Instrument Alignment Feedback System and Method

Abstract

To provide a real time feedback related to an angle direction, a position and trajectory of a surgical instrument.SOLUTION: The present invention relates to positioning of an instrument, including angle alignment of a surgical instrument used in a spine stabilizing surgery or the like, and relates to a system that measures and displays an orientation of a handheld instrument. The handheld surgical instrument that provides a feedback related to orientation includes at least one measurement sensor.SELECTED DRAWING: Figure 1

Description

Cross - reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 763,564, filed on June 21, 2018, the content of which is incorporated herein by reference. Copyright notice

[0002] This patent document contains information (materials) subject to copyright protection. The copyright owner does not object to the reproduction of this patent document or the related information in the files of the United States Patent and Trademark Office, but reserves all copyrights in other cases.

Technical Field

[0003] The present invention relates to the alignment of instruments, including the angular alignment (positioning) of surgical instruments such as those used in spinal stabilization surgery.

Background Art

[0004] Thousands of spinal stabilization surgeries are performed each year. During this procedure, a stabilizing structure such as a spinal rod and / or a spinal plate is implanted to provide support to the patient's spine. This procedure can also include the use of pedicle screws that can be implanted into the patient's spine to fix the rod / plate.

[0005] The implantation of pedicle screws can initially include creating a pilot hole that penetrates the pedicle and enters the vertebral body of the patient's spine. Then, the pedicle screw can be implanted into the pilot hole.

[0006] In order to properly place the pedicle screw and avoid damaging the patient's spine, the position, angular orientation (i.e., the angular direction), and trajectory of the pilot hole must be accurate.

[0007] Imaging devices (such as X-ray fluoroscopy systems) can provide images of the patient's spine to assist in the placement of pilot holes, but these images may be limited to real-time information that can be provided during the procedure. Furthermore, the use of such systems may expose patients and physicians / nurses to high levels of ionizing radiation, and long-term use of such systems may be undesirable. Also, while a skilled surgeon may rely on their experience to properly place pilot holes, the experience level of each surgeon varies, and this may often be inadequate.

[0008] In fact, studies have shown that up to 4% of pedicle screws implanted during spinal stabilization surgery may become displaced. Such displacement (misalignment) can cause serious health complications in patients, and in many cases, the pedicle screws need to be replaced, and therefore require additional surgery.

[0009] Other types of surgical / medical procedures may also require precise positioning of the surgical instruments used. For example, subcutaneous injection needles often require proper positioning and alignment during use.

[0010] Therefore, there is a need for systems and methods that provide real-time feedback regarding the angular direction, position, and trajectory of surgical instruments. [Disclosure of the Invention]

[0011] The present invention is as specified in the claims and the following description.

[0012] In one embodiment, a system for providing feedback on the orientation of a handheld device may include at least one measuring sensor configured with the handheld device and a controller communicating with the at least one measuring sensor, wherein the at least one measuring sensor measures the orientation of the handheld device, and the controller can provide feedback based on the measured orientation.

[0013] In one embodiment, the handheld instrument can be selected from the group consisting of an awl, probe, tap, drill, screwdriver, scalpel, and subcutaneous injection needle.

[0014] In another embodiment, the at least one measuring sensor may include at least one accelerometer.

[0015] In another embodiment, the at least one measuring sensor may include at least one gyroscope.

[0016] In another embodiment, the measured orientation may be an orientation in three-dimensional space.

[0017] In one embodiment, an assembly configured to measure the orientation of a surgical instrument may include at least one measuring sensor coupled to the surgical instrument, the at least one measuring sensor which measures the angular orientation of the surgical instrument and outputs a signal based on the measured angular orientation.

[0018] In one embodiment, the assembly may include a controller that communicates with the at least one measuring sensor, the controller which can receive signals and provide feedback based on the measured angular direction of the surgical instrument.

[0019] In another embodiment, the surgical instrument may be a handheld instrument.

[0020] In another aspect, the surgical instrument can be selected from the group consisting of an awl, a probe, a tap, a drill, a screwdriver, a scalpel, and a hypodermic needle.

[0021] In another aspect, the at least one measurement sensor can include at least one accelerometer.

[0022] In another aspect, the at least one measurement sensor can include at least one gyroscope.

[0023] In another aspect, the measured angular direction can be an angular direction in three-dimensional space.

[0024] In one embodiment, a handheld surgical instrument adapted to provide feedback regarding its orientation can include at least one measurement sensor coupled to the surgical instrument, the at least one measurement sensor being capable of measuring the angular direction of the surgical instrument and outputting a signal based on the measured angular direction.

[0025] In one aspect, the surgical instrument can also include a controller that communicates with the at least one measurement sensor, the controller being capable of receiving the signal and providing feedback based on the measured angular direction of the surgical instrument.

[0026] In another aspect, the surgical instrument can be selected from the group consisting of an awl, a probe, a tap, a drill, a screwdriver, a scalpel, and a hypodermic needle.

[0027] In another aspect, the at least one measurement sensor can include at least one accelerometer.

[0028] In another aspect, the at least one measurement sensor can include at least one gyroscope.

[0029] In another aspect, the measured angular direction may be an orientation in three-dimensional space.

[0030] In one embodiment, a method for aligning a handheld surgical instrument that can include at least one measurement sensor and a controller in communication with the at least one measurement sensor can include the following.

[0031] (A) Coupling at least one measurement sensor to the surgical instrument.

[0032] (B) Using the at least one measurement sensor to measure the angular direction of the surgical instrument.

[0033] (C) Providing the angular direction information measured in (B) to the controller.

[0034] (D) Using the controller to provide feedback based on the angular direction information.

[0035] In one aspect, the method can also include the following.

[0036] (E) Aligning the surgical instrument based on the feedback provided in (D).

[0037] One skilled in the art will understand that any method described above or below and / or claimed and described as a series of steps is not limiting in the sense of the order of the steps. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Various objects, features, and attendant advantages of the present invention will be fully understood when considered in connection with the accompanying drawings. In the accompanying drawings, like reference numerals represent the same or similar parts.

[0039] [Figure 1]This figure shows an exemplary embodiment of a pedicle screw and rod according to the present invention.

[0040] [Figure 2A] An exemplary embodiment of the present invention demonstrates how a pedicle screw is properly implanted. [Figure 2B] This shows how pedicle screws can be improperly implanted. [Figure 2C] This shows how pedicle screws can be improperly implanted.

[0041] [Figure 3] This figure shows an embodiment of an alignment feedback system according to an exemplary embodiment of the present invention.

[0042] [Figure 4] This figure shows an example of a measuring assembly according to an exemplary embodiment of the present invention. [Figure 5] This figure shows an example of a measuring assembly according to an exemplary embodiment of the present invention. [Figure 6] This figure shows an example of a measuring assembly according to an exemplary embodiment of the present invention.

[0043] [Figure 7] This figure shows an example of an active device according to an exemplary embodiment of the present invention.

[0044] [Figure 8] This figure shows a data layout and / or display configuration according to an exemplary embodiment of the present invention. [Figure 9] This figure shows a data layout and / or display configuration according to an exemplary embodiment of the present invention.

[0045] [Figure 10] This figure shows an example of an active device according to an exemplary embodiment of the present invention. [Figure 11] This figure shows an example of an active device according to an exemplary embodiment of the present invention. [Figure 12] This figure shows an example of an active device according to an exemplary embodiment of the present invention. [Modes for carrying out the invention]

[0046] In general, the systems according to the exemplary embodiments herein provide devices, tools, instruments, software, and methods for assisting in the proper alignment of apparatus. The apparatus to be aligned may include, but is not limited to, any type of manual instruments and / or instruments, such as surgical instruments, hand drills, screwdrivers, awls, probes, taps, saws, files, pliers, forceps, scalpels, hypodermic needles, and other types of handheld devices. Those skilled in the art will understand, upon reading this specification, that the systems and methods can be used with any type of apparatus that would benefit from alignment in one, two, or three dimensions, and that the scope of the systems and methods is by no means limited by the type of apparatus used together.

[0047] For the purposes of this specification and for illustrative purposes, the System and Method will be described in relation to their use with surgical instruments (e.g., instruments used in orthopedic surgery). However, it should be understood that the System and Method can be applied to and used with any type of device from which one can benefit.

[0048] Referring here to Figures 1-12, the system 10 according to an exemplary embodiment of this specification will be described in further detail. In a currently preferred embodiment, the system 10 may be used to provide feedback on the three-dimensional navigation and alignment of a handheld surgical instrument. In one currently preferred embodiment, the surgical instrument may include an instrument used to perform orthopedic surgery, such as spinal stabilization.

[0049] In one embodiment, the surgical instrument may include a device used to implant a pedicle screw into the patient's spine. As shown in Figure 1, the pedicle screw 20 is preferably implanted into the patient's vertebral body 24 through the pedicle 22. A linkage unit 26 (e.g., a spinal rod or plate) is then attached to the pedicle screw 20. Typically, two or more pedicle screws 20 are used to secure each rod / plate 26 (e.g., one pedicle screw 20 at each end of each rod 26) so that the rod / plate 26 is approximately parallel to the patient's spine 28. In this way, the linkage 26 can be securely held by the pedicle screw 20 and provide stability to the particular segment of the spine to which it is attached.

[0050] The spinal rod 26 may be contoured during the surgical procedure so that it fits properly between the implanted pedicle screws 20. For example, it may be preferable to use an intraoperative spinal rod contouring system such as that described in U.S. Provisional Patent Application No. 62 / 762478 filed on 7 May 2018 and U.S. Patent Application No. 16 / 140491 (Agent No. 999 / 002), filed on the same day as this application, titled “Surgical Implant Preparation System and Method,” the entire contents of which are incorporated herein by reference for any purpose.

[0051] The sagittal angle β of the right pedicle screw 20 is shown in Figure 1. The angle β of the angular trajectory Ps of the pedicle screw 20 can be measured with respect to the vertical axis S (e.g., the vertical line) along the sagittal plane. The placement of the pedicle screw 20 in Figure 1 can be considered to be precise enough that the screw 20 passes from the pedicle 22 into the vertebral body 24 without perforating any cortical wall.

[0052] Figures 2A, 2B, and 2C show cross-sections along the cutting line AA in Figure 1 (along the axial direction or the transverse plane).

[0053] Figure 2A shows a pedicle screw 20 located within a pilot foramen 21, with an axial angle α (trajectory from lateral to medial). The angle α of the angular trajectory Pa of the pedicle screw 20 can be measured with respect to a longitudinal axis S (e.g., a vertical line) along the axial plane. The placement of the screw 20 is considered to be precise enough that it enters the vertebral body 24 through the pedicle 22 without breaking and / or perforating the lateral or medial cortical wall.

[0054] Figure 2B shows a pedicle screw 20 in a pilot foramen 21 that penetrates and / or perforates the lateral cortical wall, and Figure 2C shows a pedicle screw 20 in a pilot foramen 21 that penetrates and / or perforates the medial cortical wall. The placement of the pedicle screws shown in Figures 2B and 2C is considered inaccurate and may cause significant neurological problems for the patient, such as chronic pain, numbness, limited mobility, or paralysis. Therefore, depending on the patient's neurological symptoms, the inaccurately placed pedicle screws 20 may need to be corrected with additional surgery, which may add additional risks and complications to the patient.

[0055] In addition, if the link unit is fixed between two or more pedicle screws 20 (as shown in Figure 1), it is understood that these pedicle screws 20 need to be properly aligned with each other so that the link unit 26 can safely pass between the pedicle screws 20 without obstruction and without causing undesirable strain or torque to the pedicle screws 20 or the patient's spine 28.

[0056] Considering these considerations, it will become clear that the lateral-to-medial trajectory and alignment (alignment) of each pedicle screw 20, as well as the cranial-to-caudal trajectory and alignment, are of paramount importance for favorable surgical outcomes. The system of the present invention

[0057] In one exemplary embodiment of the invention, the system 10 may include a measuring assembly 100, a controller 200, and other elements, components, and mechanisms as needed to perform various functions. As shown in Figure 3, the measuring assembly 100 is coupled with an instrument 117 (e.g., a hand tool, i.e., a hand-held instrument) that requires proper alignment. Generally, the measuring assembly 100 can measure the real-time three-dimensional position, orientation, and trajectory of this instrument. In this way, the user of the instrument can use this positional information to ensure that the instrument is in the correct orientation during use. Thus, for example, an instrument related to implanting a pedicle screw can be properly aligned so that the pedicle screw is properly implanted as shown in Figure 2A.

[0058] The controller 200 can communicate with the measurement assembly 100, receive information and data from the measurement assembly 100, and send information and data to the measurement assembly 100. The controller 200 can also process the information received from the measurement assembly 100 and provide feedback to the user of system 10 based on the received information. The controller 200 can also receive input from this user and can communicate (connect) with other systems, including other controllers and systems.

[0059] The controller 200 can include, but is not limited to, any type of controller, including, for example, tablet computers, smartphones, mobile devices, laptop computers, PCs, network controllers, servers (e.g., network, backend, or cloud platforms), microcontrollers, and other types of controllers 200 or various combinations of types. The controller 200 may include one or more displays that can be used to display data, feedback, or other types of information. The controller 200 may also include one or more interfaces 204 (e.g., touchscreens, keyboards, mice, etc.) that can be used by a user to interact with the controller 200 for data input, for example.

[0060] Using spinal stabilization surgery as an exemplary embodiment, the surgeon can utilize a surgical hand tool 117 (e.g., a drill) coupled with a measuring assembly 100. In one example, the drill is used to create a pilot hole in the patient's spine for the insertion of a pedicle screw 20. The measuring assembly 100 can measure the three-dimensional position, alignment, orientation, and trajectory of the drill in real time and provide this positional data to the controller 200.

[0061] Next, the controller 200 can process the data and provide the surgeon with feedback (e.g., visual, textual, audible feedback) regarding the trajectory of the drill bit and, therefore, the resulting trajectory of the pilot hole. In this way, the surgeon can utilize the real-time feedback from the system 10 to precisely guide the drill bit in the correct orientation to create a properly oriented pilot hole. The pedicle screw 20 can then be inserted into the pilot hole and positioned appropriately.

[0062] The above example is for demonstration purposes only, and it should be understood that System 10 may be used in conjunction with other types of instruments to perform other types of procedures.

[0063] Next, we will describe the various elements of System 10 in more detail. Measurement assembly

[0064] Referring to Figure 4, according to an exemplary embodiment, the measuring assembly 100 may include at least one sensor 102, at least one processor 104, memory 106, at least one radio 108, power supply 110, voltage converter 112, and other components and elements necessary for the assembly 100 to perform its desired function. Depending on the application of the instrument 117 and the measuring assembly 100, the assembly 100 may include some or all of the elements described above, or additional elements as needed.

[0065] The sensor 102 may include any type of sensor 102 capable of measuring, sensing, or determining the one-dimensional, two-dimensional, or three-dimensional orientation of the assembly 100. According to one exemplary embodiment, the sensor 102 is an accelerometer, for example, a three-axis micro-electro-mechanical system (MEMS) accelerometer. As is known in the art, the accelerometer 102 can measure both dynamic and static acceleration. By measuring the amount of static acceleration due to Earth's gravity, the orientation (angle and / or tilt) of the sensor 102 can be determined.

[0066] The 3-axis MEMS accelerometer 102 can provide simultaneous measurements in three orthogonal directions and thus can provide three-dimensional orientation and trajectory (path) information. The output of the accelerometer 102 may be a charge (e.g., a voltage waveform) proportional to the force applied to the accelerometer at any given moment. This charge can then be processed to provide real-time position and trajectory data of the unit 100.

[0067] The sensor 102 may include piezoelectric, piezoresistive, capacitive, or other components to convert mechanical or physical motion into an electrical signal. In one example, the sensor 102 may include three micro-machined pivoting arms that can flex when subjected to acceleration (e.g., gravity). The flexure can be detected by a capacitive sensor and converted into a numerical value (e.g., in micrograms, or μg). In another example, the sensor 102 may include one or more cantilever beams having a proof mass (also called seismic mass) that can flex under the influence of an external acceleration. In yet another example, the sensor may include one or more gyroscopes (preferably MEMS gyroscopes). It should be understood that other types and structures of sensors 102 may also be used, and the range of the system 10 and measuring assembly 100 is by no means limited by the type of sensor 102 utilized by the assembly 100.

[0068] In one embodiment, the sensor 102 may be a 3-axis accelerometer manufactured by STMicroelectronics (e.g., part number LIS3DSH). It will be understood that other sensors 102 manufactured by other manufacturers may also be used.

[0069] According to one exemplary embodiment, the processor 104 and memory 106 can be combined and formed as a microcontroller 114. The microcontroller 114 may also include programmable input / output peripherals and other elements such as a voltage regulator 116. The microcontroller 114, radio 108, voltage regulator 116 (and other elements and components) can be provided as a system-on-a-chip (SoC) 115. In this way, the unit 100 can be miniaturized. Figure 4 shows one currently preferred electrical layout of the assembly 100. However, it should be noted that other electronic layouts can also be used. In one example, the device 100 may have a size of 0.8 inches x 1.5 inches x 0.5 inches, but the device 100 may be formed in other sizes.

[0070] The radio 108 may be a Bluetooth® radio, which can transmit and receive information at 2.45 GHz between itself and the controller 200 (and / or other devices). In one currently preferred embodiment, the radio 108 may have an output of 0.0023 watts (e.g., Bluetooth Low Energy Protocol), but other outputs may be used. The transmission rate may be 1-2 times per second, but other transmission rates may be used.

[0071] Radio 108 may be any other type of radio 108 or combination of radio 108 that can send and receive information on any other frequency using any type of analog or digital communication protocol or any combination thereof. For example, radio 108 can utilize RF, millimeter wave, Wi-Fi, LAN, WAN, Internet, cellular connectivity, telephone type, IR, or other types of communication protocols or methods. Radio 108 may also include an antenna, input / output (I / O) ports, and any other type of communication mechanism, as needed.

[0072] In a preferred embodiment, transmitter 108 is manufactured by Raytac Corporation (e.g., part number MDBT42Q, FCC identifier SH6MDBT42Q, certificate number 162181172 / AA / 00). It will be understood that other transmitters manufactured by other manufacturers may also be used.

[0073] The power supply 110 is preferably a battery, but may include other types of energy storage devices. In one example, the battery 110 may be a 1.5V coin cell, and the voltage converter 112 may be a DC-DC converter 112 that boosts 1.5V to 2.7V as required by other components in the assembly 100.

[0074] Furthermore, the measurement assembly 100 may also include one or more external non-volatile (E2PROM) memory chips 116 that can be used to enhance the internal memory 106 of the SoC 115.

[0075] Assembly 100 may preferably be packaged as a small, single-unit device, as shown in the various diagrams in Figure 6.

[0076] In one exemplary embodiment, the measuring assembly 100 is coupled (combined) with a handheld instrument 117, and the use of the instrument benefits from proper alignment. Following the example of using a surgical instrument, the instrument 117 may be a piton 118 as shown in Figure 7. The piton 118 may include a handle 120 to which a shaft 122 is attached, as shown. The shaft 122 may include a pointed distal tip having two or more sharp lateral edges. As is known in the art, the piton 118 can be used to drill into material, and in this example, for the insertion of a pedicle screw 20, the piton 118 can be used to drill a pilot hole 21 into the vertebral body 24 of the patient's spine through the pedicle 22.

[0077] The surgeon can hold the drill bit 118 with the handle 120 and position the distal tip of the shaft 122 at the desired location on the bone where the hole is to be made. The drill bit 118 rotates back and forth along the axis defined by the shaft 122, and the sharp tip of the shaft 122 drills the hole 21.

[0078] It can be seen that the orientation and alignment of the drill shaft 122 during this procedure can determine the orientation and trajectory of the resulting pilot hole 21. It can also be seen that when the pedicle screw 20 is screwed into the resulting pilot hole 21, the pedicle screw 20 can also follow the trajectory of the hole 21.

[0079] During this procedure, the measuring assembly 100 measures the orientation and trajectory of the drill bit 118 (shaft 122) and provides this information to the controller 200. The controller 200 processes this information and provides it to the user. The user of the drill bit 118 then uses this real-time position information to properly operate the drill bit 118 in the correct orientation to produce a properly oriented pilot hole 21, and thus, once the pedicle screw 20 is inserted, a properly oriented pedicle screw 20 is obtained. This will be explained in more detail in a later section.

[0080] In the current preferred embodiment shown, the measuring assembly 100 is configured with the handle 120 of the tap 118. However, it is understood that the measuring assembly 100 may also be configured with the shaft 122 and / or any other elements of the tap 118, and may be formed at any position on the tap 118.

[0081] The measuring assembly 100 may be attached to the instrument 117 during the manufacturing process of the instrument 117, or it may be coupled to the instrument 117 in another way, or the instrument 117 may be retrofitted as an aftermarket component. The measuring assembly 100 is aligned longitudinally and along the axis defined by the instrument shaft 122 such that the coordinate system used by the sensor 102 coincides with the coordinate system of the instrument 117. This will be described in more detail in a later section. However, the measuring assembly 100 may be aligned in other orientations relative to the instrument 117.

[0082] The instrument handle 120 may include a portion for receiving the assembly 100, such as a flat portion, a slot, an internal recess, or any other type of portion that accommodates the assembly 100 and allows for its secure mounting. However, this may not be necessary (for example, when the measuring assembly 100 is coupled with an instrument 117 as an aftermarket part). The measuring assembly 100 may be secured to the handle 120 by adhesive (e.g., 3M sterile surgical adhesive), double-sided tape, screws, bolts, straps, bands, latches, crimps, or any other type of mounting mechanism. In this specification, the instrument 117 coupled with the measuring assembly 100 is referred to as the active instrument 124.

[0083] Before use, it is preferable to calibrate the measurement assembly 100 (active instrument 124) to verify the amplitude response of the measurement assembly, the linearity of the system, and other performance characteristics over the intended range of use. In this way, the sensor 102 is verified to function within its specifications. Calibration can also provide a set of scale factors (calibration coefficients, correction factors, etc.) that can be used to correlate the electrical output of the assembly 100 with the real-world physical coordinates of the assembly 100.

[0084] Calibration factors can be applied to the output signal of the measurement assembly 100 to compensate for known defects in the sensor. Generally, the calibration procedure typically includes measuring and calibrating the sensor's reference sensitivity, frequency response, output bias level, lateral sensitivity, resonant frequency, time constant, and other characteristics. In this way, during use, the calibration factors are applied to the raw data received from the measurement assembly 100, and the real-time angular position and trajectory of the measurement assembly 100 can be determined within the calculated level of accuracy and uncertainty.

[0085] The active instrument 124 can be calibrated using a reference standard, such as a standard calibrated at the National Institute of Standards and Technology (NIST). Alternatively, more typically, a transfer standard can be calibrated using the reference standard, and this transfer standard can then be used to calibrate the active instrument 124. In either case, this allows for the absolute accuracy and measurement uncertainty of the measurement assembly 100 (and the active instrument 124) to be evaluated and optimized. It is preferable to test the measurement repeatability of the active instrument 124 through a series of measurements and use this information when calculating the uncertainty of the assembly.

[0086] Several different types of calibration procedures can be used to calibrate the active instrument 124, and the appropriate calibration technique may be selected depending on the type of sensor 102 used in the measuring assembly 100 and the desired range of use of the instrument. The active instrument 124 may be calibrated before each use, after each use (to verify that the instrument 124 has not changed or slipped during use), periodically (preferably on a periodic schedule), or at any other time. It will be understood that the range of the system 10, the measuring assembly 100, and the active instrument 124 is by no means limited by the type of calibration procedure used or the interval at which calibration may be performed. control device

[0087] In one embodiment, the controller 200 may include a tablet computer, smartphone, mobile device, laptop computer, PC, network controller, server (e.g., network, backend, or cloud platform), microcontroller, and any other type or combination of controllers 200. The controller 200 may also include an operating system and software, scripts, applications (including mobile applications), and other types of code that the controller 200 can execute or otherwise make available.

[0088] The controller 200 can receive information from the active device 124 in real time and transmit information to the active device 124. The controller 200 can be paired with the active device 124 via Bluetooth communication, or it can utilize other types of communication protocols or methods, such as RF, millimeter wave, Wi-Fi, LAN, WAN, Internet, cellular connectivity, telephone, IR, or other types of communication methods, digital or analog or any combination thereof. The controller 200 may also communicate with other devices (e.g., imaging devices) as needed using the same or different communication methods.

[0089] In one exemplary embodiment, the controller 200 can receive information from the active instrument 124 during use indicating the real-time orientation and trajectory (preferably in three dimensions) of the instrument. The controller 200 can then process this positional data and provide it to the user in a meaningful real-world format, preferably associated with one or more three-dimensional coordinate systems (as described below). The controller may apply calibration coefficients (e.g., scale factor or correction coefficient) to specific active instruments 124 to improve the accuracy of the data.

[0090] Details on how the controller 200 is used while the active device 124 is in use will be described later.

[0091] The controller 200 may also be used to automate the calibration procedure described above. For example, the controller 200 may provide a software wizard or other type of interactive tool that can guide the user during the calibration process.

[0092] The controller 200 may also provide a software wizard or other type of interactive tool that can guide the user while using the active device 124, as will be described later.

[0093] It should be noted that the system 10 may have any number of measuring assemblies 100, each assembly 100 being equipped with a different active instrument 124. For example, the first measuring assembly 100 may be coupled with the tap 117 as described above, the second measuring assembly 100 with the probe 117, the third measuring assembly 100 with the driver 117, and so on. Each measuring assembly 100 may include a unique electronic identifier (e.g., serial number, IP address, etc.) that the controller 200 can query, identify, and record. In this way, the controller 200 can individually and simultaneously monitor (or communicate with) each measuring assembly 100. use

[0094] Before surgery, the patient's spine can be stabilized by placing the patient in a prone position on a radiolucent operating table. With the patient's spine stable, a series of images of the patient's spine can be taken from different viewpoints using an imaging device (e.g., a C-arm fluoroscopy device). These images can then be used to construct a one-dimensional, two-dimensional, and / or three-dimensional representation (description) of the spine. The imaging device may preferably be calibrated according to its specifications as needed.

[0095] In an exemplary embodiment, the controller 200 (or possibly the imaging device) can use the imaging data to model, calculate, or determine the appropriate (optimal) position, alignment (preferably in three dimensions), and trajectory of each pilot hole for each pedicle screw 20 to be implanted. Alternatively, the controller can allow the user to interact with the controller 200 to manually lay out the proposed position, orientation, and trajectory of each proposed pilot hole. For example, the controller 200 can display an image of the patient's spine (representations) so that the user can draw (or input) the proposed position, orientation, and trajectory of each pilot hole on the layout.

[0096] The controller 200 may also provide a software wizard or other type of interactive tool that can assist the user in laying out and / or determining the location of the proposed pilot holes. For the purposes of this specification, the proposed pilot holes (whether determined by the controller 200, by the user, by any other system, or by any combination thereof) may be referred to as the modeled pilot holes 23, as shown in Figure 8.

[0097] The controller 200 may also perform quality checks on each modeled pilot hole 23 to ensure that the modeled pilot holes 23 are actually in the correct position and orientation. If a potential problem is found, the controller 200 may draw the user's attention to it for consideration. For example, the controller 200 may check to ensure that the axial angle α and sagittal angle β of each pedicle screw 20 are correct and that there are no cortical perforations. The controller 200 may also ensure that the pedicle screws 20 are properly aligned with each other so that the link unit 26 can be mounted between the screws 20 without interference and without applying undesirable strain or torque to the screws 20 or the patient's spine 2828.

[0098] The positional and alignment information for each modeled pilot hole 23 may include, but is not limited to, the entry point information, angular direction, trajectory (path) information, length information, location, orientation and / or position of any adjacent pedicle screw pilot holes 23, location, orientation and / or position of any associated link unit 26, and other information and / or any combination of such information. The modeled orientation and trajectory of each modeled pilot hole 23 preferably describe / express the hole 23 as passing through the pedicle 22 to the vertebral body 24 without perforating the cortex (as shown in Figure 2). This information may also be complex (vector) information.

[0099] As is known in the art, three commonly used coordinate systems are available in imaging applications and surgical procedures. These include, but are not limited to, the world coordinate system, the anatomical coordinate system, and the image coordinate system. The world coordinate system can typically include the Cartesian coordinate system and can be used to represent the position and orientation of the patient. The anatomical coordinate system (also called the patient coordinate system) may consist of three planes that describe the standard anatomical position of the human body: 1) the axial plane, parallel to the ground and separating the head (upper) from the feet (lower); 2) the coronal plane, perpendicular to the ground and separating the anterior (front) from the posterior (back); and 3) the sagittal plane, perpendicular to the ground and separating the left side from the right. The image coordinate system can describe how each image is acquired relative to an anatomical structure and may consist of an origin and an i-axis increasing to the right, a j-axis increasing towards the base, and a k-axis increasing towards the posterior (all orthogonal).

[0100] It is preferable to correlate the coordinate systems used by various instrumentation devices (e.g., the active instrument 124, the controller 200, the fluoroscopy imaging system, etc.). In this way, real-time angular direction and trajectory data acquired from the active instrument 124 can be accurately correlated and superimposed with imaging data taken by the X-ray fluoroscopy imaging system. This also enables the surgeon to understand the coordinate system that can be used while operating the active instrument 124. For example, the surgeon can manipulate the axial angle α (Figure 2) and sagittal angle β (Figure 1) of the active instrument 124 with respect to a vertical reference such as a vertical line. The vertical line is approximately parallel to or corresponds to a vector that can represent the acceleration due to the force of gravity measured by the sensor 102 (e.g., an accelerometer). The starting position of the pilot hole 21 can be determined from a modeled pilot hole 23 or from anatomical landmarks using the surgeon's personal knowledge and / or experience.

[0101] When the active instrument 124 is used to form the pilot hole 21, the controller 200 superimposes the real-time orientation / trajectory of the active instrument 124 onto the orientation / trajectory of the modeled pilot hole 23 in real time (or utilizes other types of data presentation). For example, as shown in Figure 1, the controller 200 displays a cross-section of the patient's vertebrae along the axial plane, superimposing the actual axial angle αa (shown by the dashed line C) of the active instrument 124 onto the modeled axial angle αm of the modeled pilot hole 23 (solid line 23). Here, both axial angles are relative to the vertical axis S (e.g., a vertical line along the medial-sagittal plane). Other reference planes and / or coordinate systems can also be used as references.

[0102] Using this information along with the starting point information for the pilot hole 23, the surgeon can manipulate the active instrument 124 during the drilling procedure so that its orientation / trajectory matches that of the modeled pilot hole 23. As a result, a well-aligned pilot hole 21 is created in the patient's spine that closely matches that of the modeled hole 23.

[0103] In another example shown in Figure 9, the controller 200 directly displays the angle information (α, β) measured by each measuring assembly 100. In this way, the user reads the angles and operates the corresponding active instrument 124 accordingly.

[0104] Figure 9 shows the angular information (α and β) of the six individual measuring assemblies 100 that make up the system 10. Since each measuring assembly 100 is combined with a different active instrument 124, the name of the controller active instrument 124 is displayed along with its corresponding angular information. Other information may also be displayed. Figure 9 shows the position data of the six measuring assemblies 100 displayed by the controller 200, but there can be any number of measuring assemblies 100 that make up the system 10, and the controller 200 displays the information received from them.

[0105] Furthermore, the controller 200 may provide a software wizard or any other type of interactive tool to assist or guide the surgeon during the procedure.

[0106] The controller 200 can also provide the surgeon with other types of real-time feedback, such as warnings, if the alignment of the active instrument 124 deviates by a certain threshold from the position of the modeled pilot hole 23. For example, if the angular direction of the active instrument 124 is deemed to deviate from the modeled angular direction of the pilot hole 23 along any plane exceeding a predetermined threshold, an audible warning may be issued to alert the user. Other types of feedback and warnings, such as visual, sensory, or any other type of feedback, or any combination thereof, may also be used.

[0107] The controller 200 may include at least one display 202 that is easily visible to users of the system. For example, the display 202 may be positioned so that a surgeon simply tilts their eyes slightly upward to see the display 202 and the feedback shown therein. In another example, the display 202 of the controller 200 may be embedded in the user's eyeglasses so that the user can see both the display 202 and the patient simultaneously. It will be understood that the display 202 may be positioned where it can be seen by at least some of the multiple users of the system 10.

[0108] A surgeon is not required to utilize all the information provided by system 10 during any particular surgery. For example, a surgeon can determine the entry point of the pilot hole 21 based on cortical landmarks and then use the orientation and trajectory information provided by system 10 to perforate the pilot hole 21. It will be understood that any and / or all of the information provided by the system may be used by the surgeon at the surgeon's discretion, and that the scope of system 10 is never limited by the information, whether the surgeon uses it or not.

[0109] Those skilled in the art will understand, upon reading this specification, that the above example illustrating the active tool 124 as the drill bit 118 is for demonstration purposes only, and that the active tool 124 can be any type of tool 117.

[0110] For example, the instrument 117 may be a probe 126 as shown in Figure 10. The probe 126 may include a handle 128 and a shaft 130. The measuring assembly 100 is coupled to the probe 128 (either its handle 128 or elsewhere) so that the probe 128 can become an active instrument 124.

[0111] In one preferred embodiment, the probe 126 can be used to measure the angular direction and trajectory of the perforated pilot hole 21 described above. The probe 126 is inserted into the perforated pilot hole 21, and the angular direction and trajectory of the probe 126 (and therefore the angular direction and trajectory of the pilot hole 21) are measured, processed, and displayed by the system 10. In this way, the angular direction and trajectory of the pilot hole 21 are confirmed to be properly correlated with the modeled pilot hole 23 as described in the previous section.

[0112] In another embodiment shown in Figure 11, the instrument 117 is a driver 132 (e.g., a screwdriver) that can be used to screw each pedicle screw 20 into its corresponding pilot hole 21. The driver 132 may include a handle 134 and a shaft 136. The measuring assembly 132 is coupled with the driver 132 (e.g., its handle 134) so ​​that the driver 132 is the active instrument 124. In this way, the trajectory of the screw 20 during insertion can be monitored to match the trajectory of the modeled pilot hole 23 (and the actual pilot hole 21). This ensures that the pedicle screw 20 does not advance along a different trajectory outside the pilot hole 21 during its insertion.

[0113] In another preferred embodiment, the instrument 117 is a subcutaneous injection needle 138 as shown in Figure 12. The subcutaneous injection needle 138 may include a handle 140, a body 142, and a needle 144. The measuring assembly 100 is coupled to the subcutaneous injection needle 132 (its body 136 or elsewhere) so that the subcutaneous injection needle 138 becomes the active instrument 124.

[0114] In one preferred embodiment, a subcutaneous injection needle 132 can be used to administer an injection into the patient's body. In some such procedures, it may be necessary to hold the orientation of the subcutaneous injection needle 138 at a specific angle in order to properly administer the injection. As an active instrument 124, the system 10 can measure, process, and display the real-time angular orientation of the subcutaneous injection needle 132 so that the surgeon can manipulate the subcutaneous injection needle to a preferred position.

[0115] In this example, system 10 may or may not use the patient's imaging information; instead, it can guide the user through the procedure using theoretically modeled data. Alternatively, the user may simply use the positional data provided by system 10 to operate the active instrument 124 relative to a known reference coordinate system (e.g., a vertical line).

[0116] While the system 10, including the measurement assembly 100 and controller 200, has been described above in relation to surgical procedures such as spinal stabilization and injections using subcutaneous needles, other types of surgical procedures can also benefit from the use of system 10. For example, kyphoplasty, percutaneous bone biopsy of known lesions within bone, neurosurgical procedures in the brain that may require stereotactic surgery, and other surgical procedures can also be used with and benefit from system 10.

[0117] In all disclosed and undisclosed embodiments, the measuring assembly 100 and / or active instrument 124 may be disposable and designed to be used once and then discarded. Alternatively, the measuring assembly 100 and / or active instrument 124 may be designed to be used multiple times.

[0118] Furthermore, in all disclosed and undisclosed embodiments, it is preferable that the measuring assembly 100 and / or the active instrument 124 be sterilized and / or provided as a sterilization device.

[0119] If a process is described herein, those skilled in the art will understand that the process can operate without user intervention. In another embodiment, the process involves some human intervention (for example, a certain step is performed by a person or with the help of a person).

[0120] As used herein, including in the claims, the phrase "at least some" means "one or more," including the case of just one. Therefore, for example, the phrase "at least some ABCs" means "one or more ABCs," including the case of just one ABC.

[0121] As used herein, including in the claims, the term "at least one" should be understood to mean "one or more," and therefore include both embodiments having one component and embodiments having multiple components. Furthermore, any dependent claim referencing an independent claim describing a feature containing the term "at least one" has the same meaning when that feature is referred to as "the" and "the at least one."

[0122] The term "portion" means a part or all of something. Therefore, for example, "a part of X" can include a part of X or all of X. In a conversational context, the term "portion" can mean both a part and all of a conversation.

[0123] As used herein, including in the claims, the phrase "using" means "at least using" and is not exclusive. For example, the phrase "using X" means "at least using X." Unless specifically indicated by the use of the word "only," the phrase "using X" does not mean "using X only."

[0124] As used herein, including in the claims, the phrase "based on" means "partially based on" or "at least partially based on," and is not exclusive. For example, the phrase "based on factor X" means "partially based on X" or "at least partially based on X." Unless specifically indicated by the use of the word "only," the phrase "based on factor X" does not mean "based on factor X only."

[0125] Generally speaking, as used herein, including in the claims, unless a word is explicitly stated to be "only" in the text, it should not be interpreted as being included in that text.

[0126] As used herein, including in the claims, the phrase “different” means “at least partially different.” Unless otherwise specified, “different” does not mean completely different. For example, the statement “X is different from Y” means “X is at least partially different from Y,” and not “X is completely different from Y.” Therefore, as used herein, including in the claims, the statement “X is different from Y” means “X is different from Y in at least some way (in some aspect).”

[0127] It should be understood that in this specification and the claims, the words “first,” “second,” etc., are used for distinction or identification, and not for order or numerical limitation. Similarly, letter labels (e.g., “(A),” “(B),” “(C),” etc., or “(a),” “b),” “(c),” etc.) and / or numbers (e.g., “(i),” “(ii),” etc.) are used to aid readability and to help distinguish and / or identify, and are not intended to be limiting, nor to impose or suggest any sequential or numerical limitation or order. Likewise, in this specification and the claims, the words “specific,” “predetermined,” “a certain,” “given,” etc., when used, are used for distinction or identification, and are not intended to be limiting.

[0128] As used herein, including in the claims, the terms “multiple” and “plural” mean “two or more” and include the case of “two.” Therefore, for example, the phrase “multiple ABCs” means “two or more ABCs” and includes “two ABCs.” Similarly, for example, the phrase “multiple PQRs” means “two or more PQRs” and includes “two PQRs.”

[0129] The present invention also covers terms, features, values, and ranges themselves when used in conjunction with terms such as “about,” “approximately,” “around,” “roughly,” “substantially,” and “essentially” (for example, “about 3” or “approximately 3” also covers the case of exactly 3, or “substantially constant” covers being exactly constant).

[0130] As used herein, including in the claims, singular terms should be interpreted as including plural forms unless the context indicates otherwise, and vice versa. Therefore, it should be noted that the singular articles “a,” “an,” and “the,” as used herein, also refer to plural things unless the context explicitly indicates otherwise.

[0131] Throughout this specification and the claims, the terms “equipped with,” “included,” “possessing,” “containing,” etc., and variations thereof, should be understood as “including, but not limited to,” and are not intended to exclude other components unless otherwise specified.

[0132] It will be understood that modifications of embodiments of the present invention can be made as long as they remain within the scope of the invention. Alternative features serving the same, equivalent, or similar purposes may be substituted for features disclosed in the specification unless otherwise stated. Therefore, unless specifically noted, each disclosed feature represents an example of a comprehensive set of equivalent or similar features.

[0133] The present invention also covers terms, characteristics, values, and ranges exactly as they are when used with terms such as “about,” “approximately,” “around,” “roughly,” “substantially,” and “essentially” (for example, “about 3” or “approximately 3” also covers the case of exactly 3, or “substantially constant” covers being exactly constant).

[0134] The use of illustrative phrases such as "for example" and "etc." is intended merely to better illustrate the present invention and does not limit the scope of the invention unless specifically stated in the claims.

[0135] While the present invention has been described in relation to what is considered to be the most practical and preferred embodiment at present, it should be understood that the invention is not limited to the disclosed embodiments, but rather is intended to encompass a variety of modifications and equivalent configurations that fall within the spirit and scope of the appended claims.

Claims

1. A system that provides feedback regarding the angular direction of a handheld surgical instrument, A measurement assembly comprising an integrated circuit, configured to be attached to the handheld surgical instrument, and including an accelerometer that, when attached to the handheld surgical instrument, measures the angular direction of the handheld surgical instrument relative to gravity and provides a signal based on the measured angular direction, and including a unique electronic identifier that processes the signal and associates the measurement assembly only with the handheld surgical instrument to which the measurement assembly is attached, A system comprising an application configured to receive the processed signal, and which enables a visual display to provide feedback of the measured angular direction of the handheld surgical instrument.

2. The system according to claim 1, wherein the measuring assembly includes a battery that supplies power to the measuring assembly and has a lifespan corresponding to a single surgical procedure.

3. The system according to claim 1, wherein the measuring assembly is axially aligned with the handheld surgical instrument only when it is mounted thereto.

4. The system according to claim 1, wherein the measured angular direction is the orientation in three-dimensional space relative to gravity.

5. The system according to claim 1, wherein the measured angular visual representation includes the axial angle and sagittal angle of the handheld surgical instrument with respect to gravity.

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