Systems, instruments and methods for surgical navigation with validation feedback

Abstract

Systems, instruments, and methods for surgical navigation with verification feedback are provided. The systems, instruments, and methods can be used to verify the trajectory of a surgical tool during surgery. The systems, instruments, and methods can receive one or more captured images of an anatomical portion of a patient; execute a surgical plan to insert the surgical tool into the anatomical portion; receive sensor data collected from one or more sensors inserted into the anatomical portion; determine whether the sensor data corresponds to the surgical plan; and in response to determining that the sensor data does not correspond to the surgical plan, send an alert indicating that the surgical tool was not inserted according to the surgical plan. The one or more sensors can be attached to the surgical tool.

Description

Background Art

[0001] Image-based surgical techniques have been used to help doctors perform a variety of delicate surgical procedures. For example, these surgical procedures are used when the patient's anatomy obscures the visualization of surgical tools, or when the surgical tools are visible but the patient's anatomy may be difficult to visualize in three dimensions. Such surgical procedures include, for example, spinal implant placement, alignment of broken bone fragments, and fixation of fractures.

[0002] Surgical navigation and robotic systems can use X-ray images or virtual fluoroscopy to visualize the positioning of surgical tools within the patient's anatomy. By repeatedly acquiring X-ray images during surgery, the real-time placement of surgical tools relative to the patient's anatomy can be displayed. In addition, surgical navigation systems based on virtual fluoroscopy can track the trajectory of surgical tools and superimpose representations of surgical tools onto pre-acquired images of the patient's anatomy without the need to repeatedly take X-rays during surgery.

[0003] However, the accuracy of surgical navigation and robotic systems may be affected by a variety of unaccounted-for factors. For example, the patient may reposition his or her body on the surgical table; the surgeon and / or surgical team may inadvertently move the patient; and / or the surgical procedure may cause the patient's anatomy to move, all of which may compromise the accuracy of navigating the surgical tool within the patient's anatomy. Summary of the invention

[0004] The present disclosure relates generally to image-guided medical surgery, and more particularly to surgical navigation systems, devices, and methods for performing image-guided medical surgery.

[0005] In one or more embodiments, the disclosed technology relates to a method for verifying the trajectory of a surgical tool during surgery. In one or more embodiments, the method includes receiving one or more captured images of an anatomical portion of a patient. In one or more embodiments, the method includes executing a surgical plan to insert a surgical tool into the anatomical portion. In one or more embodiments, the method includes receiving sensor data collected from one or more sensors inserted into the anatomical portion, the one or more sensors being attached to the surgical tool. In one or more embodiments, the method includes determining whether the sensor data corresponds to the surgical plan; and in response to determining that the sensor data does not correspond to the surgical plan, sending an alarm indicating that the surgical tool was not inserted according to the surgical plan.

[0006] In one or more embodiments, the disclosed technology relates to a surgical navigation system for verifying the trajectory of a surgical tool during surgery. In one or more embodiments, the surgical navigation system includes: one or more sensors attached to the surgical tool; an imaging system configured to capture one or more images of an anatomical part of a patient and transmit the captured one or more images to a guidance system; and a guidance system configured to operate the surgical tool. In one or more embodiments, the guidance system is configured to receive one or more captured images. In one or more embodiments, the guidance system is configured to execute a surgical plan to insert a surgical tool into an anatomical part via a robotic arm. In one or more embodiments, the guidance system is configured to receive sensor data collected from one or more sensors inserted into the anatomical part. In one or more embodiments, the guidance system is configured to determine whether the sensor data corresponds to the surgical plan. In one or more embodiments, the guidance system is configured to send an alarm indicating that the surgical tool was not inserted according to the surgical plan in response to determining that the sensor data does not correspond to the surgical plan.

[0007] In one or more embodiments, the disclosed technology relates to a computer program product comprising a non-transitory computer-readable storage medium having program instructions embodied therewith for verifying the trajectory of a surgical tool during surgery, wherein the program instructions are executable by one or more processors. In one or more embodiments, the program instructions include receiving one or more captured images of an anatomical portion of a patient. In one or more embodiments, the program instructions include executing a surgical plan to insert a surgical tool into the anatomical portion. In one or more embodiments, the program instructions include receiving sensor data collected from one or more sensors inserted into the anatomical portion, the one or more sensors being attached to the surgical tool. In one or more embodiments, the program instructions include determining whether the sensor data corresponds to the surgical plan. In one or more embodiments, the program instructions include: in response to determining that the sensor data does not correspond to the surgical plan, sending an alarm indicating that the surgical tool was not inserted according to the surgical plan.

[0008] The foregoing and other objects, features and advantages of the invention will become apparent from the following more particular description of exemplary embodiments of the invention, as illustrated in the accompanying drawings in which like reference numerals generally represent like parts of the disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The following drawings illustrate specific embodiments of the present disclosure and therefore do not limit the scope of the present disclosure. The drawings are not drawn to scale and are intended to be used in conjunction with the explanations in the following detailed description.

[0010] Figure 1A surgical navigation system for spinal surgery according to one or more embodiments of the present disclosure is depicted.

[0011] Figure 2A Depicted is a perspective view of a probe according to one or more embodiments of the present disclosure.

[0012] Figure 2B Depicted is a perspective view of a probe according to one or more embodiments of the present disclosure.

[0013] Figure 3 is a flow chart illustrating a method of surgical navigation surgery according to one or more embodiments of the present disclosure.

[0014] Figure 4A An example of a surgical navigation procedure is depicted.

[0015] Figure 4B Another example of surgical navigation is depicted.

[0016] Figure 4C Another example of surgical navigation is depicted. DETAILED DESCRIPTION

[0017] The following discussion omits or only briefly describes certain conventional features related to surgical navigation systems that are obvious to those skilled in the art. It is noted that various embodiments are described in detail with reference to the accompanying drawings, wherein like reference numerals represent like parts and components throughout the several figures. . Reference to various embodiments does not limit the scope of the appended claims. In addition, any embodiments set forth in this specification are intended to be non-limiting and set forth only some of the many possible embodiments for the appended claims. Moreover, the specific features described herein may be used in combination with other described features in every possible combination and arrangement of the various possible combinations and arrangements.

[0018] Unless otherwise specifically defined herein, all terms should be given their broadest possible interpretation, including the meaning implicit from the specification and the meaning understood by those skilled in the art and / or as defined in dictionaries, papers, etc. It must also be noted that, unless otherwise indicated, the singular forms "a", "an" and "the" used in the specification and the appended claims include plural referents, and the terms "comprises" and / or "comprising" when used in this specification specify the presence of stated features, elements and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components and / or groups thereof.

[0019] Embodiments of the present disclosure relate generally to apparatus, methods, and systems for, for example, image-guided medical surgery, and more particularly to surgical navigation systems, apparatus, and methods for performing image-guided medical surgery, such as, for example, in a surgical procedure utilizing FluoroNav for Treatment Guidance Platform TM Those used in the system, both of which are available from MedtronicSofamor Danek. In the 2019 publication “StealthStation TM S8 Spine Navigation Solution" brochure and in the "Using Navigation and spinal surgery The Clinical and Economic Benefits of Imaging Systems is described in part in the brochure Treatment guidance platforms, and in particular Navigation system. Figures 1 to 4C Embodiments of surgical navigation systems, devices, and methods are described. Embodiments of the surgical navigation systems, devices, and methods described herein may be used in conjunction with a robotic system, such as, for example, the Mazor XR, available from Medtronic. TM Stealth Edition.

[0020] Figure 1 An operating environment for spinal surgery according to one or more embodiments of the present disclosure is depicted. Figure 1 This merely provides an illustration of one implementation and does not imply any limitation regarding the environments in which different embodiments may be implemented. Those skilled in the art may make many modifications to the depicted environment without departing from the scope of the embodiments herein.

[0021] In one or more embodiments, a surgical navigation system used in operating environment 100 includes precision guidance system 102 and imaging system 116. The surgical navigation system enables a surgeon to generate and display images of the trajectory of surgical instruments within the anatomy of patient 112 during a surgical procedure. Features of the surgical navigation system are further described in U.S. Pat. No. 8,634,897 B2, the entire disclosure of which is incorporated herein by reference.

[0022] Precision guidance system 102 may include monitor 104, robotic arm 106, camera 108, and a computer including one or more processors and at least one computer readable medium. The computer may be any programmable electronic device or computing system capable of receiving and sending data and executing computer readable program instructions on at least one computer readable medium. The computer readable program instructions may be operations such as Figure 3The one or more processors may be configured to execute one or more program instructions to verify the trajectory of a surgical tool such as a pedicle puncture needle, a Jamshidi needle, a guide wire, or a probe 110 during a surgical navigation procedure. The monitor 104, the robotic arm 106, and the camera 108 are each pivotally coupled to the base 130 of the precision guidance system 102. The camera 108 may be an integrated 3D camera with a spatial tracking feature. The camera 108 may be used to track the movement of the robotic arm 106 so that the precision guidance system 102 provides movement instructions to the robotic arm 106.

[0023] Monitor 104 may be a control panel for a user to interact with in the sterile field of operating environment 100. Monitor 104 may display a surgical plan and / or a trajectory of a surgical tool (e.g., probe 110, probe 110a, and / or probe 110b) within the anatomy of patient 112. Monitor 104 may be configured to receive and display images from imaging system 116.

[0024] To operate the robotic arm 106, the precision guidance system 102 can provide movement instructions to the robotic arm 106. The precision guidance system 102 can provide movement instructions according to the surgical plan. The robotic arm 106 can be configured to rotate about one or more axes to perform one or more functions of the surgical procedure. The robotic arm 106 can include an instrument holder 132, which is configured to fasten tools such as surgical tools to the distal end of the robotic arm 106. The instrument holder 132 can be configured in various shapes to hold the corresponding tools. For example, the instrument holder 132 can be configured to be configured to accommodate and hold the shape of the probe 110 such as the probe 110a and / or the probe 110b.

[0025] The imaging system 116 may include a workstation 124 having a workstation monitor 126, and an image receiving portion 120 coupled to an image generating portion 122 via an arm 118. The arm 118 is configured to be shaped to be positioned above and below a patient 112 lying on a surgical table 114. For example, the arm 118 may be configured to be a "C" shape, such that the image generating portion 122 is located at the bottom distal end of the C-shaped arm, and the image receiving portion 120 is located at the upper distal end of the C-shaped arm. When the imaging system 118 is positioned to capture an image of the patient 112, the image generating portion 122, the patient 112, and the image receiving portion 120 are linearly aligned with each other.

[0026] The imaging system 116 can be a surgical navigation system based on computed tomography (CT) fluoroscopic images. The imaging system 116 can acquire and display CT images and / or X-ray images suitable for a given surgical procedure. However, it should be understood that the imaging system 116 is not limited to use with this specific image-guided surgical system. For example, the imaging system 116 can acquire images from other modalities that replace the surgical navigation system based on CT fluoroscopic images. As a non-limiting example, such modalities can include CT, ultrasound, PET, or magnetic resonance imaging. When the patient 112 is positioned to lie on the surgical table 114 within the arm 118 of the imaging system 116, the CT image and / or X-ray image can be collected. Preferably, the image can be taken at a time before the surgical procedure is performed. Images can be acquired from two orthogonal directions such as anterior-posterior (AP) and lateral of the anatomical part of the patient 112. The imaging system 112 can transmit the acquired images from the image receiving portion 120 to the workstation 124, which provides the ability to display the received images via the workstation monitor 126. The imaging system 112 can provide the received images to the precision guidance system 102.

[0027] Figure 2A A perspective view of a probe 110a according to one or more embodiments of the present disclosure is depicted. In one or more embodiments, the probe 110a includes a solid body 206a having an insertion end 202a and an attached handle 208. The insertion end 202a and the handle 208 may be positioned on opposite ends of the solid body 206a.

[0028] In one or more embodiments, the solid body 206a of the probe 110a is an elongated rigid structure with a solid center. In one or more cases, the solid body 206a is a linear structure. In one or more other cases, at least a portion of the solid body 206a is curved. The insertion end 202a includes a cutting tip 212 and sensors such as sensors 214a, 214b, 214c, and 214d. In one or more cases, the insertion end 202a of the solid body 206a can have a linear shape. In one or more other cases, the insertion end 202a can have a curved shape. Note that Figure 2A A sensor 214d is depicted located at the rear of the probe 110a. Similar to a Jamshidi needle, a pedicle puncture kit (PAK) needle, etc., the cutting tip 212 can be configured to penetrate bone and / or tissue. In one or more embodiments, the cutting tip 212 can include a sharp, tapered cutting edge, such as Figure 2AAs shown. In one or more other cases, the cutting tip 212 can include one or more sharp cutting grooves. In one or more other cases, the cutting tip 212 can be a guide wire configured to penetrate bone. The insertion end 202a can be formed into various diameters and lengths to be used as a tap for inserting surgical devices or implants such as pedicle screws.

[0029] In one or more embodiments, sensors 214a, 214b, 214c, and 214d can be configured to measure anatomical information such as bone density and / or tissue density. In one or more embodiments, sensors 214a, 214b, 214c, and 214d can be impedance sensors, pressure sensors, strain gauges, etc. In one or more cases, sensors 214a, 214b, 214c, and 214d can be all sensors of the same type. For example, sensors 214a, 214b, 214c, and 214d can all be impedance sensors. In one or more other cases, sensors 214a, 214b, 214c, and 214d can be a combination of sensors. For example, one or more of the sensors can be impedance sensors, and one or more other sensors can be pressure sensors.

[0030] In one or more embodiments, the solid body 206a includes cavities, wherein each cavity is configured to accommodate a corresponding sensor, so that the sensor can be embedded in the probe 110a. The cavity can be formed into a shape similar to the shape of the corresponding sensor, for example, the cavity can be square to accommodate a square sensor. The depth of the cavity can be deep enough to accommodate the thickness of the corresponding sensor. In one or more cases, when the sensor is located in the cavity, the outer surface of the sensor that is not in contact with the surface of the cavity can be flush or substantially flush with the outer surface of the solid body 206a.

[0031] In one or more cases, such as Figure 2B The protective seal 220 shown can cover the sensor and a portion of the outer surface of the solid body 206a (e.g., the insertion end 202a). The protective seal can be configured to protect the sensor from damage when the probe 110a enters an anatomical portion of the patient 112, such as a vertebra. In one or more embodiments, when the protective seal is attached to the solid body 206a, the outer surface of the protective seal is flush or substantially flush with the outer surface of the proximal portion of the cutting tip 212.

[0032] In one or more other embodiments, the solid body 206a does not include a cavity. The sensor can be positioned on the outer surface of the solid body 206a so that the outer surface of the sensor is raised from the outer surface of the solid body 206a. In one or more cases, to prevent the sensor from being damaged, a protective seal can cover the sensor located on the outer surface of the solid body 206a.

[0033] Sensors 214a, 214b, 214c and 214d can be arranged circumferentially around the insertion end 202a. In one or more embodiments, each group of sensors can be arranged in a sensor array 216. For example, sensor 214a can form a sensor array 216. In one or more cases, sensor array 216 can be configured as a linear array. In a linear array configuration, each sensor array of sensors 214a, 214b, 214c and 214d can be spaced apart from each other around the insertion end 202a so that the width between each sensor array is equal. In one or more other embodiments, sensors 214a, 214b, 214c and 214d can be arranged in a spiral shape around the insertion end 202a.

[0034] In one or more embodiments, the probe 110a includes a transmitter array 204 attached to a solid body 206a by a fixture 204a. The fixture 204a may have a cylindrical opening configured to accommodate the solid body 206a. The fixture 204a may be fastened to a portion of the solid body 206a. The transmitter array 204 may be configured to identify the position of the probe 110a relative to a known reference point in three-dimensional space, so that the probe 110a and / or the trajectory of the probe 110a can be shown on one or more monitors such as the monitor 104 and the workstation monitor 126. The transmitter array 204 can transmit sensor data collected by sensors 214a, 214b, 214c and 214d. The collected sensor data can be information related to the anatomical part of the patient 112. The transmitter array 204 can be configured to receive data from the precision guidance system 102. Features of emitter array 204 are further described in U.S. Patent No. 7,763,035 B2, the entire disclosure of which is incorporated herein by reference.

[0035] In one or more embodiments, for situations where a portion of the surgical procedure is performed manually by the surgeon, the surgeon may grasp the handle 208 and guide the probe 110a into the anatomy of the patient 112. In one or more other embodiments, the handle 208 may be configured to attach to the instrument holder 132 of the robotic arm 106.

[0036] Figure 2B A perspective view of a probe 110b according to one or more embodiments of the present disclosure is depicted. In one or more embodiments, the probe 110b includes a hollow body 206b having an insertion end 202b and an attachment handle 208. The insertion end 202b and the attachment handle 208 may be positioned on opposite ends of the hollow body 206b.

[0037] In one or more embodiments, the hollow body 206b of the probe 110b is an elongated rigid structure with a hollow center. The hollow center of the hollow body 206b is configured to accommodate surgical tools. For example, a reamer 222 can be inserted through the hollow center so that a portion of the reamer head 224 protrudes beyond the opening 226 of the insertion end 202b. A bone drill, a guide wire, a needle, a dilator or other instruments can be inserted into the center of the probe alternatively. The opening of the insertion end 202b can be formed into various diameters to accommodate surgical tools with different diameters. Surgical tools such as reamer 222, inserters, and distractors are further described in U.S. Patent No. 7,763,035B2, and its entire disclosure is incorporated herein by reference.

[0038] In one or more embodiments, the insertion end 202b includes a tapered end 218 that tapers toward the distal end of the probe 110b. The tapered end 218 can be used to facilitate entry of the probe 110b into the anatomical portion of the patient 112. In one or more other embodiments, the insertion end 202b is substantially cylindrical and does not include the tapered end 218.

[0039] In one or more embodiments, sensors 214e, 214f, 214g, and 214h include one or more of the same features as sensors 214a, 214b, 214c, and 214d. Therefore, the description of these features will not be repeated. Sensors 214i, 214j, 214k, and 214l include one or more of the same features as sensors 214a, 214b, 214c, and 214d. Note that Figure 2B Sensors 214h and 214j are shown located at the rear of the probe 110b. Therefore, the description of these features will not be repeated. In addition, sensors 214i, 214j, 214k and 214l can be positioned on the tapered end 218 of the insertion end 202b. Sensors 214i, 214j, 214k and 214l can be located on the same inclined plane of the tapered end 218. In one or more embodiments, the insertion end 202b of the hollow body 206b includes a cavity having one or more of the same features as the cavity of the insertion end 202a of the solid body 206a. Therefore, the description of the cavity features will not be repeated.

[0040] In one or more embodiments, the probe 110b can include a protective seal 220 covering a portion of the outer surface of the sensor and the hollow body 206b (e.g., the insertion end 202b). The protective seal can be configured to protect the sensor from damage when the probe 110b enters an anatomical portion of the patient 112, such as a vertebra. In one or more embodiments, the insertion end 202b can be recessed into the hollow body 206b to a depth equal to or approximately equal to the thickness of the protective seal 220. When the protective seal 220 is attached to the insertion end 202b, the outer surface of the protective seal 220 can be flush or substantially flush with the outer surface of the hollow body 206.

[0041] In one or more embodiments, the transmitter array 204 of the probe 110b includes one or more of the same features as the transmitter array 204 of the probe 110a, and the handle 208 of the probe 110b includes one or more of the same features as the handle 208 of the probe 110a. Figure 2B A handle 208 is depicted that is configured to be attached to the instrument holder 132 of the robotic arm 106. Therefore, a description of these features will not be repeated.

[0042] In one or more embodiments, for drilling a hole in a vertebral body and / or inserting a bone screw therein, the drill tip and / or the bone screw may include one or more sensors similar to sensors 214a, 214b, 214c, and 214d. In one or more cases, one or more sensors may be included in the distal end of the bone screw. Each sensor may be recessed in the bone screw so that the outer surface of the sensor may be flush or substantially flush with the surface of the groove formed by the thread of the bone screw. In one or more other cases, one or more sensors may be recessed in the handle of the bone screw. The bone screw may be a hollow bone screw containing a circuit and an antenna in the hollow portion of the head and / or handle of the bone screw. The circuit and antenna may be connected to one or more sensors, wherein a circuit connector such as a wire is located in the hollow portion of the bone screw. The circuit and antenna may be configured to transmit sensor data from one or more sensors to the precise guidance system 102. The bone screw with one or more sensors may operate with the precise guidance system 102 in a manner similar to the sensor and probe 110a and probe 110b. In a non-limiting example, the bone screw may be a pedicle screw.

[0043] Figure 3 300 is a flowchart illustrating a method 300 of surgical navigation according to one or more embodiments of the present disclosure. Although the method 300 is described for convenience and not to limit the present disclosure to include a series and / or multiple steps, it should be understood that the process need not be as described above. Figure 3Rather than performing the two steps as a series of steps shown, the multiple steps can be abstracted into a functional unit that performs the two steps. Figure 4A An example 400a of a surgical navigation procedure is depicted. Figure 4B Another example of a surgical navigation procedure 400b is depicted. Figure 4C Another example of a surgical navigation procedure 400c is depicted.

[0044] In one or more embodiments, one or more images are captured at 302. The one or more images may preferably be captured by the imaging system 116. The one or more captured images may be CT images and / or X-ray images of the anatomical portion of the patient 112 on which the surgical procedure will be performed. The CT images and / or X-ray images may be collected while the patient 112 is lying on the surgical table 114 within the arm 118 of the imaging system 116. In one or more cases, the images are preferably taken at a time before the surgical procedure is performed. Images may be taken from two orthogonal directions such as anterior-posterior (AP) and lateral of the anatomical portion of the patient 112 (e.g., a portion of a vertebra 410 of a pedicle, such as a pedicle). The imaging system 112 may transmit the acquired images from the image receiving portion 120 to the workstation 124 and / or the precision guidance system 102.

[0045] In one or more embodiments, a surgical plan is determined at 304. In one or more instances, a user, such as a surgeon, may determine a surgical plan to be performed by precision guidance system 102. Based on one or more captured images, the surgeon may determine a surgical plan to be implanted and / or determine a trajectory placement of a surgical device or implant, such as a pedicle screw. The surgical plan may include a path, such as path 404, to implant the surgical device into the anatomical portion of patient 112. For example, the surgeon may determine that a hole configured to receive a pedicle screw may be formed via path 404, such as FIG. 4A to FIG. 4C The surgeon may determine that the path 404 enters the central portion 414 of the left pedicle 412 of the vertebra 410. The surgeon may determine data related to the anatomical portion, such as the bone density of the anatomical portion and / or the bone density surrounding the path 404, using one or more captured images.

[0046] After the surgical plan is determined, the surgical plan can be imported into the workstation 124 and / or the precision guidance system 102. In one or more cases, a mounting platform of the precision guidance system 102 (such as a fixed bone clamp described in U.S. Pat. No. 9,066,751 and the entire contents of which are incorporated herein by reference) can be rigidly attached to the patient at another anatomical part of the patient (such as the spinous process of another vertebra above or below the target vertebra). In one or more other cases, a mounting platform such as a percutaneous reference pin used with the precision guidance system 102 can be rigidly attached to the patient at another anatomical part such as the posterior superior iliac spine. The precision guidance system 102 can perform a 3D scan of the surgical location via the camera 108 and / or a 3D camera integrated into the robotic arm 106 to reconstruct a 3D volume of the patient 112 and assess the working area for the surgeon. One or more captured images can be mapped to the 3D scan of the surgical location.

[0047] In one or more embodiments, the probe is inserted into the anatomical location at 306. In one or more embodiments, the robotic arm 106 may begin inserting the probe (e.g., probe 110a or 110b) into the anatomical portion (e.g., the left pedicle 412 of the vertebra 410 of the patient 112). As the probe is inserted into the anatomical portion, sensor data is collected at 308, preferably by sensors such as sensors 214a, 214b, 214c, and 214d of the probe 110a or sensors 214e, 214f, 214g, 214h, 214i, 214j, 214k, and 214l of the probe 110b. The probe may transmit the collected sensor data to the precision guidance system 102 via the transmitter array 204. The precision guidance system 102 may be configured to convert the collected sensor data into Hounsfield units or other measurements of bone density and / or tissue density. In one or more embodiments, the probe may transmit the collected sensor data to precision guidance system 102 , and precision guidance system 102 may transform the collected sensor data in real-time.

[0048] After the collected sensor data is converted, a determination is preferably made by the precision guidance system 102 at 310 as to whether the collected sensor data corresponds to the surgical plan. In one or more cases, the precision guidance system 102 may determine whether the collected sensor data corresponds to the surgical plan at periodic time increments. In one or more other cases, the precision guidance system 102 may continuously determine whether the collected sensor data corresponds to the surgical plan while inserting the probe into the anatomical location. In one or more cases, when creating a surgical plan using one or more captured images, the precision guidance system 102 may determine data related to the anatomical portion. For example, the precision guidance system 102 may determine at least one of the bone density and tissue density of the anatomical portion and / or at least one of the bone density and tissue density around the path 404. In order to determine whether the collected sensor data corresponds to the surgical plan, the precision guidance system 102 may compare the collected sensor data with the data of the anatomical portion determined in the surgical plan. For example, for a case where the collected sensor data is related to bone density, the collected sensor data may be compared with predetermined bone density data of the anatomical portion.

[0049] For the case where the collected sensor data corresponds to the surgical plan (310: yes), the probe is inserted into the anatomical portion at 312. For example, the precision guidance system 102 determines that the path 402 measured by the sensor corresponds to the path 404 determined by the surgical plan. That is, the bone density data collected by the sensor corresponds to the bone density data predetermined in the surgical plan. In example 400a, the precision guidance system 102 determines that the collected sensor data places the path 402 on a path that is equivalent to or nearly equivalent to the path 404 determined by the surgical plan. That is, the precision guidance system 102 determines that the bone density measured by the sensor while traveling along the path 402 corresponds to the predetermined bone density measurement value of the vertebral body 410. In another example 400b, the precision guidance system 102 determines that the collected sensor data causes the path 402 to be slightly angled and / or off-center from the path 404; however, the precision guidance system 102 determines that the collected sensor data is within an acceptable range for the path 404. That is, the bone density of the anatomical portion measured by the sensor may not be equal to the predetermined bone density measurement; however, the bone density measured by the sensor may be close enough to the predetermined bone density measurement to be acceptable to the precision guidance system 102. Within the acceptable range, the robotic arm 106 continues to insert the probe into the left pedicle 412 of the vertebra 410.

[0050] For situations where the collected sensor data does not correspond to the surgical plan (310: No), an alarm is sent at 314 and insertion of the probe into the anatomical location may be stopped. For example, when the bone density data collected by the sensor is not equal to the bone density data predetermined in the surgical plan, the collected sensor data may not correspond to the surgical plan, and / or the bone density data collected by the sensor may also be outside the acceptable range of the predetermined bone density data. For situations where the collected sensor data does not correspond to the surgical plan, the precision guidance system 102 may send an alarm to the surgeon that the collected sensor data does not correspond to the surgical plan, and / or stop the robotic arm 106 from further inserting the probe into the anatomical location.

[0051] The alarm may be provided in the form of an alarm, message, feedback, or other means. In one or more cases, the alarm may also be a graded visual signal and / or an audio signal. For example, in the case where the bone density data collected by the sensor deviates from the bone density data predetermined in the surgical plan, a visual signal may appear on the monitor 104 and / or the workstation monitor 126. For example, if the precision guidance system 102 determines that the bone density data collected by the sensor deviates from the bone density data predetermined in the surgical plan by 1% or about 1%, a yellow warning light may appear on the monitor 104. In another case, if the precision guidance system 102 determines that the bone density data collected by the sensor deviates from the bone density data predetermined in the surgical plan by 10% or about 10%, an orange warning light may appear on the monitor 104. In yet another case, if the precision guidance system 102 determines that the bone density data collected by the sensor deviates from the bone density data predetermined in the surgical plan by 20% or about 20%, a red warning light may appear on the monitor 104. In another example, for a case where the bone density data collected by the sensor deviates from the bone density data predetermined in the surgical plan, an audio signal may be emitted from the probe 110 and / or the precision guidance system 102. For example, if the precision guidance system 102 determines that the bone density data collected by the sensor deviates from the bone density data predetermined in the surgical plan by 1% or approximately 1%, the first audio signal may be emitted from the probe 110 and / or the precision guidance system 102 as a simple tone. In another case, if the precision guidance system 102 determines that the bone density data collected by the sensor deviates from the bone density data predetermined in the surgical plan by 10% or approximately 10%, the second audio signal may be emitted as a tone more complex than the tone of the first audio signal. In yet another case, if the precision guidance system 102 determines that the bone density data collected by the sensor deviates from the bone density data predetermined in the surgical plan by 20% or approximately 20%, the third audio signal may be emitted as a tone more complex than the tone of the second audio signal.

[0052] In one or more cases, for situations where the collected sensor data does not correspond to the surgical plan, the precision guidance system 102 can automatically stop the robotic arm 106. The surgeon can manually stop, redirect, or interrupt the automated or manual insertion upon receiving or sensing an alarm.

[0053] In example embodiment 400c, precision guidance system 102 determines that the collected sensor data places path 408 outside of an acceptable range from path 404. For example, path 408 may be at a different insertion angle than path 404, and / or path 408 may extend beyond the determined end of path 404. That is, precision guidance system 102 may determine that the bone density measured by the sensor while traveling along path 402 does not correspond to a predetermined bone density measurement value for vertebral body 410. Determining that path 408 is outside of the acceptable range of path 404, precision guidance system 102 stops inserting the probe into left pedicle 412 of vertebra 410 and sends an alert to the surgeon to indicate that robotic arm 106 is not following surgically planned path 404. In one or more instances, when the insertion angle of path 408 is determined to be incorrect, precision guidance system 102 may issue an instruction to stop inserting the probe. In one or more other circumstances, precision guidance system 102 may issue a command to stop inserting the probe when guide portion 416 of path 408 extends beyond end portion 418 of path 408 as determined by the surgical plan.

[0054] In one or more embodiments, precision guidance system 102 may be configured to measure sensor data collected from each sensor array 216 to determine whether the probe is skewed. For example, precision guidance system 102 may determine whether the values ​​from each of sensor arrays 216 are equal to each other or within an acceptable range. For example, if precision guidance system 102 determines that one of the measurements from a sensor array is not equal to the measurements of the other sensor arrays or is not within an acceptable range of measurements, precision guidance system 102 may determine that the probe is deviating toward a sensor array with incorrect measurements and / or is approaching an area toward a sensor array with incorrect measurements, where the probe should not enter the area.

[0055] In one or more embodiments, data from the sensors may be used to provide an additional data source to the surgical navigation system 100 to confirm or refute the accuracy of the surgical plan and / or the surgical navigation system 100. The sensor data may be used as a feedback loop to the precision guidance system 102 to provide a confidence level and / or accuracy level of the path 402.

[0056] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example, the actions or events of any process or method described herein may be performed in a different order, may be added, merged, or completely excluded (e.g., all described actions and events may not be necessary for performing the technology). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single module or unit, it should be understood that the technology of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0057] In one or more instances, the described techniques, such as surgical navigation procedures, can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions can be stored as one or more computer-readable program instructions or codes on a computer-readable medium and executed by a hardware-based processing unit such as a processor. The computer-readable medium can include a non-transitory computer-readable medium, which corresponds to a tangible medium, such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and can be accessed by a computer).

[0058] The one or more processors may include one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. A processor may refer to any of the aforementioned structures or any other physical structure suitable for implementing the described techniques. Moreover, the described techniques may be fully implemented in one or more circuits or logic elements.

[0059] The various embodiments described above are provided by way of illustration only and should not be construed as limiting the appended claims. Those skilled in the art will readily appreciate that various modifications and changes may be made without following the embodiments and applications illustrated and described herein and without departing from the true spirit and scope of the claims.

Claims

1. A surgical navigation system for verifying a trajectory of a surgical tool during surgery, the surgical navigation system comprising: The surgical tool comprising one or more sensors attached to the surgical tool; an imaging system configured to capture one or more images of an anatomical portion of the patient and transmit the captured one or more images to the guidance system; as well as a guidance system configured to operate the surgical tool, wherein the guidance system is configured to: receiving said captured one or more images, executing a surgical plan to insert the surgical tool into the anatomical portion via a robotic arm, receiving sensor data collected from the one or more sensors inserted into the anatomical part, determining whether the sensor data corresponds to the surgical plan, and In response to determining that the sensor data does not correspond to the surgical plan, sending an alert indicating that the surgical tool was not inserted according to the surgical plan, Wherein, the surgical tool comprises an elongated rigid rod having a hollow body, wherein the hollow body is configured to accommodate a second surgical tool inserted therein so that the second surgical tool protrudes outwardly from an insertion end of the surgical tool into the anatomical part.

2. The surgical navigation system according to claim 1, wherein: The insertion end includes a tapered end that tapers toward a distal side of the surgical tool.

3. The surgical navigation system according to claim 1, wherein: The second surgical tool is configured to penetrate at least one of bone and tissue.

4. The surgical navigation system according to claim 1, wherein: The one or more sensors are attached to the insertion end of the surgical tool and are configured to measure anatomical information of the anatomical part.

5. The surgical navigation system according to claim 4, wherein: The one or more sensors include at least one of an impedance sensor, a pressure sensor, and a strain gauge.

6. The surgical navigation system according to claim 4, wherein: The one or more sensors are embedded in the insertion end of the surgical tool.

7. The surgical navigation system according to claim 4, wherein: A protective seal is configured to cover the one or more sensors and a portion of an outer surface of the surgical tool.

8. The surgical navigation system according to claim 4, wherein: The anatomical information includes at least one of bone density and tissue density.

9. The surgical navigation system according to claim 1, wherein: The guidance system is further configured to cease inserting the surgical tool into the anatomical portion in response to determining that the sensor data does not correspond to the surgical plan.

10. The surgical navigation system according to claim 9, wherein: The guidance system further includes a robotic arm configured to operate the surgical tool, and wherein the guidance system is further configured to instruct the robotic arm to continue inserting the surgical tool into the anatomical part in response to determining that the sensor data does correspond to the surgical plan.

11. The surgical navigation system according to claim 1, in, The guidance system is further configured to determine at least one of bone density and tissue density of the anatomical portion from the one or more captured images, and Wherein the received sensor data includes at least one of bone density and tissue density of the anatomical part.

12. The surgical navigation system according to claim 11, wherein: The guidance system is further configured to determine whether the sensor data corresponds to the surgical plan by comparing the at least one of the bone density and the tissue density of the sensor data with the at least one of the bone density and the tissue density determined in the surgical plan.

13. The surgical navigation system according to claim 12, wherein: The guidance system is further configured to determine whether the sensor data corresponds to the surgical plan by determining whether the at least one of the bone density and the tissue density of the sensor data is within a range of the at least one of the bone density and the tissue density determined in the surgical plan.

14. A computer program product comprising: A non-transitory computer readable storage medium having program instructions embodied therewith for verifying a trajectory of a surgical tool during surgery, the program instructions being executable by one or more processors, the program instructions comprising: receiving one or more captured images of an anatomical portion of a patient; executing a surgical plan to insert the surgical tool into the anatomical portion; receiving sensor data collected from one or more sensors inserted into the anatomical portion, the one or more sensors being attached to the surgical tool; determining whether the sensor data corresponds to the surgical plan; and In response to determining that the sensor data does not correspond to the surgical plan, sending an alert indicating that the surgical tool was not inserted according to the surgical plan, Wherein, the surgical tool comprises an elongated rigid rod having a hollow body, wherein the hollow body is configured to accommodate a second surgical tool inserted therein so that the second surgical tool protrudes outwardly from an insertion end of the surgical tool into the anatomical part.

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