Precise planning, guiding and placing of probes within the body

Abstract

A method for navigating a probe to a location within a patient's body, the method comprising visualizing a three-dimensional image of a region of the patient's body; receiving a selection of a target location within the three-dimensional image of the region of the patient's body; determining and visualizing a preferred path for the probe to follow from an external entry point on the patient's body to the target location; simultaneously visualizing an indication of the preferred path of the probe with a current actual location of the probe in real time, such that the simultaneous visualization enables a user to align the current actual location of the probe with the preferred path; and updating and visualizing the indication of the current actual location of the probe in real time as the probe is advanced to the target location.

Description

BACKGROUND 1. TECHNICAL FIELD

[0002] The present disclosure relates generally to the navigation of a device, such as a probe, to a site within a body and systems thereof.

[0003] 2. Discussion of Related Art

[0004] Focused thermal destruction or focused thermal therapy is a medically accepted treatment modality for many types of tumors. Focused thermal destruction devices can include radiofrequency energy sources, lasers, microwave energy sources, and high intensity focused ultrasound energy sources. The energy is delivered to the tumor in a minimally invasive manner to achieve tumor destruction but without significant damage to healthy surrounding tissue. The delivery device or probe inserted into the tumor will vary depending on the type of energy source. Long-term survival can be achieved using this treatment modality and thus represents a viable alternative to open surgical intervention and in cases where tumor removal is not an option.

[0005] In radiofrequency ablation, electromagnetic energy with a frequency less than 900 kHz is utilized to generate heat. Radiofrequency devices typically operate in a range between 375 kHz to 500 kHz. In radiofrequency ablation, an electrode probe is placed within the tumor and an alternating high frequency current displaces the molecules within the tumor, resulting in local heating up to about 90 degrees Celsius. In laser ablation, an infrared light with a wavelength between 800 nm and 1100 nm is delivered to the tumor using a laser. The laser is absorbed by tissue-specific chromophores and the photon energy is converted to heat to produce thermal damage to the target tissue. With laser ablation, local heating between 50 degrees Celsius to 100 degrees Celsius can be achieved at the desired power setting of the laser. In microwave ablation, a microwave source, i.e., a device capable of generating energy with a frequency greater than or equal to 900 kHz, is used to generate electromagnetic radiation associated with the tumor through a needle antenna. This energy creates rapid agitation of water molecules within the tumor cells to cause heating. At the desired power setting, local heating to temperatures in the range of 60 degrees Celsius to 100 degrees Celsius can be achieved. Ultrasound energy can be applied to the tumor through extracorporeal or direct needle / probe application for thermal ablation of the tumor. Ultrasound devices with a frequency between 0.8 MHz and 1.6 MHz can deliver narrow focused energy to the target tissue after harmlessly traversing through soft tissue. This energy is absorbed in the target tissue where it is converted to heat, elevating the temperature of the tissue at the target site to greater than 80 degrees Celsius. In the case of ultrasound, two mechanisms of action are at play; i.e., thermal energy damage as described above, and mechanical damage due to the vibration of the tissue via acoustic cavitation.

[0006] The reason that this type of treatment is effective is that cancer cells have increased sensitivity to heat compared to normal cells and thus can be destroyed with minimal or no damage to healthy tissue. Damage to the target tissue or tumor occurs in two different phases (direct heat damage and indirect damage). Direct heat damage is determined by the total energy applied to the tumor, tumor biology, and tumor microenvironment. Indirect heat damage occurs after the application of energy has stopped. It is damage that continues to occur after the application of energy has stopped. The progressive damage depends on many factors including microvascular damage leading to endothelial cell damage, ischemia-reperfusion damage, apoptosis or cell death, altered cytokine expression, and immune response. All of these progressive factors lead to further damage to the cancerous tissue.

[0007] As noted above, in a large number of cases, the survival rate of patients undergoing focused heat destruction is comparable to those undergoing surgical resection; however, recurrence of cancer is more likely to occur in cases where the tumor is not completely destroyed. In order to completely eradicate the tumor, the entire tumor must be heated to a temperature that will destroy the cells. Therefore, several factors should be preferably taken into account. One factor to take into account is the size and geometry of the tumor. Typically, these procedures are done percutaneously and are therefore visualized in two dimensions under fluoroscopy. CT imaging can be used to view two-dimensional slices of the patient's anatomy and tumor geometry; however, compiling these slices to accurately measure the complex geometry of a given tumor remains a challenge. This can not give the physician an accurate perception of the geometry or size. In addition, one or more probes inserted into the tumor with this method can not be accurately positioned by simple two-dimensional viewing. Another factor to take into account is the surrounding tissue, including critical anatomical structures. With two-dimensional imaging, various anatomical features can not be captured. Yet another factor to take into account is heat sink anatomical features. If heat is drawn away from the target tissue by surrounding healthy heat sink tissue, the temperature required to destroy the cancerous tissue can not be reached. Yet another factor to take into account is electromagnetic wave cancellation. If more than one probe is utilized to radiate energy, incorrect placement can result in partial or complete phase cancellation. This phase cancellation will result in less energy reaching the target tissue and thus can result in incomplete destruction of the tumor.

[0008] Therefore, there is a need for improvement. SUMMARY

[0009] The present disclosure relates to a method for navigating a probe to a location within a patient's body. The method and system of the present disclosure overcome many of the limitations associated with the prior art as briefly described above. The method includes the steps of visualizing a three-dimensional image of a region of a patient's body, selecting a target location within the three-dimensional image of the region of the patient's body, determining and visualizing a preferred path for the probe to follow from an external entry point on the patient's body to the target location, registering the three-dimensional image with a current actual location of a corresponding region of the patient's body, registering a current actual location of the probe with the three-dimensional image and the current actual location of the patient's body, visualizing in real time the calculated preferred path of the probe with the current actual location of the probe, aligning the current actual location of the probe with the preferred path and the entry point, advancing the probe along the preferred path into the patient's body, and updating and visualizing in real time the alignment of the probe as it is advanced until the target location is reached.

[0010] According to another aspect, the present disclosure relates to a system for navigating a probe to a location within a patient's body. The system includes a three-dimensional image of a region of a patient's body, a probe configured to be registered with a patient's body location in three-dimensional space, a registration system to register the probe and a current actual location of the patient's body with the three-dimensional image of the region of the patient's body, an imaging device for capturing real-time images of the region of the patient's body, a computer for calculating a preferred path of the probe to a target location within the region of the patient's body and in communication with the imaging device and the registration system, and a display for visualizing the real-time images from the imaging device and the three-dimensional alignment of the probe and the current actual location of the patient's body relative to the preferred path and the target location. BRIEF DESCRIPTION OF DRAWINGS

[0011] The above-mentioned and other features and advantages of the present disclosure will be apparent from the following more particular description of preferred embodiments of the present disclosure, as illustrated in the accompanying drawings.

[0012] Figures 1A-1C is a diagrammatic illustration of a preoperative scan of a patient, the patient, and a holographic overlay of the preoperative scan superimposed on the patient, in accordance with the present disclosure.

[0013] Figure 1D is a diagrammatic illustration of a registration marker on a patient and an image of the patient with the registration marker, in accordance with the present disclosure.

[0014] Figure 2 is a diagrammatic illustration of a human liver with a tumor and surrounding anatomy.

[0015] Figure 3A is a diagrammatic illustration of a human liver with a tumor at a first time associated with an initial scan, in accordance with the present disclosure. Figure 2

[0016] Figure 3B ​is a graphical illustration of a human liver with a tumor according to the present disclosure at a second time associated with a second scan Figure 2

[0017] Figure 4 is a graphical illustration of multiple ablation probes and associated ablation zones within a tumor.

[0018] Figure 5 is a graphical illustration of the heat sink effect of an ablation probe within a tumor.

[0019] Figure 6A is a graphical illustration of a single ablation probe trajectory according to the present disclosure.

[0020] Figure 6B and Figure 6C is a graphical illustration of a method of visualizing a calculated path according to the present disclosure. Figure 6A

[0021] Figure 7 is a graphical illustration of a calculated trajectory projection based on real-time position of an ablation probe according to the present disclosure.

[0022] Figures 8A-8C is a graphical illustration of an introducer sheath system of the present disclosure.

[0023] Figure 9 is a graphical illustration of an example feedback mechanism according to the present disclosure.

[0024] Figure 10 is a graphical illustration of an example ablation probe according to the present disclosure.

[0025] Figures 11A-11F shows a graphical illustration of an example method involving determining a preferred path from a three-dimensional image of a region of a body. DETAILED DESCRIPTION

[0026] ​​Systems and methods for navigating a probe to a location within a patient's body are described. The probe can include a needle, introducer, catheter, stylet, or sheath. Other probes can be used. The method can include visualizing a three-dimensional image of a region of the patient's body. As one example, the three-dimensional image of the region of the patient's body can be based on one or more of magnetic resonance imaging (MRI), computed tomography (CT), or ultrasound. Other imaging techniques can be used. The method can include receiving a selection of a target location within the three-dimensional image of the region of the patient's body. As one example, receiving the selection of the target location is via interaction with a display device configured to output one or more of the visualizing steps. Other inputs can be used to implement the selection. The method can include determining and visualizing a preferred path for the probe to follow from an external entry point on the patient's body to the target location. The preferred path can be determined by translating a selected point in a two-dimensional view of the three-dimensional image of the region of the patient's body into a line (e.g., line of sight) through the three-dimensional image of the region of the patient's body. The method can also include calibrating the preferred path to preoperatively compensate for shifts in anatomical structures. Alternatively or additionally, the method can also include calibrating the preferred path to intraoperatively compensate for shifts in anatomical structures. The method can include registering the three-dimensional image with a current actual location of the corresponding region of the patient's body. The method can include registering a current actual location of the probe with the three-dimensional image and the current actual location of the patient's body. The method can also include updating the registration of the three-dimensional image with the patient to compensate for shifts in anatomical structures. The method can include simultaneously visualizing an indication of the preferred path of the probe and the current actual location of the probe in real-time, such that the simultaneous visualization enables a user to align the current actual location of the probe with the preferred path. As one example, the indication of the current actual location of the probe includes a position of the probe in three-dimensional space. As another example, the indication of the current actual location of the probe includes a projected extension of the probe in three-dimensional space. The method can include updating and visualizing the indication of the current actual location of the probe in real-time as the probe is advanced to the target location. Additionally, output of auditory or visual feedback can be used to alert the user of information regarding proximity to the target location and / or information regarding proximity to critical anatomical structures.

[0027] Ablation of anatomical material, such as tumors, is used herein as an illustrative example. Other procedures and surgeries can benefit from systems and methods as described herein. Focused thermal destruction or ablation is an important treatment strategy for treating certain tissues, such as benign and malignant tumors. As described above, there are a variety of energy sources available, and each has its advantages and disadvantages. Radiofrequency ablation is widely used, and there are a variety of radiofrequency-based devices and power sources currently in use. However, radiofrequency energy has several limitations, including rapid dissipation of energy in superficial tissue, which results in a shallow "burn," and inability to access deeper tumor tissue. Another limitation associated with radiofrequency ablation systems is that the formation of eschar (dead tissue) and blood clots tends to form on the energy-emitting electrode, which in turn limits further deposition of energy.

[0028] In view of the limitations associated with radiofrequency ablation, microwave ablation offers a viable and effective alternative. More specifically, microwave energy provides deeper tissue penetration, insensitivity to charring, no need for grounding, more reliable energy deposition, faster tissue heating, and the ability to create a larger thermal lesion than radiofrequency ablation. There are a variety of devices that utilize electromagnetic energy in the microwave frequency range as a means for focused thermal destruction or ablation.

[0029] The present disclosure relates to a method and system for navigating one or more probes to a location within a patient's body. The present disclosure relates to a method and associated system for determining an accurate three-dimensional model of a tumor and its surrounding environment, including anatomical structures, and a device for automatically calculating the number of energy-emitting probes and the corresponding positioning / trajectory details of the energy-emitting probes within the tumor to ensure that the radiated energy does not destructively interfere within the patient's body and completely eradicate the targeted cancer cells. To achieve the optimal trajectory for each probe for ensuring complete destruction of the tumor, the method of the present disclosure includes a predictive analysis that takes into account the effects of tissue shrinkage due to electromagnetic radiation exposure. Although there are several energy sources available as described above, the exemplary embodiments of the present disclosure will be described with respect to a system for delivering microwave radiation as a means for focused thermal destruction. An exemplary system is described in U.S. Patent Publication No. 2018 / 0132934 assigned to NeuWave Medical, Inc.

[0030] As an illustrative example, the optimal trajectory of a probe (e.g., an ablation probe or other probe device) determined (e.g., calculated) based on anatomical geometry obtained from a variety of preoperative imaging modalities, including magnetic resonance imaging (MRI), computed tomography (CT), and ultrasound, can be calibrated in real-time for a patient to account for internal shifts in the body's anatomy between the time of imaging and the time the patient is prepared and positioned on an operating or surgical table.

[0031] As another example, calibration can be achieved by mapping preoperative imaging (e.g., CT scan) and a pre-determined direction of a surgical path vector that indicates the optimal trajectory through the body to a determined target on the patient via anatomical markers, vision systems, and / or markers placed onto the patient’s body. Similar methods are used for multiple surgeries, such as guided sinus surgery using a mask. The location and orientation of the anatomical feature of interest (e.g., a tumor) and the surgical path vector can then be verified in real-time using, for example, an ultrasound probe.

[0032] As an illustrative example, once this is achieved, the physician, an artificial intelligence (AI) module of software that implements the methods of the present disclosure in conjunction with the ablation system, and / or the physician guided by the AI can then mark and record discrete slices of the tumor and the surgical path vector as the fan beam of the ultrasound probe traverses both the surgical path vector and the full target tumor. As the ultrasound records the location of the tumor and other relevant anatomical structures in the surrounding space, the AI / software automatically adjusts the CT overlay via a best-fit line optimization in three dimensions to match the patient’s real-time anatomical structure and subsequently adjusts the optimized surgical path vector for the ablation probe trajectory to account for any anatomical shifts that can have occurred since the initial deployment of the trajectory, which can be based on historical imaging data. The ablation system described herein can also incorporate an augmented reality (AR) headset through which the physician can visualize a “holographic” CT scan superimposed onto the patient, allowing the physician to visualize the three-dimensional geometry of the tumor in space, i.e., as if the physician were directly gazing at the patient’s body, and the orientation of the optimized surgical path vector for the ablation probe trajectory.

[0033] Further, the probe, the patient, and the ultrasound probe are equipped with three- dimensional position tracking sensors that all cross-communicate with each other, as with the AURORA® system used in conjunction with the AURORA® 3 system from 3 system. The system is configured to guide the physician in placing the ablation probe by verifying that the ablation probe is accurately positioned in real-time as it is advanced into the patient’s body. The devices can be visually tracked using IR markers placed on the probe, ultrasound, and AR headset or by other means.

[0034] A detailed description of each step in the method is given below. To best illustrate and describe the method, a tumor in the liver of a patient will be utilized Figure 2); however, it is important to note that this is merely for illustrative purposes and the method can be used in any location in the body. The first step in the method is to collect data from a CT scan of the patient at the time of surgery or from historical scans and use the information captured in the scan to model the tumor and surrounding tissue and anatomy in the area of potential ablation probe insertion and energy dissipation. The CT scan described herein captures relevant data related to the tumor and surrounding structures (i.e., blood vessels, including the vena cava, aorta, hepatic artery, portal vein, hepatic vein, and organs such as the spleen when working in or near the liver). See Figures 1A-1C FIG. 1 1 shows a holographic overlay of a preoperative scan of a patient on the actual patient through an AR headset or other suitable display device. It will be appreciated that various display devices can be used. As a non-limiting example, a display device such as an AR headset facilitates visualization by the physician and instrument alignment with the ablation probe trajectory and tumor location in three-dimensional space. However, other displays can provide similar functionality.

[0035] With the preoperative scan, e.g., CT scan 102 with registration markers and emitters (the reference locations of the markers and emitters are selected for demonstration purposes, additional locations can be used for this step of the surgery), is input into the display device. The preoperative scan 102 is then overlaid on the actual patient 104 in the surgery relative to the registration markers. Figure 1D A more detailed description of the registration markers is given. As an illustrative example, when implementing AR technology, it is the physician who views the actual patient 104 in the surgery while wearing an AR headset. He or she will see a holographic overlay 106 of the preoperative scan 102 on the patient 104, which, as explained in more detail herein, allows an initial step in the precise guidance of one or more probes. As described herein, various display devices can be used.

[0036] A CT scan is a computerized x-ray imaging procedure that can be used to generate a three-dimensional image of a patient showing bones, organs, blood vessels and tissue and any abnormalities present, such as a tumor. A CT scanner or CT machine utilizes a narrow beam of x-rays that rotates around the patient's body to provide a signal that is processed by the scanner's microprocessor to produce cross-sectional images or slices of the body. After a plurality of consecutive slices are collected by the microprocessor, they are stacked and compiled together to form a three-dimensional image of the patient relative to the scanned area. Thus, the images produced by the scanner can be viewed as individual slices, two-dimensional images or three-dimensional images. The reason that a CT scan is so valuable as a diagnostic tool also makes it a valuable element in the present disclosure; namely, the data collected can be parsed or utilized in various ways. For example, individual components of the images can be isolated and then viewed relative to other portions of the patient, as explained in more detail subsequently.

[0037] As described herein, a key to the present disclosure is the protection of tissue and non-harmful anatomy surrounding a tumor while achieving complete destruction of the targeted tumor. To achieve this, the precise anatomy of the tumor and surrounding structures must be determined. A CT scan of the patient includes all data necessary or desired to model the patient's anatomy, including the tumor. Once the CT scan is performed, the data associated with the tumor and the data associated with the surrounding tissue can be separated by having the software search for any material within a certain density range. This is possible because each tissue type has a specific density and the software of the present disclosure is able to separate tumor cells from normal cells. By separating this data and using it to create a highly accurate three-dimensional model, the physician will be able to visualize the complete entirety of the target anatomy or feature (e.g., tumor) and proceed with the disclosure described in this specification, for example, to completely ablate the tumor based on calculations of an algorithm for the number of ablation probes used, ablation probe trajectories and placement, and energy delivered by each ablation probe. In this way, all tumor cells can be destroyed without damaging surrounding tissue and / or anatomy. Again, it is important to note that other functions requiring a probe or probe-like device can be used in accordance with the present disclosure.

[0038] Once the tumor is modeled and superimposed relative to the rest of the necessary or desired anatomy of the patient, the ablation probe positioning, number, and trajectory, or a combination of the above, are calculated by the physician by providing the ability to navigate the model when searching for the optimal trajectory area, avoiding healthy tissue / areas. In this way, complete destruction of the tumor can be achieved with minimal damage to surrounding tissue and organs. With respect to efficiency, the determination of proper positioning of the ablation probe within the tumor can involve considerations of ablation energy dissipation curves, which can be affected by the proximity of heat sinks, tumor volume size, the number of potential paths that provide a safe trajectory into the tumor, and the strength of the ablation energy when utilizing the probe. By doing so, the present disclosure is more efficient in terms of energy utilization and safety. Additionally or alternatively, blood flow in the area of the anatomical feature (e.g., tumor) can also be modeled by calculating a geometric algorithm, and the ablation probe energy and placement can be optimized to take this blood flow into account.

[0039] After the initial trajectory / positioning determination of the ablation probe, as part of the process of the present disclosure, the physician can select a trajectory or path for the ablation probe to follow, as described above with respect to Figures 1A-1CThe CT scan of the patient must be registered to the patient at the time of the actual procedure. Physical attached markers or anatomically structured markers are used to register the CT scan to the actual patient. Generally, any number of anatomical markers can be utilized in the registration process if the path is selected. For example, bony structures or landmarks can be utilized. In addition, surface structures such as the nipple can also be utilized. Essentially, any fixed structure on or in the body can be used to register the CT scan to the patient. In the case where the CT scan is registered to the patient at the time of the procedure, the next step in the process can involve compensating for anatomical shifts in the patient once the patient is positioned for the procedure, as well as compensating for any shifts that can have occurred if historical CT data was used to generate the 3D model and path, rather than creating the 3D model and path on the day of the procedure. During the time between the initial scan used to create the 3D model and the time point of the ablation procedure, anatomical shifts can occur for a variety of reasons. It can be as simple as the patient being placed on the operating table. Additional CT scans performed at the time of the procedure or real-time ultrasound can be utilized to generate a more accurate image of the desired region or portion of the patient in which the target is determined to be located.

[0040] Additionally or alternatively, if the tumor or any of the surrounding tissue, organs and / or blood vessels do move, the CT scan / ultrasound will be used with algorithms and software to measure the shift and the geometric algorithms will automatically calculate a new ablation probe trajectory as well as any other relevant ablation probe information, or the action can be implemented by the physician if needed. More specifically, as described above, the updated CT / ultrasound records the location of the tumor and other relevant anatomical structures in space, the AI / algorithm has the ability to automatically adjust the CT stack via best fit line optimization in three dimensions to match the real-time anatomy of the patient, and subsequently adjust the optimized ablation probe trajectory.

[0041] Once the final trajectory of the ablation probe is calculated as well as other relevant ablation probe information, the ablation probe(s) must be introduced into the sheath registered to the patient / model. There are a variety of suitable ways to gather information to register the ablation probe to the patient, including, for example, optical registration utilizing IR cameras or sensors, or by registering using precision mapping techniques similar to the 3 system technology, which is available from 3 system available from Webster, Inc. a Johnson & Johnson Company, which utilizes electromagnets to create a magnetic field through which the ablation probe can be registered. As noted above, the exemplary ablation probe can be part of the system described in U.S. Patent Publication No. 2018 / 0132934 assigned to NeuWave Medical, Inc. The introducer sheath can be interchangeable with the ablation probe for delivering energy and any necessary tools including an introducer stylet used prior to insertion of the ablation probe. Such an introducer sheath is necessary for the continued exchange from the introducer stylet to the ablation probe. The introducer sheath is an element of the present disclosure that is spatially marked and tracked relative to the emitter. The receiver gives an indication of where the surgical path trajectory is when utilizing an introducer sheath with an introducer stylet, ablation probe, or similar item. However, with that said, the receiver can be attached to any item of known geometry for the purposes of spatial tracking.

[0042] After the registration of the ablation probe guide has been completed, all relevant trajectories will be taken into account in the virtual model and software via the present disclosure with overlapping ultrasound. The ultrasound images themselves are overlaid with specific trajectories of the ablation probe sheath. These trajectories include not only the position of the ablation probe / introducer stylet within the patient relative to all tumors, but also the projected position of the ablation probe / introducer stylet as the user will be advancing down a controlled linear path.

[0043] When starting to validate the calculated ablation probe trajectory in real time with ultrasound, the relevant trajectories will be used in the next stage. The ultrasound images are overlaid with all necessary trajectories, which can be toggled on / off to zoom in to one specific trajectory at a time. Ultrasound is then utilized to scan the region of interest to validate that the minimum anatomical structure is damaged through the full length of the ablation probe path. Additionally, the validation of the termination of the path can be validated at the tumor site where the path directly intersects with the structure at a predetermined location within the tumor.

[0044] After the validation of the calculated path or trajectory is complete, the entry point is located on the patient via the introducer sheath attached with the introducer stylet / ablation probe, calibration tool, or tool with a receiver attached to it and with a known position in the virtual coordinate system. The entry point is the starting point of the calculated ablation probe path relative to the highest level of the patient’s complete material, typically the skin.

[0045] The potential sequence of ablation probe insertion into the ablation site is then described in detail. Once the entry point is located, a delivery sheath with a delivery stylet is then positioned at the entry point. Real-time ultrasound verification can be used at this step and each subsequent step to allow confirmation of ablation path deviations, if any. With real-time verification of the location of the delivery stylet or ablation probe in the patient's body, the delivery stylet or ablation probe can be inserted up to the ablation site of the tumor while having the superimposed graphical representation of the pre-planned and verified surgical path. In addition to the visual verification of the location of the ablation probe in the body relative to its target tumor and surrounding anatomy, audible sounds or additional feedback can be incorporated to provide a second sense of location relative to the target endpoint and the tumor itself. Additionally or alternatively, at this stage, the energy levels and duration are all calculated and determined based on the tumor itself and the type of ablation probe used, which the algorithm will calculate.

[0046] To summarize the method of the present disclosure, at this juncture, the modeling of the geometry of the tumor and the surrounding tissues, organs, and blood vessels provides the physician with information for determining a preferred trajectory for the delivery of the ablation probe into the body with minimal risk of damaging critical structures and achieving complete destruction of the tumor. The CT scan can be registered to the patient and, when the patient is positioned for the procedure, ultrasound images or additional CT scans can be utilized to determine if there is any compensation for any anatomical shifts and this information is used to automatically recalculate the ablation probe information. As an illustrative example, this can be accomplished by placing markers, e.g., markers 152 (FIG. 1), on the patient's body prior to the CT scan to determine a preoperative reference coordinate system. Intraoperatively, the same markers now present in the CT dataset can be positioned in the operating space via a dedicated positioning tool to generate an intraoperative reference coordinate system. By superimposing the two defined coordinate systems, the actual patient anatomy can be registered on the digitized coordinate system. Other registration mechanisms can be used.

[0047] Once the CT scan is registered to the patient, one or more ablation probes are then registered to the patient. Once the one or more ablation probes are registered to the patient's anatomy, they can be inserted or delivered into the patient by the physician along the calculated trajectory. The one or more ablation probes can be equipped with a guidance system, such as an overlaid virtual path displayed on an ultrasound screen, a projected path of the probe itself, and the location of the probe in space to ensure that the ablation probe follows the calculated trajectory to the proper location of the tumor destruction. The present disclosure described herein can be equipped with an acoustic system to facilitate the positioning of the ablation probe relative to the targeted ablation site. In addition, the ablation probe and the ultrasound probe are equipped with three-dimensional position tracking sensors that cross-communicate with each other.

[0048] Referring now to Figure 2, shows a diagrammatic illustration of a human liver 300 and surrounding anatomy. As shown, there is a tumor 304 in the liver 300. The CT scan described herein captures relevant data related to the tumor 304 and surrounding structures (i.e., blood vessels, including the vena cava 306, the aorta 308, the hepatic artery 310, the portal vein 312, the hepatic vein 314, and organs such as the spleen 316). Additionally or alternatively, the computational geometry algorithm calculates the required information for tumor ablation based on all such collected data. The CT scan and the result analysis done by the user show the proximity of the tumor to other organs and blood vessels, the reasons for which are shown herein. Figure 3A is a detailed diagrammatic illustration of the tumor 304 at the time of the initial CT scan, and Figure 3B is a detailed diagrammatic illustration captured by ultrasound or additional CT scans. As shown, due to anatomical shifts, the tumor 304 has moved position in some way and to some extent. As Figure 3A and Figure 3B shown, the distance between the vena cava 306 and the tumor 304 has moved in space by some distance represented by the arrow 302. In Figure 3B , the tumor 304 is closer to the vena cava 306, and thus due to the proximity to the main blood vessel and its heat sink effect, a new trajectory of one or more ablation probes can be required. As an illustrative example, the computational geometry algorithm automatically recalculates the new trajectory of one or more ablation probes. The algorithm compares the scans with the use of multiple registration markers 152 and emitters 154 positioned at specific known locations on or near the patient 150, as shown in Figure 1D .

[0049] Figure 4 shows the use of multiple ablation probes (i.e., ablation probe one 402, ablation probe two 404, and ablation probe three 406) to ablate the tumor 304 based on the volume burn area of each ablation probe inserted into the tumor 304, ablation area one 401, ablation area two 403, and ablation area three 405. It is important to note that three probes are chosen here for illustrative purposes. Typically, the probes will be introduced in a somewhat parallel fashion, rather than from completely different directions, as shown for ease of explanation. Many factors described herein determine the number of probes to be utilized and their trajectories. In the case of target volume size and location changes in the body, multiple probes as shown in this figure will be used to provide the required ablation to the target to cover the tumor area. As an illustrative example, this can be done by the system being able to calculate the burn area of each ablation probe depending on its location within the tumor relative to the energy delivery intensity, the size of the ablation probe, the nearby heat sink, and other general factors.

[0050] Figure 5The foregoing heat sink effect of an ablation probe is shown in a tumor 304. For illustrative reasons, a single simple ablation probe 501 is shown in the image. It is important to note that any suitable type of probe can be utilized, with the ablation probe being one such example. As shown, the ablation energy delivery region or distal tip 503 of the ablation probe 501 is within some region of the tumor 304. There is a nearby main blood vessel 505 that provides a heat sink effect to the tissue region and thus should be avoided. As a non-limiting example, the systems within the disclosure described herein can utilize an algorithm to predict a modified burn region with respect to a heat sink region 507 and a non-heat sink region 509. Thus, the system is able to predict / compute a burn region 511 with respect to the particular ablation probe being used.

[0051] Figure 6A A single computed trajectory (e.g., based on a computational geometry algorithm) to an ablation site in a tumor is shown. While reference is made to ablation of a tumor, other probes and procedures can benefit from the systems and methods described herein. In the figure, a determined (e.g., computed) trajectory 615 to the center 614 of the tumor 304 along a predetermined path is observed to start at the surface of the virtual patient 600 and end in an ablation site within the tumor 304. The system itself is designed to allow for the use of Figure 6B and Figure 6C The computed path or trajectory 615 is monitored in real-time with the ultrasound 619 device shown in Figure 6B and Figure 6C A visualization method of the computed path or trajectory 615 with respect to different ultrasound orientations (i.e., perpendicular to the computed path or trajectory 615 or along the computed path or trajectory 615) is shown. In Figure 6B the ultrasound device 619 is oriented perpendicular to the computed path or trajectory 615, creating an ultrasound slice 620 at a depth of this computed path or trajectory 615. The resulting ultrasound image 621 has the computed path or trajectory 615 overlaid, shown as a perpendicular cross-section of a customizable shape, object, or image 622. In Figure 6C the ultrasound device 619 is oriented along the direction axis of the computed path 615, creating an ultrasound slice 620 along most, if not all, of the computed path or trajectory 615. The resulting image 621 has the computed path trajectory 615 overlaid, shown as a concatenated axial cross-section of a customizable shape, object, or image 623. In addition to the computed path or trajectory 615 overlaid on the ultrasound image 621, the projected trajectory is also tracked on the image in real-time, as well as the actual position of the ablation probe.

[0052] Figure 7Point 717 is illustrated as an exemplary entry point for probe 716. A computed trajectory projection 718 can be determined based on the real-time position of ablation probe 716 during the procedure or during a planning study. The computed trajectory projection 718 can be a projected line computed based on the angle and position of real-time ablation probe 716. As illustrated, computed trajectory projection 718 can be overlaid on an image, such as an ultrasound image (e.g., image 621 in FIG. 6B) to allow the user to visualize the projection of the computed trajectory of probe 716. In this example, it is shown that computed trajectory projection 718 misses ablation site 714, which is the center of tumor 304. Thus, the user can determine that a correction is necessary based on computed trajectory projection 718. As another example, a planned trajectory 715 can be computed and overlaid on the image to allow the user to compare planned trajectory 715 with computed trajectory projection 718 and adjust based on that. As an illustrative example, the user can align computed trajectory projection 718 with planned trajectory 715 in order to follow the planned path to a particular location (e.g., ablation site 714). In addition to projection 718, when the ultrasound creates a slice image on the actual ablation probe 716, the projection or trajectory item (or other element in the display) can change its item’s color or some important element. This additional indicator can help the user to understand the real-time position of ablation probe 716 during any planning or insertion step. In addition to being represented in the overlaid ultrasound image, all computed trajectories (both pre-planned and real-time trajectories) can be displayed on a display device, such as a screen or a visualization headset. Figure 6B and Figure 6C

[0053] During the ablation probe insertion phase, the following figures are used to describe a series of potential steps that can be taken to get the ablation probe to the computed region / point. It is important to note that this is not the only series of steps that can be taken for this part of the procedure.

[0054] Figure 8A A lead-in sheath system is illustrated, which includes its lead-in sheath handle 802, receiver 804, lead-in sheath locking mechanism 806, and lead-in sheath 808 itself. This system can be used as an initial insertion, where a lead-in stylet 810 is used instead of ablation probe 716, which follows the predetermined procedure path 815 all the way to the ablation site at tumor 304. By using receiver 804, its position is tracked and used for all imaging and computations. Once lead-in stylet 810 reaches the computed depth and position, lead-in sheath locking mechanism 806 engages to lock that position in space relative to the patient and their respective body. Figure 8B ​The next stage of the ablation probe 716 insertion process is moved to by removing the introducer stylet 810 from the entire assembly. This opens the junction 802 which has the ability to mate with multiple components, in this figure the introducer sheath 808 is shown at rest in front of the tumor 304 due to the introducer stylet 810 and ablation probe 716 having the same geometry resulting in the same end offset position in the tumor 304. Again, this position is a software calculated position. Figure 8C The actual ablation probe 716 is now inserted into the path that has been set and the position created by the introducer stylet 810. As shown with the tip 807 of the ablation probe 716 it is at the exact same end point that the introducer stylet 810 was at and where the calculated ablation site is based on software. As a non-limiting example, the software of the present disclosure can determine the optimal placement and energy emitted by each probe to ensure there is no interference between the probes. A more detailed description of the ablation probe can be found in U.S. Patent Publication 2018 / 0132934. However, it is important to note that any suitable ablation probe can be utilized in accordance with the present disclosure.

[0055] Figure 9 An acoustic feedback or similar / non-similar mechanism is shown for proximity to tumor feedback. For the acoustic example, as the introducer stylet 810, ablation probe 716 or similar item approaches the tumor 304( Figure 8A , Figure 8B and Figure 8C ), a specified sound and tone is presented to the user or the appearance of the item is increased or modified. In addition to the visual cues, this will also ensure the user knows the position of the introducer stylet 810, ablation probe 716 or similar item relative to the target.

[0056] Referring now to Figure 10 a more detailed representation of an exemplary ablation probe assembly 500 is shown here. The exemplary probe 500 includes a cooling tube 502 and a cable assembly 504 connected to a probe handle assembly 506. The probe handle 506 is connected to an antenna portion 508 via a cooled probe sleeve 510. The area between the cooled probe sleeve 510 and the antenna portion 508 includes a stick portion 512 and a plug portion 514. The stick portion 512 is designed to obtain and maintain a temperature that accommodates tissue area sticking to its surface. The plug portion 514 is designed to prevent the temperature reduction created by the cooled probe sleeve 510 and stick portion 512 from affecting the temperature within the antenna portion 508. The ablation zone 516 is the energy pattern emitted by the antenna portion 508 for that single probe. As a non-limiting example, the software of the present disclosure can determine the optimal placement and energy emitted by each probe to ensure there is no interference between the probes.

[0057] Referring to Figures 11A-11F, a method for determining a preferred path from a three-dimensional image of a region of a body is disclosed. As one example, the method can include visualizing a three-dimensional image of a region of a body, as shown in Figures 11A-11F FIG. 11a, with respect to a known reference coordinate system. The method can include rotating the three-dimensional image in space in two-dimensional space, and obtaining vector information for a viewing plane, as shown in Figure 11A FIG. 1 If. The method can include determining a selected body orientation to provide a line of sight to a target location, obtaining spatial information for the target location with respect to the viewing plane, and / or determining a line in space based on at least the viewing plane and the spatial information for the target location defined with respect to the viewing plane. The line in space can represent at least a portion of the preferred path. The method can further include determining a fiducial point associated with the line in space. The fiducial point can be determined based on automated feature recognition. The fiducial point can be an end point of the preferred path. The fiducial point can be an entry point on an external surface of a portion of the body being treated. As one example, the fiducial point can be determined using one or more of the following steps: visualizing a plane perpendicular to the initial viewing plane, causing the line in space to represent an x-axis; and selecting an end point on the line in space while visualizing an imaging plane containing the line in space. The method of determining the fiducial point can include selecting an entry point on an external surface of the body being treated on the line in space while visualizing an imaging plane containing the line in space. Other methods can be used.

[0058] A method for navigating a probe to a location within a patient's body, the method comprising the steps of: visualizing a three-dimensional image of a region of the patient's body; receiving a selection of a target location within the three-dimensional image of the region of the patient's body; determining and visualizing a preferred path for the probe to follow from an external entry point on the patient's body to the target location; registering the three-dimensional image with a current actual location of a corresponding region of the patient's body; registering a current actual location of the probe with the three-dimensional image and the current actual location of the patient's body; simultaneously visualizing an indication of the preferred path of the probe and the current actual location of the probe in real time such that simultaneously visualizing enables a user to align the current actual location of the probe with the preferred path; and updating and visualizing an indication of the current actual location of the probe in real time as the probe is advanced to the target location.

[0059] The present disclosure relates to a method and associated system for guiding navigation of one or more probes to a location within a patient's body. The present disclosure also relates to a method and associated system for determining an accurate three-dimensional model of a tumor and its surrounding environment, including anatomical structures, and a device for automatically calculating the number of energy-emitting probes and their respective positioning / trajectory details within the tumor to ensure that the radiated energy does not destructively interfere within the patient's body and completely eradicate targeted cancer cells. To achieve the optimal trajectory for each probe to ensure complete destruction of the tumor, the method of the present disclosure includes predictive analysis that takes into account the effects of tissue shrinkage due to electromagnetic radiation exposure. In addition, the method of the present disclosure includes a device that takes into account anatomical shifts between the initial scan and the procedure, as well as any phase cancellation effects using multiple microwave ablation probes.

[0060] The present disclosure also relates to a method for three-dimensional modeling of a tumor and its ablation, and more particularly to a method and associated system for three-dimensional modeling of a tumor and surrounding tissue, analysis of the model, and determination of the number of ablation probes used, the energy radiated by each probe, and the optimal trajectory of each probe based on information from the model and analysis, including tumor geometry, electromagnetic wave phase interference, thermal sink anatomical features, and critical anatomical structures, to precisely and completely ablate a tumor. To achieve the optimal trajectory for each probe to ensure complete destruction of the tumor, the method of the present disclosure includes predictive analysis that takes into account the effects of tissue shrinkage due to electromagnetic radiation exposure, such as microwave radiation.

[0061] The present disclosure provides a device for mapping electromagnetic radiation distribution around an energy-emitting probe that takes into account any thermal sink effects caused by nearby anatomical structures, thereby providing predictive insights for positioning / tracking any and all necessary energy-emitting probes.

[0062] The present disclosure provides a device for quickly and efficiently eradicating tumors and other undesirable tissue. The present disclosure can be used in conjunction with existing technology to provide truly accurate irradiation therapy.

[0063] The present disclosure can be used in conjunction with any type of probe. For example, the probes can be configured to emit RF energy, microwave energy, ultrasound energy, optical energy, and electric fields capable of causing irreversible electroporation. In accordance with the present disclosure, non-energy-emitting probes can also be utilized.

[0064] The present disclosure includes methods of determining accurate three-dimensional models of tumors and their surrounding environment, as well as devices for automatically calculating the number and positioning / trajectory of energy radiation probes within a tumor to ensure no disruptive interference of radiated energy and complete eradication of cancer cells. Furthermore, any method should preferably include predictive analysis that accounts for the effects of tissue shrinkage due to electromagnetic radiation exposure, such as microwave radiation. Furthermore, the method can preferably include devices that automatically guide and position the probes and account for anatomical shifts.

[0065] While the forgoing is considered to be the most practical and preferred embodiments, it is recognized that departures can be made therefrom within the scope and spirit of the disclosure and that such departures are to be considered as being within the scope of the disclosure. The disclosure is not to be limited to the specific constructions and methods herein disclosed and making equivalents thereof as apparent from this disclosure are intended to be within the scope of the disclosure.

Claims

1. A system for navigating a probe to a location within a patient's body, the system comprising: Three-dimensional images of the area of ​​the patient's body; The probe is configured to be registered with the patient's body position in three-dimensional space; A registration system that registers the three-dimensional image of the region of the body and the current actual position of the probe with the current actual position of the patient's body; An imaging device for capturing real-time images of the area of ​​the patient's body; A computer, configured to calculate a preferred path from the probe to a target location within the region of the patient's body and to communicate with the imaging device and the registration system, is configured to calculate the preferred path by: Rotate the three-dimensional image in two-dimensional space. Obtain vector information of the view plane. Determine the chosen body orientation to provide a line of sight to the target location. Spatial information of the designed target position is obtained relative to the view plane, and The line in space is determined based at least on the viewing plane and the spatial information of the target position defined relative to the viewing plane; The computer is configured to automatically calculate the number of additional probes in the surrounding environment of the preferred path, the corresponding location of the additional probes, or the trajectory of the additional probes, to minimize interference with radiation energy from one or more of the additional probes. The computer also uses predictive analytics to calculate tissue contraction at the target location due to electromagnetic radiation exposure. as well as The display is configured to visualize and provide updates of the real-time image from the imaging device, to visualize and provide updates of a feature of the probe’s current actual position as the probe is advanced to the target position, and to visualize and provide updates of the preferred path of the probe to the target position.

2. The system according to claim 1, wherein, The imaging device is configured to register with the patient's body using the registration system.

3. The system according to claim 1, wherein, The calculated preferred path was calibrated to compensate for anatomical displacement during the preoperative period.

4. The system according to claim 1, wherein, The calculated preferred path was calibrated to compensate for displacement of anatomical structures during surgery.

5. The system according to claim 1, wherein, The computer is further configured to output auditory or visual feedback to warn the user about the proximity to the target location.

6. The system according to claim 1, wherein, The computer is further configured to output auditory or visual feedback to warn the user about the proximity of key anatomical structures.

7. The system according to claim 1, wherein, The probe includes a needle, guide, catheter, core needle, or sheath.

8. The system according to claim 1, wherein, The target site is at least a portion of the tumor.

9. The system according to claim 1, wherein, The imaging device includes one or more of magnetic resonance imaging (MRI), computed tomography (CT), or ultrasound.

10. The system of claim 1, further comprising using an augmented reality (AR) headset to visualize a feature of the probe’s current actual location and the preferred path.

11. The system according to claim 1, wherein, A feature of the probe’s current actual position includes the probe’s position in three-dimensional space.

12. The system according to claim 1, wherein, A feature of the probe’s current actual position includes the probe’s projected extension in three-dimensional space.

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