JP2015502766A - System and method for vertebral load and location detection - Google Patents

Abstract

A load balancing and alignment system is provided for assessing load forces on the vertebrae with overall spinal alignment. The system includes a spinal instrument having an electronic assembly and a sensored head. Sensored heads can be inserted between vertebrae and report vertebral conditions such as force, pressure, orientation and end loads. When the spinal instrument is installed in the intervertebral space, a GUI is provided that indicates where the spinal instrument is positioned relative to the vertebral body. The system can report optimal brace size and installation taking into account sensed load and location parameters, including optional orientation, rotation and insertion angle along the determined insertion trajectory .

Description

  The present invention relates generally to surgical electronics, and more particularly to methods and devices for assessing alignment and surgical implantation parameters during spinal surgery and long-term implantation.

  The spine is made up of many individual bones called vertebrae that are joined by muscles and ligaments. A soft intervertebral disc buffers each vertebra from the next. Because the vertebrae are separated, the spine is flexible and can bend. Together, the vertebrae, intervertebral discs, nerves, muscles, and ligaments make up the spinal column or spine. The spine varies in size and shape, with changes that can occur due to environmental factors, health, and aging. The normal spine has a front-to-back curve, but deformation due to the pathology of the normal cervical lordosis, thoracic kyphosis, and lumbar lordosis can cause pain, discomfort, and movement disorders. These conditions can be exacerbated by a herniated disc that can compress the nerve.

  There are many different causes of abnormal spinal curvature and different treatment options from treatment to surgery. The purpose of the operation is usually a solid fusion of the curved portion of the spine. Healing is performed by operating on the spine, adding bone grafts, and slowly bringing the vertebrae and bone grafts together to form a solid mass of bone. Alternatively, spinal cages are generally used that contain bone grafts to fuse the vertebrae at intervals. The bone graft can come from a bone bank or the patient's own hipbone. The spine can be almost straightened using instrumental bars and hooks, wires or screws, with instrumented instruments and techniques. A rod or possibly brace or cast holds the spine in place until the fusion is expected to heal.

  Various features of the system are set forth with particularity by the appended claims. The embodiments herein may be understood by reference to the following description, taken in conjunction with the accompanying drawings, in which:

1 illustrates a spinal alignment system according to an example embodiment. FIG. 6 illustrates a user interface showing spine registration and projection views according to an example embodiment. FIG. 1 illustrates a wand and receiver of a spinal alignment system according to an example embodiment. FIG. 6 illustrates a plurality of sensorized devices for determining spinal alignment according to example embodiments. FIG. FIG. 6 illustrates a sensorized installation for determining spinal parameters, according to an example embodiment. FIG. 6 illustrates the installation of a plurality of sensors for determining the state of a spine, according to an example embodiment. 1 illustrates a sensorized spinal instrument according to an example embodiment. 1 illustrates an integrated sensored spinal instrument according to an example embodiment. Fig. 4 shows an insertion device with a non-limiting example vertebral component. FIG. 6 illustrates a spinal instrument positioned between vertebrae of a spine for parameter sensing according to an example embodiment. FIG. 11 illustrates a user interface showing a perspective view of the sensorized spinal instrument of FIG. 10 according to an example embodiment. FIG. 4 illustrates a sensorized spinal instrument positioned between vertebrae of a spine for sensing intervertebral position and force, according to an example embodiment. FIG. 13 shows a perspective view of a user interface showing the sensorized spinal instrument of FIG. 12 according to an example embodiment. FIG. 4 illustrates a sensorized spinal insertion device for placement of a spinal cage, according to an example embodiment. FIG. 15 shows a perspective view of a user interface showing the sensorized spinal insertion device of FIG. 14 according to an example embodiment. It is a block diagram of the component of the apparatus for spines concerning the embodiment. 1 is a schematic diagram of an exemplary communication system for short-range telemetry, according to an example embodiment. 1 illustrates a communication network for measurement and reporting according to an example embodiment. FIG. 6 illustrates an example schematic diagram of a machine in the form of a computer system in which when a set of instructions is executed, the machine executes any one or more of the methods disclosed herein. Can be.

  While the specification concludes with the claims, which define the features of the embodiments of the invention deemed to be novel, the method, system, and other embodiments are described below with reference to the drawings in which reference numerals are carried forward. This can be better understood by considering the explanation.

  As required, detailed embodiments of the methods and systems of the present invention are disclosed herein. However, it should be understood that the disclosed embodiments are merely exemplary and can be implemented in various forms. Accordingly, the specific structural and functional details disclosed herein are not to be construed as limiting, but merely as a basis for the claims and virtually any suitable It is to be construed as a representative basis for teaching those skilled in the art to use the embodiments of the present invention in various structures. Furthermore, the terms and phrases used herein are not intended to be limiting, but are intended to provide an understandable description of the embodiments herein.

  In general terms, embodiments of the present invention relate to systems and methods for vertebral load and location sensing. The spine measurement system includes a receiver and a plurality of wands coupled to a remote display that visually indicates position information. A wand can be placed on or in contact with the vertebra to report various aspects of spinal alignment. The location information identifies the orientation and location of the corresponding vertebrae of the wand and spine. The system provides the ability to track vertebral movement during surgery in addition to global alignment. The system may provide and indicate intraoperative vertebral correction in response to position information captured during the procedure and pre-recorded position data regarding pre-operative vertebral condition.

  The spine measurement system further includes a load balancing and alignment system for assessing load forces on the vertebrae together with overall spinal alignment. The system includes a spinal instrument having an electronic assembly that can be coupled into a vertebral cavity and a sensor-attached head assembly. Sensored heads can be inserted between vertebrae and report vertebral conditions such as force, pressure, orientation and end loads. A GUI is used with it to indicate where the spinal instrument is positioned relative to the vertebral body as the instrument is placed in the intervertebral space during surgery. The system can report optimal brace size and installation taking into account sensed load and location parameters, including optional orientation, rotation and insertion angle along the determined insertion trajectory .

  An insertion instrument is also provided herein along with a load balancing and alignment system to insert a vertebral component, such as a spinal cage or pedicle screw. The system can check and report whether the instrument is end loading during insertion, taking into account already captured parameter measurements. The system shows insertion instrument tracking by vertebral components and provides visual guidance and feedback based on position and load sensing parameters. The system shows three-dimensional (3D) tracking of the insertion device for one or more vertebral bodies that are also modeled in orientation and position in 3D.

  FIG. 1 illustrates a non-limiting example spinal alignment system 100. System 100 includes a wand 103 and a receiver 101 that can be communicatively coupled to a remote system 105. In general, one or more wands communicate with the receiver 101 to determine position information including one of spine region orientation, rotation, angle, and location. The receiver 101 transmits position information or data 117 regarding the wand 103 to the remote system 105. The position information includes orientation and movement data used to evaluate the alignment (or predetermined curvature) of the spine 112. The remote system 105 can be a laptop or mobile workstation showing a Graphical User Interface (GUI) 107. The GUI 107 includes a workflow that shows the spine 112 and reports spine alignment considering the location information. As an example, the user interface may show the current alignment 114 of the vertebrae of the spine relative to the target alignment 113 after surgery.

  The alignment system 100 may be used in a database 123 system, such as a server 125, to provide three-dimensional (3D) imaging (eg, soft tissue) and 3D models (eg, bone) that are captured before or during surgery. It can be communicatively coupled. 3D imaging and models can be used with location information to establish relative locations and orientations. Server 125 may be a local server within close proximity or may be utilized remotely over the Internet 121. As an example, the server 125 provides a 3D spine and vertebra model. A CAT scanner (not shown) can be used to generate a series of cross-sectional X-ray images of selected parts of the body. The computer operates the scanner, and the obtained image is a slice image of the body. The server 125 generates a three-dimensional (3D) model from the slice image. Server 125 may also provide a 3D model generated from a Magnetic Resonance Imaging (MRI) scanner (not shown). Server 125 may also support fluoroscopic imaging to provide real-time animation of the patient's internal structure to alignment system 100 device through the use of an X-ray source (not shown) and a fluorescent screen.

  The spinal alignment system 100 reports the ability to track the movement of the isolated vertebrae in addition to the overall alignment and orientation of the instrument (eg, wand 103 and receiver 101). The receiver 101 accurately tracks the location of the wand 103 at a particular vertebra and along the spine 112 to determine position information. The receiver 101 is shown coupled to the sacrum (eg, fastened, screwed, and fixed). However, the receiver 101 can be located anywhere along the spine vertebra. Alternatively, the receiver 101 can be mounted on a platform near the spine 112. The wand 103 and the receiver 101 are sensorized devices that can transmit their position by ultrasonic, optical, or electromagnetic sensing. In this example, the wand 103 and the receiver 102 are ultrasonic line transducers and line of sight (LOS) devices. The sensor may be externally attached to the wand 103 away from the wand tip, or possibly within the wand tip. The wand 103 can be held in the hand or secured to the spine by a mechanical assembly. In one embodiment, the components for generating all alignment measurements (eg, receiver 101 and wand 103) reside within operating room sterilization field 109. The sterile field 109 can also be referred to as a surgical field. Typically, the remote system 105 is external to the operating room sterilization field 109. The components used in the sterile field 109 can be designed for a single use. In this example, wand 103, receiver 102, or both are discarded after being used during surgery.

  An example of an ultrasonic sensing device is disclosed in US patent application Ser. No. 11 / 683,410, entitled “Method and Device for Three-Dimensional Sensing” filed on March 7, 2007. The entire contents of which are hereby incorporated by reference. One example of optical sensing is the three in the wand 103 with corresponding high-speed camera elements in the receiver 101 for optical tracking, or high-speed photodiode elements for detecting the angle of the incident light beam and then the triangle wand position. Or four active IR reflectors. An example of electromagnetic sensing includes a metal sphere in the wand whose spatial position is determined by evaluating the change in magnetic field strength generated at the receiver 103.

  Many physical parameters of interest within a physical system or body can be measured by evaluating changes in the characteristics of energy waves or pulses. As an example, the transit time or shape change of an energy wave or pulse propagating through a changing medium can be measured to determine the force acting on the medium to cause the change. The propagation speed of energy waves or pulses in the medium is affected by physical changes in the medium. Physical parameters or parameters of interest may include, but are not limited to, measurements of load, force, pressure, displacement, density, viscosity, and local temperature. These parameters are along the orientation, alignment, orientation, or position and axis or combination of axes by a wireless sensing module or device, equipment, equipment, or other mechanical system positioned on or within the body. It can be evaluated by measuring changes in the propagation time of energy pulses or energy waves with respect to movement, rotation, or acceleration. Alternatively, the measurements of interest can be taken using thin film sensors, mechanical sensors, polymer sensors, mems devices, strain gauges, piezoresistive structures, and capacitive structures, to name just a few.

  FIG. 2 shows a graphical user interface (GUI) 150 of the system 100 showing a non-limiting example spine registration and projection view. Projections provide three-dimensional visualization to the surgical procedure and the system device of FIG. 1 while displaying quantitative measurements in real time. Each projection may be configured separately to show different perspective views of the spine with superimposed spine alignment information. The first projection 210 shows a sagittal view (ie, from front to back). The second projection 230 shows a coronal view (ie, between the sides). Sagittal and coronal views provide sufficient spatial information to visualize spinal alignment using only two projections. Projections can be customized for different viewing angles and scene graphs.

  As an example, the surgeon can hold the wand 103 and track the spine contour, for example, to determine the severity (or correction) of scoliosis symptoms. This can be done prior to surgery while the patient is standing to display the patient's posture and spinal curvature. The surgeon holds the wand and tracks the contour of the spine. The GUI 108 visually indicates the contour of the spine from the position information captured from the wand 103 during tracking. Next, the alignment angle is the primary statistics and geometry (see, for example, angle points R, P1, and P2, where R is the reference alignment and P1 is the location of the receiver 101 , P2 is the point aligned by the wand 103). The alignment angle indicates the misalignment of the spine alignment and, when projected onto the observation surface, indicates errors in the sagittal plane and the coronal plane. The GUI 108 may then report the necessary complementary correction. In this example, for example, the GUI 108 may require a +4 cm forward displacement in the display box 146 to correct the sagittal deviation of the angle between the line 152 and the line 154, and between the line 158 and the line 156. Report the required displacement to the right of +2 cm in the display box 148 to correct for the coronal deviation of the angle. This provides the surgeon with minimal visual information to provide surgical alignment correction.

  Alternatively, fast point-registration methods can be used to assess spinal alignment. The point alignment method allows the surgeon to quickly evaluate spinal alignment with minimal alignment. The user holds the wand, places the cursor on the vertebra and clicks to generate a point curve that is converted to a line. In the first step A, the receiver 101 is positioned at a fixed location, for example, a table near the operating table. Alternatively, the receiver 101 can be fastened to the sacrum as shown in FIG. In the second step B, the surgeon uses the tip of the wand 103 to identify three or more anatomical features in the reference bone, such as a point along the posterior iliac crest or dorsal surface in the sacrum. The system 100 determines the orientation of the reference bone from the spatial position of the aligned wand tip, for example, in the <x, y, z> Cartesian coordinate system with respect to the receiver 101 origin. The system 100 then retrieves the relevant 3D model spine components (eg, sacrum, vertebrae, etc.) from the image server 125 and places them in the GUI 108 with the appropriate scale and orientation (morphing and warping) according to the orientation of the reference bone. To display. Once the 3D model registration is complete, the surgeon then aligns one of the vertebrae, eg, the cervical vertebrae (C1-C7), in a third step C, with the patient stationary. next. The system 100 has sufficient aligned points to generate a local coordinate system for the reference bone, generate curves and line segments, and report the overall alignment, as shown in FIG. . Spine alignment is reported taking into account a predetermined curvature or straightness of the spine, for example, showing a line 152 relative to the desired (preoperative planning) line 154.

  FIG. 3 shows a non-limiting example of a wand 103 and receiver 101, but not all illustrated components are required, and fewer components may be used depending on the functions required. The communication mode of the receiver 101 and the wand 103 and the operation between them is disclosed in US patent application Ser. No. 12 / 900,662 entitled “Navigation Device Providing Sensory Feedback” filed on 10/8/2010. The entire contents of which are hereby incorporated by reference. Briefly, this dimension allows non-contact tracking with submillimeter spatial accuracy (<1 mm) up to a distance of about 2 m. Any device can be configured to support a variety of functions (eg, hand-held attached to an object), none of which are limited to the dimensions described below.

  The wand 103 is a handheld device having a size dimension of about 10 cm wide, 2 cm deep, and variable length between 18 cm and 20 cm. As indicated above, the wand 103 can be pointed to a point of interest (see points A, B, C) along an object or surface contour, which can be shown, for example, in a user interface (see GUI 107 in FIG. 1). Can be aligned. As already described, the wand 103 and the receiver 101 can communicate by ultrasonic, infrared and electromagnetic sensing to determine their relative location and orientation relative to each other. Other embodiments incorporating accelerometers provide additional position information.

  Wand 103 includes sensors 201-203 and wand tip 207. Sensors are ultrasonic transducers, micro electro mechanical elements (MEMS) microphones, electromagnets, optical elements (eg, infrared, laser), metal objects or physical movements of electrical signals such as voltage or current. Other transducers for converting or transmitting to They may be active elements in that they are self-powered to transmit signals, or may be passive elements in that they are reflective or exhibit detectable magnetic properties.

  In one embodiment, the wand 103 generates drive signals to three ultrasonic transmitters 201 to 203 that transmit ultrasonic signals in the air, and three ultrasonic transmitters 201 to 203 to generate ultrasonic signals. A controller (or electronic circuit) 214, a user interface 218 (eg, a button) that receives user input to perform near-field position measurement and alignment determination, relays user input, and receives timing information A communication module 216 for controlling the electronic circuit 214, and a battery 218 for supplying power to the electronic circuit 218 and related electronics in the wand 103. Controller 214 is operably coupled to ultrasonic transmitters 201-203. The transmitters 201 to 203 transmit sensory signals in response to instructions from the controller 214. The wand 103 may include more or fewer components than shown, and the functionality of several components may be shared as an integrated device.

  Additional transmitter sensors can be included to provide an over-determined system for three-dimensional detection. As an example, each ultrasonic transducer can perform separate transmit and receive functions. One such example of an ultrasonic sensor is disclosed in US Pat. No. 7,725,288, the entire contents of which are hereby incorporated by reference. The ultrasonic sensor can transmit a pulse shaped waveform according to the physical characteristics of the customized transducer for composing and shaping the waveform.

  The wand tip 207 identifies a structure in three-dimensional space, such as, but not limited to, an assembly, an object, a device, or a target point of a jig. The tip does not require a sensor because its spatial position in three-dimensional space is established by three ultrasonic transmitters 201-203 that are placed at cross ends. However, tip sensor 219 can be integrated into tip 207 to provide sensing based on ultrasound functionality (eg, structural boundaries, depth, etc.) or contact. In such cases, the tip 207 may be touch-sensitive to align the point in response to a physical action, eg, contact of the tip to an anatomical or structural location. The tip may include a mechanical spring or actuating spring assembly for such purposes. In another configuration, the tip includes a capacitive touch tip or electrostatic assembly for aligning contact. The wand tip 207 is replaceable and detachable that allows the wand tip to identify anatomical features while keeping the transmitters 201-203 within line of sight with the receiver 101 (see FIG. 1) A multi-headed stylus tip may be included. These stylus tips may be right-angled, curvilinear, or other shapes in the form of picks so that it is difficult to point to multiple touch locations. This allows the tip 207 to hold the wand in the hand to identify points of interest such as (anatomical) features in the structure, bone or jig.

  User interface 218 may include one or more buttons to allow manual operation and use (eg, an on / off / reset button) and lighting elements to provide visual feedback. In one configuration, an 8-state navigation push button 209 can communicate instructions to further control or complement the user interface. A navigation push button 209 may be ergonomically placed on the side of the wand to allow for use with one hand. Wand 103 may include a haptic module along with user interface 218. As an example, the haptic module may change (increase / decrease) the vibration to indicate improper or proper operation. Wand 103 includes a material cover for transmitters 201-202 that transmits sound (e.g., ultrasound) and light (e.g., infrared) but does not transmit biological material such as water, blood, or tissue. In one configuration, a transparent plastic membrane (or mesh) is tightened, which can vibrate under resonance by the transmitted frequency. The battery 218 can be charged by wireless energy charging (eg, magnetic induction coils and supercapacitors).

  The wand 103 may include a base coupling mechanism 205 for coupling to a structure, object or jig. As an example, the mechanism can be a magnetic assembly with a fixed insert (eg, a square posthead) to allow temporary detachment. As another example, the mechanism may be a magnetic ball with a latched increment and a joint socket. As yet another example, the mechanism can be a screw post or pin to an orthopedic screw. Other embodiments may allow sliding, moving, rotating, angling and lock-in coupling and release, and coupling to standard jigs with existing notches, ridges or holes.

  The wand 103 may further include an amplifier 213 and an accelerometer 217. The amplifier increases the signal to noise ratio of the transmitted or received signal. The accelerometer 217 identifies 3-axis and 6-axis tilt while moving and fixed. The communication module 216 may include components for transmitting signals to the receiver 101 (eg, synchronization clock, radio frequency “RF” pulse, infrared “IR” pulse, light / acoustic pulse). The controller 214 may include counters, clocks, or other analog or digital logic for controlling transmission and reception synchronization and for sequencing sensor signals, accelerometer information, and other component data or states. A battery 218 provides power to the respective circuit logic and components. Infrared transmitter 209 pulses an infrared timing signal that can be synchronized with the transmission of the ultrasound signal (to the receiver).

  The controller 214 may be a microprocessor (uP) and / or digital along with associated storage 208 such as Flash, ROM, RAM, SRAM, DRAM or other similar technology for controlling the operation of the above components of the device. Computational techniques such as a digital signal processor (DSP) may be used. The instructions may also reside in other memory and / or processors completely or at least partially during execution of instructions by another processor or computer system. The input / output port allows for portable exchange of information or data, for example, via a Universal Serial Bus (USB). The electronic circuitry of the controller 214 may be, for example, one or more Application Specific Integrated Circuit (ASIC) chips or Field Programmable Gate Arrays (FPGAs) specific to the core signal processing algorithm. ). The controller 214 may be an embedded platform that operates one or more modules of an operating system (OS). In one configuration, the storage device may store one or more instruction sets (eg, software) that use any one or more of the methods or functions described herein.

  The receiver 101 generates timing information, aligns the indicated position of the wand 103 in response to user input, and measures and aligns the short distance position from the three or more indicated positions of the wand 103 with respect to the receiver 101. A processor 233 for determining. The receiver has a size dimension of about 2 cm wide, 2 cm deep, and 10 cm to 20 cm long. The receiver includes a communication module 235 for transmitting timing information in response to the wand 103 that transmits the first, second and third ultrasound signals. The ultrasound signal may be a pulse waveform signal generated from a combination of amplitude modulation, frequency modulation, and phase modulation. Each of the three microphones 221 to 223 receives the first, second, and third pulse waveform signals transmitted in the air. The receiver 101 may be configured in a line or in a smaller configuration may have a triangular shape. An example of a device for three-dimensional detection is disclosed in US patent application Ser. No. 11 / 683,410, filed Mar. 7, 2007, entitled “Method and Device for Three-Dimensional Sensing”. The entire contents of which are hereby incorporated by reference.

  Memory 238 may store ultrasound signals and generate a history of ultrasound signals or processed signals. The memory 238 can also store the wand tip position, for example, in response to a user pressing a button to align. A wireless communication interface (input / output) 239 wirelessly transmits position information of three or more indicated positions and short-range alignment to the remote system. The remote system can be a computer, laptop or portable device that displays location information and alignment information in real time as described above. The battery supplies power to the processor 233 and associated electronics in the receiver 101. The receiver 101 may include more or fewer components than shown, and the functionality of some components may be shared or integrated in.

  Additional ultrasonic sensors can be included to provide an overdetermined system for three-dimensional detection. The ultrasonic sensor can be a MEMS microphone, a receiver, an ultrasonic transmitter, or a combination thereof. As an example, each ultrasonic transducer can perform separate transmit and receive functions. One such example of an ultrasonic sensor is disclosed in US Pat. No. 7,414,705, the entire contents of which are hereby incorporated by reference. The receiver 101 may also include a coupling mechanism 240 for coupling to a bone or jig by a pin 251. As an example, the coupling mechanism 240 can be a magnetic assembly with a fixed insert (eg, a square posthead) to allow temporary detachment. As another example, the coupling mechanism 240 can be a magnetic ball and joint socket with a latch increment.

  The receiver 101 may further include an amplifier 232, a communication module 235, an accelerometer 236, and a processor 233. The processor 233 may host software program modules such as a pulse shaper, phase detector, signal compressor, and other digital signal processor code utilities and packages. Amplifier 232 increases the signal to noise ratio of the transmitted or received signal. The processor 233 may include controllers, counters, clocks, and other analog or digital logic for control of transmit and receive synchronization and ordering of sensor signals, accelerometer information, and other component data or states. The accelerometer 236 may identify axial tilt (eg, 3 and 6 axes) while moving and fixed. A battery 234 provides power to the respective circuit logic and components. The receiver includes a photodiode 241 for detecting the infrared signal and establishing the transmission time of the ultrasonic signal to enable wireless infrared communication with the wand.

  The communication module 235 may include components for local signal transmission (to the wand 102) (eg, synchronization clock, radio frequency “RF” pulses, infrared “IR” pulses, optical / acoustic pulses). The communication module 235 is a network and data component (eg, Bluetooth®, ZigBee, Wi-Fi, GPSK, FSK, USB, etc.) for wireless communication using a remote device (eg, laptop, computer, etc.). RS232, IR, etc.). Note that external communication via the network and data components is envisaged herein, but the receiver 101 may include a user interface 237 to allow a single operation. As an example, the receiver 101 may include three LED lights 224 to indicate three or more wand tips that indicate the alignment state of the position. User interface 237 may also include a touch screen or other interface display along with its GUI to report location information and alignment.

  Processor 233 may be a microprocessor (uP) and / or associated memory device 238 such as Flash, ROM, RAM, SRAM, DRAM or other similar technology for controlling the operation of the above components of a terminal device. Computational techniques such as a digital signal processor (DSP) can be used. The instructions may also reside in other memory and / or processors completely or at least partially during execution of instructions by another processor or computer system. The input / output port allows for the portable exchange of information or data, for example, by Universal Serial Bus (USB). The controller electronics may be, for example, one or more Application Specific Integrated Circuits (ASIC) chips or Field Programmable Gate Arrays specific to core signal processing algorithms or control logic. (FPGA). The processor may be an embedded platform that runs one or more modules of an operating system (OS). In one configuration, the storage device 238 may store one or more instruction sets (eg, software) that use any one or more of the methods or functions described herein.

  In the first configuration, the receiver 101 is wired via an electrical connection (eg, wiring) connected to the wand 103. That is, the communication port of the wand 103 is physically wired to the communication interface of the receiver 101 for receiving timing information. The timing information from the receiver 101 informs the wand 103 of the transmission timing and includes optional parameters that can be applied to pulse shaping. The processor 233 at the receiver 101 uses this timing information to establish a Time of Flight measurement in the case of ultrasonic signal transmission relative to a reference time base.

  In the second configuration, the receiver 101 is communicatively coupled to the wand 103 via a wireless signal transmission connection via the wireless I / O 239. A signaling protocol is disclosed in US patent application Ser. No. 12 / 900,662, entitled “Navigation Device Providing Sensitivity Feedback”, filed 10/8/2010, the entire contents of which are incorporated by reference. Incorporated herein by reference. An infrared transmitter 209 in the wand 103 transmits an infrared timing signal along with each transmitted pulse waveform signal. Infrared transmitter 209 pulses an infrared timing signal that is synchronized with the transmission of the ultrasonic signal to the receiver. The receiver 101 can include a photodiode 241 for determining when an infrared timing signal is received. In this case, the communication port of the wand 103 is wirelessly coupled to the communication interface of the receiver 101 by an infrared transmitter and a photodiode for relaying timing information within microsecond accuracy (resolution up to 1 mm). The processor 233 at the receiver 101 uses this infrared timing information to establish first, second, and third time of flight measurements relative to the reference transmission time.

  FIG. 4 shows a plurality of sensored wands for evaluating a non-limiting example spine alignment 300. As shown, a plurality of sensored wands 301-304 may be used to track the movement of individual vertebrae and / or alignment with other tracked vertebrae. Each of the wands can be of a different size and sensor configuration. A wand is a lightweight component that can range in dimensions from 4 cm to 12 cm and a width of 1 cm or less. In general, the wands 301-304 have a form factor that is easily held manually or can be coupled or supported by a musculoskeletal system. For example, the first wand 301 may have a wider and longer sensor distance than another wand 303. Thereby, communication between the wands 301 to 304 and the receiver 308 can be facilitated. Each wand may have a separate ID to distinguish it from others, for example, stored as a characteristic low frequency magnetic wavelength unique to the wand. The system 100 may identify the wand via a passive magnetic field and determine the position by one or more ultrasound, optical, electromagnetic elements, or (passive / active) sensors.

  In conjunction with the description of FIG. 4, a workflow method is assumed herein. In a first workflow step 311, the receiver 308 is positioned in proximity to the surgical site and where the wand is expected to be used. As described above, the receiver 308 is placed on a table or secured to the sacrum (or other bone region) to track the orientation and location of the wand. The wand is held in the hand and can be used to align anatomical features in the sacrum, for example, to click the wand tip to align with the bone features. This point alignment captures anatomical points, which are then used to retrieve a 3D spine model with the appropriate orientation and dimensions. In step 312, the wand can then be used to align points in the vertebra and assess the location of that vertebra. In the first configuration, the wand can be secured directly to the vertebra without wand tip point alignment. This provides a single point for evaluating the spatial position (three-dimensional information) at the insertion point, which is not necessarily orientation.

  In the second configuration, the wand is first used to align a point on the surface of the vertebra and then inserted into it. Alignment captures anatomical vertebra points, which are then used to retrieve a 3D vertebra model with the appropriate orientation and dimensions. This allows the system 100 to track the vertebra at an appropriate scale and position as the wand is inserted therein. Upon alignment and positioning of the receiver in the sacrum and each wand in the vertebra, the system 100 provides a real-time display of instrument tracking, as shown in step 313. That is, the system 100 generates a virtual environment showing a 3D model of the spine, sensored wands 301-304, and a receiver 308.

  FIG. 5 shows a sensorized installation for determining the state of the spine in a non-limiting example. As described above, the wand tip may also include a sensor such as a biometric transducer. When the wand tip is used to align the point of interest, it can also capture biometric data directly related to the insertion site. The wand tip can also release the biometric transducer and leave it positioned at the contact site. The description of FIGS. 5 and 6 shows the installation of a wand tip sensor, which, in one configuration, deploys the tip sensor in situ for long term implantation. The system 100 can also transmit energy waves in a vibration pattern similar to the load on the bone, and can also improve bone mineral content and bone density. The sensor can also send energy waves through or across the implant, thereby assisting in healing the fracture.

  Accordingly, provided herein is a method for detecting a biometric parameter that is a function of sensored placement including position and orientation. The method includes providing a biometric transducer on a moving component of the spinal joint and energy waves from the biometric transducer to a different surgical site from the moving component of the spinal joint during movement of the spinal joint or spine. (E.g., ultrasound, optics, electromagnetic), quantitatively assessing energy wave behavior during spinal joint movement, and based on the evaluated behavior and spinal joint movement, Determining at least one parameter of a procedure site selected from the group consisting of current conditions or pressure, tension, shear, load, torque, bone density and load weight. Alternatively, an insertable head assembly incorporating one or more sensors can be used to measure a subject's biometric parameters. In this example, the biometric transducer can detect and transmit information regarding vertebral movement and loading. As an example, the sensor can detect abnormal movement of the orthopedic joint, for example, by evaluating the frequency or periodicity of the evaluated behavior when the spinal joint is flexed during movement.

  As an example shown in FIG. 5, a single sensor 352 may be used to evaluate the behavior of a moving spinal joint, such as the quality or function of a joint mechanism related to pressure, tension, shear, bone density, and load weight. Can be implanted in a bone or spinal joint orthosis component (eg, vertebrae). The sensor 352 in this embodiment is in a fixed location in the bone (vertebra) and moves with the vertebra 358 during movement relative to the procedure site 360. As shown, the procedure site 360 includes a vertebra 354, an intervertebral disc 356, and a vertebra 358. The procedure site 360 is relatively immobile with respect to the sensor because the vertebrae primarily move a single sensor. A single sensor of this configuration is exposed to various changes in the subject parameters (eg, pressure, tension, shear, bone density, and load weight) at the procedure site as a result of movement. As an example, the sensor is compressed by various joint movements caused by movements applied to various locations of the joint during movement. During movement, the sensor 352 evaluates the energy waves at the procedure site and the adjacent sites are also evaluated because the movement of the vertebra (and thus the focus of the sensor) changes relative to the procedure site as a result of the movement. The position of the sensor 352 is also determined with respect to other vertebrae (by the wand if it is coupled to it) and used to catalog the detected parameter changes with respect to orientation, location and position. .

  One of installing a sensor 352 on a moving component (eg, vertebra, dental implant) and using the knowledge of its location and orientation to transmit energy waves into a different surgical site than the moving component of the spinal joint One advantage is that it effectively changes the distance between the sensor 352 and the procedure site, thereby changing the resolution and focus of the sensor 352 and the forces on it. The position information also indicates the periodicity of movement relative to the detected parameter change. As an example, a sensor 352 operating in a switched transmit and receive mode can take measurements at different depths of the procedure site without causing operational changes. Sensors 352 differ as a result of distance changes due to articulation, for example, without making sensor adjustments that may originally require changes in the frequency, amplitude, or phase of the transmitted energy wave to match impedance. You can take measurements.

  As an example, biometric sensor 352 can be an ultrasound device. Quantitative ultrasound can measure additional properties of bone, such as mechanical integrity, in contrast to other bone density measurement methods that measure only bone mineral content. The propagation of ultrasound through bone is affected by bone mass, bone structure, and load direction. Quantitative ultrasound measurements as a means of assessing bone strength and stiffness are based on the processing of received ultrasound signals. The speed of sound and ultrasound propagates through bone and soft tissue. Looseness or settling of the brace and fracture of the femur / tibia / acetabulum or brace are associated with bone loss. Thus, an accurate assessment of the progressive quantifiable change in the amount of bone mineral around the brace is the timing at which the treating surgeon intervenes to preserve bone stock for revision arthroplasty. Can help you decide. This information is useful for the development of implants for osteoporotic bone, and for the treatment of osteoporosis and the assessment of the effects of various implant coatings.

  FIG. 6 illustrates multiple sensorized installations for determining the state of the spine in a non-limiting example. As described above, the wand tip may also include a sensor such as a biometric transducer. When the wand tip is used to align the point of interest, it can also capture biometric data directly related to the insertion site. The wand tip can also release the biometric transducer and leave it positioned at the contact site.

  Accordingly, providing a second biometric transducer at a different surgical site than the spinal joint movement component and the relative separation of the first biometric transducer and the second biometric transducer during spinal joint movement. There is provided herein a method for detecting a biometric parameter comprising quantitatively evaluating the behavior of an energy wave based on The current state of the procedure site or at least one parameter is determined from the estimated behavior and spinal joint movement. The parameter is one of strain, vibration, kinematics, and stability. The first biometric transducer or the second biometric transducer may include a transceiver for transmitting data associated with the at least one biometric parameter to an external source for evaluation.

  As shown in FIG. 6, sensor 352 may be implanted in a bone or spinal joint orthosis component (eg, vertebra), and sensor 366 may be used to assess a spinal joint behavior during movement. In different positions. The sensor 352 in this embodiment is in a fixed location in the bone (vertebra) and moves with the vertebra during articulation relative to the sensor 366 at the procedure site. Sensors 366 can be on different bones. Although both sensors can move, sensor 352 can actually be considered to move relative to sensor 366 and is displaced relative to the shown. Sensors 352 and 366 include, but are not limited to, bone density, fluid viscosity, temperature, strain, pressure, angular deformation, vibration, load, torque, distance, slope, shape, elasticity, motion, etc. Allows assessment of host bones and tissues.

  The illustrated dual sensor configuration can assess bone integrity. For example, at the spinal joint, sensors 352 and 366 coupled to the first and second vertebrae assess bone density. External and internal energy waves delivered by sensor 352, sensor 366, or both according to the present invention may be used during fracture treatment and spinal fusion. With two deployed sensors, the distance between the sensors can be determined by the area of interest and the power field that can be generated. The energy field can be a standard energy source such as ultrasound, radio frequency, and / or electromagnetic field. The deflection of the energy wave over time will allow, for example, detection of changes in the desired parameter being evaluated. As an example, a first sensor placed at the distal end of the femur may assess bone density from a second sensor implanted at the proximal end of the tibia during vertebra movement.

  One advantage of two or more sensors is that they move closer and further with respect to each other as a result of movement, for example, the frequency characteristics of the sensor under investigation and the impedance of the procedure site This is an operation that improves the evaluation of energy waves depending on the characteristics. Also, the relative separation of sensors 352 and 366 can provide different measurements without sensor adjustments that may inherently require changes in the frequency, amplitude, or phase of the transmitted energy wave, eg, to match impedance. Can take. In this example, the bone measurement is based on the processing of the received ultrasound signal. Both the speed of sound and the ultrasonic velocity provide a measurement based on how quickly the ultrasonic wave propagates through bone and soft tissue. These measurement characteristics allow for rapid three-dimensional geometry generation, and this information can be processed by the system 100 along with position, orientation and location information. Since the sensor spans the joint space, it can detect changes in implant function. Examples of implant functions include bearing wear, settling, bone integration, normal and abnormal movement, heat, viscosity changes, particulate matter, kinematics, to name a few.

  FIG. 7 shows a non-limiting example sensorized spinal instrument 400. A side view and a plan view are shown. The spinal instrument 400 includes a handle 409, a shaft 430, and a sensored head 407. Handle 409 is coupled to the proximal end of shaft 430 and sensored head 407 is coupled to the distal end of shaft 430. In one embodiment, handle 409, shaft 430, and sensored head 407 form a rigid structure that does not bend when used to distract or measure the spinal region. The spinal instrument 400 includes an electronic assembly 401 that is operatively coupled to one or more sensors in the sensored head 407. The sensor is coupled to the surface 403/406 in the moving component 404/405 of the sensored head 407. The electronic assembly 401 is disposed toward the proximal end of the shaft 407 or in the handle 409. As shown, the electronic assembly 401 is coupled to the shaft 409. The electronic assembly 401 includes electronic circuits including logic circuits, accelerometers, and communication circuits. In one embodiment, the surfaces 403 and 406 of the sensored head 407 may have a convex shape. The convex shape of the surfaces 403 and 406 supports the placement of the sensored head 407 within the spinal region, and more specifically between the vertebral contours. In one embodiment, sensored head 407 is height adjustable by top component 404 and bottom component 405 via jack 402 that extends and closes uniformly in response to pivoting motion 411 of handle 409. is there. Jack 402 is coupled to the inner surface of components 404 and 405 of sensored head 407. The shaft 430 includes one or more longitudinal passages. For example, an interconnect, such as a flexible wire interconnect, passes through one longitudinal passage of the shaft 430 so that the electronic assembly 401 is operatively coupled to one or more sensors in the sensored head 407. Can be joined through. Similarly, a threaded rod can be coupled through the second passage of the shaft 430 to couple the handle 409 to the jack 404 so that rotation of the handle 409 causes the height of the sensored head 407 to be increased. Adjustment is possible.

  The spinal instrument 400 can also determine orientation with an embedded accelerometer. Sensored head 407 includes multiple capabilities including the ability to determine parameters of the procedure site (eg, intervertebral space), including pressure, tension, shear force, load, torque, bone density, and / or bearing weight. Support the function. In one embodiment, two or more load sensors can be included in the sensored head 407. Two or more load sensors can be coupled in place on the surfaces 403 and 406. Having two or more load sensors allows the sensored head 407 to measure the magnitude of the load and the position of the load applied to the surfaces 403 and 406. Sensored head 407 can be used to measure, adjust, and test the spinal joint prior to installing the vertebral component. As will be seen below, the alignment system 100 evaluates the optimal insertion angle and position of the spinal instrument 400 upon detection of the intervertebral disc load and reproduces these conditions when using the insertion instrument.

  In the present invention, these parameters are: i) the encapsulating structure and the contact surface supporting the sensor and ii) the power source, the sensing element, one or more ultrasonic resonators or one or more ultrasonic transducers and one or Multiple ultrasonic waveguides, one or more biasing springs or other forms of elastic members, accelerometers, antennas and processing measurement data as well as energy conversion, propagation and detection and all of wireless communication It can be measured using an integrated wireless sensored head 407 or device that includes an electronic assembly that integrates the electronic circuitry that controls the operation of the device. Sensored head 407 or device 400 includes, but is not limited to, a device, appliance, vehicle, equipment, or other physical system to detect and communicate parameters of interest in real time. Various physical systems, including but not limited to, can be positioned on or engaged with, or coupled to or secured to, the animal and human body.

  An example of using spinal instrument 400 is in the spinal cage illustration. The spinal cage is used to space vertebrae during disc replacement. The spinal cage is typically hollow and can be formed with screws for fixation. Two or more cages are often placed between the vertebrae to obtain sufficient support and distribution of the load over the range of motion. In one embodiment, the spinal cage is made of titanium for light weight and strength. Bone growth material can also be placed in the cage to initiate and promote bone growth, thereby further strengthening the intervertebral region over time. The spinal instrument 400 is inserted into the gap between the vertebrae to measure the load and the position of the load. The position of the load corresponds to the vertebral region or surface that applies the load to the surface 403 or 406 of the sensored head 407. The angle and position of insertion of sensored head 407 of spinal instrument 400 can also be measured. Measurement of the magnitude of the load and the position of the load is used by the surgeon to determine the optimal location for the implant location between the vertebrae and the spinal cage for the implant location. The optimal size would be a cage height that falls within a predetermined load range when loaded by the spine. Typically, the height of the sensored head 407 used to distract the subject's vertebra and measure the force applied by the subject's vertebra is equal to the cage height implanted in a later step. After removing the sensored head 407 from the vertebra, the spinal cage can be implanted in the same area. The load on the implanted spinal cage is approximately equal to the measurement created by the spinal instrument 400 and applied by the sensor head 407. In one embodiment, the angle and position of the insertion test measurement is recorded by the spinal instrument 400 or a remote system coupled thereto. The angle and position measurements are then used to guide the spinal cage into the same region of the spine in the same path as the spinal instrument 400 during the measurement process.

  FIG. 8 illustrates a non-limiting example integrated sensored spinal instrument 410. In particular, the electronic assembly 401 is inside the integrated device 410. The electronic assembly 401 includes an external wireless energy source 414 that can be placed in proximity to the charging unit to initiate a wireless recharge operation. The wireless energy source 414 may include a power source, a modulation circuit, and a data input. The power source can be a battery, charging device, capacitor, power connection, or other energy source for generating a wireless power signal that can transfer power to spinal instrument 410. The external wireless energy source 414 can transmit energy in the form of, but not limited to, electromagnetic induction, or other electromagnetic or ultrasonic radiation. In at least one exemplary embodiment, the wireless energy source includes a coil that, when placed in close proximity, electromagnetically couples and operates (eg, is powered on) with an induction coil in the sensing device.

  The electronic assembly 401 transmits measured parameter data to the receiver via a data communication circuit to allow visualization of parameter levels and distribution at various points in the vertebral component. The data input can also be an interface or port for receiving input information from another data source such as a computer via a wired or wireless connection (eg, USB, IEEE 802.16, etc.). The modulation circuit can modulate the input information into a power signal generated by the power source. Sensored head 407 typically has a wear surface made of a low friction polymer material. Ideally, the sensored head 407, when inserted between vertebrae, has the proper load, alignment, and balance, similar to a natural spine.

  FIG. 9 shows an insertion device 420 with a non-limiting example vertebral component. The electronic assembly 401 described herein similarly supports the generation of orientation and position data for the insertion device 420. The alignment system 100 allows a user to reproduce the insertion angle, position, and trajectory (path) to achieve proper or pre-planned placement of vertebral components. Alternatively, an accelerometer in electronic assembly 401 can provide location and trajectory information. The insertion device 420 includes a handle 432, a neck 434, and a tip 451. An attachment / detachment mechanism 455 couples to the proximal end of the neck 434 to control the tip 451. The detachment mechanism 455 allows the surgeon to hold or release the vertebral component coupled to the tip 451. In this example, the handle 432 extends at an angle proximate the proximal end of the neck 434. Positioning the handle 432 allows the surgeon to accurately point the tip 451 into the spinal region while allowing access to the detachment mechanism 455.

  In the first example, the vertebral component is a spinal cage 475. The spinal cage 475 is a small hollow cylindrical device, usually made of titanium, with a perforated wall that can be inserted between the vertebrae of the spine during surgery. Generally, the distraction process spaces the vertebrae to a predetermined distance before insertion of the spinal cage 475. The spinal cage 475 can increase stability, reduce vertebral compression, and reduce neuropathy as a solution to improve patient comfort. The spinal cage 475 can include surface threads that make the cage self-tapping and provide additional stability. The spinal cage 475 can be porous to include bone graft material that supports bone growth between the vertebral bodies through the cage 475. To alleviate discomfort, more than one spinal cage can be placed between the vertebrae. Proper placement and positioning of the spinal cage 475 is important for good long-term implantation and patient outcome.

  In the second example, the vertebral component is a pedicle screw 478. Pedicle screw 478 is a specific type of bone screw designed for implantation in the pedicle. There are two pedicles per vertebra that connect to other structures (eg, lamina, vertebral arch). Multi-axis pedicle screws can be made of titanium to resist corrosion and increase component strength. The length of the pedicle screw ranges from 30 mm to 60 mm. The diameter is in the range of 5.0 mm to 8.5 mm. Pedicle screws are not limited to these dimensions used as example dimensions. The pedicle screw 478 can be used in an instrumentation procedure to fix rods and plates to the spine to correct deformation and / or treat trauma. Pedicle screws 478 can be used to secure portions of the spine to aid in healing by holding the bone structure together. The electronic assembly 401 (which can be integrated internally or externally) allows the insertion instrument 420 to determine the depth and angle for installation of the screw and guide the screw therein. In this example, one or more accelerometers are used to provide orientation, rotation, angle, or position information for tip 451 during the insertion process.

  In one configuration, the screw 478 is embedded with the sensor. The sensor can transmit energy, take a density reading, and monitor the change in density over time. As an example, the system 100 can therefore monitor and report the healing of the fracture site. The sensor can detect movement at the fracture site as well as changes in movement between the screw and the bone. Such information is useful in monitoring healing and gives the health care provider the ability to monitor the indicated vertebral weight load. The sensor can also be actuated externally to send an energy wave to the fracture itself to aid in healing.

  FIG. 10 shows a perspective view of a spinal instrument 400 positioned between vertebrae of the spine for sensing non-limiting example vertebral parameters. In general, a compressive force is applied to surfaces 403 and 406 when sensored head 407 is inserted into the spinal region. In one embodiment, the sensored head 407 includes two or more load sensors that identify a magnitude vector of load on the surface 403, the surface 406, or both associated with the intervertebral force therebetween. In the illustrated example, spinal instrument 400 is positioned between vertebra (L5) and sacrum (S) such that a compressive force is applied to surfaces 403 and 406. Because the endoscopic approach is difficult to visualize or provide good exposure, one approach for inserting the device 400 is performed from the back (back) by abdominal wall lifting. Is called. Another approach is taken from the front (front side) to allow the surgeon to reach the spine through the abdomen. In this way, the spinal muscles located on the back are not damaged or severed, and muscle weakness and scarring are avoided. The spinal instrument 400 can be used with either an anterior or posterior spinal approach.

  A sensory component aspect of spinal instrument 400 is described in US patent application Ser. No. 12 / 825,638, filed Jun. 29, 2010, entitled “System and Method for Orthopedic Load Sensing Insert Device”. And US patent application Ser. No. 12 / 825,724 filed Jun. 29, 2010, entitled “Wireless Sensing Module for Sensing a Parameter of the Muscular-Skeletal System”. Is incorporated herein by reference in its entirety. Briefly, the sensored head 407 can measure forces (Fx, Fy, and Fz) along with corresponding locations and torques (eg, Tx, Ty, and Tz) and vertebral end loads. An electronic circuit 401 (not shown) controls sensor operation and measurement in the sensor-equipped head 407. The electronic circuit 401 further includes a communication circuit for near field data transmission. The electronic circuit 401 then sends measurement data to the remote system to provide real-time visualization to help the surgeon identify the adjustments necessary to obtain optimal joint balance. be able to.

  A method for placing components in muscle tissue is disclosed below. The steps of the method may be performed in any order. The method is illustrated using an example of cage placement between vertebrae, but the method can be applied to other muscle and skeletal regions such as knees, hips, ankles, spine, shoulders, hands, arms, and feet. It is. In the first step, the sensor-equipped head having a predetermined width is installed in a muscular / skeletal system region. In this example, the insertion region is between the vertebrae of the spine. A hammer can be used to tap the end of the handle to provide sufficient force to insert the sensored head between the vertebrae. The insertion process can also distract the vertebrae, thereby increasing the separation distance. In the second step, the position of the load applied to the sensor-equipped head is measured. Thereby, the magnitude of the load and the position of the load are obtained with respect to the surface of the sensor-equipped head. How the load applied by the musculoskeletal system is positioned on the surface of the sensored head can help determine the stability of the component after insertion. An irregular load applied to the sensored head can predict the situation where the applied force pushes the component away from the insertion position. In general, sensored heads are used to identify suitable locations for component insertion based on quantitative data. In the third step, the load from the sensor-equipped head and the load position data are displayed in real time on the remote system. Similarly, in the fourth step, at least one of orientation, rotation, angle, or position is displayed in real time on the remote system. Changes made during the positioning of the sensor head are reflected in the data on the remote system display. In the fifth step, a location between vertebrae with appropriate loads and positions is identified and the corresponding quantitative measurement data is stored in memory.

  In the sixth step, the sensor-equipped head is removed. In the seventh step, the component is inserted into the muscular / skeletal system. As an example, the stored quantitative measurement data is used to support positioning the component in the musculoskeletal system. In this example, the insertion device can be used to direct the component into the musculoskeletal system. An insertion instrument is an active device that provides the orientation, rotation, angle, or position of a component as it is inserted. The pre-measured direction and location of insertion of the sensored head can be used to guide the insertion instrument. In one embodiment, the remote system display can serve to display the relative alignment of the insertion instrument and components to the pre-inserted sensored head. The insertion device, along with the system, can provide visual, audio, tactile or other feedback to further help direct the installation of the component. Generally, the inserted component has a height approximately equal to the sensored head. Ideally, the component is inserted into the pre-inserted sensor head at the same location and position so that the load and load position on the component is similar to the quantitative measurement. In the eighth step, the components are positioned and released identically to the pre-inserted sensor head. The insertion device can then be removed from the muscular / skeletal system. In the ninth step, at least the sensor-equipped head is discarded.

  Thus, the sensored head is used to identify a suitable location for component insertion. Insertion is supported by quantitative measurements including location and location. In addition, the approximate load and load location on the component is known after the procedure is complete. In general, knowing the load applied by the muscle-skeletal system and the position of the component on the surface can help determine the long-term stability of the component. If the load applied to the component is irregular, the applied force can push the component away from the insertion position.

  FIG. 11 shows a graphical user interface (GUI) 500 showing a perspective view of the sensorized spinal instrument of FIG. 10 in a non-limiting example. User interface 500 is illustrated by remote system 105 and alignment system 100 (see FIG. 1). The GUI 500 includes a window 510 and an associated window 520. Window 520 shows spinal instrument 400 and sensor head 407 with respect to vertebra 522 being evaluated. In this example, a perspective (planar) view of the vertebra is shown. This figure shows, for example, a shaft angle 523 and a rotational component 524 that indicate the approach angle and rotation of the spinal instrument 400 as it is advanced into the incision. The window 520 and corresponding GUI information is shown and updated in real time during the procedure. This allows the surgeon to visualize the use of spinal instrument 400 and sensed parameters. Window 510 shows the sensing surface (403 or 406) of sensored head 407. A line of sight 512 is overlaid on the sensor head image to identify the maximum point and location of the force. The line of sight 512 may be long to indicate the end load of the vertebra. Window 513 reports, for example, a 20 pound load force across the sensor head surface. This information is shown and updated in real time during the procedure.

  As described above, the system 100 can be used during surgery to aid in the implantation of a prosthesis / device / hardware by parameter sensing (eg, vertebral load, end load, compression, etc.). Components such as the receiver 101, the plurality of wands 103, and the spinal instrument 400 remain in the surgical field during use. Remote system 105 is typically external to the surgical field. All measurements are made in the surgical field by these components. In one embodiment, at least one of the receiver 101, the plurality of wands 103, and the spinal instrument is discarded after the procedure is completed. In general, they are designed to be powered for a single use and cannot be sterilized again.

  In the spine, effects on bone tissue and soft tissue elements, and changes in soft tissue (eg, cartilage, tendon, ligament) during surgery, including spinal correction surgery, are evaluated by the system 100. The sensor is then used during surgery (and after surgery) to assess and visualize changes over time and dynamic changes. The sensor can be activated during surgery when surgical parameter readings are stored. Immediately after the operation, the sensor is activated and the reference value is known.

  The sensor system 100 includes, but is not limited to, a spine with respect to bone density, fluid viscosity, temperature, strain, pressure, angular deformation, vibration, load, torque, distance, slope, shape, elasticity, and motion. And allow connective tissue assessment. Because the sensor is passed through the vertebral cavity, the sensor can predict changes in the function of the vertebral component prior to insertion of the vertebral component. As described above, system 100 is used to place spinal instrument 400 in an intervertebral space, where spinal instrument 400 is shown positioned relative to vertebral body 522. Once it is installed and visually confirmed at the center of the vertebra, the system 100 reports the end load on the instrument, which in turn is the appropriate vertebra device and insertion plan (eg, approach angle, rotation, etc.). , Depth, path trajectory) used to determine the size. Examples of implant component functions include bearing wear, settling, bone integration, normal and abnormal movement, heat, viscosity changes, particulate matter, kinematics, to name a few. Including.

  FIG. 12 shows a sensorized spinal instrument 400 positioned between the vertebrae of the spine for non-limiting example intervertebral position and force sensing. As shown, sensored head 407 of spinal instrument 400 is placed between vertebra L4 and L5 vertebrae. The spinal instrument 400 distracts the L4 and L5 vertebrae by the height of the sensored head 407 and provides quantitative data about the magnitude and position of the load. In one embodiment, spinal instrument 400 communicates with first wand 510 and second wand 520 positioned adjacent to each side thereof. A long shaft 514 is provided on each wand to allow placement within the vertebrae of the spine and is compatible with other wands and the electronic assembly 401 of spinal instrument 400. Wand 510 tracks the orientation and position of vertebra L4, while wand 520 tracks the orientation and position of vertebra L5. This allows the system 100 to track the orientation and movement of the spinal instrument 400 relative to the movement of adjacent vertebrae. Each wand is sensored in the same manner as spinal instrument 400. Wand 510 and wand 520 include sensor 512 and sensor 513, respectively. Sensors 512 and 513 can transmit and receive position information. The electronic assembly 401, in conjunction with the wands 510 and 520, serves a dual function to determine the orientation and position of the spinal instrument 400 during the procedure. An example of ultrasonic position detection is disclosed in US patent application Ser. No. 12 / 764,072 entitled “Method and System for Positional Measurement” filed on April 20, 2010, The entire contents are hereby incorporated by reference.

  13 shows a perspective view of a user interface 600 showing the sensorized spinal instrument of FIG. 12 in a non-limiting example. User interface 600 is shown by remote system 105 and alignment system 100 (see FIG. 1). The GUI 600 includes a first window 610 and an associated second window 620. The second window 620 shows the spinal instrument and sensored head 407 for the vertebral component 622 being evaluated. In this example, a sagittal (side) view of the spinal column is shown. This figure shows a shaft angle 623 and a rotational component 624 showing the approach angle and rotation of the spinal instrument and sensored head 407. The second window 620 and the corresponding GUI information are shown and updated in real time during the procedure. This allows the surgeon to visualize the sensored head 407 of the spinal instrument 400 and the sensed load force parameters. The first window 610 shows the sensing surface of the sensor head (see FIG. 7). A line of sight 612 is superimposed on the image of the sensored head 407 to identify the maximum point and location of the force. The line of sight 612 can also be adjusted in width and length to indicate the end load of the vertebra. Another GUI window 613 reports the load force across the surface of the sensored head 407. The GUI 600 is shown and updated in real time during the procedure.

  FIG. 14 shows a perspective view of a sensorized spinal insertion device 420 for placement of a non-limiting example spinal cage 475. The insertion instrument 420 provides a surgical means for implanting a vertebral component 475 (eg, spinal cage, pedicle screw, sensor) between the L4 and L5 vertebrae in the figure. The tip 451 of the mechanical assembly at the distal end of the neck 434 allows detachment of the vertebral component by the detachment mechanism 455. Vertebral component 475 can be placed on the back of the spine through a midline incision on the back, as shown, for example, by a posterior pathway lumbar interbody fusion (PLIF). The insertion device 420 can similarly be used in an anterior pathway lumbar interbody fusion (ALIF) procedure.

  In one method envisaged herein, the position of the cage prior to insertion is, for example, 3D imaging or as described using wands 510 and 520 with spinal instrument 400 shown in FIGS. It is optimally defined by ultrasonic navigation. A load sensor 407 (see FIG. 12) is positioned between the vertebrae to evaluate the load force described above when the optimal insertion path and trajectory are defined there. The loading force and path of instrument insertion is recorded. Thereafter, as shown in FIG. 14, the insertion device 420 inserts the final spinal cage 475 according to the recorded path and based on the loading force. During insertion, the GUI shown in FIG. 15 navigates the spinal instrument 420 to the recorded insertion location. The spinal insertion device 420 may be equipped with one or more load sensors that serve as placeholders to the final spinal cage. After placement of the spinal cage 475 between the vertebrae, release of the spinal cage from the insertion device 420, and removal of the insertion device 420, the space that occupies the spinal cage is removed by the bars and pedicle screws in the adjacent vertebrae. Closed. This forces the surrounding vertebrae against the spinal cage and provides stability to vertebral fusion. During this procedure, the GUI 700 of FIG. 15 reports changes in the anatomy of the spine due to rod adjustment and pedicle screw tightening, such as Lordosis and Kyphosis. . In particular, the GUI 700 also provides visual feedback indicating which amounts and directions achieve the planned spinal alignment by adjustment using the instrument for the bars and screws.

  FIG. 15 illustrates a user interface 700 showing a perspective view of the sensorized spinal insertion device 420 of FIG. 14 in a non-limiting example. User interface 700 is shown by remote system 105 and alignment system 100 (see FIG. 1). The GUI 700 includes a first window 710 and an associated second window 720. The second window 720 shows the insertion device 420 and vertebral component 475 for the L4 and L5 vertebrae to be evaluated. In this example, a sagittal (side) view of the spinal column is shown. This figure shows a shaft angle 723 and a rotation component 724 that show the approach angle and rotation of the insertion instrument 420 and vertebral component 475. The second window 720 and the corresponding GUI information are shown and updated in real time during the procedure. This allows the surgeon to visualize the vertebral component 475 of the insertion device 420 according to a pre-detected load force parameter.

  The first window 710 shows the target (desired) sensored head orientation 722 and the current instrument head orientation 767. The target orientation 722 shows a predetermined approach angle, rotation and trajectory path when using the spinal instrument 400 to evaluate load parameters. The current instrument head orientation 767 shows the tracking of the insertion instrument 420 currently used to insert the final cage 475. The GUI 700 shows a target orientation model 722 that takes into account the current instrument head orientation 767 to provide a visualization of a predetermined surgical plan.

  10, 11, 12, and 13 show that the spinal instrument 400 determines the optimal procedure parameters (eg, angle, rotation, path), taking into account the determined sensing parameters (eg, load, force, edge). Recall that you have shown that you have evaluated. Once these procedure parameters are determined, the system 100 guides the surgeon using the GUI 700 to insert a vertebral component 475 (eg, spinal cage, pedicle screw) using the insertion instrument 420. In one configuration, the system 100 provides haptic feedback to guide the insertion device 420 during the insertion procedure. For example, if the current approach angle 713 deviates from the target approach angle, or the orientation 767 does not coincide with the target trajectory path 722, the system 100 will vibrate and display a visual cue (red / green indication). ) Can be provided. Alternatively, audio feedback can be provided by the system 100 to supplement the visual information provided. The GUI 700 effectively reproduces the position and target path in the sensored insertion instrument 420 with visual and haptic feedback based on previous instrumentation.

  Load, balance, and position are determined quantitatively by surgical techniques and adjustments using data from the registration and load balancing system 100 sensorized devices (eg, 101, 103, 400, 420, 475). Within the measured range, it can be adjusted during surgery. Both the trial and final insert (eg, spinal cage, pedicle screw, sensor, etc.) may include a sensing module for providing measurement data to a remote system for display. The final insert can also be used for long term monitoring of the spinal joint. Data can be used by patients and health care providers to ensure that spinal joints or fused vertebrae function properly during rehabilitation and when the patient returns to an active normal lifestyle . Conversely, the patient or health care provider can be notified when the measured parameter is out of specification. This allows early detection of spinal problems that can be resolved with minimal stress on the patient. Data from the final insert can be displayed on the screen in real time using data from the embedded sensing module. In one embodiment, a handheld device is used to receive data from the final insert. The handheld device can be held in close proximity to the spine so that a strong signal is obtained for data reception.

  A method for distracting the spinal region is disclosed below. The steps of the method can be performed in any order. Reference may be made to FIGS. 10, 11, 12, 13, and 14. FIG. An example of placing a brace component, such as a spinal cage, between vertebrae is used to illustrate the method, which involves the knee, hip, ankle, spine, shoulder, hand, arm, and foot. It can be applied to other muscle / skeletal regions. In general, quantitative measurement data needs to be collected in the spinal region. The spinal instruments, alignment devices, and insertion instruments disclosed herein can be used to generate a database of quantitative data. At this point, there is a lack of quantitative measurement data due to the lack of active instruments and measurement devices. The measurement data generated by the instrument during installation of the brace component, if relevant to the patient's health, can be used to determine the impact of load, load position, and brace component alignment. Can be correlated with long-term data. The system disclosed herein can generate data during installation of the brace component and is applicable to provide long term periodic measurements of implants and spinal regions. Thus, the result of the distraction method is to generate sufficient data to support installation procedures that reduce recovery time, minimize failure, improve performance, reliability, and extend the useful life of the device. .

  In the first step, the spinal instrument is inserted to distract the spinal region. The spinal instrument includes sensors for generating quantitative measurement data in real time during surgery. In the second step, the load applied to the spinal instrument by the spinal region is measured. The spinal instrument has a first height such that the spinal region is distracted to a first height. The system shows the measurement data by visual, audio or tactile means. In one example, the system discloses that a load measurement from a spinal instrument is outside a predetermined load range. The predetermined load range used by the system to assess the spinal region can be determined by clinical studies. For example, the predetermined load range may support the placement of the device by associating load measurement data with surgical results. In general, measurements outside of a predetermined load range can statistically increase the likelihood of device failure. In the third step, the spinal region is distracted to a second height. In the fourth step, the load applied to the spinal instrument by the spinal region at the second height is measured. The system indicates that the load measurement from the spinal instrument is within a predetermined load range. By bringing the measured load within a predetermined load range, failure due to excessive load on the brace component is reduced. In general, this process can be repeated as many times as necessary at different distraction heights until spinal instrument measurements indicate that the measured load is within a predetermined load range.

  In the fifth step, at least one of the orientation, rotation, angle, or position of the spinal instrument is measured. In one embodiment, the measurement may correspond to the portion of the spinal instrument that is inserted into the spinal region. For example, the position data may relate to a sensored head of a spinal instrument. The data can be used to place the brace component in the same position and in the same trajectory as measured by the spinal instrument. In the sixth step, the load applied to the spinal instrument by the spinal region can be monitored in the remote system. In this example, the remote system includes a display that allows data to be viewed in real time during the procedure. In the seventh step, the height of the spinal instrument can be adjusted. As disclosed, the spinal instrument may include a scissor type mechanism for reducing or increasing the height of the distraction surface. In one embodiment, the spinal instrument handle is rotated to change the distraction height. Adjustments can be made while monitoring load data in real time in a remote system. In general, the height is adjusted until the measured load falls within a predetermined load range. In the eighth step, the height is increased or decreased so that the adjusted height corresponds to the height of the brace component. In one embodiment, orthotic components having the same distraction height can be placed at the location of load measurement in the spinal region. When the brace component is aligned with the track and installed in the same location as the spinal instrument, it is subjected to a load similar to the load measurement.

  In the ninth step, the spinal instrument measures the position of the applied load. The spinal instrument can have a surface coupled to the spinal region. In this example, two or more sensors are coupled to the surface of the spinal instrument to support load measurement locations. The position of the load provides quantitative measurement data on how force, pressure, or load can be applied to the brace component when placed in the spinal region. For example, an improperly positioned load may cause a situation where the brace component becomes unstable at that location and eventually is removed from the spinal region, resulting in a catastrophic failure. In one embodiment, the position of the load data from the spinal instrument can be used to evaluate the position for placement of the brace component. The quantitative data can include a predetermined range or region corresponding to the measurement surface of the spinal instrument to assess the position of the load. In a tenth step, the spinal instrument is moved to a different location in the spinal region when the position of the load applied to the spinal instrument by the spinal region is outside the predetermined position range. The new location can be evaluated by quantitative data of load magnitude and load location as a site for the brace component.

  In an eleventh step, an appropriate location in the spinal region for the brace component is identified when the measured quantitative data is within a predetermined load range and a predetermined position range. As mentioned above, placing orthotic components in the area of the spinal region measured within a given load range and a given position range produces positive results and reduces failure rates based on clinical evidence . In the twelfth step, the brace component is placed at a location that is measured by the spinal instrument. Prosthetic components installed at this location will have a load magnitude and load location applied by the spinal region similar to that measured by spinal instruments. The brace component is inserted into a spinal region having a trajectory similar to a spinal instrument. In this example, the trajectory and position of the spinal instrument during the measurement process is recorded. In a thirteenth step, the brace component insertion process may be further supported by comparing the trajectory of the brace component with the trajectory of the spinal instrument. In one embodiment, the surgeon may be given visual, tactile, or audio feedback that helps align the brace component to its location. In the fourteenth step, the trajectory of the brace component and spinal instrument is seen in the remote system. When the remote system identifies a location in the spinal region, it may indicate the actual or simulated position and trajectory of the brace component relative to the position and trajectory of the spinal instrument. In one embodiment, the surgeon can simulate the trajectory by the device or insertion instrument holding the brace component by visualization, or overlay the data displayed on the remote system at the location of the spinal instrument. As disclosed herein, spinal instruments may have a mechanism such as a scissor jack that can change the height of the distraction surface. A bar for raising and lowering the scissor jack is coupled to the handle of the spinal instrument. In a fifteenth step, the spinal instrument handle may be rotated to change the distraction height. In the sixteenth step, a visual, audio or haptic signal is provided when the load applied to the spinal instrument by the spinal region is within a predetermined load range. Similarly, in the seventeenth step, a visual, audio or haptic signal is provided when the load applied to the spinal instrument by the spinal region is within a predetermined position range.

  FIG. 16 is a block diagram of components of a spinal instrument 400 according to an example embodiment. Note that spinal instrument 400 may include more or fewer components than shown. The spinal instrument 400 is a built-in instrument that can measure muscular / skeletal parameters. In this example, spinal instrument 400 measures the load and load location when inserted into the spinal region. The active components of spinal instrument 400 include one or more sensors 1602, load plate 1606, power supply 1608, electronic circuit 1610, transceiver 1612, and accelerometer 1614. In a non-limiting example, the applied compressive force is applied to sensor 1602 by the spinal region and measured by spinal instrument 400.

  Sensor 1602 may be positioned, engaged, attached, or fixed to surfaces 403 and 406 of spinal instrument 400. In general, compressive forces are applied by the spinal region to surfaces 403 and 406 when inserted into the spinal region. Surfaces 403 and 406 couple to sensor 1602 so that a compressive force is applied to each sensor. In one embodiment, the position of the load applied to the surfaces 403 and 406 can be measured. In this example, three load sensors are used in the sensored head to identify the position of the applied load. Each load sensor is coupled to a predetermined position on the load plate 1606. The load plate 1606 couples to the surface 403 to distribute the compressive force applied to the sensored head of the spinal instrument 400 to each sensor. The load plate 1606 may be rigid and will not bend when distributing force, pressure, or load to the sensor 1606. The force or load magnitude measured by each sensor can be correlated back to the location of the load applied to the surface 403.

  In the example of intervertebral measurement, a sensored head having surfaces 403 and 406 may be positioned between the vertebrae of the spine. The surface 403 of the sensored head is coupled to the first vertebra surface, and similarly, the surface 406 is coupled to the second vertebra surface. An accelerometer 1614 or external alignment system can be used to measure the position and orientation of the sensored head as it is directed into the spinal region. Sensor 1602 is coupled to electronic circuit 1610. The electronic circuit 1610 includes a logic circuit, an input / output circuit, a clock circuit, a D / A, and an A / D circuit. In one embodiment, the electronic circuit 1610 includes an application specific integrated circuit that reduces form factor, reduces power, and improves performance. In general, the electronic circuit 1610 controls the measurement process, receives the measurement signal, converts the measurement signal to digital format, supports the display at the interface, and initiates data transfer for the measurement data. The electronic circuit 1610 measures physical changes in the sensor 1602 to determine parameters of interest, for example, the level, distribution and direction of forces acting on the surfaces 403 and 406. The insertion detection device 400 can be powered by an internal power source 1608. Accordingly, all the components necessary to measure muscular / skeletal parameters are present in spinal instrument 400.

  As an example, sensor 1602 may include an elastic or compressible propagation structure between the first transducer and the second transducer. The transducer can be an ultrasonic (or ultrasonic) resonator and the elastic or compressible propagation structure can be an ultrasonic waveguide. The electronic circuit 1610 is electrically coupled to the transducer to convert the change in length (or compression or extension) of the compressible propagation structure into a parameter of interest such as force. The system measures the change in length of the compressible propagation structure (eg, waveguide) in response to the applied force and converts this change into an electrical signal that is transmitted via the transceiver 1612. The level and direction of the applied force can then be communicated. For example, a compressible propagation structure has a known and reproducible characteristic of the applied force with respect to the length of the waveguide. Using known properties, an accurate measurement of the length of the waveguide using ultrasound signals can be converted into a force.

  Sensor 1602 is not limited to waveguide measurements of force, pressure, or load sensing. In yet another configuration, the sensor 1602 is a piezoresistive sensor, a compressible polymer sensor, a capacitive sensor, a light sensor, a mems sensor, a strain gauge sensor, a chemical sensor, and a temperature sensor for measuring muscle / skeletal parameters. , PH sensors, and mechanical sensors. In an alternative embodiment, a piezoresistive thin film sensor can be used to sense the load. Piezoresistive films have a low profile, which reduces the form factor required for mounting. A piezoresistive film changes its resistance by the applied pressure. A voltage or current can be applied to the piezoresistive film to monitor the change in resistance. Electronic circuit 1610 may be coupled to apply a voltage or current. Similarly, electronic circuit 1610 can be coupled to measure voltage and current corresponding to the resistance of the piezoresistive film. The relationship of piezoresistive film resistance to applied force, pressure, or load is known. The electronic circuit 1610 can convert the measured voltage or current into force, pressure, or load applied to the sensored head. In addition, the electronic circuit 1610 can convert the measurement to a digital format for display or transfer for real-time use or for storage. The electronic circuit 1610 can include converters, inputs, outputs, and inputs / outputs that allow serial and parallel data transfer so that measurement and transmission of data can occur simultaneously. In one embodiment, the ASIC is included in an electronic circuit 1610 that incorporates digital control logic to manage the control functions and measurement process of the spinal instrument 400 as directed by the user.

  The accelerometer 1614 can measure acceleration and static gravity. The accelerometer 1614 can be a uniaxial and multi-axis accelerometer structure that detects the magnitude and direction of acceleration as a vector quantity. The accelerometer 1614 can also be used to detect orientation, vibration, effects and shocks. The electronic circuit 1610, together with the accelerometer 1614 and the sensor 1602, measures parameters of interest for the orientation of the spinal instrument 400 (eg, load, force, pressure, displacement, movement, rotation, torque, location, and acceleration distribution). can do. In such a configuration, the spatial distribution of measured parameters for a selected reference system can be calculated and shown for real-time display.

  The transceiver 1612 includes a transmitter 1622 and an antenna 1620 to enable wireless operation and telemetry functions. In various embodiments, the antenna 1620 may be configured with a design as an integrated loop antenna. Integrated loop antennas are composed of various layers and locations on a printed circuit board to which other electrical components are attached. For example, the electronic circuit 1610, the power source 1608, the transceiver 1612, and the accelerometer 1614 can be attached to a circuit board located on or in the spinal instrument 400. The transceiver 1612 can communicate the target parameters in real time after being started. Telemetry data may be received and decoded using various receivers or using a custom receiver. The possibility of physical interference due to wiring and cables coupling the sensing module with the power supply or associated data collection, storage, display equipment, and data processing equipment by radio operation, or limitations imposed by such wiring and cables The measurement distortion caused by or the limitations on such a measurement can be eliminated.

  The transceiver 1612 receives power from the power source 1608 and can operate at low power over various radio frequencies, for example, by an efficient power management scheme incorporated within the electronic circuit 1610 or application specific integrated circuit. As an example, the transceiver 1612 can transmit data at a predetermined frequency in a predetermined emission mode by the antenna 1620. The predetermined frequency may include, but is not limited to, the ISM bands recognized in the International Telecommunication Union Regions 1, 2, and 3. The predetermined emission mode is not limited to the following, but includes Gaussian Frequency Shift Keying (GFSK), Amplitude Shift Keying (ASK), and Phase Shift Modulation (Phase Kifting). ) (PSK), Minimum Shift Keying (MSK), Frequency Modulation (FM), Amplitude Modulation (AM), or other forms of frequency or amplitude modulation (e.g., Binary, coherent, quadrature, etc.).

  The antenna 1620 may be integrated with the sensing module components to provide radio frequency transmission. The antenna 1620 and the electronic circuit 1610 are attached and coupled to form a circuit using a wire trace on the printed circuit board. The antenna 1620 may further include a matching network for efficient transmission of signals. This level of integration of antenna and electronics allows for a reduction in the size and cost of the radio equipment. Potential applications include, but are not limited to, any type of short-range portable, wearable, or other portable communication equipment, where a small antenna is typically used. used. This includes disposable modules or devices as well as reusable modules or devices and modules or devices for long term use.

  The power source 1608 provides power to the electronic components of the spinal instrument 400. In one embodiment, the power source 1608 can be charged by wired energy transfer, near field wireless energy transfer, or a combination thereof. External power sources for providing wireless energy to power source 1608 include, but are not limited to, one or more batteries, an alternating current power source, a radio frequency receiver, an electromagnetic induction coil, one or more photovoltaic cells, One or more thermocouples, or one or more ultrasonic transducers. With power supply 1608, spinal instrument 400 can be operated with a single charge until the internal energy is exhausted. The spinal instrument 400 can be periodically recharged to allow continuous operation. The power source 1608 may further employ power management techniques for efficiently supplying and providing energy to the components of the spinal instrument 400 to facilitate measurement and wireless operation. A power management circuit may be incorporated into the ASIC to manage both ASIC power consumption as well as other components of the system.

  The power source 1608 minimizes the additional energy radiation sources needed to power the sensing module during the measurement operation. In one embodiment, as illustrated, the energy store 1608 may include a capacitive energy storage device 1624 and an induction coil 1626. An external source of charging power may be wirelessly coupled to capacitive energy storage device 1624 via one or more electromagnetic induction coils 1626 by inductive charging. The charging operation may be controlled by a power management system designed to or with electronic circuit 1610. For example, during operation of the electronic circuit 1610, power can be transferred from the capacitive energy storage device 1624 by efficient step-up and step-down voltage conversion circuits. This saves the operating power of the circuit block at a minimum voltage level in order to support the required level of performance. Alternatively, the power source 1608 can include one or more batteries housed within the spinal instrument 400. The battery can provide power to the disposable spinal instrument 400 so that the device is discarded after it has been used in surgery.

  In one form, the external power source may further serve to communicate downlink data to the transceiver 1612 during a recharge operation. For example, downlink control data can be modulated into a wireless energy source signal and then demodulated from induction coil 1626 by electronic circuit 1610. This can serve as a more efficient way to receive downlink data instead of configuring the transceiver 1612 for both uplink and downlink operations. As an example, the downlink data may include updated control parameters, such as external location information, that the spinal instrument 400 uses when making measurements or for recalibration purposes. Downlink data can also be used to download serial numbers or other identification data.

  The electronic circuit 1610 manages and controls various operations of the sensing module components, such as sensing, power management, telemetry, and acceleration sensing. Electronic circuit 1610 may include analog circuits, digital circuits, integrated circuits, discrete components, or any combination thereof. In one configuration, the electronic circuit 1610 can be partitioned among integrated circuits and discrete components to minimize power consumption without compromising performance. The ability to distinguish between digital and analog circuits increases design flexibility and promotes minimum power consumption without sacrificing functionality or performance. Thus, the electronic circuit 1610 may include, for example, one or more integrated circuits or ASICs specific to the core signal processing algorithm.

  In another configuration, the electronic circuit 1610 may include a controller, such as a programmable processor, a digital signal processor (DSP), a microcontroller, or a microprocessor with associated storage and logic. The controller may use computing techniques with associated storage devices such as Flash, ROM, RAM, SRAM, DRAM or other similar techniques for controlling the operation of the above components of the sensing module. In one configuration, the storage device may store one or more instruction sets (eg, software) that use any one or more of the methods or functions described herein. The instructions may also reside in other memory and / or processors completely or at least partially during execution of instructions by another processor or computer system.

  The electronics assembly also supports testability and calibration features that ensure the quality, accuracy, and reliability of the completed wireless sensing module or device. Temporary bidirectional coupling can be used to ensure a high level of electrical observability and controllability of the electronics. The test interconnect also provides a high level of electrical observability of the sensing subsystem including transducers, waveguides, and mechanical springs or elastic assemblies. The carrier or fixture emulates the final enclosure of the finished wireless sensing module or device during the manufacturing process, thereby calibrating the calibrated parameters of the finished wireless sensing module or device. Allows accurate calibration data to be captured. These calibration parameters are stored in an on-board memory that is integrated into the electronics assembly.

  Applications for electronic assemblies including sensor 1602 and electronic circuit 1610 include, but are not limited to, disposable modules or devices and available modules or devices and re-modules or devices for long-term use. In addition to non-medical applications, examples of a wide range of potential medical applications include, but are not limited to, implantable devices, modules within implantable devices, intraoperative implants, or modules within intraoperative implants or test inserts. A module in an inserted or captured device, a module in a wearable device, a module in a handheld device, a module in an instrument, appliance, equipment, or all of these accessories, or an implant, a test insert, Examples include inserted or incorporated devices, wearable devices, handheld devices, equipment, appliances, consumables in equipment, or accessories for these devices, equipment, appliances, or equipment.

  FIG. 17 is a diagram of an example communication system 1700 for near field telemetry, according to an example embodiment. As shown, the communication system 1700 includes a receiving system communication in a remote system based on a medical device communication component 1710 in a spinal instrument and a processor. In one embodiment, the receiving remote system communication is in or coupled to a computer or laptop computer that can be viewed by the surgical team during the procedure. The remote system may be outside the operating room sterilization field, but is within the range that is visible for real time evaluation of the measured quantitative data. The medical device communication component 1710 includes, but is not limited to, an antenna 1712, a matching network 1714, a telemetry transceiver 1716, a CRC circuit 1718, a data packetizer 1722, a data input 1724, a power supply 1726, and a specific Operatively coupled to include an application specific integrated circuit (ASIC) 1720. The medical device communication component 1710 may include more or fewer components than illustrated, but is not limited to what is illustrated or the order of the components.

  The receiving station communication component 1750 includes an antenna 1752, a matching network 1754, a telemetry receiver 1756, a CRC circuit 1758, a data packetizer 1760, and optionally a USB interface 1762. In particular, other interface systems can be directly coupled to the data packetizer 1760 to process and render sensor data.

  Referring to FIG. 16, the electronic circuit 1610 is operably coupled to one or more sensors 602 of the spinal instrument 400. In one embodiment, data generated by one or more sensors 602 can be converted into measured parameters of the musculoskeletal system, mems structures, piezoresistive sensors, strain gauges, mechanical sensors, pulsed continuous waves Or voltage, current, frequency, or count values from other sensor types. Referring back to FIG. 17, the data packetizer 1722 collects sensor data into packets that include sensor information received or processed by the ASIC 1720. The ASIC 1720 may include specific modules for efficiently performing the core signal processing functions of the medical device communication component 1710. The ASIC 1720 further provides the advantage of reducing the form factor of the instrument.

  The CRC circuit 1718 applies error code detection in the packet data. Cyclic redundancy check is based on an algorithm that calculates a checksum of a data stream or packet of any length. These checksums can be used to detect interference or accidental alteration of data being transmitted. Cyclic redundancy check is particularly good at detecting errors caused by electrical noise, thus allowing for robust protection from improper handling of corrupted data in environments with high levels of electromagnetic activity To do. Telemetry transmitter 1716 then transmits a CRC encoded data packet via matching network 1714 via antenna 1712. Matching networks 1714 and 1754 provide impedance matching for optimal communication power efficiency.

  Receive system communication component 1750 receives transmissions sent by spinal instrument communication component 1710. In one embodiment, telemetry transmitter 1716 is operated with a dedicated telemetry receiver 1756 that is constrained to receive data stream communications at a specified frequency in a specified emission mode. A telemetry receiver 1756 by the receiving station antenna 1752 detects incoming transmissions at a specified frequency. The antenna 1752 may be a directional antenna that is directed to the directional antenna of the component 1710. Using at least one directional antenna can reduce data corruption while improving data security by further restricting the data to be in a radiation pattern. Matching network 1754 couples to antenna 1752 to provide impedance matching that efficiently transmits signals from antenna 1752 to telemetry receiver 1756. Telemetry receiver 1756 may reduce the carrier frequency in one or more steps and strip off information or data sent by component 1710. Telemetry receiver 1756 is coupled to CRC circuit 1758. CRC circuit 1758 verifies the cyclic redundancy checksum of individual packets of data. CRC circuit 1758 is coupled to data packetizer 1760. The data packetizer 1760 processes individual packet data. In general, data identified by CRC circuit 1758 is decoded (eg, decompressed) and sent to an external data processing device, such as an external computer, for later processing, display, or storage or some combination thereof. Transferred.

  Telemetry receiver 1756 is designed and configured to operate with very low power, such as, but not limited to, powered USB port 1762 or power obtained from a battery. In another embodiment, the telemetry receiver 1756 is designed for use with minimal controllable functions to limit the chance of inadvertent corruption or malicious tampering with the received data. Telemetry receiver 1756 can be designed and configured to be small, inexpensive, and easily manufactured in a standard manufacturing process while ensuring a consistently high level of quality and reliability.

  In one form, the communication system 1700 operates in a transmission-only operation with a communication range on the order of a few meters to provide high security and protection from any form of fraudulent or unexpected query. The transmission range may be controlled by transmitted signal strength, antenna selection, or a combination of both. High repetition rate transmission can be used with Cyclic Redundancy Check (CRC) bits embedded in transmitted data packets during data acquisition operations, thereby operating or static physical systems Including, but not limited to, measurements of loads, forces, pressures, displacements, flexures, postures, and positions within the receiving system without substantially affecting the integrity of the data display or data visual display. It becomes possible to discard damaged data.

  By limiting the operating range to a distance on the order of a few meters, the telemetry transmitter 1716 allows very low power in a suitable emission mode or mode for a given operating frequency without compromising the data transmission repetition rate. Can be operated on. This mode of operation also supports operation with small antennas such as integrated loop antennas. The combination of low power and small antennas allows the construction of very small telemetry transmitters that can be used for a wide range of non-medical and medical applications, including but not limited to:

  Transmitter security as well as transmitted data integrity is ensured by operating the telemetry system within predetermined conditions. Because it is operated in a transmit-only mode, the transmitter security is not compromised and there is no path to enter the medical device communication component. Data integrity is ensured by the use of CRC algorithms and measurement repetition rates. The risk of unauthorized reception of data is minimized by the limited communication range of the device. There are certain countermeasures that further inhibit data access even if unauthorized reception of data packets should occur. The first means is that the transmitted data packet contains only binary bits from the counter along with the CRC bits. The second measure is that no data is available or needed to interpret the significance of binary communication at any point in time. A third means that may be implemented is that patient or device identification data is not communicated at any time.

  Telemetry transmitter 1716 may also operate in accordance with some FCC regulations. According to section 18.301 of the FCC regulations, the USA domestic ISM bands are 6.78, 13.56, 27.12, 30.68, 915, 2450, and 5800 MHz and 24.125, 61.25, 122. .50, and 245 GHz. Globally, other ISM bands, including 433 MHz, are defined by the International Telecommunications Union in some geographic locations. The list of forbidden frequency bands defined in 18.303 is as follows, and the following safe search and rescue frequency bands (safety, search and rescue frequency bands) are prohibited. That is, 490 to 510 kHz, 2170 to 2194 kHz, 8354 to 8374 kHz, 121.4 to 121.6 MHz, 156.7 to 156.9 MHz, and 242.8 to 243.2 MHz. Section 18.305 specifies the field strengths and emission levels that an ISM facility must not exceed when operated outside the specified ISM band. In summary, if the limits on field strength and emission levels specified in section 18.305 are maintained by design or by active control, within the ISM band and in most other frequency bands above 9 KHz, It can be concluded that ISM equipment can be operated worldwide. Alternatively, commercial ISM transceivers, including commercial integrated circuit ISM transceivers, can be designed to meet these field strength and emission level requirements when used properly.

  In one form, the telemetry transmitter 1716 can also operate in an unauthorized ISM band or in unauthorized operation of a low power facility, where the ISM facility (eg, telemetry transmitter 1716) is FCC coded. Except as indicated in section 18.303, it may be operated at ANY frequencies above 9 kHz.

  Wireless operation causes a wireless sensing module or device due to the possibility of physical interference with wiring and cables that couple with power or data collection, storage, or display equipment, or limitations imposed by such wiring and cables There is no measurement distortion, or restrictions on such measurement. Power for sensing components and electronic circuits is maintained within a wireless sensing module or device in the internal energy storage device. The energy storage device includes one or more batteries, supercapacitors, capacitors, alternating current power supplies, radio frequency receivers, electromagnetic induction coils, one or more photovoltaic cells, one or more thermocouples, or one or It is charged using an external power source including, but not limited to, a plurality of ultrasonic transducers. The wireless sensing module can be operated with a single charge until there is no internal energy source, or the energy source can be periodically recharged to allow continuous operation. The built-in power supply minimizes the additional energy radiation sources required to power the wireless sensing module or device during the measurement operation. Telemetry functions are also integrated within the wireless sensing module or device. The telemetry transmitter communicates measurement data continuously in real time after being started. Telemetry data can be received and decoded using a commercial receiver or using a simple, low cost custom receiver.

  FIG. 18 shows a communication network 1800 for measurement and reporting, according to an example embodiment. Briefly, communication network 1800 extends spinal alignment system 100, spinal instrument 400, and insertion instrument 420 to provide a broad data connection to other devices or services. As shown, spinal alignment system 100, spinal instrument 400, and insertion instrument 420 may be communicatively coupled to communication network 1800 and any associated system or service.

  By way of example, spinal alignment system 100, spinal instrument 400, and insertion instrument 420 may be used to analyze and report on their parameters (eg, load, force, Pressure, displacement, movement, rotation, torque and acceleration distribution) may be shared with the remote service or provider. If the sensor system is permanently implanted, data from the sensor can be shared with the service manager, for example, for surgical planning purposes or effectiveness studies, for example, to monitor progress, or for surgical planning purposes. Communication network 1800 may be further coupled to an Electronic Medical Record (EMR) system for performing medical information technology implementations. In other embodiments, the communication network 1800 includes HIS (Hospital Information System), HIT (Hospital Information Technology), and HIM (Hospital Information Management), EMT. Health Record (Electronic Health Record), CPOE (Computerized Physician Order Entry), and CDSS (Computerized Decision Support System). This provides the ability for various information technology systems and software applications to exchange data accurately and effectively and consistently and to communicate using the exchanged data.

  The communication network 1800 includes a local area network (LAN) 1801, a wireless local area network (WLAN) 1805, a cellular network 1814, and / or other radio frequency (RF) systems. A wired or wireless connection can be provided on top. LAN 1801 and WLAN 1805 may be communicatively coupled to the Internet 1820 via, for example, a central office. The central office may accommodate a shared network switching facility for providing telecommunications services. Telecommunication services include conventional POTS (Plain Old Telephone Service) and cable, HDTV, DSL, VoIP (Voice over Internet Protocol), IPTV (Internet Protocol Television). Television)), broadband services such as Internet services, and the like.

  Communication network 1800 may support circuit-switched and / or packet-switched communications using common computing and communication techniques. Each of the standards for Internet 1820 and other packet-switched network transmissions (eg, TCP / IP, UDP / IP, HTML, HTTP, RTP, MMS, SMS) represent examples of the prior art. Such standards are periodically replaced by faster or more efficient equivalents having substantially the same function. Thus, alternative standards and protocols having the same functionality are considered equivalent.

  The cellular network 1814 provides several access such as GSM®-GPRS, EDGE, CDMA, UMTS, WiMAX, 2G, 3G, WAP, software defined radio (SDR), and other known technologies. Technology can support voice and data services. The cellular network 1814 may be coupled to the base receiver 1810 under a frequency reuse plan for communicating using the mobile device 1802.

  Base receiver 1810 may in turn connect portable device 1802 to the Internet 1820 over a packet-switched link. Internet 1820 may support application services and service layers for distributing data from spinal alignment system 100, spinal instrument 400, and insertion instrument 420 to portable device 502. The portable device 1802 can also be connected to other communication devices via the Internet 1820 using a wireless communication channel.

  The portable device 1802 can also be connected to the Internet 1820 over the WLAN 1805. A Wireless Local Access Network (WLAN) provides wireless access within a local geographic area. A WLAN is typically composed of a collection of Access Points (APs) 1804, also known as base stations. The spinal alignment system 100, spinal instrument 400, and insertion instrument 420 can communicate with other WLAN stations such as a laptop 1803 in the base station area. In a typical WLAN implementation, the physical layer uses various technologies such as 802.11b or 802.11g WLAN technology. The physical layer uses infrared frequency hopping spread spectrum in 2.4 GHz band, direct sequence spread spectrum in 2.4 GHz band, or, for example, 5.8 GHz ISM band or higher ISM band Other access technologies may be used (eg, 24 GHz, etc.).

  Communication network 1800 may allow spinal alignment system 100, spinal instrument 400, and insertion instrument 420 to establish a connection with remote server 1830 and other portable devices to exchange data over the network. Remote server 1830 may have access to database 1840, which may be stored locally or remotely and may include application specific data. The remote server 1830 can also host application services directly or over the Internet 1820.

  FIG. 19 illustrates an exemplary schematic diagram of a machine in the form of a computer system 1900 in which, when an instruction set is executed, causes the machine to perform any one or more of the methods described above. obtain. In certain embodiments, the machine operates as a stand-alone device. In certain embodiments, the machine may be connected to other machines (eg, using a network). In a networked deployment, the machine may operate as a server or client user machine in a server client user network environment, or as a peer machine in a peer-to-peer (or distributed) network environment.

  This machine defines server computers, client user computers, personal computers (PCs), tablet PCs, laptop computers, desktop computers, control systems, network routers, switches or bridges, or actions to be taken by appropriate machines (sequentially). Or any other form of machine capable of executing the instruction set. It will be appreciated that the devices of the present disclosure include a wide variety of electronic devices that provide voice, video or data communications. Further, although a single machine is shown, the term “machine” also performs any one or more of the methods described herein. It should be construed to include any set of machines that execute the set (or sets) of instructions individually or collectively.

  Computer system 1900 communicates with each other via a bus 1908, such as a processor 1902 (eg, a central processing unit (CPU), a graphics processing unit (GPU, or both)), main memory, and the like. 1904 and static memory 1906. The computer system 1900 may further include a video display device 1910 (eg, a liquid crystal display (LCD), flat panel, solid state display, or cathode ray tube (CRT)). The system 1900 includes an input device 1912 (eg, a keyboard), a cursor control device 1914. For example, a mouse), a disk drive unit 1916, a signal generation device 1918 (e.g., may include a speaker or remote control) and a network interface device 1920.

  The disk drive unit 1916 stores one or more instruction sets (eg, software 1924) that use any one or more of the methods or functions described herein, including the methods shown above. A machine-readable medium 1922 may be included. Instruction 1924 may also reside in main memory 1904, static memory 1906, and / or processor 1902, either completely or at least partially during execution of instructions by computer system 1900. Main memory 1904 and processor 1902 may also be machine-readable media.

  Dedicated hardware implementations, including but not limited to application specific integrated circuits, programmable logic arrays, and other hardware devices, may be similarly configured to perform the methods described herein. Applications that may include the devices and systems of a wide variety of embodiments include various electronic and computer systems. Some embodiments employ two or more specific interconnected hardware modules or with associated control and data signals that are communicated between modules and via modules or as part of an application specific integrated circuit. Perform the function on the device. Here, the example system is applicable to software, firmware, and hardware implementations.

  According to various embodiments of the present disclosure, the methods described herein are directed to operation as a processor, digital signal processor, or software program running on a logic circuit. Further, software implementations include, but are not limited to, distributed processing or component / object distributed processing, parallel processing, or virtual machine processing so as to implement the methods described herein. Can be configured.

  The disclosure includes instructions 1924 such that a device connected to the network environment 1926 can use the instructions 1924 to transmit or receive audio, video or data and communicate over the network 1926; Or, assume a machine-readable medium that receives and executes instructions 1924 from a propagated signal. The instructions 1924 may be further transmitted or received over the network 1926 via the network interface device 1920.

  Although the machine-readable medium 1922 is shown to be a single medium in the example embodiments, the term “machine-readable medium” refers to a single medium or multiple media (one or more) that stores one or more instruction sets ( For example, it should be understood to include centralized or distributed databases and / or associated caches and servers. The term “machine-readable medium” can store, encode, or implement a set of instructions for execution by a machine that causes the machine to perform any one or more of the disclosed methods. It should also be understood to include any arbitrary medium.

  Thus, the term “machine-readable medium” includes, but is not limited to, a memory card that contains one or more read-only (non-volatile) memory, random access memory, or other rewritable (volatile) memory. It should be understood to include solid state memory such as or other packages, magneto-optical or optical media such as disks or tapes, and carrier wave signals such as signals that implement computer instructions in a transmission medium and / or electronic Attachment of digital files to mail or other built-in information archives or series of archives is considered a distribution medium equivalent to a tangible storage medium. Accordingly, this disclosure includes any one or more of the machine-readable media or distribution media listed herein and is equivalent in the art to which the software implementations herein are stored. Material and successor media.

  Although this specification describes components and functions implemented in the embodiments with reference to specific standards and protocols, the present disclosure is not limited to such standards and protocols. Each of the standards for Internet and other packet-switched network transmissions (eg, TCP / IP, UDP / IP, HTML, HTTP) represent examples of the prior art. Such standards are periodically replaced by faster or more efficient equivalents having substantially the same function. Thus, alternative standards and protocols having the same functionality are considered equivalent.

  The descriptions of the embodiments described herein are intended to provide a general understanding of the structures of the various embodiments, and are illustrative of devices and systems that can use the structures described herein. It is not intended to serve as a complete description of all elements and features. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. Other embodiments may be used and obtained from it so that structural and logical substitutions and changes can be made without departing from the scope of the present disclosure. Also, the figures are for illustration only and may not be drawn to scale. That particular ratio can be exaggerated, while other ratios can be minimized. The specification and drawings are, accordingly, to be regarded in an illustrative sense rather than a restrictive sense.

  Such embodiments of the present inventive subject matter merely limit the scope of this application to any one invention or inventive concept, merely for convenience and when more than one invention is actually disclosed. May be referred to individually and / or collectively by the term “invention” herein. Here, although specific embodiments are shown and described herein, it is understood that any configuration calculated to achieve the same purpose may be substituted for the specific embodiments shown. I want to be. This disclosure is intended to cover any adaptations or variations of various embodiments. Combinations of the above embodiments with other embodiments not specifically described herein will be apparent to those of skill in the art upon review of the above description.

  The present invention relates generally to surgical electronics, and more particularly to methods and devices for assessing alignment and surgical implantation parameters during spinal surgery and long-term implantation.

  The spine is made up of many individual bones called vertebrae that are joined by muscles and ligaments. A soft intervertebral disc buffers each vertebra from the next. Because the vertebrae are separated, the spine is flexible and can bend. Together, the vertebrae, intervertebral discs, nerves, muscles, and ligaments make up the spinal column or spine. The spine varies in size and shape, with changes that can occur due to environmental factors, health, and aging. The normal spine has a front-to-back curve, but deformation due to the pathology of the normal cervical lordosis, thoracic kyphosis, and lumbar lordosis can cause pain, discomfort, and movement disorders. These conditions can be exacerbated by a herniated disc that can compress the nerve.

  There are many different causes of abnormal spinal curvature and different treatment options from treatment to surgery. The purpose of the operation is usually a solid fusion of the curved portion of the spine. Healing is performed by operating on the spine, adding bone grafts, and slowly bringing the vertebrae and bone grafts together to form a solid mass of bone. Alternatively, spinal cages are generally used that contain bone grafts to fuse the vertebrae at intervals. The bone graft can come from a bone bank or the patient's own hipbone. The spine can be almost straightened using instrumental bars and hooks, wires or screws, with instrumented instruments and techniques. A rod or possibly brace or cast holds the spine in place until the fusion is expected to heal.

  Various features of the system are set forth with particularity by the appended claims. The embodiments herein may be understood by reference to the following description, taken in conjunction with the accompanying drawings, in which:

1 illustrates a spinal alignment system according to an example embodiment. FIG. 6 illustrates a user interface showing spine registration and projection views according to an example embodiment. FIG. 1 illustrates a wand and receiver of a spinal alignment system according to an example embodiment. FIG. 6 illustrates a plurality of sensorized devices for determining spinal alignment according to example embodiments. FIG. FIG. 6 illustrates a sensorized installation for determining spinal parameters, according to an example embodiment. FIG. 6 illustrates the installation of a plurality of sensors for determining the state of a spine, according to an example embodiment. 1 illustrates a sensorized spinal instrument according to an example embodiment. 1 illustrates an integrated sensored spinal instrument according to an example embodiment. Fig. 4 shows an insertion device with a non-limiting example vertebral component. FIG. 6 illustrates a spinal instrument positioned between vertebrae of a spine for parameter sensing according to an example embodiment. FIG. 11 illustrates a user interface showing a perspective view of the sensorized spinal instrument of FIG. 10 according to an example embodiment. FIG. 4 illustrates a sensorized spinal instrument positioned between vertebrae of a spine for sensing intervertebral position and force, according to an example embodiment. FIG. 13 shows a perspective view of a user interface showing the sensorized spinal instrument of FIG. 12 according to an example embodiment. FIG. 4 illustrates a sensorized spinal insertion device for placement of a spinal cage, according to an example embodiment. FIG. 15 shows a perspective view of a user interface showing the sensorized spinal insertion device of FIG. 14 according to an example embodiment. It is a block diagram of the component of the apparatus for spines concerning the embodiment. 1 is a schematic diagram of an exemplary communication system for short-range telemetry, according to an example embodiment. 1 illustrates a communication network for measurement and reporting according to an example embodiment. FIG. 6 illustrates an example schematic diagram of a machine in the form of a computer system in which when a set of instructions is executed, the machine executes any one or more of the methods disclosed herein. Can be.

  While the specification concludes with the claims, which define the features of the embodiments of the invention deemed to be novel, the method, system, and other embodiments are described below with reference to the drawings in which reference numerals are carried forward. This can be better understood by considering the explanation.

  As required, detailed embodiments of the methods and systems of the present invention are disclosed herein. However, it should be understood that the disclosed embodiments are merely exemplary and can be implemented in various forms. Accordingly, the specific structural and functional details disclosed herein are not to be construed as limiting, but merely as a basis for the claims and virtually any suitable It is to be construed as a representative basis for teaching those skilled in the art to use the embodiments of the present invention in various structures. Furthermore, the terms and phrases used herein are not intended to be limiting, but are intended to provide an understandable description of the embodiments herein.

  In general terms, embodiments of the present invention relate to systems and methods for vertebral load and location sensing. The spine measurement system includes a receiver and a plurality of wands coupled to a remote display that visually indicates position information. A wand can be placed on or in contact with the vertebra to report various aspects of spinal alignment. The location information identifies the orientation and location of the corresponding vertebrae of the wand and spine. The system provides the ability to track vertebral movement during surgery in addition to global alignment. The system may provide and indicate intraoperative vertebral correction in response to position information captured during the procedure and pre-recorded position data regarding pre-operative vertebral condition.

  The spine measurement system further includes a load balancing and alignment system for assessing load forces on the vertebrae together with overall spinal alignment. The system includes a spinal instrument having an electronic assembly that can be coupled into a vertebral cavity and a sensor-attached head assembly. Sensored heads can be inserted between vertebrae and report vertebral conditions such as force, pressure, orientation and end loads. A GUI is used with it to indicate where the spinal instrument is positioned relative to the vertebral body as the instrument is placed in the intervertebral space during surgery. The system can report optimal brace size and installation taking into account sensed load and location parameters, including optional orientation, rotation and insertion angle along the determined insertion trajectory .

  An insertion instrument is also provided herein along with a load balancing and alignment system to insert a vertebral component, such as a spinal cage or pedicle screw. The system can check and report whether the instrument is end loading during insertion, taking into account already captured parameter measurements. The system shows insertion instrument tracking by vertebral components and provides visual guidance and feedback based on position and load sensing parameters. The system shows three-dimensional (3D) tracking of the insertion device for one or more vertebral bodies that are also modeled in orientation and position in 3D.

  FIG. 1 illustrates a non-limiting example spinal alignment system 100. System 100 includes a wand 103 and a receiver 101 that can be communicatively coupled to a remote system 105. In general, one or more wands communicate with the receiver 101 to determine position information including one of spine region orientation, rotation, angle, and location. The receiver 101 transmits position information or data 117 regarding the wand 103 to the remote system 105. The position information includes orientation and movement data used to evaluate the alignment (or predetermined curvature) of the spine 112. The remote system 105 can be a laptop or mobile workstation showing a Graphical User Interface (GUI) 107. The GUI 107 includes a workflow that shows the spine 112 and reports spine alignment considering the location information. As an example, the user interface may show the current alignment 114 of the vertebrae of the spine relative to the target alignment 113 after surgery.

  The alignment system 100 may be used in a database 123 system, such as a server 125, to provide three-dimensional (3D) imaging (eg, soft tissue) and 3D models (eg, bone) that are captured before or during surgery. It can be communicatively coupled. 3D imaging and models can be used with location information to establish relative locations and orientations. Server 125 may be a local server within close proximity or may be utilized remotely over the Internet 121. As an example, the server 125 provides a 3D spine and vertebra model. A CAT scanner (not shown) can be used to generate a series of cross-sectional X-ray images of selected parts of the body. The computer operates the scanner, and the obtained image is a slice image of the body. The server 125 generates a three-dimensional (3D) model from the slice image. Server 125 may also provide a 3D model generated from a Magnetic Resonance Imaging (MRI) scanner (not shown). Server 125 may also support fluoroscopic imaging to provide real-time animation of the patient's internal structure to alignment system 100 device through the use of an X-ray source (not shown) and a fluorescent screen.

  The spinal alignment system 100 reports the ability to track the movement of the isolated vertebrae in addition to the overall alignment and orientation of the instrument (eg, wand 103 and receiver 101). The receiver 101 accurately tracks the location of the wand 103 at a particular vertebra and along the spine 112 to determine position information. The receiver 101 is shown coupled to the sacrum (eg, fastened, screwed, and fixed). However, the receiver 101 can be located anywhere along the spine vertebra. Alternatively, the receiver 101 can be mounted on a platform near the spine 112. The wand 103 and the receiver 101 are sensorized devices that can transmit their position by ultrasonic, optical, or electromagnetic sensing. In this example, the wand 103 and the receiver 102 are ultrasonic line transducers and line of sight (LOS) devices. The sensor may be externally attached to the wand 103 away from the wand tip, or possibly within the wand tip. The wand 103 can be held in the hand or secured to the spine by a mechanical assembly. In one embodiment, the components for generating all alignment measurements (eg, receiver 101 and wand 103) reside within operating room sterilization field 109. The sterile field 109 can also be referred to as a surgical field. Typically, the remote system 105 is external to the operating room sterilization field 109. The components used in the sterile field 109 can be designed for a single use. In this example, wand 103, receiver 102, or both are discarded after being used during surgery.

  An example of an ultrasonic sensing device is disclosed in US patent application Ser. No. 11 / 683,410, entitled “Method and Device for Three-Dimensional Sensing” filed on March 7, 2007. The entire contents of which are hereby incorporated by reference. One example of optical sensing is the three in the wand 103 with corresponding high-speed camera elements in the receiver 101 for optical tracking, or high-speed photodiode elements for detecting the angle of the incident light beam and then the triangle wand position. Or four active IR reflectors. An example of electromagnetic sensing includes a metal sphere in the wand whose spatial position is determined by evaluating the change in magnetic field strength generated at the receiver 103.

  Many physical parameters of interest within a physical system or body can be measured by evaluating changes in the characteristics of energy waves or pulses. As an example, the transit time or shape change of an energy wave or pulse propagating through a changing medium can be measured to determine the force acting on the medium to cause the change. The propagation speed of energy waves or pulses in the medium is affected by physical changes in the medium. Physical parameters or parameters of interest may include, but are not limited to, measurements of load, force, pressure, displacement, density, viscosity, and local temperature. These parameters are along the orientation, alignment, orientation, or position and axis or combination of axes by a wireless sensing module or device, equipment, equipment, or other mechanical system positioned on or within the body. It can be evaluated by measuring changes in the propagation time of energy pulses or energy waves with respect to movement, rotation, or acceleration. Alternatively, the measurements of interest can be taken using thin film sensors, mechanical sensors, polymer sensors, mems devices, strain gauges, piezoresistive structures, and capacitive structures, to name just a few.

  FIG. 2 shows a graphical user interface (GUI) 150 of the system 100 showing a non-limiting example spine registration and projection view. Projections provide three-dimensional visualization to the surgical procedure and the system device of FIG. 1 while displaying quantitative measurements in real time. Each projection may be configured separately to show different perspective views of the spine with superimposed spine alignment information. The first projection 210 shows a sagittal view (ie, from front to back). The second projection 230 shows a coronal view (ie, between the sides). Sagittal and coronal views provide sufficient spatial information to visualize spinal alignment using only two projections. Projections can be customized for different viewing angles and scene graphs.

  As an example, the surgeon can hold the wand 103 and track the spine contour, for example, to determine the severity (or correction) of scoliosis symptoms. This can be done prior to surgery while the patient is standing to display the patient's posture and spinal curvature. The surgeon holds the wand and tracks the contour of the spine. The GUI 108 visually indicates the contour of the spine from the position information captured from the wand 103 during tracking. Next, the alignment angle is the primary statistics and geometry (see, for example, angle points R, P1, and P2, where R is the reference alignment and P1 is the location of the receiver 101 , P2 is the point aligned by the wand 103). The alignment angle indicates the misalignment of the spine alignment and, when projected onto the observation surface, indicates errors in the sagittal plane and the coronal plane. The GUI 108 may then report the necessary complementary correction. In this example, for example, the GUI 108 may require a +4 cm forward displacement in the display box 146 to correct the sagittal deviation of the angle between the line 152 and the line 154, and between the line 158 and the line 156. Report the required displacement to the right of +2 cm in the display box 148 to correct for the coronal deviation of the angle. This provides the surgeon with minimal visual information to provide surgical alignment correction.

  Alternatively, fast point-registration methods can be used to assess spinal alignment. The point alignment method allows the surgeon to quickly evaluate spinal alignment with minimal alignment. The user holds the wand, places the cursor on the vertebra and clicks to generate a point curve that is converted to a line. In the first step A, the receiver 101 is positioned at a fixed location, for example, a table near the operating table. Alternatively, the receiver 101 can be fastened to the sacrum as shown in FIG. In the second step B, the surgeon uses the tip of the wand 103 to identify three or more anatomical features in the reference bone, such as a point along the posterior iliac crest or dorsal surface in the sacrum. The system 100 determines the orientation of the reference bone from the spatial position of the aligned wand tip, for example, in the <x, y, z> Cartesian coordinate system with respect to the receiver 101 origin. The system 100 then retrieves the relevant 3D model spine components (eg, sacrum, vertebrae, etc.) from the image server 125 and places them in the GUI 108 with the appropriate scale and orientation (morphing and warping) according to the orientation of the reference bone. To display. Once the 3D model registration is complete, the surgeon then aligns one of the vertebrae, eg, the cervical vertebrae (C1-C7), in a third step C, with the patient stationary. next. The system 100 has sufficient aligned points to generate a local coordinate system for the reference bone, generate curves and line segments, and report the overall alignment, as shown in FIG. . Spine alignment is reported taking into account a predetermined curvature or straightness of the spine, for example, showing a line 152 relative to the desired (preoperative planning) line 154.

  FIG. 3 shows a non-limiting example of a wand 103 and receiver 101, but not all illustrated components are required, and fewer components may be used depending on the functions required. The communication mode of the receiver 101 and the wand 103 and the operation between them is disclosed in US patent application Ser. No. 12 / 900,662 entitled “Navigation Device Providing Sensory Feedback” filed on 10/8/2010. The entire contents of which are hereby incorporated by reference. Briefly, this dimension allows non-contact tracking with submillimeter spatial accuracy (<1 mm) up to a distance of about 2 m. Any device can be configured to support a variety of functions (eg, hand-held attached to an object), none of which are limited to the dimensions described below.

  The wand 103 is a handheld device having a size dimension of about 10 cm wide, 2 cm deep, and variable length between 18 cm and 20 cm. As indicated above, the wand 103 can be pointed to a point of interest (see points A, B, C) along an object or surface contour, which can be shown, for example, in a user interface (see GUI 107 in FIG. 1). Can be aligned. As already described, the wand 103 and the receiver 101 can communicate by ultrasonic, infrared and electromagnetic sensing to determine their relative location and orientation relative to each other. Other embodiments incorporating accelerometers provide additional position information.

  Wand 103 includes sensors 201-203 and wand tip 207. Sensors are ultrasonic transducers, micro electro mechanical elements (MEMS) microphones, electromagnets, optical elements (eg, infrared, laser), metal objects or physical movements of electrical signals such as voltage or current. Other transducers for converting or transmitting to They may be active elements in that they are self-powered to transmit signals, or may be passive elements in that they are reflective or exhibit detectable magnetic properties.

  In one embodiment, the wand 103 generates drive signals to three ultrasonic transmitters 201 to 203 that transmit ultrasonic signals in the air, and three ultrasonic transmitters 201 to 203 to generate ultrasonic signals. A controller (or electronic circuit) 214, a user interface 218 (eg, a button) that receives user input to perform near-field position measurement and alignment determination, relays user input, and receives timing information A communication module 216 for controlling the electronic circuit 214, and a battery 218 for supplying power to the electronic circuit 218 and related electronics in the wand 103. Controller 214 is operably coupled to ultrasonic transmitters 201-203. The transmitters 201 to 203 transmit sensory signals in response to instructions from the controller 214. The wand 103 may include more or fewer components than shown, and the functionality of several components may be shared as an integrated device.

  Additional transmitter sensors can be included to provide an over-determined system for three-dimensional detection. As an example, each ultrasonic transducer can perform separate transmit and receive functions. One such example of an ultrasonic sensor is disclosed in US Pat. No. 7,725,288, the entire contents of which are hereby incorporated by reference. The ultrasonic sensor can transmit a pulse shaped waveform according to the physical characteristics of the customized transducer for composing and shaping the waveform.

  The wand tip 207 identifies a structure in three-dimensional space, such as, but not limited to, an assembly, an object, a device, or a target point of a jig. The tip does not require a sensor because its spatial position in three-dimensional space is established by three ultrasonic transmitters 201-203 that are placed at cross ends. However, tip sensor 219 can be integrated into tip 207 to provide sensing based on ultrasound functionality (eg, structural boundaries, depth, etc.) or contact. In such cases, the tip 207 may be touch-sensitive to align the point in response to a physical action, eg, contact of the tip to an anatomical or structural location. The tip may include a mechanical spring or actuating spring assembly for such purposes. In another configuration, the tip includes a capacitive touch tip or electrostatic assembly for aligning contact. The wand tip 207 is replaceable and detachable that allows the wand tip to identify anatomical features while keeping the transmitters 201-203 within line of sight with the receiver 101 (see FIG. 1) A multi-headed stylus tip may be included. These stylus tips may be right-angled, curvilinear, or other shapes in the form of picks so that it is difficult to point to multiple touch locations. This allows the tip 207 to hold the wand in the hand to identify points of interest such as (anatomical) features in the structure, bone or jig.

  User interface 218 may include one or more buttons to allow manual operation and use (eg, an on / off / reset button) and lighting elements to provide visual feedback. In one configuration, an 8-state navigation push button 209 can communicate instructions to further control or complement the user interface. A navigation push button 209 may be ergonomically placed on the side of the wand to allow for use with one hand. Wand 103 may include a haptic module along with user interface 218. As an example, the haptic module may change (increase / decrease) the vibration to indicate improper or proper operation. Wand 103 includes a material cover for transmitters 201-202 that transmits sound (e.g., ultrasound) and light (e.g., infrared) but does not transmit biological material such as water, blood, or tissue. In one configuration, a transparent plastic membrane (or mesh) is tightened, which can vibrate under resonance by the transmitted frequency. The battery 218 can be charged by wireless energy charging (eg, magnetic induction coils and supercapacitors).

  The wand 103 may include a base coupling mechanism 205 for coupling to a structure, object or jig. As an example, the mechanism can be a magnetic assembly with a fixed insert (eg, a square posthead) to allow temporary detachment. As another example, the mechanism may be a magnetic ball with a latched increment and a joint socket. As yet another example, the mechanism can be a screw post or pin to an orthopedic screw. Other embodiments may allow sliding, moving, rotating, angling and lock-in coupling and release, and coupling to standard jigs with existing notches, ridges or holes.

  The wand 103 may further include an amplifier 213 and an accelerometer 217. The amplifier increases the signal to noise ratio of the transmitted or received signal. The accelerometer 217 identifies 3-axis and 6-axis tilt while moving and fixed. The communication module 216 may include components for transmitting signals to the receiver 101 (eg, synchronization clock, radio frequency “RF” pulse, infrared “IR” pulse, light / acoustic pulse). The controller 214 may include counters, clocks, or other analog or digital logic for controlling transmission and reception synchronization and for sequencing sensor signals, accelerometer information, and other component data or states. A battery 218 provides power to the respective circuit logic and components. Infrared transmitter 209 pulses an infrared timing signal that can be synchronized with the transmission of the ultrasound signal (to the receiver).

  The controller 214 may be a microprocessor (uP) and / or digital along with associated storage 208 such as Flash, ROM, RAM, SRAM, DRAM or other similar technology for controlling the operation of the above components of the device. Computational techniques such as a digital signal processor (DSP) may be used. The instructions may also reside in other memory and / or processors completely or at least partially during execution of instructions by another processor or computer system. The input / output port allows for portable exchange of information or data, for example, via a Universal Serial Bus (USB). The electronic circuitry of the controller 214 may be, for example, one or more Application Specific Integrated Circuit (ASIC) chips or Field Programmable Gate Arrays (FPGAs) specific to the core signal processing algorithm. ). The controller 214 may be an embedded platform that operates one or more modules of an operating system (OS). In one configuration, the storage device may store one or more instruction sets (eg, software) that use any one or more of the methods or functions described herein.

  The receiver 101 generates timing information, aligns the indicated position of the wand 103 in response to user input, and measures and aligns the short distance position from the three or more indicated positions of the wand 103 with respect to the receiver 101. A processor 233 for determining. The receiver has a size dimension of about 2 cm wide, 2 cm deep, and 10 cm to 20 cm long. The receiver includes a communication module 235 for transmitting timing information in response to the wand 103 that transmits the first, second and third ultrasound signals. The ultrasound signal may be a pulse waveform signal generated from a combination of amplitude modulation, frequency modulation, and phase modulation. Each of the three microphones 221 to 223 receives the first, second, and third pulse waveform signals transmitted in the air. The receiver 101 may be configured in a line or in a smaller configuration may have a triangular shape. An example of a device for three-dimensional detection is disclosed in US patent application Ser. No. 11 / 683,410, filed Mar. 7, 2007, entitled “Method and Device for Three-Dimensional Sensing”. The entire contents of which are hereby incorporated by reference.

  Memory 238 may store ultrasound signals and generate a history of ultrasound signals or processed signals. The memory 238 can also store the wand tip position, for example, in response to a user pressing a button to align. A wireless communication interface (input / output) 239 wirelessly transmits position information of three or more indicated positions and short-range alignment to the remote system. The remote system can be a computer, laptop or portable device that displays location information and alignment information in real time as described above. The battery supplies power to the processor 233 and associated electronics in the receiver 101. The receiver 101 may include more or fewer components than shown, and the functionality of some components may be shared or integrated in.

  Additional ultrasonic sensors can be included to provide an overdetermined system for three-dimensional detection. The ultrasonic sensor can be a MEMS microphone, a receiver, an ultrasonic transmitter, or a combination thereof. As an example, each ultrasonic transducer can perform separate transmit and receive functions. One such example of an ultrasonic sensor is disclosed in US Pat. No. 7,414,705, the entire contents of which are hereby incorporated by reference. The receiver 101 may also include a coupling mechanism 240 for coupling to a bone or jig by a pin 251. As an example, the coupling mechanism 240 can be a magnetic assembly with a fixed insert (eg, a square posthead) to allow temporary detachment. As another example, the coupling mechanism 240 can be a magnetic ball and joint socket with a latch increment.

  The receiver 101 may further include an amplifier 232, a communication module 235, an accelerometer 236, and a processor 233. The processor 233 may host software program modules such as a pulse shaper, phase detector, signal compressor, and other digital signal processor code utilities and packages. Amplifier 232 increases the signal to noise ratio of the transmitted or received signal. The processor 233 may include controllers, counters, clocks, and other analog or digital logic for control of transmit and receive synchronization and ordering of sensor signals, accelerometer information, and other component data or states. The accelerometer 236 may identify axial tilt (eg, 3 and 6 axes) while moving and fixed. A battery 234 provides power to the respective circuit logic and components. The receiver includes a photodiode 241 for detecting the infrared signal and establishing the transmission time of the ultrasonic signal to enable wireless infrared communication with the wand.

  The communication module 235 may include components for local signal transmission (to the wand 102) (eg, synchronization clock, radio frequency “RF” pulses, infrared “IR” pulses, optical / acoustic pulses). The communication module 235 is a network and data component (eg, Bluetooth®, ZigBee, Wi-Fi, GPSK, FSK, USB, etc.) for wireless communication using a remote device (eg, laptop, computer, etc.). RS232, IR, etc.). Note that external communication via the network and data components is envisaged herein, but the receiver 101 may include a user interface 237 to allow a single operation. As an example, the receiver 101 may include three LED lights 224 to indicate three or more wand tips that indicate the alignment state of the position. User interface 237 may also include a touch screen or other interface display along with its GUI to report location information and alignment.

  Processor 233 may be a microprocessor (uP) and / or associated memory device 238 such as Flash, ROM, RAM, SRAM, DRAM or other similar technology for controlling the operation of the above components of a terminal device. Computational techniques such as a digital signal processor (DSP) can be used. The instructions may also reside in other memory and / or processors completely or at least partially during execution of instructions by another processor or computer system. The input / output port allows for the portable exchange of information or data, for example, by Universal Serial Bus (USB). The controller electronics may be, for example, one or more Application Specific Integrated Circuits (ASIC) chips or Field Programmable Gate Arrays specific to core signal processing algorithms or control logic. (FPGA). The processor may be an embedded platform that runs one or more modules of an operating system (OS). In one configuration, the storage device 238 may store one or more instruction sets (eg, software) that use any one or more of the methods or functions described herein.

  In the first configuration, the receiver 101 is wired via an electrical connection (eg, wiring) connected to the wand 103. That is, the communication port of the wand 103 is physically wired to the communication interface of the receiver 101 for receiving timing information. The timing information from the receiver 101 informs the wand 103 of the transmission timing and includes optional parameters that can be applied to pulse shaping. The processor 233 at the receiver 101 uses this timing information to establish a Time of Flight measurement in the case of ultrasonic signal transmission relative to a reference time base.

  In the second configuration, the receiver 101 is communicatively coupled to the wand 103 via a wireless signal transmission connection via the wireless I / O 239. A signaling protocol is disclosed in US patent application Ser. No. 12 / 900,662, entitled “Navigation Device Providing Sensitivity Feedback”, filed 10/8/2010, the entire contents of which are incorporated by reference. Incorporated herein by reference. An infrared transmitter 209 in the wand 103 transmits an infrared timing signal along with each transmitted pulse waveform signal. Infrared transmitter 209 pulses an infrared timing signal that is synchronized with the transmission of the ultrasonic signal to the receiver. The receiver 101 can include a photodiode 241 for determining when an infrared timing signal is received. In this case, the communication port of the wand 103 is wirelessly coupled to the communication interface of the receiver 101 by an infrared transmitter and a photodiode for relaying timing information within microsecond accuracy (resolution up to 1 mm). The processor 233 at the receiver 101 uses this infrared timing information to establish first, second, and third time of flight measurements relative to the reference transmission time.

  FIG. 4 shows a plurality of sensored wands for evaluating a non-limiting example spine alignment 300. As shown, a plurality of sensored wands 301-304 may be used to track the movement of individual vertebrae and / or alignment with other tracked vertebrae. Each of the wands can be of a different size and sensor configuration. A wand is a lightweight component that can range in dimensions from 4 cm to 12 cm and a width of 1 cm or less. In general, the wands 301-304 have a form factor that is easily held manually or can be coupled or supported by a musculoskeletal system. For example, the first wand 301 may have a wider and longer sensor distance than another wand 303. Thereby, communication between the wands 301 to 304 and the receiver 308 can be facilitated. Each wand may have a separate ID to distinguish it from others, for example, stored as a characteristic low frequency magnetic wavelength unique to the wand. The system 100 may identify the wand via a passive magnetic field and determine the position by one or more ultrasound, optical, electromagnetic elements, or (passive / active) sensors.

  In conjunction with the description of FIG. 4, a workflow method is assumed herein. In a first workflow step 311, the receiver 308 is positioned in proximity to the surgical site and where the wand is expected to be used. As described above, the receiver 308 is placed on a table or secured to the sacrum (or other bone region) to track the orientation and location of the wand. The wand is held in the hand and can be used to align anatomical features in the sacrum, for example, to click the wand tip to align with the bone features. This point alignment captures anatomical points, which are then used to retrieve a 3D spine model with the appropriate orientation and dimensions. In step 312, the wand can then be used to align points in the vertebra and assess the location of that vertebra. In the first configuration, the wand can be secured directly to the vertebra without wand tip point alignment. This provides a single point for evaluating the spatial position (three-dimensional information) at the insertion point, which is not necessarily orientation.

  In the second configuration, the wand is first used to align a point on the surface of the vertebra and then inserted into it. Alignment captures anatomical vertebra points, which are then used to retrieve a 3D vertebra model with the appropriate orientation and dimensions. This allows the system 100 to track the vertebra at an appropriate scale and position as the wand is inserted therein. Upon alignment and positioning of the receiver in the sacrum and each wand in the vertebra, the system 100 provides a real-time display of instrument tracking, as shown in step 313. That is, the system 100 generates a virtual environment showing a 3D model of the spine, sensored wands 301-304, and a receiver 308.

  FIG. 5 shows a sensorized installation for determining the state of the spine in a non-limiting example. As described above, the wand tip may also include a sensor such as a biometric transducer. When the wand tip is used to align the point of interest, it can also capture biometric data directly related to the insertion site. The wand tip can also release the biometric transducer and leave it positioned at the contact site. The description of FIGS. 5 and 6 shows the installation of a wand tip sensor, which, in one configuration, deploys the tip sensor in situ for long term implantation. The system 100 can also transmit energy waves in a vibration pattern similar to the load on the bone, and can also improve bone mineral content and bone density. The sensor can also send energy waves through or across the implant, thereby assisting in healing the fracture.

  Accordingly, provided herein is a method for detecting a biometric parameter that is a function of sensored placement including position and orientation. The method includes providing a biometric transducer on a moving component of the spinal joint and energy waves from the biometric transducer to a different surgical site from the moving component of the spinal joint during movement of the spinal joint or spine. (E.g., ultrasound, optics, electromagnetic), quantitatively assessing energy wave behavior during spinal joint movement, and based on the evaluated behavior and spinal joint movement, Determining at least one parameter of a procedure site selected from the group consisting of current conditions or pressure, tension, shear, load, torque, bone density and load weight. Alternatively, an insertable head assembly incorporating one or more sensors can be used to measure a subject's biometric parameters. In this example, the biometric transducer can detect and transmit information regarding vertebral movement and loading. As an example, the sensor can detect abnormal movement of the orthopedic joint, for example, by evaluating the frequency or periodicity of the evaluated behavior when the spinal joint is flexed during movement.

  As an example shown in FIG. 5, a single sensor 352 may be used to evaluate the behavior of a moving spinal joint, such as the quality or function of a joint mechanism related to pressure, tension, shear, bone density, and load weight. Can be implanted in a bone or spinal joint orthosis component (eg, vertebrae). The sensor 352 in this embodiment is in a fixed location in the bone (vertebra) and moves with the vertebra 358 during movement relative to the procedure site 360. As shown, the procedure site 360 includes a vertebra 354, an intervertebral disc 356, and a vertebra 358. The procedure site 360 is relatively immobile with respect to the sensor because the vertebrae primarily move a single sensor. A single sensor of this configuration is exposed to various changes in the subject parameters (eg, pressure, tension, shear, bone density, and load weight) at the procedure site as a result of movement. As an example, the sensor is compressed by various joint movements caused by movements applied to various locations of the joint during movement. During movement, the sensor 352 evaluates the energy waves at the procedure site and the adjacent sites are also evaluated because the movement of the vertebra (and thus the focus of the sensor) changes relative to the procedure site as a result of the movement. The position of the sensor 352 is also determined with respect to other vertebrae (by the wand if it is coupled to it) and used to catalog the detected parameter changes with respect to orientation, location and position. .

  One of installing a sensor 352 on a moving component (eg, vertebra, dental implant) and using the knowledge of its location and orientation to transmit energy waves into a different surgical site than the moving component of the spinal joint One advantage is that it effectively changes the distance between the sensor 352 and the procedure site, thereby changing the resolution and focus of the sensor 352 and the forces on it. The position information also indicates the periodicity of movement relative to the detected parameter change. As an example, a sensor 352 operating in a switched transmit and receive mode can take measurements at different depths of the procedure site without causing operational changes. Sensors 352 differ as a result of distance changes due to articulation, for example, without making sensor adjustments that may originally require changes in the frequency, amplitude, or phase of the transmitted energy wave to match impedance. You can take measurements.

  As an example, biometric sensor 352 can be an ultrasound device. Quantitative ultrasound can measure additional properties of bone, such as mechanical integrity, in contrast to other bone density measurement methods that measure only bone mineral content. The propagation of ultrasound through bone is affected by bone mass, bone structure, and load direction. Quantitative ultrasound measurements as a means of assessing bone strength and stiffness are based on the processing of received ultrasound signals. The speed of sound and ultrasound propagates through bone and soft tissue. Looseness or settling of the brace and fracture of the femur / tibia / acetabulum or brace are associated with bone loss. Thus, an accurate assessment of the progressive quantifiable change in the amount of bone mineral around the brace is the timing at which the treating surgeon intervenes to preserve bone stock for revision arthroplasty. Can help you decide. This information is useful for the development of implants for osteoporotic bone, and for the treatment of osteoporosis and the assessment of the effects of various implant coatings.

  FIG. 6 illustrates multiple sensorized installations for determining the state of the spine in a non-limiting example. As described above, the wand tip may also include a sensor such as a biometric transducer. When the wand tip is used to align the point of interest, it can also capture biometric data directly related to the insertion site. The wand tip can also release the biometric transducer and leave it positioned at the contact site.

  Accordingly, providing a second biometric transducer at a different surgical site than the spinal joint movement component and the relative separation of the first biometric transducer and the second biometric transducer during spinal joint movement. There is provided herein a method for detecting a biometric parameter comprising quantitatively evaluating the behavior of an energy wave based on The current state of the procedure site or at least one parameter is determined from the estimated behavior and spinal joint movement. The parameter is one of strain, vibration, kinematics, and stability. The first biometric transducer or the second biometric transducer may include a transceiver for transmitting data associated with the at least one biometric parameter to an external source for evaluation.

  As shown in FIG. 6, sensor 352 may be implanted in a bone or spinal joint orthosis component (eg, vertebra), and sensor 366 may be used to assess a spinal joint behavior during movement. In different positions. The sensor 352 in this embodiment is in a fixed location in the bone (vertebra) and moves with the vertebra during articulation relative to the sensor 366 at the procedure site. Sensors 366 can be on different bones. Although both sensors can move, sensor 352 can actually be considered to move relative to sensor 366 and is displaced relative to the shown. Sensors 352 and 366 include, but are not limited to, bone density, fluid viscosity, temperature, strain, pressure, angular deformation, vibration, load, torque, distance, slope, shape, elasticity, motion, etc. Allows assessment of host bones and tissues.

  The illustrated dual sensor configuration can assess bone integrity. For example, at the spinal joint, sensors 352 and 366 coupled to the first and second vertebrae assess bone density. External and internal energy waves delivered by sensor 352, sensor 366, or both according to the present invention may be used during fracture treatment and spinal fusion. With two deployed sensors, the distance between the sensors can be determined by the area of interest and the power field that can be generated. The energy field can be a standard energy source such as ultrasound, radio frequency, and / or electromagnetic field. The deflection of the energy wave over time will allow, for example, detection of changes in the desired parameter being evaluated. As an example, a first sensor placed at the distal end of the femur may assess bone density from a second sensor implanted at the proximal end of the tibia during vertebra movement.

  One advantage of two or more sensors is that they move closer and further with respect to each other as a result of movement, for example, the frequency characteristics of the sensor under investigation and the impedance of the procedure site This is an operation that improves the evaluation of energy waves depending on the characteristics. Also, the relative separation of sensors 352 and 366 can provide different measurements without sensor adjustments that may inherently require changes in the frequency, amplitude, or phase of the transmitted energy wave, eg, to match impedance. Can take. In this example, the bone measurement is based on the processing of the received ultrasound signal. Both the speed of sound and the ultrasonic velocity provide a measurement based on how quickly the ultrasonic wave propagates through bone and soft tissue. These measurement characteristics allow for rapid three-dimensional geometry generation, and this information can be processed by the system 100 along with position, orientation and location information. Since the sensor spans the joint space, it can detect changes in implant function. Examples of implant functions include bearing wear, settling, bone integration, normal and abnormal movement, heat, viscosity changes, particulate matter, kinematics, to name a few.

  FIG. 7 shows a non-limiting example sensorized spinal instrument 400. A side view and a plan view are shown. The spinal instrument 400 includes a handle 409, a shaft 430, and a sensored head 407. Handle 409 is coupled to the proximal end of shaft 430 and sensored head 407 is coupled to the distal end of shaft 430. In one embodiment, handle 409, shaft 430, and sensored head 407 form a rigid structure that does not bend when used to distract or measure the spinal region. The spinal instrument 400 includes an electronic assembly 401 that is operatively coupled to one or more sensors in the sensored head 407. The sensor is coupled to the surface 403/406 in the moving component 404/405 of the sensored head 407. The electronic assembly 401 is disposed toward the proximal end of the shaft 407 or in the handle 409. As shown, the electronic assembly 401 is coupled to the shaft 409. The electronic assembly 401 includes electronic circuits including logic circuits, accelerometers, and communication circuits. In one embodiment, the surfaces 403 and 406 of the sensored head 407 may have a convex shape. The convex shape of the surfaces 403 and 406 supports the placement of the sensored head 407 within the spinal region, and more specifically between the vertebral contours. In one embodiment, sensored head 407 is height adjustable by top component 404 and bottom component 405 via jack 402 that extends and closes uniformly in response to pivoting motion 411 of handle 409. is there. Jack 402 is coupled to the inner surface of components 404 and 405 of sensored head 407. The shaft 430 includes one or more longitudinal passages. For example, an interconnect, such as a flexible wire interconnect, passes through one longitudinal passage of the shaft 430 so that the electronic assembly 401 is operatively coupled to one or more sensors in the sensored head 407. Can be joined through. Similarly, a threaded rod can be coupled through the second passage of the shaft 430 to couple the handle 409 to the jack 404 so that rotation of the handle 409 causes the height of the sensored head 407 to be increased. Adjustment is possible.

  The spinal instrument 400 can also determine orientation with an embedded accelerometer. Sensored head 407 includes multiple capabilities including the ability to determine parameters of the procedure site (eg, intervertebral space), including pressure, tension, shear force, load, torque, bone density, and / or bearing weight. Support the function. In one embodiment, two or more load sensors can be included in the sensored head 407. Two or more load sensors can be coupled in place on the surfaces 403 and 406. Having two or more load sensors allows the sensored head 407 to measure the magnitude of the load and the position of the load applied to the surfaces 403 and 406. Sensored head 407 can be used to measure, adjust, and test the spinal joint prior to installing the vertebral component. As will be seen below, the alignment system 100 evaluates the optimal insertion angle and position of the spinal instrument 400 upon detection of the intervertebral disc load and reproduces these conditions when using the insertion instrument.

  In the present invention, these parameters are: i) the encapsulating structure and the contact surface supporting the sensor and ii) the power source, the sensing element, one or more ultrasonic resonators or one or more ultrasonic transducers and one or Multiple ultrasonic waveguides, one or more biasing springs or other forms of elastic members, accelerometers, antennas and processing measurement data as well as energy conversion, propagation and detection and all of wireless communication It can be measured using an integrated wireless sensored head 407 or device that includes an electronic assembly that integrates the electronic circuitry that controls the operation of the device. Sensored head 407 or device 400 includes, but is not limited to, a device, appliance, vehicle, equipment, or other physical system to detect and communicate parameters of interest in real time. Various physical systems, including but not limited to, can be positioned on or engaged with, or coupled to or secured to, the animal and human body.

  An example of using spinal instrument 400 is in the spinal cage illustration. The spinal cage is used to space vertebrae during disc replacement. The spinal cage is typically hollow and can be formed with screws for fixation. Two or more cages are often placed between the vertebrae to obtain sufficient support and distribution of the load over the range of motion. In one embodiment, the spinal cage is made of titanium for light weight and strength. Bone growth material can also be placed in the cage to initiate and promote bone growth, thereby further strengthening the intervertebral region over time. The spinal instrument 400 is inserted into the gap between the vertebrae to measure the load and the position of the load. The position of the load corresponds to the vertebral region or surface that applies the load to the surface 403 or 406 of the sensored head 407. The angle and position of insertion of sensored head 407 of spinal instrument 400 can also be measured. Measurement of the magnitude of the load and the position of the load is used by the surgeon to determine the optimal location for the implant location between the vertebrae and the spinal cage for the implant location. The optimal size would be a cage height that falls within a predetermined load range when loaded by the spine. Typically, the height of the sensored head 407 used to distract the subject's vertebra and measure the force applied by the subject's vertebra is equal to the cage height implanted in a later step. After removing the sensored head 407 from the vertebra, the spinal cage can be implanted in the same area. The load on the implanted spinal cage is approximately equal to the measurement created by the spinal instrument 400 and applied by the sensor head 407. In one embodiment, the angle and position of the insertion test measurement is recorded by the spinal instrument 400 or a remote system coupled thereto. The angle and position measurements are then used to guide the spinal cage into the same region of the spine in the same path as the spinal instrument 400 during the measurement process.

  FIG. 8 illustrates a non-limiting example integrated sensored spinal instrument 410. In particular, the electronic assembly 401 is inside the integrated device 410. The electronic assembly 401 includes an external wireless energy source 414 that can be placed in proximity to the charging unit to initiate a wireless recharge operation. The wireless energy source 414 may include a power source, a modulation circuit, and a data input. The power source can be a battery, charging device, capacitor, power connection, or other energy source for generating a wireless power signal that can transfer power to spinal instrument 410. The external wireless energy source 414 can transmit energy in the form of, but not limited to, electromagnetic induction, or other electromagnetic or ultrasonic radiation. In at least one exemplary embodiment, the wireless energy source includes a coil that, when placed in close proximity, electromagnetically couples and operates (eg, is powered on) with an induction coil in the sensing device.

  The electronic assembly 401 transmits measured parameter data to the receiver via a data communication circuit to allow visualization of parameter levels and distribution at various points in the vertebral component. The data input can also be an interface or port for receiving input information from another data source such as a computer via a wired or wireless connection (eg, USB, IEEE 802.16, etc.). The modulation circuit can modulate the input information into a power signal generated by the power source. Sensored head 407 typically has a wear surface made of a low friction polymer material. Ideally, the sensored head 407, when inserted between vertebrae, has the proper load, alignment, and balance, similar to a natural spine.

  FIG. 9 shows an insertion device 420 with a non-limiting example vertebral component. The electronic assembly 401 described herein similarly supports the generation of orientation and position data for the insertion device 420. The alignment system 100 allows a user to reproduce the insertion angle, position, and trajectory (path) to achieve proper or pre-planned placement of vertebral components. Alternatively, an accelerometer in electronic assembly 401 can provide location and trajectory information. The insertion device 420 includes a handle 432, a neck 434, and a tip 451. An attachment / detachment mechanism 455 couples to the proximal end of the neck 434 to control the tip 451. The detachment mechanism 455 allows the surgeon to hold or release the vertebral component coupled to the tip 451. In this example, the handle 432 extends at an angle proximate the proximal end of the neck 434. Positioning the handle 432 allows the surgeon to accurately point the tip 451 into the spinal region while allowing access to the detachment mechanism 455.

  In the first example, the vertebral component is a spinal cage 475. The spinal cage 475 is a small hollow cylindrical device, usually made of titanium, with a perforated wall that can be inserted between the vertebrae of the spine during surgery. Generally, the distraction process spaces the vertebrae to a predetermined distance before insertion of the spinal cage 475. The spinal cage 475 can increase stability, reduce vertebral compression, and reduce neuropathy as a solution to improve patient comfort. The spinal cage 475 can include surface threads that make the cage self-tapping and provide additional stability. The spinal cage 475 can be porous to include bone graft material that supports bone growth between the vertebral bodies through the cage 475. To alleviate discomfort, more than one spinal cage can be placed between the vertebrae. Proper placement and positioning of the spinal cage 475 is important for good long-term implantation and patient outcome.

  In the second example, the vertebral component is a pedicle screw 478. Pedicle screw 478 is a specific type of bone screw designed for implantation in the pedicle. There are two pedicles per vertebra that connect to other structures (eg, lamina, vertebral arch). Multi-axis pedicle screws can be made of titanium to resist corrosion and increase component strength. The length of the pedicle screw ranges from 30 mm to 60 mm. The diameter is in the range of 5.0 mm to 8.5 mm. Pedicle screws are not limited to these dimensions used as example dimensions. The pedicle screw 478 can be used in an instrumentation procedure to fix rods and plates to the spine to correct deformation and / or treat trauma. Pedicle screws 478 can be used to secure portions of the spine to aid in healing by holding the bone structure together. The electronic assembly 401 (which can be integrated internally or externally) allows the insertion instrument 420 to determine the depth and angle for installation of the screw and guide the screw therein. In this example, one or more accelerometers are used to provide orientation, rotation, angle, or position information for tip 451 during the insertion process.

  In one configuration, the screw 478 is embedded with the sensor. The sensor can transmit energy, take a density reading, and monitor the change in density over time. As an example, the system 100 can therefore monitor and report the healing of the fracture site. The sensor can detect movement at the fracture site as well as changes in movement between the screw and the bone. Such information is useful in monitoring healing and gives the health care provider the ability to monitor the indicated vertebral weight load. The sensor can also be actuated externally to send an energy wave to the fracture itself to aid in healing.

  FIG. 10 shows a perspective view of a spinal instrument 400 positioned between vertebrae of the spine for sensing non-limiting example vertebral parameters. In general, a compressive force is applied to surfaces 403 and 406 when sensored head 407 is inserted into the spinal region. In one embodiment, the sensored head 407 includes two or more load sensors that identify a magnitude vector of load on the surface 403, the surface 406, or both associated with the intervertebral force therebetween. In the illustrated example, spinal instrument 400 is positioned between vertebra (L5) and sacrum (S) such that a compressive force is applied to surfaces 403 and 406. Because the endoscopic approach is difficult to visualize or provide good exposure, one approach for inserting the device 400 is performed from the back (back) by abdominal wall lifting. Is called. Another approach is taken from the front (front side) to allow the surgeon to reach the spine through the abdomen. In this way, the spinal muscles located on the back are not damaged or severed, and muscle weakness and scarring are avoided. The spinal instrument 400 can be used with either an anterior or posterior spinal approach.

  A sensory component aspect of spinal instrument 400 is described in US patent application Ser. No. 12 / 825,638, filed Jun. 29, 2010, entitled “System and Method for Orthopedic Load Sensing Insert Device”. And US patent application Ser. No. 12 / 825,724 filed Jun. 29, 2010, entitled “Wireless Sensing Module for Sensing a Parameter of the Muscular-Skeletal System”. Is incorporated herein by reference in its entirety. Briefly, the sensored head 407 can measure forces (Fx, Fy, and Fz) along with corresponding locations and torques (eg, Tx, Ty, and Tz) and vertebral end loads. An electronic circuit 401 (not shown) controls sensor operation and measurement in the sensor-equipped head 407. The electronic circuit 401 further includes a communication circuit for near field data transmission. The electronic circuit 401 then sends measurement data to the remote system to provide real-time visualization to help the surgeon identify the adjustments necessary to obtain optimal joint balance. be able to.

  A method for placing components in muscle tissue is disclosed below. The steps of the method may be performed in any order. The method is illustrated using an example of cage placement between vertebrae, but the method can be applied to other muscle and skeletal regions such as knees, hips, ankles, spine, shoulders, hands, arms, and feet. It is. In the first step, the sensor-equipped head having a predetermined width is installed in a muscular / skeletal system region. In this example, the insertion region is between the vertebrae of the spine. A hammer can be used to tap the end of the handle to provide sufficient force to insert the sensored head between the vertebrae. The insertion process can also distract the vertebrae, thereby increasing the separation distance. In the second step, the position of the load applied to the sensor-equipped head is measured. Thereby, the magnitude of the load and the position of the load are obtained with respect to the surface of the sensor-equipped head. How the load applied by the musculoskeletal system is positioned on the surface of the sensored head can help determine the stability of the component after insertion. An irregular load applied to the sensored head can predict the situation where the applied force pushes the component away from the insertion position. In general, sensored heads are used to identify suitable locations for component insertion based on quantitative data. In the third step, the load from the sensor-equipped head and the load position data are displayed in real time on the remote system. Similarly, in the fourth step, at least one of orientation, rotation, angle, or position is displayed in real time on the remote system. Changes made during the positioning of the sensor head are reflected in the data on the remote system display. In the fifth step, a location between vertebrae with appropriate loads and positions is identified and the corresponding quantitative measurement data is stored in memory.

  In the sixth step, the sensor-equipped head is removed. In the seventh step, the component is inserted into the muscular / skeletal system. As an example, the stored quantitative measurement data is used to support positioning the component in the musculoskeletal system. In this example, the insertion device can be used to direct the component into the musculoskeletal system. An insertion instrument is an active device that provides the orientation, rotation, angle, or position of a component as it is inserted. The pre-measured direction and location of insertion of the sensored head can be used to guide the insertion instrument. In one embodiment, the remote system display can serve to display the relative alignment of the insertion instrument and components to the pre-inserted sensored head. The insertion device, along with the system, can provide visual, audio, tactile or other feedback to further help direct the installation of the component. Generally, the inserted component has a height approximately equal to the sensored head. Ideally, the component is inserted into the pre-inserted sensor head at the same location and position so that the load and load position on the component is similar to the quantitative measurement. In the eighth step, the components are positioned and released identically to the pre-inserted sensor head. The insertion device can then be removed from the muscular / skeletal system. In the ninth step, at least the sensor-equipped head is discarded.

  Thus, the sensored head is used to identify a suitable location for component insertion. Insertion is supported by quantitative measurements including location and location. In addition, the approximate load and load location on the component is known after the procedure is complete. In general, knowing the load applied by the muscle-skeletal system and the position of the component on the surface can help determine the long-term stability of the component. If the load applied to the component is irregular, the applied force can push the component away from the insertion position.

  FIG. 11 shows a graphical user interface (GUI) 500 showing a perspective view of the sensorized spinal instrument of FIG. 10 in a non-limiting example. User interface 500 is illustrated by remote system 105 and alignment system 100 (see FIG. 1). The GUI 500 includes a window 510 and an associated window 520. Window 520 shows spinal instrument 400 and sensor head 407 with respect to vertebra 522 being evaluated. In this example, a perspective (planar) view of the vertebra is shown. This figure shows, for example, a shaft angle 523 and a rotational component 524 that indicate the approach angle and rotation of the spinal instrument 400 as it is advanced into the incision. The window 520 and corresponding GUI information is shown and updated in real time during the procedure. This allows the surgeon to visualize the use of spinal instrument 400 and sensed parameters. Window 510 shows the sensing surface (403 or 406) of sensored head 407. A line of sight 512 is overlaid on the sensor head image to identify the maximum point and location of the force. The line of sight 512 may be long to indicate the end load of the vertebra. Window 513 reports, for example, a 20 pound load force across the sensor head surface. This information is shown and updated in real time during the procedure.

  As described above, the system 100 can be used during surgery to aid in the implantation of a prosthesis / device / hardware by parameter sensing (eg, vertebral load, end load, compression, etc.). Components such as the receiver 101, the plurality of wands 103, and the spinal instrument 400 remain in the surgical field during use. Remote system 105 is typically external to the surgical field. All measurements are made in the surgical field by these components. In one embodiment, at least one of the receiver 101, the plurality of wands 103, and the spinal instrument is discarded after the procedure is completed. In general, they are designed to be powered for a single use and cannot be sterilized again.

  In the spine, effects on bone tissue and soft tissue elements, and changes in soft tissue (eg, cartilage, tendon, ligament) during surgery, including spinal correction surgery, are evaluated by the system 100. The sensor is then used during surgery (and after surgery) to assess and visualize changes over time and dynamic changes. The sensor can be activated during surgery when surgical parameter readings are stored. Immediately after the operation, the sensor is activated and the reference value is known.

  The sensor system 100 includes, but is not limited to, a spine with respect to bone density, fluid viscosity, temperature, strain, pressure, angular deformation, vibration, load, torque, distance, slope, shape, elasticity, and motion. And allow connective tissue assessment. Because the sensor is passed through the vertebral cavity, the sensor can predict changes in the function of the vertebral component prior to insertion of the vertebral component. As described above, system 100 is used to place spinal instrument 400 in an intervertebral space, where spinal instrument 400 is shown positioned relative to vertebral body 522. Once it is installed and visually confirmed at the center of the vertebra, the system 100 reports the end load on the instrument, which in turn is the appropriate vertebra device and insertion plan (eg, approach angle, rotation, etc.). , Depth, path trajectory) used to determine the size. Examples of implant component functions include bearing wear, settling, bone integration, normal and abnormal movement, heat, viscosity changes, particulate matter, kinematics, to name a few. Including.

  FIG. 12 shows a sensorized spinal instrument 400 positioned between the vertebrae of the spine for non-limiting example intervertebral position and force sensing. As shown, sensored head 407 of spinal instrument 400 is placed between vertebra L4 and L5 vertebrae. The spinal instrument 400 distracts the L4 and L5 vertebrae by the height of the sensored head 407 and provides quantitative data about the magnitude and position of the load. In one embodiment, spinal instrument 400 communicates with first wand 510 and second wand 520 positioned adjacent to each side thereof. A long shaft 514 is provided on each wand to allow placement within the vertebrae of the spine and is compatible with other wands and the electronic assembly 401 of spinal instrument 400. Wand 510 tracks the orientation and position of vertebra L4, while wand 520 tracks the orientation and position of vertebra L5. This allows the system 100 to track the orientation and movement of the spinal instrument 400 relative to the movement of adjacent vertebrae. Each wand is sensored in the same manner as spinal instrument 400. Wand 510 and wand 520 include sensor 512 and sensor 513, respectively. Sensors 512 and 513 can transmit and receive position information. The electronic assembly 401, in conjunction with the wands 510 and 520, serves a dual function to determine the orientation and position of the spinal instrument 400 during the procedure. An example of ultrasonic position detection is disclosed in US patent application Ser. No. 12 / 764,072 entitled “Method and System for Positional Measurement” filed on April 20, 2010, The entire contents are hereby incorporated by reference.

  13 shows a perspective view of a user interface 600 showing the sensorized spinal instrument of FIG. 12 in a non-limiting example. User interface 600 is shown by remote system 105 and alignment system 100 (see FIG. 1). The GUI 600 includes a first window 610 and an associated second window 620. The second window 620 shows the spinal instrument and sensored head 407 for the vertebral component 622 being evaluated. In this example, a sagittal (side) view of the spinal column is shown. This figure shows a shaft angle 623 and a rotational component 624 showing the approach angle and rotation of the spinal instrument and sensored head 407. The second window 620 and the corresponding GUI information are shown and updated in real time during the procedure. This allows the surgeon to visualize the sensored head 407 of the spinal instrument 400 and the sensed load force parameters. The first window 610 shows the sensing surface of the sensor head (see FIG. 7). A line of sight 612 is superimposed on the image of the sensored head 407 to identify the maximum point and location of the force. The line of sight 612 can also be adjusted in width and length to indicate the end load of the vertebra. Another GUI window 613 reports the load force across the surface of the sensored head 407. The GUI 600 is shown and updated in real time during the procedure.

  FIG. 14 shows a perspective view of a sensorized spinal insertion device 420 for placement of a non-limiting example spinal cage 475. The insertion instrument 420 provides a surgical means for implanting a vertebral component 475 (eg, spinal cage, pedicle screw, sensor) between the L4 and L5 vertebrae in the figure. The tip 451 of the mechanical assembly at the distal end of the neck 434 allows detachment of the vertebral component by the detachment mechanism 455. Vertebral component 475 can be placed on the back of the spine through a midline incision on the back, as shown, for example, by a posterior pathway lumbar interbody fusion (PLIF). The insertion device 420 can similarly be used in an anterior pathway lumbar interbody fusion (ALIF) procedure.

  In one method envisaged herein, the position of the cage prior to insertion is, for example, 3D imaging or as described using wands 510 and 520 with spinal instrument 400 shown in FIGS. It is optimally defined by ultrasonic navigation. A load sensor 407 (see FIG. 12) is positioned between the vertebrae to evaluate the load force described above when the optimal insertion path and trajectory are defined there. The loading force and path of instrument insertion is recorded. Thereafter, as shown in FIG. 14, the insertion device 420 inserts the final spinal cage 475 according to the recorded path and based on the loading force. During insertion, the GUI shown in FIG. 15 navigates the spinal instrument 420 to the recorded insertion location. The spinal insertion device 420 may be equipped with one or more load sensors that serve as placeholders to the final spinal cage. After placement of the spinal cage 475 between the vertebrae, release of the spinal cage from the insertion device 420, and removal of the insertion device 420, the space that occupies the spinal cage is removed by the bars and pedicle screws in the adjacent vertebrae. Closed. This forces the surrounding vertebrae against the spinal cage and provides stability to vertebral fusion. During this procedure, the GUI 700 of FIG. 15 reports changes in the anatomy of the spine due to rod adjustment and pedicle screw tightening, such as Lordosis and Kyphosis. . In particular, the GUI 700 also provides visual feedback indicating which amounts and directions achieve the planned spinal alignment by adjustment using the instrument for the bars and screws.

  FIG. 15 illustrates a user interface 700 showing a perspective view of the sensorized spinal insertion device 420 of FIG. 14 in a non-limiting example. User interface 700 is shown by remote system 105 and alignment system 100 (see FIG. 1). The GUI 700 includes a first window 710 and an associated second window 720. The second window 720 shows the insertion device 420 and vertebral component 475 for the L4 and L5 vertebrae to be evaluated. In this example, a sagittal (side) view of the spinal column is shown. This figure shows a shaft angle 723 and a rotation component 724 that show the approach angle and rotation of the insertion instrument 420 and vertebral component 475. The second window 720 and the corresponding GUI information are shown and updated in real time during the procedure. This allows the surgeon to visualize the vertebral component 475 of the insertion device 420 according to a pre-detected load force parameter.

  The first window 710 shows the target (desired) sensored head orientation 722 and the current instrument head orientation 767. The target orientation 722 shows a predetermined approach angle, rotation and trajectory path when using the spinal instrument 400 to evaluate load parameters. The current instrument head orientation 767 shows the tracking of the insertion instrument 420 currently used to insert the final cage 475. The GUI 700 shows a target orientation model 722 that takes into account the current instrument head orientation 767 to provide a visualization of a predetermined surgical plan.

  10, 11, 12, and 13 show that the spinal instrument 400 determines the optimal procedure parameters (eg, angle, rotation, path), taking into account the determined sensing parameters (eg, load, force, edge). Recall that you have shown that you have evaluated. Once these procedure parameters are determined, the system 100 guides the surgeon using the GUI 700 to insert a vertebral component 475 (eg, spinal cage, pedicle screw) using the insertion instrument 420. In one configuration, the system 100 provides haptic feedback to guide the insertion device 420 during the insertion procedure. For example, if the current approach angle 713 deviates from the target approach angle, or the orientation 767 does not coincide with the target trajectory path 722, the system 100 will vibrate and display a visual cue (red / green indication). ) Can be provided. Alternatively, audio feedback can be provided by the system 100 to supplement the visual information provided. The GUI 700 effectively reproduces the position and target path in the sensored insertion instrument 420 with visual and haptic feedback based on previous instrumentation.

  Load, balance, and position are determined quantitatively by surgical techniques and adjustments using data from the registration and load balancing system 100 sensorized devices (eg, 101, 103, 400, 420, 475). Within the measured range, it can be adjusted during surgery. Both the trial and final insert (eg, spinal cage, pedicle screw, sensor, etc.) may include a sensing module for providing measurement data to a remote system for display. The final insert can also be used for long term monitoring of the spinal joint. Data can be used by patients and health care providers to ensure that spinal joints or fused vertebrae function properly during rehabilitation and when the patient returns to an active normal lifestyle . Conversely, the patient or health care provider can be notified when the measured parameter is out of specification. This allows early detection of spinal problems that can be resolved with minimal stress on the patient. Data from the final insert can be displayed on the screen in real time using data from the embedded sensing module. In one embodiment, a handheld device is used to receive data from the final insert. The handheld device can be held in close proximity to the spine so that a strong signal is obtained for data reception.

  A method for distracting the spinal region is disclosed below. The steps of the method can be performed in any order. Reference may be made to FIGS. 10, 11, 12, 13, and 14. FIG. An example of placing a brace component, such as a spinal cage, between vertebrae is used to illustrate the method, which involves the knee, hip, ankle, spine, shoulder, hand, arm, and foot. It can be applied to other muscle / skeletal regions. In general, quantitative measurement data needs to be collected in the spinal region. The spinal instruments, alignment devices, and insertion instruments disclosed herein can be used to generate a database of quantitative data. At this point, there is a lack of quantitative measurement data due to the lack of active instruments and measurement devices. The measurement data generated by the instrument during installation of the brace component, if relevant to the patient's health, can be used to determine the impact of load, load position, and brace component alignment. Can be correlated with long-term data. The system disclosed herein can generate data during installation of the brace component and is applicable to provide long term periodic measurements of implants and spinal regions. Thus, the result of the distraction method is to generate sufficient data to support installation procedures that reduce recovery time, minimize failure, improve performance, reliability, and extend the useful life of the device. .

  In the first step, the spinal instrument is inserted to distract the spinal region. The spinal instrument includes sensors for generating quantitative measurement data in real time during surgery. In the second step, the load applied to the spinal instrument by the spinal region is measured. The spinal instrument has a first height such that the spinal region is distracted to a first height. The system shows the measurement data by visual, audio or tactile means. In one example, the system discloses that a load measurement from a spinal instrument is outside a predetermined load range. The predetermined load range used by the system to assess the spinal region can be determined by clinical studies. For example, the predetermined load range may support the placement of the device by associating load measurement data with surgical results. In general, measurements outside of a predetermined load range can statistically increase the likelihood of device failure. In the third step, the spinal region is distracted to a second height. In the fourth step, the load applied to the spinal instrument by the spinal region at the second height is measured. The system indicates that the load measurement from the spinal instrument is within a predetermined load range. By bringing the measured load within a predetermined load range, failure due to excessive load on the brace component is reduced. In general, this process can be repeated as many times as necessary at different distraction heights until spinal instrument measurements indicate that the measured load is within a predetermined load range.

  In the fifth step, at least one of the orientation, rotation, angle, or position of the spinal instrument is measured. In one embodiment, the measurement may correspond to the portion of the spinal instrument that is inserted into the spinal region. For example, the position data may relate to a sensored head of a spinal instrument. The data can be used to place the brace component in the same position and in the same trajectory as measured by the spinal instrument. In the sixth step, the load applied to the spinal instrument by the spinal region can be monitored in the remote system. In this example, the remote system includes a display that allows data to be viewed in real time during the procedure. In the seventh step, the height of the spinal instrument can be adjusted. As disclosed, the spinal instrument may include a scissor type mechanism for reducing or increasing the height of the distraction surface. In one embodiment, the spinal instrument handle is rotated to change the distraction height. Adjustments can be made while monitoring load data in real time in a remote system. In general, the height is adjusted until the measured load falls within a predetermined load range. In the eighth step, the height is increased or decreased so that the adjusted height corresponds to the height of the brace component. In one embodiment, orthotic components having the same distraction height can be placed at the location of load measurement in the spinal region. When the brace component is aligned with the track and installed in the same location as the spinal instrument, it is subjected to a load similar to the load measurement.

  In the ninth step, the spinal instrument measures the position of the applied load. The spinal instrument can have a surface coupled to the spinal region. In this example, two or more sensors are coupled to the surface of the spinal instrument to support load measurement locations. The position of the load provides quantitative measurement data on how force, pressure, or load can be applied to the brace component when placed in the spinal region. For example, an improperly positioned load may cause a situation where the brace component becomes unstable at that location and eventually is removed from the spinal region, resulting in a catastrophic failure. In one embodiment, the position of the load data from the spinal instrument can be used to evaluate the position for placement of the brace component. The quantitative data can include a predetermined range or region corresponding to the measurement surface of the spinal instrument to assess the position of the load. In a tenth step, the spinal instrument is moved to a different location in the spinal region when the position of the load applied to the spinal instrument by the spinal region is outside the predetermined position range. The new location can be evaluated by quantitative data of load magnitude and load location as a site for the brace component.

  In an eleventh step, an appropriate location in the spinal region for the brace component is identified when the measured quantitative data is within a predetermined load range and a predetermined position range. As mentioned above, placing orthotic components in the area of the spinal region measured within a given load range and a given position range produces positive results and reduces failure rates based on clinical evidence . In the twelfth step, the brace component is placed at a location that is measured by the spinal instrument. Prosthetic components installed at this location will have a load magnitude and load location applied by the spinal region similar to that measured by spinal instruments. The brace component is inserted into a spinal region having a trajectory similar to a spinal instrument. In this example, the trajectory and position of the spinal instrument during the measurement process is recorded. In a thirteenth step, the brace component insertion process may be further supported by comparing the trajectory of the brace component with the trajectory of the spinal instrument. In one embodiment, the surgeon may be given visual, tactile, or audio feedback that helps align the brace component to its location. In the fourteenth step, the trajectory of the brace component and spinal instrument is seen in the remote system. When the remote system identifies a location in the spinal region, it may indicate the actual or simulated position and trajectory of the brace component relative to the position and trajectory of the spinal instrument. In one embodiment, the surgeon can simulate the trajectory by the device or insertion instrument holding the brace component by visualization, or overlay the data displayed on the remote system at the location of the spinal instrument. As disclosed herein, spinal instruments may have a mechanism such as a scissor jack that can change the height of the distraction surface. A bar for raising and lowering the scissor jack is coupled to the handle of the spinal instrument. In a fifteenth step, the spinal instrument handle may be rotated to change the distraction height. In the sixteenth step, a visual, audio or haptic signal is provided when the load applied to the spinal instrument by the spinal region is within a predetermined load range. Similarly, in the seventeenth step, a visual, audio or haptic signal is provided when the load applied to the spinal instrument by the spinal region is within a predetermined position range.

  FIG. 16 is a block diagram of components of a spinal instrument 400 according to an example embodiment. Note that spinal instrument 400 may include more or fewer components than shown. The spinal instrument 400 is a built-in instrument that can measure muscular / skeletal parameters. In this example, spinal instrument 400 measures the load and load location when inserted into the spinal region. The active components of spinal instrument 400 include one or more sensors 1602, load plate 1606, power supply 1608, electronic circuit 1610, transceiver 1612, and accelerometer 1614. In a non-limiting example, the applied compressive force is applied to sensor 1602 by the spinal region and measured by spinal instrument 400.

  Sensor 1602 may be positioned, engaged, attached, or fixed to surfaces 403 and 406 of spinal instrument 400. In general, compressive forces are applied by the spinal region to surfaces 403 and 406 when inserted into the spinal region. Surfaces 403 and 406 couple to sensor 1602 so that a compressive force is applied to each sensor. In one embodiment, the position of the load applied to the surfaces 403 and 406 can be measured. In this example, three load sensors are used in the sensored head to identify the position of the applied load. Each load sensor is coupled to a predetermined position on the load plate 1606. The load plate 1606 couples to the surface 403 to distribute the compressive force applied to the sensored head of the spinal instrument 400 to each sensor. The load plate 1606 may be rigid and will not bend when distributing force, pressure, or load to the sensor 1606. The force or load magnitude measured by each sensor can be correlated back to the location of the load applied to the surface 403.

  In the example of intervertebral measurement, a sensored head having surfaces 403 and 406 may be positioned between the vertebrae of the spine. The surface 403 of the sensored head is coupled to the first vertebra surface, and similarly, the surface 406 is coupled to the second vertebra surface. An accelerometer 1614 or external alignment system can be used to measure the position and orientation of the sensored head as it is directed into the spinal region. Sensor 1602 is coupled to electronic circuit 1610. The electronic circuit 1610 includes a logic circuit, an input / output circuit, a clock circuit, a D / A, and an A / D circuit. In one embodiment, the electronic circuit 1610 includes an application specific integrated circuit that reduces form factor, reduces power, and improves performance. In general, the electronic circuit 1610 controls the measurement process, receives the measurement signal, converts the measurement signal to digital format, supports the display at the interface, and initiates data transfer for the measurement data. The electronic circuit 1610 measures physical changes in the sensor 1602 to determine parameters of interest, for example, the level, distribution and direction of forces acting on the surfaces 403 and 406. The insertion detection device 400 can be powered by an internal power source 1608. Accordingly, all the components necessary to measure muscular / skeletal parameters are present in spinal instrument 400.

  As an example, sensor 1602 may include an elastic or compressible propagation structure between the first transducer and the second transducer. The transducer can be an ultrasonic (or ultrasonic) resonator and the elastic or compressible propagation structure can be an ultrasonic waveguide. The electronic circuit 1610 is electrically coupled to the transducer to convert the change in length (or compression or extension) of the compressible propagation structure into a parameter of interest such as force. The system measures the change in length of the compressible propagation structure (eg, waveguide) in response to the applied force and converts this change into an electrical signal that is transmitted via the transceiver 1612. The level and direction of the applied force can then be communicated. For example, a compressible propagation structure has a known and reproducible characteristic of the applied force with respect to the length of the waveguide. Using known properties, an accurate measurement of the length of the waveguide using ultrasound signals can be converted into a force.

  Sensor 1602 is not limited to waveguide measurements of force, pressure, or load sensing. In yet another configuration, the sensor 1602 is a piezoresistive sensor, a compressible polymer sensor, a capacitive sensor, a light sensor, a mems sensor, a strain gauge sensor, a chemical sensor, and a temperature sensor for measuring muscle / skeletal parameters. , PH sensors, and mechanical sensors. In an alternative embodiment, a piezoresistive thin film sensor can be used to sense the load. Piezoresistive films have a low profile, which reduces the form factor required for mounting. A piezoresistive film changes its resistance by the applied pressure. A voltage or current can be applied to the piezoresistive film to monitor the change in resistance. Electronic circuit 1610 may be coupled to apply a voltage or current. Similarly, electronic circuit 1610 can be coupled to measure voltage and current corresponding to the resistance of the piezoresistive film. The relationship of piezoresistive film resistance to applied force, pressure, or load is known. The electronic circuit 1610 can convert the measured voltage or current into force, pressure, or load applied to the sensored head. In addition, the electronic circuit 1610 can convert the measurement to a digital format for display or transfer for real-time use or for storage. The electronic circuit 1610 can include converters, inputs, outputs, and inputs / outputs that allow serial and parallel data transfer so that measurement and transmission of data can occur simultaneously. In one embodiment, the ASIC is included in an electronic circuit 1610 that incorporates digital control logic to manage the control functions and measurement process of the spinal instrument 400 as directed by the user.

  The accelerometer 1614 can measure acceleration and static gravity. The accelerometer 1614 can be a uniaxial and multi-axis accelerometer structure that detects the magnitude and direction of acceleration as a vector quantity. The accelerometer 1614 can also be used to detect orientation, vibration, effects and shocks. The electronic circuit 1610, together with the accelerometer 1614 and the sensor 1602, measures parameters of interest for the orientation of the spinal instrument 400 (eg, load, force, pressure, displacement, movement, rotation, torque, location, and acceleration distribution). can do. In such a configuration, the spatial distribution of measured parameters for a selected reference system can be calculated and shown for real-time display.

  The transceiver 1612 includes a transmitter 1622 and an antenna 1620 to enable wireless operation and telemetry functions. In various embodiments, the antenna 1620 may be configured with a design as an integrated loop antenna. Integrated loop antennas are composed of various layers and locations on a printed circuit board to which other electrical components are attached. For example, the electronic circuit 1610, the power source 1608, the transceiver 1612, and the accelerometer 1614 can be attached to a circuit board located on or in the spinal instrument 400. The transceiver 1612 can communicate the target parameters in real time after being started. Telemetry data may be received and decoded using various receivers or using a custom receiver. The possibility of physical interference due to wiring and cables coupling the sensing module with the power supply or associated data collection, storage, display equipment, and data processing equipment by radio operation, or limitations imposed by such wiring and cables The measurement distortion caused by or the limitations on such a measurement can be eliminated.

  The transceiver 1612 receives power from the power source 1608 and can operate at low power over various radio frequencies, for example, by an efficient power management scheme incorporated within the electronic circuit 1610 or application specific integrated circuit. As an example, the transceiver 1612 can transmit data at a predetermined frequency in a predetermined emission mode by the antenna 1620. The predetermined frequency may include, but is not limited to, the ISM bands recognized in the International Telecommunication Union Regions 1, 2, and 3. The predetermined emission mode is not limited to the following, but includes Gaussian Frequency Shift Keying (GFSK), Amplitude Shift Keying (ASK), and Phase Shift Modulation (Phase Kifting). ) (PSK), Minimum Shift Keying (MSK), Frequency Modulation (FM), Amplitude Modulation (AM), or other forms of frequency or amplitude modulation (e.g., Binary, coherent, quadrature, etc.).

  The antenna 1620 may be integrated with the sensing module components to provide radio frequency transmission. The antenna 1620 and the electronic circuit 1610 are attached and coupled to form a circuit using a wire trace on the printed circuit board. The antenna 1620 may further include a matching network for efficient transmission of signals. This level of integration of antenna and electronics allows for a reduction in the size and cost of the radio equipment. Potential applications include, but are not limited to, any type of short-range portable, wearable, or other portable communication equipment, where a small antenna is typically used. used. This includes disposable modules or devices as well as reusable modules or devices and modules or devices for long term use.

  The power source 1608 provides power to the electronic components of the spinal instrument 400. In one embodiment, the power source 1608 can be charged by wired energy transfer, near field wireless energy transfer, or a combination thereof. External power sources for providing wireless energy to power source 1608 include, but are not limited to, one or more batteries, an alternating current power source, a radio frequency receiver, an electromagnetic induction coil, one or more photovoltaic cells, One or more thermocouples, or one or more ultrasonic transducers. With power supply 1608, spinal instrument 400 can be operated with a single charge until the internal energy is exhausted. The spinal instrument 400 can be periodically recharged to allow continuous operation. The power source 1608 may further employ power management techniques for efficiently supplying and providing energy to the components of the spinal instrument 400 to facilitate measurement and wireless operation. A power management circuit may be incorporated into the ASIC to manage both ASIC power consumption as well as other components of the system.

  The power source 1608 minimizes the additional energy radiation sources needed to power the sensing module during the measurement operation. In one embodiment, as illustrated, the energy store 1608 may include a capacitive energy storage device 1624 and an induction coil 1626. An external source of charging power may be wirelessly coupled to capacitive energy storage device 1624 via one or more electromagnetic induction coils 1626 by inductive charging. The charging operation may be controlled by a power management system designed to or with electronic circuit 1610. For example, during operation of the electronic circuit 1610, power can be transferred from the capacitive energy storage device 1624 by efficient step-up and step-down voltage conversion circuits. This saves the operating power of the circuit block at a minimum voltage level in order to support the required level of performance. Alternatively, the power source 1608 can include one or more batteries housed within the spinal instrument 400. The battery can provide power to the disposable spinal instrument 400 so that the device is discarded after it has been used in surgery.

  In one form, the external power source may further serve to communicate downlink data to the transceiver 1612 during a recharge operation. For example, downlink control data can be modulated into a wireless energy source signal and then demodulated from induction coil 1626 by electronic circuit 1610. This can serve as a more efficient way to receive downlink data instead of configuring the transceiver 1612 for both uplink and downlink operations. As an example, the downlink data may include updated control parameters, such as external location information, that the spinal instrument 400 uses when making measurements or for recalibration purposes. Downlink data can also be used to download serial numbers or other identification data.

  The electronic circuit 1610 manages and controls various operations of the sensing module components, such as sensing, power management, telemetry, and acceleration sensing. Electronic circuit 1610 may include analog circuits, digital circuits, integrated circuits, discrete components, or any combination thereof. In one configuration, the electronic circuit 1610 can be partitioned among integrated circuits and discrete components to minimize power consumption without compromising performance. The ability to distinguish between digital and analog circuits increases design flexibility and promotes minimum power consumption without sacrificing functionality or performance. Thus, the electronic circuit 1610 may include, for example, one or more integrated circuits or ASICs specific to the core signal processing algorithm.

  In another configuration, the electronic circuit 1610 may include a controller, such as a programmable processor, a digital signal processor (DSP), a microcontroller, or a microprocessor with associated storage and logic. The controller may use computing techniques with associated storage devices such as Flash, ROM, RAM, SRAM, DRAM or other similar techniques for controlling the operation of the above components of the sensing module. In one configuration, the storage device may store one or more instruction sets (eg, software) that use any one or more of the methods or functions described herein. The instructions may also reside in other memory and / or processors completely or at least partially during execution of instructions by another processor or computer system.

  The electronics assembly also supports testability and calibration features that ensure the quality, accuracy, and reliability of the completed wireless sensing module or device. Temporary bidirectional coupling can be used to ensure a high level of electrical observability and controllability of the electronics. The test interconnect also provides a high level of electrical observability of the sensing subsystem including transducers, waveguides, and mechanical springs or elastic assemblies. The carrier or fixture emulates the final enclosure of the finished wireless sensing module or device during the manufacturing process, thereby calibrating the calibrated parameters of the finished wireless sensing module or device. Allows accurate calibration data to be captured. These calibration parameters are stored in an on-board memory that is integrated into the electronics assembly.

  Applications for electronic assemblies including sensor 1602 and electronic circuit 1610 include, but are not limited to, disposable modules or devices and available modules or devices and re-modules or devices for long-term use. In addition to non-medical applications, examples of a wide range of potential medical applications include, but are not limited to, implantable devices, modules within implantable devices, intraoperative implants, or modules within intraoperative implants or test inserts. A module in an inserted or captured device, a module in a wearable device, a module in a handheld device, a module in an instrument, appliance, equipment, or all of these accessories, or an implant, a test insert, Examples include inserted or incorporated devices, wearable devices, handheld devices, equipment, appliances, consumables in equipment, or accessories for these devices, equipment, appliances, or equipment.

  FIG. 17 is a diagram of an example communication system 1700 for near field telemetry, according to an example embodiment. As shown, the communication system 1700 includes a receiving system communication in a remote system based on a medical device communication component 1710 in a spinal instrument and a processor. In one embodiment, the receiving remote system communication is in or coupled to a computer or laptop computer that can be viewed by the surgical team during the procedure. The remote system may be outside the operating room sterilization field, but is within the range that is visible for real time evaluation of the measured quantitative data. The medical device communication component 1710 includes, but is not limited to, an antenna 1712, a matching network 1714, a telemetry transceiver 1716, a CRC circuit 1718, a data packetizer 1722, a data input 1724, a power supply 1726, and a specific Operatively coupled to include an application specific integrated circuit (ASIC) 1720. The medical device communication component 1710 may include more or fewer components than illustrated, but is not limited to what is illustrated or the order of the components.

  The receiving station communication component 1750 includes an antenna 1752, a matching network 1754, a telemetry receiver 1756, a CRC circuit 1758, a data packetizer 1760, and optionally a USB interface 1762. In particular, other interface systems can be directly coupled to the data packetizer 1760 to process and render sensor data.

  Referring to FIG. 16, the electronic circuit 1610 is operably coupled to one or more sensors 602 of the spinal instrument 400. In one embodiment, data generated by one or more sensors 602 can be converted into measured parameters of the musculoskeletal system, mems structures, piezoresistive sensors, strain gauges, mechanical sensors, pulsed continuous waves Or voltage, current, frequency, or count values from other sensor types. Referring back to FIG. 17, the data packetizer 1722 collects sensor data into packets that include sensor information received or processed by the ASIC 1720. The ASIC 1720 may include specific modules for efficiently performing the core signal processing functions of the medical device communication component 1710. The ASIC 1720 further provides the advantage of reducing the form factor of the instrument.

  The CRC circuit 1718 applies error code detection in the packet data. Cyclic redundancy check is based on an algorithm that calculates a checksum of a data stream or packet of any length. These checksums can be used to detect interference or accidental alteration of data being transmitted. Cyclic redundancy check is particularly good at detecting errors caused by electrical noise, thus allowing for robust protection from improper handling of corrupted data in environments with high levels of electromagnetic activity To do. Telemetry transmitter 1716 then transmits a CRC encoded data packet via matching network 1714 via antenna 1712. Matching networks 1714 and 1754 provide impedance matching for optimal communication power efficiency.

  Receive system communication component 1750 receives transmissions sent by spinal instrument communication component 1710. In one embodiment, telemetry transmitter 1716 is operated with a dedicated telemetry receiver 1756 that is constrained to receive data stream communications at a specified frequency in a specified emission mode. A telemetry receiver 1756 by the receiving station antenna 1752 detects incoming transmissions at a specified frequency. The antenna 1752 may be a directional antenna that is directed to the directional antenna of the component 1710. Using at least one directional antenna can reduce data corruption while improving data security by further restricting the data to be in a radiation pattern. Matching network 1754 couples to antenna 1752 to provide impedance matching that efficiently transmits signals from antenna 1752 to telemetry receiver 1756. Telemetry receiver 1756 may reduce the carrier frequency in one or more steps and strip off information or data sent by component 1710. Telemetry receiver 1756 is coupled to CRC circuit 1758. CRC circuit 1758 verifies the cyclic redundancy checksum of individual packets of data. CRC circuit 1758 is coupled to data packetizer 1760. The data packetizer 1760 processes individual packet data. In general, data identified by CRC circuit 1758 is decoded (eg, decompressed) and sent to an external data processing device, such as an external computer, for later processing, display, or storage or some combination thereof. Transferred.

  Telemetry receiver 1756 is designed and configured to operate with very low power, such as, but not limited to, powered USB port 1762 or power obtained from a battery. In another embodiment, the telemetry receiver 1756 is designed for use with minimal controllable functions to limit the chance of inadvertent corruption or malicious tampering with the received data. Telemetry receiver 1756 can be designed and configured to be small, inexpensive, and easily manufactured in a standard manufacturing process while ensuring a consistently high level of quality and reliability.

  In one form, the communication system 1700 operates in a transmission-only operation with a communication range on the order of a few meters to provide high security and protection from any form of fraudulent or unexpected query. The transmission range may be controlled by transmitted signal strength, antenna selection, or a combination of both. High repetition rate transmission can be used with Cyclic Redundancy Check (CRC) bits embedded in transmitted data packets during data acquisition operations, thereby operating or static physical systems Including, but not limited to, measurements of loads, forces, pressures, displacements, flexures, postures, and positions within the receiving system without substantially affecting the integrity of the data display or data visual display. It becomes possible to discard damaged data.

  By limiting the operating range to a distance on the order of a few meters, the telemetry transmitter 1716 allows very low power in a suitable emission mode or mode for a given operating frequency without compromising the data transmission repetition rate. Can be operated on. This mode of operation also supports operation with small antennas such as integrated loop antennas. The combination of low power and small antennas allows the construction of very small telemetry transmitters that can be used for a wide range of non-medical and medical applications, including but not limited to:

  Transmitter security as well as transmitted data integrity is ensured by operating the telemetry system within predetermined conditions. Because it is operated in a transmit-only mode, the transmitter security is not compromised and there is no path to enter the medical device communication component. Data integrity is ensured by the use of CRC algorithms and measurement repetition rates. The risk of unauthorized reception of data is minimized by the limited communication range of the device. There are certain countermeasures that further inhibit data access even if unauthorized reception of data packets should occur. The first means is that the transmitted data packet contains only binary bits from the counter along with the CRC bits. The second measure is that no data is available or needed to interpret the significance of binary communication at any point in time. A third means that may be implemented is that patient or device identification data is not communicated at any time.

  Telemetry transmitter 1716 may also operate in accordance with some FCC regulations. According to section 18.301 of the FCC regulations, the USA domestic ISM bands are 6.78, 13.56, 27.12, 30.68, 915, 2450, and 5800 MHz and 24.125, 61.25, 122. .50, and 245 GHz. Globally, other ISM bands, including 433 MHz, are defined by the International Telecommunications Union in some geographic locations. The list of forbidden frequency bands defined in 18.303 is as follows, and the following safe search and rescue frequency bands (safety, search and rescue frequency bands) are prohibited. That is, 490 to 510 kHz, 2170 to 2194 kHz, 8354 to 8374 kHz, 121.4 to 121.6 MHz, 156.7 to 156.9 MHz, and 242.8 to 243.2 MHz. Section 18.305 specifies the field strengths and emission levels that an ISM facility must not exceed when operated outside the specified ISM band. In summary, if the limits on field strength and emission levels specified in section 18.305 are maintained by design or by active control, within the ISM band and in most other frequency bands above 9 KHz, It can be concluded that ISM equipment can be operated worldwide. Alternatively, commercial ISM transceivers, including commercial integrated circuit ISM transceivers, can be designed to meet these field strength and emission level requirements when used properly.

  In one form, the telemetry transmitter 1716 can also operate in an unauthorized ISM band or in unauthorized operation of a low power facility, where the ISM facility (eg, telemetry transmitter 1716) is FCC coded. Except as indicated in section 18.303, it may be operated at ANY frequencies above 9 kHz.

  Wireless operation causes a wireless sensing module or device due to the possibility of physical interference with wiring and cables that couple with power or data collection, storage, or display equipment, or limitations imposed by such wiring and cables There is no measurement distortion, or restrictions on such measurement. Power for sensing components and electronic circuits is maintained within a wireless sensing module or device in the internal energy storage device. The energy storage device includes one or more batteries, supercapacitors, capacitors, alternating current power supplies, radio frequency receivers, electromagnetic induction coils, one or more photovoltaic cells, one or more thermocouples, or one or It is charged using an external power source including, but not limited to, a plurality of ultrasonic transducers. The wireless sensing module can be operated with a single charge until there is no internal energy source, or the energy source can be periodically recharged to allow continuous operation. The built-in power supply minimizes the additional energy radiation sources required to power the wireless sensing module or device during the measurement operation. Telemetry functions are also integrated within the wireless sensing module or device. The telemetry transmitter communicates measurement data continuously in real time after being started. Telemetry data can be received and decoded using a commercial receiver or using a simple, low cost custom receiver.

  FIG. 18 shows a communication network 1800 for measurement and reporting, according to an example embodiment. Briefly, communication network 1800 extends spinal alignment system 100, spinal instrument 400, and insertion instrument 420 to provide a broad data connection to other devices or services. As shown, spinal alignment system 100, spinal instrument 400, and insertion instrument 420 may be communicatively coupled to communication network 1800 and any associated system or service.

  By way of example, spinal alignment system 100, spinal instrument 400, and insertion instrument 420 may be used to analyze and report on their parameters (eg, load, force, Pressure, displacement, movement, rotation, torque and acceleration distribution) may be shared with the remote service or provider. If the sensor system is permanently implanted, data from the sensor can be shared with the service manager, for example, for surgical planning purposes or effectiveness studies, for example, to monitor progress, or for surgical planning purposes. Communication network 1800 may be further coupled to an Electronic Medical Record (EMR) system for performing medical information technology implementations. In other embodiments, the communication network 1800 includes HIS (Hospital Information System), HIT (Hospital Information Technology), and HIM (Hospital Information Management), EMT. Health Record (Electronic Health Record), CPOE (Computerized Physician Order Entry), and CDSS (Computerized Decision Support System). This provides the ability for various information technology systems and software applications to exchange data accurately and effectively and consistently and to communicate using the exchanged data.

  The communication network 1800 includes a local area network (LAN) 1801, a wireless local area network (WLAN) 1805, a cellular network 1814, and / or other radio frequency (RF) systems. A wired or wireless connection can be provided on top. LAN 1801 and WLAN 1805 may be communicatively coupled to the Internet 1820 via, for example, a central office. The central office may accommodate a shared network switching facility for providing telecommunications services. Telecommunication services include conventional POTS (Plain Old Telephone Service) and cable, HDTV, DSL, VoIP (Voice over Internet Protocol), IPTV (Internet Protocol Television). Television)), broadband services such as Internet services, and the like.

  Communication network 1800 may support circuit-switched and / or packet-switched communications using common computing and communication techniques. Each of the standards for Internet 1820 and other packet-switched network transmissions (eg, TCP / IP, UDP / IP, HTML, HTTP, RTP, MMS, SMS) represent examples of the prior art. Such standards are periodically replaced by faster or more efficient equivalents having substantially the same function. Thus, alternative standards and protocols having the same functionality are considered equivalent.

  The cellular network 1814 provides several access such as GSM®-GPRS, EDGE, CDMA, UMTS, WiMAX, 2G, 3G, WAP, software defined radio (SDR), and other known technologies. Technology can support voice and data services. The cellular network 1814 may be coupled to the base receiver 1810 under a frequency reuse plan for communicating using the mobile device 1802.

  Base receiver 1810 may in turn connect portable device 1802 to the Internet 1820 over a packet-switched link. Internet 1820 may support application services and service layers for distributing data from spinal alignment system 100, spinal instrument 400, and insertion instrument 420 to portable device 502. The portable device 1802 can also be connected to other communication devices via the Internet 1820 using a wireless communication channel.

  The portable device 1802 can also be connected to the Internet 1820 over the WLAN 1805. A Wireless Local Access Network (WLAN) provides wireless access within a local geographic area. A WLAN is typically composed of a collection of Access Points (APs) 1804, also known as base stations. The spinal alignment system 100, spinal instrument 400, and insertion instrument 420 can communicate with other WLAN stations such as a laptop 1803 in the base station area. In a typical WLAN implementation, the physical layer uses various technologies such as 802.11b or 802.11g WLAN technology. The physical layer uses infrared frequency hopping spread spectrum in 2.4 GHz band, direct sequence spread spectrum in 2.4 GHz band, or, for example, 5.8 GHz ISM band or higher ISM band Other access technologies may be used (eg, 24 GHz, etc.).

  Communication network 1800 may allow spinal alignment system 100, spinal instrument 400, and insertion instrument 420 to establish a connection with remote server 1830 and other portable devices to exchange data over the network. Remote server 1830 may have access to database 1840, which may be stored locally or remotely and may include application specific data. The remote server 1830 can also host application services directly or over the Internet 1820.

  FIG. 19 illustrates an exemplary schematic diagram of a machine in the form of a computer system 1900 in which, when an instruction set is executed, causes the machine to perform any one or more of the methods described above. obtain. In certain embodiments, the machine operates as a stand-alone device. In certain embodiments, the machine may be connected to other machines (eg, using a network). In a networked deployment, the machine may operate as a server or client user machine in a server client user network environment, or as a peer machine in a peer-to-peer (or distributed) network environment.

  This machine defines server computers, client user computers, personal computers (PCs), tablet PCs, laptop computers, desktop computers, control systems, network routers, switches or bridges, or actions to be taken by appropriate machines (sequentially). Or any other form of machine capable of executing the instruction set. It will be appreciated that the devices of the present disclosure include a wide variety of electronic devices that provide voice, video or data communications. Further, although a single machine is shown, the term “machine” also performs any one or more of the methods described herein. It should be construed to include any set of machines that execute the set (or sets) of instructions individually or collectively.

  Computer system 1900 communicates with each other via a bus 1908, such as a processor 1902 (eg, a central processing unit (CPU), a graphics processing unit (GPU, or both)), main memory, and the like. 1904 and static memory 1906. The computer system 1900 may further include a video display device 1910 (eg, a liquid crystal display (LCD), flat panel, solid state display, or cathode ray tube (CRT)). The system 1900 includes an input device 1912 (eg, a keyboard), a cursor control device 1914. For example, a mouse), a disk drive unit 1916, a signal generation device 1918 (e.g., may include a speaker or remote control) and a network interface device 1920.

  The disk drive unit 1916 stores one or more instruction sets (eg, software 1924) that use any one or more of the methods or functions described herein, including the methods shown above. A machine-readable medium 1922 may be included. Instruction 1924 may also reside in main memory 1904, static memory 1906, and / or processor 1902, either completely or at least partially during execution of instructions by computer system 1900. Main memory 1904 and processor 1902 may also be machine-readable media.

  Dedicated hardware implementations, including but not limited to application specific integrated circuits, programmable logic arrays, and other hardware devices, may be similarly configured to perform the methods described herein. Applications that may include the devices and systems of a wide variety of embodiments include various electronic and computer systems. Some embodiments employ two or more specific interconnected hardware modules or with associated control and data signals that are communicated between modules and via modules or as part of an application specific integrated circuit. Perform the function on the device. Here, the example system is applicable to software, firmware, and hardware implementations.

  According to various embodiments of the present disclosure, the methods described herein are directed to operation as a processor, digital signal processor, or software program running on a logic circuit. Further, software implementations include, but are not limited to, distributed processing or component / object distributed processing, parallel processing, or virtual machine processing so as to implement the methods described herein. Can be configured.

  The disclosure includes instructions 1924 such that a device connected to the network environment 1926 can use the instructions 1924 to transmit or receive audio, video or data and communicate over the network 1926; Or, assume a machine-readable medium that receives and executes instructions 1924 from a propagated signal. The instructions 1924 may be further transmitted or received over the network 1926 via the network interface device 1920.

  Although the machine-readable medium 1922 is shown to be a single medium in the example embodiments, the term “machine-readable medium” refers to a single medium or multiple media (one or more) that stores one or more instruction sets ( For example, it should be understood to include centralized or distributed databases and / or associated caches and servers. The term “machine-readable medium” can store, encode, or implement a set of instructions for execution by a machine that causes the machine to perform any one or more of the disclosed methods. It should also be understood to include any arbitrary medium.

  Thus, the term “machine-readable medium” includes, but is not limited to, a memory card that contains one or more read-only (non-volatile) memory, random access memory, or other rewritable (volatile) memory. It should be understood to include solid state memory such as or other packages, magneto-optical or optical media such as disks or tapes, and carrier wave signals such as signals that implement computer instructions in a transmission medium and / or electronic Attachment of digital files to mail or other built-in information archives or series of archives is considered a distribution medium equivalent to a tangible storage medium. Accordingly, this disclosure includes any one or more of the machine-readable media or distribution media listed herein and is equivalent in the art to which the software implementations herein are stored. Material and successor media.

  Although this specification describes components and functions implemented in the embodiments with reference to specific standards and protocols, the present disclosure is not limited to such standards and protocols. Each of the standards for Internet and other packet-switched network transmissions (eg, TCP / IP, UDP / IP, HTML, HTTP) represent examples of the prior art. Such standards are periodically replaced by faster or more efficient equivalents having substantially the same function. Thus, alternative standards and protocols having the same functionality are considered equivalent.

  The descriptions of the embodiments described herein are intended to provide a general understanding of the structures of the various embodiments, and are illustrative of devices and systems that can use the structures described herein. It is not intended to serve as a complete description of all elements and features. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. Other embodiments may be used and obtained from it so that structural and logical substitutions and changes can be made without departing from the scope of the present disclosure. Also, the figures are for illustration only and may not be drawn to scale. That particular ratio can be exaggerated, while other ratios can be minimized. The specification and drawings are, accordingly, to be regarded in an illustrative sense rather than a restrictive sense.

  Such embodiments of the present inventive subject matter merely limit the scope of this application to any one invention or inventive concept, merely for convenience and when more than one invention is actually disclosed. May be referred to individually and / or collectively by the term “invention” herein. Here, although specific embodiments are shown and described herein, it is understood that any configuration calculated to achieve the same purpose may be substituted for the specific embodiments shown. I want to be. This disclosure is intended to cover any adaptations or variations of various embodiments. Combinations of the above embodiments with other embodiments not specifically described herein will be apparent to those of skill in the art upon review of the above description.

Some embodiments include a spinal measurement system. The spine measurement system may include a receiver, one or more wands, and a load sensor configured to evaluate intervertebral forces between vertebrae. One or more wands may be configured to communicate with a receiver to determine location information. On the other hand, the positional information may include at least one of orientation, rotation, angle, or location of at least one vertebra of the vertebra. Further, the receiver can be configured to communicate with a remote system.

Some embodiments include a load balancing and position measurement system. The load balance and position measurement system may include a spinal alignment system configured to use ultrasound signals to measure position in three-dimensional space. Further, the load balance and position measurement system may include a spinal instrument that includes a sensored head configured to measure a load on the sensored head when the sensored head is located in the spinal region. Still further, the load balancing and positioning system may include a remote system configured to communicate with the spinal alignment system and spinal instrument and display quantitative measurements from the spinal alignment system and spinal instrument.

Certain embodiments include a method of placing a component in a muscular / skeletal system. The method includes a step of inserting a sensor-equipped head into the muscle / skeletal system, a step of measuring a sensor head load applied to the sensor-equipped head by the muscle / skeletal system, and a step of inserting the sensor-equipped head into the muscle / skeletal system. , Measuring at least one of orientation, rotation, angle, or position of the sensor-equipped head, and using at least one of orientation, rotation, angle, or position, And inserting the component into the muscle / skeletal system such that the component load applied to the component by the muscle / skeletal system is approximately equal to the head load with sensor.

Certain embodiments include a method of distracting a spinal region. The method includes inserting a spinal instrument at the spinal region, extending the spinal region to a first height while the spinal device remains in the spinal region, and the spinal region at the first height. And measuring a first load measurement of a first load applied to the spinal instrument by the spinal region, wherein the first load measurement is outside a predetermined load range; Extending the spinal region to a second height while the device remains in the spinal region; and a second load applied by the spinal region to the spinal device while the spinal region remains at the second height. Measuring the second load measurement, wherein the second load measurement is within a predetermined load range.

Certain embodiments include a method of distracting a spinal region. The method includes inserting a spinal instrument in the spinal region to distract the spinal region, and a first load applied by the spinal region to the spinal device when the spinal region is extended to a first height. Measuring a first load measurement value of the first load measurement value, a step of indicating that the first load measurement value is outside a predetermined load range, and a second load applied to the spinal instrument by the spine region. Adjusting the spinal instrument so that the second load measurement is extended to a second height that is within a predetermined load range.

Some embodiments include placing the receiver in proximity to the one or more wands such that the receiver is in a fixed position and within the line of sight of the one or more wands; Aligning one or more anatomical features with one or more wand sacral wands, and a 3D spine model having an orientation and dimensions corresponding to the one or more anatomical features of the sacrum Extracting and identifying at least one of the location or location of at least one vertebra of the spine by ultrasound measurement.

Claims (40)

A receiver,
Multiple wands,
A spine measurement system comprising: a load sensor for evaluating intervertebral force;
The plurality of wands communicate with the receiver to determine position information including at least one of vertebral orientation, rotation, angle, and location related to the intervertebral force determined therebetween.
A system characterized by that.   The receiver includes one or more sensors, a processor, and an interface, the processor interprets sensory signals from the at least one wand received via the one or more sensors, and The system of claim 1, wherein the location information is transmitted to a remote system for display.   Each of the plurality of wands includes a controller operably coupled to the one or more sensors, the one or more sensors transmitting sensory signals in response to instructions from the controller. The system according to claim 1 or 2.   The one or more sensors and the plurality of wands of the receiver are selected from the group comprising optical sensors, ultrasonic sensors, and magnetic sensors. The described system.   The system according to claim 1, wherein the load sensor is coupled to a sensor-equipped head. A shaft with the sensored head coupled to the distal end;
A handle coupled to the proximal end of the shaft;
The system of claim 5 further comprising:   The electronic circuit further includes an electronic circuit housed toward the proximal end of the shaft, the electronic circuit including a logic circuit, an accelerometer, and a communication circuit, the electronic circuit being operably coupled to the load sensor. The system according to claim 6.   8. The system according to claim 6, wherein the sensor-equipped head includes a plurality of load sensors for specifying a position of a load applied to the sensor-equipped head.   9. The system of any one of claims 6-8, wherein the wand is coupled to the sensored head for measuring at least one of orientation, rotation, angle, or location. .   10. Data from the receiver, the plurality of wands, and the load sensor are wirelessly transmitted to a remote system to display quantitative measurements therefrom. The system described in the section.   11. The system according to any one of claims 1 to 10, wherein one of the receiver, the plurality of wands, and the load sensor is discarded after use. A spinal alignment system using ultrasound signals to measure position in three-dimensional space;
A spinal instrument having a sensor-equipped head for measuring a load when the sensor-equipped head is inserted into a spinal region;
A remote system for communicating with the spinal alignment system and the spinal instrument and displaying quantitative measurements therefrom;
A load balance and position measurement system comprising:   The load balance and position measurement system of claim 12, wherein the spinal alignment system and the spinal instrument are within an operating field of an operating room.   14. A load balancing and positioning system according to claim 12 or 13, wherein the spinal alignment system or the spinal instrument is discarded after use. The alignment system includes:
A receiver having a plurality of ultrasonic transducers;
A plurality of wands having a plurality of ultrasonic transducers;
15. The load balancing and position measuring system according to any one of claims 12 to 14, characterized by comprising: The spinal instrument is:
A shaft coupled to the sensored head, wherein the sensored head is coupled to a distal end of the shaft;
A handle at the proximal end of the shaft;
An electronic circuit housed toward a proximal end of the shaft, the electronic circuit including a logic circuit, an accelerometer, and a communication circuit, and operably coupled to the load sensor;
The load balance and position measurement system according to any one of claims 12 to 15, characterized in that In the method of installing the components in the muscular / skeletal system,
Inserting a sensor-equipped head into the muscular / skeletal system;
Measuring a load applied to the sensor-equipped head by the muscular / skeletal system;
Measuring at least one of orientation, rotation, angle, and position of the sensor-equipped head inserted into the musculoskeletal system;
Aligning the component with the musculoskeletal system using the measured at least one orientation, rotation, angle, or position;
Inserting the component into the musculoskeletal system such that the load on the component is approximately equal to the measured load;
A method comprising the steps of:   The method of claim 17, further comprising measuring a position of the load applied to the sensored head. Displaying the load from the sensor-equipped head and load position data in real time on a remote system;
Displaying the at least one orientation, rotation, angle, or position measured in real time on the remote system;
The method according to claim 17 or 18, further comprising:   20. The method according to any one of claims 17 to 19, further comprising the step of discarding at least the sensored head after a procedure. In a method of distracting the spinal region,
Inserting a spinal instrument to distract the spinal region;
Measuring a load applied to the spinal instrument by the spinal region, wherein if the load measurement is outside a predetermined load range, the spinal region is distracted to a first height;
Distracting the spinal region to a second height;
Measuring the load applied to the spinal instrument by the spinal region at the second height if the load is within the predetermined load range;
A method comprising the steps of:   The method of claim 21, further comprising measuring at least one of orientation, rotation, angle, or position of the spinal instrument. Monitoring a load measured by the spinal instrument in a remote system;
Adjusting the height of the spinal instrument coupled to the spinal region to increase or decrease distraction of the spinal instrument until the measured load is within the predetermined load range;
The method according to claim 21 or 22, further comprising:   24. The method of claim 23, wherein adjusting the height includes increasing or decreasing a distraction height corresponding to the height of a brace component. Measuring the position of a load applied to the spinal instrument by the spinal region;
Moving the spinal instrument to a different location when a position of a load applied to the spinal instrument by the spinal region is outside a predetermined position range;
25. The method according to any one of claims 21 to 24, further comprising:   26. The method of claim 25, further comprising identifying a location in the spinal region for the brace component that is within the predetermined load range and the predetermined position range.   27. The method of claim 26, further comprising installing the brace component at the location in the spinal region. Comparing the trajectory of the brace component with the trajectory of the spinal instrument;
Viewing the trajectory of the brace component and the spinal instrument in the remote system such that the brace component is installed at the location in the spinal region along a trajectory similar to the spinal instrument; ,
28. The method of claim 26 or 27, further comprising:   29. The method of any one of claims 21 to 28, further comprising rotating a handle of the spinal instrument to change distraction height.   30. The method of any one of claims 21 to 29, further comprising the step of indicating by visual, audio or tactile means when the load applied to the spinal instrument by the spinal region is within the predetermined load range. The method according to one item. In a method of distracting the spinal region,
Inserting a spinal instrument to distract the spinal region;
Measuring the load applied to the spinal instrument by the spinal region when the spinal region is extended to a first height;
Indicating that the measured load is outside a predetermined load range;
Adjusting the spinal instrument to extend the spinal region to the second height if the load measurement at a second height is within the predetermined load range; and
A method comprising the steps of:   32. The method of claim 31, further comprising the step of measuring at least one of orientation, rotation, angle, or position of a sensor-equipped head in the musculoskeletal system. Measuring the position of a load applied to the spinal instrument by the spinal region;
Moving the spinal instrument to a different location when the position of a load applied to the spinal instrument by the spinal region is outside a predetermined position range; and
The method according to claim 31 or 32, further comprising:   34. The method of any one of claims 31 to 33, further comprising identifying a location in the spinal region for a brace component that is within the predetermined load range and the predetermined position range. .   35. The method of claim 34, further comprising installing the brace component at the location in the spinal region. Comparing the trajectory of the brace component with the trajectory of the spinal instrument;
Viewing the trajectory of the brace component and spinal instrument in a remote system such that the brace component is installed at the location in the spinal region along a trajectory similar to the spinal instrument;
36. The method of claim 34 or 35, further comprising: In a method for tracking the alignment and orientation of a spinal region,
Installing a receiver in proximity to a plurality of wands, wherein the receiver is in a fixed position and within a line of sight of the plurality of wands;
Aligning one or more anatomical features of the sacrum with the wand;
Retrieving a 3D spine model having an orientation and dimensions corresponding to the registered anatomical features;
Identifying at least one position or location of one or more vertebrae, wherein the location measurement is determined by ultrasound;
A method comprising the steps of:   38. The method of claim 37, further comprising attaching the wands of the plurality of wands to different vertebrae of the spine. Aligning one or more anatomical features of the vertebra with the wand;
Attaching the wand to the vertebrae;
Repeating the alignment and the attachment for different vertebrae using the plurality of wands;
Retrieving a 3D vertebra model having an orientation and dimensions corresponding to the aligned anatomical features of each vertebra;
40. The method of claim 37 or 38, further comprising:   Inserting a sensor-equipped head of the measuring device between the vertebrae of the spine and measuring a load thereon, wherein one of orientation, rotation, angle, and position data is applied to the vertebra 40. The method according to any one of claims 37 to 39, wherein the method is generated corresponding to the sensor-equipped head.

Images