Method and apparatus for planning placement of an implant

Abstract

A system for planning and positioning an implant in a subject is disclosed. The planned localization may be based on various features and structures identified in a group of subjects of the current subject. The implant may then be positioned in a selected location including the relative location and orientation of the one or more electrodes on the implant, which may be identified as an optimal location of the selected current subject.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application includes subject matter related to U.S. Patent Application No. 17 / 975,148 (5074A-000250-US), the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to a system for planning a procedure for a subject, such as evaluating one or more placement and stimulation areas (e.g., existing placement and stimulation areas or previously implanted placement and stimulation areas) in one or more subjects for use in planning future procedures. Background Art

[0004] This section provides background information related to the present disclosure which is not necessarily prior art.

[0005] When performing a procedure on a human subject, the implant may be positioned within the human subject for a variety of purposes. For example, the implant may be positioned within the human brain to provide stimulation or therapy at a selected location therein. However, based on various parameters of the implant (including implant location, brain network details, delivery characteristics, etc.), the therapy within the brain may vary in efficacy, speed, etc.

[0006] According to various systems, an implant may be positioned within a subject to provide therapy thereto. The therapy may include electrical stimulation of a portion of the brain adjacent to the implant. For example, in various embodiments, diffusion tensor image data may be used during selected portions of a procedure, as disclosed in U.S. Pat. No. 8,532,741. In various embodiments, non-electrical stimulation may also be provided by an implant or device, such as delivery of a medication. The medication may be delivered using a selected device, and various image data may be analyzed to assist in determining placement or delivery of the medication, such as disclosed in U.S. Pat. No. 8,335,552. Summary of the invention

[0007] This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

[0008] A portion of a subject (such as a human anatomical structure) may be imaged to generate image data of the portion, which a user may analyze as data and / or visually analyze. However, it should be understood that the subject may include a non-human subject and / or a non-living subject. A non-living subject may include a closed structure, such as a wing, a robotic system, etc. When analyzing the image data, various features may be identified and / or used to identify various additional features. For example, anatomical landmarks may be identifiable in the selected image data and may be used to assist in identifying an area or a portion of the image data that cannot be distinguished visually. Various types of image data may include magnetic resonance imaging (MRI) data, x-ray image data, functional MRI data, diffusion data (such as MRIDTI data), etc. For example, anterior and posterior commissures may be identified in the image data to assist in locating and / or approximating the position of the subthalamic nucleus in the image based on a predetermined common position of the subthalamic nucleus relative to the anterior and posterior commissures, such as disclosed in U.S. Pat. No. 8,160,677, which is incorporated herein by reference.

[0009] In various embodiments, the implant may be positioned relative to the features identified in the image. The implant may include a deep brain stimulation (DBS) device. DBS may also be referred to and / or understood as a neuromodulator. As discussed herein, stimulation of the brain may be stimulation including electrical stimulation, such as applying voltage, amperage, etc. As used herein, stimulation including electrical stimulation may refer to neuromodulation. Therefore, stimulation may lead to excitatory or inhibitory responses in brain networks. Therapeutic devices such as DBS may be used to provide therapy to the subject. In various embodiments, the features identified in the image data may include the anterior nucleus of the thalamus (ANT), also known as the anterior thalamic nucleus (ATN). Stimulation of ANT and / or parts of the brain relative to ANT may assist in the therapy of patients diagnosed with various disorders (e.g., epilepsy). In particular, treatments such as stimulation may assist in the treatment of epilepsy or the therapy of resistant patients. Therefore, analysis of image data may assist in identifying ANT and / or parts of the brain relative to ANT. These parts may be used for various purposes, such as therapy for epilepsy.

[0010] A system is disclosed that can receive data, such as real-time acquisition and / or transfer to a processor module. The received data can be used to make decisions based on the data. The data can include inputs such as procedure type, positioning of the implant during the procedure, and use of the implant after the implant procedure. The inputs can also include results with each of the other inputs or for each input. Correlations can be determined based on the results of the inputs.

[0011] Additional procedures, such as a current patient or current subject procedure, may be planned based on the determined correlations. The determined correlations may be called into a planned procedure to assist in planning the current procedure. The planned procedure may then be performed with the assistance of various other systems. For example, a surgical navigation system may be used to assist in performing a planned procedure on the current subject.

[0012] Thus, a planned procedure may be performed on the subject. The planned procedure may be based on correlation of previous results according to specific inputs, including the position and activation volume of the implant. The navigation system may assist in attempting to reconstruct the specific position of the implant and the current procedure.

[0013] Further areas of applicability will become apparent from the description provided herein.The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

[0015] Figure 1A is a schematic diagram of the subject and the implant device;

[0016] Figure 1B is a schematic diagram of the subject and the implant device;

[0017] Figure 2 It is the environment view of the operation suite;

[0018] Figure 3A are detailed views of implants according to various embodiments;

[0019] Figure 3B It is taken along line 3B-3B Figure 3A A cross-sectional view of an implant;

[0020] Figure 3C It is taken along line 3C-3C Figure 3A A cross-sectional view of an implant;

[0021] Figure 4 are screen shots of systems according to various implementation schemes;

[0022] Figure 5 is a flow chart of a process for determining the relevance of results and inputs associated with a procedure according to various embodiments; and

[0023] Figure 6is a flow diagram of a process for planning a procedure based at least in part on determining the relevance of results to inputs, according to various embodiments.

[0024] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. DETAILED DESCRIPTION

[0025] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0026] Initial reference Figure 1A and Figure 1B , subject 20 can be any suitable subject. Although the following discussion relates to human subjects, it should be understood that any suitable living or non-living subjects may be provided or provided within the scope of the present disclosure. For example, a non-human living subject may be evaluated and a selected procedure may be performed on it. In addition, various non-living subjects may have image data of internal portions collected, and procedures may be determined, planned, and performed within the outer shell or body (such as the hull) of the non-living subject. Various non-living subjects include internal portions of a motor, a hull, or other suitable subjects. In addition, although the following discussion exemplarily relates to the placement of a deep brain stimulation (DBS) device as an implant for stimulating the brain, other suitable implants and / or therapies are also within the scope of the subject disclosure.

[0027] As described above, for example, a human subject (also referred to herein as a subject) may have a selected treatment prescribed therefor. The treatment may include providing various implants to subject 20 (such as into brain 24) to assist in providing therapy to the subject. In various embodiments, for example, subject 20 may be diagnosed with epilepsy or other movement disorders, and stimulation may be selected to treat or prevent therapy to subject 20.

[0028] In various embodiments, the thalamus 28 can be identified, and / or a selected portion of the thalamus, such as an internal portion (e.g., the anterior thalamic nucleus (ANT), also known as the anterior thalamic nucleus (ATN)), can be identified for treatment with a selected therapy. In various embodiments, the implant 34 can be positioned relative to a selected portion of the brain, such as the thalamus 28 or other appropriate portion in the brain 24 of the subject 20. The implant 34 can be any suitable implant and can include a deep brain stimulation probe or implant, such as the one sold by Medtronic, Inc., having a place of business in Minnesota. DBS lead. However, it should be understood that other suitable DBS leads may be used to position within subject 20, and The DBS lead is exemplary only. In addition, the lead 34 may include one or more electrodes 40 as discussed herein, and a connector 42 that connects to a selected stimulator or tremor control device, such as or Stimulator or tremor control device (sold by Medtronic, Inc.) or other suitable neurostimulator for providing stimulation therapy to subject 20. Stimulator 36 may be programmed in any suitable manner, such as further discussed herein, to provide a selected therapy to subject 20. Programming of stimulator 36 may be based on various selections and / or determinations, as further discussed herein, to provide a selected therapy to subject 20.

[0029] Continue to refer Figure 1A and Figure 1B And turn to reference Figure 2 As will be appreciated by those skilled in the art, the process for identifying and selecting placement and / or therapy to be provided to the subject 20 may include positioning the implant 34 and programming the stimulation. The process may be performed as instructions being executed using a selected processor module 50, which accesses a selected memory and / or input from a user 52. The processor module may be a general purpose processor and / or a dedicated processor module. The processor module 50 may be included in and / or accessed by the exemplary processor system 54, which may include the processor module 50 and the memory module 58. Output may also be performed, and the output may include a display device 62.

[0030] The processor module 50 can execute instructions for various sub-processes and parts, including those optional instructions. In addition, the implant 36 can include one or more processor modules, memory, power supply, etc. Therefore, the implant 36 can be programmed, such as selecting or storing instructions to be executed by the processor module of the implant. Programming can be selected and / or input to provide selected stimulation to the patient 20, also known as conditioning.

[0031] Continue to refer Figure 1A and Figure 1B And also refer to Figure 3A and Figure 3B, the implant 34 may include one or more electrodes 40. If more than one electrode is provided on the implant, each electrode may be different or the same. For example, the electrode 40 may include three electrodes. For example, a tip electrode 40a, a continuous ring electrode 40b, and a discontinuous or segmented ring electrode 40c. If selected, the three electrodes 40a, 40b, and 40c may each be solid or segmented. The segmented electrodes allow each electrode in the electrode 40 to have multiple foci. It should also be understood that more or fewer electrodes may be provided, and / or more or less than three segments may be provided for the electrode 40. In any case, the electrode 40 may provide selected stimulation and / or directional stimulation. In addition, the electrode 40 may also be referred to as a contact 40. The electrode or contact 40 is typically a conductive portion that contacts the subject to provide stimulation.

[0032] In short, the implant 34 including various electrode portions or contacts 40 may have various different contacts and / or adjustments, as briefly mentioned above. The tip electrode 40a may be substantially hemispherical or partially spherical and contact tissue along its entire surface. The continuous ring electrode 40b may include a single electrode contact that completely surrounds the implant 34. The implant 34 may include a selected outer dimension, which may be substantially cylindrical so that the implant 34 has a diameter 34d. The electrode or contact 40b may have an outer surface 40b' equal to the diameter 34d. The electrical contact 40c may have a plurality of contact nodes, including a first contact node 40c1, a second contact node 40c2, and a third contact node 40c3, the electrical contact having an outer surface 40c', which may be defined by all electrode nodes and equal to the diameter 34d. Likewise, as will be appreciated by those skilled in the art and discussed further herein, the contact nodes and each of 40c1 , 40c2 , and 40c3 may be selectively energized to provide therapy to subject 20 , including neuromodulation thereof.

[0033] In short, the electrodes 40 can be programmed and operated individually and / or collaboratively (e.g., together, in sequence, etc.) to provide a selected activation volume therapy (VAT) to the subject 20. The VAT can be an area that is directly stimulated and / or regulated due to stimulation. The VAT is based on the activation volume generated due to the activation of the subject or the selected portion of the subject under study based on the implant 34. The implant 34 includes one or more of the electrodes and / or electrode contacts 40 (such as the tip electrode 40a). When the implant 34 and / or its portion (such as the electrode 40a) is in the target location 72, the electrode 40a can be activated and generate an activation area that can be referred to as or identified as the boundary of the activation area 70. The boundary of the activation area 70 can identify those parts of the subject that are activated due to the therapy applied from the electrode. The boundary of the activation area 70 can be various shapes, including two-dimensional and / or three-dimensional shapes, including spherical, partially spherical and / or other regular or irregular shapes. It should be understood that, as discussed herein, various electrodes may include selected activation areas and / or more than one electrode may be used to provide therapy to form activation areas. Exemplary therapy may include stimulation of about 0.5 volts to about 10 volts amplitude, about 50 Hz to about 150 Hz frequency, and about 10 microseconds to about 150 microseconds pulse width. The volume of stimulation may be defined by a boundary 70. The simulated boundary 70 may be based on the selected features of the adjacent electrodes 40a and other constraints. However, the determined activation boundary 70 may be identified by a graphical representation that is displayed and / or superimposed on an image of the subject 20 that may be displayed on the display 62.

[0034] Continue to refer Figure 2 , subject 20 may position implant 34 within the body to assist in providing therapy to subject 20. User 52 may position implant 34 within subject 20. Processing system 50 may assist in evaluating a plan for placing implant 34. In addition, processing system 50 and / or various additional systems may also be used to assist in performing a procedure on subject 20. In various embodiments, including those discussed herein, implant 34 may be positioned within subject 20 in an appropriate manner. In various embodiments, for example, a selected navigation system (such as a surgical navigation system, including those sold by Medtronic Navigation, Inc., such as A surgical navigation system) guides the implant 34 into the subject 20.

[0035] In short, in surgical navigation, a subject may be tracked using a selected tracking device, such as subject tracking device 100. Subject tracking device 100 may be tracked using a suitable tracking system, such as electromagnetic tracking system 104 and / or optical tracking system 108. It should be understood that other suitable tracking systems may be used, and that the EM 104 and optical 108 tracking systems are merely exemplary.

[0036] The tracking system may track the position of the patient tracker 100 and maintain registration of the patient space with another selected space, such as an image space, to track and determine the pose of the patient tracking device 100 relative to an image, such as a subject image 110, displayed on the display 62. Based on the tracked position of the device 34, a representation of the device relative to the subject image 110, such as a graphical representation 34' thereof, may be displayed on the display device 62. As will be appreciated by those skilled in the art, the tracking system 104, 108 may be utilized to track the device tracking device 120. It will also be appreciated by those skilled in the art that the tracking position and navigation position of the device 34 may be performed based on the registration of the image or image space 110 with the subject or subject space of the subject 20. As discussed herein, various registrations may also occur between the subject image 110 and / or additional images, such as to construct various different image modalities.

[0037] Device 34 may be positioned in a selected suite, such as surgical suite 130. The surgical suite may include selected structures or portions, such as patient support 134 and imaging system 138. Imaging system 138 may be used to generate or acquire image data of subject 20 according to various embodiments. As is generally understood by those skilled in the art, imaging system 138 may also be tracked using imaging system tracker 142. Various imaging systems may include those sold by Medtronic, Inc. Imaging system 138'. Thus, implant 34 can be positioned within subject 20 based on a planned or target location, such as identified using processor module 50, as discussed above. Image data of subject 20 can be acquired at any appropriate time (such as before a procedure, during a procedure, and / or after a procedure) using any appropriate imaging system, such as imaging systems 138, 138'. In addition, according to various embodiments, a tracking system and / or various tracking devices can be incorporated into the surgical navigation system.

[0038] To assist in the procedure, an appropriate imaging system 138, 138' may be utilized to acquire image data of the subject 20. The imaging system 138' may include a Medtronic Navigation system sold by Medtronic Navigation, Inc. having a place of business in Louisville, CO, USA. Imaging system. Includes An imaging system 138' or other suitable imaging system, including an imaging system, may be used during the selected procedure, such as the imaging systems described in the following U.S. Patents: U.S. Patent Nos. 7,188,998; 7,108,421; 7,106,825; 7,001,045; 6,940,941; 11,344,268; 11,399,784; and U.S. Patent Application No. 13 / 016,718 published on April 26, 2012 as U.S. Patent Application Publication No. 2012 / 0099768, all of which are incorporated herein by reference. In addition, the imaging system may include various features and elements, such as slot filters, such as those disclosed in U.S. Patent Nos. 10,881,371 and 11,071,507 to Helm et al., all of which are incorporated herein by reference. Other suitable imaging systems may include a C-arm imaging system including opposing x-ray sources and x-ray detectors and associated processor modules and / or memory.

[0039] As described above, suite 130 may include a navigation system including various tracking devices 100, 120, 142 that may be tracked using a navigation system including one or more of tracking systems 104, 108. Tracking information may be used to allow the pose of an item (e.g., a tool or instrument 34) to be displayed on display 62. For example, a graphical representation 34' of the instrument may be displayed alone and / or superimposed on any appropriate image (such as an image of a subject 110). Instrument 34 may be operated, controlled, and / or held by user 52. User 52 may be one or more of a surgeon, a nurse, a welder, etc. In short, tracking devices such as patient tracking device 100, imaging device tracking device 142, and instrument tracking device 120 allow selected portions of operating room 130 to be tracked relative to each other using appropriate tracking systems including optical locators 108 and / or EM locators 104. However, it should be understood that other tracking modalities may be used, such as ultrasound, acoustics, radar, etc. Typically, tracking occurs within a selected reference frame, such as within a patient reference frame.

[0040] It should be understood that any of the tracking devices 100, 120, 142 may each be an optical EM tracking device or other suitable tracking device and / or more than one type of tracking device, depending on the tracking locator used to track the corresponding tracking device. It should be understood that the tracking devices 100, 120, 142 may all be similar or different, and may all be interchangeable, but selected or assigned a selected purpose during the navigation procedure. It should be further understood that any suitable tracking system (such as an additional tracking system or in addition to the tracking system) may be used with the navigation system. Alternative tracking systems may include radar tracking systems, acoustic tracking systems, ultrasonic tracking systems, etc.

[0041] An exemplary EM tracking system may include the EM tracking system sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado. AXIEM TM Navigation System. Exemplary tracking systems are also disclosed in the following U.S. Patents: U.S. Patent No. 7,751,865, issued on July 6, 2010; U.S. Patent No. 5,913,820, issued on June 22, 1999; and U.S. Patent No. 5,592,939, issued on January 14, 1997, all of which are incorporated herein by reference.

[0042] Furthermore, with respect to the EM tracking system, it may be necessary to provide a shielding or distortion compensation system to shield or compensate for distortion in the EM field generated by the EM locator 108. Exemplary shielding systems include shielding systems disclosed in U.S. Patent No. 7,797,032, issued on September 14, 2010, and U.S. Patent No. 6,747,539, issued on June 8, 2004; the distortion compensation system may include the distortion compensation system disclosed in U.S. Patent Application No. 10 / 649,214, filed on January 9, 2004, published as U.S. Patent Application Publication No. 2004 / 0116803, all of which are incorporated herein by reference.

[0043] Using the EM tracking system, the locator 108 and various tracking devices can communicate through the EM controller 105. The EM controller can contain various amplifiers, filters, electrical isolation and other systems. The EM controller 105 can also control the coils of the locator 104 to transmit or receive EM fields for tracking. However, a wireless communication channel (such as that published in U.S. Patent No. 6,474,341, issued on November 5, 2002, which is incorporated herein by reference) can be used instead of being directly connected to the EM controller 105.

[0044] It should be understood that the tracking system may also be or include any suitable tracking system, including a tracking system having an optical locator (similar to optical locator 108) sold by Medtronic Navigation, Inc., having a place of business in Louisville, Colorado. and / or S7 TM Navigation system. In addition, additional tracking systems are disclosed in U.S. Patent No. 5,983,126, issued on November 9, 1999, which is hereby incorporated by reference. Other tracking systems include acoustic, radiation, radar, etc.

[0045] A physical space of and / or relative to a subject (such as patient 20) may be referred to as subject or patient space. An image space defined by an image or a coordinate system of an image generated or reconstructed using image data from an imaging system (such as imaging systems 138, 138') may be referred to as image space. The image space may be registered to the patient space by identifying matching points or reference points in the patient space and related points or equivalent points in the image space. The imaging devices 138, 138' may be used to generate image data with precise and known positioning. This may allow image data that is automatically or "inherently registered" with the patient 20 when the image data is acquired. In essence, due to the accurate positioning of the imaging systems 138, 138' in the patient space, the positioning of the patient 20 relative to the imaging systems 138, 138' is precisely known. This allows points in the image data to be known relative to points of the patient 20 due to the precisely known positions of the imaging systems 138, 138'. Likewise, it should be understood that the imaging system may be used to generate image data of the subject 20 at any appropriate time. Furthermore, the imaging system may include one or more of a magnetic resonance imaging (MRI) device, a computed tomography (CT) device, and the like.

[0046] Alternatively and / or in addition, manual or automatic registration can occur by matching fiducials in the image data with fiducials on the patient 20. For example, selected patient anatomical structures (e.g., ear portions, nose tip, brow line, etc.) can be identified in the image space to patient space registration, which allows a translation map between patient space and image space to be generated. According to various embodiments, registration can occur by determining points that are substantially equivalent in image space and patient space. Equivalent points can include anatomical fiducials or implanted fiducials. Exemplary tracking and navigation systems and appropriate registration techniques are disclosed in at least one of the following U.S. patents: U.S. Patent No. 9,737,235 issued on August 22, 2017; U.S. Patent No. 7,751,865 issued on July 6, 2010; U.S. Patent No. 6,474,341 issued on November 5, 2002; U.S. Patent No. 5,913,820 issued on June 22, 1999; U.S. Patent No. 5,592,939 issued on January 14, 1997; and / or U.S. Patent No. 5,983,126 issued on November 9, 1999, all of which are incorporated herein by reference.

[0047] Once registration occurs, a navigation system including a tracking system 104, 108 having and / or including an imaging system 138, 138' can be used during the execution of a selected procedure. The selected procedure can use image data generated or acquired using the imaging system 138, 138', and the tracking pose of one or more tracked items can be displayed relative to the image, such as superimposed on the image. The determined pose typically includes a selected number of degrees of freedom, such as six degrees of freedom. These may include position (x, y, and z axis position) and orientation (yaw, pitch, and roll) in at least three dimensions. In addition, the imaging system 138, 138' can be used to acquire image data at different times relative to the procedure. As discussed herein, image data of the patient 20 can be acquired after a selected portion of the procedure for various purposes, including confirmation of portions of the procedure.

[0048] The implant can be positioned in the subject 20 including the implant 34. Based on the tracking or navigation of the implant 34 relative to the subject 20, the implant 34 can be positioned in the subject. Therefore, during the procedure, the tracked position or pose of the implant 34 can be known. The tracked position of the implant 34 can be saved to allow viewing of the tracked pose of the implant. Therefore, the path and final pose of the implant 34 in the subject 20 can be known.

[0049] The final pose of implant 34 may include the final pose of one or more of electrodes 40, including the pose of electrode 40 relative to the subject. With the known pose of electrode 40, a determination or assessment of stimulation of subject 20 relative to electrode 40 may be measured. As further discussed herein, the stimulation or neuromodulation provided to subject 20 may be measured or determined. In addition, an outcome or prognosis of subject 20 may be determined over time. A determined outcome or tracked outcome of treatment of subject 20 may be obtained and also stored for comparison with the tracked or navigated pose of implant 34 relative to subject 20.

[0050] Thus, as further discussed herein, the posture of implant 34 may be correlated with the outcome of subject 20. For example, a specific posture including the location and orientation of one or more electrodes of electrode 40 may be correlated with the outcome of subject 20 after and / or during treatment. This correlation may be stored for later analysis and / or planning of procedures for additional subjects including the current subject. In various embodiments, the posture of implant 34 may be known for the outcome of a subject (such as a past subject). This may also be determined and stored for multiple subjects, including the associated outcomes and posture of implant 34. After a sufficient or selected number of associated postures and outcomes have been determined, planning of implant posture for a subject may include associated and stored information to assist in planning the posture of the implant in a later subject (also referred to as the current subject). This may allow for assisting planning of the posture of the implant and the subject before positioning implant 34 in subject 20.

[0051] Turn to reference Figure 4 , a graphical representation of implant 34 is displayed on display device 62 or any suitable display device. As discussed above and as generally understood by those skilled in the art, possible therapy locations within subject 20 may be determined. For example, 3 and / or 4 software enables creation of patient-specific anatomical and lead positions and orientations based on post-procedural data, such as image data sold by Medtronic, Inc. The system can be used to identify an area or volume 200 being activated by one or more of the electrodes 40. For example, Figure 4As illustrated, one or more of the segments of electrode segment 40c may be powered to generate a treatment volume 200, which may also be referred to as an activation volume and / or VAT. VAT 200 may be in or near a specific portion of the anatomical structure of subject 20, which may also be displayed on display device 62. The specific anatomical structure may include a subthalamic nucleus (STN) 204. One or more images of the subject may be generated for display based on the subject's data. Various portions of the image (such as the STN) may also be segmented in the image. Various other portions (such as the red nucleus 214) may also be displayed and / or segmented.

[0052] Although the implant may be positioned relative to any suitable portion of subject 20, STN 204 may be the selected portion. One or more of electrodes 40 are then powered to provide therapy. The therapy may include VAT. Figure 4 As illustrated, a graphical user interface (GUI) may include one or more areas to illustrate the portions that are activated and / or to illustrate input provided by a user 52, such as which electrode 40 is operated to generate a VAT 200. The GUI 210 may also illustrate which portions of the electrodes are being activated to form the VAT 200.

[0053] The pose of the implant 34 may be determined after implantation in a selected subject, such as a past subject. The past subject may include the current subject 20 in a previous procedure. Similarly, the VAT 200 in the previous subject may also be determined and displayed, such as using the display 62. Thus, after performing the procedure, the pose including the position and orientation of the electrodes on the implant 34 may be known and may be used to determine the VAT 200. The relationship between the VAT 200 and the position and orientation of the electrodes may then be stored for later use, as further discussed herein.

[0054] Additionally, as described above, the position of the implant 34 during implantation may also be determined based on tracking the position of the implant 34. The instrument tracker 120 may be used to track the position of the implant 34 using one or more positioners 104, 108. Thus, during the procedure, the position of the implant 34 may also be known or determined and illustrated on the display 62. Then based on the tracked position of the implant 34 during implantation, the possible activation volume 200 may also be known. Based on the position of the implant 34, the VAT 200 may be displayed for use, such as by the user 52. Thus, based on one or more inputs including which electrode to activate, how to activate, etc., the implant 34 may have a real-time VAT illustration. Those skilled in the art will appreciate that, and in the art, the VAT 200 may be displayed based on the position of the implant 34. Figure 4As illustrated in , the electrodes can be activated in various ways. For example, one or more of the segments (if available) can be selected for activation or powering. The powered electrodes can then be changed, including amperage, pulse (e.g., length of activation), and frequency. As described above, changes in amperage, pulse, and frequency can be used to change the VAT from one or more of the selected electrodes 40. The VAT can also be changed by changing or making different electrodes 40 and / or the portion thereof that is activated to provide treatment.

[0055] Continue to refer to Figures 1 to Figure 4 , and additionally refer to Figure 5 , illustrates a process 250 for collecting and determining the correlation of results and the determined activation volume (also referred to as VAT above). As described above, the VAT can be determined relative to the selected electrode. In addition, when the VAT is determined, the posture of the electrode can be determined. This information can be gathered and associated to associate the results of the subject 20 with the posture and / or VAT. For example, after positioning and programming the implant 34, the results of the therapy for the patient 20 can be determined. The results of the therapy for the patient 20 can also be referred to as the results applied to the patient. The results can be alone and / or in combination with other inputs. In any case, the results of the patient 20 can be determined. Process 250 can be used to determine the correlation between the results and one or more of the outputtable posture or VAT.

[0056] Initially, process 250 may begin in start box 254. After start box 254, a data collection or receiving process or subprocess 258 may be initiated. The data receiving process includes one or more receptions of data that may be acquired in any appropriate manner and / or sequence. For example, a user may send data to a selected data collection center. The data may be sent electronically, as physical data, etc. However, data may be collected and received to perform process 250. While receiving subprocess 258, reception of an implant pose may be performed in box 262. The implant pose received in box 262 may include the position and orientation of the implant 34, one or more electrodes in the electrode 40, or any other appropriate portion of the implant 34. The pose of the implant 34 may be used to reconstruct or determine VAT relative to one or more of the activated electrodes during therapy. Therefore, an appropriate system may be utilized to determine the pose of the implant received in box 262.

[0057] The associated VAT is received in box 268. The associated or related VAT is related to the implant pose received in box 262. Therefore, the VAT can be determined and received in box 268. The VAT can be related to or based on the pose of the implant received in box 262. Therefore, the VAT generated in the subject received in box 268 and the pose of the implant received in box 262 are known relative to each other.

[0058] The result of the received association can be received in box 272. As described above, the result can be based on various features, such as determined by the subject 20 himself, determined by the clinician, or through other appropriate evaluations. The result is also related to the VAT received in box 268 and the implant posture received in box 262. Therefore, the correlation of the relationship of the result to at least one of the VAT and posture can be received in process 250.

[0059] The received data may be stored in block 280. The data may be stored for any suitable purpose, such as further discussed herein. The received data may be stored in any suitable manner, including those discussed herein, but is generally accessible by a processor module for use in performing process 250, as discussed herein. The data may be stored for long-term storage and / or immediate retrieval.

[0060] Process 250 can then determine in determination box 284 whether to collect more past data.As discussed above, process 250 can receive data related to the subject after implantation has been performed, and determine the result based on implant posture and VAT, or the result is related to implant posture and VAT.Therefore, process 250 can be understood as data related to the subject before the current subject, and the current subject is being executed and / or planning procedures.As discussed herein, past data can be collected or received and used for the current subject.In addition, past data can be data collected from one or more subjects who are not subject 20.For example, data can be collected from many subjects who are not the current subject within a period of time.In any case, more data can be collected by following "yes" path 288.Following "yes" path 288 flows to receive additional data in receiving subprocess 258.

[0061] If there is no additional data to collect, the "no" path 292 can be followed. After following the "no" path 292, at least one selected portion of the stored data is aggregated in box 296. The aggregation of the stored data can be any appropriate aggregation or correlation process. A suitable aggregation process includes establishing a heat map of the results across different locations of the brain. The results can be classified into any appropriate number of categories, such as desired or undesirable. Other categories may include long-term improvement or short-term improvement. More categories and / or combinations of categories may be obtained. Results can be collected from multiple subjects after implantation and the results for each subject are determined. The locations and results can be stored data. Various locations can be determined relative to each other and / or in an atlas model. As discussed herein, the atlas model can then be mapped to the current subject for planning.

[0062] According to various embodiments, the algorithm may aggregate the result data to identify the selected target location. The target location may or may not include a visualization for the user to view. As described above, the target location may be based on aggregation.

[0063] In general, clustering allows for storage and selection of data prior to the clustering or aggregation process in block 296. For example, the same or similar poses may be aggregated, and similar results may be aggregated, and related poses and / or VATs may also be associated and aggregated. Regardless, the clustering in block 296 allows the data to be further processed, as discussed herein.

[0064] In box 300, the correlation of the selected result with at least one of the received implant posture or VAT is determined. The determination of the correlation in box 300 allows the determination of the result related to at least one of the received implant posture or the received VAT. The correlation can be associated with the result at the selected threshold, such as those that can be identified as "good" results and / or those that can be identified as "unexpected" results. Based on the received data stored at box 280 for gathering data in box 296, the threshold difference between each result type can be obtained and / or determined. This determination implements the relationship between the posture of the received implant from box 262 and / or the received VAT from box 268. The determination of the result associates the result with at least one of the two, and at least one of the two can be used for various processes, such as planning discussed herein. Therefore, the determination of box 300 allows the determination of the correlation between each result type and the type of other received data, and the other received data includes implant posture and at the received VAT.

[0065] As mentioned above, correlation can be based on the classified previous results of the previous VAT of each determined previous position and / or one or more previous subjects for implant.One or more previous positions and / or VAT can be co-located relative to each other.For example, they are in the determined position in the selected anatomical structure (for example, standard anatomical structure or atlas anatomical structure).The selected anatomical structure can be identified in any subject such as the current subject.Previous results can be known and associated with each previous position and / or VAT in the selected anatomical structure.As discussed herein, the standard anatomical structure can be associated with the current subject for planning.

[0066] As disclosed above, the classified results and related locations can be displayed to the clinician without recommendations (e.g., heat maps), thereby allowing the clinician to make decisions based on the combined historical data. According to various embodiments, with or without support for display, target locations can be determined for the clinician based on aggregation and relevance.

[0067] The determination may be output in box 304. The determination output may include a database of the selected results. The results may be classified into a plurality of different results, such as different types of results. The classification may include two or more types of results. In the relevant received data, the result may be a determined or classified "good" result, or a determined or classified "unexpected" result. For example, a "good" result and a related determination associated with one or more selected received implant postures may be output in box 304. Similarly, the result may be classified as "unexpected" associated with another received posture. Then, the output determination may be stored in box 308 for subsequent call. The output determination 304 may be stored so that it may be called in box 308 for various purposes, such as for subsequent subject planning procedures including the current subject. Therefore, the determination may be useful for assisting or determining a later posture and VAT.

[0068] Then, in block 312, process 250 may determine or may allow for a determination as to whether an update is to be performed. Determining an update in block 312 may be a determination as to whether additional data has been received for determining the dependency in block 300. If an update is determined, a "yes" path 314 may be followed to receive additional data in block 258. If no update is to be performed, a "no" path 320 may be followed to end at block 324.

[0069] Thus, process 250 may end in box 324 after being output and saved for later recall. As described above, process 250 allows for the collection and determination of relevance based on data collection and result classification. The relevance may be output and saved for subsequent recall, thereby assisting in the execution of subsequent procedures after the time of the received data. Subsequent procedures may be used or include planning for the current subject, as further discussed herein.

[0070] Turn to reference Figure 6 , illustrating process 400. Process 400 can use the determination of the correlation of the result with at least one posture of the implant for the procedure. The correlation can be based at least on the output from process 250 discussed above, including a past patient information and / or gathered information. Process 400 can use previous and / or known information to assist and / or plan the procedure for the current subject.

[0071] In short, process 400 allows the determined posture associated with the selected result, which is to be used for planning procedures and / or performing procedures on the current subject (such as subject 20). When using planning process 400, the user can determine the selected result and use the determined posture of the implant associated with the previous result for planning procedures. For example, based on the selected diagnosis of subject 20 and the selected result of subject 20, the output determination from box 304 of process 250 can be used to determine the planning posture of implant 34 in the current subject 20. Therefore, planning process 400 can be used to plan procedures for positioning implant 34 based on previous determinations (such as determinations from process 250).

[0072] The planning process 400 may begin at a start block 404. Optionally, the process 400 may begin by receiving a subject diagnosis in block 406. The subject diagnosis may include or be based on subject data. The diagnosis may include tumor identification, neurological disorders, etc. The diagnosis may allow the user 52 to determine and / or select an outcome for the subject 20. In addition, the diagnosis may include a selected or determined treatment, such as implanting an implant 34 and using it to provide stimulation and / or neuromodulation.

[0073] In box 408, process 400 may also receive a desired result for subject 20. The desired result may be any appropriate result, such as a "good" result as categorized above. The desired result received in box 408 may be similar and / or identical to the result used in process 250. As discussed herein, the desired result received in box 408 and the diagnosis in box 406 may be used in process 400 to select and / or plan the position of the implant in subject 20.

[0074] The planning process may include a planning subprocess 410, which may include various parts or steps, such as those discussed herein, in any appropriate order. For example, the planning process 400 may call an output determination in box 414, which may be an output determination from box 304. As described above, in box 308, the output determination may be stored for subsequent call, and box 414 may include calling the saved or determined output. In box 420, the called output may be used to determine the posture in the current subject. The called output may be related to at least one of the subject diagnosis received in box 406 and / or the expected results received in box 408. As described above, the output includes the correlation of the result with at least one of the posture and / or VAT in a previous subject or many previous subjects.

[0075] When determining the pose of the current subject, the determined correlation of the pose and the desired result from box 408 can be used to determine the pose in the current subject 20. For example, as described above, the implant 34 can be positioned relative to the STN 204. However, the implant 34 includes multiple electrodes 40, including possible segmented electrodes 40c. Therefore, the orientation of the electrodes relative to the STN 204 can also be part of the pose determined for the current subject in box 420. The determined pose can be based on the determined correlation output in box 308 of process 250, and is used to determine the pose of the current subject in box 420 based on the desired result selected in box 408.

[0076] After the current subject's posture is determined in box 420, a plan can be made in box 424 for achieving the determined posture based on the determined posture. The plan may include the trajectory of the implant 34 to achieve the posture within the subject 20, the selection of a specific implant, the insertion depth, and / or other appropriate determinations for planning. As will be appreciated by those skilled in the art, the implant 34 may include various sizes, such as length, diameter, etc. Various different implants may include different sizes and may require different plans. In addition, various instruments may be used to assist in insertion, such as The plan may include a trajectory guide and / or an overt tach trajectory guide, both of which are sold by Medtronic, Inc., having a place of business in Minnesota. However, any suitable guide may be used to assist in positioning implant 34 within subject 20. The plan may include an entry point, an angle for inserting the implant, a guide (e.g., Positioning of trajectory guide, etc.

[0077] The planning may include selecting an appropriate guide, selecting an appropriate implant, determining a position within a particular subject 20, etc. Again, as discussed above and as described above, Figure 4 As illustrated, image data of subject 20 may be displayed on display device 62. Planning a pose within current subject 20 may include determining or segmenting an anatomical structure of the current subject and determining a pose within that particular anatomical structure. However, in the determined correlation of the result with a previous pose, it may assist in determining or be used to determine a pose within the current subject.

[0078] After planning the posture based on the determined posture in box 424, the plan can be navigated in box 430. The planning navigation in box 430 may include tracking the posture of various parts of the implant 34, such as including the position and / or orientation of the electrode 40. When tracking the position and orientation of the electrode 40, one or more electrode contacts in the electrode contacts may be specifically tracked and / or all electrode contacts may be specifically tracked. As described above, the electrode 40c may include segments, and tracking the posture of the electrode 40c may include tracking the posture of one or more of the segments 40c1, 40c2 and / or 40c3. Therefore, the navigation of the implant 34 can be used to assist in ensuring that the implant 34 is implanted in the subject in the planned posture.

[0079] The tracking device 120 may be tracked with an appropriate positioner to allow determination of the pose of the selected implant including one or more of the electrodes 40. Thus, the user may view the display 62 to view the graphical representation 34' of the implant 34 to determine whether the plan is being achieved with the current tracked pose of the implant 34. Thus, the user may be assisted in determining whether the implant 34 should be moved and / or altered to achieve the planned pose.

[0080] In block 434, a graphical representation of the implant may be displayed on display device 62. Display of the graphical representation allows user 52 to observe the current pose as the tracked pose of implant 34 in substantially real time. In addition, one or more planned poses may also be illustrated, such as planned pose graphical representation 424' (in Figure 4 To this end, the user 52 may utilize the graphical representation 34' to view the current pose of the implant 34 relative to the trajectory planned using the graphical representation 424'. This may allow for a visual representation and confirmation that the current pose of the implant 34 substantially meets or is within the selected threshold to achieve the planned pose.

[0081] Thus, planning process 410 may be used to plan a procedure based on the determination saved in box 308. The planning may be used to execute the procedure. The procedure may navigate implant 34 relative to subject 20. The navigation pose planned in box 424 may also be stored in box 436. Storing the navigation pose may further assist in providing data about the pose determined after implantation, the results based on the navigation pose, or other selected correlations. Thus, in process 250, the planning pose and / or navigation pose may be stored for correlation.

[0082] Then, process 400 can end in frame 440.Should be understood that various processes including process 250 and / or process 400 (including pre-planning process 410) can be incorporated into the instruction executed by processor module.Processor module can include processor module discussed above and / or any suitable processor module.As discussed above, these instructions can allow to determine correlation and / or planning procedures.Although processing module can usually execute instructions without additional input, it should be understood that the user can provide input, such as selecting selected result or desired result, the limitation of implant that can be used for planning, etc.However, process 250 and 400 can be incorporated into and executed by processing module to assist in providing the instruction for determining the output of correlation, planning procedures and / or navigation procedures with selected result.

[0083] Exemplary embodiments are provided so that the present disclosure will be thorough and will fully convey the scope of the present disclosure to those skilled in the art. Many specific details, such as examples of specific components, devices, and methods, are set forth to provide a thorough understanding of the embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that the exemplary embodiments may be embodied in many different forms, and should not be construed as limiting the scope of the present disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0084] Instructions may be executed by a processor and may include software, firmware, and / or microcode, and may refer to procedures, routines, functions, classes, data structures, and / or subjects. The term shared processor circuit encompasses a single processor circuit that executes some or all code from multiple modules. The term grouped processor circuit encompasses a processor circuit that combines with another processor circuit to execute some or all code from one or more modules. References to multiple processor circuits encompass multiple processor circuits on discrete dies, multiple processor circuits on a single die, multiple cores of a single processor circuit, multiple threads of a single processor circuit, or a combination of the above. The term shared memory circuit encompasses a single memory circuit that stores some or all code from multiple modules. The term grouped memory circuit encompasses a memory circuit that combines with another memory to store some or all code from one or more modules.

[0085] The apparatus and methods described in this application may be implemented in part or in whole by a special-purpose computer created by configuring a processor and / or a general-purpose computer to perform one or more specific functions implemented in a computer program. A computer program includes processor-executable instructions stored on at least one non-transitory, tangible computer-readable medium. A computer program may also include or rely on stored data. A computer program may include a basic input / output system (BIOS) that interacts with the hardware of the special-purpose computer, device drivers that interact with specific devices of the special-purpose computer, one or more operating systems, user application programs, background services, background application programs, and the like.

[0086] The computer program may include: (i) assembly code; (ii) object code generated by a compiler from the source code; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time compiler, (v) descriptive text for parsing, such as HTML (Hypertext Markup Language) or XML (Extensible Markup Language), etc. By way of example only, the source code may be C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, ASP, Perl, HTML5, Ada, Active Server Pages (ASP), Perl, Scala, Erlang, Ruby, Visual Lua or To write.

[0087] Communications may include wireless communications as described in the present disclosure, which may be conducted in whole or in part in accordance with IEEE Standard 802.11-2012, IEEE Standard 802.16-2009, and / or IEEE Standard 802.20-2008. In various embodiments, IEEE 802.11-2012 may be supplemented by Draft IEEE Standard 802.11ac, Draft IEEE Standard 802.11ad, and / or Draft IEEE Standard 802.11ah.

[0088] The term "circuitry" may be substituted for processor, processor module, or module or "controller". Any of these terms may refer to, be part of, or include: an application specific integrated circuit (ASIC); a digital, analog, or mixed analog / digital discrete circuit; a digital, analog, or mixed analog / digital integrated circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor circuit (shared, dedicated, or grouped) that executes code; a memory circuit (shared, dedicated, or grouped) that stores code executed by the processor circuit; other suitable hardware components that provide the described functionality; or a combination of some or all of the above, such as in a system on a chip.

[0089] For the purpose of illustration and description, the foregoing description of the embodiment has been provided. The above description is not intended to be exhaustive or to limit the present invention. The individual elements or features of a particular embodiment are generally not limited to the particular embodiment, but are interchangeable and can also be used in the selected embodiment, even if not specifically shown or described, where applicable. The same element or feature can be changed in many ways. Such variations will not be considered to be out of the present invention, and all such modifications are intended to be included within the scope of the present invention.

Claims

1. A method for evaluating the inputs and outcomes of a procedure, receiving a plurality of signals associated with at least one of: (i) at least one tracking pose of an implant or (ii) at least one activation volume generated by the implant in the received tracking pose; Aggregating multiple received signals; receiving a result of each of the received signals in the plurality of signals; evaluating the aggregated plurality of received signals to determine a correlation of the selected result with at least one of: (i) the at least one tracking pose of the implant or (ii) at least one activation volume generated by the implant in the received tracking pose; as well as The determined dependencies are output to plan the current procedure.

2. The method of claim 1 , wherein outputting the determined dependencies to plan the current procedure comprises: The determined dependencies are stored for recall to plan the current procedure.

3. The method according to claim 1, further comprising: providing an implant tracking device associated with the implant; as well as The implant is tracked.

4. The method of claim 3, wherein receiving the plurality of signals is based on tracking the implant.

5. The method according to claim 1, further comprising: determining an activation volume after implantation of the implant; as well as associating the activation volume with the tracked pose of the implant; The relevance of the selected result is determined based at least on the associated activation volume.

6. The method according to claim 1, further comprising: tracking the implant using an implant tracking device; determining the tracking pose based on the implant tracking device tracking at the final implant pose; The received signal is based on tracking the implant tracking device in the final implant pose.

7. The method according to claim 6, further comprising: The final implant pose is stored.

8. The method according to claim 1, further comprising: Determining the tracking position of the implant using a tracking system; storing the determined tracking pose using the tracking system; wherein receiving the result is operable to be received using the tracking system; A processor module of the tracking system is operated to evaluate the aggregated plurality of received signals to determine the relevance of the selected results.

9. The method of claim 8, wherein the result is classified into at least a first result and a second result; The determined correlation includes at least a relationship between the tracking pose and the first result or the second result.

10. The method according to claim 8, further comprising: The determined tracking pose of the implant relative to an image of a subject in which the implant is positioned is displayed using a display device.

11. A system for evaluating the inputs and results of procedures, a navigation system configured to receive a plurality of signals associated with at least one of: (i) at least one tracking pose of an implant or (ii) at least one activation volume generated by the implant in the received tracking pose; A processor module configured to execute instructions to: Aggregating multiple received signals; receiving a result of each of the received signals in the plurality of signals; evaluating the aggregated plurality of received signals to determine a correlation of the selected result with at least one of: (i) the at least one tracking pose of the implant or (ii) at least one activation volume generated by the implant in the received tracking pose; as well as The determined dependencies are output to plan the current procedure.

12. The system of claim 11, wherein outputting the determined dependencies to plan the current procedure comprises: The determined dependencies are stored for recall to plan the current procedure.

13. The system according to claim 11, further comprising: an implant tracking device associated with the implant; and Wherein the processor module is further configured to execute instructions to track the implant.

14. The system of claim 13, wherein the plurality of signals received are based on the tracked implant.

15. The system of claim 11, wherein the processor module is further configured to execute instructions to: determining an activation volume after implanting the implant; and associating the activation volume with the tracked pose of the implant; The relevance of the selected result determined therein is based at least on the associated activation volume.

16. The system according to claim 11, further comprising: an implant tracking device operable to track the implant; wherein the navigation system is further configured to determine the tracking pose based on the implant tracking device tracked in the final implant pose; Wherein the received signal is based on tracking the implant tracking device in the final implant pose.

17. The system according to claim 11, further comprising: Tracking system; a storage system, the storage system communicating with the navigation system; The navigation system is further configured to: Determining the tracking position of the implant using the tracking system; The storage system is used to store the determined tracking pose.

18. The system of claim 17, wherein the result is classified into at least a first result and a second result; The determined correlation includes at least a relationship between the tracking pose and the first result or the second result.

19. The system according to claim 17, further comprising: A display device is provided for displaying the determined tracking pose of the implant relative to an image of a subject in which the implant is positioned.

20. The system of claim 19, further comprising: An imaging system is configured to acquire image data of the subject to generate the image.

Images