KR20140077183A - System and method for vertebral load and location sensing - Google Patents

Abstract

 A load balancing and alignment system is provided to evaluate the load force on the vertebrae bone with total spinal alignment. The system includes an electronic assembly and a spinal instrument with a sensorized head. The sensorized head is inserted between the vertebrae to indicate the state of the spine, such as force, pressure, direction and edge load. At the same time, a GUI is provided to show where the spinal instrument is located corresponding to the vertebral body, which is located in the space between the vertebrae. The system can provide optimal prosthesis size and placement in terms of positional parameters and sensed load including optimal orientation, rotation and insertion angle along the determined insertion trajectory.

Description

FIELD OF THE INVENTION [0001] The present invention relates to a system and method for detecting spinal load and position,

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

The vertebrae consist of many individual bones, called vertebrae, which are joined together by muscles and ligaments. Because the vertebra is separated, the vertebrae are flexible and can bend. Together with the vertebral, disk, nerve, and muscle, ligaments constitute the vertebral column or spine. Spine changes in size and shape due to changes in environmental factors, health, and aging. A healthy vertebra has an anteroposterior curve, but malformations from normal cervical vertebrae, thoracic kyphosis, and lumbar vertebrae can cause pain, discomfort, and difficulty. This condition can be exacerbated by herniated discs and can cause nerve damage.

There are various treatment options from the various causes of abnormal spinal curves and from surgery to surgery. The purpose of the surgery is usually a solid fusion at the curve of the spine. Bone union is achieved by adding a bone graft to the spinal surgery and gradually healing the vertebrae and implanted bones to form a solid bone mass. Alternatively, a vertebral cage including a bone graft is usually used to separate and fuse the vertebrae. Bone grafting can come from the bone bank or from the patient's own hip bone. The vertebrae can be practically straightened with metal rods and hooks, wires or screws through instrumentation tools and techniques. Until the fusion has an opportunity to heal, the rod or occasionally the staple or cast is held in place.

Various features of the system are specifically set forth in the following claims. 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 in accordance with one embodiment;
2 illustrates a user interface and a projection view illustrating a spinal alignment according to one embodiment;
3 illustrates a wand and receiver of a spinal alignment system, according to one embodiment;
Figure 4 illustrates a multiple sensored device for measuring spinal alignment, in accordance with one embodiment;
Figure 5 illustrates a sensored arrangement for measuring spinal parameters, according to one embodiment;
Figure 6 illustrates the location of various sensors for measuring spinal conditions, according to one embodiment;
Figure 7 illustrates a sensorized spinal instrument, according to one embodiment;
Figure 8 illustrates an integrated sensorized vertebral instrument, according to one embodiment;
Figure 9 shows a non-limiting example as an insert mechanism with spine components;
10 illustrates a spinal instrument positioned between the vertebrae for parameter sensing, according to one embodiment;
Figure 11 illustrates a user interface illustrating a perspective view of the sensorized vertebral instrument of Figure 10, in accordance with one embodiment;
Figure 12 illustrates a sensorized spinal instrument positioned between vertebrae and sensing an intervertebral position and load, according to one embodiment;
Figure 13 shows a perspective view of a user interface representing the sensorized spinal instrument of Figure 12, in accordance with one embodiment;
Figure 14 illustrates a sensored vertebra insert mechanism for placement of a vertebrae cage, according to one embodiment;
Figure 15 shows a perspective view of a user interface showing the sensored vertebra insert mechanism of Figure 14, in accordance with one embodiment;
16 is a block diagram of the components of a spinal instrument according to an exemplary embodiment;
17 is a diagram of an exemplary communication system for short range telemetry in accordance with an exemplary embodiment;
18 shows a communication network for measurement and reporting in accordance with an exemplary embodiment;
19 illustrates an exemplary schematic diagram of a machine, when executed, in the form of a computer system in which a set of instructions can cause the machine to perform one or more of the methods described herein.

While the specification concludes with claims defining the features of embodiments of the invention that are regarded as novel, it is to be understood that the method, system and other embodiments are better understood when taken in conjunction with the following description, It is believed to be understood.

As required, detailed embodiments of the method and system of the present invention are disclosed herein. However, it should be understood that the disclosed embodiments, which may be embodied in various forms, are illustrative only. Accordingly, the specific structures and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching those skilled in the art the use of the embodiments of the present invention in variously nearly all suitable detailed structures as a basis for the claims Should be interpreted. In addition, the terms and phrases used herein are not intended to be limiting, but rather to provide an understandable description of the practice of the invention.

In general, embodiments of the present invention are directed to systems and methods for sensing spinal loads and positions. The spinal measurement system consists of a receiver and a plurality of wands connected to a remote display that visually displays position information. The wand is placed on the vertebra bone or contacts the vertebra bone to reveal various aspects of the spinal alignment. The position information identifies the orientation and position of the wrist and corresponding spine bones. The system provides the ability to track spinal motion in addition to total alignment during surgical operations. The system can propose and display the chiropractic items during surgery corresponding to the position information obtained during the surgical procedure and the pre-recorded position data related to the spinal condition prior to surgery.

The spinal measurement system also includes a load balancing and alignment system that evaluates the force of the load on the vertebrae with the overall spinal alignment. The system includes an electronic assembly and a spinal instrument having a sensorized head assembly that can clearly be in the spinal space. This sensorized head is inserted between the vertebrae to indicate the state of the spine, such as force, pressure, bearing, and edge load. The GUI used with the sensorized head indicates where the spinal instrument is positioned relative to the vertebral body when the spinal instrument is placed in the space between the vertebrae during the surgical procedure. The system can report the size and placement of the optimal prosthesis in terms of position parameters, including selective alignment, rotation, and angle of insertion along the sensed load and insert determined trajectory.

An insert mechanism having a load balance and alignment system for inserting a vertebra component such as a spinal cage or pedicle screw is also provided herein. From the perspective of previously acquired parameter measurements, the system can be checked and can report whether the instrument is an edge load during insertion. This illustrates the tracking of the insert mechanism with the vertebral component and provides visual guidance and feedback based on position and load sensing parameters. The system shows three dimensional (3D) tracking of the insert mechanism in relation to one or more vertebrae whose alignment and position are also modeled in 3D.

FIG. 1 illustrates a spinal alignment system 100 in a non-limiting embodiment. The system 100 is comprised of a wand 103 and a receiver 101 communicatively coupled to the remote system 105. Typically, one or more wands communicate with the receiver 101 to measure positional information, including orientation, rotation, angle, and location, for the vertebral region. The receiver 101 transmits position information or data 107 about the rod member 103 to the remote system 105. The location information includes orientation and translation data used to evaluate alignment (or a predetermined curvature) of the vertebrae 112. The remote system 105 is a portable or mobile workstation that provides a graphical user interface (GUI) 107. The GUI 107 represents the spine 112 and includes a workflow that informs the spine alignment in terms of location information. As an example, the user interface shows the current state of the vertebral bone orientation 114 relative to the post-operative goal orientation state 113. [

The alignment system 100 includes a database 123 such as a server 125 that provides three-dimensional (3D) images (e.g., soft tissue) and 3D models (e.g., bones) Lt; RTI ID = 0.0 > system. 3D images and models can be used with position information to set relative positions and alignments. The server 125 may access the Internet 121 near or remotely nearby. As one example, the server 125 provides a three-dimensional spine and vertebral model. A CAT scanner (not shown) may be used to generate a series of cross-sectional x-ray images of a selected portion of the body. The computer activates the scanner, and the resulting image represents a slice of the human body. The server 125 creates a three-dimensional (3D) model from the slice. The server 125 may also provide a three-dimensional model generated from a magnetic resonance imaging (MRI) scanner (not shown). The server 125 may also support the fluoroscopic image to provide real-time motion pictures of the patient's internal structure to the spinal measurement system 100 through the use of a device X-ray source (not shown) and a fluorescent screen.

The spinal alignment system 100 informs about the overall alignment and the ability to track the motion of an isolated vertebra, in addition to the orientation of the instrument (e.g., wand 103 and receiver 101). The receiver 101 accurately measures the positional information by tracking the position of the wand 103 along with the vertebrae 112 and the vertebrae 112. Receiver 101 is shown connected to the sacrum (e.g., by pinning, screwing, attaching). However, the receiver 101 may be located anywhere alongside the vertebral bones of the vertebrae. Alternatively, the receiver 101 may be mounted to a stand near the vertebrae 112. The wand 103 and the receiver 101 are sensored devices capable of transmitting their positions via an ultrasonic sensor, an optical sensor, or an electromagnetic sensor. In this embodiment, the wand 103 and the receiver 102 utilize an ultrasonic transducer and are a line of sight device. The sensors are mounted on the outside of a rod member that is remote from the end of the rod member, or in some cases, are mounted within the end of the wand. The wand 103 may be gripped by hand or attached to the vertebra via a mechanical assembly. In one embodiment, the components (e.g., receiver 101 and wand 103) for generating all alignment measurements reside within a sterile field 109 of the operating room. The sterile site 109 is also referred to as the surgical site. Usually, the remote system 105 is outside the sterile section 109 of the operating room. The component (109) used in the aseptic area is designed for disposable use. In this embodiment, the wand 103, the receiver 102, or both are discarded after being used during surgery.

An example of an ultrasonic sensor device is filed on March 7, 2007, and is filed in U. S. Patent Application No. 11 / 683,410 entitled " 3D Detection Method and Device ", the entire contents of which are incorporated herein by reference . As an example of an optical sensor, includes three or four active IR reflectors provided on the wand 103 corresponding to a high speed camera member provided on the receiver 101 for tracking light, or alternatively, And a photo-diode member that triangulates the position of the wand. As an example of an electromagnetic sensor, it includes a metallic sphere on the wand, on which the spatial position is measured by evaluating the change in intensity of the generated magnetic field on the receiver 103.

Many physical parameters of a physical system or object of interest within the human body can be measured by evaluating changes in the characteristics of the energy waves or pulses. As an example, a change in the residence time or shape of an energy wave or pulse propagating through the change medium can be measured to determine the force acting on the medium and causing the change. The energy wave of the medium or the propagation speed of the pulse is influenced by the physical change of the medium. Physical parameters or parameters of interest include, but are not limited to, measurements of load, force, pressure, displacement, density, viscosity and local temperature. These parameters may include energy pulses for movement, rotation, or acceleration along an axis, axis, or combination of axes, as well as alignment, alignment, direction or position, by a wireless sensing module located on or within a human body, instrument, Or by measuring the change in the propagation time of the wave. Alternatively, measurements of interest can be taken using film sensors, mechanical sensors, polymer sensors, MEMS devices, strain gauges, piezo resistive structures, and capacitive structures, for example.

FIG. 2 illustrates a graphical user interface (GUI) 150 of the system 100 showing spinal alignment and projection in a non-limiting embodiment. The projection view provides stereoscopic visualization of the surgical procedure and system device of FIG. 1 and displays quantitative measurements in real time. The respective projection views are individually configured to represent the vertebrae from different viewpoints as alignment information of the overlapping vertebrae. The first projective figure 210 represents the sagittal plane (i.e., front and rear). And the second projective figure 230 represents the corrugation (i.e., left and right). Sagittal and coronal views provide sufficient spatial information to visualize the alignment of the spine as only two projections. Projections can be defined with different viewing angles and scene graphs.

As an example, a physician may grasp the wand 103 to track the contours of the spine to measure, for example, the severity (or correction) of a scoliosis condition. This provides the patient with posture and signs of vertebral flexion with the patient standing prior to surgery. The doctor grasps the wand and follows the contours of the spine. The GUI 108 visually represents the spine contour from the position information identified as wand 103 during tracking. Then, an alignment angle is calculated from the first order statistics and shape (e.g., with reference to angle points R, P1, and P2, where R is the reference alignment, P1 is the position of the receiver 101, 103). ≪ / RTI > The alignment angle represents the offset of the spinal alignment and also, when projected on a plan view, a deviation error on the sagittal and coronal planes. The GUI 108 then displays the required compensation calibration. In the current example, it is shown that a displacement of + 4 cm forward is required in the display box 146 to compensate for the sag deflection angle between line 152 and line 154, 156 to the right of the display box 148 so as to correct the coronal deviation angle. This provides the physician with minimal visual information for surgical alignment correction.

Alternatively, a rapid point registration method may be used to evaluate the spinal alignment. The branch registration method allows the physician to quickly evaluate the spinal alignment as a minimum registration. When the user grasps the wand, creates a point curve by clicking on the spine bone and clicking, it is converted to a line. In the first step A, the receiver 101 is placed in a fixed position, for example on a stand near the operating table. Alternatively, the receiver 101 is securely pinned to the sacrum as shown in Fig. In a second step B, the surgeon identifies anatomical features such as three or more posterior iliac crest on the reference bone at the end of the wand 103, or points parallel to the dorsal surface. The system 100 measures the reference bone orientation from the spatial position of the registered wand tip, e.g., in the <x, y, z> orthogonal coordinate system with respect to the receiver 101 origin. The system 100 then retrieves the relevant 3D model spine components (e.g., sacrum, vertebrae, etc.) from the image server 125 and converts it to appropriate magnification and orientation Warping &quot;). Once the registration of the 3D model is complete, while the patient is stationary, the physician registers a spinal column, such as the cervical spine (C1-C7), in a subsequent third step C. The system 100 then has a registration point sufficient to create a local coordinate system for the reference bone, create curves and line segments, and show the overall alignment as shown in FIG. Spinal alignment is seen in terms of the desired curvature or straightness of the vertebra, for example, line 152 for the required line 154 (pre-operative planning).

FIG. 3 illustrates a non-limiting embodiment of wand 103 and receiver 101, although fewer components may be used depending on the functionality required, although not all components are shown. The receiver 101 and the wand 103 and the surgical communication mode therebetween are described in U.S. Patent Application No. 12 / 900,662, filed October 8, 2010, entitled " Navigation Device Providing Sensor Feedback & , The entire contents of which are incorporated herein by reference. In summary, current dimensions allow noncontact tracking with a spatial accuracy of less than 1 millimeter (<1 mm), with an upper limit of approximately 2 meters in distance. These devices may be configured to support various functions (e.g., portable, object-mounted), and are not limited to the numerical values set forth below.

The wand 103 is a portable device having a width of approximately 10 cm and a size dimension of 2 cm deep and has an extension length of 18 cm to 20 cm. As noted above, the wand 103 may register points of interest (see points A, B, C) parallel to, for example, the contour or surface of the object, The wand 103 and the receiver 101 may communicate via ultrasonic, infrared, and electromagnetic sensors to measure the relative position and orientation with respect to each other, as described below. The example provides additional location information.

The wand 103 includes sensors 201-203 and an end 207 of the wand. The sensor may include an ultrasound sensor, a microelectromechanical device (MEMS) microphone, an electromagnet, an optical element (e.g. infrared, laser), a metallic object, or any other device that converts or transports body movements into electrical signals such as voltage or current There is a converter. These are either active elements that transmit their own power signals, or passive elements that exhibit reflective or detectable magnetic properties.

In one embodiment, the wand 103 includes three ultrasonic transmitters 201-203 each of which transmits an ultrasonic signal into the air, and a drive signal to the three ultrasonic transmitters 201-203 to generate an ultrasonic signal A user interface 218 (for example, a button) for performing close-up position measurement and alignment measurement in response to a user's input value, and a controller A communication module 216 for receiving and controlling the electronic circuitry 214 and a battery 218 for supplying power to the electronic circuitry 218 and the associated electronic device on the wand 103. The controller 214 is connected to operate the ultrasonic transmitters 201-203. The transmitter 201-203 transmits a sensor signal in response to an instruction from the controller 214. [ The wand 103 contains more or fewer components than are shown, wherein the functionality of a particular component is shared as an integrated device.

Additional transmitter sensors may be included to provide an over-determined system for stereoscopic sensing. As an example, each ultrasonic transducer can perform a separate transmission / reception function. An example of such an ultrasonic sensor is disclosed in U.S. Patent No. 7,725,288, the entire contents of which are incorporated herein by reference. The ultrasonic sensor can transmit a pulse-shaped waveform according to the physical characteristics of the user-defined transducer to construct and shape the waveform.

The tip 207 of the wand identifies, but is not limited to, a point of interest on a structure, e.g., an assembly, object, instrument, or jig in a three-dimensional space. The end does not require a sensor since its spatial position in the three-dimensional space is established by the three ultrasonic transmitters 201-203 located at the crossing end. However, the end sensor 219 is integrated at the end 207 to provide detection based on ultrasound functionality (e.g., boundary, depth, etc.) or contact. In this case, the end 207 becomes a contact sensor and registers a point that responds to the physical behavior, for example, bringing the end into an anatomical or structural position. The ends may be made of mechanical or actuating spring assemblies for this purpose. In another device, a contact is registered including a capacitive touch tip or an electrostatic assembly. The tip 207 of the wand includes a replaceable detachable or multi-headed stylus tip so that while the transmitter 201-203 remains in the line of sight with the receiver 101 ), It is possible to identify anatomical features by the end of the wand. These stylus tips are either right angled or curved, but are difficult to contact if they have an outer shape that is pierced by a pointed end. Thereby, it becomes possible to identify a point of interest, such as an anatomical feature on the structure, bone or jig, through its end 207 as a hand held wand.

The user interface 218 may include one or more buttons that enable manipulation and use during carry (e.g., an on / off / reset button) and an illumination member that provides visual feedback. In one configuration, an 8-state search pushbutton 209 may send and receive instructions to additionally control or execute a user interface. This button is ergonomically positioned on one side of the wand, allowing one-handed use. The wand 103 also includes a haptic module with a user interface 218. As an example, the sensory module changes the (increase / decrease) frequency and signals for improper or proper operation. The wand 103 includes a material cover for the emitter 201-202 that transmits sound (e.g., ultrasound) and light (e.g., infrared) and does not transmit biological material such as water, blood, . In one device, a transparent plastic film (or mesh) is guided and extends, which vibrates under resonance with a transmission frequency. The battery 218 may be charged via wireless energy charging (e.g., a magnetic induction coil and a supercapacitor).

The wand 103 includes a base attachment device 205 for coupling to a structure, an object, or a jig. As an example, such a device includes a magnetic assembly with a fixed insert (e.g., a square post head) that allows for temporary isolation. As another example, it may be a magnetic ball and a joint socket with a latched increment. As another example, it can be a screw post or pin that fits into an orthopedic screw. Other embodiments are capable of sliding, translating, rotating, angling, and attaching and detaching a locking function and connecting to a standard jig using conventional 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 the tilt of axis 3 and axis 6 during and during operation. The communication module 216 includes components (e.g., a synchronous clock, a radio frequency 'RF' pulse, an infrared 'IR' pulse, and an optical / acoustic pulse) that signals the receiver 101. The controller 214 includes counters, clocks, or other analog or digital logic that controls the transmission and reception of sensor signals, acceleration information, and synchronization and sequencing on the status of the data or components. The battery 218 provides power to each circuit logic and component. The infrared transmitter 209 pulses an infrared timing signal that is synchronized with the transmission of the ultrasonic signal (to the receiver).

Controller 214 may utilize computing technology such as a microprocessor (uP) and / or a digital signal processor (DSP) with associated storage memory 208 such as flash, ROM, RAM, SRAM, DRAM, And controls operation of the components of the apparatus. Further, the instructions may reside completely or at least partially within a processor in which another memory and / or processor is being operated by another processor or computer system. The input / output port enables exchange of portable information or data, for example, using a universal serial bus (USB). The electronics of the controller 214 may comprise one or more application specific integrated circuits or field programmable gate arrays (FPGAs). Controller 214 is an embedded platform running one or more operating system (OS) modules. In one arrangement, the storage memory stores one or more instruction sets (e.g., software) that implement one or more methods or functions described herein.

A receiver 101 is a processor that generates timing information, registers point positions in accordance with user input, and measures near position and alignment from three or more point positions of the wand 103 with respect to the receiver 101. [ (233). The receiver has a width dimension of about 2 cm, a depth of 2 cm, and a size dimension of 10 cm to 20 cm in length. Which includes a communication module 235 for transmitting timing information to the wand 103 in response to the transmission of the first, second and third ultrasound signals. The ultrasound signal may be a pulse-like signal resulting from a combination of amplitude modulation, frequency modulation and phase modulation. Each of the three microphones 221-223 receives the first, second and third pulse shaped signals transmitted via air. The receiver 101 is configured as a linear or more compact device, and may include a triangular shape. An example of a three-dimensional sensor device is filed on Mar. 7, 2007, and is filed in U.S. Patent Application No. 11 / 683,410 entitled " Method and Apparatus for Three-dimensional Sensing ", the entire contents of which are incorporated herein by reference .

The memory 238 may store ultrasound signals and may also generate a record of ultrasound signals or processed signals. Further, the memory can store the end position of the wand, for example, in response to the user registering the position by pressing a button. The wireless communication interface (input / output) 239 wirelessly transmits location information and short-range alignment for three or more point locations to the remote system. The remote system is a computer, a notebook, or a mobile device, and displays location information or sorting information as described above in real time. The battery supplies power to the processor 233 and the associated electronics on the receiver 101. The receiver 101 contains more or fewer components than are shown, wherein the functionality of certain components may be shared or incorporated therein.

Additional ultrasonic sensors may be included to provide a transient determination system for stereoscopic sensing. The ultrasonic sensor may be a MEMS microphone, a receiver, an ultrasonic transmitter, or a combination thereof. As an example, each ultrasonic transducer may perform separate transmission and reception functions. An example of such an ultrasonic sensor is disclosed in U.S. Patent No. 7,414,705, the entire contents of which are incorporated herein by reference. The receiver 101 also includes an attachment mechanism 240 for connection to a bone or jig by a pin 251. As an example, attachment mechanism 240 can be a magnetic assembly with a fixed insert (e.g., a rectangular post head) that allows for temporary isolation. As another example, it can be a magnetic ball and a joint socket with a latch type expander.

The receiving unit 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 pulse shapers, phase detectors, signal compressors, and other digital processor code utilities and packages. The amplifier 232 amplifies the signal-to-noise of the transmitted or received signal. The processor 233 may include analog or digital logic for transmitting and receiving control, synchronization, and sequencing of the controller, counter, clock, and sensor signal, accelerometer information, and other data or component states. Accelerometer 236 identifies the axial tilt during operation and during stop (e.g., axes 3 and 6). The battery 234 supplies power to each circuit logic and components. The receiver includes a photodiode 241 for detecting an infrared signal and setting a transmission time of an ultrasonic signal to enable wand and wireless infrared communication.

The communication module 235 may include components (e.g., a synchronous clock, a radio frequency 'RF' pulse, an infrared 'IR' pulse, an optical / acoustic pulse) for local signaling (to the wand 102) have. It also includes network and data components (e.g., Bluetooth, ZigBee, WiFi, GPSK, FSK, USB, RS232, IR, etc.) for wireless communication with remote devices (e.g., . &Lt; / RTI &gt; It should be noted that although external communication via the network and data components may be considered here, the receiver 101 may include a user interface 237 that enables single operation. As an example, three LED lights 224 are included to indicate the alignment of the end points of three or more wands. The user interface 237 also includes a touch screen or other display with its own GUI showing location information and alignment.

The processor 233 may utilize computing technology such as a microprocessor (uP) and / or a digital signal processor (DSP) with associated storage memory 208 such as flash, ROM, RAM, SRAM, DRAM, And controls operation of the terminal device on the component. Further, the instructions may reside completely or at least partially within the processor in which another memory and / or processor is being operated by another processor or computer system. The input / output port enables exchange of portable information or data, for example, using a universal serial bus (USB). The electronic circuitry of the controller may consist of one or more application specific integrated circuit chips or a field programmable gate array (FPGA) specific to, for example, a core signal processing algorithm or control logic. The processor is an embedded platform running one or more operating system (OS) modules. In one arrangement, the storage memory 238 stores one or more instruction sets (e.g., software) that implement one or more methods or functions described herein.

In the first device, the receiver 101 is connected via a constrained electrical connection (e. G., An electrical wire) to the wand 103. In other words, the communication port of the wand 103 is physically wired to the communication interface of the receiver 101 receiving the timing information. Timing information from receiver 101 refers to when wand 103 transmits and includes optional parameters applied to the pulse shape. The processor 233 on the receiver 101 adopts the timing information in the timing information and sets the propagation time measurement in the case of the ultrasonic signal for the reference time base.

In a second device, the receiver 101 is communicatively coupled to the wand 103 via a wireless signal connection by a wireless I / O 239. The signaling protocol is filed on October 8, 2010, and is filed in U.S. Patent Application No. 12 / 900,662, entitled " Navigation Device That Provides Sensor Feedback ", the entire content of which is incorporated herein by reference . The infrared transmitter 209 on the wand 103 transmits infrared timing signals each having a pulp-shaped signal transmitted thereto. The redirecting transmitter pulses the infrared timing signal synchronized with the transmission of the ultrasonic signal to the receiver. The receiver 101 may include a photo-diode 241 for measurement when an infrared timing signal is received. In this case, the communication port of the wand 103 is wirelessly connected to the communication interface of the receiver 101 by an infrared transmitter and a photo-diode relaying the timing information within an accuracy of microseconds (-1 mm resolution). The processor 233 on the receiver 101 employs this infrared timing information to set the first, second, and third propagation time measurements for the reference transmission time.

FIG. 4 illustrates various sensored wands for evaluating spinal alignment 300 in a non-limiting example. As shown, the multiple sensorized wands 301-304 can be used to track movement and / or alignment of individual vertebrae to other trabecular vertebrae. Each wand can be of different size and sensor configuration. The wand is a lightweight component that can be extended in the range of 4-12 cm, and of a width less than or equal to 1 cm in width. In general, the wands 301-304 have a form factor that can be easily gripped by hand or attached or supported on a muscle-skeletal system. For example, the first wand 301 has a wider and longer sensor spacing than the other wand 303. Thereby, the communication between the wand 301-304 and the receiver 308 is extended. Each wand has a distinct ID that can be distinguished from the other, for example, is stored as a distinctive low-frequency magnetic wavelength that is unique for each wand. The system 100 identifies the wand through passive magnetic field measurements and measures its position through one or more ultrasonic, optical, electromagnetic, or (passive / active) sensors.

With reference to Fig. 4, a workflow method is considered here. In a first workflow step 311, the receiver 308 is located close to the surgical area, where the wand is used. As indicated above, the receiver 308 is located on the stand or attached to the sacrum (or other bone region) to track the orientation and position of the wand. The wand is gripped by hand, for example, to register the anatomical feature on the sacrum by clicking on the feature of the bone with the tip of the wand and clicking. This point registration is used to capture anatomical points and to search for 3D spine models with appropriate orientation and dimensions. Then, at step 312, the wand is used to register a point on the vertebral bone to evaluate the position of the vertebra bone. In the first device, the wand may be attached to the vertebra bone directly without registering the point of the other wand end. This provides one point for evaluating the spatial position at the insertion point, but orientation (stereoscopic information) is not essential.

In the second device, the wand is first used to register a point on the surface of the vertebra and then inserted. In this registration, an anatomical spine point is captured, and then the entry is used to search for a 3D spine model with appropriate orientation and dimensions. This allows the system 100 to track the spine by appropriate scaling and position when the wand is inserted into the spinal bone. Upon registration and positioning of each wand on the receiver and vertebrae on the sacrum, the system 100 provides a real time trace of the instrument, as shown in step 313. In other words, the system creates a three-dimensional model of the vertebrae, a virtual environment displaying the sensorized wands 301-304 and the receiver 308

Figure 5 shows a sensored arrangement for measuring spinal conditions in a non-limiting embodiment. As noted above, the end of the wand also includes a sensor such as a biotransducer. When the end of the wand is used to register a point of interest, biometric data directly associated with the insertion site can also be captured. The tip of the wand may also separate the biotransducer and out of position at the contact site. Figures 5 and 6 illustrate the placement of a wand-end sensor, in which the end sensor is located in a location for organ transplantation. The system 100 also enables delivery of energy waves in a vibration pattern that can lead to improved bone mineral content and density by mimicking the load on the bone. The sensors also aid in fracture healing by sending an energy wave through the implant or across it.

Thus, here a method is provided for detecting biometric parameters, and the sensored arrangement of functions includes position and orientation. The method includes the steps of providing a living body transducer to a moving component of the spinal joint, and a step of moving an energy wave (e.g., ultrasound, optics, electronic paper, etc.) Evaluating the behavior of an energy wave during a spinal joint motion and quantitatively evaluating the behavior based on the evaluated behavior and the motion of the spinal joint; Measuring at least one parameter of a procedure area selected from the group consisting of shear, load, torque, bone density, and support body weight. Alternatively, an insertable head assembly incorporating one or more sensors may be used to measure the bio-parameter of interest. In this example, the bio-converter can detect and transmit information about the motion and load of the vertebrae. As an example, the sensor can sense abnormal movement of the orthopedic joint by evaluating the frequency or periodicity of the evaluated motion, e.g., when the spinal joint is fixed during motion.

5, a single sensor 352 may be implanted in an artificial element of a bone or a spinal joint (e.g., vertebrae) to create a binding force that is related to pressure, tensile, shear, The behavior of the spinal joint during exercise, such as qualitative level or function, can be assessed. The sensor 352 in this embodiment is in a fixed position on the bones (vertebrae) and moves with the vertebrae 358 during an exercise related to the procedure area 360. [ As shown, the procedural area 360 comprises a vertebra 354, a disc 356, and a vertebra 358. The procedure region 360 is relatively stationary relative to the sensor, since the spine primarily transfers a single sensor. The single sensor of the device is exposed to various changes of the parameters of interest (e.g., pressure, tension, shear, bone density, support weight) within the procedural area as a result of the motion. As an example, the sensor is compressed over the range of articulation as a result of motion applied at different locations in the joint during exercise. In operation, the sensor 352 evaluates the energy wave in the procedural area, but the peripheral area is also evaluated because the movement of the vertebra (and therefore the sensor focus) changes with respect to the procedural area as a result of the operation. The position of the sensor 352 (via the wand when the sensor is attached to the wand) is also measured in relation to the other vertebrae and is used to catalog changes in the sensed parameters for orientation, position, and placement .

One advantage of placing the sensor 352 in a moving component (e.g., a vertebra, an artificial implant) and transferring an energy wave to a procedural area different from the moving component of the spinal joint is the knowledge of its position and orientation Effectively changing the distance between the sensor 352 and the resolution and focus of the sensor 352, as well as the procedural area for changing the force thereon. The position information also indicates the period of motion associated with this change in the sensed parameter. As an example, the sensor 352 operating in the switching mode between originating and receiving can make measurements at different depths of the procedural area without incurring operational changes. As a result of the varying distance due to the joint motion, the sensor 352 may perform other measurements without sensor adjustment, which may otherwise require frequency, amplitude, or phase changes of the transmitted wave energy, for example to match the impedance .

As an example, the biometric sensor 352 may be an ultrasonic device. Quantitative ultrasound can measure additional bone properties, such as mechanical integrity, as opposed to other bone densitometric methods of measuring bone mineral content. Propagation of ultrasound through bone is affected by bone mass, bone structure, and direction of load. Quantitative ultrasonic measurement as a measure for evaluating the bone strength and stiffness is based on the processing of the received ultrasonic signal. The speed of sound and ultrasound propagate through the bones and soft tissues. Prosthetic relaxation or subsidence, fractures of the femur / tibia / acetabulum or artifacts are associated with bone loss. Thus, an accurate assessment of progressive quantification changes in bone mineral content around artifacts will help the practitioner decide when to intervene to maintain bone inventory for revision replacement surgery. This information is helpful in the development of osteoporotic bone implants, and helps in the therapeutic evaluation of osteoporosis and the effects of different implant coatings.

Figure 6 shows multiple sensored positions for measuring spinal conditions in a non-limiting embodiment. As indicated above, the tip of the wand also includes a sensor, such as a biotransducer. The wand may also capture biometric data directly associated with the insertion site when used to register a point of interest. The tip of the wand may also separate the bio-converter and leave its position at the contact site.

Accordingly, a method provided herein for detecting a biometric parameter comprises providing a second biometric transducer in a procedural area different from the moving element of the spinal joint, and providing a first biometric transducer and a second biometric transducer during movement of the vertebral joint, And quantitatively evaluating the behavior of the energy wave based on mutual separation. At least one parameter of the current state or the procedural area is measured from the evaluated behavior and the spinal motion. The parameters are either strain, vibration, kinematics, or stability. The first biometric transducer or the second biometric transducer may include a transceiver for transmitting data regarding at least one biometric parameter to an external source for evaluation.

6, the sensor 352 may be implanted in a bone or an artificial element of a spinal joint (e.g., vertebrae) and a sensor 366 may be implanted in a procedural area for evaluating the motion of the spinal joint during movement As shown in FIG. In this embodiment, the sensor 352 is in a fixed position on the bone (vertebrae) and moves with the vertebral wall during joint motion to the sensor 366 in the procedural area. The sensor 366 may be on a different bone. Although both sensors are moving, the effect sensor 352 is moved relative to the sensor 366 and is relatively displaced as indicated. The sensors 352 and 366 are capable of evaluating the host bone and tissue but are not limited to the bone density and the fluid viscosity, temperature, stress, pressure, angle strain, vibration, load, torque, distance, , Operation, and the like.

The dual sensor device shown can evaluate the integrity of the bones. For example, at the vertebral joint, sensors 352 and 366 connected to the first and second vertebrae evaluate the density of the bone. External and internal energy waves sent from sensor 352, sensor 366, or both of these sensors, according to the present invention, can be used during treatment of fracture and spinal fusion. The distance between the two sensors placed and their distance can be measured in the region of interest and a power field is generated. The energy field can be a standard energy source, such as ultrasound, radio frequency, and / or electromagnetic fields. Over time, the deflection of the wave energy enables detection of a change in the desired parameter, for example, to be evaluated. As an example, a first sensor disposed at the distal end of the femur bone may evaluate bone density from a second sensor inserted into the proximal end of the tibia bone during movement of the vertebrae.

One advantage of two or more sensors is that they can move relatively close and far apart relative to each other as a result of the motion, for example due to the frequency and impedance characteristics of the sensors in the procedural area being studied, Improve the evaluation. In other words, the separation of the sensors 352 and 366 from each other may require different measurements without sensor adjustment, which would otherwise require, for example, frequency, amplitude, or phase variation of the transmitted wave energy to match the impedance . In the present example, the measurement of bone is based on the processing of the received ultrasound signal. Both sound velocity and ultrasonic velocity provide measurements based on how fast the ultrasonic waves propagating through bone and soft tissue proceed. This dimensional property information enables the creation of rapid three-dimensional shapes, which are processed by the system 100 with position, orientation and position information. Since the sensors span the joint space, they can detect changes in the insertion function. Some examples of implantable functions include bearing wear, subsidence, bone integration, normal and abnormal movements, changes in heat, viscosity, particulate matter, kinematics, and the like.

FIG. 7 illustrates a sensorized vertebral instrument 400 in a non-limiting embodiment. A side view and a plan view are displayed. The spinal instrument 400 comprises a handle 409, a shaft 430, and a sensorized head 407. The handle 409 is coupled to the proximal end of the shaft 430 and the sensorized head 407 is coupled to the distal end of the shaft 430. In one embodiment, the handle 409, the shaft 430, and the sensored head 407 form a rigid structure that does not bend when used for dispersion or measurement of the vertebral region. The spinal instrument 400 includes an electronic assembly 401 operably connected to one or more sensors of the sensored head 407. The sensors are connected to the surfaces 403/406 on the movable elements 404/405 of the sensorized head 407. The electronic assembly 401 is disposed toward the proximal end of the shaft 407 or at the handle 409. As shown, the electronic assembly 401 is connected to a shaft 409. The electronic assembly 401 comprises an electronic circuit including a logic circuit, an accelerometer, and a communication circuit. In one embodiment, the surfaces 403 and 406 of the sensor mounting head 407 may have a convex shape. The convex shape of the surfaces 403 and 406 supports the placement of the sensor mounting head 407 within the vertebral region, particularly between the contours of the vertebra. In one embodiment, the sensor mounting head 407 is adjustable in height by way of the upper component 404 and the lower component 405 through the jack 402, (411) is evenly distributed and closed. The jack 402 is coupled to the inner surfaces of the components 404 and 405 of the sensor mounting head 407. Shaft 430 includes one or more longitudinal passages. For example, an interconnect connector, such as a flexible wire interconnect, may be coupled through a passageway in the shaft 430 to allow the electronic device assembly 401 to operatively engage one or more sensors in the sensor mounting head 407 have. Similarly, the threaded rod can be coupled through the second passageway of the shaft 430 to engage the handle 409 with the jack 404, thereby allowing the rotation of the handle 409 to move the sensor mounting head 407 Height adjustment is possible.

The spinal instrument 400 can be aligned by the manner of the built-in accelerometer. Sensor mounting head 407 supports multiple functions including the ability to determine parameters of a treatment area (e.g., intervertebral space) including pressure, tension, shear, load, torque, bone density, and / do. In one embodiment, one or more load sensors may be included within the sensor mounting head 407. One or more load sensors may be coupled to predetermined positions of surfaces 403 and 406. [ Having more than one load sensor allows the sensor mounting head 407 to measure the magnitude of the load applied to the surfaces 403 and 406 and the position of the load. The sensor mounting head 407 can be used to measure, adjust, and test the vertebral body joint before installing the vertebral bone component. As seen above, the alignment system 100 evaluates the optimal insertion angle and position of the spinal instrument 400 during bone-to-bone load sensing and duplicates these conditions when using an insert instrument.

In the present invention, these parameters include: i) an encapsulation structure for supporting the sensors and contact surfaces, ii) a power supply, sensing element, ultrasonic resonator or resonators or transducers or transducers and ultrasonic waveguides or waveguides, An electronic device assembly incorporating an electronic circuit for processing energy conversion, propagation, and detection and wireless communications as well as for processing springs or other types of elastic members, accelerometers, antennas, measurement data, (407) or device. The sensor mounting head 407 or instrument 400 may include, but is not limited to, instruments, appliances, vehicles, equipment, or other physical systems as well as animals and humans for sensing and communicating parameters of interest in real time Located on or in or on a wide range of physical systems, or attached or fixed therein or in it.

An example of use of the spinal instrument 400 is in the installation of a spine cage. The spine cage is used in the space spine in disc replacement. The spine cage is generally cavity and can be configured to have a fixing screw. More than one cage is often placed between the vertebrae to provide sufficient support and load distribution over loads beyond the range of motion. In one embodiment, the spine cage is made of lightweight, strong titanium. Bone growth material can also be placed in the cage to further strengthen the long-term intercostal area and thereby be placed in the cage to initiate and promote bone growth. The spinal instrument 400 is inserted into the gap between the vertebrae, which measure the position of the rod and the rod. The load position corresponds to a vertebra region or surface that applies a load to the surface 403 or 406 of the sensor mounting head 407). The insertion angle and position of the sensor mounting head 407 of the spinal instrument 400 can also be measured. The load magnitude and load measurement positions are used by the physician to determine the optimal size of the spinal cage for the implant location between the vertebrae and the implant location. The optimal size is the height of the cage when the load is applied by the fall of the vertebrae within a predetermined load range. In general, the height of the sensorized head 407 in the dispersion and measurement of the load applied to the spine of interest is equal to the height of the implanted cage in the subsequent step. After removing the sensorized head 407 from the vertebrae, the cage can be implanted in the same area. The load of the implanted vertebral cage is approximately the same as the measurement made in the spinal instrument 400 and applied to the sensor head 407. In one embodiment, the angle and position of the insert test measurement is recorded by the spinal instrument 400 or a remote system coupled thereto. Angle and position measurements are used to continuously guide the spine cage to the same spinal region in the same path as the spinal instrument 400 during the measurement process.

FIG. 8 shows an integrated sensorized vertebral instrument 410 in a non-limiting embodiment. In particular, the electronic assembly 401 is disposed within the integration mechanism 410. This includes an external wireless energy source 414 that is placed close to the charging unit to initiate a wireless power charging operation. The wireless energy source 414 may include a power supply, a modulation circuit, and a data input. The power source may be a battery, a charging device, a capacitor, a power connection, or other energy source for generating a wireless power signal capable of delivering power to the spinal instrument 410. The external wireless energy source 414 may 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 (e. G., Power on) to activate electromagnetic coupling with the induction coil in the sensing device when positioned proximately.

The electronics assembly 401 dispenses the measured parameter data to a receiver via a data communication circuit to enable visualization of the level and distribution of the parameters at various points on the vertebral element. The data input also receives input information from another data source, such as a computer, via a wired or wireless connection (e.g., USB, IEEE 802.16, etc.) as an interface or port. The modulation circuit can modulate the input information on the power signal generated by the power supply of the input information. The sensorized head 407 typically has a wear surface made of a low friction polymer material. Ideally, when inserting between the vertebrae, the sensored head 407 is similar to the natural vertebrae and has the proper load, alignment and balance.

FIG. 9 illustrates an insert mechanism 420 having a vertebral component in a non-limiting example. The electronic apparatus assembly 401 as described herein similarly supports the generation of alignment and position data of the insert mechanism 420. With the alignment system 100, the user can duplicate the insertion angle, position and locus (path) to achieve an appropriate or pre-planned placement of the spinal components. Alternatively, the accelerometer of electronic assembly 401 may provide position and orbit information. The insert mechanism 420 includes a handle 432, a neck 434 and a tip 451. The engagement / release mechanism 455 engages the proximal end of the neck 434 to control the tip 451. The engagement / release mechanism 455 allows the physician to see or release the vertebra component attached to the tip 451. In this example, the handle 432 extends at an angle close to the proximal end of the neck 434. Positioning of the handle 432 permits access to the engagement / release mechanism 455 while allowing the surgeon to accurately guide the tip 451 in the vertebral region.

In a first embodiment, the vertebral component is a vertebrae cage 475. The vertebral cage 475 is a hollow, generally cylindrical, titanium-like device with a perforated wall that can be inserted between the vertebrae of the vertebrae during surgery. Generally, the dispersing process separates the vertebrae to a predetermined distance of the vertebrae cage 475. The spinal cage 475 can reduce nerve impingement as a solution to increase stability, reduce vertebral compression, and improve patient comfort. The spine cage 475 may include surface screws that allow the cage to self taping and provide additional stability. The vertebrae cage 475 may be porous to include bone graft material that supports the growth of bone between the vertebral bodies via the cage 475. One or more vertebrae cages may be disposed between the vertebrae to relieve discomfort. Proper placement and positioning of the spinal cage 475 is important for successful long-term implantation and patient outcomes.

In a second embodiment, the component of the vertebrae is a pedicle screw 478. Pedicle screw 478 is a specific type of bone screw designed for implantation into the vertebral body. There are two vertebrae for the vertebra that bind to other structures of the vertebrae (eg, lamina, vertebral arches). Multiaxial pedicle screws can be made of titanium to prevent corrosion and increase the strength of the components. The length of the pedicle screw is 30 mm to 60 mm. The diameter is between 5.0 mm and 8.5. It is not limited to these dimensions which contribute as a dimensional example. The pedicle screw 478 may be used in a tooling procedure to modify the deformity and / or attach the rod and plate to treat the trauma. This can be used to immobilize a portion of the vertebrae to support fusion by holding the bone structures together. By way of the electronic appliance assembly 401 (which may be integrated internally or externally), the insert mechanism 420 may be determined to determine the depth and angle of the screw arrangement and guide the screw thereto. In this example, one or more accelerometers are used to provide direction, rotation angle, or position information of tip 451 during the insertion process.

In one arrangement, the screw 478 incorporates a sensor. The sensor can transfer energy, obtain density readings, and monitor changes in density over time. As an example, the system 100 may thus monitor and report healing of the fracture site. The sensor can detect not only movement at the fracture site but also changes in motion between the screw and the bone. This information provides the healthcare provider with the ability to support healing monitoring and monitor vertebral weight support as directed. The sensor can be activated externally to send energy waves to the fracture itself to support treatment.

10 shows a perspective view of a spinal instrument 400 positioned between the vertebrae of a vertebra for sensing vertebral bone parameters in a non-limiting embodiment. Generally, a compressive force is applied to the surfaces 403 and 406 when the sensor mounting head 407 is inserted into the vertebral region. In one embodiment, the sensor mounting head 407 includes two or more load sensors that identify the surface 403, the surface 406, or the magnitude vector of the load both on the vertebrae force. In the illustrated example, the spinal instrument 400 is positioned between the vertebra L5 and the vaginal sow S such that a compressive force is applied to the surfaces 403 and 406. One approach to inserting the instrument 400 is from the back (back side) through micro-laparotomy because the endoscopic approach can be difficult to visualize and provide good exposure. Another method is from the front (front side), which allows the physician to work through the abdomen to reach the spine. In this way, the spinal muscles on the back are not damaged or severed; Avoid muscle weakness and scars. The spinal instrument 400 may be used with either the anterior or posterior vertebral approach.

Aspects of the sensored components of the spinal instrument 400 are described in United States Patent Application Serial No. 12 / 825,638 entitled " System and Method for Orthomodal Load Sensing Insertion Device ", filed June 29, 2010, Quot ;, which is incorporated herein by reference in its entirety, which is incorporated herein by reference in its entirety for &lt; RTI ID = 0.0 &gt; U. &lt; / RTI &gt; Briefly, the sensor mounting head 407 is capable of measuring corresponding positions and torques (e.g., Tx, Ty, and Tz) and edge loading and forces (Fx, Fy, and Fz) of the vertebrae. Electronic circuit 401 (not shown) controls the operation and measurement of the sensor in sensor mounting head 407. The electronic circuit 401 includes a communication circuit for short-distance data transmission. The electronic circuitry can then transmit the measured data to a remote system that provides real-time visualization to assist the physician in identifying arbitrary adjustments to achieve optimal joint balance.

The method of installing the components of the muscle system is described below. The steps of the method may be performed in any order. The example of placing the cage between the vertebrae is used to illustrate the method, but the method is applicable to areas of muscle bone system such as knees, hips, ankles, spine, shoulders, hands, arms and legs. In a first step, a sensor mounting head of a predetermined width is placed in the region of the muscle bone system. In this example, the insertion area is between the vertebrae of the vertebrae. The hammer can be used to tap the end of the handle to provide sufficient force to insert the sensor mounting head between the vertebrae. The insertion process disperses the vibration, thereby increasing the separation distance. In the second step, the position of the load applied to the sensor mounting head is measured. Therefore, the magnitude of the load on the surface of the sensor mounting head and the loading position can be used. The insertion of how the load applied by the muscle bone system is placed on the surface of the sensor mounting head can help determine the stability of the component. The irregular load applied to the sensor mounting head can predict a scenario in which an applied force pushes the component away from the insertion position. In general, a sensor mounting head is used to identify a suitable position for insertion of a component based on quantitative data. In a third step, the position of the load and load data from the sensor mounting head is displayed on the remote system in real time. Similarly, in a fourth step, at least one of the rotation, angle, or position of the alignment is displayed in real time on the remote system. Changes made to place the sensor mounting head are reflected in the data on the display of the remote system. In a fifth step, the position between the vertebrae with the proper loading position is identified, and the corresponding quantitative measurement data is stored in memory.

In a sixth step, the sensor mounting head is removed. In a seventh step, the component is inserted into the muscle bone system. As an example, the stored quantitative measurement data is used to support positioning of components in the muscle bone system. In this example, the insert mechanism may be used to guide the component into the muscle bone system. An insert mechanism is an active device that is inserted to provide alignment, rotation, angle, or positioning of components. The previously measured direction and position of insertion of the sensor mounting head may be used to guide the insert mechanism. In one embodiment, the remote system display may be capable of displaying the rotational arrangement of the insert mechanism and components on the previously inserted sensor mounting head. The insert mechanism with the system may provide visual, audible, tactile or other feedback to further assist in directing the placement of the components. Generally, the components to be inserted have substantially the same height as the sensor mounting head. Ideally, the component is inserted in the same position and positioning as the previously inserted sensor mounting head position so that the position of the load and load on the component is similar to the quantitative measurement. In an eighth step, the component is positioned and released in the same way as the previously inserted sensor mounting head. The insert mechanism may be removed from the muscle bone system. In the ninth step, at least the sensor mounting head is discarded.

Thus, the sensor mounting head is used for proper positioning for insertion of the component. Insertion is supported by quantitative measurements including location and location. After the treatment is completed, the approximate load of the load on the component and the position of the load are known. In general, knowing the load applied by the muscle bone system on the surface of the component and the location on the surfaces of the component can help determine the stability of the long-term component. An irregular load applied on a component may cause an applied force to push the component away from the insertion position.

FIG. 11 illustrates a graphical user interface (GUI) 500 that illustrates a perspective view of the sensorized spinal instrument of FIG. 10 in a non-limiting embodiment. The user interface 500 is presented by the remote system 105 and the alignment system 100 (see FIG. 1). The GUI 500 includes a window 510 and an associated window 520. The window 520 shows the spinal instrument 400 and the sensor mounting head 407 in relation to the vertebra 522 under evaluation. In this example, a (flat) perspective view of the vertebra is shown. This shows a shaft angle 523 and a rotating component 524 that are moved forward into the incision, for example, to show the approach angle and rotation of the spinal instrument 400. Window 520 and corresponding GUI information are provided and updated in real time during the treatment. This allows the physician to visualize the use of the spinal instrument 400 and sensed parameters. The window 510 shows the sensing surface 403 or 406 of the sensor mounting head 407. The crosshairs 512 are superimposed on the image of the sensor mounting head to determine the maximum point of force and position. It can also be stretched to show vertebral edge loading. The window 513 reports, for example, the load force 201bs over the sensor mounting head surface. This information is presented during the treatment and updated in real time.

As discussed above, the system 100 may be used during surgery to support implantation of prostheses / instruments / hardware by way of parameter sensing (e.g., vertebral load, edge loading, compression, etc.). Configurations such as the receiver 101, the plurality of wands 103, and the spinal instrument 400 remain within the surgical area in use. The remote system 105 is typically outside the surgical area. All measurements are made within the surgical area by these configurations. In one embodiment, at least one of the receiver 101, the plurality of wands 103, and the spinal instrument is discarded when the process is complete. In general, they are designed for one-off use and can not be reused.

In the vertebrae, the effects on bone and soft tissue elements are assessed by changes in soft tissue (e.g., cartilage, tendons, ligaments) as well as system 100 during surgery including orthopedic surgery. The sensors are then used during surgery (and post-operatively) to assess temporal or dramatic changes. When the surgical parameter readings are stored, the sensor can be activated during surgery. Immediately after surgery, the sensor is activated and the reference is known.

The sensor system 100 can be used to evaluate the vertebral and connective tissue, including but not limited to bone density, fluid viscosity, temperature, strain, pressure, angular deformations, vibration, load torque, distance, tilt, shape, . Because the sensors span the vertebral space, sensors can predict changes in the vertebral component before insertion. As described above, the system 100 is used to place the spinal instrument 400 in the intervertebral space and is shown positioned relative to the vertebral body 522. Once the measurement system is deployed and visually confirmed at the center of the vertebrae, the system 100 reports any edge stacking on the instrument, which in turn can be used to determine the appropriate vertebral instrument and insertion plan (e.g., approach angle, ). &Lt; / RTI &gt; Examples of implant component functions include wear, subsidence, bone integration, normal and abnormal movements, changes in heat, viscosity, particulate matter, and kinematics in a few examples.

Figure 12 shows a stylus spinal instrument 400 positioned between the vertebrae of a vertebrae to sense vertebral position and force, which is not a limiting example. As shown, the sensor mounting head 407 of the spinal instrument 400 is disposed between the vertebra L4 and vertebra L5. The spinal instrument 400 disperses the vertebrae L4 and L5 at the height of the sensor mounting head 407 and provides quantitative data on the magnitude of the load and the position of the load. In one embodiment, the spinal instrument 400 communicates with a first wand 510 and a second wand 520 positioned adjacent to each other. The elongate shaft 514 is provided in each rod to allow placement within the vertebrae of the vertebra and also to lace with other rods and electronics assemblies 401 of the spinal instrument 400. [ The rod 510 tracks the alignment and position of the vertebra L4 and the rod 520 tracks the alignment and position of the vertebra L5. This allows the system 100 to track the alignment and movement of the spinal instrument 400 relative to the movement of the adjacent vertebra. Each rod is sensed similarly to the spinal instrument 400. The rod 510 and the rod 520 include a sensor 512 and a sensor 513, respectively. Sensors 512 and 513 transmit and receive position information. The electronics assemblies 401 along with the rods 510 and 520 serve to confirm alignment and position of the spinal instrument 400 during treatment. An example of ultrasound location sensing is disclosed in United States Patent Application 12 / 764,072 entitled " Method and System for Position Measurement "filed on April 20, 2010, the entire contents of which are incorporated herein by reference .

FIG. 13 is a perspective view of the user interface 600 showing the sensorized spinal instrument of FIG. 12, which is not a limiting example. The user interface 600 is shown in the same format as the remote system 105 and the 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 sensor mounting head 407 in relation to the vertebra component 622 under evaluation. In this example, a sagittal (lateral) view of the vertebral column is shown. Which indicates the shaft angle 623 and the rotating component 624, which represent the approach angle and rotation of the spinal instrument and sensor mounting head 407. The second window 620 and the corresponding GUI information are provided and updated in real time during the treatment. This allows the physician to visualize the spinal instrument 400 and the sensor mounting head 407 of the sensed load-gravity parameter. The first window 610 shows the sensing surface of the sensor mounting head (see FIG. 7). The cross hair 612 overlaps the image of the sensor mounting head 407 to identify the maximum point and position of the force. You can also adjust the width and length to show vertebral edge loading. Another GUI window 613 reports the loading force over the surface of the sensor mounting head 407. [ The GUI 600 is provided and updated in real time during the treatment.

14 shows a perspective view of a sensored vertebra implant device 420 for placement of a vertebrae cage 475, which is not a limiting example. The insert mechanism 420 provides surgical means for implanting a vertebra component 475 (e.g., a vertebral cage, pedicle screw, sensor) between L4 and L5 vertebrae. The mechanical assembly tip 451 at the distal end of the neck 434 permits attachment and release of the vertebrae component by the manner of the connection and attachment / release mechanism 455. The vertebra component 475 is disposed behind the vertebrae through medical incision, for example, through a posterior lumbar interbody fusion (PLIF) as shown. The insert mechanism 420 may similarly be used in anterior vertebral interbody fusion (ALIF) procedure.

One method contemplated here is that the position of the cage prior to insertion is optimized as ultrasound locating or 3D imaging as described for example with the spinal instrument 400 and wands 510 and 520 shown in Figures 12 and 13 Is defined. The load sensor 407 (see FIG. 12) is located between the vertebrae and evaluates the force of the load applied as described above, wherein the optimal insertion path and trajectory are defined. The load gravity and the path of instrument insertion are recorded. 14, the insert mechanism 400 inserts the final vertebral cage 475 along the recording path of the spinal instrument 400 and on the basis of the loading force. During insertion, the GUI as shown in Figure 15 moves the spinal instrument 420 to the recorded insertion point. The vertebra insert mechanism 420 may be equipped with one or more load sensors acting as placeholders in the final vertebral cage. The open space occupying the perimeter of the vertebral cage after insertion of the cage 475 between the vertebrae, release of the vertebrae cage from the insert mechanism 420 and removal of the insert mechanism 420, Lt; / RTI &gt; This compresses the surrounding vertebrae with a spinal cage and provides stability to vertebral fusion. During this process, the GUI 700 of Figure 15 reports changes in vertebral anatomy, such as vertebral dorsal and posterior cervical vertebrae, due to adjustment of the rods and close contact of the pedicle screws. In particular, the GUI 700 also provides visual feedback indicating the amount and direction of achieving the planned spine alignment by the manner of adjustment provided by the rods and screws.

FIG. 15 shows a perspective view of the sensorized vertebra implant device 420 of FIG. 14, which is not a limiting example. The user interface 700 is shown in the form of a remote system 105 or an 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 insert mechanism 420 and vertebral component 475 in relation to the L4 and L5 vertebrae being evaluated. In this example, a sagittal (side) view of the vertebral column is shown. This shows the shaft angle 723 and the rotation angle 723 and the rotation angle 723 which show the approach angle and rotation of the insert mechanism 420 and the vertebra component 475. The second window 720 and the corresponding GUI information are provided and updated in real time during the treatment. This allows the physician to visualize the vertebral component 475 of the insert mechanism 420 according to previously sensed load gravity parameters.

The first window 710 shows the (desired) target sensor mounting head alignment 722 and the current instrument head alignment 767. The target alignment 722 shows the previously determined trajectory path when the approach angle, rotation, and spinal instrument 400 were used to evaluate the load parameter. The current instrument head alignment 767 shows the trace of the insert mechanism 420 currently used to insert the final cage 475. [ The GUI 700 presents the target orientation model 722 in terms of the current instrument head alignment 767 to provide a visualization of the previously planned surgery plan.

Again, Figures 10,11, 12 and 13 illustrate the use of a spinal instrument (not shown) for evaluating optimal procedural parameters (e.g., angles, rotations, paths), in terms of sensed parameters Lt; / RTI &gt; Once these procedural parameters have been determined, the system 100 may be operated by insertion device 420 to insert the vertebral bone configuration 475 (e.g., a vertebral cage, vertebral bone screw) . In one configuration, the system 100 provides tactile feedback to guide the insertion device 420 during the insertion process. For example, if the current approach angle 713 deviates from the target approach angle or direction 767 is not aligned with the target trajectory 722, it will provide a vibration or visual signal (red / green mark). Alternatively, speech feedback may be provided by the system 100 to supplement the provided visual information. The GUI 700 effectively re-establishes the location and target path on the sensed insertion device 420, via visual, tactile feedback, based on the previous device.

The load, balance, and position can be used during surgery, using data from the sensorized devices (e.g., 101, 103, 400, 420, 475) of the load balancing system 100, , And can be adjusted within a predetermined quantitative measurement range. The test and final insert (e.g., a spine cage, pedicle screw, sensor, etc.) may include a sensing module that provides measured data to a remote system for the display. The final insert can also be used to monitor long-term spinal joints. The data may be used by the patient and the health care provider to ensure that the vertebral joint or fused vertebra function properly by returning the patient during the rehabilitation process and into normal activity life. Conversely, when the measured parameter is outside the specification, it may be notified to the patient or medical care provider. This provides the patient with early detection of a spinal problem that can be resolved with minimal stress. 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 hand gripping device is used to receive data from the final insert. The hand-held device is held close to the vertebrae so that strong signals can be received to receive the data.

A method of dispersing the vertebral region is described below. The steps of the method may be performed in any order. Reference may be made to Figs. 10, 11, 12, 13 and 14. Although an example of placing a prosthetic component such as a spinal cage between vertebrae has been used to illustrate the present invention, the present invention is applicable to other musculature such as knees, hips, ankles, spine, shoulders, hands, Area. &Lt; / RTI &gt; In general, quantitative analysis data need to be collected in the vertebral region. The spinal instrument, alignment device and insertion mechanism disclosed herein can be used to create a database of quantitative data. There is a shortage of quantitative measurement data due to lack of active measurement tools and measurement devices. The measurement data generated by the devices during installation of the prosthetic configuration are associated with other short-term and mid-term data to determine the impact of the load on the patient's health, the location of the load and the prosthetic configuration alignment. The system disclosed herein can generate data during the installation of a prosthetic configuration and can be applied to provide long term measurements of the implant and vertebral region. Thus, the results of the method of dispersion generate sufficient data to aid in the recovery process, minimizing failure, improving performance, reliability, and the installation process to extend the life of the device.

In the first step, the spinal instrument is inserted to disperse the vertebral region. The spinal instrument includes sensors that produce 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 and the vertebral region is dispersed to the first height. The system displays the measurement data by visual, auditory or tactile means. As an example, the system discloses that the load measurement from the spinal instrument is outside a predetermined load range. The predetermined load range used in the present system for measuring the spinal region can be determined by medical research. For example, a predetermined load range can aid in device installation by associating load measurement data with the results of the surgical procedure. In general, measurements outside of a predetermined load range may statistically increase the likelihood of device failure. In the third step, the spinal region distributes the second height. In a fourth step, the load applied by the vertebral region to the second height of the spinal instrument is measured. The system shows that the load measurement from the spinal instrument is within a predetermined load range. Having a measured load within a predefined load range reduces failure because the prosthetic configuration is overloaded. In general, the procedure can be repeated as many times as required at different dispersion heights until the spinal instrument measurement shows that the measured load is within a predetermined load range.

In a fifth step, the position of at least one of the direction, rotation, angle, or spinal instrument is measured. In one embodiment, the measurement may correspond to a configuration of a spinal instrument inserted within the vertebral region. For example, the position data may be associated with the sensor head of the spinal instrument. The data can be used to place prosthetic configurations in similar locations and in the same orbit as measured by a spinal instrument. In the sixth step, the load applied by the spinal region to the spinal instrument can be monitored on a remote system. In this embodiment, the remote system includes a display capable of displaying data in real time during the course of the process. In the seventh step, the height of the spinal instrument can be adjusted. As disclosed, the spinal instrument may include a scissors type mechanism for reducing or increasing the height of the dispersed surface. In one embodiment, the handle of the spinal instrument is rotated to change the dispersion height. Adjustments can be made while monitoring the load data in real time on the remote system. In general, the height is adjusted until the measured load is within the predetermined load range. In the eighth step, the height is increased or decreased so that the adjusted height corresponds to the height of the prosthesis configuration. In one embodiment, a prosthetic configuration with the same dispersion height can be placed at the location of the load measurement in the vertebral region. The prosthetic configuration is aligned with the orbit and is similarly loaded in the load measurement when placed in the same position as the spinal instrument.

In the ninth step, the spinal instrument measures the position of the applied load. The spinal instrument may have a surface connected to the vertebral region. In this embodiment, one or more sensors are connected to the surface of the spinal instrument to assist in locating the load measurement. The position of the load provides quantitative measurement data as to how the force, pressure or load will be applied to the prosthesis configuration when placed in the spinal region. For example, a misplaced position of the load could create a situation in which the prosthesis configuration is not stable at that location, resulting in force from the spinal region, which can lead to catastrophic failure. In one embodiment, the load data position from the spinal instrument may be used to evaluate the position for the prosthetic configuration position. The quantitative data may include a range or predetermined range corresponding to the measurement surface of the spinal instrument for evaluating the position of the load. In the tenth stage, the spinal instrument is moved from the vertebral region to a different position when the position of the load applied by the vertebral region to the spinal instrument is out of the predetermined position range. The new location is the location for the prosthetic configuration and can be assessed by the location and load size of the load quantification data.

In the eleventh step, when the measured quantitative data enters a predetermined load range and predetermined position range, a suitable position is identified in the vertebral region for the prosthetic configuration. As mentioned earlier, placing a prosthetic configuration in the area of the spinal area measurement within a predefined load range and predefined location range produces positive results and reduces failure rates based on medical evidence. In the twelfth step, the prosthetic configuration is placed in the position measured by the spinal instrument. The prosthetic device in this position will have a load size and position imposed by the vertebral region, similar to that measured by a spinal instrument. The prosthetic configuration is inserted into a vertebral region having an orbit similar to the spinal instrument. In this example, the trajectory and position of the spinal instrument are recorded during the measurement process. In the thirteenth step, the insertion process of the prosthetic component can be supported by comparing the trajectory of the prosthetic component to the trajectory of the spinal device. In one embodiment, the surgeon may receive visual, tactile, or auditory feedback to help align the prosthetic configuration to the location. In the fourth step, the prosthetic configurations and trajectories of the spinal instrument are shown by the remote system. The remote system can show the actual or virtual position and trajectory of the prosthetic configuration associated with the position and trajectory of the spinal instrument when identifying the location in the spinal region. In one embodiment, the surgeon can follow the trajectory with visualization or overlay on the spinal instrument position data displayed on the remote system, with a prosthetic configuration or insertion device. As disclosed herein, the spinal instrument may have a mechanism, such as a scissor jack, to change the height of the dispersed surface. A rod connected to the handle of the spinal device for lifting or lowering the scissor jack is connected to the handle of the spinal device. In the fifteenth step, the handle of the spinal device can be rotated to change the dispersion height. In the sixteenth stage, visual, auditory or tactile signals are provided when the load applied to the spinal instrument by the spinal region is within a predetermined load range. Similarly, at the seventeenth stage, a visual, auditory or tactile signal is provided when the load applied to the spinal instrument by the spinal region is within a predetermined range of positions.

16 is a block diagram showing a configuration of a spinal instrument 400 according to an embodiment. It should be noted that the spinal instrument 400 may include more or less than the number of components shown. The spinal instrument 400 is a self-contained instrument capable of measuring the parameters of the vertebral muscle bone system. In this example, the spinal instrument 400 measures the load and the load position when inserted into the vertebral region. The active components of the spinal instrument 400 include one or more sensors 1602, a load plate 1606, a power source 1608, an electronic circuit 1610, a transceiver 1612, and an accelerometer 1614. In a non-limiting example, the applied compressive force is applied to the sensor 1602 by the vertebral region and measured by the spinal instrument 400. [

The sensors 1602 may be located, joined, attached, or attached to the surfaces 403 and 406 of the spinal instrument 400. Generally, a compressive force is applied by the vertebral region to the surfaces 403 and 406 when inserted therein. Surfaces 403 and 406 are coupled to sensors 1602 such that a compressive force is applied to each sensor. In one embodiment, the position of the load applied to surfaces 403 and 406 can be measured. In this example, three load sensors are used in the sensor mounting head to identify the location of the applied load. The negatively charged sensor is coupled to a predetermined position of the load plate 1606. The load plate 1606 couples to the surface 403 to distribute the compressive force applied to the sensor mounting head of the spinal instrument 400 by each sensor. The load plate 1606 is rigid and does not bend when distributing forces, pressures, or loads to the sensor 1606. The magnitude of the force or load measured by each sensor may again be correlated to the position of the reloaded load on surface 403. [

In the intervertebral measurement example, the sensor mounting head 403 with surfaces 403 and 406 may be located between the vertebrae of the vertebrae. The surface 403 of the sensor mounting head engages the first vertebra surface and similarly the surface 406 engages the second vertebra surface. The accelerometer 1614 or external alignment system can be used to measure the position and alignment of the sensor mounting head by being directed into the vertebral region. Sensors 1602 couple to electronics 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, electronic circuitry 1610 includes an application specific integrated circuit that reduces form factor, reduces power, and increases performance. In general, electronic circuitry 1610 controls the measurement process, receives measurement signals, converts the measurement signals in digital form, supports display at the interface, and initiates data transfer of measurement data. The electronic circuit 1610 measures the physical changes in the sensors 1602, for example, the level, the distribution and the direction of the forces acting on the surfaces 403 and 406 to determine the parameters of interest. The insert sensing apparatus 400 may be driven by an internal power supply 1608. [ Thus, all of the components are required to measure the parameters of the muscle bone system that reside in the spinal instrument 400.

As one example, the sensors 1602 may comprise an elastic or compressible propagation structure between the first transducer and the second transducer. The transducers may be ultrasonic (or ultrasonic) resonators, while the resilient or compressible propagation structure acts as an ultrasonic waveguide. The electronic circuit 1610 is electrically coupled to the transducers to transfer a change (or compression or extension) in the length of the compressible propagation structure to a parameter of interest. The system can measure the change in length of a compressible propagation structure (e.g., a waveguide) that is responsive to an applied force and can be transmitted through the transceiver 1612 to carry the level, direction, This change is converted to an electrical signal. For example, the compressible propagation structure has known and repeatable characteristics of the length of the applied force versus waveguide. Precise measurement of the length of a waveguide using an ultrasonic signal can be converted to force using known features.

Sensors 1602 are not limited to force, pressure, or load sensing measurement waveguides. In still other embodiments, the sensors may include piezo-resistive, compressive polymers, capacitive, optical, MEMS, strain gauge, chemical, temperature, pH, mechanical sensors to provide other parameter measurements of the muscle bone system. In an alternative embodiment, the piezo resistive film sensor may be used to sense the load. The piezoresistive film has a low profile, thereby reducing the form factor required for performance. The piezoresistive film changes the resistance to the applied pressure. The voltage or current may be applied to the piezo resistive film to monitor the change in resistance. Electronic circuit 1610 may be coupled to apply a voltage or current. Similarly, the electronic circuit 1610 can be coupled to measure the voltage and current corresponding to the resistance of the piezoresistive film. The relationship of the resistance of a piezo resistive film to an applied force, pressure, or load is well known. The electronic circuit 1610 can convert the measured voltage or current into force, pressure, or load applied to the sensor mounting head. In addition, electronic circuitry 1610 can convert measurements in digital form for display or delivery for real-time use or storage. Electronic circuitry 1610 includes a converter, an input, an output, and an input / output, which allows serial and parallel data transmission, thereby allowing simultaneous measurement and data transfer. In one embodiment, the ASIC is included in an electronic circuit 1610 that integrates control functions and digital control logic that manages the measurement process of the spinal instrument 400 guided to the user.

The accelerometer 1614 can measure acceleration and stationary gravity. Accelerometer 1614 may be a single-axis and multi-axis accelerometer structure that detects the magnitude and direction of acceleration as a vector quantity. The accelerometer 1614 may also be used to sense alignment, vibration, impact, and impact. The electronic circuitry 1610 along with the accelerometer 1614 and the sensors 1602 are configured to determine parameters of interest (e.g., load, force, pressure, displacement, motion , Rotation, torque and acceleration distribution) can be measured. In this arrangement, the spatial distribution of the measured parameters for the selected reference frame can be calculated and presented for real-time display.

The transceiver 1612 includes a transmitter 1622 and an antenna 1620 to allow for wireless operation and telemetry functions. In various embodiments, the antenna 1620 may be configured as an integrated loop antenna by design. The integrated loop antenna is configured at various layers and locations on a printed circuit board having different interconnected electrical components. For example, electronic circuitry 1610, power source 1608, transceiver 1612, and accelerometer 1614 may be mounted on a substrate positioned in spinal instrument 400. [ Once initiated, the transceiver 1612 may broadcast the parameters of interest in real-time. The telemetry data may be received and decoded by various receivers or common receivers. Wireless operation is a distortion of the measurement caused by physical interference by cables and interconnects that combine the power module or sensing module with associated data acquisition, storage, display equipment, and data processing equipment, or the potential for imposed limitations Or limitations.

The transceiver 1612 can receive power from the power source 1608 and operate at low power using a variety of radio frequencies by way of an efficient power management scheme, e.g. integrated into the electronic circuitry 1610. As one example, the transceiver 1612 may transmit data at a selected frequency in the selected mode of radiation by way of the antenna 1620. The selected frequency may include, but is not limited to, the ISM band recognized in International Telecommunication Union regions 1, 2 and 3. The selected mode of radiation is selected from Gaussian Frequency Shift Keying (GFSK), Amplitude Shift Keying (ASK), Phase Shift Keying (PSK), Minimum Shift Keying (MSK), Frequency Modulation (FM), Amplitude Modulation (E.g., binary, coherent, quadrature, and the like).

Antenna 1620 may be integrated with the components of the sensing module to provide radio frequency transmission. An antenna 1620 that couples the electronic circuitry 1610 may be integrated into the printed circuit board. The antenna 1620 may further include a matching network for efficient delivery of signals. This level of integration of antennas and electronic devices enables reductions in the size and cost of the radio equipment. Potential applications may include, but are not limited to, short-range hand grips, wearable, or other portable communications equipment in which compact antennas are commonly used. This includes reusable modules or devices as well as disposable modules or devices or modules or devices for extended use.

The power source 1608 provides power to the electronic components of the spinal instrument 400. [ In one embodiment, the power source 1608 may be charged by a wired energy transfer, a short-range wireless energy transfer, or a combination thereof. The external power source for providing the wireless energy to the power source 1608 may be a battery or batteries, an alternative power supply, a radio frequency receiver, an electromagnet induction coil, an energy harvesting, a magnetic resonance, a photocell or a battery, Or ultrasonic transducers or transducers. By way of the power supply 1608, the spinal instrument 400 can be operated with a single charge until internal energy is evacuated. It can be periodically recharged to enable continuous operation. The power source 1608 may further utilize power management techniques to efficiently provide and provide energy to the components of the spinal instrument 400 to facilitate measurement and wireless operation. The power management network can be integrated on the ASIC to manage the different components of the system as well as the ASIC power consumption.

The power supply 1608 minimizes the energy radiation source required to power the sensing module during the measurement operation. In one embodiment, as illustrated, the energy storage 1608 may include a capacitive energy storage 1624 and an induction coil 1626. [ An external source that charges the power is coupled wirelessly to the capacitive energy storage 1624 via inductive coils or coils 1626 by an inductive charging scheme. The charging operation can be controlled by the power management system designed into or with the electronic circuitry 1610. For example, during operation of the electronic network 1610, power may be delivered from the capacitive energy storage device 1610 by way of efficient step-up and step-down voltage conversion network. This preserves the operating power of the circuit block at the minimum voltage level to support the required level of performance. Alternatively, the power source 1608 may include one or more batteries in which the spinal instrument 400 is received. The batteries can power a single use of the spinal instrument 400 and are therefore discarded after being used in surgery.

In one configuration, the external power source may further contribute to communicating downlink data to the transceiver 1612 during a recharging operation. For example, the downlink control data may be modulated onto the radio energy source signal and then demodulated from the induction coil 1626 by way of the electronic network 1610. [ This can contribute as a more efficient way to receive downlink data instead of configuring transceiver 1612 for uplink and downlink. As one example, the downlink data may be used by the spinal instrument 400 when making measurements such as external position information, or may include updated control parameters for recalibration purposes. It can also be used to down load the serial number or other identification data.

The electronic circuitry 1610 manages and controls various operations of components of the sensing module, such as sensing, power management, telemetry, and acceleration sensing. Which may include analog circuits, digital circuits, integrated circuits, discrete components, or any combination thereof. In one arrangement, this can be split among integrated circuits and discrete components to minimize power consumption without compromising performance. The division between digital and analog circuits enhances design flexibility and facilitates minimizing power consumption without sacrificing functionality or performance. Thus, the electronic circuitry 1610 may include, for example, one or more integrated circuits or ASICs specific to the core signal processing algorithm.

In yet another arrangement, the electronic circuitry 1610 may comprise a programmable processor, a digital signal processor (DSP), microcontroller, or microprocessor with associated storage memory and logic. The controller may utilize a computing technology with associated storage memory such as flash, ROM, RAM, SRAM, DRAM or other similar technology for controlling the operation of the above described components of the sensing module. In one arrangement, the storage memory may store one or more sets of instructions (e.g., software) that implement any one or more of the methods or functions described herein. The instructions may reside completely or at least partially within another memory and / or processor during execution thereof by another processor or computing system.

The electronic appliance assembly also supports test capability and calibration to ensure the quality, accuracy, and reliability of the completed wireless sensing module or device. The transient bidirectional interconnects ensure electrical identifiability and control capability of high level electronic devices. The test interconnect also provides a high level of electrical identification of the sensing subsystem including transducers, waveguides, and mechanical springs or resilient assemblies. The carriers or fixtures mimic the finished enclosure of the wireless sensing module or device during the manufacturing process and thus enable the capture of accurate calibration data for the calibrated parameters of the completed wireless sensing module or device. These calibration parameters are stored in an on-board memory incorporated in the electronic appliance assembly.

Applications for an electronics appliance assembly including sensors 1602 and an electronic network 1610 may include a waste module or devices as well as a reusable module or devices or modules or devices for long term use, It does not. In addition to non-medical applications, examples of a wide range of potential medical applications include implantable devices, modules in implantable devices, intra-operative or intra-operative implants or modules in a test insert, modules in an inserted or ingested device, A module in a hand-held device, a module in an appliance, an appliance, an appliance, or a module in an accessory of all of these, or a waste in an implant, a test insert, an inserted or ingested device, a wearable device, a hand- But are not limited to, all of these accessories, equipment, appliances, or equipment.

17 is a drawing of an exemplary communication system 1700 for short range telemetry in accordance with an exemplary embodiment. As shown, the communication system 1700 includes a medical device communication component 1710 in a spinal instrument and a receiving system communication in a processor-based remote system. In one embodiment, the receiving remote system communication is or is coupled to a computer or laptop computer outside the sterile field of the operating room. The doctor can view the laptop screen or display coupled to the computer while performing the surgery. Medical device communication components 1710 include 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 source 1726 ), And application specific integrated circuit (ASIC) 1720. The medical device communication components 1710 may include more or less than the number of components shown and are not limited to the illustrated or order of components.

The receiving station communication components 1750 include an antenna 1752, a matching network 1754, a telemetry transceiver 1756, a CRC circuit 1758, a data packetizer 1760, and optionally a USB interface 1762 . Other interface systems may be coupled directly to data packetizer 1760 to process and provide sensor data.

 16, electronic circuit 1610 is operatively coupled to one or more sensors 602 of spinal instrument 400. [ In one embodiment, the data generated by one or more sensors includes voltage or current values from other sensor types used to measure parameters of the MEMS structure, piezoelectric resistive sensor, strain gauge, mechanical sensor or muscle bone system . 17, data packetizer 1722 assembles sensor data into packets; This includes the sensor information received and 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 components 1710. The ASIC 1720 further provides the advantage of reducing the form factor of the tool.

The CRC circuit 1718 applies error code detection on the packet data. The periodic redundancy check is based on an algorithm for computing a checksum for a data stream or packet of arbitrary length. Such a check sum may be used to detect interference or accidental changes of data during transmission. The periodic redundancy check is particularly good at detecting errors caused by electrical noise and therefore allows strong protection against improper handling of erroneous data in environments with high levels of electromagnetic activity. The telemetry transceiver 1716 then transmits the CRC encoded data packet via the matching network 1714 by way of the antenna 1712. The matching networks 1714 and 1754 provide an impedance match to achieve optimal communication power efficiency.

Receiving system communication components 1750 receive transmissions sent by medical device communication component 1710. In one embodiment, telemetry transceiver 1716 is operated with a dedicated telemetry transceiver 1756 that is forced to receive a data stream broadcast on a particular frequency in a particular mode of emission. By way of the receiving station antenna 1752, the telemetry transceiver 1756 detects transmissions coming at a particular frequency. The antenna 1752 may be a directional antenna that is guided to the directional antenna of the components 1710. Using at least one directional antenna can reduce data deformation while increasing data security by further limiting when data is emitted. The matching network 1754 couples to the antenna 1752 to provide an impedance match that efficiently conveys the signal from the antenna 1752 to the telemetry receiver 1756. The telemetry receiver 1756 reduces the carrier frequency in one or more steps and removes the information or data sent by the components 1710. The telemetry receiver 1756 couples to a CRC circuit 1758. The CRC circuit 1758 verifies the cyclic redundancy check sum for individual packets of data. The CRC circuit 1758 is coupled to the data packetizer 1760. Data packetizer 1760 processes individual packets of data. In general, the data verified by the CRC circuit 1758 is decoded (e.g., unpacked), processed into an external data processing device such as an external computer for a series of processing, display or storage, or some combination of these .

The telemetry transceiver 1756 is designed and configured to operate at very low power, such as power available from, but not limited to, a powered USB port 1762 or battery. In another embodiment, the telemetry transceiver 1756 is designed for use with minimal controllable functionality to limit the chance of accidental errors or maliciousness interfering with the received data. The telemetry transceiver 1756 is compact, inexpensive, and can be designed and configured to be easily manufactured in a standard manufacturing process while ensuring a consistently high level of quality and reliability.

In one configuration, communication system 1700 operates with only transmit operations with a broadcast range of approximately several meters to provide high security and protection for any form of unauthorized or accidental queries. The transmission range may be controlled by transmitted signal strength, antenna selection, or a combination thereof. The high repetition rate of the transmission may be used with cyclic redundancy check (CRC) bits embedded in the packets of data transmitted during the data acquisition operation, thereby allowing for the determination of load, force, pressure, displacement, Enabling the receiving system to discard the error data without affecting the display of data or the integrity of the visual representation of the data, including, but not limited to, measurements of bending, posture, and position.

By limiting the operating range to a distance of approximately several meters, the telemetry transceiver 1716 can operate at very low power in the appropriate radiation mode or modes for the selected operating frequency without compromising the repetition rate of transmission of data . This mode of operation also supports operation with a compact antenna, such as an integrated loop antenna. The combination of low power and compact antennas enables a configuration of, but not limited to, a high compact telemetry transmitter that can be used for a wide range of non-medical and medical applications.

The integrity of the transmitted data as well as transmitter safety are ensured by operating the telemetry system within predetermined conditions. The safety of the transmitter may not be at stake since it is only operating in the transmit mode and there is no hack path into the medical device communication component. The completeness of the data is ensured by the use of the CRC algorithm and the repetition rate of the measurements. The risk of unacknowledged data is minimized by the limited broadcast area of the device. Even if unauthorized receipt of data must occur, there are appropriate countermeasures to further mitigate data access. The first measure is that transmitted data packets contain only binary bits from the counter with CRC bits. The second measure can be used to account for the importance of binary broadcast at any time or there is no data required. A third measure that can be implanted is that patient or device identification data is not broadcast at any time.

The telemetry transceiver 1716 may also be operated in accordance with some FCC regulations. In accordance with Section 18.301 of the FCC Rules, the ISM bands in the United States include 24.125, 61.25, 122.50, and 245 GHz as well as 6.78, 13.56, 27.12, 30.68, 915, 2450, and 5800 MHz. Globally, the ISM band, including 433 MHz, is defined by the International Telecommunications Union in some geographic locations. The list of banned frequency bands in 18.303 reads as follows: "The following safety, search and structural frequency bands are prohibited: 490-510 kHz, 2170-2194 kHz, 8354-8374 kHz, 121.4-121.6 MHz, 156.7-156.9 MHz, and 242.8- 243.2 MHz. Section 18.305 specifies the field strength and radiation level. The ISM facility shall not exceed when operating outside the defined ISM band. In summary, it is concluded that the ISM facility can be operated worldwide within the ISM band as well as in most other frequency bands above 9 kHz, provided that the limits at the field strength and emission levels specified in Section 18.305 are maintained by design or active control. Can be lowered. Alternatively, a commercially available ISM transceiver, including a commercially available integrated circuit ISM transceiver, can be designed to fulfill these field strength and radiation level requirements when used properly.

In one configuration, telemetry transceiver 1716 may also operate in the unlicensed SIM band or in unlicensed operation of low power equipment, and ISM equipment (e.g., telemetry transmitter 1716) may operate in section 18.303 May be operated at any frequency of 9 kHz or more.

Wireless operation may be caused by the potential for physical interference by, or limitations imposed by, interconnection and cable coupling power or associated data acquisition, storage, display equipment, and wireless sensing modules or devices with data processing equipment Distortion or limitation of the measurement can be eliminated. The power for the sensing components and the electronic circuitry is maintained within the wireless sensing module or device on the internal energy storage device. Such energy storage devices include batteries or batteries, supercapacitors, capacitors, ac current power supplies, radio frequency receivers, electromagnetically induction coils, photovoltaics or batteries, thermocouples or thermocouples, or ultrasonic transducers or transducers But is charged with an external power source which is not limited thereto. The wireless sensing module can be operated with a single charge until the internal energy storage device is emptied or the energy source can be periodically recharged to enable continuous operation. The embedded power supply minimizes the additional energy radiation source required to power the wireless sensing module or device during the measurement operation. The telemetry function is also integrated into the wireless sensing module or device. Once initialized, the telemetry transmitter continuously broadcasts the measurement data in real time. The telemetry data may be received and decoded either by a commercially available receiver or by a simple, low cost conventional receiver.

18 shows a communication network 188 for measurement and reporting in accordance with an exemplary embodiment. Briefly, communication network 1800 extends spinal alignment system 100, spinal instrument 400 and insertion device 420 to provide extensive data connectivity to other devices or services. As shown, the spinal alignment system 100, spinal instrument 400 and insertion device 420 may be communicatively coupled to the communication network 1800 and other systems or services associated therewith.

In one example, the spinal alignment system 100, the spinal instrument 400 and the insertion device 420 may be configured to measure a desired parameter (e.g., load, intensity, pressure , Disposition, motion, rotation, torque and variance of acceleration) can be shared with remote services or providers. Such data may be shared with a service provider or plan manager for monitoring progress, for example, for surgical monitoring purposes or efficacy studies. The communications network 1800 may be further coupled to an Electronic Medical Records (EMR) system to implement health information technology practices. In another embodiment, the communication network 1800 may be a HIS (Hospital Information System), a HIT (Hospital Information Technology), a HIM (Hospital Information Management), an Electronic Health Record (EHR), a Computerized Physician Order Entry (CPOE) Computerized Decision Support Systems). This provides the ability of other information technology systems and software applications to purify data, communicate and exchange effectively and consistently, and use the exchanged data.

The communication network 1800 may be a wired or wireless connection using a Local Area Network (LAN) 1801, a Wireless Local Area Network (WLAN) 1805, a Cellular Network 1814, and / Can be provided. LAN 1801 and WLAN 1805 may be communicatively coupled to the Internet 1820, for example, via a central station. The central office can accommodate a common network switching facility for distributing telephony services. Telephony services may include traditional Plain Old Telephone Service (POTS) and broadband services such as cable, HDTV, DSL, Voice over Internet Protocol (VoIP), Internet Protocol Television (IPTV), and Internet services.

Communications network 1800 may utilize a common computing and communications technology to support circuit-switched and / or packet switched communications. Each standard for the Internet 1820 and other packet switched network transmissions (e.g., TCP / IP, UDP / IP, HTML, HTTP, RTP, MMS, SMS) represents an example of state of the art. These standards are replaced periodically by faster or more efficient devices that have essentially the same functionality. Accordingly, alternative standards and protocols having the same functionality are considered equivalents.

The cellular network 1814 may use a number of access technologies such as GSM-GPRS, EDGE, CDMA, UMTS, WiMAX, 2G, 3G, 4G, WAP, SDR, . The cellular network 1814 may be coupled to the base receiver 1810 under a frequency reuse scheme to communicate with the mobile device 1802.

The base receiver 1810 may in turn connect the mobile device 1802 to the Internet 1820 using a packet switched link. The Internet 1820 may support an application service and a service layer for distributing data from the spinal alignment system 100, the spinal instrument 400, and the insert mechanism 420 to the mobile device 1802. The mobile device 1802 may also connect to other communication devices via the Internet 1820 using a wireless communication channel.

The mobile device 1802 may also connect to the Internet 1820 using a WLAN 1805. Wireless Local Access Networks (WLANs) provide wireless access within the local geographical area. WLANs typically consist of cluster of access points (APs) 1804 also known as base stations. The measurement system 1855 can communicate with other WLAN stations, such as a laptop 1803, within the base station area. In a typical WLAN run, the physical layer uses a variety of technologies, such as 802.1lb or 802.11g WLAN technology. The physical layer may be an infrared, frequency hopping spread spectrum in the 2.4 GHz band, a direct sequence spread spectrum in the 2.4 GHz band, or other approaches (e.g., 5.8 GHz ISM band or higher ISM band (e.g., 24 GHz) Technology can be used.

By way of communication network 1800, measurement system 1855 can establish a connection with remote server 1830 and other mobile devices on the network to exchange data. The remote server 1830 may access the database 1840, which may be stored locally or remotely and may contain application designation data. The remote server 1830 may host the application service directly or using the Internet 1820.

FIG. 19 is an illustration of a system in the form of a computer system 1900 that can cause a machine to perform one or more of the methods described above when a set of instructions in it is executed. In some embodiments, the machine operates as a stand-alone device. In some embodiments, the machine may be connected to another machine (e.g., using a network). In network deployment, the machine may operate as a peer machine in the server-client user's network, or in a peer-to-peer (or distributed) network environment, with the capacity of the server or client user machine.

The machine may include a server computer, a client user computer, a personal computer (PC), a tablet PC, a notebook computer, a desktop computer, a control system, a network router, a switch or a bridge or mechanism. It will also be appreciated that the device of the present invention broadly includes any electronic device that provides wide range of voice, video, or data communications. Although a single system is shown, it is to be understood that the term "machine &quot; includes all machine collections that execute a set (or multiple sets) of instructions individually or in a cavity to perform one or more of the methodologies discussed herein Will be taken.

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

The disk drive unit 1916 is a machine-readable medium having stored thereon instructions of one or more sets of instructions (e.g., software 1924) implementing one or more of the methodologies or functions described herein, (1922). The instructions 1924 are also fully or at least partially resident in the main memory 1904, the static memory 1906, and / or the processor 1902 during its execution by the computer system 1900. The main memory 1904 and the processor 1902 also constitute machine readable media.

Dedicated hardware implementations, including but not limited to application specific integrated circuits, programmable logic arrays, and other hardware devices, may likewise be configured to implement the methods described herein. The application program may include an apparatus and a system including various electronic apparatuses and computer systems. Some embodiments implement functionality such as a portion of a device or application specific integrated circuit with data signals communicated between two or more specific interconnected hardware modules or associated controls and modules. Thus, the exemplary system may be applied to software, firmware, and hardware implementations.

According to various embodiments of the present invention, the methods described herein are intended for operation as a software program executing on a processor, digital signal processor, or logic circuit. In addition, software execution, including but not limited to, distributed processing or component / entity distributed processing, parallel processing, or virtual machine processing, may also be configured to implement the methods described herein.

The present invention contemplates a machine-readable medium including instructions 1924 or a device connected to the network environment 1926 may transmit or receive voice, video or data, (1926) from the propagation signal to communicate via the antenna (1926). The command 1924 may be transmitted or received using the network 1926 to the network interface device 1920.

Although the machine-readable medium 1922 is shown in the exemplary embodiment to be a single medium, the term "machine-readable medium" is intended to encompass a single medium or multiple medium (e.g., Or related cache and server). The term "machine-readable medium" may also be taken to include any medium that can store, encode, or transport a set of instructions for execution and cause the machine to perform one or more of the methods of the present invention.

The term "machine-readable medium" includes solid state memory, random access memory, or other rewritable (volatile) memory, such as one or more read-only (nonvolatile) memory, memory card or other package; Discs or tapes such as magneto-optical or optical media; A carrier signal as a signal for implementing a computer instruction on a transmission medium; And / or digital file attachments, such as distribution media, to this type of storage medium in an information archive or archive set contained in an electronic mail or otherwise. Accordingly, the present invention is intended to encompass any one or more machine-readable media or distribution media, including software-stored technology-recognized equivalents and subsequent media as enumerated herein.

Although the present specification describes components and functions implemented in embodiments with reference to specific standards and protocols, the present invention is not limited to these standards and protocols. Each standard for the Internet and other packet switched transmissions (ie, TCP / IP, UDP / IP, HTML, HTTP) represents a state of the art. These standards are replaced periodically with faster or more efficient equivalents having essentially the same functionality. Thus, a protocol with the same functionality as an extra standard is considered equivalent.

The illustrations of the embodiments described herein are intended to provide a general understanding of the structure of the various embodiments, which are not intended to serve as a complete description of all components and functional devices and systems. Many other embodiments described herein will be apparent to those skilled in the art from reviewing the above description. Other embodiments may be derived therefrom such that utilization and structural and logical substitutions and modifications may be made without departing from the scope of the present invention. The drawings are merely exemplary and may not be drawn to scale. Certain parts may be exaggerated while others may be minimized. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense.

Such an embodiment of the subject matter of the present invention may be embodied solely and / or collectively by the term "present invention " for convenience only and without intending to limit the scope of the present application to the concept of a single invention or invention, Can be described herein. Although specific embodiments have been illustrated and described, it should be understood that any configuration calculated to achieve the same purpose may be substituted for the specific embodiments shown. The invention is intended to cover any and all modifications or variations of the various embodiments. It will be apparent to those skilled in the art that the above embodiments, and combinations of other embodiments not specifically described herein, will review the above description.

Claims (40)

receiving set;
A plurality of wands; And
A load sensor for measuring the intervertebral force,
Wherein the plurality of pea is in communication with the receiver to determine positional information including any one of direction, rotation, angle, or position of the vertebrae associated with an intervertebral force determined between the vertebrae. The method according to claim 1,
Wherein the receiver comprises one or more sensors, a processor and an interface, the processor interprets the sensor signals from the at least one wand via the one or more sensors, and transmits the position information to a remote system for display system. 3. The method according to claim 1 or 2,
Each of the plurality of wands including a controller operatively connected to one or more sensors, the one or more sensors transmitting sensor signals in response to an indication by the controller. 4. The method according to any one of claims 1 to 3,
Wherein the at least one sensor and the plurality of wands of the receiver are selected from the group comprising an optical sensor, an ultrasonic sensor, and a magnetic sensor. 5. The spinal metrology system according to any one of claims 1 to 4, wherein the load sensor is connected to a sensored head. 6. The method of claim 5,
A shaft to which the sensor head is connected at an outer end; And
And a handle coupled to a proximal end of the shaft. The method according to claim 6,
Further comprising electronic circuitry mounted toward a base end of the shaft, wherein the electronic circuitry comprises logic circuitry, an accelerometer and a communication circuitry, the electronic circuitry operatively connected to the load sensor. 8. The method according to claim 6 or 7,
Wherein the sensor head includes a plurality of load sensors for locating a load applied to the sensor head. 9. The method according to any one of claims 6 to 8,
Wherein the wand is connected to the sensor head for measuring at least one of direction, rotation, angle or position. 10. The method according to any one of claims 1 to 9,
Wherein data from the receiver, the plurality of wands, and the load sensor is wirelessly transmitted to a remote system for displaying quantitative measurements therefrom. 11. The method according to any one of claims 1 to 10,
Wherein one of the receiver, the plurality of wands, or 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 head for measuring a load when the sensor head is inserted into a vertebral region; And
And a remote system in communication with the spinal alignment system and the spinal instrument for displaying quantitative measurements therefrom. 13. The method of claim 12,
Wherein the spinal alignment system and the spinal instrument are within a surgical field of an operating room. The method according to claim 12 or 13,
Wherein the spinal alignment system or the spinal instrument is discarded after use. 15. The method according to any one of claims 12 to 14,
The spinal alignment system comprising:
A receiver having a plurality of ultrasonic transducers; And
A load balancing and position system comprising a plurality of wands having a plurality of ultrasonic transducers. 16. The method according to any one of claims 12 to 15,
Wherein the spinal mechanism comprises:
A shaft having a sensor head and connected to the sensor head at an outer end thereof;
A handle coupled to a base end of the shaft; And
Further comprising an electronic circuit mounted toward an inner end of the shaft, the electronic circuit comprising a logic circuit, an accelerometer and a communication circuit, the electronic circuit operably connected to the load sensor. A method for installing a component in a musculoskeletal system,
Inserting a sensor head into the musculoskeletal system;
Measuring a load applied to the sensor head by the musculoskeletal system;
Measuring at least one of a direction, a rotation, an angle or a position of the sensor head inserted in the musculoskeletal system;
Aligning the component with the musculature system in at least one direction, rotation, angle or position measured; And
Inserting the component into the musculoskeletal system, the load on the component being approximately equal to the measured load. 18. The method of claim 17,
And measuring a position of a load applied to the sensor head. The method according to claim 17 or 18,
Displaying the load from the sensor head and the position of the load on the remote system in real time; And
Displaying on the remote system at least one of the measured direction, rotation, angle or position in real time. 20. The method according to any one of claims 17 to 19,
And discarding at least the sensor head after the process. A method of distracting a vertebral region, the method comprising:
Inserting a spinal instrument to disperse the vertebral region;
Measuring a load applied to the spinal instrument by the spinal region, the spinal region being dispersed at a first height at which the load measurement is outside a predetermined load range,
Dispersing the vertebral region in a second location; And
Measuring a load applied by the spinal region to the spinal instrument at the second position where the load is within a predetermined load range. 22. The method of claim 21,
Measuring at least one of a direction, a rotation, an angle, or a position of the spinal instrument. 23. The method of claim 21 or 22,
Monitoring the load measured by the spinal instrument on a remote system; And
Further comprising adjusting the height of the spinal instrument connected to the spinal region to increase or decrease the variance of the spinal instrument until the measured load is within a predetermined load range. 24. The method of claim 23,
Wherein adjusting the height comprises increasing or decreasing a dispersion height with height of the prosthesis configuration. 25. The method according to any one of claims 21 to 24,
Measuring a position of a load applied to the spinal instrument by the spinal region; And
Further comprising moving the spinal instrument to a different position when the position of the load exerted by the spinal instrument by the spinal region exceeds a predetermined position range. 26. The method of claim 25,
Further comprising identifying a position in the vertebral region of the prosthesis configuration within the predetermined load range and the predetermined position range. 27. The method of claim 26,
Further comprising positioning said prosthetic configuration in said location within said vertebral region. 28. The method according to any one of claims 26-27,
Comparing the trajectory of the prosthesis configuration with the trajectory of the spinal instrument; And
Further comprising displaying the trajectory of the prosthetic configuration and the spinal instrument on the remote system such that the prosthetic configuration is in the position within the spinal region along an orbit similar to the spinal instrument. 29. The method according to any one of claims 21 to 28,
Further comprising the step of rotating the handle of the spinal instrument to change the dispersion height. 30. The method according to any one of claims 21 to 29, further comprising the step of visual, audible or tactile means when the load applied to the spinal instrument by the spinal region is within the predetermined load range How to. A method of dispersing a vertebral region, the method comprising:
Inserting a spinal instrument into the vertebral region;
Measuring a load applied to the spinal instrument by the spinal region dispersed to a first height;
Indicating that the measured load is outside a predetermined load range; And
And adjusting the spinal instrument to disperse the spinal region to a second height that is within a predetermined load range. 32. The method of claim 31, further comprising measuring at least one of a direction, a rotation, an angle, or a position of the sensor head in the musculoskeletal system. 33. The method according to claim 31 or 32,
Measuring a position of a load applied to the spinal instrument by the spinal region; And
And moving the spinal instrument to a different position when the position of the load applied to the spinal instrument by the spinal region is outside a predetermined position range. 34. The method according to any one of claims 31 to 33,
Further comprising identifying a position within the vertebral region for prosthetic configuration within a predetermined load range and predetermined position range. 35. The method of claim 34,
And positioning the prosthetic configuration at the location within the vertebral region. 35. The method according to claim 34 or 35,
Comparing the trajectory of the prosthesis configuration with the trajectory of the spinal instrument; And
And displaying the trajectory of the prosthetic configuration and the spinal instrument on a remote system such that the prosthetic configuration is located at a location of the spinal region along an orbit similar to the spinal instrument. A method of tracking alignment and orientation of a vertebral region, the method comprising:
Positioning the receiver proximate to the plurality of wands such that the receiver coincides with the view of the plurality of wands and is in a fixed position;
Registering at least one anatomical feature of the sacrum with the wand;
Extracting a 3D spine model having a direction and a size corresponding to the registered anatomical characteristics; And
Wherein the location measurement is determined by ultrasound and identifying at least one location or location of one or more vertebrae. 39. The method of claim 37,
Attaching a plurality of wands to different vertebrae of the vertebra. 39. The method of claim 37 or 38,
Registering one or more anatomical features of the vertebral bone in the wand;
Attaching the wand to a vertebra;
Repeating the registration and attachment steps for different vertebrae using a plurality of wands; And
Extracting a 3D vertebral bone model having a direction and size corresponding to the registered anatomical characteristics of each vertebra bone. 40. The method according to any one of claims 37 to 39,
Inserting a sensor head of a measurement device between vertebrae of a vertebra; And
And measuring a load applied thereto,
Wherein one of the direction, rotation, angle or position data is generated corresponding to the sensor head along the vertebrae.

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