System and method for tissue resection margin measurement device

Abstract

Embodiments of the present invention provide a system and method for resecting a tissue block. The system for resecting a tissue block includes a first sensor for measuring a signal corresponding to the position and orientation of the tissue block. The first sensor is sized to fit within or near the tissue block. The system also includes a second sensor attached to a surgical instrument, the second sensor being configured to measure the position and orientation of the surgical instrument. A controller communicates with the first sensor and the second sensor, and the controller executes a stored program to calculate the distance between the first sensor and the second sensor. Thus, visual, auditory, tactile, or other feedback is provided to the clinician to guide the surgical instrument to the surgical margin.

Description

[0001] Citations to pending prior patent applications

[0002] This invention application claims the benefit of the following patent applications:

[0003] (1) pending prior U.S. provisional patent application Ser. No. 62 / 923,137, filed October 18, 2019, by Raphael Bueno et al., for “SYSTEM AND METHOD FOR A TISSUE RESECTION MARGIN MEASUREMENT DEVICE” (Attorney Docket No. 129319.00702.BWH22238); and

[0004] (2) Pending prior U.S. provisional patent application serial number 63 / 054,921 filed on July 22, 2020 by Raphael Bueno et al. for “SYSTEM AND METHOD FOR ATISSUE RESECTION MARGIN MEASUREMENT DEVICE” (attorney docket number 129319.00734.BWH2020-564).

[0005] Both (2) patent applications identified above are hereby incorporated by reference. Technical Field

[0006] The present invention relates generally to surgery and, more particularly, to computer-assisted surgery. Background Art

[0007] Minimally invasive surgical resection of a lesion involves precisely excising the lesion while sparing surrounding healthy and critical tissue. Some examples include, but are not limited to, breast-conserving surgery and video-assisted thoracoscopic surgery (VATS). Surgical resection of a lesion requires removing a margin of tissue surrounding the lesion to ensure complete removal of the diseased cells and improved long-term survival. The default margin depends on the type of lesion and the minimal invasion of the lesion into the surrounding tissue. While this is particularly true in cancer, where the size of the original lesion and the margin of normal tissue removed along with the lesion correlates with survival, the same is true for non-cancerous lesions. Significant deformation of tissue due to high viscoelasticity, physiological motion (such as lung collapse, breathing or pulsatile motion), or tissue manipulation can make it difficult to locate and precisely remove the lesion. Consequently, this can lead to inadequate resection, local recurrence of the lesion, or metastasis (in cancer), and poorer long-term outcomes compared to cases where adequate margins are achieved. Two surgical applications are listed below as examples. However, the disclosed systems and methods can be applied to the resection or biopsy of other lesions using minimally invasive or image-guided methods or open surgery, or a combination of these methods.

[0008] Lung surgery

[0009] Current clinical practice for removing lung tissue segments involves opening the chest by cutting the sternum or by spreading the ribs. During these procedures, ribs are often broken and the segments are often surgically removed. Orthopedic trauma itself presents considerable pain, and it can complicate the patient's recovery process. This level of chest pain also complicates the task of recovering from general anesthesia, as the body becomes accustomed to forced ventilation and this pain can interrupt the natural chest rhythm. Patients would benefit greatly from procedures that can be performed through small chest incisions or ports without inflicting this orthopedic trauma.

[0010] Despite the well-known benefits that minimally invasive or VATS techniques offer patients by minimizing trauma and accelerating recovery time compared to open-chest surgery, a significant number of open-chest surgeries are still performed. This is due, at least in part, to the limited number of instruments specifically designed to facilitate thoracic surgery in this manner.

[0011] However, surgery for lung cancer is shifting towards minimally invasive approaches that use VATS and smaller anatomical or non-anatomical lung resections (e.g., wedge resections or segmental resections), particularly for small lesions. However, in conventional methods of performing VATS, the lung collapses during surgery, making it difficult to accurately locate the lesion and determine the resection margins. Additionally, palpation of lung tissue is not always possible due to the minimally invasive approach to surgery (especially in the case of smaller or early-stage cancers). Imprecise surgical resection can lead to incomplete resection and subsequent recurrence of the lesion.

[0012] Breast lesion surgery

[0013] Breast-conserving surgery (BCS) involves the removal of the lesion while preserving the surrounding healthy breast parenchyma. Studies have shown that BCS combined with chemotherapy has similar long-term benefits to mastectomy, with additional cosmetic advantages. However, due to the highly deformable nature of the breast, identifying and removing the entire lesion is a challenging task. Due to the soft tissue nature of the breast, achieving negative surgical margins with minimal damage to the healthy parenchyma is not easy. In fact, studies have shown that up to 25% of mastectomies leave positive margins and require retreatment.

[0014] Therefore, there is a need for a tissue resection margin measurement device that overcomes the aforementioned limitations by providing an improved method for accurately locating lesions and determining resection margins. Summary of the Invention

[0015] The present invention relates to systems and methods for resecting tissue while compensating for tissue deformation due to its elastic properties and physiologically induced motion. In a non-limiting example, the present invention enables minimally invasive surgery by providing an apparatus and method for performing tissue resection that discriminates against trauma to critical tissue and accurately determines resection margins. Additionally, auditory, visual, and tactile cues can be provided to the surgeon to identify and more accurately measure lesion margins and critical structures surrounding the lesion to ensure complete and safe resection of the lesion.

[0016] Some embodiments of the present invention provide a system for resecting a tissue mass. The system includes a surgical instrument and a first sensor for measuring a first signal. The first sensor is sized to fit within or near (e.g., immediately adjacent to) a target lesion / tissue mass, typically between the tissue mass and an edge of a final resection area. The system also includes a second sensor for measuring a second signal, and the second sensor is coupled to the surgical instrument. A controller communicates with the first sensor and the second sensor, and the controller executes a stored program to calculate a distance between the first sensor and the second sensor based on the first signal and the second signal.

[0017] In some embodiments, the system may further include a sleeve sized to engage at least one of the housing of the surgical instrument and the second sensor. The second sensor may be coupled to the housing of the surgical instrument by, for example, an adhesive. The surgical instrument may be, for example, a stapler, a Bovi pencil, or a cutting device configured to cut along a resection margin around a target tissue block, which may be a lesion (e.g., a tumor, a nodule, etc.). The resection margin may be included in the calculated distance between the first sensor and the second sensor. Other factors may be included in calculating the margin, such as the distance between the block and the first sensor, and the configuration of the block.

[0018] In one embodiment, the first signal received by the first sensor can indicate the position and orientation of the tissue mass relative to the surgical instrument in real time. Similarly, the second signal received by the second sensor can indicate the position and orientation of the surgical instrument relative to the tissue mass. In one embodiment, the second sensor indicates the position and orientation of the surgical instrument in the same reference frame as the first sensor. The first sensor can be a reference marker embedded in an anchor made of a hyperelastic material (sometimes referred to as a reference sensor or reference tracker), and the second sensor can be an instrument sensor (sometimes referred to as an instrument tracker). In one embodiment, the first sensor can be configured to measure the position and orientation of the tissue mass, and the second sensor can be configured to measure the position and orientation of the surgical instrument.

[0019] In one embodiment, the system may further include a third sensor for measuring a third signal. The third sensor may be sized to fit adjacent to the tissue mass at a position opposite the first sensor, such that the third signal received by the third sensor indicates a position and orientation of the tissue mass relative to the first sensor.

[0020] In one embodiment, the first sensor can be embedded in a hook structure made of a superelastic material (e.g., nitinol). The hook structure can be in the form of a T-shaped rod or a J-shaped rod, and the hook structure can be sized to fit within a delivery needle and / or sheath. The delivery needle and / or sheath can be configured to guide the first sensor, and the hook structure can be configured to anchor the first sensor within the tissue mass. In one embodiment, the first sensor embedded in the hook structure can be inserted into the tissue mass under real-time image guidance.

[0021] In one embodiment, a first sensor is embedded within a hook structure comprising a plurality of prongs, and the first sensor can be sized to fit within a delivery needle and / or sheath. The delivery needle and / or sheath can be configured to guide the first sensor, and the plurality of prongs can be configured to anchor the first sensor within the tissue mass. The hook structure can further include a plurality of extensions extending from a tubular portion of the hook structure, wherein the plurality of extensions are sized to receive the first sensor.

[0022] The system may further include a display in communication with the controller. The display may be coupled to the surgical instrument and configured to display the distance between the first sensor and the second sensor as calculated by a stored program executed by the controller, and the stored program may also be configured to include additional calculations. The distance to the base, middle, and tip of a surgical instrument (e.g., a cutting instrument such as a stapler) may also be displayed. The display may be, but is not limited to, an OLED display or an LCD display. In one embodiment, the system may include an auditory source for emitting an auditory signal. The auditory source may communicate with the controller, and the controller may be configured to execute a stored program to change the auditory signal based on the distance between the first sensor and the second sensor. In one embodiment, the stored program is a navigation system.

[0023] The system may further include a piezoelectric actuator coupled to the handle of the surgical instrument. The piezoelectric actuator may be configured to emit a tactile signal. The piezoelectric actuator may communicate with a controller configured to execute a stored program to change the tactile signal based on a distance between the first sensor and the second sensor.

[0024] In some embodiments, the system may further include a monitor for emitting a visual signal. The monitor may communicate with a controller configured to execute a stored program to change the visual signal based on the distance between the first sensor and the second sensor. Additionally or alternatively, the system may include a monitor for displaying a video overlay. The monitor may communicate with a controller configured to execute a stored program to fuse a laparoscope, thoracoscopic or endoscopic image (i.e., a "scope image") with a virtual model image (i.e., a computer-generated image of a virtual model of the anatomy) to create a video overlay of the scope image and the virtual model image. The video overlay may be configured to identify the position of the tissue block and the first sensor.

[0025] In one embodiment, the present invention provides a method for resecting a tissue mass within a patient. The method includes inserting a first sensor within or near (e.g., immediately adjacent to) a target tissue mass and capturing at least one image of the first sensor embedded within or near (e.g., immediately adjacent to) the tissue mass. Calculating a resection margin around the tissue mass using the at least one image. A surgical instrument is inserted into the patient and coupled to a second sensor. The second sensor is tracked relative to the resection margin, and a cut is made on the resection margin using the surgical instrument. The surgeon will determine the best margin possible based on the diagnosis and size of the mass. This information can also be used to determine the exact procedure required.

[0026] In some embodiments, the method may further include designing the size of the sleeve to engage at least one of the housing of the surgical instrument and the second sensor. Or the second sensor can be coupled to the housing of the surgical instrument by, for example, an adhesive. In another embodiment, the sensor can be embedded in the device / instrument, or the sensor can be built into the device / instrument. The surgical instrument can be, for example, a stapler, a Bovi pencil, or a cutting device configured to cut along a resection edge around a tissue block, which can be a lesion (e.g., a tumor, a nodule, etc.). The resection edge can be included in the calculated distance between the first sensor and the second sensor.

[0027] In some embodiments, the first signal received by the first sensor can indicate in real time the position and orientation of the first sensor (and therefore the tissue mass) relative to the surgical instrument. Similarly, the second signal received by the second sensor can indicate the position and orientation of the surgical instrument relative to the tissue mass. In one embodiment, the second sensor indicates the position and orientation of the surgical instrument in the same reference frame as the first sensor. The first sensor can be a fiducial marker made of a hyperelastic material, and the second sensor can be an instrument sensor. In one embodiment, the first sensor can be configured to measure the position and orientation of the tissue mass, and the second sensor can be configured to measure the position and orientation of the surgical instrument.

[0028] In one embodiment, the method may further include providing a third sensor for measuring a third signal. The third sensor may be sized to fit adjacent to the tissue mass at a position opposite the first sensor, such that the third signal received by the third sensor indicates a position and orientation of the tissue mass relative to the first sensor.

[0029] In some embodiments, the first sensor can be embedded within a hook structure. The hook structure can be in the form of a T-bar or a J-bar, and the hook structure can be sized to fit within a delivery needle and / or sheath. The delivery needle and / or sheath can be configured to guide the first sensor, and the hook structure can be configured to anchor the first sensor within the tissue mass. In one embodiment, the first sensor embedded within the hook structure can be inserted into the tissue mass under real-time image guidance or under direct visual guidance.

[0030] In one embodiment, a first sensor is embedded within a hook structure comprising a plurality of prongs, and the first sensor can be sized to fit within a delivery needle and / or sheath. The delivery needle and / or sheath can be configured to guide the first sensor, and the plurality of prongs can be configured to anchor the first sensor within the tissue mass. The hook structure can further include a plurality of extensions extending from a tubular portion of the hook structure, wherein the plurality of extensions are sized to receive the first sensor.

[0031] The method may further include providing a display in communication with the controller. The display may be coupled to the surgical instrument and configured to display the distance calculated by a stored program executed by the controller. The display may be, but is not limited to, an OLED display or an LCD display. The display may also include information about the distance between the various sensors and the quality of the measurements. In some embodiments, the method may include emitting an auditory signal from an auditory source. The auditory source may be in communication with the controller, which is configured to execute a stored program to change the auditory signal based on the distance between the first sensor and the second sensor. In one embodiment, the stored program is a navigation method.

[0032] The method may further include emitting a haptic signal from a piezoelectric actuator coupled to a handle of the surgical instrument.The piezoelectric actuator may be in communication with a controller configured to execute a stored program to vary the haptic signal based on a distance between the first sensor and the second sensor.

[0033] In some embodiments, the method may further include issuing a visual signal on the monitor. The monitor may communicate with a controller configured to execute a stored program to change the visual signal based on the distance between the first sensor and the second sensor. Additionally or alternatively, the method may include displaying a video overlay on the monitor. The monitor may communicate with a controller configured to execute a stored program to fuse the laparoscopic / thoracoscopic / endoscopic image(s) to the virtual model image to create a video overlay. The video overlay may be configured to identify the location of the tissue mass and the first sensor.

[0034] In one form of the invention, the system can be used to identify the location of a specific airway. In this form of the invention, the system includes a device for positioning a sensor into an airway of the lung via a bronchoscope. This bronchoscopic positioning of the sensor in the airway of the lung (e.g., by positioning the sensor on a bronchoscope or on a catheter within the bronchoscope and advancing the bronchoscope into the airway of interest) can be used to define a lobar, segmental, or subsegmental bronchi during the actual procedure for a surgical procedure such as a segmentectomy, lobectomy, or wedge resection. This function can be independent of lesion margin measurement, and the position of the sensor identifying the bronchus can be correlated with the position of another device (e.g., a surgical instrument) carrying another sensor so that the surgeon can define the correct bronchus for the surgical procedure from the thoracic side of the procedure. Thus, in this form of the invention, one sensor is positioned on a bronchoscope or on a catheter placed within a bronchoscope that is inserted into a particular airway in order to define the location of that particular airway, and another sensor is positioned on a surgical instrument that is advanced for performing surgery from the chest side of the operation, wherein the system continuously tracks the position of the sensor on the surgical instrument and the position of the sensor on the bronchoscope so that the surgeon can continuously track the position of the surgical instrument relative to the airway of interest (identified by the sensor on the bronchoscope), for example, to target the airway identified by the sensor on the bronchoscope, avoid the airway identified by the sensor on the bronchoscope, etc.

[0035] In one form of the invention, the system includes means for mapping and tracking the airways around the lesion.

[0036] In one form of the invention, the system includes means for bronchoscope-deploying a fiducial sensor or another sensor into the tissue (eg, bronchoscope-deploying a fiducial sensor into or adjacent to the mass).

[0037] In one form of the invention, the system includes: a device for measuring articulation of a surgical stapler.

[0038] In one form of the invention, the system includes means for marking the boundaries of the resection margin of the lesion and positioning the surgical stapler adjacent the boundaries of the resection margin of the lesion.

[0039] In one form of the invention, there is provided a method for determining a position of an instrument relative to a selected lumen in an anatomical structure, the method comprising:

[0040] positioning a tracked catheter in a selected lumen of an anatomical structure, wherein the tracked catheter is tracked relative to a given reference frame; and

[0041] A position of a tracked instrument relative to a tracked catheter is determined, wherein the tracked instrument is tracked relative to a given reference frame, thereby determining a position of the tracked instrument relative to a selected lumen of the anatomical structure.

[0042] In another form of the invention, there is provided a system for determining a position of an instrument relative to a selected lumen in an anatomical structure, the system comprising:

[0043] a catheter sized for single use (disposable) in a selected lumen of an anatomical structure;

[0044] a catheter tracker for providing a catheter signal representing a position of the catheter tracker relative to a given reference frame, the catheter tracker being carried by the catheter;

[0045] instrument;

[0046] an instrument tracker for providing an instrument signal representing a position of the instrument tracker relative to a given reference frame, the instrument tracker being carried by the instrument; and

[0047] A controller is provided for determining a position of the tracked instrument relative to the tracked catheter, whereby when the tracked catheter is disposed in the selected lumen of the anatomical structure, the controller determines the position of the tracked instrument relative to the selected lumen in the anatomical structure.

[0048] In another form of the present invention, there is provided a method for mapping and tracking a plurality of lumens in an anatomical structure, wherein the anatomical structure is deformable, the method comprising:

[0049] providing a virtual model of the anatomical structure when the anatomical structure is in a first configuration;

[0050] positioning the tracked catheter in one of the lumens in the anatomical structure to be mapped and tracked when the anatomical structure is in the first configuration, and determining a position of the tracked catheter in the lumen to map the position of the lumen;

[0051] Repeating the aforementioned steps for each lumen in the anatomical structure to be mapped and tracked so that the lumens are mapped;

[0052] supplementing the virtual model with the mapped lumen, thereby providing a supplemented virtual model of the anatomical structure and the mapped lumen when the anatomical structure is in its first configuration;

[0053] maintaining the tracked catheter in one of the mapped lumens of the anatomical structure as the anatomical structure deforms from its first configuration to its second configuration;

[0054] determining a position of the tracked catheter in the anatomical structure when the anatomical structure is in the second configuration; and

[0055] The supplemental virtual model is modified to represent the anatomical structure and the mapped lumen when the anatomical structure is in its second configuration, thereby providing a modified supplemental virtual model, wherein the modification is achieved by:

[0056] determining a spatial transformation of the tracked catheter as the anatomical structure deforms from its first configuration to its second configuration; and

[0057] The spatial transformation of the tracked catheter is applied to the mapped lumen of the supplemental virtual model to provide a modified supplemental virtual model of the anatomical structure and the mapped lumen when the anatomical structure is in its second configuration.

[0058] In another form of the present invention, there is provided a method for mapping and tracking a selected lumen in an anatomical structure, wherein the anatomical structure is deformable, the method comprising:

[0059] positioning the tracked catheter in a selected lumen of the anatomical structure when the anatomical structure is in the first configuration;

[0060] determining a position of the tracked catheter when the anatomical structure is in the first configuration;

[0061] scanning the anatomical structure and the tracked catheter positioned in a selected lumen of the anatomical structure when the anatomical structure is in a first configuration;

[0062] creating a virtual model of the scanned anatomical structure and the tracked catheter positioned in a selected lumen of the anatomical structure when the anatomical structure is in its first configuration;

[0063] maintaining the tracked catheter in position within a selected lumen of the anatomical structure as the anatomical structure is deformed into the second configuration;

[0064] determining a position and orientation of the tracked catheter when the anatomical structure is in its second configuration, thereby determining a position of a selected lumen of the anatomical structure when the anatomical structure is in the second configuration;

[0065] The virtual model is adjusted to represent the anatomical structure and the selected lumen when the anatomical structure is in its second configuration, thereby providing an adjusted virtual model, wherein the modification is achieved by:

[0066] determining a spatial transformation of the tracked catheter as the anatomical structure deforms from its first configuration to its second configuration; and

[0067] The spatial transformation of the tracked catheter is applied to the selected lumen of the virtual model to provide an adjusted virtual model of the anatomical structure and the selected lumen when the anatomical structure is in its second configuration.

[0068] In another form of the present invention, there is provided a system for mapping and tracking a plurality of lumens in an anatomical structure, wherein the anatomical structure is deformable, the system comprising:

[0069] a catheter sized to be disposed in a plurality of lumens of the anatomical structure to be mapped and tracked and configured to remain in a selected lumen of the anatomical structure during deformation of the anatomical structure;

[0070] a catheter tracker configured to provide a catheter signal indicating a position of the catheter tracker, the catheter tracker being carried by the catheter;

[0071] a virtual model of the anatomical structure, the virtual model representing the anatomical structure in a first configuration; and

[0072] A controller that is used to:

[0073] (i) determining a position of the tracked catheter when the tracked catheter is disposed within each of the plurality of lumens to map the plurality of lumens when the anatomical structure is in its first configuration; and

[0074] (ii) supplementing the virtual model with the mapped lumen, thereby providing a supplemented virtual model of the anatomical structure and the mapped lumen, the supplemented virtual model representing the anatomical structure in its first configuration.

[0075] In another form of the present invention, there is provided a system for mapping and tracking a selected lumen in an anatomical structure, wherein the anatomical structure is deformable, the system comprising:

[0076] a catheter sized to be disposed in a selected lumen of the anatomical structure and configured to remain in the selected lumen of the anatomical structure during deformation of the anatomical structure;

[0077] a catheter tracker configured to provide a catheter signal indicating a position of the catheter tracker, the catheter tracker being carried by the catheter;

[0078] a virtual model of the anatomical structure and the tracked catheter positioned in a selected lumen of the anatomical structure, wherein the virtual model is created when the anatomical structure is in a first configuration; and

[0079] A controller that is used to:

[0080] (i) determining a position of the tracked catheter after the anatomical structure assumes the second configuration; and

[0081] (ii) adjusting the virtual model of the anatomical structure and the tracked catheter so that the virtual model conforms to the position of the tracked catheter when the anatomical structure is in its second configuration.

[0082] In another form of the present invention, there is provided a method for tracking a tissue mass disposed in or on an anatomical structure, wherein the anatomical structure includes at least one lumen, the method comprising:

[0083] advancing a scope along at least one lumen until a distal end of the scope is disposed in a vicinity of the selected tissue mass;

[0084] advancing the fiducial sensor through the scope and into the anatomical structure, and securing the fiducial sensor to the anatomical structure in a proximal region of the tissue mass; and

[0085] Detecting the location of a fiducial sensor within an anatomical structure.

[0086] In another form of the present invention, there is provided a method for tracking a tissue mass disposed in or on an anatomical structure, wherein the anatomical structure includes at least one lumen, the method comprising:

[0087] providing a sensor assembly comprising a reference sensor and an electrical lead extending distally from the reference sensor, and providing a deployment assembly comprising a needle cannula and a pusher, wherein the sensor assembly is slidably disposed in the needle cannula distal to the pusher;

[0088] advancing a scope along at least one lumen until a distal end of the scope is disposed in a vicinity of the selected tissue mass;

[0089] advancing the needle cannula through the scope, into the anatomical structure, and through the outer surface of the anatomical structure;

[0090] retracting the needle cannula to expose a portion of the electrical lead extending through the outer surface of the anatomical structure;

[0091] supplying electrical power to the reference sensor via electrical leads extending through an outer surface of the anatomical structure;

[0092] securing the fiducial sensor to an anatomical structure in a proximal region of the tissue mass by advancing the pusher relative to the needle cannula or retracting the needle cannula relative to the pusher; and

[0093] Detecting the location of a fiducial sensor within an anatomical structure.

[0094] In another form of the invention, there is provided a system for determining a position of an instrument relative to a tissue mass carried by an anatomical structure, the system comprising:

[0095] a wireless fiducial tracker for providing a fiducial signal indicative of a position of the wireless fiducial tracker, the wireless fiducial tracker being adapted to be fixed in an anatomical structure in a vicinity of the tissue mass;

[0096] instrument;

[0097] an instrument tracker configured to provide an instrument signal indicating a location of the instrument tracker, the instrument tracker being carried by the instrument; and

[0098] A controller is configured to determine a position of the tracked device relative to the wireless reference tracker.

[0099] In another form of the invention, there is provided a system for determining a position of an instrument relative to a tissue mass carried by an anatomical structure, the system comprising:

[0100] a fiducial tracker for providing a fiducial signal representing a position and orientation of the fiducial tracker, the fiducial tracker being adapted to be fixed in an anatomical structure in a vicinity of the tissue mass;

[0101] an electrical lead for providing electrical power to the reference tracker, the electrical lead being releasably connected to the reference tracker;

[0102] instrument;

[0103] an instrument tracker configured to provide an instrument signal indicating a location of the instrument tracker, the instrument tracker being carried by the instrument; and

[0104] A controller is configured to determine a position of the tracked instrument relative to the reference tracker.

[0105] In another form of the invention, there is provided a system for determining a position and orientation of an instrument relative to a tissue mass disposed in or on an anatomical structure, the system comprising:

[0106] A sensor assembly, the sensor assembly comprising:

[0107] a fiducial tracker for providing a fiducial signal representing a position of the fiducial tracker, the fiducial tracker being adapted to be fixed in an anatomical structure in a vicinity of the tissue mass; and

[0108] an electrical lead for providing electrical power to the reference tracker, the electrical lead extending distally from the reference tracker;

[0109] instrument;

[0110] an instrument tracker for providing an instrument signal representing a position and orientation of the instrument tracker, the instrument tracker being carried by the instrument; and

[0111] A controller is configured to determine a position and orientation of the tracked instrument relative to the reference tracker.

[0112] In another form of the invention, there is provided a system for determining a position and orientation of an instrument relative to a tissue mass disposed in or on an anatomical structure, the system comprising:

[0113] A sensor assembly, the sensor assembly comprising:

[0114] a fiducial tracker for providing a fiducial signal representing a position of the fiducial tracker, the fiducial tracker being adapted to be fixed in an anatomical structure in a vicinity of the tissue mass; and

[0115] an electrical lead for providing electrical power to the reference tracker, the electrical lead extending distally from the reference tracker;

[0116] a deployment assembly comprising a needle cannula and a pusher, wherein the sensor assembly is slidably disposed within the needle cannula distal to the pusher;

[0117] instrument;

[0118] an instrument tracker for providing an instrument signal representing a position and orientation of the instrument tracker, the instrument tracker being carried by the instrument; and

[0119] A controller is configured to determine a position and orientation of the tracked instrument relative to the reference tracker.

[0120] In another form of the invention, there is provided a method for determining a position of an end effector of an instrument relative to a tissue mass carried by an anatomical structure, wherein the instrument includes a shaft and the end effector, and wherein the disposition of the end effector relative to the shaft is adjustable, the method comprising:

[0121] Tracking the location of tissue blocks;

[0122] Tracking device rods;

[0123] determining a disposition of the end effector relative to the rod; and

[0124] Determine the setup of the end effector relative to the tissue block.

[0125] In another form of the invention, there is provided a system for determining a position of an end effector of an instrument relative to a tissue mass carried by an anatomical structure, the system comprising:

[0126] a wireless fiducial tracker for providing a fiducial signal indicative of a position of the wireless fiducial tracker, the wireless fiducial tracker being adapted to be fixed in an anatomical structure in a vicinity of the tissue mass;

[0127] An instrument comprising a shaft and an end effector, wherein the disposition of the end effector relative to the shaft is adjustable;

[0128] an instrument tracker configured to provide an instrument signal indicating a position of the instrument tracker, the instrument tracker being carried by a pole of the instrument;

[0129] a sensor for detecting a position of the end effector relative to the rod; and

[0130] A controller is configured to determine a position of the tracked device relative to the wireless reference tracker.

[0131] In another form of the invention, there is provided a method for guiding positioning of an instrument relative to a tissue mass carried by an anatomical structure, the method comprising:

[0132] Determine the tangent lines of the tissue block;

[0133] Tracking the location of tissue blocks;

[0134] Tracking the location of devices;

[0135] Determining the placement of the instrument relative to the tangent line; and

[0136] The movement of the instrument is guided so that a portion of the instrument is aligned with the tangent line.

[0137] In another form of the invention, there is provided a system for guiding positioning of an instrument relative to a tissue mass carried by an anatomical structure, the system comprising:

[0138] a fiducial tracker for providing a fiducial signal representing a position of the fiducial tracker, the fiducial tracker being adapted to be fixed in an anatomical structure in a vicinity of the tissue mass;

[0139] instrument;

[0140] an instrument tracker configured to provide an instrument signal indicating a location of the instrument tracker, the instrument tracker being carried by the instrument; and

[0141] A controller is configured to determine a tangent line to the tissue volume and to guide a position of the tracked instrument relative to the tangent line.

[0142] These and other features, aspects, and advantages of the present invention will become better understood with consideration of the following detailed description, drawings, and appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0143] Figure 1 is a perspective view of an exemplary fiducial sensor deployed through a delivery needle in accordance with one embodiment of the present invention.

[0144] Figure 2 is deployed near a tissue mass by a delivery needle according to one embodiment of the present invention. Figure 1 A perspective view of an exemplary fiducial sensor of FIG. 1 (note that the fiducial sensor can be placed adjacent to a tissue mass such that the fiducial sensor is in contact with the tissue mass, or such that the fiducial sensor is slightly spaced apart from the tissue mass).

[0145] Figure 3 is an additional fiducial sensor deployed near a tissue mass by a delivery needle according to one embodiment of the present invention and Figure 1 A perspective view of an exemplary reference sensor.

[0146] Figure 4 is a perspective view of an exemplary reference sensor embedded within a hook structure according to another embodiment of the present invention.

[0147] Figure 5 is embedded Figure 2 A perspective view of a fiducial sensor in a tissue block with a resection margin surrounding the tissue block.

[0148] Figure 6 is embedded Figure 2 Perspective view of a fiducial sensor near a tissue block with a resection margin surrounding the tissue block (note that the fiducial sensor can be placed adjacent to the tissue block such that the fiducial sensor is in contact with the tissue block, or such that the fiducial sensor is slightly spaced apart from the tissue block).

[0149] Figure 7 is a partial perspective view of a conventional stapler device for resecting a tissue mass.

[0150] Figure 8 According to one embodiment of the present invention Figure 7 A partial perspective view of a stapler device having a sleeve including an instrument sensor above a housing of the stapler device.

[0151] Figure 9 It is inserted into the patient's body Figure 8 A perspective view of a stapler device is shown, showing the distance between the reference sensor and the instrument sensor.

[0152] Figure 10 is an example screenshot of a virtual endoscope or "scope" view of a tissue block superimposed on a laparoscopic view.

[0153] Figure 11 is an example screenshot of a laparoscopic view of a tissue block.

[0154] Figure 12 A diagram showing the tree-like structure of the lung's airways.

[0155] Figure 13 、 Figure 13A and Figure 13B is a schematic diagram showing how a bronchoscope can be used to position a tracked catheter (i.e., a catheter carrying a sensor) in a specific airway of the lung, thereby identifying the specific airway of the lung, and how a surgical instrument carrying another sensor can be guided relative to that airway (e.g., to target that airway, avoid that airway, etc.).

[0156] Figures 14-35 is a schematic diagram showing how the location of an airway can be identified using a tracked catheter.

[0157] Figure 36 and Figure 37 is a schematic diagram showing another way a tracked catheter can be used to identify the location of an airway.

[0158] Figure 38 is a schematic diagram showing the anatomical site containing the lesion, the fiducial sensor, and the tracked catheter.

[0159] Figure 39 is a schematic diagram showing a reference sensor deployed using percutaneous access.

[0160] Figure 40 and Figure 41 is a schematic diagram showing a wireless fiducial sensor deployed through a bronchoscope.

[0161] Figure 42 is a schematic diagram showing a wire-based fiducial sensor being deployed through a bronchoscope and then having its wire pushed through the bronchoscope under image guidance, through the lung parenchyma, to the surface of the skin.

[0162] Figure 43 is a schematic diagram showing a wire-based fiducial sensor being deployed through a bronchoscope and having its wire thereafter detached from the fiducial sensor and withdrawn up the airway.

[0163] Figures 44-46 is a schematic diagram of an apparatus showing another method for transbronchoscope deployment of a fiducial sensor into tissue (eg, transbronchoscope deployment of a fiducial sensor into or adjacent to a tissue mass).

[0164] Figure 46A and Figure 46B is a schematic diagram showing another apparatus for transbronchoscope deployment of a fiducial sensor into tissue (eg, transbronchoscope deployment of a fiducial sensor into or adjacent to a tissue mass).

[0165] Figures 47-52 Shows how to use Figures 44-46 Schematic diagram of an apparatus for deploying a reference sensor into tissue through a bronchoscopic lens (eg, deploying a reference sensor into or adjacent to a tissue mass through a bronchoscopic lens).

[0166] Figure 52A is a schematic diagram showing how a temporary proximal electrical connection may be provided for a fiducial sensor (eg, such as when the fiducial sensor is deployed through a bronchoscope).

[0167] Figure 53 and Figure 54 is a schematic diagram showing a surgical stapler having an articulation sensor for detecting articulation of a head of the surgical stapler.

[0168] Figure 55 and Figure 56 is a schematic diagram showing (i) a model of a lesion and (ii) a model of a resection margin combined with the model of the lesion.

[0169] Figures 57-60 is a schematic diagram showing how a stapler may be deployed adjacent to the resected margins of a lesion. DETAILED DESCRIPTION

[0170] Before explaining any embodiment of the present invention in detail, it should be understood that the present invention is not limited to the construction details and component configurations set forth in the following description or shown in the accompanying drawings in this application. The present invention can have other embodiments and can be implemented or realized in other ways. Moreover, it should be understood that the words and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "including", "comprising" or "having" and their variations herein is meant to include the items listed thereafter and their equivalents as well as additional items. Unless otherwise specified or limited, the terms "mount", "connect", "support" and "couple" and their variations are widely used and include direct mounting, connection, support and coupling as well as indirect mounting, connection, support and coupling. In addition, "connect" and "couple" are not limited to physical or mechanical connections or couplings.

[0171] The following discussion is provided to enable those skilled in the art to make and use embodiments of the present invention. Various modifications to the illustrated embodiments will be apparent to those skilled in the art, and the general principles herein can be applied to other embodiments and applications without departing from the scope of the present invention. Therefore, embodiments of the present invention are not intended to be limited to the specific embodiments shown, but rather to conform to the widest scope consistent with the principles and features disclosed herein. The following detailed description is read with reference to the accompanying drawings, in which the same elements in different drawings have the same reference numerals. The drawings, which are not necessarily drawn to scale, depict selected embodiments and are not intended to limit the scope of the present invention. Those skilled in the art will recognize that the examples provided herein have many useful alternatives and fall within the scope of embodiments of the present invention.

[0172] Tracking the position of tissue blocks using a fiducial sensor

[0173] Figure 1-Figure 3 An exemplary fiducial sensor 10 (sometimes also referred to as a fiducial marker or fiducial tracker) is shown inserted through a delivery needle 12. The fiducial sensor 10 may be, for example, a marker that includes a transmitter that measures the position and orientation of a tissue mass 18 in real time. Figure 1-Figure 3 As shown, the reference sensor 10 can be attached to a cable 14, or the reference sensor 10 can be wireless. Figure 1 As shown, the reference sensor 10 can be embedded within the hook structure 16. The hook structure 16 of the reference sensor 10 can be made of a superelastic material (e.g., nitinol, stainless steel, or any other suitable material). This allows the reference sensor 10 to be inserted through the delivery needle 12 and deployed through the opening 22 (i.e., the lumen) of the delivery needle 12 to the center or periphery of the tissue mass 18. The tissue mass 18 can be, for example, a lesion (e.g., a tumor, a nodule, etc.).

[0174] like Figure 4FIGURE 1 shows a more detailed view of reference sensor 10 and hook structure 16. Hook structure 16 can include a tube portion 15 having a plurality of extensions 17 extending from one end of tube portion 15 and a plurality of prongs 20 extending from an opposite end of tube portion 15. Tube portion 15 can be, for example, a nitinol tube having an outer diameter D1 between approximately 0.6 mm and approximately 0.8 mm, and hook structure 16 can have an overall length L between approximately 8 mm and approximately 12 mm. Tube portion 15 can be laser micromachined into a cylindrical shape with a plurality of extensions 17 extending therefrom to secure reference sensor 10 in place. In some embodiments, reference sensor 10 can be an electromagnetic sensor that is attached to the proximal end of hook structure 16 using a medical-grade epoxy adhesive such as AA-Bond FDA22.

[0175] like Figure 4 As shown, the plurality of prongs 20 may be configured to anchor the hook structure 16 (including the reference sensor 10) to a tissue mass (such as a Figure 2 The plurality of prongs 20 may be formed of a superelastic shape memory alloy such as nitinol. For example, the plurality of prongs 20 may be bent and extend outward from the central axis Y of the hook structure 16. For example, the plurality of prongs 20 may also be heat treated to ensure that the prongs 20 maintain their bent shape and that the phase structure of the nitinol is in the martensite phase. Figure 4 In the illustrated embodiment, the hook structure 16 includes three prongs 20 , however, any suitable number of prongs may be provided to anchor the hook structure 16 to a tissue mass, such as the tissue mass 18 , or at the periphery of the tissue mass.

[0176] The reference sensor 10, along with the hook structure 16, can be inserted through the distal end of a delivery needle 12, which can be, for example, an 18-gauge needle. The plurality of prongs 20 of the hook structure 16 can first be inserted into the lumen 22 of the delivery needle 12. Advantageously, due to the superelastic nature of Nitinol, the hook structure 16 can be easily inserted into the lumen 22 of the delivery needle 12. The hook structure 16 can be deployed using a metal stylet (not shown) inserted through the lumen 22 of the delivery needle 12. After full deployment, the plurality of prongs 20 will return to their original curved shape and open to securely anchor the hook structure 16 into or at the periphery of the tissue mass 18. The delivery needle 12 can then be removed after the hook structure 16 is deployed.

[0177] In some embodiments, the reference sensor 10 and the hook structure 16 can be inserted through the delivery needle 12 and embedded in the tissue mass 18 under real-time image guidance (eg, CT, C-arm CT, MRI, ultrasound, etc.). Figure 5 As shown, or embedded near the tissue block 18 (e.g., adjacent to the tissue block 18), as shown Figure 6As shown. The reference sensor 10 can be embedded in or near the tissue block 18 before or during the surgical procedure. By using real-time image guidance, the spatial relationship (i.e., position and orientation) of the reference sensor 10 to the tissue block 18 in three dimensions is always known. The hook structure 16 can be in the form of a T-bar or a J-bar, for example, to anchor the reference sensor 10 in or near the tissue block 18, thereby inhibiting migration. Advantageously, due to the wire 14, the force is located at the center of the T-bar 16, thereby helping to anchor the reference sensor 10 in or near the tissue block 18. Despite any deformation introduced, for example, due to soft tissue deformation or physiological movement (such as collapse of the lung or breathing), the reference sensor 10 embedded in or near the tissue block 18 will measure the position and orientation of the tissue block 18 in real time, thereby easily identifying the position of the tissue block 18 that is usually difficult to determine.

[0178] In an alternative embodiment, if Figure 3 As shown, the second reference sensor 11 (e.g., in the form of a T-bar assembly) can be placed in different locations near the tissue mass 18. Figure 3 As shown, second reference sensor 11 can have a separate cable 14 from first reference sensor 10, or first and second reference sensors 10, 11 can share the same cable 14. Second reference sensor 11, or any other such device, can be used to improve the localization of tissue mass 18, even in the presence of potential deformation. For example, second reference sensor 11 can be placed on the opposite side of tissue mass 18 from first reference sensor 10 and identified by first reference sensor 10 through distortion in the electromagnetic field. Thus, by knowing that tissue mass 18 is located between these two sensors, localization of tissue mass 18 can be achieved even in the presence of soft tissue deformation.

[0179] Now refer to Figure 5 and Figure 6 Once the position and orientation of the tissue block 18 are known, a resection margin 24 having a predetermined distance D2 around the tissue block 18 is determined by creating a three-dimensional envelope around the tissue block 18. The resection margin 24 can be manually set to a desired predetermined distance D2 (e.g., two centimeters) and depends on the surgeon's preference and the type of lesion. The predetermined distance D2 defines a threshold, so when a surgical device 26 (e.g., a surgical stapler), as described in further detail below, is in a position less than the threshold, an auditory, visual, and / or tactile prompt can be provided to the surgeon or the surgical device 26 to ensure accurate and complete resection of the tissue block 18.

[0180] Tracking the location of surgical equipment using instrument sensors

[0181] Now refer to Figure 7, shows a conventional surgical instrument 26, such as a surgical stapler, a Bovi pencil, a kitner, a laparoscope and / or any suitable cutting, resection or ablation device. The surgical instrument 26 may include a handle 30 coupled to a fastening assembly 32 at the other end of the surgical instrument 26. The fastening assembly 32 may be a disposable component that is removably connected to the handle 30, that is, the fastening assembly 32 may be a box that is connected to the handle 30 and removed after use. The fastening assembly 32 includes a housing 34 that contains a plurality of fasteners 36 that are secured to the tissue during the resection of the tissue block 18. The fastening assembly 32 may also include a blade slot 38 that accommodates a blade (not shown) for cutting along the resection edge 24 of the tissue block 18.

[0182] In a preferred embodiment, the surgical device 26 includes a sleeve 40 that is sized to slide over the housing 34, e.g., Figure 8 As shown. The sleeve 40 can be any commercially available sleeve, for example, which is configured to pass over the housing 34 of the surgical device 26. The instrument sensor 28 (sometimes referred to as an instrument tracker) can be attached to the sleeve 40 by, for example, suturing. Alternatively, the instrument sensor 28 can be directly attached to the housing 34 of the surgical device 26 via any suitable adhesive, or integrated into the housing 34 itself. Regardless of where the instrument sensor 28 is mounted, whether to the sleeve 40 or the housing 34, the instrument sensor 28 can measure the position and instruments of the surgical device 26 in the same imaging reference frame as the reference sensor 10 embedded in or near the tissue block 18. In other words, the position of the surgical device 26 can be accurately measured relative to the reference sensor 10 located in or near the tissue block 18, as will be described in further detail below. Because both the reference sensor 10 and the instrument sensor 28 are measured in the same reference frame, errors introduced by alignment and calibration steps that require changing the reference axis can be minimized.

[0183] The sleeve 40 may also include a display 42 that displays to the user the distance D3 between the surgical device 26 and the resection edge 24, as shown in FIG. Figure 9 As will be described below. Display 42 can be attached to handle 30 of surgical device 26 and can be any commercially available organic light emitting diode (OLED) display or liquid crystal (LCD) display. In the case of an OLED display, a reformatted CT image of tissue mass 18 located at the tip of surgical device 26, for example, can be displayed to the user.

[0184] Guiding surgical instruments into tissue blocks

[0185] Now refer to Figure 9During the procedure, the plurality of prongs 20 of the hook structure 16 are used to position the fiducial sensor 10 near or embedded within the tissue mass 18, as previously described. A CT / MRI / fluoroscopic / C-arm CT examination, for example, is performed to acquire an image of the fiducial sensor 10 positioned near or embedded within the tissue mass 18. The tissue mass 18 is then segmented from the preoperative diagnostic CT / MRI examination and a three-dimensional model of the tissue mass 18 is generated (not shown). Intraoperative images obtained during placement of the fiducial sensor 10 can be registered to the patient's diagnostic examination, and the position of the fiducial sensor 10 can be estimated. As previously discussed, a resection margin 24 having a predetermined distance D2 around the tissue mass 18 is displayed to the user on a monitor (not shown) as a three-dimensional envelope or proximity sphere surrounding the tissue mass 18. The predetermined distance D2 of the resection margin 24 can be determined based on the surgeon's preference and the type of tissue mass 18.

[0186] The surgical device 26 is then inserted into the body 44 (i.e., the patient), as shown. Figure 9 As shown, the tissue block 18 is cut along the resection edge 24. The reference sensor 10 embedded in or near the tissue block 18 is in electrical or wireless communication with a controller 48. The controller 48 can be a programmable logic controller (PLC) and is configured to interpret the signal generated by the reference sensor 10. The reference sensor 10 can be an electromagnetic sensor, for example, which generates a signal indicating the position and orientation (e.g., one or more spatial coordinates) of the reference sensor 10. The signal generated by the reference sensor 10 can be, for example, an electrical signal, and the controller 48 can interpret the signal via a stored program 50. The stored program 50 can include, for example, a navigation system that communicates with the reference sensor 10 and the instrument sensor 28.

[0187] Similarly, the instrument sensor 28 can be an electromagnetic sensor, for example, which generates a signal indicative of the position and orientation (e.g., one or more spatial coordinates) of the instrument sensor 28. The signal generated by the instrument sensor 28 can be, for example, an electrical signal, and the controller 48 can interpret the signal via the stored program 50. The reference sensor 10 and the instrument sensor 28 communicate with the controller 48 and forward the position and orientation of the tissue mass 18 and the surgical device 26 using a navigation system. In some embodiments, the stored program 50 can be configured to run a calibration and / or registration algorithm to track the distal tip of the surgical device 26 and the normal vector to the surgical device 26. Thereafter, the stored program 50 of the controller 48 calculates the distance D3 between the reference sensor 10 and the instrument sensor 28, as Figure 9 As shown, when the surgical device 26 is below the threshold of D3, an auditory, visual or tactile prompt is generated for the user.

[0188] As the surgical device 26 navigates toward the resection margin 24 of the tissue mass 18, because both the reference sensor 10 and the instrument sensor 28 are actively tracked, the surgical device 26 can excise the tissue mass 18 while minimizing damage to surrounding tissue. Minimizing damage to surrounding healthy tissue also ensures normal physiological function, such as lung function. Using feedback from the reference sensor 10 and the instrument sensor 28 on the surgical device 26, the distance D3 from the tissue mass 18 and the surgical device 26 is known to the user and is always visible on the display 42. As a result, the desired resection margin 24 can be maintained at all times, thereby ensuring complete resection of the tissue mass 18. In one embodiment, the position and orientation data of the tissue mass 18 and the surgical device 26 can be used to lock or unlock the surgical device 26 to prevent erroneous resection of the tissue mass 18.

[0189] Tissue deformation algorithm

[0190] In some embodiments, the stored program 50 of the controller 48 can be configured to include one or more deformation algorithms that estimate or model changes that may occur to the resection margin 24 during surgery due to deformation of the tissue mass 18 and / or surrounding tissue. The deformation algorithm attempts to account for any such changes in the resection margin 24 to provide the user with a more accurate resection margin during surgery, which facilitates complete resection of the tissue mass 18 while limiting damage to or removal of healthy surrounding tissue.

[0191] In one non-limiting example, the stored program 50 includes a deformation algorithm that assumes that the tissue mass 18 (e.g., a breast lesion) is rigid and that the surrounding tissue (e.g., parenchyma) deforms. The algorithm assumes that each point on the tissue mass 18 moves with the fiducial sensor 10, which is anchored to the tissue mass 18 as described above. In another non-limiting example, the stored program 50 includes a deformation algorithm that assumes that the tissue mass 18 is a rigid object moving through a viscoelastic or fluid medium. In yet another non-limiting example, patient-specific properties of the tissue mass 18 and surrounding tissue can be measured, for example, via CT / MRI / fluoroscopy, to predict the deformation of the tissue mass 18 or resection margin 24 that will occur during a procedure for that particular patient. It should be understood that the deformation algorithm of the stored program 50 can operate in real time with the navigation system of the stored program 50.

[0192] More specifically, a tissue mass 18 (e.g., a lesion) can be segmented from a volumetric image obtained, for example, from CT / MRI / fluoroscopy to create a surface model. Based on a default resection margin input by a user to the navigation system, the segmented lesion label map can be expanded to the desired resection margin to create a surface model corresponding to the resection margin. Due to deformation of the lesion and surrounding tissue, the resection margin may change, for example, due to movement of the patient. Therefore, a linear elastic volume finite element model ("FEM") mesh can be created from the surface model of the lesion and the resection margin. Given real-time position measurements of the reference sensor 10, using the FEM model, estimates of the displacements of other nodes of the tissue mass 18 and the resection margin 24 can be made. For the FEM model, the stiffness values ​​may not be completely accurate, and in one example, the FEM model may be constrained by the tissue mass 18 and surrounding tissue. Therefore, an uncertainty measure of the deformation of the tissue mass 18 and surrounding tissue can be provided to the user in real time based on the uncertainty in the estimated stiffness values ​​of the FEM mesh.

[0193] Auditory, visual, quantitative, and tactile cues

[0194] As described above, auditory, visual, and tactile cues can be provided to the surgeon and / or surgical device 26 to identify the resection margin 24, thereby ensuring accurate and complete resection of the tissue mass 18. For example, the auditory source 52 can be configured to emit an auditory signal. The auditory source 52 can communicate with the controller 48, which is configured to execute a stored program 50 to change the auditory signal based on the distance D3 between the instrument sensor 28 and the reference sensor 10. The instrument sensor 28 uses the signal generated by the reference sensor 10 to enable the controller 48 to execute the stored program 50 to calculate the distance D3 between the reference sensor 10 and the instrument sensor 28 (e.g., Figure 9 , such that an auditory signal is generated when surgical device 26 is below the threshold of distance D3. The auditory signal may be, for example, a tone, a beep, or an alarm. As distance D3 decreases, the frequency or duty cycle of the auditory signal may increase, such that the frequency or duty cycle of the auditory signal increases when surgical device 26 navigates too close to resection margin 24.

[0195] In addition to the auditory cues, visual cues may be provided to the user on one or more displays 54 in communication with the controller 48. The one or more displays 54 may include, for example, visual cues provided on an endoscope display or a separate monitor. For example, the endoscope display or the separate monitor may be configured to emit a visual signal. The endoscope display or the separate monitor may be in communication with the controller 48, which is configured to execute a stored program 50 to change the visual signal based on the distance D3 between the instrument sensor 28 and the reference sensor 10. The instrument sensor 28 uses the signal generated by the reference sensor 10 to enable the controller 48 to execute the stored program 50 to calculate the distance D3 between the reference sensor 10 and the instrument sensor 28 (e.g., near the tip of the surgical device 26) and / or between the instrument sensor 28 (e.g., near the tip of the surgical device 26) and a vector perpendicular to the hook structure 16 (e.g., Figure 9 ), such that when the surgical device 26 is below the threshold of D3, a visual signal is generated. The visual signal can be, for example, a solid light or a flashing light displayed on one or more displays 54 (such as an endoscope display or a separate monitor). The frequency or brightness of the visual signal can also, for example, increase as the distance D3 decreases, such that when the surgical device 26 navigates too close to the resection edge 24, the frequency and / or brightness of the visual signal increases. In addition, the distance to the tip, middle, or base of the cutting surface of the instrument can also be determined based on a stored program and displayed to the user. This display of a distance number may sometimes be referred to herein as a so-called quantitative prompt.

[0196] In one non-limiting example, the visual cue may be displayed as a color-changing sphere, for example, on one of the displays 54. The color-changing sphere may represent the tissue resection margin 24, for example, such that the color changes based on the distance D3 between the instrument sensor 28 and the reference sensor 10. Thus, for example, when the instrument sensor 28 approaches the reference sensor 10, the sphere may be displayed in a first color on the display 54. Similarly, when the instrument sensor 28 moves away from the reference sensor 10, the sphere may be displayed in a second color on the display 54, for example, thereby allowing the surgeon to visually understand the distance D3 between the instrument sensor 28 and the reference sensor 10.

[0197] While quantitative, visual, and auditory cues can be provided to the clinician to identify the distance of the resection margin 24 from the surgical instrument 26, visual cues can also include video overlays provided to the user on one or more displays 54 in communication with the controller 48. For example, a video overlay can be implemented to fuse laparoscopic images with virtual endoscopic images to confirm the position of the fiducial sensor 10 and tissue mass 18, such as Figure 10 Based on the position of the laparoscope 56, as shown in the display 54. Figure 11As shown on the display 54, a virtual endoscopic video of the three-dimensional anatomy can be generated. The focus and field of view can be input to control the virtual endoscopic view generated using, for example, a three-dimensional view visualization toolkit camera.

[0198] Tactile cues may also be provided to the user on the surgical device 26. For example, a piezoelectric actuator 46 may be attached to the handle 30 of the surgical device 26 configured to emit a tactile signal. The piezoelectric actuator 46 may be in electrical communication with a controller configured to execute a stored program to vary the tactile signal based on the distance D3 between the instrument sensor 28 and the reference sensor 10. The instrument sensor 28 uses the signal generated by the reference sensor 10 to enable the controller to execute the stored program to calculate the distance D3 between the reference sensor 10 and the instrument sensor 28 (e.g., Figure 9 3 ), such that a haptic signal is generated when surgical device 26 is below a threshold of D3. The haptic signal can be, for example, a vibration applied to handle 30 of surgical device 26. The amplitude and / or frequency of the haptic signal can also increase, for example, as distance D3 decreases, such that the amplitude and / or frequency of the haptic signal increases when surgical device 26 navigates too close to resection margin 24.

[0199] Application of lung cancer surgery

[0200] Nearly 230,000 new cases of lung cancer are diagnosed in the United States each year, at an estimated cost to the healthcare system of $12.1 billion. The one- and five-year survival rates for patients with lung cancer are 44% and 17%, respectively. For the treatment of small, early-stage lesions, minimally invasive parenchymal-sparing wedge resection surgery (WRS) or segmentectomy is becoming the preferred surgical resection method over lobectomy. Maintaining healthy lung function becomes even more important when lung physiology is impaired due to excessive smoking, aging, multiple lesions, previous lung surgery, concomitant cardiac disease, or chronic obstructive pulmonary disease (COPD). While these approaches (i.e., WRS and segmentectomy) result in better lung function, the lesion recurrence rate is nearly twice that of lobectomy, and the five-year survival rate is significantly reduced. Furthermore, segmentectomy is associated with significant complications. The local recurrence and complications associated with segmentectomy may be due to the difficulty in accurately locating and resecting the lesion in the deflated lung and the difficulty in identifying the intersegmental planes. Careful identification and adherence to precise anatomical landmarks (eg, vascular and bronchial anatomic variations) are necessary to avoid perioperative and postoperative complications.

[0201] In the previous section, it was taught to place a reference sensor 10 (e.g., a T-bar or J-bar assembly) near the lesion 18 so that the lesion can be tracked in real time. An instrument sensor 28 is also used to track a surgical stapler (or other surgical device) 26 in real time to accurately guide the resection of the lung lesion 18. More specifically, the navigation software calculates the distance from the surgical stapler to the reference sensor (e.g., a T-bar or J-bar assembly) 26, and therefore calculates the distance from the surgical stapler 26 to the lesion 18, and displays the distance measurement to the surgeon in real time to ensure complete resection of the lesion. In addition, the distance from the reference sensor 10 or the tumor surface to the tip, middle, and base of the stapler cutting line (sometimes also referred to herein as the resection line) can also be calculated and displayed in real time.

[0202] Use this system to identify specific airways in the lungs to help surgeons perform surgery from the chest side of the procedure. Identify the airway during surgery

[0203] The system can also be used to identify specific airways in the lungs to help surgeons identify that airway during surgery from the chest side of the operation.

[0204] More specifically, the airways of the lungs have a complex tree-like structure. Figure 12 .

[0205] When treating a lesion in the lung, particularly where the treatment may involve resection of the lung to remove the lesion, it may be important to plan the resection relative to a particular airway (i.e., remove a particular airway, avoid a particular airway, etc.). Therefore, when performing a resection surgery, it may be important to know the location of the relevant airways.

[0206] During bronchoscopy, identifying the position of the bronchoscope relative to a specific airway is possible because as the bronchoscope travels down the tree-like structure of the airways, it follows a descending path characterized by specific branches. However, given the size of the bronchoscope and the gradually decreasing size of the airways, the bronchoscope can generally only traverse a limited distance down the airways of the lungs. Furthermore, during surgical procedures performed from the chest side of the operation, the visualization provided to the surgeon from the chest side is limited to the direct field of view, and identifying a specific airway from the chest side can be very difficult due to the limited field of view provided to the surgeon from the chest side.

[0207] The present invention may be used to identify a specific airway in the lung to aid the surgeon in identifying that airway during surgery performed from the thoracic side of the operation.

[0208] More specifically, and now Figure 13 、 Figure 13A and Figure 13BIn this form of the invention, a bronchoscope 60 is used to position a catheter 65 carrying a sensor 70 (i.e., a "tracked catheter" 75) into the relevant airway of the lung. More specifically, in a preferred form of the invention, the bronchoscope 60 can be advanced through the airway under bronchoscope guidance or by some other form of guidance (e.g., CT imaging, C-arm imaging, etc.) until the bronchoscope 60 is advanced as far as possible toward the relevant airway. See Figure 13 The tracked catheter 75 (i.e., the catheter 65 carrying the sensor 70) is then advanced down the bronchoscope 60 and then out the end of the bronchoscope 60 into the relevant airway of the lung. Figure 13A Note that it is preferred that the tracked catheter 75 is not advanced through the bronchoscope 60 until after the bronchoscope 60 is positioned in the lung in order to maintain maximum flexibility of the bronchoscope 60. Once the tracked catheter 75 is advanced out of the bronchoscope 60 and in position in the relevant airway, the bronchoscope 60 can be withdrawn. Figure 13B It is generally desirable to withdraw the bronchoscope 60 at this point as it may be obstructing ventilation.

[0209] Bronchoscopic positioning of the sensor in the relevant airway of the lung (i.e., positioning the tracked catheter in the relevant airway of the lung via the bronchoscope) can then be used to define the lobar, segmental, or subsegmental bronchi for performing a surgical procedure, such as a segmentectomy, lobectomy, or wedge resection, during the actual procedure. More specifically, the position of the sensor identifying the bronchus (i.e., sensor 70 on the tracked catheter 75) can be correlated with the position of another device (e.g., surgical instrument) 80 carrying another sensor 85 (i.e., tracked instrument 90), so that the surgeon can use the system to identify the correct bronchus for surgical procedures from the thoracic side of the procedure (when direct visualization is limited and the specific airway is often ambiguous). Thus, in this form of the invention, one sensor 70 is positioned on a catheter 65 inserted into a particular airway to identify the location of that particular airway, and another sensor 85 is positioned on a surgical instrument 80 that is advanced for surgical procedures from the operative chest side, and the system then tracks the position of the surgical instrument 80 relative to the tracked catheter 75 (and therefore the position of the surgical instrument 80 relative to the airway in which the tracked catheter 75 is located). In this way, even though direct visualization from the operative chest side may be limited and may not be clear about a particular airway, the surgeon can identify the position of the surgical instrument 80 relative to the airway of interest (which is identified by the sensor 70 on the tracked catheter 75). Thus, the surgeon can use the system to target the airway identified by the sensor 70 on the tracked catheter 75, avoid the airway identified by the sensor 70 on the tracked catheter 75, and so on.

[0210] Notably, the tracked catheter 75 can be inserted into the relevant airway of the lung when the lung is in a first configuration (e.g., an inflated configuration), and the tracked catheter 75 can be maintained in place within the airway when the lung is transitioned to a second configuration (e.g., a deflated configuration). This can be particularly advantageous when attempting to identify the relevant airway of the lung during limited access surgery (e.g., where visualization is provided by a scope advanced into the chest) while the lung is transitioning between the first and second configurations.

[0211] Note that, if desired, the tracked catheter 75 can be inserted into the bronchoscope 60 before the bronchoscope 60 is advanced down the airways of the lung. However, as described above, it is generally desirable to insert the tracked catheter 75 into the bronchoscope 60 after the bronchoscope 60 has been positioned in the lung because this provides the bronchoscope 60 with the greatest flexibility.

[0212] Note also that, if desired, the bronchoscope 60 can be left in place in the lung after the tracked catheter 75 is advanced into the relevant airway. However, as described above, in many cases, it is desirable to remove the bronchoscope 60 after the tracked catheter 75 is advanced into the relevant airway because this can provide better ventilation of the lung.

[0213] In addition to the above, it should be understood that, if desired, the bronchoscope 60 itself can carry sensors (not shown) so that the bronchoscope 60 itself can be tracked within the airways of the lungs. This approach can be useful where the bronchoscope 60 is able to be advanced into the airway of interest, for example, where the airway of interest is a relatively large airway that can be directly accessed by the bronchoscope 60.

[0214] Note that, if desired, the tracked catheter 75 (and / or tracked bronchoscope) can also be used to map multiple airways in the lungs when the lungs are in a given configuration (eg, a first inflated configuration).

[0215] In one form of the invention, a reference sensor 10 (e.g., a T-rod or J-rod assembly) is placed within a lung while the lung is in a first (e.g., inflated) configuration; a tracked catheter 75 is placed in a selected airway of the lung while the lung is in its first (e.g., inflated) configuration; the relative disposition of the reference sensor 10 and the tracked catheter 75 is determined while the lung is in its first (e.g., inflated) configuration; the lung is transformed to a second (e.g., deflated) configuration; the relative disposition of the reference sensor 10 and the tracked catheter 75 is determined while the lung is in its second (e.g., deflated) configuration; and a change in the relative disposition of the reference sensor 10 and the tracked catheter 75 is determined after the lung is transformed from its first (e.g., inflated) configuration to its second (e.g., deflated) configuration and is used to estimate the extent of lung deformation and the position of lung structure while the lung is in its second (e.g., deflated) configuration.

[0216] Mapping and tracking peripheral airways

[0217] The above system can be enhanced by mapping and tracking the surrounding airways (and lesions) to ensure that the correct segment of the lung is resected. This is because during deflation of the lung, the anatomy will shift and the surgeon may not be able to see the tissue section to be resected.

[0218] A procedure for mapping and tracking the airways of the lungs may be performed as follows.

[0219] First, the patient is placed in the supine position. Subsequently, under bronchoscopy, a flexible catheter 65 with an on-board catheter sensor 70 is placed in the nearest / target bronchus of the lung segment containing the lesion 18. This can be done by visually identifying the correct bronchus or by some form of guidance (e.g., CT imaging, C-arm imaging, etc.). The tracked catheter 75 is inserted into the target bronchus near the mass of the lesion 18, and as the catheter 65 is inserted, the trajectory of the catheter 65 is recorded using the on-board catheter sensor 70 and the electromagnetic tracker system, which are configured to identify the position and orientation of the catheter sensor 70 (and therefore the position and orientation of the catheter 65). This trajectory marks the position of the airway 95 in the coordinate space of the electromagnetic tracker system. See Figure 14-Figure 34 As the catheter 65 is advanced down the airway 95, the successive sensing positions of the catheter sensor 70 can be connected to provide the centerline of the targeted airway. Figure 35 .

[0220] Alternatively, the catheter 65 may include multiple catheter trackers 70 positioned along its length so that after the catheter 65 is fully inserted into the airway, airway mapping can be performed by simply noting the positions of the various catheter sensors 70. Figure 36 and Figure 37Note that catheter 65 may be advanced through the airway under bronchoscopic guidance or by some other form of guidance (eg, CT imaging, C-arm imaging, etc.).

[0221] The process can then be repeated for adjacent airways to map the airways surrounding the lesion.

[0222] Once mapping of the relevant airways is complete, the positions of the reference sensor 10 (eg, a T-rod or J-rod assembly or similar tracker) and the mapped airways are recorded in the inflated lung (and eventually in the deflated lung).

[0223] Thereafter, with the fiducial sensor 10 near the lesion 18 and the tracked catheter 75 positioned in a critical airway near the lesion, the lung is collapsed before the surgical procedure begins. As the lung collapses, the fiducial sensor 10 (e.g., a T-rod or J-rod assembly) and the tracked catheter 75 are tracked in real time. Figure 38 . The positions of the reference sensor 10 (e.g., a T-rod or J-rod assembly) and the critical airway (e.g., an airway containing a tracked catheter 75) are recorded in the deflated lung. Using a finite element-based particle filter or FEM deformation algorithm, the spatial translation of the reference sensor 10 (e.g., a T-rod or J-rod assembly) and the critical airway from the inflated state to the deflated state is estimated. A smooth deformation field around the critical airway is estimated. The deformation field is then applied to other airways mapped in the inflated lung to estimate the positions of these other airways in the deflated lung. In the navigation system, the "deformed" airway (i.e., the airway in the deflated lung) and the lesion are displayed to the surgeon to accurately guide the surgical stapler 26 to the optimal resection margin while ensuring that key anatomical structures are preserved. Even without stapler navigation, this approach helps to define the correct resection segment (and the correct bronchial segment to be resected or not as part of the planned operation). Once the appropriate bronchial segment has been identified in a thoracoscopy or chest view, the catheter 65 can be removed by simply pulling it out of the mouth, nose, or endotracheal tube prior to any surgical resection.

[0224] In one aspect of the present invention, multiple lumens in a deformable anatomical structure may be mapped and tracked by:

[0225] providing a virtual model of the anatomical structure when the anatomical structure is in a first configuration;

[0226] positioning the tracked catheter in one of the lumens in the anatomical structure to be mapped and tracked when the anatomical structure is in the first configuration, and determining a position of the tracked catheter in the lumen to map the position of the lumen;

[0227] Repeating the aforementioned steps for each lumen in the anatomical structure to be mapped and tracked so that the lumens are mapped;

[0228] supplementing the virtual model with the mapped lumen, thereby providing a supplemented virtual model of the anatomical structure and the mapped lumen when the anatomical structure is in its first configuration;

[0229] maintaining the tracked catheter in one of the mapped lumens of the anatomical structure as the anatomical structure deforms from its first configuration to its second configuration;

[0230] determining a position of the tracked catheter in the anatomical structure when the anatomical structure is in the second configuration; and

[0231] The supplemental virtual model is modified to represent the anatomical structure and the mapped lumen when the anatomical structure is in its second configuration, thereby providing a modified supplemental virtual model, wherein the modification is achieved by:

[0232] determining a spatial transformation of the tracked catheter as the anatomical structure deforms from its first configuration to its second configuration; and

[0233] The spatial transformation of the tracked catheter is applied to the mapped lumen of the supplemental virtual model to provide a modified supplemental virtual model of the anatomical structure and the mapped lumen when the anatomical structure is in its second configuration.

[0234] In another aspect of the present invention, a selected lumen in a deformable anatomical structure may be mapped and tracked by:

[0235] positioning the tracked catheter in a selected lumen of the anatomical structure when the anatomical structure is in the first configuration;

[0236] determining a position of the tracked catheter when the anatomical structure is in the first configuration;

[0237] scanning the anatomical structure and the tracked catheter positioned in a selected lumen of the anatomical structure when the anatomical structure is in a first configuration;

[0238] creating a virtual model of the scanned anatomical structure and the tracked catheter positioned in a selected lumen of the anatomical structure when the anatomical structure is in its first configuration;

[0239] maintaining the tracked catheter in position within a selected lumen of the anatomical structure when the anatomical structure is deformed into the second configuration;

[0240] determining a position and orientation of the tracked catheter when the anatomical structure is in its second configuration, thereby determining a position of a selected lumen of the anatomical structure when the anatomical structure is in the second configuration;

[0241] The virtual model is adjusted to represent the anatomical structure and the selected lumen when the anatomical structure is in its second configuration, thereby providing an adjusted virtual model, wherein the modification is achieved by:

[0242] determining a spatial transformation of the tracked catheter as the anatomical structure deforms from its first configuration to its second configuration; and

[0243] The spatial transformation of the tracked catheter is applied to the selected lumen of the virtual model to provide an adjusted virtual model of the anatomical structure and the selected lumen when the anatomical structure is in its second configuration.

[0244] Bronchoscope deployment of benchmark sensors

[0245] In the above-described systems, the reference sensor 10 (eg, a T-rod or J-rod assembly) is described as being deployed percutaneously. Figure 39 However, if desired, the fiducial sensor 10 (eg, a T-rod or J-rod assembly) may be deployed via a bronchoscopic approach, a thoracotomy approach, or a VATS approach.

[0246] More specifically, the reference sensor 10 (e.g., a T-rod or J-rod assembly) is a metal anchor having a wireless electromagnetic sensor embedded in a hook-like structure. The metal anchor can be made of a superelastic material (e.g., Nitinol), or it can be made of stainless steel. The reference sensor 10 (e.g., a T-rod or J-rod assembly) is placed inside a long, flexible hollow tube with a beveled tip at the end. The hollow tube is inserted through the working channel of a bronchoscope 60. Under real-time image guidance using a navigation system, the wireless reference sensor 10 (e.g., a T-rod or J-rod assembly) is navigated through the airway using the bronchoscope 60 and placed near the lesion. See Figure 40 Once the fiducial sensor 10 (eg, a T-rod or J-rod assembly) has been deployed adjacent the lesion 18, the bronchoscope 60 (and the hollow tube extending through the working channel of the bronchoscope) is removed. Figure 41 . Thereafter, the lung is collapsed and the lesion 18 is tracked in real time using the reference sensor 10 (e.g., a T-bar or J-bar assembly). The surgical stapler (not shown) can also be tracked in real time using an instrument sensor attached to the surgical stapler. Note that the surgical stapler is tracked in the same reference frame as the reference sensor 10 (e.g., a T-bar or J-bar assembly). The surgical stapler can then be navigated to the optimal resection margin using a navigation system.

[0247] Alternatively, if desired, the reference sensor 10 (e.g., a T-rod or J-rod assembly) can carry a wire-based electromagnetic sensor. In this case, after the reference sensor 10 (e.g., a T-rod or J-rod assembly) has been deployed, the wire 14 of the reference sensor is pushed through the lung parenchyma to the skin surface at the spot closest to the lesion 18 under image guidance through a bronchoscope to mark the lesion 18. Figure 42 .

[0248] In yet another form of the invention, where the reference sensor 10 (e.g., a T-rod or J-rod assembly) carries a wire-based electromagnetic sensor, the wire 14 has a detachable connection to the electromagnetic sensor. Subsequently, after the stapler is used to establish the resection line, the wire 14 is detached from the electromagnetic sensor and pulled back up the airway. Figure 43 .

[0249] In yet another form of the invention, and now looking at Figures 44-52 A bronchoscopic sensor unit 100 is provided for deploying a reference sensor 10 into or near a tissue mass 18 under bronchoscopy.

[0250] More specifically, and now looking at Figures 44-46 , bronchoscope sensor unit 100 ( Figure 44 ) typically includes a J-shaped rod and an electrical lead assembly 105 ( Figure 45 ) and deployment component 110( Figure 46 ).

[0251] The J-rod and electrical lead assembly 105 generally includes a J-rod assembly 115 and an electrical lead 120. The J-rod assembly 115 includes the aforementioned hook structure 16, which carries the aforementioned reference sensor 10 and the aforementioned tip 20. One end 125 of the electrical lead 120 is connected to the reference sensor 10 so that electrical power delivered to the electrical lead 120 can power the reference sensor 10. The other end 130 of the electrical lead 120 includes an atraumatic tip 135. The electrical lead 120 can be covered with a hydrophobic braid to allow for easy insertion and retraction of the J-rod and electrical lead assembly 105 through the lumen 150 (see below) of the deployment assembly 110.

[0252] Alternatively, if desired, the distal end of the J-rod and electrical lead assembly 105 may include a second anchor, rather than the atraumatic tip 135, which second anchor may prevent the electrical lead 120 from re-entering the lung once the distal end of the electrical lead 120 has been extended from the lung. In other words, this second anchor will prevent the distal end of the electrical lead 120 from migrating retrogradely after deployment. Furthermore, in this form of the invention, the tip 120 of the J-rod assembly 115 may have a configuration that prevents antegrade migration of the J-rod assembly 115 after release from the deployment assembly 110. See, e.g., Figure 46A and Figure 46B , which shows a tip 135A at the distal end of the electrical lead 120, and a tip 20A at the distal end of the J-rod assembly 115, wherein the tip 135A prevents proximal movement of the distal end of the electrical lead 120 after deployment, and the tip 20A prevents distal movement of the J-rod assembly 115 after deployment.

[0253] The deployment assembly 110 includes a needle cannula 140 and a pusher 145. The needle cannula 140 includes a hollow lumen 150 and terminates in a sharp tip 155. The pusher 145 includes a shaft 160. One end of the shaft 160 terminates in a blunt distal end 165. The other end of the shaft 160 terminates in a handle 170. The shaft 160 of the pusher 145 is sized to be slidably received in the lumen 150 of the needle cannula 140. Note that the needle cannula 140 of the deployment assembly 110 is sized to be inserted through the working channel of a bronchoscope.

[0254] like Figure 44 As shown, the J-rod and electrical lead assembly 105 and the rod 160 of the pusher 145 are initially positioned within the lumen 150 of the needle cannula 140, wherein the tip 20 of the J-rod assembly 115 is elastically deformed to a straighter configuration so as to be received within the lumen 150 of the needle cannula 140, and wherein the proximal end of the elastically deformed tip 20 is just distal to the blunt end 165 of the pusher 145. It should also be noted that when the J-rod and electrical lead assembly 105 is positioned within the lumen 150 of the needle cannula 140, the atraumatic tip 135 of the electrical lead 120 is elastically deformed such that it is substantially straight within the needle cannula 140 (note that the tip 135 of the electrical lead 120 is substantially straight). Figure 44 This is intended to be illustrative, and in practice, the electrical lead 120 has a diameter that more tightly fills the lumen 150 of the needle cannula 140, such that the atraumatic tip 135 of the electrical lead 120 is substantially straight when the electrical lead 120 is restrained within the needle cannula 140 and returns to a substantially straight position when the atraumatic tip 135 is not restrained within the needle cannula 140. Figure 45In this manner, the needle cannula 140 can carry the J-rod and electrical lead assembly 105, wherein the needle cannula 140 shields the J-rod and electrical lead assembly 105 from contact with surrounding structures (e.g., bronchoscope, tissue, etc.). However, distal movement of the pusher 145 can eject the J-rod and electrical lead assembly 105 from the lumen 150 of the needle cannula 140.

[0255] In a preferred method of use, the intended position of the J-rod and electrical lead assembly 105 relative to the patient's anatomy is planned prior to deployment in the lung using diagnostic or intraoperative CT, C-arm CT, MRI, or other imaging modalities. That is, the intended position of the J-rod assembly 115 and the exit point of the electrical lead 120 as it emerges from the lung surface are planned in advance on diagnostic or intraoperative CT, C-arm CT, MRI, or other imaging modalities. Electromagnetic (EM) tracking coordinates are mapped to diagnostic / intraoperative imaging coordinates using image registration algorithms known in the art to track the bronchoscope and J-rod and electrical lead assembly 105 in the imaging coordinates. The position of the J-rod assembly 115 is selected in the vicinity of the tumor, preferably along a line connecting the bronchoscope's target position and the electrical lead's exit point, while the electrical lead's exit point from the lung is selected to be (i) the shortest path from the J-rod position to the lung surface (or fissure surface), or (ii) based on the surgeon's preference.

[0256] By way of example and not limitation, in the preferred method of use, and now see Figures 47-52 , the bronchoscope 60 is advanced through the patient's airway until the distal tip of the bronchoscope 60 is positioned adjacent to the lesion (ie, tissue mass) 18. Figure 47 Note that the bronchoscope 60 can be advanced under direct visualization, and its position can be tracked using one or more sensors 180 carried by the bronchoscope 60. Alternatively, assuming a temporary electrical connection is provided to the J-rod assembly 115 (i.e., via an electrical connection extending through the interior of the needle cannula 140, such as by energizing a portion of the pusher 145), the position of the bronchoscope 60 can be tracked using the J-rod assembly 115. The position of the tracked bronchoscope 60 can be mapped to imaging coordinates (see above) using image registration algorithms known in the art in order to guide the bronchoscope 60 to the lesion 18.

[0257] Next, if not already done, a target point 185 is identified on the outer surface of the lung as the point where the needle cannula 140 is expected to protrude from the lung and enter the pleural cavity. Figure 48 .

[0258] The bronchoscope sensor unit 100 (including the deployment assembly 110 and its passenger J-rod and electrical lead assembly 105) is then advanced with its distal end through the bronchoscope 60, through the lung, through the target point 185, and into the pleural cavity. Figure 49 . Note that the distal end of the bronchoscope sensor unit 100 can be visually guided via the bronchoscope 60 and / or via scanner visualization (e.g., CT imaging, C-arm imaging, ultrasound imaging, etc.) or by using a temporary electrically connected J-rod assembly 115 (if a temporary electrical connection has been established through the interior of the needle cannula 140).

[0259] Next, the pusher 145 of the deployment assembly 110 can be used to push the J-rod and electrical lead assembly 105 distally so that (i) a portion of the electrical lead 120 and the atraumatic tip 135 exit the needle cannula 140 and enter the pleural cavity, and (ii) the J-rod assembly 115 is positioned adjacent to the lesion 18 (note, however, that at this point, a portion of the electrical lead 120 and the J-rod assembly 115 remain within the needle cannula 140). Figure 50 .

[0260] Next, the needle cannula 140 is retracted proximally while maintaining the pusher 145 in place, thereby exposing (i) the portion of the electrical lead 120 extending from the target point 185 to the J-rod assembly 115, and (ii) the J-rod assembly 115. As the needle cannula 140 is retracted over the tip 20 of the J-rod assembly 115, the tip 20 is no longer constrained within the lumen 150 of the needle cannula 140 and is free to spring outward and dispose into the tissue, thereby anchoring the J-rod assembly 115 (and therefore the fiducial sensor 10) adjacent to the lesion 18. Figure 51 At this point, if the J-rod assembly 115 is temporarily connected to a power source through the interior of the needle cannula 140, the wires of the J-rod are disconnected and retracted into the needle cannula 140. Note that this disconnection and retraction of the electrical leads passing through the needle cannula 140 is desirable because it removes them from the intended resection line. The power clamping tool 190 is then advanced into the pleural cavity and clamped onto the portion of the electrical lead 120 extending out of the lung, thereby providing electrical power to the electrical lead 120 and, therefore, to the reference sensor 10 of the J-rod assembly 115. See Figure 52 Note that by supplying electrical power to the J-rod assembly 115 via a power source gripping tool 190 that is advanced into the pleural cavity from a point outside the body (rather than through a needle cannula 140 and bronchoscope 60 that are advanced through the bronchus), the electrical lead does not cross the intended resection line.

[0261] The power supply gripping tool 190 can take various forms. Essentially, it is an elongated tool that is configured to extend from outside the body into the pleural cavity and electrically connect to the portion of the electrical lead 120 that extends out of the lung and into the pleural cavity, thereby delivering power to the J-rod assembly 115. By way of example and not limitation, the power supply gripping tool 190 can include a pair of electrically connected jaws that can be closed around the portion of the electrical lead 120 that extends out of the lung and into the pleural cavity. Note that the power supply gripping tool 190 can be deployed via a needle extending through the skin or via a port created on the surface of the skin. The power supplied to the electrical lead 120 by the power supply gripping tool 190 enables the J-rod assembly 115 to be connected to an EM tracking system.

[0262] Once powered on, the fiducial sensor 10 communicates with the electromagnetic (EM) tracking system, and the location of the fiducial sensor 10 (and therefore the location of the lesion 18 ) can be determined by the controller 48 .

[0263] At this point, surgical instrument 80 (carrying instrument sensor 85) can be used to achieve the desired resection line in the lung, thereby resecting lesion 18 from the rest of the lung. Note that the J-rod and electrical lead assembly 105 extends from lesion 18 to the pleural cavity and is therefore contained within the tissue being resected and does not cross the resection line. In other words, the J-rod and electrical lead assembly 105 is always outboard of lesion 18. As a result, the fiducial sensor 10 of the J-rod assembly 115 can remain powered throughout the resection procedure without interfering with the procedure, and after resection is complete, the J-rod and electrical lead assembly 105 can be removed along with the resected tissue.

[0264] As described above, in one form of the present invention, the bronchoscope 60 is advanced through the patient's airway until the distal tip of the bronchoscope 60 is positioned adjacent to the lesion (i.e., tissue mass) 18. As also described above, the bronchoscope 60 can be advanced under direct visualization, and its position can be tracked using one or more sensors 180 carried by the bronchoscope 60. Alternatively, assuming that a temporary electrical connection is provided to the J-rod assembly 115 (i.e., via an electrical connection extending through the interior of the needle cannula 140, such as by energizing a portion of the pusher 145), the position of the bronchoscope 60 can be tracked using the J-rod assembly 115. Therefore, it may be desirable to provide a temporary electrical connection to the J-rod assembly 115 (i.e., via an electrical connection extending through the interior of the needle cannula 140, such as by energizing a portion of the pusher 145) so that the J-rod assembly 115 can be powered while in the needle cannula 140.

[0265] It may also be desirable to provide a temporary electrical connection to the J-rod assembly 115 (i.e., via an electrical connection extending through the interior of the needle cannula 140, for example by energizing a portion of the pusher 145) so that the J-rod assembly 115 can be energized prior to connecting the power clamping tool 190 to the portion of the electrical lead 120 that extends out of the lung.

[0266] In one preferred form of the invention, and now referring to Figure 52A A temporary electrical connection for the J-rod assembly 115 can be provided as follows. The reference sensor 10 of the J-rod assembly 115 includes a proximal electrical connector 200 (and an electrical lead 120 extending distally from the reference sensor 10). The pusher 145 is cannulated and includes a distal electrical connector 205. Electrical power is provided to the distal electrical connector 205 of the pusher 145 via a wire 210 extending through the pusher 145 (and the pusher 145 is connected to a power source, not shown). When the J-rod assembly 115 is positioned within the needle cannula 140, the proximal electrical connector 200 of the J-rod assembly 115 is connected to the distal electrical connector 205 of the pusher 145, thereby powering the reference sensor 10. After the J-rod assembly 115 has been deployed in the patient's anatomy (and after the tip 20 has been positioned in the tissue), the pusher 145 is retracted, separating the distal electrical connector 205 of the pusher 145 from the proximal electrical connector 200 of the J-rod assembly 115, thereby disconnecting the J-rod assembly 115 from the power supplied by the wire 210 extending through the pusher 145. However, it should be understood that power may still be delivered to the J-rod assembly 115 via the electrical leads 120 and the power source gripping tool 190 (connected to the electrical leads 120).

[0267] Stapler articulation measurement

[0268] The surgical stapler head can be articulated about a pivot point 220 to provide a desired orientation when resecting a lesion. Although the instrument sensor 28 can be placed on the articulating head of the surgical stapler 26 (e.g., such as Figure 8 and Figure 9 ), but this can cause interference from ferromagnetic materials on the stapler head. Therefore, in practice, the instrument sensor 28 is typically positioned on the rod of the surgical stapler 26, just proximal to the hinge point, for example, about 10 cm from the stapler tip, in order to avoid interference from ferromagnetic materials on the stapler head. In this position, the instrument sensor 28 is proximal to the pivot point 220 on the surgical stapler 26, so that the instrument sensor 28 is located on the non-articulated portion of the stapler 26. See Figure 53 As a result, the instrument sensor 28 placed on the non-articulating portion of the surgical stapler 26 does not capture the articulating motion of the surgical stapler 26.

[0269] Therefore, in another form of the present invention, a surgical stapler 26 is configured to measure the articulation angle of the stapler head. More specifically, an articulation sensor 225 is provided that preferably includes two parts. The first part 230 of the articulation sensor 225 is placed on the stapler rod. The second part 235 of the articulation sensor 225 is placed on the articulating stapler head. The connection between the first part 230 and the second part 235 of the articulation sensor 225 is through a flexible encoder circuit that measures the angle of the articulated end of the stapler head. The encoder circuit is preferably a modified circular potentiometer for measuring the angle of the stapler head. See Figure 54 The Wheatstone bridge circuit measures the variable resistance generated by the encoder circuit to estimate the stapler articulation angle. In addition, the surgical stapler 26 may also include an LED indicator (not shown) on the stapler rod to confirm the placement of the articulation sensor 225 on the surgical stapler 26. Once the articulation sensor 225 is placed on the surgical stapler 26, the circuit is completed to illuminate the LED indicator.

[0270] If desired, the articulation sensor 225 can measure the articulation of the stapler head using a solution other than resistance, for example, an optical encoder can be used to measure the articulation of the stapler head, or a magnetic encoder can be used to measure the articulation of the stapler head, etc. The articulation sensor 225 can also be internalized into a specific working interior of the stapler device 26. Alternatively, a second sensor (not shown) can be placed on an elastic extension from the sleeve toward the tip and through the articulation to allow direct measurement of the stapler articulation angle. The extension can be fixed with tape or other adhesive.

[0271] Marking of boundaries for resection margins and stapler positioning

[0272] In one form of the invention, the lesion is segmented from the diagnostic CT imaging to create a 3D model of the lesion 240 that is input to the navigation system. In another form of the invention, the lesion can be segmented based on the surgeon's direct visualization of the lesion, with or without input from radiological findings. The resection margin will be determined based on input from the surgeon or a machine learning algorithm. A segmented model 245 of the resection margin is generated by extending the lesion label map with the desired resection margin. See Figure 55 and Figure 56 With knowledge of the positions of the fiducial sensor (eg, T-rod or J-rod assembly) and the lesion model 240 , the position of the tracked surgical stapler can be accurately estimated relative to the lesion model 240 and the estimated resection margin model 245 .

[0273] In addition to the foregoing, in one form of the invention, navigation software can guide the surgeon to precisely resect around a lesion based on the distance used to secure an adequate margin defined by the surgeon based on the block size and assumed diagnosis. Figures 57-59 More specifically, in one form of the invention, and now looking at Figure 60 , the navigation software calculates tangent lines 250 at the periphery of the modeled resection margin 245 and then guides the surgeon to place the stapler 255 just outside those tangent lines 250 so that the stapler 255 follows a tangent path around the estimated resection margin model 245 .

[0274] Although the above-described system and method for resecting a tissue mass is described for use in surgical procedures involving the lung, it is also applicable to resecting lesions in any other organ or structure of the body, for example, resection for breast-conserving surgery, liver resection, sarcoma resection, partial nephrectomy, or lung wedge resection. Furthermore, the above-described system and method for resecting a tissue mass is not limited to VATS or minimally invasive surgery.

Claims

1. A system for tracking a tissue mass disposed in or on an anatomical structure, wherein the anatomical structure includes at least one lumen, the system comprising: a sensor assembly comprising a reference sensor and electrical leads, wherein a scope is advanced along the at least one lumen until a distal end of the scope is positioned in a vicinity of a selected tissue mass, and the fiducial sensor is advanced through the scope, into the anatomical structure, and secured to the anatomical structure in the vicinity of the tissue mass; as well as a controller for detecting a position of the reference sensor within the anatomical structure, The reference sensor is part of the sensor assembly and the electrical lead extends distally from the reference sensor, wherein the electrical lead is positioned ahead of the reference sensor when the reference sensor is advanced through the scope.

2. The system according to claim 1, wherein After the fiducial sensor is secured to the anatomical structure, the electrical lead is removed from the scope and advanced through the anatomical structure to be disposed distal to a resection line implemented into the anatomical structure to resect a portion of the anatomical structure from a remainder of the anatomical structure.

3. The system according to claim 2, wherein: After the electrical lead is positioned distal to the resection line, the electrical lead is powered.

4. The system according to claim 1, wherein: After the fiducial sensor is secured to the anatomical structure, the electrical lead is separated from the fiducial sensor and withdrawn along the path of the scope.

5. The system according to claim 4, wherein: The electrical leads are withdrawn through the scope.

6. The system according to claim 4, wherein: The scope is withdrawn with the electrical lead in place, and the electrical lead is then withdrawn along the path of the scope.

7. The system according to claim 2, wherein: After some, but not all, of the ablation line is achieved, the electrical lead is separated from the reference sensor and withdrawn along the path of the scope.

8. The system according to claim 1, wherein: The sensor assembly is advanced through the scope and into the anatomical structure using a deployment assembly including a needle cannula and a pusher.

9. The system according to claim 8, wherein The sensor assembly is slidably disposed within the needle cannula, the needle cannula is advanced through the scope to advance the sensor assembly through the scope, and the sensor assembly is deployed out of the needle cannula and into the anatomical structure by advancing the pusher relative to the needle cannula or by retracting the needle cannula relative to the pusher.

10. The system according to claim 9, wherein: The electrical lead passes through an outer surface of the anatomical structure.

11. The system according to claim 10, wherein: The electrical leads pass through an outer surface of the anatomical structure before the sensor assembly is deployed out of the needle cannula and into the anatomical structure.

12. The system according to claim 11, wherein When the electrical lead is disposed within the needle cannula, the needle cannula extends through the outer surface of the anatomical structure.

13. The system according to claim 12, wherein: After the distal portion of the electrical lead is carried by the outer surface of the anatomical structure, the needle cannula is retracted to expose the distal portion of the electrical lead extending through the outer surface of the anatomical structure.

14. The system according to claim 13, wherein: After the distal portion of the electrical lead extends through the outer surface of the anatomical structure, the sensor assembly is released from the needle cannula and engages the anatomical structure.

15. The system according to claim 10, wherein: A surgical navigation system is used to determine the location of the electrical lead extending through the outer surface of the anatomical structure.

16. The system according to claim 15, wherein: The surgical navigation system uses tracking of the fiducial sensor to determine a location where the electrical lead is to extend through an exterior surface of an anatomical structure.

17. The system of claim 1, wherein: The electrical leads include hydrophobic braided wires.

18. The system of claim 1, wherein: The electrical lead includes an atraumatic tip.

19. The system of claim 1, wherein: The electrical lead includes at least one barb that limits proximal movement of the electrical lead.

20. The system of claim 1, wherein: The reference sensor includes at least one barb that limits distal movement of the reference sensor.

21. The system of claim 1, wherein: The electrical lead includes at least one barb that limits proximal movement of the electrical lead, and wherein the reference sensor includes at least one barb that limits distal movement of the reference sensor.

22. The system of claim 1, wherein: The sensor assembly further includes a proximal electrical lead for powering the fiducial sensor, wherein the proximal electrical lead extends through the scope when the fiducial sensor is advanced through the scope and secured to an anatomical structure in the vicinity of the tissue mass.

23. The system of claim 22, wherein: The fiducial sensor is tracked as the scope is inserted along the at least one lumen.

24. The system of claim 22, wherein: The fiducial sensor is tracked as it is advanced through the scope, into the anatomy, and secured to the anatomy in the vicinity of the tissue mass.

25. The system of claim 22, wherein: After the fiducial sensor is secured to the anatomical structure, the proximal electrical lead is detached from the sensor assembly after the sensor assembly is deployed in the anatomical structure.

26. The system of claim 22, wherein: After the reference sensor is secured to the anatomical structure, the reference sensor is powered via the electrical lead extending distally from the reference sensor.

27. A system for tracking a tissue mass disposed in or on an anatomical structure, wherein the anatomical structure includes at least one lumen, the system comprising: a sensor assembly comprising a reference sensor and electrical leads extending distally from the reference sensor; a deployment assembly comprising a needle cannula and a pusher, wherein the sensor assembly is slidably disposed in the needle cannula distal to the pusher; as well as a controller for detecting a position of the fiducial sensor within the anatomical structure, wherein a scope is advanced along the at least one lumen until a distal end of the scope is positioned in a vicinity of a selected tissue mass, and the needle cannula is advanced through the scope, into the anatomical structure, and through an outer surface of the anatomical structure; wherein the needle cannula is retracted to expose a portion of the electrical lead extending through the outer surface of the anatomical structure; wherein the electrical lead is used to supply electrical power to the reference sensor and extends through the outer surface of the anatomical structure; Wherein, the reference sensor is fixed to an anatomical structure in a vicinity of the tissue mass by advancing the pusher relative to the needle cannula or retracting the needle cannula relative to the pusher.

28. The system of claim 27, wherein: The electrical lead is a distal electrical lead, and the sensor assembly further includes a proximal electrical lead for powering the reference sensor, wherein the proximal electrical lead is releasably attached to the reference sensor and extends through the pusher when the reference sensor is disposed in the needle cannula, and the proximal electrical lead powers the reference sensor when the reference sensor is disposed in the needle cannula.

29. The system of claim 28, wherein: After supplying electrical power to the reference sensor via the distal electrical lead, the proximal electrical lead is separated from the reference sensor.

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