Removable lung isolation device for topical drug therapy

Abstract

A system and method of applying therapy to a patient includes navigating a dual lumen catheter to a desired segment of bronchus; inflating, via a first tube of the dual lumen catheter, a balloon located on a distal portion of the catheter to isolate the segment bronchial tube; injecting a therapeutic medium into the isolated segment bronchial tube via a second tube of the dual lumen catheter; and retracting the dual lumen catheter to leave the balloon indwelling, where the balloon retains the injected therapeutic medium in the isolated segment bronchial tube.

Description

Cross-references to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 530,658, filed August 3, 2023, and U.S. Patent Application Serial No. 18 / 752,565, filed June 24, 2024, the entire contents of which are incorporated herein by reference. Background Technology TECHNICAL FIELD

[0002] This disclosure pertains to the field of local treatment, specifically the use of chemical ablation techniques for local treatment of lung tissue. RELATED ART

[0003] The use of systemic therapies (e.g., chemotherapy) is well-known and has proven beneficial for many patients in treating cancer within the body. In fact, in many cases, due to the nature of the tumor, its location, and adjacent tissues, systemic therapy is currently the only treatment mechanism. However, systemic therapy is not without its drawbacks. It places enormous stress on the patient's immune system, often making them more susceptible to other illnesses, infections, and sepsis, not to mention the pain and stress associated with these treatments. In many cases, the treatment leads loved ones to question whether the "cure" is worse than the disease itself.

[0004] Where possible, surgical and radiological methods have long been considered the logical first step in removing cancerous growths and tumors. However, this is not always possible. In other cases, such as in the treatment of lung tumors, surgical methods (e.g., resection) to remove diseased portions of the lung can be extremely challenging due to the possibility of pneumothorax, the highly vascularized nature of the lung tissue itself, and the difficulty in accurately assessing lung segments during surgery.

[0005] Furthermore, even when surgical methods (such as resection) are used, systemic therapy is usually administered post-surgery as a preventative measure to ensure that all cancer cells have been eliminated. Therefore, some of the benefits of more targeted surgical approaches are negated.

[0006] This disclosure aims to address the shortcomings of both systemic and surgical approaches to cancer treatment, specifically lung cancer. Summary of the Invention

[0007] One aspect of this disclosure relates to a method of applying treatment. The method includes navigating a double-lumen catheter to a desired segmental bronchus. The method further includes inflating a balloon located on a distal portion of the double-lumen catheter via a first tube to isolate the segmental bronchus; injecting a treatment medium into the isolated segmental bronchus via a second tube of the double-lumen catheter; and retracting the double-lumen catheter to leave the balloon in place, the balloon retaining the injected treatment medium in the isolated segmental bronchus. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each computer program configured to perform the actions of the methods and systems described herein.

[0008] Implementations of this aspect of the disclosure may include one or more of the following features. In this method, inflation of the balloon causes a fixation feature to engage with the segmental bronchus to hold the balloon in place. The fixation feature is microbarbs. The fixation feature is an adhesive coating formed on the outer surface of the balloon, the adhesive coating adhering to the airway wall of the segmental bronchus. The method further includes imaging the segmental bronchus with the balloon indwelling to assess treatment progress. The method further includes determining whether treatment media is being drained from the segmental bronchus. A biomarker is configured to bind to a tumor or lesion. The method further includes navigating a two-lumen catheter to the indwelling balloon. A first tube is configured to supply additional inflatable media into the balloon. The method further includes passing a second tube through a second valve on the balloon. The method further includes injecting additional treatment media into the isolated segmental bronchus. The method further includes aspirating treatment media from the segmental bronchus. The method further includes deflating the balloon. Deflating includes applying a vacuum to the balloon, wherein the vacuum fixes the balloon to a portion of the two-lumen catheter. The method further includes withdrawing a double-lumen catheter and balloon from a segmental bronchus. Embodiments of the described technology may include hardware, methods or processes, or computer software on a computer-accessible medium, including software, firmware, hardware, or combinations thereof installed on a system that causes the system to perform these actions in operation. One or more computer programs may be configured to perform specific operations or actions by including instructions that, when executed by a data processing device, cause the device to perform these actions.

[0009] Another aspect of this disclosure relates to a therapeutic application system having a dual-lumen catheter including a first tube and a second tube, the dual-lumen catheter being configured for navigation within a patient's airway; a balloon formed on a distal portion of the dual-lumen catheter, the balloon including a first valve on a proximal portion of the balloon and a second valve on a distal portion of the balloon; an inflation source in fluid communication with the first tube; and a therapeutic medium source in fluid communication with the second tube, wherein the dual-lumen catheter extends through the first valve and into the balloon, the first tube being in fluid communication with the balloon, and inflation medium released from the inflation source inflates the balloon and isolates a segmental bronchus, and wherein the second tube extends beyond the second valve and therapeutic medium released from the therapeutic medium source flows into the isolated segmental bronchus. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each computer program being configured to perform the actions of the methods and systems described herein.

[0010] Embodiments of this aspect of the disclosure may include one or more of the following features. The therapeutic application system further includes a vacuum source fluidly in communication with a second tube and configured to draw therapeutic media from an isolated segmental bronchus. The vacuum source is fluidly in communication with a first tube to deflate a balloon. A vacuum applied to the balloon secures it to a two-lumen catheter for removal from the patient's airway. The securing feature is one or more of adhesives, microbarbs, hooks, or spikes. Embodiments of the described technology may include hardware, methods, or processes, or computer software on a computer-accessible medium, including software, firmware, hardware, or combinations thereof installed on a system that causes the system to perform these actions in operation. One or more computer programs may be configured to perform specific operations or actions by including instructions that, when executed by a data processing device, cause that device to perform those actions. Attached Figure Description

[0011] Various aspects and embodiments of this disclosure are described below with reference to the accompanying drawings, in which:

[0012] FIG. 1 This is a schematic diagram of a navigation system based on the content of this disclosure;

[0013] FIG. 2 The catheter segment, guided to the left upper lobe of the patient's lung according to this disclosure, is depicted.

[0014] FIG. 3A This is a schematic diagram of a catheter and indwelling occlusion device placed in the airway for the application of local treatment, in accordance with the contents of this disclosure.

[0015] FIG. 3B This is a schematic diagram of an indwelling occlusion device, in which the catheter has been removed;

[0016] FIG. 4 This is a view of the valve based on the contents of this disclosure;

[0017] FIG. 5 This is a flowchart of the method according to this disclosure; and

[0018] FIG. 6 This is a schematic diagram of the calculation system based on the contents of this disclosure. Detailed Implementation

[0019] This disclosure relates to systems and methods for localized treatment, specifically localized lung treatment. According to this disclosure, a catheter is guided to the location of an identified tumor within the lung. Once at, near, or just beyond the entrance to a single lung segment (the segment where the tumor has been identified, a location that can be confirmed by imaging), an indwelling occlusion device on the catheter is expanded (e.g., inflated), allowing medication, chemoablation media, chemotherapy drugs, or other therapeutic media to act on the tumor and other cancer cells within that lung segment. The catheter is then removed, leaving the indwelling occlusion device in place while allowing treatment to take effect. After a specified period (e.g., 2–4 weeks), an evaluation of the tumor can be performed (e.g., by imaging) to assess whether additional treatment should be applied to the lung segment using the indwelling occlusion device as described above. If no additional treatment is required, the catheter is reinserted into the patient's lung. Any remaining therapeutic media can be aspirated from the lung segment to remove it and other cellular tissue from the patient. The indwelling occlusion device is then deflated and removed from the lung using the catheter.

[0020] In this way, the long-term benefits of systemic therapy can be realized within a limited area, allowing it to act only on the tissues where its effects are actually needed. Thus, many of the negative side effects of systemic therapy and the burden on the patient's immune system are significantly reduced. Furthermore, due to the occlusion of one or more affected segments of the lung, the impact on the patient's respiratory system is less, thus improving their quality of life during treatment. Even further, the risks associated with surgical methods (such as resection) are completely eliminated. And it may be unnecessary to require any postoperative prophylactic systemic therapy.

[0021] FIG. 1 This is a three-dimensional diagram of an exemplary system for facilitating the navigation of a catheter to a soft tissue target via the airway through the lungs. FIG. 1As shown, catheter 102 is part of catheter guiding assembly 106. In one embodiment, catheter 102 is inserted into bronchoscope 108 to access the lumen network of patient P. Specifically, catheter 102 of catheter guiding assembly 106 can be inserted into the working channel of bronchoscope 108 to navigate through the patient's lumen network. Catheter 102 itself may include imaging capabilities via an integrated camera or optics component 109, thus not strictly requiring a separate bronchoscope 108. A positionable guide (LG) 110 (second catheter) including sensor 104 can be inserted into catheter 102 and locked in place such that sensor 104 extends beyond the distal tip of catheter 102 to a desired distance. The position and orientation of sensor 104 relative to a reference coordinate system, and thus the position and orientation of the distal portion of catheter 102 in an electromagnetic field, can be determined. The catheter guidance kit 106 is currently marketed and sold by Medtronic PLC under the trade names SUPERDIMENSION® Program Kit, ILLUMISITE™ Intrabronchial Program Kit, ILLUMISITE™ Navigation Catheter or EDGE™ Program Kit, and is believed to be usable in conjunction with this disclosure.

[0022] System 100 typically includes: an operating table 112 and monitoring equipment 114 configured to support a patient P, the monitoring equipment being coupled to a bronchoscope 108 or catheter 102 (e.g., a video display for displaying video images received from a video imaging system of the bronchoscope 108 or catheter 102); a positioning or tracking system 115 including a positioning module 116, multiple reference sensors 18, and a transmitter pad 120 including multiple coupled markers; and a computing device 122 including software and / or hardware for facilitating target identification, path planning to the target, navigation of medical devices to the target, and / or confirmation and / or determination of the placement of the catheter 102 or appropriate devices passing through it relative to the target.

[0023] As is typical for navigation of the catheter guidance assembly 10, a six-degree-of-freedom electromagnetic positioning or tracking system 115, or other suitable systems (described below) for determining the position and orientation of the distal portion of the catheter 102, are used to perform registration of the detected position of the sensor 104 with a 3D model generated from CT or MRI image scans. The tracking system 114 includes a tracking module 116, multiple reference sensors 118, and a transmitter pad 120 (including markers). The tracking system 114 is configured for use with the positionable guide 110, and in particular the sensor 104. As described above, the positionable guide 110 and the sensor 104 are configured for insertion through the catheter 102 into the airway of the patient P (with or without a bronchoscope 108) and can be selectively locked relative to each other via a locking mechanism.

[0024] The transmitter pad 120 is positioned below the patient P. The transmitter pad 120 generates an electromagnetic field around at least a portion of the patient P, within which the tracking module 116 can be used to determine the positions of a plurality of reference sensors 118 and sensors 104. A second electromagnetic sensor 126 may also be incorporated into the end of the catheter 102. The second electromagnetic sensor 126 may be a five-DOF or six-DOF sensor. One or more of the reference sensors 118 are attached to the chest of the patient P. Registration is typically performed to reconcile the positions from the three-dimensional model and two-dimensional images from the planning phase with the airway of the patient P as observed through the bronchoscope 108, and to allow for the navigation phase with the positions of the sensors 104 known.

[0025] Registration of the patient P's position on the transmitter pad 120 can be performed by moving the sensor 104 through the patient P's airway. More specifically, as the positionable guide 110 moves through the airway, data relating to the position of the sensor 104 is recorded using the transmitter pad 120, reference sensor 118, and tracking system 114. The shape generated from this position data is compared to the internal geometry of the passage in the 3D model, and the positional correlation between the compared shape and the 3D model is determined, for example, using software on computing device 122. Additionally, the software identifies non-organic spaces (e.g., air-filled cavities) in the 3D model. The software aligns or registers an image representing the position of the sensor 104 with the 3D model and / or 2D images generated from the 3D model, based on the recorded position data and the assumption that the positionable guide 110 remains within non-organic spaces in the patient P's airway. Alternatively, a manual registration technique can be employed by navigating the bronchoscope 108 and sensor 104 to a pre-designated location in the lungs of patient P and manually correlating the images from the bronchoscope with model data from the 3D model.

[0026] Although this document describes an EMN system using EM sensors, this disclosure is not limited thereto and can be used in conjunction with flexible sensors (such as fiber Bragg grating sensors), inertial measurement units (IMUs), ultrasonic sensors, or without sensors. Furthermore, with or without the application of near-infrared light and fluorescence-detecting optics, one or more dyes, including methylene blue, indocyanine green (ICG), or other fluorescent dyes, can be used to guide the desired lung segment within the patient. Additionally, as outlined below, the methods described herein can be used in conjunction with robotic systems, enabling robotic actuators or manipulators to drive the catheter 102 or bronchoscope 108 toward the target.

[0027] According to various aspects of this disclosure, visualization of in vivo navigation of a medical device (e.g., a biopsy tool or treatment tool) toward a target (e.g., a lesion) can be part of a larger workflow of the navigation system. Imaging devices 124 capable of acquiring 2D and 3D images or videos of patient P (e.g., CT imaging devices, such as cone-beam computed tomography (CBCT) devices, including but not limited to Medtronic's O-arm™ system) are also included in this particular aspect of system 100. Images, image sequences, or videos captured by imaging device 124 can be stored within imaging device 124 or transmitted to computing device 122 for storage, processing, and display. Additionally, imaging device 124 can be moved relative to patient P, allowing images to be acquired from different angles or perspectives relative to patient P to create image sequences such as fluorescence fluoroscopy videos. The orientation of imaging device 124 relative to patient P during image acquisition can be estimated via markers attached to emitter pad 120. The markers are positioned below patient P, between patient P and operating table 112, and between patient P and the radiation source or sensing unit of imaging device 124. The marker associated with the transmitter pad 120 may be two separate elements that can be fixedly connected, or the marker may alternatively be manufactured as a single unit. The imaging device 124 may include a single imaging device or more than one imaging device.

[0028] The computing device 122 can be any suitable computing device including a processor and a storage medium, wherein the processor is capable of executing instructions stored on the storage medium. The computing device 122 may further include a database configured to store patient data, CT datasets including CT images, fluoroscopy datasets including images and videos, 3D reconstructions, navigation planning, and any other such data. Although not explicitly shown, the computing device 122 may include input terminals or may be configured to receive CT datasets, fluoroscopy images / videos, and other data described herein. Additionally, the computing device 122 includes a display configured to display a graphical user interface. The computing device 122 may be connected to one or more networks through which one or more databases can be accessed.

[0029] Although this document describes bronchoscopy and catheter-based navigation systems, which are typically handheld and user-actuated, this disclosure is not limited thereto. Without departing from the scope of this disclosure, the systems and methods described herein can be motor-driven via user interaction, or robot-driven via either controller-based user interaction or autonomous or semi-autonomous robotic systems.

[0030] FIG. 2 A schematic diagram of the patient's airway 200 is depicted. Specifically, FIG. 2 The characteristics of the left lung are depicted. Airway 200 begins at trachea 202, which bifurcates at the main carina 204, with the left and right main bronchuses 206 extending downwards from the main carina. Focusing on the left main bronchus 206, at the next bifurcation 208, the upper lobe bronchus 210 separates from the lower lobe bronchus 212. Although in FIG. 2 Not clearly shown, but the upper lobe bronchus 210 branches into the superior branch bronchus 214 and the lingular branch bronchus 216. From the superior branch bronchus 214 and the lingular branch bronchus, segmental bronchus 218 supplies air to the upper lobe segment of the left lung. Similarly, from the lower lobe bronchus 214, segmental bronchus 218 supplies air to the lower lobe segment of the left lung. It is well known that the right lobe has a similar physiological structure, but the bronchus divides into three lobes.

[0031] During bronchoscopy, the endotracheal tube 220 is inserted into the trachea 202, and the balloon 222 attached to it is inflated to stably hold the tube in the trachea 202. FIG. 2 As shown, the bronchoscope 108 is inserted into the endotracheal tube 220. The bronchoscope is guided using path planning developed with the preoperative imaging and navigation system described above, intraoperative imaging (such as fluorescein endoscopy), or the imaging capabilities of the bronchoscope 108, until the bronchoscope is wedged into the airway. FIG. 2In this configuration, the bronchoscope 108 is wedged into the superior branch bronchus 214. The catheter 102 is inserted through the working channel through the bronchoscope 108. The catheter 102 extends from the bronchoscope 108 and is advanced into the desired segmental bronchus 218.

[0032] Those skilled in the art will understand that the use of a bronchoscope 108 is not necessary, and that the catheter 102 can be navigated to the desired segmental bronchus 218 without the need for a separate bronchoscope 108, particularly when equipped with a camera 109 as described above.

[0033] FIG. 3A The distal portion of catheter 102 is depicted. Catheter 102 is part of a therapeutic application system comprising a therapeutic medium source, a vacuum source, and an inflation source, all of which are maintained outside the patient and in fluid communication with catheter 102, as described below. As mentioned above, catheter 102 includes a working channel (not shown) through which insertion can be made if LG 110 is used. If LG 110 is used, it can be removed and a double-lumen catheter 302 inserted therein. Alternatively, catheter 102 can be navigated to or near a desired segmental bronchus 218, with the double-lumen catheter 302 positioned within that desired segmental bronchus. The double-lumen catheter 302 is advanced from catheter 102 to the desired location (e.g., just past the bifurcation and into the desired segmental bronchus 218). Once the double-lumen catheter 302 is thus positioned, balloon 304 is inflated. In this example, the double-lumen catheter 102 is formed by an outer tube 306 and an inner tube 308. The space between the inner tube 308 and the outer tube 306 is a first lumen, and a second lumen is formed inside the inner tube 308. The outer tube 306 can be connected to an inflation source containing an inflation medium (e.g., gas or liquid). The inflation medium is forced through the outer lumen (between the outer tube 306 and the inner tube 308) and into the balloon 304, inflating the balloon 304 and forcing the fixing features 310 (barbs, hooks, microbarbs, or other devices) formed on the outside of the balloon 304 to engage with the airway 312 and secure the balloon 304 at the desired location within the airway 312.

[0034] Although depicted as two coaxial tubes (outer tube 306 and inner tube 308), this disclosure is not limited thereto, and other configurations are contemplated within this disclosure. For example, the coaxial tubes may alternatively be configured as two adjacent tubes of equal size without departing from the scope of this disclosure. Those skilled in the art will also recognize that, without departing from the scope of this disclosure, the inner tube 308 may be a needle or other therapeutic injection device capable of traversing the balloon 304 and valve 402.

[0035] According to various aspects of this disclosure, instead of mechanical structures (such as barbs or spikes) or in addition to mechanical structures, the outer surface of the balloon 304 is coated with an adhesive material that adheres to the epithelium of the airway. This adhesion, combined with the force applied by the inflation medium, secures the balloon 304 in place after it has deployed. Furthermore, an expandable metal structure, similar to a stent, can be used to secure the exterior of the balloon 304 within the airway.

[0036] like FIG. 3A As shown, the inner tube 308 extends through the balloon 304 and exits on the treatment side of the balloon 304. The inner tube 308 is connected and in fluid communication with a treatment medium source located outside the patient. After the balloon 304 is inflated and the fixation feature 310 engages the airway 312, the placement of the balloon 304 within the airway can optionally be confirmed by imaging (such as fluoroscopy, computed tomography, cone-beam computed tomography, or other imaging modalities). Once the positioning is confirmed, the treatment medium 313 can be forced from the treatment medium source through the inner tube 308 and into the segmental bronchus 218 distal to the balloon 304. The balloon 304 prevents the treatment medium from escaping from the desired segmental bronchus 218 and effectively isolates this segmental bronchus 218 from the remaining airways and lung structures.

[0037] Once the treatment medium has been injected into the segmental bronchus 218, the double-lumen catheter 302 can be withdrawn from the balloon 304, such as FIG. 3B As shown. The balloon 304 may include a valve 402 (e.g., a duckbill valve or other self-sealing valve, see [reference needed]) on both the proximal end 314 and the distal end 316 of the balloon 304. FIG. 4 Valve 402 allows the double-lumen catheter to be withdrawn from balloon 304 without allowing treatment media to enter balloon 304 or allows balloon 304 to deflate. Removal of the double-lumen catheter 302 allows the patient to resume normal activities, but may impose some limitations on some patients (e.g., inability to fly, engage in contact sports, or lift heavy objects). FIG. 4 As shown, valve 402 includes an opening 403, a top valve flap 404, a bottom valve flap 406, and two pleated sides 408. The pleated sides 408 allow the top valve flap 404 and the bottom valve flap 406 to separate, for example, when the inner tube 308 passes between them. When the inner tube 308 is removed, the pleated sides 408 are configured to collapse and prevent the inflation medium from escaping from the balloon 304 into the segmental bronchus 218, and to prevent the treatment medium from escaping from the segmental bronchus into the balloon 304. Valve 402 is merely one example of a valve that can be used for these purposes; other valves include, for example, a moving ball valve, which allows a needle similar to the inner tube 308 to pass through for inflating the moving ball, but seals to prevent deflation when the needle is removed.

[0038] In one aspect of this disclosure, during the initial navigation and placement of balloon 304, balloon 304 is held in place on the double-lumen catheter 302 by a combination of frictional forces applied by one or more valves 402 and a vacuum applied to the proximal portion of the outer tube 306. This vacuum causes balloon 304 to remain collapsed on the inner tube 308. As will be understood, the inner tube 308 may initially be held within balloon 304 to maintain the vacuum during navigation and placement, and then valve 402 is advanced through the distal end 316 of the balloon to release the treatment medium 313.

[0039] Because the balloon 304 remains inflated, the treatment medium 313 is isolated within the segmental bronchus 218 receiving treatment and leakage into other parts of the airway is prevented. The treatment medium is retained in the desired segmental bronchus 218 for the desired period of time (e.g., 2–4 weeks). In some cases, the treatment medium is retained in the segmental bronchus for at least longer than the average cell doubling rate between approximately 17 and 25 days.

[0040] Although described as employing an inner tube 308 coaxial with the outer tube 306, this disclosure is not limited thereto. Alternatively, the inner tube 308 may be a component of the balloon 304. A rigid component is incorporated with a distal valve 402 and has a passage for air to travel through the proximal valve 402. In this manner, the internal passage of 308 does not contact the interior of the balloon 304.

[0041] Furthermore, catheter 102 may include a mechanical capture feature. The mechanical capture feature secures balloon 304 to catheter 102. Therefore, balloon 304 can be inflated, treatment medium 313 deployed, and inner tube 308 and outer tube 306 retracted into catheter 102 without releasing balloon 304. In this way, the placement and safety of balloon 304 can be confirmed before disengagement from catheter 102.

[0042] As described above, treatment progress can be observed via imaging techniques such as CT, MRI, and fluorescence microscopy to assess the impact of the treatment medium on the tumor or lesion located within the isolated portion of the airway. If further treatment is required, the dual-lumen catheter 302 can be advanced again into the patient's airway, passing through the valve 402 on the balloon 304, to achieve [further treatment]. FIG. 3A The orientation is as depicted in the diagram. Additional treatment media can be injected through the inner tube 308, and additional inflation media can be injected through the outer tube 306 to ensure complete balloon inflation.

[0043] However, once treatment is complete, a vacuum is applied to the inner tube 308 to aspirate the treatment medium and any secretions or tissue released from the isolated segmental bronchus 218 as a result of the treatment. Next, a vacuum is applied to the outer tube 306 to deflate the balloon 304. By applying sufficient vacuum and maintaining it constant, the balloon 304 is aspirated onto the inner tube 308, and the double-lumen catheter 302 and balloon 304 can be safely removed from the patient. In some cases, if necessary, a retrieval tool (not shown) can be deployed from the bronchoscope 108 to retrieve the balloon 304, for example, under fluoroscopic guidance. Once removed, the previously isolated segmental bronchus 218 begins to receive air and begins to regain its normal function.

[0044] The treatment medium may include one or more labeling materials. The labeling materials may be visible, for example, under imaging techniques including fluorescence microscopy, magnetic resonance imaging (MRI), computed tomography (CT), cone-beam computed tomography (CBCT), positron emission tomography (PET), etc. After isolating the treatment medium within the desired segmental bronchus 218, the patient may be periodically imaged using one of these techniques to identify any systemic drainage (e.g., via lymph nodes or via capillary action). This assessment allows determination of the necessity to apply additional treatment medium as described above.

[0045] Alternatively or concurrently, therapeutic agents may include one or more biomarkers designated for binding to cells forming tumors or lesions. For example, biomarkers may bind to specific proteins present only in cancer cells, not in healthy tissue. Similarly, the progress of treatment can be assessed using one or more of the imaging techniques described above, and the identification of the location, concentration, and pattern of biomarkers in the patient can determine whether additional therapeutic agents can be added or treatment can be discontinued. For example, if a concentration indicating the location of a tumor or lesion is present at a location, the image can be analyzed to determine the distribution of the biomarker. However, if the biomarker is relatively uniformly distributed throughout the isolated segmental bronchus, it can be determined that the tumor or lesion has been completely treated.

[0046] FIG. 5A method according to this disclosure is described. At step 502, a clinician receives instructions that a patient has a tumor or lesion that is palpable via a lung segment and suitable for segmental treatment in isolation. At step 504, catheter 102 is navigated to the vicinity of the segment where the tumor or lesion is located. Catheter 102 may be navigated, for example, just beyond an airway bifurcation that separates the segment containing the tumor or lesion from the rest of the lung. At step 506, balloon 304 on catheter 102 is inflated, thereby isolating the segment containing the tumor or lesion from the rest of the airway. After isolation, at step 508, treatment medium is released from a treatment medium source and allowed to flow into the segment containing the tumor or lesion. Balloon 304 isolating the segment containing the tumor or lesion prevents the treatment medium from escaping into the rest of the airway. At step 510, catheter 102 is withdrawn, with balloon 304 remaining in place to isolate the lung segment containing the tumor or lesion. At step 512, treatment may be periodically observed using one or more imaging modalities, as described above. Optionally, at step 514, catheter 102 can be navigated through the airway and additional treatment media can be applied to the segment where the tumor or lesion is located. At the end of treatment, for example as assessed at step 512, catheter 102 can be re-navigated into balloon 304 at step 516. At step 518, catheter 102 is used to remove any residual treatment media, other secretions, and any tissue or material from the segment where the tumor or lesion was located. Next, at step 520, balloon 304 is deflated using catheter 102, and at step 522, balloon and catheter are withdrawn.

[0047] Now for reference FIG. 6 This diagram is configured to be used with, including FIG. 4 This disclosure illustrates a system 700 used in conjunction with the methods described herein. System 700 may include a workstation 701 and optionally an imaging device 715 (e.g., a fluoroscope or ultrasound device). In some embodiments, workstation 701 may be directly or indirectly connected to imaging device 715, for example, via wireless communication. Workstation 701 may include a memory 702, a processor 704, a display 706, and an input device 710. The processor or hardware processor 704 may include one or more hardware processors. Workstation 701 may optionally include an output module 712 and a network interface 708. Memory 702 may store an application program 718 and image data 77. Application program 718 may include functions executable by processor 704 for performing tasks including... FIG. 4 The method disclosed herein is the instruction of the method.

[0048] Application 718 may further include user interface 716. Image data 714 may include CT scans, fluoroscopic 3D reconstructions of the generated target region, and / or any other fluoroscopic image data and / or one or more slices of the generated 3D reconstruction. Processor 704 may be connected to memory 702, display 706, input device 710, output module 712, network interface 708, and imaging device 715. Workstation 701 may be a fixed computing device such as a personal computer, or a portable computing device such as a tablet computer. Workstation 701 may embed multiple computing devices.

[0049] Memory 702 may include any non-transitory computer-readable storage medium for storing data and / or software including instructions executable by processor 704 and controlling the operation of workstation 701, and in some embodiments, also controlling the operation of imaging device 715. Imaging device 715 may be used to capture fluorescence fluoroscopic image sequences (on which fluorescence fluoroscopic 3D reconstructions are generated) and capture real-time 2D fluorescence fluoroscopic views according to this disclosure. In embodiments, memory 702 may include one or more storage devices, such as solid-state storage devices (e.g., flash memory chips). As an alternative to or supplement to one or more solid-state storage devices, memory 702 may include one or more mass storage devices connected to processor 704 via a mass storage controller (not shown) and a communication bus (not shown).

[0050] Although the description of computer-readable media contained herein refers to solid-state storage devices, those skilled in the art will understand that computer-readable storage media can be any available medium accessible to the processor 704. That is, computer-readable storage media can include non-transitory, volatile and non-volatile, removable and non-removable media implemented using any method or technique for storing information such as computer-readable instructions, data structures, program modules, or other data. For example, computer-readable storage media can include RAM, ROM, EPROM, EEPROM, flash memory or other solid-state storage technologies, CD-ROM, DVD, Blu-ray or other optical storage devices, magnetic tape cassettes, magnetic tape, disk storage devices or other magnetic storage devices, or any other medium that can be used to store desired information and is accessible by workstation 1001.

[0051] When executed by processor 704, application 718 can cause display 706 to present user interface 716. User interface 716 can be configured to present a single screen to the user, including a 3D view of a three-dimensional (3D) model of the target from the perspective of the tip of the medical device, a real-time two-dimensional (2D) fluorescence perspective view of the medical device, and target markers corresponding to the 3D model of the target overlaid on the real-time 2D fluorescence perspective view. User interface 716 can be further configured to display the target markers in different colors depending on whether the tip of the medical device is aligned with the target in three dimensions.

[0052] Network interface 708 can be configured to connect to a network, such as a local area network (LAN), wide area network (WAN), wireless mobile network, Bluetooth network, and / or the Internet, consisting of wired and / or wireless networks. Network interface 708 can be used to establish a connection between workstation 701 and imaging device 715. Network interface 708 can also be used to receive image data 714. Input device 710 can be any device that a user can use to interact with workstation 701, such as a mouse, keyboard, foot pedal, touchscreen, and / or voice interface. Output module 712 can include any connection port or bus, such as a parallel port, serial port, universal serial bus (USB), or any other similar connection port known to those skilled in the art. Based on the foregoing and with reference to the various accompanying drawings, those skilled in the art will understand that certain modifications can be made to this disclosure without departing from the scope of this disclosure. Example

[0053] This disclosure can be further described with reference to the following examples:

[0054] Example 1 - A therapeutic application system comprising: a dual-lumen catheter including a first tube and a second tube, the dual-lumen catheter being configured for navigation within a patient's airway; a balloon formed on a distal portion of the dual-lumen catheter, the balloon including a first valve on a proximal portion of the balloon and a second valve on a distal portion of the balloon; an inflation source in fluid communication with the first tube; and a therapeutic medium source in fluid communication with the second tube, wherein the dual-lumen catheter extends through the first valve and into the balloon, the first tube being in fluid communication with the balloon, and inflation medium is released from the inflation source to inflate the balloon and isolate a segmental bronchus, and wherein the second tube extends beyond the second valve and therapeutic medium released from the therapeutic medium source flows into the isolated segmental bronchus.

[0055] Example 2 - A therapeutic application system as described in Example 1 further includes a vacuum source in fluid communication with a second tube and configured to draw therapeutic media from an isolated segmental bronchus.

[0056] Example 3 - A therapeutic application system as described in one of the preceding examples, wherein a vacuum source is in fluid communication with a first tube to deflate the balloon.

[0057] Example 4 - A treatment application system as described in Example 3, wherein a vacuum applied to the balloon secures the balloon to a two-lumen catheter for removal from the patient's airway.

[0058] Example 5 - A treatment application system as described in one of the preceding examples further includes fixation features on the outer surface of the balloon, wherein these fixation features are one or more of an adhesive, microbarbs, hooks, or spikes.

[0059] Example 6 - A therapeutic application system as described in one of the preceding examples, wherein the catheter includes an electromagnetic (EM) sensor.

[0060] Example 7 - A therapeutic application system as described in Example 6 further includes an EM emitting pad, wherein a sensor on the catheter detects an EM field generated by the EM emitting pad.

[0061] Example 8 - A therapeutic application system as described in Example 7, further comprising an application stored in a memory and executed by a processor, wherein the application receives a signal representing a detected EM field from an EM sensor and presents a representation of the position of the catheter within the patient's airway on a user interface.

[0062] Example 9 - A therapeutic application system as described in Example 8, wherein a memory stores images of a patient's airway and displays the location of a catheter in a three-dimensional model generated from these stored images.

[0063] Example 10 - A treatment application system as described in Example 9, further comprising an intraoperative imaging device.

[0064] Example 11 - A treatment application system as described in Example 10, wherein the intraoperative imaging device has an optical sensor on the distal portion of the catheter.

[0065] Example 12 - A treatment application system as described in Example 10, wherein the intraoperative imaging device is a fluorescence microscope, a computed tomography device, a cone-beam computed tomography device, a magnetic resonance imaging device, or a positron emission tomography device.

[0066] Example 13 - A treatment application system as described in Example 10, wherein the captured intraoperative images are analyzed by the application to assess the progress of treatment.

[0067] Example 14 - A treatment application system as described in Example 10, wherein the captured intraoperative images are analyzed by the application to evaluate catheter placement.

[0068] Example 15 - A therapeutic application system as described in one of the foregoing examples further includes a robotic manipulator operatively connected to a catheter for placing the catheter into the patient's airway.

[0069] While detailed embodiments are disclosed herein, these embodiments are merely examples of the disclosure, which can be embodied in various forms and aspects. For example, embodiments of an electromagnetic navigation system. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but rather as the basis for the claims and as a representative basis for teaching those skilled in the art to employ the disclosure in various ways in virtually any suitably described structure.

Claims

1. A therapeutic application system, comprising: a dual-lumen catheter including a first tube and a second tube, the dual-lumen catheter configured for navigation within an airway of a patient; a balloon formed on a distal portion of the dual-lumen catheter, the balloon including a first valve on a proximal portion of the balloon and a second valve on a distal portion of the balloon; an inflation source in fluid communication with the first tube; and a therapeutic media source in fluid communication with the second tube, wherein the dual-lumen catheter extends past the first valve and into the balloon, the first tube is in fluid communication with the balloon, and inflation media released from the inflation source causes the balloon to expand and isolate a segmental bronchus, and wherein the second tube extends past the second valve and therapeutic media released from the therapeutic media source flows into the isolated segmental bronchus.

2. The therapeutic application system of claim 1, further comprising a vacuum source in fluid communication with the second tube and configured to extract the therapeutic media from the isolated segmental bronchus. the vacuum source is in fluid communication with the first tube to deflate the balloon.

3. The therapeutic application system according to one of the preceding claims, wherein, a vacuum applied to the balloon secures the balloon to the dual-lumen catheter for removal from the airway of the patient.

4. The therapeutic application system of claim 3, wherein, the securing feature is one or more of an adhesive, micro-barbs, hooks, or spikes.

5. The therapeutic application system of one of the preceding claims, further comprising a fixation feature on an outer surface of the balloon, wherein, the catheter includes an electromagnetic (EM) sensor.

6. The therapeutic application system according to one of the preceding claims, wherein the sensor on the catheter detects an EM field generated by the EM emitting pad.

7. The therapeutic application system of claim 6, further comprising an EM emitting pad, wherein, the application receives signals representative of the detected EM field from the EM sensor and presents a representation of the location of the catheter within the airway of the patient on a user interface.

8. The therapeutic application system of claim 7, further comprising an application stored in the memory and executed by the processor, wherein, the memory stores an image of the airway of the patient therein and displays the location of the catheter in a three-dimensional model generated from the stored image.

9. The therapeutic application system of claim 8, wherein, 10. The therapeutic application system of claim 9, further comprising an intraoperative imaging device. the intraoperative imaging device is an optical sensor on a distal portion of the catheter.

11. The therapeutic application system as claimed in claim 10, wherein, the intraoperative imaging device is a fluoroscope, a computed tomography device, a cone-beam computed tomography device, a magnetic resonance imaging device, or a positron emission tomography device.

12. The therapeutic application system of claim 10, wherein, the application analyzes the captured intraoperative images to assess progress of the therapy.

13. The therapeutic application system of claim 10, wherein, the application analyzes the captured intraoperative images to assess placement of the catheter.

14. The therapeutic application system as claimed in claim 10, wherein, 15. The therapeutic application system of one of the preceding claims, further comprising a robotic manipulator operably connected to the catheter for placement of the catheter within the airway of the patient. ​

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