SYSTEMS, METHOD AND DEVICES FOR ASSISTING OR PERFORMING GUIDING INTERVENTIONAL PROCEDURES USING INERTIAL MEASUREMENT UNITS AND MAGNETOMETER SENSORS

An instrument tracker includes a case having an interior and exterior with a plurality of instrument seats, an inertial measurement unit (IMU), and a controller. The IMU and controller are arranged within the interior of the case and the controller is disposed in communication with the IMU and is responsive to instructions recorded on a memory to receive position information from the IMU, determine at least one of position and orientation of an instrument fixed relative to the case by the plurality of instrument seats using the position information received from the IMU, and transmit the at least one of position and orientation to a display device for displaying position and orientation of the instrument relative to a predetermined insertion path through a subject between an entry point on the surface of the subject and a region of interest within the interior of the subject. Instrument tracking systems and methods tracking position of instruments are also described.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present disclosure is directed to interventional procedures, and more particularly to a guided interventional procedures using instrument-mounted inertial measurement units.

2. Description of Related Art

Intervention procedures, such as computed tomography intervention procedures, are commonly used to deliver therapy to a targeted region of the subject undergoing the intervention procedure. Intervention procedures generally entail inserting a needle into the subject and advancing the needle into the subject to the targeted region and delivering a selected therapy. Examples of therapies include ablation, etc. Needle orientation and position is typically done freehand, i.e., by relying on the skill of a surgeon in manipulating the needle during advancement, to avoid damaging structures along the needle advancement path.

Various techniques are known to control accuracy of needle positioning during freehand needle insertions. For example, robotic-assisted, cone beam computed tomography, laser guidance, optical tracking, electromagnetic tracking, fused modality imaging have all been used to improve needle accuracy during needle insertions in intervention procedures. Robotic systems with guidance systems have been employed in microwave thermoablation intervention procedures. Cone beam computed tomography has been used to reduce tip to target error between the needle and target in certain intervention procedures. Laser guidance systems have been used track needle position during other intervention procedures. Optical tracking systems, generally employing cameras and tracking markers emplaced on the subject have been used in still other intervention procedures. Electromagnetic tracking, which utilizes the electromagnetic properties of the need for tracking, has been used to improve needle positioning accuracy in other intervention procedures. Modality fusion techniques, where imaging information from more than imaging modality as fused to provide an image using date from the more than one imaging modality, have been used in still other intervention procedures to improve needle position accuracy.

While generally satisfactory for their intended purpose the known methods of needle position monitoring each have limitations that can limit the application of the technique. For example, robotic systems can bring added cost, complexity, and additional workflow to intervention procedures. Cone beam CT techniques can be limited to needle size. Laser guidance systems can impose requirements on the patient that are impractical, for example requiring the patient to remain motionless for extended periods of time. Optical tracking can require line of sight between the cameras and tracking markers on the instrument, imposing restrictions on movement during the intervention procedure. Electromagnetic tracking techniques can be frustrated by the presence of metal or magnetic objects in the vicinity of the needle. And mixed mode imaging techniques require registration of images using fiducial markers, which adds complexity sources error.

Such conventional methods and systems have generally been considered satisfactory for their intended purpose. However, there is still a need in the art for improved systems and methods for instrument tracking, visualizing, and monitoring during intervention procedures.

The present disclosure provides a solution for this need.

SUMMARY OF THE INVENTION

An instrument tracker includes a case having an interior and exterior with a plurality of instrument seats, an inertial measurement unit (IMU) arranged within the interior of the case, and a controller. The controller is arranged within the interior of the case, is disposed in communication with the IMU, and is responsive to instructions recorded on a non-transitory machine readable medium to receive position information from the IMU and determine at least one of position and orientation of an instrument fixed relative to the case by the plurality of instrument seats using the position information received from the IMU. The instructions also cause the controller to transmit the at least one of position and orientation to a display device for displaying position and orientation of the instrument relative to a predetermined insertion path through a subject between an entry point on the surface of the subject and a region of interest within the interior of the subject.

In certain embodiments the case can include four supports arranged on the interior of the case to support the IMU. The plurality of instrument seats can define an instrument channel. The instrument channel can be substantially perpendicular to the case. The case can include a grip with a finger seat disposed on the exterior of the case. The finger seat can be disposed on the on a side of the grip opposite the plurality of instrument seats. The case can include a finger ring disposed on the exterior of the case. One of the plurality of instrument seats can be disposed on a side of the other of the plurality of instrument seats opposite the finger ring.

In accordance with certain embodiments the IMU can include one or more of a magnetometer, an accelerometer, and a gyroscope. The one or more of a magnetometer, an accelerometer, and a gyroscope can be disposed in communication with the controller. A battery can be battery arranged within the interior of the case end. The battery can be electrically connected to the IMU and the controller. A wired charging circuit can be electrically connected to the battery for direct-connect charging of the battery. A wireless charging circuit can be electrically connected to the battery for wirelessly charging of the battery. The instrument tracker can include a wireless communication module for communication with a display device. The controller can be operatively connected to the wireless communication module.

It is contemplated that an instrument can be received within the plurality of instrument seats and fixed relative to the case. The instrument can include a needle, a catheter, or a portable imaging device. The tracking instrument can include a tracker user interface. The tracker user interface can be fixed relative to the case. The controller can be operatively connected to the tracker user interface. The tracker user interface can include an auditory module and/or a display module. It is also contemplated that the region of interest can include an anatomical target of a subject undergoing an intervention procedure, such as a tumor.

In further embodiments a display device can be in wireless communication with the tracker controller. The display device can have a display device controller communicative with a display device memory. The display device memory can have instructions recorded on it that, when read by the display device controller, cause the display device controller to receive image data including the subject of interest, define a path to the subject of interest extending between an entry point located on a subject and a region of interest disposed within the subject, and receive data from the instrument tracker indicative of angular position and insertion depth of the instrument fixed relative to the tracker. The instructions can cause the display device to display the instrument angular position and/or insertion depth relative to the insertion path defined between the surfaced of the subject and the region of interest.

An instrument tracking system includes an instrument tracker as described above with a wireless communication module and a display device. The tracker controller is operatively connected to the wireless communication module for communicating at least one of angular orientation and insertion depth to the display device. The display device is in wireless communication with the tracker controller has a display device controller in communication with a memory. The memory has a non-transitory machine readable medium with instructions recorded on it that, when read by the display device controller, cause the display device controller to receive image data of the subject including a region of interest, define an insertion path to the region of interest extending between an entry point located on the surface of the subject and the region of interest, receive data from the instrument tracker indicative of at least one of angular position and insertion depth of an instrument received within the plurality of instrument seats on the case of the instrument tracker, and display the at least one of the instrument angular position and insertion depth relative to the insertion path defined to the region of interest located within the subject.

In certain embodiments the instrument tacking system includes an imaging device disposed in communication with the display device. The imaging device can include one or more of an x-ray imaging device, a computerized tomography device, a positron emission tomography imaging device. The imaging device can include one or more of a magnetic resonance imaging device, a ultrasound imaging device, and a fluoroscopic imaging device.

A method of tracking position of an instrument includes fixing an instrument tracker as described above to an instrument, receiving position information from the IMU, and determining at least one of angular orientation and insertion depth of the instrument using the position information received from the IMU. The at least one of the angular orientation and insertion depth of the instrument is transmitted to a display device disposed in communication with the instrument tracker, the at least one of angular orientation and insertion depth of the instrument compared to a predetermined instrument insertion path defined between an entry point, located on the subject, and the region of interest within the subject, and the difference between the at least one of angular orientation and insertion depth of the instrument to the instrument path displayed on the display device.

In certain embodiments the method can include imaging a subject including a region of interest located within the subject. The method can include determining the predetermined instrument insertion path using imaging data acquired during imaging of the subject. At least one of the angular orientation and the insertion depth of the instrument can be adjusted based on the comparison between the difference between the at least one of angular orientation and insertion depth of the instrument to the instrument path on a display device. Position of the instrument can be confirmed by imaging the instrument and the subject including the region of interest subsequent to completion of insertion of the instrument along the insertion path. These and other features of the systems and methods of the subject disclosure will become more readily apparent to those skilled in the art from the following detailed description of the preferred embodiments taken in conjunction with the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made to the drawings wherein like reference numerals identify similar structural features or aspects of the subject disclosure. For purposes of explanation and illustration, and not limitation, a partial view of an exemplary embodiment of an instrument tracker in accordance with the disclosure is shown inFIG. 3and is designated generally by reference character100. Other embodiments of instrument trackers, instrument tracking systems, and methods of tracking instruments in accordance with the disclosure, or aspects thereof, are provided inFIGS. 1, 2 and 4-25B, as will be described. The systems and methods described herein can be used for tracking position of instruments during intervention procedures, such as needle position relative to a predetermined insertion during cancer treatments, though the present disclosure is not limited to cancer treatment interventions nor to needle positioning in general.

Referring toFIG. 1, a subject10is shown. Subject10has surface12with a region of interest14located within an interior16of subject10. Subject10also has a plurality of obstacles18located within interior16between surface12and region of interest14, obstacles18limiting the possible insertion paths to region of interest14from surface12. In certain embodiments subject10is a patient, region of interest14is a tumor that is the subject of an intervention procedure entailing the insertion of an instrument20(shown inFIG. 4) into subject10, and obstacles18are bony structures or blood vessels which are to be avoided when introducing instrument20into subject10. Instrument20can include one or more of a needle, a catheter, and a portable imaging device, as suitable for an intended intervention procedure. It is contemplated that region of interest14include an anatomical target of subject10undergoing the intervention procedure, such as a tumor by way of non-limiting example.

With reference toFIG. 2, imaging subject10including region of interest14located within subject10is shown. Imaging subject10includes positioning subject10within an imaging device22and acquiring image data24including subject10and region of interest14. Imaging data24is communicated using a communications link to a display device26, which reconstructs an image of subject10include region of interest14and obstacles18. It is contemplated that imaging device22can include one or more of an x-ray imaging device, a computerized tomography device, a positron emission tomography imaging device, a magnetic resonance imaging device, and a ultrasound imaging device disposed in communication with display device26, as suitable for an intended application.

With reference toFIG. 3, display device26is shown. Display device26includes a display device controller28, a memory30, a user interface32, a processor34, and an interface36. Processor34is disposed in communication with memory30. Memory30includes a non-transitory machine readable medium having a plurality of program modules38recorded on memory30. Program modules38include instructions that, when read by processor34cause processor34to undertake certain actions, e.g., a method200(shown inFIG. 21) of tracking position of an instrument.

Display device26receives image data24from imaging device22(shown inFIG. 2) and reconstructs an image40including subject10. Further, using image data24and/or in conjunction with user input received at user interface32, display device26generates an insertion path42. Predetermined insertion path42extends between an entry point44surface12of subject10and region of interest14. It is contemplated that predetermined insertion path42bypass obstacles18during an intervention procedure targeting region of interest14, avoiding obstacles and/or collateral injury that otherwise could occur to obstacles18during insertion and/or intervention. This path planning, which can be coincident with imaging subject10, results in the generation of a predetermined insertion path42between entry point44and region of interest14. Although a single insertion path and region of interest are show inFIG. 3those of skill in the art will appreciate that more than one insertion path and/or more than one region of interest14can exist within subject10.

With reference toFIG. 4, instrument20is shown in an initial placement on surface12of subject10. As is possible under some circumstances, the illustrated placement of instrument20is offset from the entry point44. To visualize the relative position of instrument20relative to predetermined insertion path42instrument tracker100is removably fixed to instrument20. Instrument tracker100is configured and adapted to transmit at least one of position information46and angular orientation information48of instrument20to display device26. Display device26in turn displays at least one of position information46and angular orientation information48of instrument20relative to predetermined insertion path42, thereby providing the user with real-time indication of registration (and/or registration error) of instrument20with predetermined insertion path42in image40. It is contemplated that, based on display

It is contemplated that, based on image40containing subject10and predetermined insertion path42, that a user50adjust position of instrument20relative to subject10. This is illustrated schematically inFIG. 5, wherein user50is shown adjusting52position of instrument20using tactile engagement of instrument tracker100, and therethrough instrument20, to register instrument20with entry point44. It is also contemplated that, based on image40containing subject10and predetermined insertion path42, that user50adjust angular orientation of instrument20relative to subject10. This is illustrated schematically inFIG. 6, wherein user50is shown adjusting54position of instrument20using tactile engagement of instrument tracker100, and therethrough instrument20, to align instrument20with predetermined insertion path42.

With reference toFIG. 7, instrument20is shown being advanced into subject10along predetermined insertion path42. Instrument20is advanced58along predetermined insertion path42by user50by tactile engagement with instrument tacker100. This causes instrument20to approach region of interest14in the general direction of predetermined insertion path42. Progress of instrument20through subject10is provided real time through at least one of position information46and angular orientation information48of instrument20relative to predetermined insertion path42communicated wireless by instrument tracker100to display device26, which displays position and orientation of instrument20relative to predetermined insertion path42in image40.

As will be appreciated by those of skill in the art, position and/or orientation of instrument20can diverge from predetermined insertion path42. Display device26displays divergence56, which allows user to make one or more corrective adjustments58during insertion response to the at least one of position information46and angular orientation information48of instrument20relative to predetermined insertion path42presented in image40on display device26. An exemplary corrective adjustment58is shown inFIG. 8, which shows instrument20aligned and registered to predetermined insertion path42.

With reference toFIGS. 9 and 10, it is contemplated that user50advance instrument20along predetermined insertion path42using at least one of position information46and angular orientation information48of instrument20relative to predetermined insertion path42presented in image40until instrument20reaches region of interest14. Subject10and instrument20are thereafter imaged using imaging device22, optionally, to confirm the at least one of position information46and angular orientation information48of instrument20relative to predetermined insertion path42reported by instrument tracker100adequately represent the position and orientation of instrument20relative to region of interest14prior to proceeding with further steps in the selected intervention therapy.

With reference toFIG. 11, instrument tracking system200is shown. Instrument tracking system includes instrument tracker100(shown inFIG. 4) and display device26(shown inFIG. 3). Instrument tracker100includes a wireless communication module108(shown inFIG. 12) for wireless communication with display device26and controller106(shown inFIG. 12) operatively connected to wireless communication module108for communicating at least one of position information46(shown inFIG. 4) and angular orientation information48(shown inFIG. 4) of instrument tracker100to display device. Position information46and angular orientation information48are generated using position information controller106receives from IMU104(shown inFIG. 12), which can include magnetometer134(shown inFIG. 12). Controller106fuses the position information46and angular information48with image data24(shown inFIG. 2) of subject10(shown inFIG. 1) for display on display device26.

Display device26is in wireless communication with tracker controller106(shown inFIG. 12). Controller34(shown inFIG. 3) of display device26is in communication with memory30of display device26, which has a non-transitory machine readable medium with instructions recorded on it that, when read by the display device controller34, cause the display device controller to receive image data24of subject10(shown inFIG. 1) including region of interest14(shown inFIG. 1), define predetermined insertion path42(shown inFIG. 3) to region of interest10extending between entry point44(shown inFIG. 3) located on surface12(shown inFIG. 3) of subject10and region of interest14, receive the at least one of position information46(shown inFIG. 4) and angular orientation information48(shown inFIG. 4) from instrument tracker100indicative of at least one of angular position and insertion depth of instrument20received within the plurality of instrument seats126(shown inFIG. 12) on case102(shown inFIG. 12) of instrument tracker100, and display the at least one of the instrument angular position and insertion depth relative to predetermined insertion path42defined to the region of interest14located within subject10. Although the data fusing and processing is shown inFIG. 11as occurring on instrument tracker controller106(shown inFIG. 12), it is to be understood that the data fusing and processing can be done on the display unit controller34(shown inFIG. 3), such as in a smartphone or tablet app. As will be appreciated by those of skill in the view of the present disclosure, the data fusing can be done on both instrument tracker controller106and display unit controller34, as suitable for an intended application.

Referring toFIGS. 12-15, instrument tracker100is shown. Instrument tracker100includes a case102, an inertial measurement unit104, and a controller106. Instrument tracker100also includes a wireless communication module108, a battery module110, a charging module112, and user interface module114. A memory116having a non-transitory machine readable medium with a plurality of program modules119recorded on it is disposed in communication with controller106.

Controller106has a processor and is disposed in communication with IMU104and memory116. The instructions recorded in the plurality of program modules119on memory116cause controller106to perform certain operations to generate the at least one of position information46and angular orientation information48of instrument20. More particularly, the instructions recorded in the plurality of program modules119cause controller106to receive position information P from IMU104, determine at least one of position information46and angular orientation information48(e.g., insertion depth) of instrument20, and transmit the at least one of position information46and angular orientation information48relative to subject10(shown inFIG. 1) and relation to region of interest14(shown inFIG. 1) located within subject10to display device26(shown inFIG. 2).

Display device26in turn determines the instrument position and instrument orientation, compares the instrument position and instrument orientation to a predetermined insertion path42(shown inFIG. 2) defined between an entry point44(shown inFIG. 2) located on the subject and the region of interest within the subject, and displays the comparison in an image40(shown inFIG. 3) to provide indication of position and orientation of instrument20relative the predetermined insertion path42(shown inFIG. 2)

Controller106is further operatively connected to wireless communication module108for wireless communication with display device26(shown inFIG. 2) to communicate thereto the at least one of position information46and angular orientation information48of instrument20. Controller106is also operatively connected to user interface114for providing indication of the at least one of position information46and angular orientation information48of instrument20directly to user to user50(shown inFIG. 5).

User interface114is fixed relative to case102and is disposed in communication with controller106, controller106thereby being operatively connected to user interface114. In certain embodiments user interface114includes an auditory module136, which is configured to provide auditory messages to user50(shown inFIG. 5). In accordance with certain embodiments user interface114includes a display module138, which is configured to provide a visual indication directly to user50, such as state of charge, etc. Battery module110is electrically connected to user interface114to provide a supply of electrical power to user interface114.

Battery module110is electrically connected to wireless communication module108, IMU104, and controller106for providing a supply of electrical power wireless communication module108, IMU104, and controller106. In certain embodiments battery module114is configured to provide about four (4) hours of power to instrument tracker100. In accordance with certain embodiments battery module114have a charging cycle of about one (1) hour, thereby requiring a relatively short period of time for use. Charging can be accomplished using wireless charging module112. Examples of suitable batteries include lithium batteries, e.g., DTP502535-PHR, capable of providing 400 mAh for about four hours of service between charging cycles.

Charging module112is electrically connected to battery module110for charging battery module110. In certain embodiments charging module112can include a physical wire receptacle140for providing power to instrument tracker100and battery module110. In accordance with certain embodiments charging module112can include a wireless charging module142for wireless charging battery module110, such as with a coil and/or winding arrangement. As will be appreciated, wireless charging module142can simplify the arrangement of instrument tracker100while extending to time interval during which instrument tracker100can provide the at least one of position information46and angular orientation information48of instrument20.

Wireless communication module108is configured and adapted for wireless communication of the at least one of position information46and angular orientation information48of instrument20to display device26(shown inFIG. 2). In this respect controller106is operatively connected to wireless communication module108and arranged to push the at least one of position information46and angular orientation information48of instrument20to display device via wireless communication module108. The wireless communication can be via Bluetooth, WiFi, Zeebee, or any other wireless communication protocol, as suitable for an intended application.

With reference toFIG. 15, case102is shown. Case102has interior118, an exterior120, and a plurality of instrument seats122arranged on exterior120. Instrument seats122define an instrument channel124and are arranged to removably fix instrument20to instrument tracker100. This allows instrument20to be received within the plurality of instrument seats122, instrument20thereby being fixed relative to case102. It is contemplated that case102can be formed using an additive manufacturing technique, such as by use of a Formlab® 3D printer, available from Formlabs Inc. of Somerville, Mass. It is contemplated that case102can disposable or reusable with a sterilization cover bag.

As will be appreciated by the those of skill in the art in view of the present disclosure, supporting IMU104at a 90-degree angle suitable aligns the principle axis (or exes) of devices contained within IMU104to provide the at least one of position information46and angular orientation information48of instrument20relative to instrument tracker100. As also shown inFIG. 12, case102can have four supports126arranged within interior118to support IMU104. It is contemplated that supports126be arranged to support IMU104at an angle relative to instrument channel that is about 90-degrees.

With reference toFIGS. 16A-16C, an instrument tracker300is shown according to an exemplary embodiment. Instrument tracker300is similar to instrument tracker100(shown inFIG. 3) and additionally includes a case302. Case302includes a grip304with a finger seat306. Finger seat302is disposed on an exterior308of case302and on a side310of grip304opposite the plurality of instrument seats312. As will be appreciated by those of skill in the art in view of the present disclosure, the illustrated arrangement provides tactile engagement of user50suitable for manipulating instrument20with suitable control during insertion subject10(shown inFIG. 1) while providing the at least one of position information46and angular orientation information48of instrument20relative instrument tracker300.

With reference toFIG. 17, an instrument tracker400is shown according to another exemplary embodiment. Instrument tracker400is similar to instrument tracker100(shown inFIG. 3) and additionally includes a case402. Case402includes a grip404with a finger ring406. Finger ring406is disposed on an exterior408of case402. Finger ring406is arranged along instrument channel410such that a first412of the plurality of instrument seats is disposed on a side of a second414of the plurality of instrument seats opposite finger ring406. As will be appreciated by those of skill in the art in view of the present disclosure, the illustrated arrangement also provides tactile engagement of user50suitable for manipulating instrument20with suitable control during insertion subject10(shown inFIG. 1) while providing the at least one of position information46and angular orientation information48of instrument20relative instrument tracker400.

With continuing reference toFIGS. 12-15, IMU104is configured and adapted to provide the at least one of position information46and angular orientation information48of instrument20relative to instrument tracker100using one or more measurement device. In this respect IMU104includes at least one of a gyroscope130, an accelerometer132, and a magnetometer134for angular tracking required for instrument navigation in image-guided intervention therapies.

IMU104is an electronic device that measures and reports a body's specific force, angular rate, and sometimes the magnetic field surrounding the body, using a combination of accelerometers, gyroscopes, and/or magnetometers. IMU104operates by detecting linear acceleration using one or more accelerometers132and rotational rate using one or more gyroscopes130. In certain embodiments IMU104employs the one or more magnetometer134to provide a heading reference. In certain embodiments IMU104includes one accelerometer, one gyroscope, and one magnetometer per axis for each of the three axes: pitch, roll and yaw.

In certain embodiments IMU104includes a vibrating structure gyroscopes manufactured with micro-electro-mechanical system (MEMS) technology. The MEMS-based IMU104is packaged like an integrated circuit and can provide either analog or digital outputs. In accordance with certain embodiments, a singular MEMS package includes gyroscopes130for more than one axis. It is contemplated IMU103can include a plurality of gyroscopes130and accelerometers132(or multiple-axis gyroscopes and accelerometers) to provide positional information and angular information indicative of six full degrees of freedom on instrument20. Advantageously, IMU104implemented with MEMS device is relatively simple and inexpensive relative to rotating gyroscopes of having similar accuracy, and can be similar in arrangement to MEMS devices employed in smartphone, gaming device, and camera applications.

Magnetometer134is configured and adapted to measure magnetism—either magnetization of magnetic material like a ferromagnet, or the direction, strength, or the relative change of a magnetic field at a particular location. In certain embodiments magnetometer134has solid state devices cooperatively defining a miniature Hall-effect sensor, which detects the Earth's magnetic field along three perpendicular axes X, Y and Z. The Hall-effect sensor in turn produces a voltage which is proportional to the strength and polarity of the magnetic field along the axis each sensor is directed. The sensed voltage is converted to digital signal representing the magnetic field intensity. In certain embodiments magnetometer134can include one or more magneto-resistive device have resistance that changes based on changes in the magnetic field. It is contemplated that magnetometer134can be packaged in a small electronic chip, with or without another sensor device, e.g., accelerometer132, for purposes of correcting the raw magnetic measurements using tilt or gyroscopic information from co-packaged sensor device. In addition to providing rotational information, magnetometer134can provide information for detecting the relative orientation of instrument tracker100relative to the Earth's magnetic north.

In the illustrated exemplary embodiment IMU104includes each of gyroscope130, accelerometer132, and magnetometer134. In certain embodiments IMU104can include a plurality of gyroscopes, a plurality of accelerometers, and a plurality of magnetometers.

In an exemplary embodiment instrument tracker100has a needle guide, a solid case, and electronics of one or more IMUs and/or magnetometers, batteries, one or more controllers, wire and wireless charger modules, wire and wireless communication modules, and audio and visual indicator electronics. The IMU and magnetometer measure the orientation and positional information of the needle guide by fusing the acquired data. The controller provides kinematic calculation, a manages communication between internal audio and visual indicators and external computer, tablet, smartphone devices that display navigation information. The battery provides power of the tracker. A charger module charges the battery of the tracker in the form of wire and/or wireless charging. A communication module connects an external device, including a computer, a tablet, and/or a smartphone device using wire or wireless communication module including but not limited to Bluetooth, WIFI, Zeebee or other wireless communication protocol. The needle guide is configured to allow an instrument to pass through for use in the guided interventional medical procedure.

With reference toFIGS. 18A-18C, instrument tracker100can provide a compact wireless device that can be clipped onto any medical device/needle instrument. Further, instrument tracker100can provide 6 degrees-of-freedom (DOF) sensing (3DOF from the gyroscope, 3DOF from the accelerometer, and 3DOF from the magnetometer). Moreover, instrument tracker100can be configured to wirelessly stream data via Bluetooth and has embedded rechargeable battery.

In an aspect instrument tracker100can employ sensor fusion. More particularly IMU104, which can have one or more of an accelerometer, a gyroscope, and a magnetometer, and the measured gravity vector together with data fusion and signal processing methods to enhance needle tracking accuracy. Combining a magnetometer with a gravity sensor can help correct for gyroscope drift. Employing sensor models and a sensor fusion algorithm an accurate estimate of orientation given the inertial guidance input can be provided.

In another aspect no pre-calibration is required for in-axial-plane needle insertions. Instead, during instrument tracking the needle angles (e.g., X and Y axis rotations) are dynamically adjusted with the gravity vector to ensure its accuracy by eliminating accumulative errors caused by gyroscope drifts. In-axial-plane needle instrument insertion is the most common approach in CT-guided procedures.

With reference toFIGS. 19A-19B, calibration of instrument tracker100is shown. In a further aspect one-touch calibration can be used for off-axial-plane needle insertion. In this respect, for tumor targets at different locations requiring off-plane targeting, a calibration procedure of the instrument tracker can be done in a fast and simple one-touch step. Calibration can be accomplished by placing instrument tracker100at any two perpendicular edges of the CT table that aligns the tracker to the X and Z-axes of the CT table, as shown inFIG. 19B. The calibration can be takes approximately a few seconds to generate the calibration matrices and can be performed prior to instrument insertion.

With reference toFIG. 20, instrument tracking system200is shown. It is contemplated that display device26and instrument tracker100feature an optimized clinical workflow for CT-guided needle ablative procedures, which has been tested for targeting accuracy of ablations in tumors using an anthropomorphic abdominal phantom and using swine models. Program modules on instrument tracker100and display device26can be configured for computer Windows OS, and a lightweight version of the software application is also available on smartphones and tablets (FIG. 3). In certain embodiments the program modules include one or more of three-dimensional volumetric rendering, segmentation, treatment planning, and visualization of regions of interest14(e.g., tumor targets) and obstacles18(e.g., adjacent structure). User50, such as a physician, uses the application interface to view and edit segmentation results; contribute to trajectory planning by indicating possible needle insertion points; review and, if necessary, change the treatment plan; and deliver ablations.

Display device26can include a computer device, a tracking device, an imaging device, a template (or needle guide assembly), one or more surgical device or surgical device assemblies, a dynamic reference device, or other components. Further, display device26can be communicative with one or more servers, personal computers, portable (e.g., laptop) computers, mobile computers, tablet computers, cell phones, smart phones, PDAs, or other computer devices. Computer device may send, receive, store, or manipulate data necessary to perform any of the processes, calculations, image formatting, image display, or other processing operations described herein. The computer devices may also perform any processes, calculations, or processing operations necessary for the function of the devices, instruments, or other system components described herein. The computer device may include one or more processor(s), one or more storage device(s), a power source, a control application comprising computer program instructions, one or more inputs/outputs, at least one display device, one or more user input devices, or other components.

Processor(s), such as those within the controllers, may include one or more physical processors that are programmed by computer program instructions that enable various features and functionality described herein. For example, processor(s) may be programmed by control application (described below) and/or other instructions.

Storage device may comprise random access memory (RAM), read only memory (ROM), and/or other memory. The storage device may store the computer program instructions to be executed by processor(s) as well as data that may be manipulated by processor(s). Storage device may also comprise floppy disks, hard disks, optical disks, tapes, or other storage media for storing computer-executable instructions and/or data.

The actual display of display device26can include a computer monitor or other visual display device such as, for example, an LCD display, a plasma screen display, a cathode ray tube display, or other display device. The user interface of display device26can include a mouse, a stylus, a keyboard, a touchscreen interface (which may be associated or integrated with display device), a voice-activated input device (e.g., including a microphone and/or associated voice processing software), or other device that enables a user (e.g., a physician performing a procedure, an assistant thereto, or other user) to provide input to computer device and/or other components of system. One or more input devices may be utilized. In one implementation, display device and input device may together be configured as a mobile computing platform such as a tablet computer that is connected wirelessly to computer. Other configurations may be implemented. Inputs/outputs enable various system components such as tracking device, imaging device, template (or needle guide assembly), one or more surgical device or surgical device assemblies, dynamic reference device, or other components to communicate with computer device (e.g., in a wired or wireless manner) as known and understood by those having skill in the art.

Display device26can be connected to other computer devices and/or other system components via a network, which may include any one or more of, for instance, the Internet, an intranet, a PAN (Personal Area Network), a LAN (Local Area Network), a WAN (Wide Area Network), a SAN (Storage Area Network), a MAN (Metropolitan Area Network), a wireless network, a cellular communications network, a Public Switched Telephone Network, and/or other network.

Display device26can be operatively connected (e.g., via the aforementioned network) to one or more databases. A database may be, include, or interface to, for example, an Oracle™ relational database sold commercially by Oracle Corporation. Other databases, such as Informix™, DB2 (Database 2) or other data storage, including file-based, or query formats, platforms, or resources such as OLAP (On Line Analytical Processing), SQL (Structured Query Language), a SAN (storage area network), Microsoft Access™ or others may also be used, incorporated, or accessed. The database may comprise one or more such databases that reside in one or more physical devices and in one or more physical locations. The database may store a plurality of types of data and/or files and associated data or file descriptions, administrative information, or any other data, as described herein.

Imaging device22can include an x-ray imaging device, computerized tomography imaging device, a positron emission tomography imaging device, a magnetic resonance imaging device, a fluoroscopy imaging device, an ultrasound imaging device, an isocentric fluoroscopic imaging device, a rotational fluoroscopic reconstruction imaging device, a multi-slice computerized tomography imaging device, an intravascular ultrasound imaging device, an optical coherence tomography (OCT) device, an optical imaging device, a single photon emission computed tomography imaging device, a magnetic particle imaging device, or any other suitable imaging/scanning imaging device. In certain embodiments, imaging device22may include one or more instrument tracker100so that the location and orientation of the imaging device22may be tracked by the one or more instrument tracker100. For example, an ultrasound imaging device may include a position-indicating element enabling its scan plane to be known. Similarly, a fluoroscopic imaging device may include a tracking target. In certain embodiments a template (or needle guide assembly) assembly can be employed using template (also referred to as a targeting template or needle guide) and a position-indicating element or template tracker, which may be attached (permanently or removably) to the template or to a frame that surrounds (or encompasses) all or a portion of the template.

Template tracker may comprise a mechanical template that can be tracked by the tracker. The template (or needle guide assembly) may further comprise a support mechanism or structure used to support and/or position the template assembly vis-à-vis a target (e.g., a patient's anatomy). The support mechanism may comprise dials or other controls to adjust and fine tune the position of the template. Examples of a support mechanism may include a Biojet (D&K Technologies GmbH, Barum Germany) or the Multi-purpose Workstation LP (Civco Inc., Coralville Iowa) that may include motors and/or encoders. In certain embodiments, the template assembly may be supported and/or moved into position in an automated manner using a robotic mechanism attached to the support mechanism.

In accordance with certain embodiment, instrument tracking system200may include one or more surgical devices or device assemblies, the position and orientation of which may be tracked by tracking device. Examples of surgical devices may include therapeutic devices such as needles, ablation needles, radiofrequency ablation needles, lasers and laser delivery systems, blades, cryoablation needles, microwave ablation needles, HIFU delivery systems, and radiation delivery devices, or other therapeutic devices. Monitoring probes for measuring temperature or dose, etc. may also be used along with probes that perform a protective function such as cooling an area that is adjacent to a region that is being ablated using heat, etc. In some implementations, needles may further serve as elements that also restrain the anatomy from motion.

In further embodiments a dynamic reference device can be employed. For example, instrument tracking system200can include a dynamic reference device capable of tracking a patient's anatomy. Examples of dynamic reference device may include, but are not limited to, a tracked Foley catheter, a skin patch, etc.

The controller can employ a control application, such as a host control application. The control application can include a computer software application that includes instructions that program processor(s) (and therefore computer device) to perform various processing operations. For example, the control application may cause computer device to send, receive, and/or manipulate data regarding the anatomy of a patient, one or more objects, or other data. This data may be stored in memory device, or in another data storage location (e.g., the one or more databases described above). In certain embodiments the computer device may receive live data (in real-time) or stored data. The computer device may send, receive, and/or manipulate data regarding the location, position, orientation, or coordinate(s) of a position indicating element (e.g., sensor coils or other position indicating elements), or one or more other elements, received by tracking device. This data may also be stored in memory device or in another data storage location (e.g., the one or more databases described above).

Control application may further cause computer device to produce, format, reformat, or otherwise manipulate one or more images, position/orientation/location data, or other data. Images may be displayed on display device. In some implementations, one or more live images may be displayed. Display device may further display (or otherwise convey) audio data in addition to, or instead of, visual data. Such an audio display may produce tones or other indicators regarding the system.

Control application may additionally cause computer device to generate and display images of the anatomy of a patient along with the position or orientation of an instrument, fiducials, or both (or other information) superimposed thereon in real-time such that motion of the tracked instrument within the anatomy of the patient is indicated on the superimposed images for use in an image-guided procedure.

In certain embodiments, indicators (e.g., markings, lines, circles, spheres, letters, numbers or other indicators) may be produced on an image of the anatomy of a patient. These indicators may mark or identify features such as the boundaries of another image stored in memory device.

In further embodiments the control application may facilitate mapping of a target lesion (e.g., a cancerous region) or other portion of a patient's anatomy, or other operations related to a map of the target lesion or portion of the patient's anatomy. For example, control application may generate and display (e.g., on display device) the position of a tracker relative to a location in a target lesion, a projected path (of the target paths of the tracker) including a path a needle or other instrument inserted into a hole (or a needle guide or a channel) of the tracking device will follow if the needle or instrument is extended past a distal end portion of the tracker. Control application may additionally generate and display (e.g., on display device) a point at which a needle or other instrument placed in a hole of the tracker will intersect a target lesion if the projected path of the needle or instrument intersects the determined path of the target lesion, as well as an indicator of the closest approach from a needle or other instrument passing through a hole in the tracker to the target lesion if the projected path of the needle or instrument does not intersect tissue not intended to be treated or biopsied. Additional displays may be presented. The foregoing system architecture is exemplary only, and should not be viewed as limiting. The invention described herein may work with various system configurations. Accordingly, more or less of the aforementioned system components may be used and/or combined in various implementations.

With reference toFIGS. 21A-21D, a method500of tracking position of an instrument, e.g., instrument20(shown inFIG. 3), is shown. Method500includes imaging a subject including a region of interest, as shown inFIG. 21A. An insertion path is defined between an entry point, e.g., entry point44(show inFIG. 3) an instrument includes fixing an instrument tracker, e.g., instrument tracker100(shown inFIG. 3), to the instrument, as shown inFIG. 21B. The instrument is registered with the entry point, as shown inFIG. 21C, and the instrument inserted into the subject along the insertion path, as shown inFIG. 21D.

As the instrument is inserted into the subject positional information is received from an IMU, e.g., IMU104(shown inFIG. 4), of the instrument tracker. The positional information is used to determine at least one of angular orientation and insertion depth of the instrument using the information received from the IMU.

The at least one of the angular orientation and insertion depth of the instrument is transmitted to a display device disposed in communication with the instrument tracker, the at least one of angular orientation and insertion depth of the instrument compared to a predetermined instrument insertion path defined between an entry point, located on the subject, and the region of interest within the subject. Based on the difference between the at least one of angular orientation and insertion depth of the instrument to the instrument path displayed on the display device user50(shown inFIG. 5) makes adjustments to the position of the instrument.

In certain embodiments program modules38(shown inFIG. 3) is configured to receive DICOM images from imaging device22(shown inFIG. 2), e.g., through the CT scanner host workstation. A four-quadrant display can be generated containing 2D and 3D rendered volumetric CT images of the tumor, vasculature, and other peripheral structures, as shown inFIG. 21A. Responsive to a prompt the user can then select an entry point on the surface of the subject and a region of interest within the subject, and an insertion path thereafter be defined. It is contemplated that insertion paths to various region of interest be defined (or optimized) to avoid obstacles, such as critical structures during insertion. The user can then select an insertion path and the display device assists the user with carrying out the treatment plan by providing visual targeting assistance and image overlay.

In certain embodiments ablation locations and needle trajectories are determined by solving an optimization problem for a given tumor volume and adhering to the constraints set, such as rules requiring (a) minimizing the number of ablations to reduce treatment time and probability of complication; (b) limiting the number of instrument insertions, e.g., by preferentially selecting reinserts of an instrument through previous insertion entry points and/or performing multiple ablations along the same linear trajectory; (c) incorporating instrument trajectory constraints such as anatomical physical/spatial restrictions associated with irregularly shaped regions of interest, as can be the case with tumor targets. In further embodiments instrument tracking system200can uses segmented image data from a specific subject (e.g., by-name patient) so treatment planning is specific to the individual's unique anatomy.

With reference toFIGS. 22A-22C, intra-procedural visual guidance for assisting in instrument positioning is shown. As shown inFIGS. 22B and 22C, a visual guidance bullseye view for off-plane needle navigation provides pointing knowledge of an instrument20relative to predetermined insertion path42(shown inFIG. 3). In the first step, a tip of instrument20needle is placed at entry point44(shown inFIG. 3) as identified in a reconstructed image, e.g., image40(shown inFIG. 3). First a circle, e.g., a blue circle, is generated in image40on display device26to represent the tip of instrument20and a crosshair generated in image40to represent the region of interest14(shown inFIG. 1) in subject10(shown inFIG. 1). A shaft of instrument20is then generated, e.g., as a red circle, and is aligned towards the correct insertion angle while maintaining the tip of instrument20at entry point44. User50then drives the shaft circle into registration with tip circle while retaining the tip of instrument20at entry point44. Optionally, angular error can be displayed within the shaft circle. When the shaft circle is centered on the crosshairs the angle of instrument20is aligned to the angle of predetermined insertion path42, and instrument20inserted to the desired depth using the above described position information provided by instrument tracker100and instrument tracking system200.

With reference toFIGS. 23A and 23B, insertion of instrument20is shown with auditory guidance. As shown inFIG. 23A, as user (e.g., a physician) moves instrument20in-axial-plane with the CT axial image by aligning the instrument tip and the instrument hub of a needle instrument with the laser plane at the CT scanner gantry instrument tracker generates audio signals. The audio signals denote the in-axial-plane angular position of needle instrument20. Changes in absolute angle are linearly mapped to speed between pulses, slow at the left and right edges, progressing faster towards the center of the planned angle, and finally stop at a small angle, such as ±1 degree within the planned angle, denoting the correct angle for insertion. The auditory display shown inFIG. 23Acan be generated in instrument tracker100, in display device26(shown inFIG. 3), or in another external device such as a computer, tablet or smartphone devices via a wireless communication protocol.

The auditory display can include but not limiting to the form of (1) intermittent sound beeps with different time intervals, (2) sound with different frequency pitches, and (3) audio read-outs of the angle degrees, to represent the spatial alignment between the needle and the tumor target. The auditory display can also be replaced or shown simultaneously with the visual display in the tracker or through an external computer, tablet or smartphone devices via a wireless communication protocol.

With reference toFIGS. 24A-24B, proof of concept is shown. As shown inFIG. 24A, an entry point44and predetermined insertion path42are defined in subject10and displayed in image40. Predetermined insertion path42has a planned angle of about 66 degrees.FIG. 24Bshows instrument20inserted in subject10along predetermined insertion path42and into region of interest14. Notably, image40shows instrument20with an angle of about 66 degrees. This demonstrates that instrument trackers, instrument tracking systems, and method of tracking instruments described herein can for accurately position instruments in regions of interest within subjects, particularly in intervention procedures targeting deep-seated tumors.

With reference toFIGS. 25A and 25B, show an exemplary depiction of the visual display in a smartphone device for angular navigation in CT in-axial plane targeting is shown. As shown inFIG. 25A, image40shows instrument20and instrument tracker100. In the illustrated exemplary image instrument20and instrument tracker100are shown in a CT image of a needle instrument and instrument tracker in a CT in-axial-plane view acquired with an imaging device.FIG. 25Bshown the angular orientation of instrument20on display unit26, which in illustrated exemplary embodiment is a smartphone display running a smartphone application.

The methods and systems of the present disclosure, as described above and shown in the drawings, provide for instrument trackers, instrument tracking systems, and methods tracking position of an instrument along an insertion path within a subject with superior properties including real-time positional awareness by fusing image data with positional and or angular orientation information. While the apparatus and methods of the subject disclosure have been shown and described with reference to preferred embodiments, those skilled in the art will readily appreciate that changes and/or modifications may be made thereto without departing from the scope of the subject disclosure.