Patent Application
20240000399
The present disclosure relates to the field of navigation of medical devices within a patient, and in particular, planning a pathway through a luminal network of a patient and navigating medical devices to a target.
There are several commonly applied medical methods, such as endoscopic procedures or minimally invasive procedures, for treating various maladies affecting organs including the liver, brain, heart, lungs, gall bladder, kidneys, and bones. Often, one or more imaging modalities, such as magnetic resonance imaging (MM), ultrasound imaging, computed tomography (CT), cone-beam computed tomography (CBCT) or fluoroscopy (including 3D fluoroscopy) are employed by clinicians to identify and navigate to areas of interest within a patient and ultimately a target for biopsy or treatment. In some procedures, pre-operative scans may be utilized for target identification and intraoperative guidance. However, real-time imaging may be required to obtain a more accurate and current image of the target area. Furthermore, real-time image data displaying the current location of a medical device with respect to the target and its surroundings may be needed to navigate the medical device to the target in a safe and accurate manner (e.g., without causing damage to other organs or tissue).
For example, an endoscopic approach has proven useful in navigating to areas of interest within a patient. To enable the endoscopic approach endoscopic navigation systems have been developed that use previously acquired Mill data or CT image data to generate a three-dimensional (3D) rendering, model, or volume of the particular body part such as the lungs.
In some applications, the acquired Mill data or CT Image data may be acquired during the procedure (perioperatively). The resulting volume generated from the Mill scan or CT scan is then utilized to create a navigation plan to facilitate the advancement of the endoscope (or other suitable medical device) within the patient anatomy to an area of interest. In some cases, the volume generated may be used to update a previously created navigation plan. A locating or tracking system, such as an electromagnetic (EM) tracking system, or fiber-optic shape sensing system may be utilized in conjunction with, for example, CT data, to facilitate guidance of the endoscope to the area of interest.
However, CT-to-body divergence can cause inaccuracies in navigation using locating or tracking systems, leading to the use of fluoroscopic navigation to identify a current position of the medical device and correcting the location of the medical device in the 3D model. As can be appreciated, these inaccuracies can lead to increased surgical times to correct the real-time position of the medical device within the 3D models and the use of fluoroscopy leads to additional set-up time and radiation exposure.
In accordance with the present disclosure, a method of performing a surgical procedure includes obtaining images of a patient's anatomy using a cone beam computed tomography machine while the patient is sedated, identifying an area of interest in the images obtained by the cone beam computed tomography machine, identifying a pathway to the identified area of interest using the images obtained by the cone beam computed tomography machine, and navigating a catheter within the patient's airways to the identified area of interest.
In aspects, obtaining the images of the patient's anatomy may include obtaining the images of a patient's anatomy using a fixed cone beam computed tomography machine while the patient is sedated.
In other aspects, obtaining the images of the patient's anatomy may include obtaining the images of a patient's anatomy using a mobile cone beam computed tomography machine while the patient is sedated.
In certain aspects, the method may include generating a three-dimensional model of the patient's anatomy from the images obtained by the cone beam computed tomography machine.
In aspects, identifying the area of interest may include identifying the area of interest within the three-dimensional model of the patient's anatomy.
In certain aspects, the method may include registering a location of the catheter within the patient's anatomy to the images obtained by the cone beam computed tomography machine.
In other aspects, obtaining images of the patient's anatomy may include obtaining images of the patient's anatomy using the cone beam computed tomography machine while the patient is sedated and before advancement of the catheter within the patient's body cavity.
In accordance with another aspect of the present disclosure, a method of performing a surgical procedure includes navigating a catheter to a lobe of a patient's lung including an area of interest, obtaining images of the patient's anatomy using a cone beam computed tomography machine, identifying the area of interest in the images obtained by the cone beam computed tomography machine, identifying a pathway to the area of interest using the images obtained by the cone beam computed tomography machine, and navigating the catheter to the area of interest using the identified pathway.
In aspects, obtaining the images of the patient's anatomy may include obtaining the images of a patient's anatomy using a fixed cone beam computed tomography machine.
In other aspects, obtaining the images of the patient's anatomy may include obtaining the images of a patient's anatomy using a mobile cone beam computed tomography machine.
In certain aspects, the method may include generating a three-dimensional model of the patient's anatomy from the images obtained by the cone beam computed tomography machine.
In other aspects, identifying the area of interest may include identifying the area of interest within the three-dimensional model of the patient's anatomy.
In aspects, the method may include registering a location of the catheter within the patient's anatomy to the images obtained by the cone beam computed tomography machine.
In certain aspects, the method may include obtaining an anteroposterior image of the patient's anatomy using the cone beam computed tomography machine and identifying an angle of the cone beam computed tomography machine when the anteroposterior image was obtained.
In other aspects, the method may include identifying a location of a portion of the catheter within the images obtained by the cone beam computed tomography machine.
In aspects, the method may include registering the identified location of the catheter to the images obtained by the cone beam computed tomography machine.
In accordance with another aspect of the present disclosure, a system for performing a surgical procedure includes a cone beam computed tomography machine, a catheter configured to be navigated within a patient's airways, and a controller operably coupled to the cone beam computed tomography machine, the controller including a memory and a processor, the memory storing instructions, which when executed by the processor cause the processor to obtain images of a patient's anatomy using the cone beam computed tomography machine while the patient is sedated, identify an area of interest in the images obtained by the cone beam computed tomography machine, identify a pathway to the identified area of interest using the images obtained by the cone beam computed tomography machine, and aid navigation of the catheter within the patient's airways to the identified area of interest using the identified pathway.
In aspects, the cone beam computed tomography machine is a fixed cone beam computed tomography machine.
In other aspects, the cone beam computed tomography machine is a mobile cone beam computed tomography machine.
In certain aspects, the instructions, when executed by the processor, may cause the processor to obtain images of the patient's anatomy using the cone beam computed tomography machine while the patient is sedated and before advancement of the catheter within the patient's body cavity.
Various aspects and embodiments of the disclosure are described hereinbelow with references to the drawings, wherein:
The present disclosure is directed to surgical imaging system, and more particularly, to system and methods for assisting a clinician in navigation of endoscopes, catheters, and tools to area of interest or targets within a patient for biopsy and therapy while reducing the number of times a patient must be imaged and increasing the accuracy of the navigational model. The system and methods include utilizing fixed or mobile cone beam computed tomography (CBCT) machines to obtain intra-procedural images of the patient's anatomy. The intra-procedural images can be used in lieu of pre-procedural images or otherwise update models, pathways, and/or plans generated using pre-procedural images. It is envisioned that inputs may be made on a user interface to identify a position of the endoscope and/or area of interest within the intra-procedural images to increase the accuracy of a registration between the position of the endoscope and/or area of interest within the model generated from the intra-procedural images. Although generally described with reference to the lung, it is contemplated that the systems and methods described herein may be used with any structure within the patient's body, such as the liver, kidney, prostate, gynecological, amongst others.
Turning now to the drawings,
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A network interface 36 enables the workstation 20 to communicate with a variety of other devices and systems via the Internet. The network interface 36 may connect the workstation to the Internet via a wired or wireless connection. Additionally, or alternatively, the communication may be via an ad-hoc Bluetooth® or wireless networks enabling communication with a wide-area network (WAN) and/or a local area network (LAN). The network interface 36 may connect to the Internet via one or more gateways, routers, and network address translation (NAT) devices. The network interface 36 may communicate with a cloud storage system 38, in which further image data and videos may be stored. The cloud storage system 38 may be remote from or on the premises of the hospital such as in a control or hospital information technology room. An input device 40 receives inputs from an input device such as a keyboard, a mouse, voice commands, amongst others. An output module 42 connects the processor 30 and the memory 32 to a variety of output devices such as the display 24. It is envisioned that the output module 42 may include any connectivity port or bus, such as, for example, parallel ports, serial ports, universal serial busses (USB), or any other similar connectivity port known to those skilled in the art. In embodiments, the workstation 20 may include its own display 44, which may be touchscreen display.
In embodiments, the network interface 36 may couple the workstation 20 to a Hospital Information System (HIS) to enable the review of patient information. As such, the workstation includes a synthesizer which communicates with the HIS either directly or through a cloud computing network via a hardwired connection or wirelessly. Information accessible by the system includes information stored on a Picture Archiving and Communication system (PACS), a Radiology Information System (RIS), an Electronic Medical Records System (EMR), a Laboratory Information System (LIS), and in embodiments, a Cost and Inventory System (CIS), wherein each of which communicates with the HIS. Although generally described as utilizing the HIS, it is envisioned that the patient information may be obtained from any other suitable source, such as private office, compact-disc (CD) or other storage medium, etc.
The system 10 includes a Patient/Surgeon Interface System or Synthesizer which enables communication with the HIS and its associated database. Using information gathered from the HIS, an Area of Interest (AOI) is able to be identified illustrating the effects of lung disease, and in embodiments, the software application associated with the synthesizer may be able to automatically identify areas of interest and present these identified areas to a clinician for review via the user interface 26. In embodiments, pre-procedure image data gathered from the HIS is processed by the software application to generate a three-dimensional (3D) reconstruction of the patient's lungs, and using medical information gathered from the HIS, such as, for example, prior surgical procedures, diagnosis of common lung conditions such as Chronic Pulmonary Obstruction Disorder (COPD), and the location of common structures within the patient's body cavity, the software application generates a 3D model of the patient's lungs incorporating this information. In embodiments, the system 10 may facilitate an approach of a medical device to the target area using Electromagnetic Navigation (EMN) and for determining the location of a medical device with respect to the AOI. One such EMN system is the ILLUMISITE system currently sold by Medtronic PLC, though other systems for intraluminal navigation are considered within the scope of the disclosure including shape sensing technology which detect the shape of the distal portion of the catheter and match that shape to the shape of the luminal network in a 3D model.
In embodiments, the CBCT machine 50 may be a fixed CBCT machine or a mobile CBCT machine. In one embodiment, the fixed CBCT machine 50 is utilized to scan the patient during the surgical procedure but before the endoscope or catheter 100 is inserted within the patient's airways. In this manner, the patient is sedated or otherwise under anesthesia to ensure that the patient is generally immobilized during the scan performed by the fixed CBCT machine Once the scan has been completed, the images captured by the fixed CBCT machine 50 are saved on a memory associated with fixed CBCT machine 50. It is envisioned that the images captured by the fixed CBCT machine 50 and saved on the memory may be transferred to the workstation 20 via any suitable means, such as via the internet or intranet (e.g., PACS, etc.), via computer readable storage media (e.g., memory stick, CD-ROM, etc.), amongst others.
With the images captured by the fixed CBCT machine 50 received by the workstation 20, a planning phase for generating and viewing a 3D model of the patient's anatomy, enabling the identification of target tissue (“TT”) on the 3D model (automatically, semi-automatically, or manually), and in embodiments, allowing for the selection of a pathway (“PW”) through the patient's anatomy to the target tissue. One example of such an application is the ILLUMISITE® planning and navigation suites currently marketed by Medtronic. The 3D model may be displayed on the display 24 or another suitable display (not shown) associated with the controller 20, or in any other suitable fashion. Using the controller 20, various views of the 3D model may be provided and/or the 3D model may be manipulated to facilitate identification of target tissue on the 3D model and/or selection of a suitable pathway to the target tissue. With the pathway to the target tissue selected, the endoscope or catheter 100 is inserted within the patient's airways and the detected location and/or images obtained by the endoscope or catheter 100 within the patient's airways is automatically registered to the 3D model.
In embodiments, the 3D model generated from the images acquired by the fixed CBCT machine 50 can be utilized to update or otherwise correct a 3D model generated from the pre-procedure images. In this manner, the navigation of the endoscope or catheter 100 to the target tissue is completed using up to date information regarding the condition of the patient's lungs and reduces the need to perform additional intra-operative imaging to verify the location of the endoscope or catheter 100 within patient's airways during navigation to the target tissue and/or before treatment of the target tissue. It is envisioned that the 3D model or images obtained by the fixed CBCT machine 50 may be overlaid or otherwise associated with an intra-operative image (e.g., fixed CBCT machine 50 images, images captured by the endoscope or catheter 100, fluoroscopic images, etc.).
In another embodiment, before the surgical procedure begins, the software application utilizes pre-procedure image data stored on the memory 32 or via the HIS and is processed by the software application to generate a three-dimensional (3D) reconstruction of the patient's lungs, identify target tissue on the 3D model (automatically, semi-automatically, or manually), and in embodiments, allowing for the selection of a pathway (“PW”) through the patient's anatomy to the target tissue. With the pathway to the target tissue selected, the endoscope or catheter 100 is inserted within the patient's airways and the detected location of the endoscope or catheter 100 within the patient's airways is automatically registered to the 3D model. The endoscope or catheter 100 is then navigated to a portion of the lobe of the patient's lung in which the target tissue is located. Although generally described as utilizing a 3D model to aid navigation of the endoscope or catheter 100 to the lobe in which the target tissue is located, it is envisioned that the endoscope or catheter 100 may be manually navigated to the lobe in which the target tissue is located without the aid of a navigation tool.
Once the endoscope is located within the lobe in which the target tissue is located, intra-procedure images are obtained from a mobile CBCT machine 50 and transferred to the workstation 20. The application generates a 3D model of the patient's anatomy using the intra-procedure images obtained from the mobile CBCT machine 50. The software application enables a user to enter the planning phase to identify of target tissue (“TT”) on the 3D model (automatically, semi-automatically, or manually), and in embodiments, may allow for the selection of a pathway (“PW”) through the patient's anatomy to the target tissue. With the pathway to the target tissue selected, the 3D model generated from the images obtained by the mobile CBCT machine 50 is registered (either manually or automatically) to the real time images obtained by the endoscope or catheter 100, or in embodiments, updates or otherwise replaces the 3D model generated from the pre-procedure image data and navigation to the target tissue is completed using the updated 3D model.
In embodiments, the software application permits the user to select and/or mark the location of the endoscope within the 3D model generated from the imaged obtained by the intra-operative mobile CBCT machine 50 to updated and/or correct differences between the initial 3D model generated from the pre-procedure images and the intra-operative images obtained by the mobile CBCT machine 50.
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With the location of the endoscope or catheter 100 identified within the intra-procedure images obtained by the mobile CBCT machine 50, the position of the endoscope or catheter 100 is registered to the 3D model (manually or automatically) and navigation to the target tissue is continued. In embodiments, one or more further scans by the mobile CBCT machine 50 to further update and/or confirm the position of the endoscope or catheter 100 within the patient's airways or relative to the target tissue.
In embodiments, rather than manually navigating the endoscope or catheter 100 to the target lobe, it is envisioned that the endoscope or catheter 100 may be navigated to the target lobe utilizing a 3D model formed from pre-procedure images obtained by the system 10, as described in further detail hereinabove. It is envisioned that the user may choose to manually navigate the endoscope or catheter 100 to the target lobe or may utilize a navigation aid utilizing the 3D model generated from pre-procedure images.
In some embodiments, during navigation of the endoscope or catheter 100 within the patient's airways using a 3D model constructed of pre-procedure images, the mobile CBCT machine 50 may be utilized to capture an intra-operative 2D video of the surgical site and generate a composite utilizing tomosynthesis. Utilizing a volume reconstructed from tomosynthesis of the 2D video, the location of the catheter within the images is identified (manually or automatically) and registration is completed. In embodiments, the 2D video captured by the mobile CBCT machine 50 may be captured during navigation of the endoscope or catheter 100 through the patient's airways using a 3D model generated using pre-procedure images. The 2D video is continuously displayed to the user during navigation to provide real-time corrections of the location of the endoscope or catheter 100 displayed on the 3D model. It is envisioned that the user may be able to provide inputs on the user interface 26 to identify a path through the patient's airways to reach the target tissue. In this manner, the software application utilizes the user inputs to create a pathway through the patient's airways corresponding to the user's inputs on the user interface 26.
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Although described generally hereinabove, it is envisioned that the memory 32 may include any non-transitory computer-readable storage media for storing data and/or software including instructions that are executable by the processor 30 and which control the operation of the controller 20 and, in some embodiments, may also control the operation of the endoscope or catheter 100. In an embodiment, memory 32 may include one or more storage devices such as solid-state storage devices, e.g., flash memory chips. Alternatively, or in addition to the one or more solid-state storage devices, the memory 32 may include one or more mass storage devices connected to the processor 30 through a mass storage controller (not shown) and a communications bus (not shown).
Although the description of computer-readable media contained herein refers to solid-state storage, it should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 30. That is, computer readable storage media may include non-transitory, volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. For example, computer-readable storage media may include RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which may be used to store the desired information, and which may be accessed by the controller 20.
While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
