Patent Description:
Patients who undergo certain procedures, such as a spinal fusion, may- have pedicle screws placed into their vertebrae. The pedicle screws are typically implanted into the vertebrae through the pedicles of the vertebrae. Once a pilot hole is created through the cortex of the bone, a probe is used to create the path through which the pedicle screw will be placed into the vertebrae. Placing the pedicle screw at the correct angle helps to assure a mechanically sound construct and to avoid injury to surrounding structures such as the spinal cord, nerve roots, and blood vessels. The orientation of the screw can be described in two planes: (<NUM>) the transverse plane, which is parallel to the ground if the person is standing upright, and (<NUM>) the sagittal plane, which divides a person into left and right halves.

To assist surgeons to properly place and orient a pedicle screw in a vertebra, a variety of machines have been used. However, these machines are typically costly and bulky, thereby reducing the number of available surgical suites that have suitable equipment for use in assisting a surgeon with properly placing and orienting a pedicle screw. Therefore, further developments in medical technology are needed so as to enable physically smaller, cost effective devices that provide the desired level of assistance to surgeons.

The subject matter of the present invention is defined in the attached claims. The electronic device of claim <NUM> may be used for simulating an insertion point and an orientation of a simulated surgical hardware installation on a diagnostic representation of the bone, and then using an electronic device to align an instrument for inserting a surgical hardware installation at a desired orientation through an insertion point of the bone by indicating when an orientation of the electronic device is within a threshold of the simulated orientation. Hereinafter, the electronic device of claim <NUM> is also called "apparatus".

The electronic device disclosed herein is for determining orientation of an instrument for inserting a medical device in a bone. The electronic device has an orientation sensor, and a processor. The processor is configured to simulate insertion of the medical device in an image of the bone to determine a desired insertion angle of the medical device relative to a plane of the bone, determine an orientation of the electronic device relative to the plane using the orientation sensor, and output a notification when the orientation of the electronic device is such that the electronic device is positioned adjacent the desired angle of the medical device relative to the plane.

Another method aspect not according to the claimed invention is directed to a method for verifying an insertion angle of an instalment for determining a correct angle for a pedicle screw in a vertebra. The method includes aligning an axis of an apparatus with at least one of a sagittal plane, transverse plane, and coronal plane of the vertebra in a representation thereof. The method also includes capturing an image of the representation of the vertebra, and generating an angle-indicative line on a display, wherein the angle- indicative line adjusts in response to rotation and orientation of the apparatus and provides a notification when the apparatus is at the correct angle, the correct angle being a desired angle between the axis of the apparatus and at least one of the sagittal plane, transverse plane, and coronal plane.

A further aspect not according to the claimed invention is directed to a system for indicating an insertion sagittal angle of a tract for receiving a pedicle screw in a vertebra. The system includes an image acquisition unit, an orientation sensor, a display, and a processor. The processor is configured to obtain an image of a cross sectional view in a transverse plane of the vertebra, using the image acquisition unit, and measure orientation of the system and calibrate the orientation to align with a sagittal plane, transverse plane, or coronal plane of the vertebra. The processor is further configured to receive definitions of an insertion sagittal angle, transverse angle, or coronal angle of the tract and an initial position thereof relative to the vertebra, and generate an angle -indicative line on the display, wherein the angle-indicative line rotates in response to rotation of the system, and provides a notification when at least a portion of the system approximately forms the insertion sagittal angle, transverse angle, or coronal angle between an axis of the apparatus and the sagittal plane, transverse plane, or coronal plane of the vertebrae. <CIT> teaches a method for determining a desired trajectory and/or monitoring the trajectory of a surgical instrument or implant in a surgical procedure. <CIT> pertains to tracking the position of an object relative a planned position of the surgical object within a pre-operative plan, wherein the surgical object is moveable relative to a patient structure during surgery. Feedback is provided of the position and orientation of the surgical object relative to a virtual representation thereof in the preoperative plan. A deviation between the two is indicated to the surgeon. <CIT> discloses a method of controlling a surgical intervention to a bone comprising, obtaining a three-dimensional image or multiplanar reconstruction of the bone, defining a position and an axis of intervention on the three-dimensional image or multiplanar reconstruction of the bone, and controlling the orientation of an intervention instrument equipped with an orientation sensor during the surgical intervention by evaluating a signal provided by the orientation sensor.

For a more complete understanding of various embodiments of the present invention and the advantages thereof, reference is now made to the following brief description, taken in connection with the accompanying drawings, appendices, and detailed description, wherein like reference numerals represent like parts, and in which:.

In the following detailed description and the attached drawings and appendices, numerous specific details are set forth to provide a thorough understanding of the present disclosure. However, those skilled in the art will appreciate that the present disclosure may be practiced, in some instances, without such specific details. In other instances, well-known elements have been illustrated in schematic or block diagram form in order not to obscure the present disclosure in unnecessary detail. Additionally, for the most part, specific details, and the like, have been omitted inasmuch as such details are not considered necessary to obtain a complete understanding of the present disclosure, and are considered to be within the understanding of persons of ordinary skill in the relevant art.

It is further noted that, unless indicated otherwise, all functions described herein may be performed in hardware or as software instructions for enabling a computer, radio or other device to perform predetermined operations, where the software instructions are embodied on a computer readable storage medium, such as RAM, a hard drive, flash memory or other type of computer readable storage medium known to a person of ordinary skill in the art. In certain embodiments, the predetermined operations of the computer, radio or other device are performed by a processor such as a computer or an electronic data processor in accordance with code such as computer program code, software, firmware, and, in some embodiments, integrated circuitry that is coded to perform such functions. Furthermore, it should be understood that various operations described herein as being performed by a user may be operations manually performed by the user, or may be automated processes performed either with or without instruction provided by the user.

This disclosure describes a system and computer-implemented method for indicating an angle formed between a guiding direction for drilling a pilot hole (also referred to herein as a tract) for receiving a pedicle screw and a reference plane such as, for example, the sagittal plane.

The disclosed system and method may be implemented to guide the insertion of pedicle screws at a desired angle. The desired angle may be a transverse angle, sagittal angle, or any other angle. This process may include, in some embodiments, the creation of pilot holes.

<FIG> illustrates a sagittal or median plane <NUM>, a coronal or frontal plane <NUM>, and a transverse or horizontal plane <NUM> relative to a patient's body part <NUM> located at the intersection of the sagittal plane <NUM>, coronal plane <NUM>, and transverse plane <NUM>. Each plane is orthogonal to each other. When discussing a vertebra (or other body parts) in the following disclosure, reference is made to the sagittal plane, coronal plane, and transverse plane. It should be understood that, when these planes are mentioned, they are not intended as a reference to the specific sagittal, coronal, and transverse planes illustrated in <FIG>, but rather, are intended as a reference to illustrate an orientation or location relative to the specific vertebra being discussed.

<FIG> illustrates a cross sectional view (i.e., superior view) <NUM> of a vertebra <NUM> having pedicle screws <NUM> installed in respective pilot holes <NUM>. A driver <NUM> may be used to screw the pedicle screws <NUM> into the pilot holes <NUM>. <FIG> illustrates a lateral view (i.e., side view) <NUM> of a vertebra, and <FIG> illustrates a posterior view <NUM> of a vertebra. The following discussion focuses on properly creating the pilot holes with a tool guided by the method disclosed.

<FIG> presents a schematic diagram of an apparatus <NUM> used to define and verify an angle for a pilot hole, or tract, such as the pilot hole <NUM> of <FIG>. The apparatus <NUM> has an axis <NUM> (such as, for example, a longitudinal axis) that is used in some embodiments to align the apparatus <NUM> for image capture. The apparatus <NUM> includes an image acquisition unit <NUM> for capturing an image <NUM> of the vertebra. In some embodiments, the image <NUM> may be obtained by positioning the apparatus <NUM> and/or image acquisition unit <NUM> in parallel with the transverse, sagittal, or coronal plane to obtain an image of the vertebra.

In some embodiments, the image acquisition unit <NUM> can be a camera having sufficient field of view <NUM> to properly align the axis <NUM> of the apparatus <NUM> with the desired plane. In some embodiments, the axis <NUM> is representative of a vertical line centered laterally with respect to the image being captured. For example, if the desired image is intended to capture the vertebra from a cross sectional, superior view (e.g., see <FIG>), the axis <NUM> is aligned with the sagittal plane (i.e., the plane that is sagittal to the vertebra) and the image acquisition unit <NUM> is positioned parallel to the transverse plane to capture the top-down view of the vertebra shown in <FIG>. If the desired image is intended to capture the vertebra from a side view (e.g., a lateral image of the vertebra, see <FIG>), the axis <NUM> is aligned with the transverse plane (i.e., the plane that is transverse to the vertebra) and the image acquisition unit <NUM> is positioned parallel to the sagittal plane. If the desired image is intended to capture the vertebra from a posterior or anterior view (see, for example, <FIG>), the axis <NUM> is aligned with the sagittal plane and the image acquisition unit <NUM> is positioned parallel to the coronal plane.

In some embodiments, the image <NUM> may be a processed image, e.g., an image displayed on a screen, a film, or a printed photograph. In other embodiments, the image acquisition unit <NUM> can directly use an image taken from an external machine (not illustrated), such as a radiograph, computed tomography (CT) scanner, or a magnetic resonance imaging (MRI) machine.

The orientation apparatus <NUM> is operable to detect changes in movement, orientation and position. In some embodiments, the orientation apparatus <NUM> includes at least one of a gyroscope <NUM>, an inertial measurement unit <NUM>, and an accelerometer <NUM>. The gyroscope <NUM> is operable to measure at least one axis of rotation, for example, the axis parallel to the intersection of the sagittal plane and the coronal plane. In other embodiments, the gyroscope <NUM> includes more than one sensing axes of rotation, such as three axes of rotation, for detecting changes in orientation. The inertial measurement unit <NUM> can detect changes of position in one or more directions in a cardinal coordinate system. The accelerometer <NUM> can detect changes of speeds in one or more directions in a cardinal coordinate system. In some embodiments, data from all components of the orientation apparatus <NUM> are used to calculate the continuous, dynamic changes in orientation and position.

The apparatus <NUM> further includes, in some embodiments, an input component <NUM> that is operable to receive user input, and insertion location and the desired angle representing an insertion direction of the pedicle screw. An example illustration of the user input component <NUM> is presented in accordance with <FIG>. In some embodiments, the input component <NUM> can include a multi-touch screen, a computer mouse, a keyboard, a touch sensitive pad, or any other input device.

The apparatus <NUM> further includes a processor <NUM>. The processor <NUM> can be any processing unit capable of basic computation and capable of executing a program, software, firmware, or any application commonly known in the art of computer science. As to be explained, the processor <NUM> is operable to output an angle-indicative line representing the apparatus orientation on the display. In some embodiments, the angle-indicative line provides a notation that the orientation of the apparatus <NUM> approximately forms the desired angle. The angle-indicative line is not limited to showing sagittal angles, but also angles in different planes, such as, for example, the coronal plane or the transverse plane.

The apparatus <NUM> may, in some embodiments, further include a memory storage unit <NUM> and network module <NUM>. The memory storage unit <NUM> can be a hard drive, random access memory, solid-state memory, flash memory, or any other storage device. Memory storage unit <NUM> saves data related to at least an operating system, application, and patient profiles. The network module <NUM> allows the apparatus <NUM> to communicate with external equipment as well as communication networks.

The apparatus <NUM> further includes a display <NUM>. In some embodiments, the display <NUM> is a liquid crystal display for a multi-touch screen. In some embodiments, the display <NUM> shows the angle-indicative line to a user and provides a notification when the apparatus is approximately aligned with the predefined desired angle. For example, the notification can include a highlighted line that notifies the user the axis <NUM> has reached the desired angle, or is within an acceptable range of the desired angle.

Referring briefly to <FIG> the apparatus <NUM> further includes an attachment mechanism that allows the apparatus <NUM> to be attached to medical equipment, for example, for creating the pilot holes as shown in <FIG>. The attachment mechanism <NUM> may be comprised of plastic, stainless steel, titanium, or any other material. The attachment mechanism <NUM> couples the apparatus <NUM> to the equipment <NUM> by, for example, providing a casing that is attached to the apparatus <NUM> and is configured to connect to the equipment <NUM>. In some embodiments, the attachment mechanism <NUM> may include a magnetic attachment apparatus for coupling the apparatus <NUM> to the equipment <NUM>. The attachment mechanism <NUM> allows the apparatus <NUM> to provide real-time measurement and display of the orientation of the attached medical equipment <NUM>.

<FIG> illustrates a schematic diagram for defining the sagittal angle <NUM> for the pilot hole <NUM> in the vertebra <NUM>. The field of view <NUM> of the image acquisition unit <NUM> allows a user to align the axis <NUM> of the apparatus <NUM> with the desired plane (e.g., the sagittal plane). In the embodiment shown in <FIG>, the sagittal angle <NUM> is the angle between the central axis <NUM> of the pilot hole <NUM> and the sagittal plane.

<FIG> illustrates a schematic side view of a medical operation system <NUM>, which may be used in some embodiments for defining the sagittal angle <NUM> of the vertebra shown in <FIG> and <FIG>. The medical operation system <NUM> includes a machine <NUM> for capturing a cross-sectional view of the vertebra <NUM>. The machine <NUM> may be, for example, a CT scanner or MRI machine. The patient <NUM> exits the machine <NUM> after the image is taken, as shown in <FIG>.

<FIG> illustrates a schematic front view <NUM> of the medical operation system <NUM> taken in the transverse plane for defining the sagittal angle <NUM> of the vertebra <NUM>. The axis of the pilot hole <NUM> should to be precisely defined for the drilling guide <NUM>. In some embodiments, the apparatus <NUM> may be attached to the drilling guide <NUM> with the attachment mechanism <NUM>. Defining and verifying the sagittal angle <NUM> may be performed at the apparatus <NUM>, as explained in connection with the method illustrated in <FIG>.

First, however, a method of determining an orientation of an instrument for inserting a medical device in a bone is now described with reference to the flowchart <NUM> of <FIG>.

First an insertion point and an orientation of a simulated surgical hardware installation are simulated on a diagnostic representation of a bone <NUM>. Then, an electronic device is used to align an instrument for inserting a surgical hardware installation at a desired orientation through an insertion point of the bone by indicating when an orientation of the electronic device is within a threshold of the simulated orientation <NUM>.

Simulating the insertion point and the orientation of the simulated surgical hardware installation on the diagnostic representation of the bone includes acquiring the diagnostic representation of the bone <NUM>, aligning the diagnostic representation of the bone with a reference point <NUM>, designating the insertion point of the simulated surgical hardware installation on the diagnostic representation of the bone <NUM>, and designating the orientation of the simulated surgical hardware installation on the diagnostic representation of the bone relative to the reference point <NUM>.

Using the electronic device to align the instrument for inserting the surgical hardware installation at the desired orientation through the insertion point includes aligning the electronic device with the instrument at the insertion point <NUM>, tracking movement of the electronic device and the instrument using an orientation sensor of the electronic device until the orientation of the electronic device and the instrument are within the threshold of the simulated orientation <NUM>, and indicating when the electronic device and the instrument are within the threshold of the simulated orientation <NUM>.

<FIG> illustrates an example flow chart <NUM> of a method for indicating the sagittal angle <NUM>. The method of the flowchart <NUM> is for verifying any insertion angle <NUM> of the pilot hole <NUM> in the sagittal plane <NUM> for receiving a pedicle screw <NUM> in the vertebra <NUM>. At <NUM>, the axis <NUM> of the apparatus <NUM> is aligned with the sagittal plane. In some embodiments, a user may hold the apparatus <NUM> and rotate the apparatus <NUM> to match a marking indicating the axis <NUM> with features of the vertebra <NUM> that indicate the sagittal plane. In some embodiments, the marking may be displayed on the screen as the user aligns the device.

At <NUM>, the image of the cross-sectional view is captured in the transverse plane. In one embodiment, the apparatus <NUM> includes a smart phone, a tablet computer, a laptop computer, or any portable computational device including those that include a camera for capturing a representation of the cross-sectional view of the vertebra <NUM>. In other embodiments, the image of the vertebra <NUM> may be sent to the apparatus <NUM> via a wired or wireless connection to be displayed on the apparatus <NUM> such that no physical representation (e.g., films, photos, monitors) may be needed for this step.

At <NUM>, definitions of the insertion sagittal angle <NUM> of the pilot hole <NUM> and the initial position <NUM> of the pilot hole are provided by a user. This input operation may be performed using various input devices, including a computer mouse, a keyboard, a touchscreen, or the like. In one embodiment, a multi-touch screen (e.g., the display <NUM>) is used for both displaying the image and receiving the definition input from a user. Example illustrations of this input are provided in <FIG>.

At <NUM>, an angle-indicative line is generated by a processor and displayed on the display <NUM>. The angle-indicative line can rotate in response to the apparatus <NUM> rotation and provides a notification when the apparatus <NUM> approximately forms the insertion sagittal angle <NUM> between the apparatus <NUM> longitudinal axis <NUM> and the sagittal plane. In some implementations, the angle-indicative line is a rotating line generated in the display <NUM> that allows a user to constantly monitor the change of orientation of the apparatus <NUM>. The orientation monitoring is performed with an orientation apparatus <NUM>. More specifically, in some embodiments, a gyroscope <NUM> that includes at least one axis of rotation may provide the function of monitoring the apparatus's orientation or position.

The indicative line may generate notations in various forms, including a visual alert such as highlighting the angle-indicative line, an audio alert such as providing a continuous sound with variable frequency indicative of the proximity between the current angle and the desired angle, and a small vibration that allows the user to notice the angular change. It should be appreciated that any audio alert may be used, such as a single sound or series of sounds when the desired angle is reached. Likewise, a single vibration or a series of vibrations may be emitted when the desired angle is reached. In some implementations, the flow chart <NUM> illustrated in <FIG> may be applicable for generating indication angles in the transverse plane or the coronal plane for indicating a respective transverse angle or a coronal angle.

<FIG> illustrates a flow chart <NUM> of an implementation for indicating a transverse angle, which is an angle with respect to the transverse plane of the vertebra. The method of the flowchart <NUM> is for verifying any pedicle screw insertion angle in the transverse plane of the vertebra <NUM>. At <NUM>, the axis <NUM> of the apparatus <NUM> is aligned with the transverse plane. In some embodiments, a user may hold the apparatus <NUM> and rotate the apparatus <NUM> to match a marking indicating the axis <NUM> with features of the vertebra <NUM> that indicate the transverse plane. In some embodiments, the marking may be displayed on the screen as the user aligns the device.

At <NUM>, the image of the posterior view is captured in the coronal plane. In one embodiment, the apparatus <NUM> includes a smart phone, a tablet computer, a laptop computer, or any portable computational device including those that include a camera for capturing a representation of the cross-sectional view of the vertebra <NUM>. In other embodiments, the image of the vertebra <NUM> may be sent to the apparatus <NUM> via a wired or wireless connection to be displayed on the apparatus <NUM> such that no physical representation (e.g., films, photos, monitors) may be needed for this step.

At <NUM>, definitions of the insertion angle in the transverse plane <NUM>, and the initial position <NUM> of the pilot hole are provided by a user, as similar to the sagittal angle defined at <NUM>.

At <NUM>, an angle-indicative line for the corresponding transverse angle is generated by a processor and displayed on the display <NUM>. The angle-indicative line can rotate in response to the apparatus <NUM> rotation and provides a notification when the apparatus <NUM> approximately forms the insertion transverse angle, as defined in step <NUM>, between the apparatus <NUM> longitudinal axis <NUM> and the transverse plane. In some implementations, the angle-indicative line is a rotating line generated in the display <NUM> that allows a user to constantly monitor the change of orientation of the apparatus <NUM>. The orientation monitoring is performed with an orientation apparatus <NUM>. More specifically, in some embodiments, a gyroscope <NUM> that includes at least one axis of rotation may provide the function of monitoring the apparatus's orientation or position.

<FIG> illustrates a flow chart <NUM> of another implementation for indicating a coronal angle. The method of the flowchart <NUM> is for verifying any insertion angle of a pedicle screw <NUM> in the vertebra <NUM> in the coronal plane <NUM>. At <NUM>, the axis <NUM> of the apparatus <NUM> is aligned with the coronal plane. In some embodiments, a user may hold the apparatus <NUM> and rotate the apparatus <NUM> to match a marking indicating the axis <NUM> with features of the vertebra <NUM> that indicate the coronal plane. In some embodiments, the marking may be displayed on the screen as the user aligns the device.

At <NUM>, the image of the lateral view is captured in the sagittal plane. In one embodiment, the apparatus <NUM> includes a smart phone, a tablet computer, a laptop computer, or any portable computational device including those that include a camera for capturing a representation of the posterior view of the vertebra <NUM>. In other embodiments, the image of the vertebra <NUM> may be sent to the apparatus <NUM> via a wired or wireless connection to be displayed on the apparatus <NUM> such that no physical representation (e.g., films, photos, monitors) may be needed for this step.

At <NUM>, respective definitions of the insertion angle in the coronal plane <NUM>, and the initial position <NUM> of the pilot hole are provided by a user, as similar to the sagittal angle defined at <NUM>.

At <NUM>, an angle-indicative line for one of the corresponding coronal angle is generated by a processor and displayed on the display <NUM>. The angle-indicative line can rotate in response to the apparatus <NUM> rotation and provides a notification when the apparatus <NUM> approximately forms the insertion coronal angle between the apparatus <NUM> longitudinal axis <NUM> and the coronal plane. In some implementations, the angle-indicative line is a rotating line generated in the display <NUM> that allows a user to constantly monitor the change of orientation of the apparatus <NUM>. The orientation monitoring is performed with an orientation apparatus <NUM>. More specifically, in some embodiments, a gyroscope <NUM> that includes at least one axis of rotation may provide the function of monitoring the apparatus's orientation or position.

<FIG> illustrate examples of user interfaces for controlling a computer implemented program to perform the methods shown in <FIG>. <FIG> illustrates an interface <NUM> for selecting vertebra of a patient, <FIG> illustrates aligning the axis <NUM> of the apparatus <NUM> with the sagittal plane, <FIG> illustrates defining a pedicle screw's position and its sagittal angle <NUM>, and <FIG> illustrates generating an angle-indicative line <NUM> for showing the angle between the longitudinal axis of the apparatus and the sagittal plane. In some embodiments, the angle-indicative line may represent a virtual gearshift probe, or other instrument for aligning a pedicle screw or pilot hole. Where the virtual gearshift is properly aligned, the virtual gearshift may change colors, or may change length or width. The angle-indicative line can rotate in response to the apparatus <NUM> rotation and provides a notification when the apparatus <NUM> approximately forms the insertion coronal angle between the apparatus <NUM> longitudinal axis <NUM> and the coronal plane.

In <FIG>, the patient's profile may be selected or added by typing the last name of the patient in the window <NUM>. The corresponding vertebra for the desired angle is selected in the window <NUM>. The camera button <NUM> allows a user to take a picture of the vertebra. The picture is then shown in the window <NUM>. The button <NUM> allows the user to move onto the next step. As previously discussed, the picture at the vertebra may be provided without use of the camera or camera button <NUM>.

For example, by using a camera of a mobile device, a user can take a picture of an axial view (either CT or MRI) in the transverse plane <NUM>, of the desired vertebral body <NUM>. Use the red line <NUM> to line up the vertebral body so that it is proximately vertical for aligning with the sagittal plane (or other desired plane), as shown in <FIG>. A retake button <NUM> allows the user to go back to the previous steps to retake the image to ensure the alignment is proper. The button <NUM> allows the user to select the current photo to be used in the following operations.

After selecting button <NUM>, the user may be returned to the detail view as shown in <FIG>. The photo may, in some embodiments, be automatically flipped to approximate its position during surgery. Button <NUM> may be selected to flip the orientation of the photo. For example, the RL button <NUM> can be used to flip the picture (and pedicle screw) depending on whether the surgeon is placing the screw while looking towards the patient's head or towards their feet.

The user next selects the optimal pedicle screw position by selecting the navigation button <NUM>. and by moving the crosshairs <NUM> to the cortical entry point of the screw, then tapping the trajectory button <NUM> and rotate the screw to its desired position <NUM>.

Tap the Nav button <NUM> and a virtual gearshift probe <NUM> appears on the screen. The gearshift probe's orientation matches the orientation of the apparatus <NUM>. In some embodiments, once the angle of the gearshift probe <NUM> is about <NUM> degrees within the selected trajectory, the gearshift probe <NUM> will turn yellow, at <NUM> degrees, it will turn green, and when the alignment is within <NUM> degree of the target angle, a green line <NUM> will extend outward and the pedicle screw will disappear.

In some embodiments, the device or apparatus <NUM> can be placed in a sterile bag and then be placed against the gearshift probe as it is being used to create the path for the pedicle screw.

Some gearshift probes may be too short to allow the device (apparatus <NUM>) to be placed against them lengthwise. If this is the case, tap the <NUM> degree button <NUM> and the screen will be rotated so the short edge of the device can be placed against the gearshift probe.

Other implementations of the disclosed system and method are possible. For example, the apparatus <NUM> may also use a second or more views to define various angles not limited within the sagittal plane. For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.

In addition, different mobile computer devices may be used or modified into the apparatus <NUM> by equipping corresponding image acquisition units, input terminals, and motion or orientation sensing units. In some embodiments, the apparatus <NUM> includes a smart phone or another electronic device having a gyroscope. In addition, other motion or orientation sensors may be included such as the inertial measurement unit <NUM>, and the accelerometers <NUM>. The apparatus <NUM> may also be attached onto various medical devices or equipment for guiding insertion angles that require high precision and ease of use. The smartphone may be an iPhone for example. Also, in some application, the mobile computer device may be an iPod Touch, iPad, Android phone, Android tablet, Windows Phone, Windows tablet, or Blackberry phone. Also, in some applications, the mobile computer device may be an Apple TV in combination with an Apple TV remote, or a Nintendo Wii in combination with a Nintendo Wii remote. Indeed, the mobile computer device may be any combination of electronic devices where the orientation sensor (such as a gyroscope) is in one electronic device and the processor is in another electronic device.

Claim 1:
An electronic device (<NUM>) for determining orientation of an instrument for inserting a medical device in a bone, the electronic device (<NUM>) being configured to align the instrument for inserting the medical device at a desired orientation at an insertion point of the bone by indicating when an orientation of the electronic device is within a threshold of the simulated orientation, the electronic device comprising:
an attachment mechanism (<NUM>) for affixing or coupling the electronic device to the instrument for creating a tract in the bone for receiving the medical device;
an orientation sensor (<NUM>);
a display (<NUM>); and
a processor (<NUM>) configured to:
simulate insertion of the medical device in an image of the bone, and show the simulated insertion of the medical device in the image of the bone on the display (<NUM>) of the electronic device, wherein the simulated insertion allows a user to determine a desired insertion angle of the medical device relative to a plane of the bone;
receive, from the orientation sensor (<NUM>), an orientation of the electronic device;
determine an orientation of the electronic device relative to the plane based on the orientation from the orientation sensor (<NUM>);
output a notification on the display (<NUM>) of the electronic device when the orientation of the electronic device is such that the electronic device is positioned adjacent the desired insertion angle of the medical device relative to the plane of the bone, wherein the notification includes a first graphical element representing the orientation of the electronic device and a second graphical element representing the desired insertion angle of the medical device; and
monitor, using the orientation sensor (<NUM>), the orientation of the electronic device based on calculating the orientation based on dynamic changes in the orientation and position of the electronic device.