque-limiting condition is satisfied.

[0007] Furthermore, this application also discloses a torque-limiting surgical device, comprising: a body including a handle; a motor positioned within the body; a drive head configured to be rotated by the motor and drive a drill or screw; and a processor positioned within the body; wherein, under the control of the processor, the torque-limiting surgical device is configured to: drive the drill or screw into the bone; monitor a torque value while the drill or screw is being drilled into the bone; determine whether the drill or screw has drilled through a first cortical layer of the bone; determine whether the drill or screw has drilled through a second cortical layer of the bone and has exited the second cortical layer of the bone; and stop drilling of the drill or screw in the bone in response to determining whether the drill or screw has drilled through a second cortical layer of the bone and has exited the second cortical layer of the bone.

[0008] It may be beneficial to detect when a surgical drill is drilling through a specific layer of bone, transitioning between different layers of bone, and / or has penetrated the entire cross-section of bone. Such detection can avoid or reduce potential damage to tissues near the patient's bone, such as tissues or nearby organs. For example, it may be beneficial for the surgical drill to differentiate between different densities of bone to provide continuous feedback on the current position of the drill bit within the bone. This "tissue differentiation" or "density differentiation" may help prevent the drill bit from "jumping forward" through and / or outside the bone, which could cause damage to tissues near or adjacent to the bone. This can be achieved using a surgical actuator that monitors the torque applied to the drill bit and stops or reduces the rotation of the drill bit when certain torque criteria are met. For example, these criteria could include the amount of torque applied, how the torque changes over time (e.g., whether the torque increases or decreases consistently or inconsistently), how the current torque value is compared to previously measured torque values, and / or thresholds. Certain comparisons or thresholds of the measured torque values ​​can help determine whether the sensed current or recent torque value indicates that the drill bit is located at (or is drilling through) a harder portion of the bone, which in turn can indicate that the drill bit will exit the bone cross-section. Additionally or alternatively, certain comparisons or thresholds of the measured torque values ​​can help determine whether the sensed current or recent torque value indicates that the drill bit has penetrated the bone. As discussed further below, the surgical actuator can detect whether the drill bit is drilling through or has drilled through a harder (cortical) portion of the bone surrounding a softer (cancellous) portion, and / or whether the drill bit has drilled through one or both of the entry and exit portions of the harder (cortical) portion. Some embodiments are configured to detect that the drill bit has penetrated softer tissue and then stop when encountering and / or beginning to drill into harder tissue or shortly thereafter. For example, detecting that the drill bit has penetrated the spinal disc and is at the vertebra. Some embodiments operate using algorithms such as those described herein, but without those steps that are related to and / or dependent on detecting the first cortical layer of bone.

[0009] Various surgical actuators and associated systems and methods for solving one or more of the problems discussed above are disclosed. Embodiments of the surgical actuators, systems, and methods can be used in many different surgical procedures, such as reconstructive surgery, clavicle surgery, craniofacial surgery, thoracic surgery, spinal surgery, fracture repair surgery, and limb surgery. Furthermore, during reconstruction, the embodiments can be used for joint replacement (such as for patients with arthritis), where reconstructive surgery can restore joint function by replacing the joint. This can include knee, hip, and shoulder surgeries, although other surgical procedures can also be used. Fracture repair can be used on bones that have undergone trauma, such as large bones like the femur. Further, limbs can be reconstructed, which can include joints such as the ankle, wrist, hand, fingers, foot, and toes. Each of the determined torque values ​​can vary depending on the specific application, such as those discussed above. The embodiments can be used in and beyond the fields of orthopedic surgery.

[0010] Some embodiments are configured to represent differences in torque characteristics. In some embodiments, the surgical actuator can distinguish between different body tissues (e.g., different bone tissues), so that the user will know where they are operating (e.g., where the end of the drill is located). In some embodiments, the surgical actuator is configured to reduce or avoid penetration of bone (e.g., the clavicle), such as with a drill.

[0011] A surgical actuator may include a body and a motor. The motor may be operatively connected to a drive head at the distal end of the surgical actuator, such that the motor can rotate the drive head. The drive head may receive a drill bit. The drill bit may be positioned at a desired drilling location on a substrate (e.g., bone), and the motor may be operated to drive the drill bit into the substrate. Various embodiments of the surgical actuator may limit and / or control the torque applied to the drill bit. Some embodiments reduce the speed of the drill bit during the drilling process. Various embodiments provide one or more of the advantages described above, or other advantages.

[0012] In some embodiments, the power unit (such as a surgical actuator) may be capable of determining torque (e.g., by reading current and / or voltage), and a controller (inside or outside the device) may be configured to implement torque limiting functionality. In some embodiments, the device may be programmed to use current, voltage, and / or torque values ​​to identify the substrate through which the drill is drilling and to manage the drive speed accordingly. In some embodiments, the device may be programmed to use current, voltage, and / or torque values ​​to identify variations in the drill path through denser or less dense materials (such as through harder or softer portions of bone). In some embodiments, the device may use discrete current, voltage, and / or torque values ​​to identify cortical and cancellous bone and may use these values ​​to indicate the current substrate of the drill and control the power unit accordingly. For example, some implementations are configured to stop the device if a higher-density tissue type (such as the cortical portion of bone) is detected.

[0013] This document discloses an embodiment of a torque-limiting surgical actuator, comprising: a body including a handle configured for gripping by a user; a motor positioned within the body; a drive head configured to be rotated by the motor and receive a drill bit; a power source configured to supply power to the motor; and a processor positioned within the body; wherein, under the control of the processor, the torque-limiting surgical actuator is configured to: apply torque to the drill bit for drilling into bone; monitor the current or voltage supplied to the motor; determine a torque value applied to the drill bit based on the current or voltage supplied to the motor as the drill bit drills through the bone; determine that a torque limiting condition has been met, wherein determining that the torque limiting condition has been met includes: determining that the drill bit has drilled in or through a first cortical layer of the bone; and determining that the drill bit has drilled through a second cortical layer of the bone; and stopping the application of torque to the drill bit in response to determining that the torque limiting condition has been met.

[0014] In some embodiments, the torque-limiting surgical actuator is configured to determine whether the drill has drilled in the first cortical layer of the bone or has drilled through the first cortical portion of the bone by comparing the difference between a first pair of consecutive torque values ​​with a first threshold. In some embodiments, the torque-limiting surgical actuator is configured to determine whether the drill has drilled in the first cortical layer of the bone or has drilled through the first cortical portion of the bone by further comparing the difference between a second pair of consecutive torque values ​​with the first threshold. In some embodiments, if the difference between the first pair of consecutive torque values ​​is not greater than or equal to the first threshold, the torque-limiting surgical actuator is further configured to compare the difference between a first pair of discontinuous torque values ​​with a second threshold, wherein the second threshold is greater than the first threshold. In some embodiments, if the difference between the first pair of discontinuous torque values ​​is not greater than or equal to the second threshold, the torque-limiting surgical actuator is further configured to compare a second pair of discontinuous torque values ​​with the second threshold.

[0015] In some embodiments, the torque-limiting surgical actuator is further configured to determine at least one of the following: whether the drill has drilled an entry point through a second cortical portion of the bone; and whether the drill is drilling within the second cortical portion of the bone. In some embodiments, the torque-limiting surgical actuator is configured to determine whether the drill has drilled an entry point through a second cortical portion of the bone by comparing the difference between a second pair of consecutive torque values ​​obtained after a first pair of consecutive torque values. In some embodiments, the second threshold is equal to a percentage of the average of a subset of all determined torque values. In some embodiments, the subset of all determined torque values ​​is equal to all determined torque values ​​greater than or equal to a third threshold, wherein the third threshold represents drilling through a material other than air. In some embodiments, the torque-limiting surgical actuator is configured to determine whether the drill is drilling within the second cortical portion of the bone by comparing the difference between a current torque value and a maximum measured torque value with a second threshold.

[0016] In some embodiments, in response to determining that the drill bit has drilled an entry point through the second cortical portion of the bone or in response to determining that the drill bit is drilling in the second cortical portion of the bone, the torque-limiting surgical actuator is further configured to determine an average torque value, the average torque value representing a torque value measured while the drill bit is drilling in the second cortical portion of the bone. In some embodiments, the torque-limiting surgical actuator is further configured to determine a difference between a first torque value and the average torque value, the first torque value being a current torque value measured by the torque-limiting surgical actuator.

[0017] In some embodiments, the surgical actuator is configured to limit the amount of torque applied to the drill bit in response to determining that the first torque value is less than the average torque value. In some embodiments, the torque-limiting surgical actuator is further configured to: determine the difference between a second torque value and the average torque value, the second torque value being measured prior to the first torque value; and limit the amount of torque applied to the drill bit in response to determining that both the first torque value and the second torque value are less than the average torque value.

[0018] This document discloses a method for controlling a torque limiting driver to limit the amount of torque applied to a drill after bone breaching. In some embodiments, the torque limiting driver includes a body having a handle, a motor positioned within the body, a drive head configured to receive and be rotated by the motor to allow the drill to drill into the bone, and a processor. In some embodiments, under the control of the processor, the method includes: driving the drill into the bone, wherein the bone includes a first cortical layer, a second cortical layer, and a cancellous layer between the first and second cortical layers; detecting a torque value as the drill is drilling into the bone; determining whether the drill has drilled into the first cortical layer of the bone; determining whether the drill has drilled through and exited the second cortical layer of the bone; and stopping the driving of the drill in response to determining that the drill has drilled through and exited the second cortical layer of the bone. In some embodiments, the step of determining whether the drill has drilled into the first cortical layer of the bone includes comparing the difference between a first pair of consecutive torque values ​​with a first threshold. In some embodiments, the method further includes determining at least one of the following: whether the drill has drilled an entry point through the second cortical layer of the bone; and whether the drill is drilling in the second cortical layer of the bone.

[0019] In some embodiments, in response to determining that the drill bit has drilled through the entry point of the second cortical layer of the bone or in response to determining that the drill bit is drilling in the second cortical layer of the bone, the method further includes determining an average torque value, the average torque value representing a torque value measured while the drill bit is drilling in the second cortical layer of the bone. In some embodiments, the method further includes determining a difference between a first torque value and an average torque value, the first torque value being a current torque value measured by the torque-limiting surgical actuator. In some embodiments, the method further includes limiting the amount of torque applied to the drill bit in response to determining that the first torque value is less than the average torque value.

[0020] Any of the structures, materials, steps, or other features disclosed above or elsewhere herein may be used in any of the embodiments of this disclosure. Any structure, material, step, or other feature of any embodiment may be combined with any structure, material, step, or other feature of any other embodiment to form further embodiments, which are part of this disclosure.

[0021] The foregoing summary is intended to be a high-level overview of certain features within the scope of this disclosure. The summary, the following detailed description, and the associated drawings do not limit or restrict the scope of protection. The scope of protection is defined by the claims. No single feature is critical or indispensable. Attached Figure Description

[0022] Certain features of this disclosure are described below with reference to the accompanying drawings. The embodiments shown are intended to illustrate, not limit, the embodiments. Various features of the different disclosed embodiments can be combined to form other embodiments, which are part of this disclosure.

[0023] Figure 1 An example implementation of a surgical actuator is illustrated schematically.

[0024] Figure 2A It shows Figure 1 Perspective view of the surgical actuator.

[0025] Figure 2B It shows that it can be used with Figure 1 An attachment used in conjunction with a surgical drive.

[0026] Figure 3 An example end view of the handle shape of an embodiment for a surgical actuator is shown.

[0027] Figures 4 to 7 An example of a surgical actuator is shown, which includes a body with a handle that includes a power source such as a battery.

[0028] Figure 8 The cross-section of the drill bit and the skeleton according to various aspects of this disclosure is schematically shown.

[0029] Figure 9 An example method of torque-limited drilling according to various aspects of this disclosure is shown.

[0030] Figure 10 It shows what can be used for Figure 9 The method for analyzing the position of drilled parts.

[0031] Figure 11 Showing more details Figure 10 It is part of the method.

[0032] Figure 12 Showing more details Figure 10 It is part of the method.

[0033] Figure 13 It shows Figure 10 Additional features of the method. Detailed Implementation

[0034] The various features and advantages of the disclosed technology will become more apparent from the following description of several specific embodiments illustrated in the accompanying drawings. These embodiments are intended to illustrate the principles of this disclosure. However, this disclosure should not be limited to the embodiments shown. As will be apparent to those skilled in the art when considering the principles disclosed herein, features of the illustrated embodiments may be modified, combined, removed, and / or substituted.

[0035] Surgical drive overview

[0036] Various embodiments of torque limiting devices, systems, and methods are disclosed. For illustrative purposes, these devices are referred to as "surgical drivers." A surgical driver can be any power device capable of drilling a drill bit into, for example, a patient's bone. Several embodiments are configured to drive a drill bit into bone. However, the features, characteristics, and / or operation of the surgical drivers described herein may also be available in other contexts. For example, the features, characteristics, and / or operation of the surgical drivers described herein can be applied to driving screws into bone. Additionally, although the phrase "surgical driver" is used herein, this phrase does not limit this disclosure to the "surgical" context only. Rather, the devices, methods, systems, features, characteristics, and / or operation discussed herein may also be applied to other contexts.

[0037] As described more fully below, the apparatus, system, and method can determine when to stop a drill being driven into various types of bone and / or various layers of bone to avoid “plunging” through the bone and potentially damaging nearby tissue. The term “plunging” refers to the transition of the drill from a state where it is drilling through bone to a state where it is breaching the bone and advancing away from the bone and into and / or through nearby tissue close to said bone.

[0038] Certain embodiments of the disclosed surgical actuator can be used as, for example, an anon-plane form factor powered surgical device, an anon-plane form factor powered surgical device for clavicle applications, an anon-plane form factor powered surgical device for spine applications, an anon-plane form factor powered surgical device for limbs, and / or an anon-plane form factor powered surgical device for large bones. The surgical actuator can also be used for other procedures, and the specific procedures described are not limiting. In some embodiments, the surgical actuator can be remotely operated, for example, by using a robot.

[0039] like Figure 1 As shown, the torque-limiting surgical actuator 100 may include a body 102 (also referred to as a “housing,” “handle,” or “enclosure”) supporting a motor 12. A transmission assembly 14 (e.g., one or more shafts, gears, etc.) operatively connects the motor 12 to a drive head 104 at the distal end of the surgical actuator 100, allowing the motor 12 to rotate the drive head 104. The drive head 104 may receive a drill bit 200 (also referred to herein as a “drill”) capable of drilling through various portions of a patient’s bone. Thus, the drill bit 200 may be positioned at a desired location on a substrate (e.g., bone), and the motor 12 may be operated to drive the drill bit 200 into the substrate. In some applications, the motor 12 may be operated to rotate the drive head 104 to drive the drill bit 200 into and / or through various portions of bone (such as the clavicle). In some embodiments, the drive head 104 may receive the drill bit, which engages with and drives a surgical screw of other fasteners.

[0040] In some variations, motor 12 is powered by an energy source such as AC or DC power. In some embodiments, motor 12 is powered by an on-board energy source 28 such as a battery, capacitor, or other power source. In some embodiments, motor 12 is configured to receive energy from an external source such as a console, wall socket, or other external energy source. In some embodiments, motor 12 is a brushless DC motor. In some embodiments, motor 12 is a three-phase motor. Motor 12 may include one or more Hall sensors that can send signals to controller 20 to enable controller 20 to determine the rotational speed of motor 12. In some variations, controller 20 determines the rotational speed of drill bit 200 based on the rotational speed of motor 12.

[0041] The surgical actuator 100 can monitor and / or limit the torque being applied to the drill bit 200 during the drilling process. For example, as described in more detail below, the surgical actuator 100 may include a sensor 18 that senses the current supplied to the motor 12. The sensor 18 may transmit this data to a controller 20, which may include a processor 22 coupled to a memory 24, and other electronic components. Because, in some embodiments, the current supplied to the motor 12 may be proportional to the torque applied to the drill bit 200, the controller 20 can dynamically determine the amount of torque being applied to the drill bit 200. In some variations, the controller 20 is configured to determine or receive signals representing one or more of the following data characteristics: the current supplied to the motor 12, the rotational speed of the drill bit 200 and / or the motor 12, the speed of the motor 12, or others.

[0042] As described in more detail below, various embodiments of the surgical actuator 100 may include one or more algorithms suitable for limiting and / or controlling the torque applied to the drill bit 200. The algorithm may be included as program code 26 in memory 24 for implementation on a computer-readable, non-transitory medium. Processor 22 may run program code 26 to perform various operations, such as determining torque limits, commanding motor 12 to stop operating, commanding energy source 28 to reduce and / or stop supplying power to motor 12, or other operations. Processor 22 and / or program code 26 may control and / or implement any of the features described in this disclosure, such as any of the torque limiting features. Some embodiments are configured to stop the rotation of the drill bit 200 by (e.g., substantially or completely) cutting off energy to motor 12. Some embodiments have brakes capable of actively decelerating motor 12 or components. For example, some embodiments include friction or electromagnetic brakes.

[0043] In various embodiments, the surgical drive 100 may include one or more computers or computing devices that implement the various functions described herein under the control of program modules stored on one or more non-transitory computer storage devices (e.g., hard disk drives, solid-state storage devices, etc.). Each such computer or computing device typically includes a hardware processor and memory. Where the surgical drive 100 includes multiple computing devices, these devices may (but do not need to) be co-located. In some cases, the surgical drive 100 may be controlled by cloud-based or shared computing resources that can be dynamically allocated. The processes and algorithms described herein may be implemented, in part or in whole, in application-specific circuitry such as application-specific integrated circuits and programmable gate array devices. The results of the disclosed processes and process steps may be permanently or otherwise stored in any type of non-transitory computer memory, such as volatile or non-volatile memory.

[0044] Figure 2A An example of a surgical actuator 100 is further illustrated. As shown, the body 102 of the surgical actuator 100 may include an input device 106, such as a button, switch, or others. Through the input device 106, a user can control various aspects of the operation of the surgical actuator 100 (such as controller 20). For example, the user can command the surgical actuator 100 in terms of rotational direction (e.g., forward or backward), speed, and / or other aspects. The input device 106 can turn the surgical actuator 100 on or off, or keep the surgical actuator 100 in a standby mode. In some embodiments, the surgical actuator 100 may have a variable speed option and forward and backward movement capabilities.

[0045] In some implementations, different attachments can be removably attached to the surgical actuator 100, for example, at the collet of the surgical actuator 100. An example of attachment 110 is shown in... Figure 2BAs shown in the diagram. Attachment 110 can allow the user to access more difficult-to-reach areas; for example, as shown, the attachment can include an offset, which is approximately 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, or other values. Attachment 110 can change the plane of rotation of surgical actuator 100. Furthermore, attachment 110 can be an extension for further access to various positions. Attachment 110 can be selectively attached to and / or removed from surgical actuator 100, for example, by attaching to or disconnecting from the clamp of surgical actuator 100. As shown, attachment 110 can include a low-profile and / or elongated configuration and can extend the range of motion. This can be advantageous in certain types of procedures, such as certain chest procedures involving a posterior approach for accessing the anterior ribs. In some embodiments, attachment 110 includes an extension adapter having a first end 111 and a second end 112. The first end 111 may be configured to engage with the drive head 104 of the surgical actuator 100. The second end 112 may include a drill bit and / or may be configured to engage with a drill bit and / or may be configured to engage with a screw. Attachment 110 may include a power transmission assembly (e.g., a drive shaft) operably connecting the drive head 104 of the surgical actuator 100 to the second end 112 of attachment 110. For example, the power transmission assembly may transmit rotational motion from the drive head 104 to the second end 112 of attachment 110. In various embodiments, the attachment 110 is configured to penetrate into a target site (e.g., bone) spaced considerably from the body 102 of the surgical actuator 100 (e.g., at least approximately: 10 mm, 25 mm, 50 mm, 75 mm, 100 mm, 150 mm, 200 mm, 250 mm, 300 mm, distances between the foregoing, or other distances). In some embodiments, the attachment 110 has a reflective and / or mirror-like surface that may be added, attached, or integrated into the attachment 110 to enhance visibility of the target site. The attachment 110 may be articulated or fixed relative to the body 102 of the surgical actuator 100. The attachment 110 may be configured for use with the surgical actuator 100, which may include a torque-limiting function. In some embodiments, the attachment 110 is configured for use with actuators that do not include a torque-limiting function.

[0046] In some embodiments, the surgical actuator 100 may include a mode switch (or similar mechanism) that allows a user to switch between various modes, such as power mode and manual mode discussed below. In some embodiments, the mode switch may change the parameters of the surgical actuator 100 based on a specific type of drill bit. In some embodiments, the mode switch may allow the surgical actuator 100 to recognize the presence of different adapters or attachments.

[0047] In some embodiments, the body 102 may provide a user with visual output regarding certain parameters of the surgical actuator 100, such as energy state, mode, speed, or others. Some embodiments are configured to provide trajectory orientation, for example, by using a MIMS (Medical Information Management System), MEMS (Micro-Electromechanical System), gyroscope, or other technologies that can prompt the user regarding the orientation of the surgical actuator. In some embodiments, the surgical actuator 100 is configured to indicate (e.g., to the user) deviations from a "zeroing" orientation, such as angular deviations relative to a horizontal or vertical position. In some embodiments, the body 102 may include an LED or LCD display for providing information to the user. In some embodiments, the surgical actuator 100 may be connected to an external display (e.g., a monitor) via a wireless network to provide visual output to the external display. In some embodiments, tactile cues (e.g., small vibrations) may provide information to the user. In some embodiments, electromagnetic field (EMF) or Hall effect sensors may be incorporated into the implementation of the surgical actuator 100.

[0048] This disclosure envisions various shapes for the surgical actuator 100. For example, some embodiments are on-plane, which can enhance the feel. In this disclosure, the term "on-plane" describes a device having a generally linear arrangement. This contrasts with an "off-plane" device, which typically has an L-shaped arrangement, such as a pistol grip. In some embodiments, the surgical actuator 100 has a on-plane configuration in which the end is generally in a straight line with the user's hand, for example, the end and handle are generally collinear. In some variations, the surgical actuator 100 has an off-plane configuration, such as having a pistol grip shape.

[0049] Planar configurations offer numerous advantages. For example, a planar configuration allows the user to apply force to the screw along a linear axis via a surgical actuator, rather than, for example, via a curve or elbow. In some implementations, the planar design reduces or eliminates torques that may be associated with certain pistol grip-shaped designs, such torques as those caused by forces applied to the handle of the pistol grip and then transmitted through the tube of the pistol grip. Reducing or eliminating torque can increase control over the screw and / or reduce user fatigue (e.g., by reducing the effort required to counteract the torque). Some implementations with a planar configuration can avoid or reduce slippage of the drill 200 relative to the substrate, or at least increase the chance that such slippage will occur substantially in the desired direction. For example, compared to a pistol grip-shaped design, a planar arrangement allows the fingers to be positioned closer to the drill, which allows the user to better detect when or about to slippage and act accordingly.

[0050] In some implementations, a planar configuration allows the user to use larger muscles (e.g., upper arm muscles) compared to a pistol grip-shaped device (e.g., which may require the use of wrist muscles or other smaller muscles). The engagement of larger muscles can provide greater power and / or control. In some implementations, there may be no cantilever or no pistol grip.

[0051] A planar arrangement can provide improved weight distribution, such as by removing weight from the cantilever of the handle. In some arrangements, the planar configuration can enhance sensitivity, allowing the user to discern the characteristics of the drill bit and / or substrate. For example, while larger muscles control the initial drive, the fingers (positioned closer to the distal end compared to an off-plane arrangement) can be used for final manipulation. Therefore, the user can use their fingers for fine-tuning, which provides greater dexterity when operating the surgical actuator. Furthermore, a planar arrangement can suppress vibrations because the surgical actuator is held by larger arm muscles. Moreover, by stabilizing with upper arm muscles and manipulating with the wrist / fingers, the surgical actuator can exhibit less migration, especially migration caused by unwanted bumps, compared to an off-plane arrangement that uses a larger torque arm and is therefore more susceptible to abrupt movements / movements.

[0052] In some implementations, the sleek form factor of the device can reduce package size, resulting in cost savings. Certain implementations can facilitate the transition from a manual surgical actuator to a powered surgical actuator, increase end-effector visibility and visibility of the tissue being driven into it, and / or reduce the weight of the surgical actuator (which can reduce user fatigue).

[0053] In some embodiments, the surgical actuator 100 may be partially or completely cannulated and / or configured to be cannulated. This may allow guidewires and / or k-wires (or other wires, the type of which is not limiting) to pass through the surgical actuator 100. Furthermore, the cannulation configuration may allow aspiration to be used in conjunction with the surgical actuator 100. The cannula may extend throughout the entire surgical actuator 100 (e.g., from back to front), or may include a hole on the side of the body 102 that provides access to (or near the end of) the surgical actuator 100. The cannula may typically extend along (or parallel to) the longitudinal axis of the surgical actuator 100.

[0054] Furthermore, in some embodiments, the motor 12 within the surgical actuator 100 may itself be cannulated. Thus, the cannula may extend through at least a portion of the motor within the surgical actuator 100. The motor 12 may be partially or completely cannulated and / or configured to be cannulated. The cannula may extend through the entire motor 12 (e.g., from rear to front), or may include a hole on the side of the body 102 that provides access to (or near) the end of the surgical actuator 100. In some embodiments, the cannula may typically extend along (or parallel to) the longitudinal axis of the motor within the surgical actuator 100. The cannulated motor can be used in a variety of different applications, including, for example, in powered surgical devices, in planar powered surgical devices, in planar powered surgical devices for clavicle applications, in planar powered surgical devices for spine applications, in planar powered surgical devices for limbs, and / or in planar powered surgical devices for applications involving larger bones. However, the cannulated motor can also be used in other surgical procedures, and specific procedures are not limiting.

[0055] In some embodiments, the body 102 may include handles (or grips) of different shapes. Different handles may be used to replace a portion of the body 102 and, therefore, may be integrally formed with the body 102 in some embodiments. In some embodiments, different handles may be detachable from the proximal end of the body 102, allowing the user to select which particular handle is suitable for a specific purpose (e.g., surgical procedures). In some embodiments, the handle may be swapped out by the surgeon during surgical procedures. For example, the handle may have an attachment mechanism to the body 102, such as via male / female threads, snaps, fasteners, or other non-limiting removable attachment devices.

[0056] Handles can be made of a variety of different materials, such as metal, plastic, or rubber, and can come in a variety of different shapes. Handles can also include gripping features (such as bumps or recesses) to make them easier for the user to control. Figure 3 An example cross-sectional shape of a handle 30 that can be used with the surgical actuator disclosed herein is shown. As shown, these handles 30 can have a generally "T" shaped shape (…). Figure 3 (left side) or roughly circular or spherical shape ( Figure 3 (Right side). Although these two specific handles 30 are shown, other handles may also be used, such as the typical "J" shaped pistol grip or closed loop handle, or others. Figure 3 The specific handle shape and size are not limiting.

[0057] Figures 4 to 7 Another example of a surgical actuator 100 is shown. The surgical actuator 100 has a body 102 with a handle that can be gripped by a user. In the illustrated embodiment, the handle has a pistol grip configuration. In some embodiments, the surgical actuator 100 is approximately 7 inches long. The surgical actuator 100 may have a power source, such as a battery 28. The power source 28 may be housed within the body 102, for example, within the handle.

[0058] Figure 5 The bottom opening of the body 102 is shown. The body 102 may have multiple cavities, such as a first cavity 42 designed to hold the battery 28 and a second cavity 44 designed to hold electronic components (such as a circuit board). After the circuit board is installed, a cover plate can be attached to seal the second cavity 44 to prevent moisture intrusion. Inserting both the circuit board and the battery into the handle allows for a reduction in the length and profile of the surgical actuator 100.

[0059] Figure 6 A battery 28 is shown placed in the handle of the body 102 of the surgical actuator 100. In some embodiments, the battery 28 is completely enclosed within the body 102. A completely enclosed battery 28 ensures that it is not exposed to biomaterials during operation. In some embodiments, the battery 28 is contained and / or sealed with a door. Figure 7 The battery 28 is shown inside the handle. The surgical actuator design may include a mechanism that covers the battery 28 from the bottom and forces it upwards into the handle. This feature ensures that the battery 28 engages with the power contacts of the surgical actuator 100 during use. In some embodiments, this mechanism may be hinged to one side to function like a trapdoor. In other embodiments, this mechanism may be pinned to a corner to rotate over or away from the cavity, thereby allowing the battery 28 to be inserted.

[0060] Various embodiments of the surgical actuator 100 have a variety of different operating characteristics. For example, some embodiments provide a maximum rotational speed (at no load) of at least approximately the following values: 3000 rpm, 4000 rpm, 5000 rpm, 6000 rpm, 10000 rpm, values ​​between the foregoing values, or other values. Some embodiments can slow down the rotation of the drill 200 after a deceleration point has been reached. Some such embodiments have a deceleration rate (at no load) less than or equal to approximately the following values: 500 rpm, 600 rpm, 700 rpm, 800 rpm, 900 rpm, 1000 rpm, 1100 rpm, 1200 rpm, values ​​between the foregoing values, or other values. Some embodiments of the surgical actuator 100 can provide torque on the drill 200 of at least approximately the following values: 25 in-oz, 30 in-oz, 35 in-oz, 40 in-oz, 45 in-oz, values ​​between the foregoing values, or other values. Some embodiments of the surgical actuator 100 may provide torque on the drill 200 at least approximately the following values: 25 N-cm, 30 N-cm, 35 N-cm, 40 N-cm, 45 N-cm, values ​​between the foregoing, or other values.

[0061] Various embodiments of the surgical actuator 100 include a positive input that a user can engage to command the surgical actuator 100 to rotate the drill 200 in a positive direction (such as in the direction used for drilling the drill 200 into the bone). For example, the positive input can be a switch, button, dial, trigger, slider, touchpad, etc. Some embodiments have multiple input elements, such as a fast-forward switch (e.g., the motor will rotate at approximately 4100 RPM when unloaded) and a slow-forward switch (e.g., the motor will rotate at 500 RPM when unloaded). Some embodiments have a reverse input that can command the surgical actuator 100 to rotate the drill 200 in an opposite direction, such as in the direction for removing the drill 200 from the bone. The reverse input can be similar to the positive input, such as the options described above. In some embodiments, engaging the reverse input causes the motor to rotate at approximately 500 RPM when unloaded. In some embodiments, the final rotational speed of the drill 200 is approximately 500 RPM. In some implementations, the forward input and the override input are the same component. In some implementations, the surgical actuator 100 may include an input device 106 (such as a button, switch, or others) that allows the user to select an operating mode. For example, the user may choose between a mode in which the actuator stops drilling before a break occurs (e.g., before the drill bit emerges from the opposite side of the bone) and a mode in which the actuator stops drilling after a break occurs.

[0062] In various embodiments, the surgical actuator 100 includes components configured to regulate torque data, such as by filtering the torque data, reducing noise in signals from sensor 18 (e.g., a motor current sensor), or otherwise. For example, the surgical actuator 100 may include one or more low-pass filters. The filters may be implemented in hardware and / or software. For example, in some embodiments, the filters include a resistor-capacitor circuit system. Some embodiments include software filters configured to filter out certain frequencies and / or levels of torque data. In various embodiments, filtering components can contribute to a smoother torque profile. In some variations, filtering components can reduce errors in torque limiting functions that might be caused by noise and / or outlier measurements without filtering. In some embodiments, the conversion of current, voltage, power, etc., to torque values ​​(e.g., nm, inch-ounce, etc.) can be performed using lookup tables or mathematical equations.

[0063] In some embodiments, the surgical actuator may incorporate additional features that can (e.g., by a higher initial torque value) identify and / or differentiate the starting torque of an already in place screw from the starting torque of a screw that has just begun to move. This can inhibit or prevent the device from continuing to drive and potentially stripping the already in place screw. Further disclosures regarding torque-limiting surgical devices (such as those concerning dynamically determining and / or limiting torque to inhibit or prevent screw stripping or damage to the patient's bone when attempting to secure a plate to bone with screws) can be found in U.S. Patent No. 10,383,674, filed June 6, 2017, which is incorporated herein by reference in its entirety. Any of the features described in the '674 patent may be incorporated into the systems, devices, and methods disclosed herein.

[0064] Overview of substrate identification and / or differentiation

[0065] In some embodiments, data input (e.g., measurements performed during or throughout the drilling process) can be used by the surgical actuator 100 to make certain determinations. For example, the surgical actuator 100 can be configured to use the data input to differentiate and / or identify different types of tissue being driven into the drill bit. This can be referred to as “tissue differentiation”.

[0066] Data input can come from, for example, motor current and / or speed, although other torque measurement methods may also be used. In some embodiments, the data input includes measured torque, which may be data derived from or indicating the torque supplied by the surgical drive 100. In some embodiments, the data input includes current and / or voltage measurements, and one or more algorithms or data tables may be used to convert the input into torque values.

[0067] As discussed in more detail below, in some embodiments, the surgical actuator 100 can use data input and / or variations in data input to determine the specific tissue type into which the surgical actuator 100 is driving the drill 200. For example, the surgical actuator 100 can be configured to distinguish whether the drill 200 is being driven into soft tissue or bone based on variations in data input and / or variations in data input. Furthermore, the surgical actuator 100 can be configured to distinguish different soft tissues or different bone types or bone segments (e.g., cortical and cancellous) based on variations in data input and / or variations in data input.

[0068] In some embodiments, the data input and / or the determination can be used to adjust the operation of the surgical actuator 100. For example, an algorithm (e.g., a discrete torque analysis algorithm) can use the data input to manage the drill bit speed of the surgical actuator 100. The algorithm can be used to adjust other characteristics / functions of the surgical actuator 100, such as voltage, current, drill bit rotation speed, and / or power supplied to the motor. In some embodiments, the measured torque and / or changes in the measured torque can be used to control the drive of the drill bit 200, such as stopping the motor, changing the drive speed of the drill bit 200, or other variations.

[0069] In some embodiments, variations in torque may be provided to the user (e.g., shown or displayed). For example, embodiments of the surgical actuator 100 may include one or more indicators (such as light or sound) indicating that the drill 200 is being driven within a specific torque range and / or that the drill 200 is being driven into a specific tissue layer or tissue type. For example, a first indicator may be activated when the drill 200 is being driven into a first tissue type and / or tissue layer, and a second indicator may be activated when the drill 200 is being driven into a second tissue type and / or tissue layer. The surgical actuator 100 may include a display (e.g., an electronic screen) showing information such as the torque applied to the drill, the type of tissue into which the drill is being driven, or other information. The display may be located directly on the surgical actuator 100 or may be a visual device connected to another component, such as a TV screen or monitor to which the surgical actuator 100 is connected, for example, wirelessly or wiredly.

[0070] As discussed in detail below, torque and / or variations in torque can be measured in a variety of different ways. For example, torque measurements can be taken (consistently or inconsistently) during some or all of the drilling process. In some implementations, the user can be provided with the variation between consecutive measurements. In some embodiments, an alert is provided to the user when the measured torque is outside a certain range or exceeds a threshold. This threshold can be created, for example, by having the user input a specific torque distribution into the surgical actuator 100 for a specific process. For example, the torque distribution can be used to drill the drill 200 into the clavicle and can include pre-programmed thresholds for that specific process. Additionally, the user can be provided with variations in torque or other aspects of torque, such as the first or second derivative of the torque measurement.

[0071] The surgical actuator 100 can be used for tissue differentiation in a variety of applications and settings. For example, the surgical actuator 100 can be configured to differentiate and / or identify different tissue types during clavicle plastic surgery. However, other types of surgical procedures or processes are possible.

[0072] Further disclosures relating to certain features of a torque-limiting surgical actuator can be found in U.S. Patent No. 9,265,551, filed July 16, 2014, and U.S. Patent No. 10,383,674, filed June 6, 2017, both of which are incorporated herein by reference in their entirety. Any of the features disclosed in the '551 and / or '674 patents (e.g., certain torque-limiting features) may be used in conjunction with the surgical actuator disclosed herein.

[0073] The torque required to drill through a given bone can vary significantly. One factor influencing the amount of torque required to drill through bone is bone density, which can vary depending on the patient's age, sex, disease, and other factors. Generally, the denser the bone, the greater the force required to drill through it. Additionally, density can vary depending on the bone's location within the body.

[0074] Several torque limiting methods, algorithms, and components are described below. Any method, algorithm, or component disclosed anywhere in this specification may be used in combination with any other method, algorithm, or component disclosed anywhere in this specification, or may be used separately.

[0075] "Anti-lurch" torque limiting application

[0076] As discussed above, in certain surgical procedures, medical professionals (e.g., surgeons) use hand-powered instruments to drill into a patient's bone. However, after drilling through the entry side of the bone (e.g., the first cortical portion of the bone), it can be difficult to determine when to stop the motor to inhibit or prevent the drill from "rushing" into tissue near the exit side of the bone, which could cause significant damage to said tissue. Embodiments of the surgical actuator described herein can be configured to limit or stop the operation of the motor and / or the rotation of the drill when the surgical actuator detects that the drill has breached or is close to breaching the bone. For example, embodiments of the surgical actuator described herein can limit or stop the operation of the motor and / or the rotation of the drill when: (1) the surgical drill detects that the drill is approaching or drilling through a location on or near the exit point or exit area of ​​the bone; and / or (2) the surgical drill detects that the drill has breached (leaved) or has breached the bone. Regarding “(1)” (also referred to herein as the “pre-breakage” stage), some embodiments of the surgical actuator described herein may limit or stop the operation of the motor and / or the rotation of the drill bit when: (a) the surgical drill detects that the drill bit has transitioned from a softer portion of the bone (e.g., cancellous portion) to a harder portion of the bone (e.g., cortical portion); and / or (b) when the surgical drill detects that the drill bit is currently located within (and / or drilling within) a second layer of the harder portion of the bone (e.g., cortex) and thus close to the bone departure side. Regarding “(2)” (also referred to herein as the “post-breakage” stage), some embodiments of the surgical actuator described herein may limit or stop the operation of the motor and / or the rotation of the drill bit when the surgical drill detects that the drill bit has broken (departed) or has broken through the bone.

[0077] Figure 8A simplified cross-section of the patient's bone 202 is shown. For example, bone 202 could be the clavicle, etc. A drill 200 (which can be any type of drill capable of engaging and / or drilling through bone 202) is shown close to bone 202, but spaced apart from it. Drill 200 can be received and / or driven by drive head 104 and / or motor 12, as discussed earlier with respect to surgical actuator 100. In some surgical scenarios, a medical professional may wish to drill and / or cut through bone 202 to remove material for screws and / or plates used to repair bone 202 or a portion thereof. As described above, a typical approach is to operate surgical actuator 100 to drill through a first side of bone 202 (e.g., at point A of bone 202) with drill 200, and to stop immediately when drill 200 breaks through an opposite second side of bone 202 (e.g., at point D). However, it is difficult for medical professionals to know the location of the drill 200 within the bone and / or when to stop the motor of the surgical actuator. As discussed above, the ability to detect when the drill 200 has broken through or is close to breaking through the bone 202 is important for inhibiting or preventing damage to nearby tissues close to the bone 202.

[0078] The surgical actuator 100 can utilize various methods and / or algorithms to detect the position of the drill 200 within the bone 202 and to stop the rotation of the drill 200 before breaking through the bone 202 and / or before it plunges into or through tissue near the point of breakage of the bone 202. The surgical actuator 100 can measure torque values ​​at different consecutive times to monitor and / or detect the position of the drill 200 within the bone 202. For example, in some embodiments, the measured amount of torque (or the current drawn by the motor, or other methods for determining rotation / torque discussed herein) is sampled at a sampling rate such as approximately every: 2 milliseconds (ms), 5 ms, 10 ms, 20 ms, 30 ms, or any value between these, or any range defined by any combination of these values, although other values ​​outside these ranges are also possible. Torque and time data can be stored in the memory 24 of the surgical actuator 100. This facilitates monitoring changes in torque relative to time (e.g., the first derivative of torque) and / or facilitates monitoring torque at discrete intervals defined by the sampling time (e.g., every 10 ms). As described above, the torque can be proportional to the motor power required to make the drill bit 200 perform drilling. In several embodiments, the torque at a given time is determined by a controller 20, which receives a signal from a sensor 18 indicating the current drawn by the motor 12.

[0079] Exemplary Torque Limiting Process Overview

[0080] Figure 9An exemplary torque-limiting drilling method and / or algorithm 201 is shown for suppressing or preventing the drill bit 200 from rushing through the bone 202 and causing damage to nearby tissues. Figures 10 to 13 Further variations and / or details of the exemplary method and / or algorithm 201 are shown.

[0081] Method 201 can begin after the actuator 100 is turned on (e.g., energized). In block 210, the surgical actuator 100 determines whether the motor 12 is turned on. The motor 12 can be turned on in response to a user activation input (e.g., a button or switch) and an instruction from the controller 20 to supply power to the motor 12. Power can be used to begin rotating the drill bit 200 received within and / or attached to the drive head 104. Figure 9 As shown, if block 210 determines that motor 12 is not on, method 201 can end. As shown in block 212, if it is determined that motor 12 is on, the surgical actuator 100 can begin collecting and / or storing torque values ​​at a sampling rate, such as at 10 ms intervals as discussed above. The surgical actuator 100 can collect the torque values ​​via sensor 18, such as a sensor capable of measuring the amount of current being drawn by motor 12. This current-drawing data can be used to determine the amount of torque, as the current drawn by motor 12 is typically proportional to the amount of torque that the motor is applying to the drill bit 200 driven by actuator 100 (e.g., via drive head 104). The measured / collected torque values ​​can be stored in the memory 24 of actuator 100.

[0082] As shown in box 214, the surgical actuator 100 can (e.g., via controller 20 and / or processor 22) compare each collected and / or stored torque value with a first threshold T. Thresh1 A comparison is made. This can be used to determine whether the drill bit 200 is engaging and / or drilling through the bone 202, rather than simply rotating in the air (e.g., free rotation). The torque value detected when the drill bit 200 is freely rotating in the air is typically significantly lower than the torque value detected when the drill bit 200 is engaging and / or drilling through the bone 202. In some embodiments, a first threshold T... Thresh1 It can be 0.035 in-oz, 0.036 in-oz, 0.037 in-oz, 0.038 in-oz, or 0.039 in-oz, or any range defined by any combination of these values, or any value within a range defined by any of these values, although other values ​​are also possible. As shown in box 216, if the given torque value is greater than or equal to the first threshold T Thresh1Then, controller 20 can collect / store each occurrence of this situation as a "count," the benefits of which will be further described below. In some cases, the measured torque value is greater than or equal to the first threshold T. Thresh1 The number / frequency of occurrences can provide an indication of the thickness of bone 202.

[0083] In some embodiments, the controller 20 tracks torque data that meets specific requirements. For example, in Figure 9 In the illustrated embodiment, at block 218, controller 20 can determine and store values ​​greater than or equal to a first threshold T. Thresh1 The sum of torques.

[0084] In various embodiments, controller 20 can use torque data to infer the position of drill bit 200. For example, at block 220, controller 20 can perform drill bit position analysis to determine the position of drill bit 200 relative to bone 202, which will be described further below. In some embodiments, at block 214, controller 20 can perform drill bit position analysis regardless of whether a given torque value is greater than or equal to a first threshold T. Thresh1 Therefore, frames 214, 216, and / or 218 are not required for the operation of frame 220. As discussed in more detail below, after a drill position analysis is performed at frame 220, the surgical actuator 100 can be configured to determine whether to change the operating characteristics of motor 12. For example, the surgical actuator 100 can be configured to determine, in response to determinations derived from the analysis performed at frame 220, whether to reduce or stop the rotation of drill 200 (via motor 12 and / or drive head 104) and to implement such a change. This drill position analysis may include determining whether the measured torque values(s) meet criteria indicating that drill 200 has broken through the bone or that drill 200 is close to breaking through the bone. Figure 9 As shown, if the measured torque values ​​do not meet the criteria indicating that the drill bit 200 has broken or is close to breaking the bone, the method can return to box 210 and collect additional torque values.

[0085] Standard analysis of drilled part position / torque

[0086] Figure 10Box 220 is shown in more detail. As discussed above, torque values ​​can be collected at different sampling rates, for example, every 10 ms. It may be beneficial to ignore or discard a certain amount of initial values ​​before the torque values ​​within a given time period are used to determine the position of the drill 200 within the bone 202. For example, when the motor 12 of the surgical actuator 100 is first turned on, there is a considerable amount of “noise” originating from the gears of the motor 12, which may produce variable torque values ​​that do not represent engagement between the drill 200 and the bone 202. Therefore, in box 222, the controller 20 discards a first set or group of torque values ​​before further analysis. The amount of initial torque values ​​ignored or discarded by the controller 20 can be equal to one, two, three, or four initial torque values, although other values ​​are also possible.

[0087] After box 222 is completed, controller 20 proceeds to boxes 224 and 226, each of which will be described in more detail below. At a high level, boxes 224 and 226 can determine the position of drill 200 within bone 202. More specifically, box 224 can determine whether drill 200 is drilling or has drilled through or within the first cortical portion of bone 202. For example, see... Figure 8 Box 224 can determine whether the drill bit 200 is drilling or has drilled through the first cortical portion of bone 202 between points A and B of bone 202, or within the first cortical portion of bone 202 between points A and B of bone 202. Similarly, box 226 can determine whether the drill bit 200 is drilling relative to the second cortical portion of bone 202 (e.g., Figure 8 The position of the middle skeleton 202 (between point C and point D).

[0088] As will be discussed in more detail below, determining the position of the drill 200 relative to the second cortical portion of the bone 202 may include using the surgical actuator 100 to determine whether the drill 200 is in a “pre-breakage” stage (e.g., close to breaking the bone) or in a “post-breakage” stage (e.g., the bone has already been broken). The surgical actuator 100 may determine whether the drill 200 is at the point of departure or departure area of ​​the bone 202 (such as...) Figure 8 The surgical actuator 100 determines whether the drill bit 200 is in the pre-breakage stage by drilling near or through the exit point D of the bone 202. The surgical actuator 100 can determine whether the drill bit 200 is breaking (e.g., leaving) or has broken the exit point or exit area of ​​the bone 202 (such as...). Figure 8The departure point D in the diagram is used to determine whether the drill bit 200 is in the post-fracture stage. Regarding "pre-fracture" and as discussed further below, in block 226, the surgical actuator 100 can determine whether the drill bit 200 has recently transitioned from the inner cancellous portion of bone 202 to the second cortical portion of bone 202, and / or whether the drill bit 200 is currently drilling through this second cortical portion of bone 202. As discussed in more detail below, after the surgical actuator 100 determines that the drill bit 200 is in the "pre-fracture" or "post-fracture" stage (specifically, depending on the configuration of a particular implementation), the surgical actuator 100 can, in response, change the operating characteristics of the motor 12 at block 240. For example, the surgical actuator 100 can, in response to either of these determinations, shut off the motor 12 or reduce the rotation of the drill bit 200.

[0089] Position of the drill bit relative to the first cortical portion of the bone

[0090] Figure 11 Box 224 is shown in more detail. As discussed above, the first group or set of torque samples collected (e.g., measured) by the surgical actuator 100 may be ignored or discarded before further analysis according to box 220. For example, the first group of samples may be the first three or four torque samples (e.g., torque values ​​one to three or four). As shown in box 224a, a second group or set of torque samples may be collected and analyzed to determine whether the drill 200 is drilling or has drilled through or within the first cortical portion of the bone 202. Such a second group of torque samples may include multiple torque samples, such as five torque samples. For example, the second group of torque samples may be the fifth, sixth, seventh, eighth, and ninth torque samples, and may follow the torque samples discarded in the first group. The controller 20 may track the maximum torque value experienced in the second group of torque samples, the benefits of which will be further described in box 226 below.

[0091] In box 224a, the torque samples of the second group or a portion thereof (e.g., torque samples 5 to 9) can be analyzed and / or compared to determine whether the difference between consecutive torque values ​​within this second group is greater than or equal to a second threshold T. Thresh2 For example, controller 20 can determine whether the difference between the 7th and 6th torque values ​​(numbered consecutively relative to the torque values ​​in the first group) within the second group is greater than or equal to a second threshold T. Thresh2 Whether the difference between the 6th and 5th torque values ​​in the second group (numbered consecutively relative to the torque values ​​in the first group) is greater than or equal to the second threshold T Thresh2 If one or both of these differences are greater than or equal to the second threshold T Thresh2If so, then box 224a is affirmative. An affirmative box 224a can indicate that the drill bit 200 is drilling through a hard portion of the bone 202, such as the first cortical portion of the bone 202 at points A and B or between points A and B, as... Figure 8 As shown. If box 224a is affirmative, then surgical actuator 100 can record and / or store (in memory 24) the occurrence of such threshold exceedance as an event in box 224c. This can provide an indicator that the method has encountered the first cortical portion of bone 202. As shown, surgical actuator 100 can analyze (e.g., compare) additional torque values ​​within this second group, e.g., until all torque values ​​within this second group have been analyzed according to boxes 224a to 224g. For example, as Figure 11 As shown, if either box 224a or box 224b is affirmative and is led into box 224c, controller 20 can move to box 224h and determine whether there are additional torque values ​​to be analyzed in the second group. If box 224h is affirmative, controller 20 can return to box 224a and analyze the remaining torque values ​​according to boxes 224a through 224c until box 224h responds negatively. Alternatively, in some embodiments, if box 224a is affirmative, controller 20 of surgical actuator 100 does not move to box 224h, but instead moves from box 224c to box 226 (see box 224g), where additional analysis can be performed as discussed further below. If box 224a is not affirmative, the method / algorithm can move to box 224b, where additional analysis can be performed as described further below.

[0092] In some embodiments, the controller 20 may determine the first cortical portion of the bone 202 (e.g., in...). Figure 8 The area between points A and B has actually been drilled through (e.g., through...). Figure 8 Point B in the diagram). For example, in some variations, controller 20 is configured to detect that drill bit 200 has penetrated the first portion of cortical bone by detecting a decrease in torque value. Some embodiments are configured to determine that the first cortical portion of bone 202 has been drilled through by: (1) recording an event in box 224c; (2) determining that boxes 224a and 224b return "no" for subsequently collected torque values; and (3) analyzing both results together (e.g., recognizing that "(1)" and "(2)" may indicate that the departure point of the first cortical layer portion has been drilled through).

[0093] Second threshold T Thresh2It can be 0.00195 in-oz, 0.00196 in-oz, 0.00197 in-oz, 0.00198 in-oz, 0.00199 in-oz, 0.002 in-oz, 0.00201 in-oz, 0.00202 in-oz, 0.00203 in-oz, 0.00204 in-oz, or 0.00205 in-oz, or any range defined by any combination of these values, or any value within a range defined by any one of these values, although other values ​​are also possible.

[0094] In box 224b, the torque samples of the second group (e.g., torque samples 5 to 9) or a portion thereof can be analyzed and / or compared to determine whether the difference between discontinuous torque values ​​within this second group is greater than or equal to a third threshold T. Thresh3 For example, one or more discontinuous torque samples within a second group, separated by an intermediate torque sample, can be compared to determine whether the difference between them is greater than or equal to a third threshold T. Thresh3 For example, controller 20 can determine whether the difference between the 9th and 7th torque values ​​is greater than or equal to a third threshold T. Thresh3 Is the difference between the 7th and / or 5th torque values ​​greater than or equal to the third threshold T? Thresh3 If one or two of these differences are greater than or equal to the third threshold T Thresh3 This could indicate that the drill bit 200 is drilling through the hard portion of the bone 202, such as the first cortical portion of the bone 202 at points A and B or between points A and B, as... Figure 8 As shown. If one or both of these differences are greater than or equal to the third threshold T. Thresh3 Then the surgical actuator 100 can record and / or store (in memory 24) in frame 224c the occurrence of such threshold exceedance as an event indicating that the first cortical portion of bone 202 is being drilled through. If one or both of these differences are greater than or equal to a third threshold T Thresh3 In box 224h, the surgical actuator 100 can determine whether there are additional torque values ​​to be analyzed within the second group. If box 224h is affirmative, the controller 20 can return to box 224a and analyze the remaining torque values ​​according to boxes 224a through 224c until box 224h responds negatively. Alternatively, in some embodiments, if box 224b is affirmative and an event is recorded at box 224c, the controller 20 of the surgical actuator 100 does not move to box 224h, but instead moves from box 224c to box 226 (see box 224g), where additional analysis can be performed as discussed further below.

[0095] If the difference between discontinuous torque values ​​within this second group (e.g., two values ​​separated by an intermediate value) is not greater than or equal to the third threshold T Thresh3 This could mean that: (a) the drill bit 200 is not engaged with the bone 202 (e.g., it is rotating freely); or (b) the drill bit 200 has drilled through the first cortical portion of the bone 202 (e.g., through...). Figure 8 Point B). To determine which of "(a)" or "(b)" is true, controller 20 can check in box 224d whether the event at box 224c was previously recorded. If controller 20 determines that event 224c was previously recorded, then controller 20 determines in box 224e that the first cortical portion of bone 202 has been drilled through (e.g., through point B). Figure 8 Point B in the diagram). In this case, drill bit 200 may be drilling through the softer, looser portion of bone 202. Alternatively, if controller 20 determines that event 224c has not been previously recorded and all second group torque values ​​have been collected (e.g., measured), controller 20 determines at box 224f that drill bit 200 is “free-spinning.” In some embodiments, controller 20 is configured to move to box 240 if controller 20 determines that drill bit 200 is free-spinning, which may stop or reduce the rotation of drill bit 200. This can advantageously save power (e.g., power drawn from the power supply) and / or processing power that would otherwise be used for further operation of motor 12 and performing torque value analysis.

[0096] In some embodiments, the third threshold T Thresh3 It can be greater than the second threshold T Thresh2 The third threshold T Thresh3 It can be 0.00215 in-oz, 0.00216 in-oz, 0.00217 in-oz, 0.00218 in-oz, 0.00219 in-oz, 0.0022 in-oz, 0.00221 in-oz, 0.00222 in-oz, 0.00223 in-oz, 0.00224 in-oz, or 0.00225 in-oz, or any value within a range defined by any of these values, although other values ​​are also possible.

[0097] As discussed above, controller 20 may move to box 226 after determining a "yes" result from box 224a or 224b, or it may wait until all torque values ​​in the second group have been analyzed according to boxes 224a and 224b (e.g., via the determination at box 224h) before moving to box 226. As discussed above, in box 226, additional analysis may be performed to determine the end of drill bit 200 relative to the internal (e.g., cancellous bone) portion of bone 202 and / or the second cortical portion of bone 202 (e.g., in…). Figure 8 The location of points C and D (or between points C and D). In some embodiments, if an event is recorded in box 224c (e.g., drill 200 is recorded as drilling through the first cortical portion of bone 202) and / or controller 20 determines that drill 200 has drilled through the first cortical portion of bone 202 (box 224e), this determination may be made when attempting to determine whether drill 200 is currently in the second cortical portion of bone 202, or whether it has recently drilled through the second cortical portion of bone 202 (e.g., in Figure 8 When points C and D are located (or between points C and D), they are advantageously used for further analysis, as discussed in more detail below.

[0098] Boxes 224a and 224b provide two methods by which the drilling motion of the drill 200 through the first cortical portion of the bone 202 can be detected. When drilling through a thinner bone cross-section (and, for example, a thinner cortical portion of such bone), it may be advantageous to compare the differences between one or more (or groups of groups) of consecutive torque values ​​in the second group of torque samples (as done in box 224a). When drilling through thicker bone, or when the surgeon angles the drill 200 at an angle different from that perpendicular to the surface of the bone 202 (e.g., within 15 degrees of the axis perpendicular to the bone surface), it may be advantageous to compare one or more (or groups of groups of groups) of discontinuous torque values ​​separated by intermediate torque values ​​within the second group (as done in box 224b). Combining frames 224a and 224b advantageously allows the controller 20 of the surgical actuator 100 to be used for both thin and thick bones and / or to predict whether the drill bit 200 is drilling through or within the first cortical portion of the bone 202 (e.g., between points A and B of the bone 202, such as...). Figure 8 (As shown).

[0099] Position of the drill bit relative to the second cortical portion of the bone

[0100] As described above, controller 20 can move to box 226 after box 224g or box 224e. As discussed above, box 226 can be positioned at a higher level to help define the second cortical portion of the drill 200 relative to the bone 202 (e.g., Figure 8 The position of the portion of the middle bone 202 between points C and D. Also as discussed above, determining the position of the drill bit 200 relative to the second cortical portion of the bone 202 may involve using the surgical actuator 100 to determine: (1) when the drill bit is at the point of departure or departure area of ​​the bone 202 (such as...) Figure 8 (1) Drilling at a location near the departure point D) or when drilling is proceeding through that location; and / or (2) when the drill bit breaks (leaves) or has broken through the departure point or departure area of ​​bone 202 (such as...). Figure 8 (D) Regarding “(1)” and as discussed further below, in box 226, the surgical actuator 100 can determine whether the drill bit 200 has recently transitioned from the inner cancellous portion of the bone 202 to the second cortical portion of the bone 202 (e.g., has transitioned through). Figure 8 The entry point C), and / or determining whether the drill bit 200 is currently drilling through this second cortical portion of the bone 202 (e.g., drilling through the second cortical portion and located in...). Figure 8 Some embodiments of the surgical actuator described herein may restrict or stop the operation of the motor and / or the rotation of the drill bit when the surgical actuator determines “(1)” (also referred to herein as the “pre-breakage” stage). Some embodiments of the surgical actuator described herein may restrict or stop the operation of the motor and / or the rotation of the drill bit when the surgical actuator determines “(2)” (also referred to herein as the “post-breakage” stage).

[0101] As discussed above, the controller 20 of the surgical actuator 100 can collect torque values ​​measured and / or communicated by the sensor 18 at a sampling rate. Also, as discussed, the first group of torque samples can be discarded (see...). Figure 10 And frame 222), and the second group of torque samples can be used to determine whether the drill bit 200 is drilling in and / or has drilled through the first cortical portion of the bone 202 (see frame 222). Figures 10 to 11 (and box 224). Additionally, a third group of torque samples can be used for the analysis in box 226. As a non-limiting example, the first group of samples may include four samples (e.g., samples numbered 1 to 4), the second group of samples may include five samples (e.g., samples numbered 5 to 9), and the third group of samples may include ten or more samples (e.g., 16 samples numbered 10 to 25).

[0102] In box 226, a third group of torque samples can be collected. Controller 20 can analyze (e.g., compare) one or more torque values ​​within the third group of torque samples. This helps determine whether drill bit 200 has recently transitioned from the inner cancellous portion of bone 202 to the second cortical portion of bone 202, and / or whether drill bit 200 is currently drilling through this second cortical portion of bone 202. Before performing this comparison, as... Figure 12 As shown, controller 20 can determine whether a sufficient number of bone drilling or bone engagement torque samples have been obtained at a given time point (e.g., after a given amount of torque values ​​have been sampled at a sampling rate). (Refer to the previous text.) Figure 9 As discussed, controller 20 can track how many measured torque values ​​are greater than or equal to a first threshold T. Thresh1 And given a torque value greater than or equal to this first threshold T Thresh1 In this case, it indicates that the torque value represents the value experienced by the drill bit 200 when drilling into a material other than air (e.g., bone), which represents a "bone engagement torque sample". In box 226a, if the number of bone engagement torque samples is greater than or equal to a threshold percentage P of the total number of measured torque values. Thresh1 If a certain confidence level is reached, controller 20 will continue with the analysis described below. For example, such a threshold percentage P Thresh1 This can be 60%, 70%, 80%, 90%, 95%, 96%, 97%, 98%, or 99%. As shown in box 226b, if the number of bone engagement torque samples is less than this threshold percentage P... Thresh1 If this occurs, controller 20 can stop further analysis and require the measurement to be greater than or equal to the first threshold T. Thresh1 More torque samples. For example, in some variations, after box 226b, the method returns to box 210 for further analysis and value collection.

[0103] If the number of bone engagement torque samples is greater than or equal to this threshold percentage P Thresh1 Then controller 20 proceeds to block 226c. Block 226c can help determine whether drill bit 200 has recently transitioned from the inner cancellous portion of bone 202 to the second cortical portion of bone 202 (e.g., has recently transitioned through...). Figure 8 Point C in the diagram). In some embodiments, in order to “capture” or detect this transition, in block 226c, controller 20 compares a consecutive pair of torque values ​​(e.g., from a third group of torque values) to determine whether the difference between the pair of torque values ​​is greater than or equal to a fourth threshold (referred to herein as “step Delta” or “Δ”). 阶跃 If this difference is greater than or equal to Δ 阶跃This demonstrates the large rate of change between consecutive torque values, indicating the transition from the cancellous to the cortical portion of bone 202. Δ 阶跃 It can be determined based on statistical values ​​of past torque values ​​(e.g., one or more torque values ​​in the first, second, and / or third groups). For example, Δ 阶跃 This can be equal to a second threshold percentage P, which is the average of all torque values ​​measured at a given point in the analysis. Thresh2 Average torque value "T" Avg. "It can be equal to the sum of all previously measured, stored, and / or recorded torque values ​​divided by the number of skeletal engagement torque samples (e.g., greater than or equal to a first threshold T)." Thresh1 The number of torque samples). In some embodiments, T Avg. This excludes discarded torque values, such as those from box 222.

[0104] If the difference between consecutive pairs of torque values ​​from the third group of torque samples is greater than or equal to Δ 阶跃 This can indicate a significant rate of change in torque values ​​between such consecutive torque values, which in turn can indicate that the drill bit 200 has recently transitioned from the cancellous skeleton to the second cortical portion of the skeleton 202 (e.g., through...). Figure 9 Point C is shown in the diagram. If this is true, then controller 20 moves to box 226d, which will be described in more detail below. For example, as discussed below, in some embodiments, if the difference between consecutive pairs of torque values ​​from a third group of torque samples is greater than or equal to Δ... 阶跃 Then controller 20 operates to stop or reduce the rotation of drill 200 (e.g., if it is desired that drill 200 move to box 240 before breaking bone 202). If the difference between consecutive pairs of torque values ​​from the third group of torque samples is less than Δ 阶跃 Then controller 20 continues to move to box 226e, which will be described further below. Second threshold percentage P Thresh2 It can be 8%, 9%, 10%, 11%, 12%, 13%, 14%, or 15%, or any percentage within a range defined by any of these percentages, although other values ​​are also possible.

[0105] In box 226e, controller 20 can analyze one or more torque values ​​within the third group of samples to determine whether drill bit 200 is currently drilling through the second cortical portion of bone 202 (e.g., in...). Figure 8 Between points C and D in the diagram). In cases where it is desired to stop the rotation of the drill bit 200 before breaking through bone 202, box 226c indicates "No" (e.g., the difference between a consecutive pair of torque values ​​from the third group of torque samples is less than Δ). 阶跃Following step 226e is advantageous. For example, in some cases, the two consecutive torque values ​​in the third group may be difficult to “capture” the transition point from cancellous bone to cortical bone (e.g., Figure 8 Point C in the equation is used because these two torque values ​​are measured at discrete time intervals (e.g., every 10 ms). The transition point from cancellous to cortical bone may not "fall" within these two consecutive torque values / measurements. In these cases, alternative methods are provided for detecting whether the drill bit 200 is close to breaking through the bone 202 (e.g., while drilling through...). Figure 8 The second cortical portion between midpoint C and point D may be advantageous.

[0106] In box 226e, controller 20 compares a given (e.g., current or recent) torque value with a fifth threshold, referred to herein as "torque". Δ "or "T Δ The comparison is performed. If such a current (e.g., most recent) torque value is greater than or equal to T... Δ This indicates that drill bit 200 is currently drilling through the second part of the cortical bone. Δ It can be equal to the average torque value T Avg. Add Δ 阶跃 (Both have been discussed previously). Therefore, relative to previously recorded (e.g., measured) torque values, T Δ This represents a high torque value.

[0107] If the given (e.g., current) torque value is greater than or equal to T Δ Then controller 20 can move to box 226f to determine whether a given torque value is close to the maximum torque value T recorded to date (e.g., measured). Max Additional testing. More specifically, in box 226f, controller 20 can determine the current (e.g., recent) torque value and T. Max The difference between them, and further determine whether this difference is greater than or equal to the sixth threshold T. Thresh6 In some embodiments, the controller 20 determines the current torque value and T. Max Is the absolute value of the difference between them greater than or equal to the sixth threshold T? Thresh6 The sixth threshold T Thresh6It can be 0.00295 in-oz, 0.00296 in-oz, 0.00297 in-oz, 0.00298 in-oz, 0.00299 in-oz, 0.003 in-oz, 0.00301 in-oz, 0.00302 in-oz, 0.00303 in-oz, 0.00304 in-oz, or 0.00305 in-oz, or any range defined by any combination of these values, or any value within a range defined by any one of these values, although other values ​​are also possible.

[0108] If controller 20 determines the current torque value and T Max The difference (or the absolute value of the difference) between them is greater than or equal to the sixth threshold T. Thresh6 If so, controller 20 moves to box 226d, which will be discussed further below. Alternatively, if controller 20 determines that this difference (or the absolute value of the difference) is less than the sixth threshold T... Thresh6 Then controller 20 moves to frame 226g.

[0109] In box 226g, controller 20 can check whether an event (indicating that drill 200 is drilling through the first cortical portion) was recorded according to box 224c, and / or can check the result of the determination made in box 224d (whether drill 200 actually drilled through the first cortical portion of the bone). If controller 20 has previously determined that drill 200 is drilling in or through the first cortical portion of bone 202, controller 20 can move from box 226g to box 226d, which will be further described below. Box 226g may be advantageous because even if controller 20 determines the current (e.g., recent) torque value in box 226f with respect to T Max Not close enough (e.g., at the sixth threshold T) Thresh6 If, as soon as controller 20 detects that the first cortical portion has been drilled into or penetrated, the current (e.g., most recent) torque value is high enough (as determined by box 226e) that it instructs drill 200 to currently be drilling through the second cortical portion of bone 202. Alternatively, if controller 20 analyzes the results of box 224d and determines that the first cortical portion of bone 202 has not been drilled into or penetrated (e.g., determined by box 224f), controller 20 may continue to collect and analyze subsequent torque values ​​and then proceed to one or more of boxes 226a to 226g.

[0110] In some embodiments, when the determination of blocks 226c and / or blocks 226e to 226g causes the process to proceed to block 226d, this can indicate that the drill bit 200 is drilling through the second cortical portion of bone 202. In response, the controller 22 can communicate with the motor 12 to stop or reduce the rotation of the drill bit 200. For example, in block 226c, when the controller 20 determines that the drill bit 200 has recently transitioned from cancellous bone to the second cortical portion of bone 202 (e.g., through...), this indicates that the drill bit 200 is drilling through the second cortical portion of bone 202. Figure 8 As shown at point C), the controller 20 of the surgical actuator 100 can communicate with the power supply 28 and / or the motor 12 to shut off the motor 12 and / or stop or reduce the rotation of the drill 200 (e.g., the controller 20 can continue to move to box 240). As another example, when the controller 20 determines at box 226e that the drill 200 is currently drilling through a second cortical portion of the bone 202, and either box 226f or box 226 gives "yes," the controller 20 of the surgical actuator 100 can communicate with the power supply 28 and / or the motor 12 to shut off the motor 12 and / or stop or reduce the rotation of the drill 200 (e.g., the controller 20 can move to box 240). Alternatively, in some embodiments, such as Figure 12 As shown, in box 226d, controller 20 can perform further analysis and / or measure additional torque values. For example, when it is desired to stop or reduce the rotation of drill bit 200 after (rather than before) breaking bone 202, controller 20 can measure additional torque values ​​and / or perform further analysis to detect when such breaking occurs. See below. Figure 13 Describe this analysis.

[0111] Drilling parts break

[0112] Figure 13 Box 230 is shown in more detail. Box 230 can help determine the "break-in" (departure) point or "break-in" (departure) area (e.g., ...) of the drill 200 relative to the second cortical portion of the bone 202 at a higher level. Figure 8 The location is shown as point D in the diagram. To determine whether the drill bit 200 has broken through such a point or area, it may be helpful to compare the current / most recently measured torque value with previous torque values ​​collected when the drill bit 200 was drilling through the second cortical portion of the bone 202. For example, if the measured torque value appears to decrease or fall below a certain threshold while the drill bit 200 is drilling through the second cortical portion, this could indicate that the drill bit 200 has broken through the bone 202 (e.g., through...). Figure 8 (Point D in the diagram). In this case, controller 20 can be configured to move to frame 240 and, for example, reduce or stop the rotation of drill 200.

[0113] Referring to block 230a, in some embodiments, for each torque value within the third group that gives "yes" to blocks 226c, 226e, and 226f or 226g, the controller 20 and / or processor 22 can determine a rolling average of such torque values. For example, if five torque samples from the third group result in blocks 226c, 226e, and 226f or 226g giving "yes" (indicating drilling through the second cortical portion of bone 202), the controller 20 and / or processor 22 can determine the average of these torque values, store this average, and update this average after each subsequent sample of these five samples. This average can advantageously be used as a breaking threshold T. Breach This is to determine whether the drill bit 200 has broken through the bone 202. The controller 20 can perform blocks 226 and 230a for each of the torque samples in the third group until all torque samples in the third group have been measured. The exact number of torque values ​​in the third group can be modified and depends on the sampling rate. For example, the third group of samples may include 15 torque samples, each measured at 10 ms intervals.

[0114] Some embodiments include collecting a fourth group of torque samples. In some variations, after all torque samples in the third group have been analyzed according to blocks 226 and 230a, the controller 20 can measure and analyze the fourth group of torque samples in block 230b. Figure 13 As shown, in some embodiments, in block 230b, controller 20 can correlate one or more measured torque values ​​from the fourth group with a breaking threshold T. Breach The comparison is performed. For example, in box 230b, controller 20 can determine whether the current measured torque value in the fourth group is less than the breaking threshold T. Breach As another example, in box 230b, controller 20 can determine whether two consecutive torque values ​​within the fourth group are less than the breaking threshold T. Breach As shown in box 230c, if one or more recent torque measurements within the fourth group are less than the breaking threshold T Breach ,like Figure 13 As shown in box 230d, controller 20 can move to box 240 and can reduce or stop the rotation of drill 200. Similarly, as shown in box 230c, if one or more recent torque measurements within the fourth group are not less than the breaking threshold T... Breach ,like Figure 13 As shown in box 230e, the surgical actuator 100 can continue drilling of the drill bit 200, and the controller 20 can continue to collect and analyze torque values ​​according to box 230b.

[0115] In some cases, the drill bit 200 in the third group of samples without torque is recorded as drilling / drilling through the second cortical portion of bone 202. In this case, refer to Figure 12 The complete collection of torque values ​​in the third group will cause the process to proceed to block 226b. As a result, when controller 20 begins collecting torque values ​​in the fourth group, there will be no breaking threshold T for comparing these torque values. Breach (For example, T) Breach =0). In this case, the controller 20 can use the measured torque values ​​from the fourth group to determine the rolling average, and thus determine the breaking threshold T. Breach And subsequently, the torque measurements from the fourth group will be compared with this breaking threshold T. Breach Compare them.

[0116] In some embodiments, controller 20 does not proceed to block 230a. In such embodiments, controller 20 may analyze whether the torque value is decreasing, and upon making such a determination, may immediately move to block 240 to reduce or stop the rotation of drill 200. For example, in block 230b, controller 20 may compare the current (e.g., recent) torque value with one or more past torque values, and in block 230c, determine whether the current (e.g., recent) torque value is less than one or more past torque values. If the current (e.g., recent) torque value is less than one or more past torque values, then controller 20 may move to block 240 as shown in block 230c. Alternatively, if the current (e.g., recent) torque value is not less than one or more past torque values, the surgical actuator 100 may continue drilling with drill 200, and controller 20 may continue to collect and analyze torque values ​​according to block 230b (see block 230e).

[0117] Reference box 230c, if controller 20 determines that the torque value is decreasing or the torque value is dropping to a threshold (e.g., T...). Breach This can indicate that the drill bit 200 has broken through the bone 202. As discussed earlier, this determination and subsequent actions taken according to frame 240 can advantageously inhibit or prevent drilling through tissue adjacent to or near the bone 202.

[0118] While the various steps and methods discussed above use the phrases "first group," "second group," "third group," and "fourth group," these phrases are not intended to be limiting. These phrases are only used to describe one or more of the aforementioned boxes, steps, or processes involving the measurement and / or analysis of one or more torque values ​​to make various determinations that can advantageously assist controller 20 in determining the position of drill bit 200 relative to the cross-section of skeleton 202. For example, the use of the phrase "first group torque sample / value" with respect to box 222 is intended to convey the intention to discard a certain amount of initial torque values ​​before measuring / analyzing additional torque values. Regarding boxes 224 and... Figure 11 The phrase "second group torque samples / values" is used to convey that a certain amount of torque values ​​(measured after "first group") are measured / analyzed to determine whether drill bit 200 is drilling in and / or has drilled through the first cortical portion of bone 202. Regarding box 226 and... Figure 12 The phrase "third group torque sample / value" is used to convey that a certain amount of torque value (measured after "second group") is measured / analyzed to determine whether drill bit 200 is currently drilling in the second cortical portion of bone 202. Additionally, regarding box 230 and... Figure 13 The phrase "fourth group torque sample / value" is used to convey that a certain amount of torque value (measured after "third group") is measured / analyzed to determine the position of drill bit 200 relative to the second cortical portion of bone, and more specifically, to determine whether drill bit 200 has drilled through the second cortical portion of bone 202. Where the precise amount of torque value within the first, second, third, and / or fourth groups may vary, controller 20 may execute the aforementioned boxes, steps, and / or processes to determine the precise position of drill bit 200 relative to the cross-section of any bone 202.

[0119] In order to implement Figures 9 to 13 The number of torque samples used and / or required by the method / algorithm may depend on factors including, but not limited to, the sampling rate, the bone thickness, and the angle of the drill 200 relative to the axis perpendicular to the bone surface. For example, if the angle of the drill 200 relative to the axis perpendicular to the bone surface is greater than 15 degrees, more than 25 torque samples may be required to implement boxes 224 and / or 226.

[0120] Although Figure 8 An example cross-section of the skeleton 202 is shown, and points A to D represent points through which the drill bit 200 can pass. However, for the drill bit 200 relative to... Figure 8 The case of the skeleton 202 drilling through other points, regions, or angles, as illustrated, is also applicable to any of the apparatuses, methods, systems, and / or algorithms discussed above. For example, the above reference... Figures 9 to 13The described method / algorithm applies to situations where the drill bit 200 drills through the bone 202 at an angle not perpendicular to any point or surface of the bone 202 and / or at an angle not aligned with the middle or central axis of the bone 202. Regardless of the precise angle of the drill bit 200 relative to any point or surface of the bone 202, the above references... Figures 9 to 12 The described method / algorithm can be used to determine whether the drill 200 is drilling through the second cortical portion of the bone 202 in order to stop the motor 12 and inhibit or prevent damage to tissues near the exterior of the second cortical portion of the bone 202.

[0121] certain terms

[0122] The conditional language used herein (such as “can” or “could”, “may” or “might”, “e.g.”) is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Therefore, such conditional language is not generally intended to imply that one or more embodiments require features, elements, and / or steps in any way, or that one or more embodiments must include logic for (with or without author input or prompting) determining whether such features, elements, and / or steps are included in or will be performed in any particular embodiment.

[0123] Unless otherwise specified, connective language (such as the phrase "at least one of X, Y, and Z") is understood in context as such commonly used to convey that an item, term, etc., is X, Y, or Z. Therefore, such connective language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z, respectively.

[0124] The terms "comprising," "including," and "having" are synonymous and used inclusively in an open-ended manner, without excluding additional elements, features, actions, operations, etc. Furthermore, the term "or" is used in its inclusive sense (rather than its exclusive sense), such that when used, for example, to connect lists of elements, the term "or" means one, some, or all of the elements in the list. The terms "and / or" mean that "and" applies to some embodiments, and "or" applies to some embodiments. Therefore, A, B, and / or C are equivalent to A, B, and C written in one sentence, and A, B, or C written in another sentence. The term "and / or" is used to avoid unnecessary redundancy.

[0125] As used herein, the terms “approximately,” “about,” and “substantially” mean a quantity close to the stated quantity that still performs the desired function or achieves the desired result. For example, in some embodiments, as indicated by the context, the terms “approximately,” “about,” and “substantially” may refer to a quantity less than or equal to 10% of the stated quantity. The term “generally” as used herein means a value, quantity, or characteristic that primarily comprises or tends to include a particular value, quantity, or characteristic. As an example, in some embodiments, as indicated by the context, the term “generally parallel” may refer to something deviating from exact parallelism by less than or equal to 20 degrees.

[0126] As used herein, terms related to circular shapes (such as diameter or radius) should be understood to mean that a perfectly circular structure is not required, but rather should be applied to any suitable structure having a cross-sectional area that can be measured from one side to the other. Shape-related terms (such as “circular” or “cylindrical” or “semicircular” or “semi-cylindrical” or any related or similar terms) are not required to strictly conform to the mathematical definition of a circle or cylinder or other structure, but can include structures that are fairly close. Similarly, a shape modified by the word “approximately” (e.g., “approximately cylindrical”) can include a fairly close approximation of the stated shape. As used herein, any discussion of a “drill bit,” such as the position of the drill bit relative to a bone, can refer to the end of said drill bit (e.g., the farthest end of the drill bit).

[0127] Some embodiments have been described in conjunction with the accompanying drawings. The drawings are drawn to scale, but this scale should not be construed as limiting, as dimensions and scales beyond those shown are also contemplated and within the scope of this disclosure. Distances, angles, etc., are merely illustrative and do not necessarily have a precise relationship to the actual dimensions and layout of the illustrated apparatus. Components may be added, removed, and / or rearranged. Furthermore, any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc., disclosed herein in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be appreciated that any method described herein can be practiced using any apparatus suitable for performing the cited steps.

[0128] Summarize

[0129] Various surgical actuator devices, systems, and methods have been disclosed in the context of certain embodiments, examples, and variations. The scope of this disclosure extends beyond the specifically disclosed embodiments, examples, and other alternative embodiments and / or variations of the invention, as well as their obvious modifications and equivalents. Furthermore, while various variations of surgical actuators have been shown and described in detail, other modifications within the scope of this disclosure will be apparent to those skilled in the art. Moreover, although certain examples have been discussed in the context of surgical actuators, the various inventions disclosed herein are not limited to use in surgical actuators. In fact, the various inventions disclosed herein are contemplated for use in a variety of other types of devices and other environments.

[0130] Certain features already described in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented separately in multiple implementations or in any suitable sub-combination. Moreover, although features may function in certain combinations as described above, in some cases, one or more features from the claimed / stated combination may be removed from that combination, and that combination may be claimed as any sub-combination or any variation of a sub-combination.

[0131] Any part of any of the steps, processes, structures, and / or devices disclosed or illustrated in one embodiment, flowchart, or example of this disclosure may be combined with or used (or used in place of) any other part of any of the steps, processes, structures, and / or devices disclosed or illustrated in different embodiments, flowcharts, or examples. The embodiments and examples described herein are not intended to be separate and isolated from each other. Combinations, variations, and other implementations of the disclosed features are within the scope of this disclosure.

[0132] Any of the steps and blocks can be adjusted or modified. Additional or supplementary steps may be used. The steps or blocks described herein are not necessary or indispensable. Furthermore, while operations may be depicted in a specific order in the drawings or described in the specification, these operations do not need to be performed in the specific order shown or in a sequential order, and it is not necessary to perform all operations to achieve the desired result. Other operations not depicted or described may be combined in the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Further, in other embodiments, operations may be rearranged or reordered. Moreover, the separation of various system components in the embodiments described above should not be construed as requiring such separation in all embodiments, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.

[0133] The various features and processes described above can be used independently of each other or combined in various ways. All possible combinations and sub-combinations are intended to fall within the scope of this disclosure. Furthermore, in some embodiments, certain method, event, state, or process blocks may be omitted. The methods and processes described herein are not limited to any particular order, and the associated blocks or states may be performed in other suitable orders. For example, the described tasks or events may be performed in an order different from that specifically disclosed. Multiple steps may be combined in a single block or state. Example tasks or events may be performed serially, in parallel, or in some other manner. Tasks or events may be added to or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently than those described. For example, elements may be added, removed, or rearranged compared to the disclosed example embodiments.

[0134] In summary, various embodiments and examples of torque-limiting surgical drive systems and methods have been disclosed. Although this disclosure is made in the context of those embodiments and examples, it extends beyond the specific disclosed embodiments to other alternative embodiments and / or other uses of the embodiments, as well as certain modifications thereto and their equivalents. Furthermore, this disclosure expressly contemplates that various features and aspects of the disclosed embodiments can be combined with or substituted for each other. Therefore, the scope of this disclosure should not be limited to the specific disclosed embodiments described above, but should be determined solely by a fair interpretation of the appended claims.

Claims

1. A torque-limiting surgical device, comprising: The main body includes a handle configured for gripping by a user; A motor, which is positioned within the body; A drive head configured to be rotated by the motor and drive a screw or drill bit; as well as A processor, which is located within the body; Under the control of the processor, the torque-limiting surgical device is configured to: Apply torque to the screw or drill to drill into the bone; Monitor the current or voltage supplied to the motor; As the screw or drill bit drills through the bone, the torque value applied to the screw or drill bit is determined based on the current or voltage supplied to the motor. The torque limit condition is determined to be satisfied, wherein the torque limit condition is determined to be satisfied includes: The difference between a first pair of consecutive torque values ​​is compared to a first threshold to determine whether the screw or drill has drilled into or through the first cortical layer of the bone; and Determining the point at which the screw or drill has penetrated the second cortical layer of the bone and exited the second cortical layer of the bone, wherein determining the point at which the screw or drill has penetrated the second cortical layer includes comparing the difference between a second pair of consecutive torque values ​​with a second threshold; and In response to the determination that the torque limit condition has been met, the application of torque to the screw or drill bit is stopped.

2. The torque-limiting surgical device according to claim 1, wherein, The torque-limiting surgical device is also configured to determine: Is the screw or drill bit drilling into the second cortical layer of the bone? 3. The torque-limiting surgical device according to claim 1, wherein, The second threshold is equal to a percentage of the average of a subset of all determined torque values.

4. The torque-limiting surgical device according to claim 3, wherein, A subset of all determined torque values ​​is equal to all determined torque values ​​that are greater than or equal to a third threshold, where the third threshold represents the material through which the screw or drill passes, excluding air.

5. The torque-limiting surgical device according to claim 2, wherein, The torque-limiting surgical device is configured to determine whether the screw or drill is drilling into the second cortical layer of the bone by comparing the difference between the current torque value and the maximum measured torque value with a second threshold.

6. The torque-limiting surgical device according to claim 2, wherein, In response to determining that the screw or drill has drilled through the second cortical layer of the bone at an entry point or in response to determining that the screw or drill is drilling in the second cortical layer of the bone, the torque-limiting surgical device is further configured to determine an average torque value, which represents the torque value measured when the screw or drill is drilling in the second cortical layer of the bone.

7. The torque-limiting surgical device according to claim 6, wherein, The torque-limiting surgical device is also configured to determine the difference between a first torque value and the average torque value, the first torque value being a current torque value measured by the torque-limiting surgical device.

8. The torque-limiting surgical device according to claim 7, wherein, The surgical device is configured to limit the amount of torque applied to the screw or drill bit in response to determining that the first torque value is less than the average torque value.

9. The torque-limiting surgical device according to claim 7, wherein, The torque-limiting surgical device is also configured to: Determine the difference between a second torque value and the average torque value, wherein the second torque value is measured before the first torque value; and In response to determining that both the first torque value and the second torque value are less than the average torque value, the amount of torque applied to the screw or drill bit is limited.

10. A torque-limiting surgical device, comprising: The main body includes a handle; A motor, which is positioned within the body; A drive head configured to be rotated by the motor and drive a drill or screw; A processor, which is located within the body; Under the control of the processor, the torque-limiting surgical device is configured to: Drive the drill or screw to penetrate the bone; Monitor the torque value as the drill bit or screw is being drilled into the bone; Whether the drill bit or screw has been drilled in the first cortical layer of the bone is determined by comparing the difference between a first pair of consecutive torque values ​​with a first threshold. Determining whether the drill bit or screw has drilled through the entry point of the second cortical layer of the bone and has exited the second cortical layer of the bone, wherein determining whether the screw or drill bit has passed through the entry point of the second cortical layer includes comparing the difference between a second pair of consecutive torque values ​​with a second threshold; and In response to determining whether the drill or screw has drilled through and exited the second cortical layer of the bone, the drilling of the drill or screw is stopped.

11. The torque-limiting surgical device according to claim 10, wherein, The torque-limiting surgical device is also configured to determine: Is the screw or drill bit drilling into the second cortical layer of the bone? 12. The torque-limiting surgical device according to claim 11, wherein, In response to determining that the drill or screw has drilled through the second cortical layer of the bone at an entry point or in response to determining that the drill or screw is drilling in the second cortical layer of the bone, the torque-limiting surgical device is further configured to determine an average torque value, which represents the torque value measured when the drill or screw is drilling in the second cortical layer of the bone.

13. The torque-limiting surgical device according to claim 12, wherein, The torque-limiting surgical device is also configured to determine the difference between a first torque value and the average torque value, the first torque value being a current torque value measured by the torque-limiting surgical device.

14. The torque-limiting surgical device according to claim 13, wherein, The surgical device is also configured to limit the amount of torque applied to the drill bit or screw in response to determining that the first torque value is less than the average torque value.

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