Systems and methods for local intracavitary thermal fluid treatment

Abstract

A system for treating target tissue located at a first position along an anatomical lumen includes a catheter comprising a distal portion configured for deployment within the anatomical lumen. The system also includes a dilation device coupled to the distal portion of the catheter. The dilation device has an expansion dimension in a deployment configuration. The dilation device in the deployment configuration occludes the anatomical lumen at a second position along the anatomical lumen, different from the first position. The dilation device also occludes at least one of a plurality of vessels adjacent to the anatomical lumen to reduce blood flow to the target tissue at the first position.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefits of U.S. Provisional Application No. 62 / 871,569, filed July 8, 2019; U.S. Provisional Application No. 62 / 871,677, filed July 8, 2019; U.S. Provisional Application No. 62 / 871,678, filed July 8, 2019; U.S. Provisional Application No. 62 / 938,614, filed November 21, 2019; and U.S. Provisional Application No. 62 / 988,299, filed March 11, 2020, all of which are incorporated herein by reference in their entirety.

[0003] This application is incorporated in its entirety by reference to PCT application filed on July 7, 2020, entitled "Systems and Method for Diffuse Endoluminal Thermal Liquid Treatment" (Case No.: P02303-WO). Technical Field

[0004] The examples described herein relate to systems and methods for localized intracavitary thermotherapy of diseased anatomy. Background Technology

[0005] Minimally invasive medical techniques are typically designed to reduce the amount of tissue damaged during medical procedures, thereby reducing patient recovery time, discomfort, and adverse side effects. These techniques can be performed through natural openings in the patient's anatomy or through one or more surgical incisions. Through these natural openings or incisions, the operator can insert minimally invasive medical devices, such as therapeutic, diagnostic, imaging, and surgical instruments. In some examples, minimally invasive medical devices may be thermotherapy devices for use within endoscopic channels within the patient's anatomy. Summary of the Invention

[0006] The following is a simplified overview of the various examples described herein and is not intended to identify key or essential elements or to outline the scope of the claims.

[0007] In some examples, a system for treating target tissue located at a first position along an anatomical lumen may include a catheter comprising a distal portion configured for deployment within the anatomical lumen. The system may also include a dilation device coupled to the distal portion of the catheter. The dilation device has an expansion dimension in the deployment configuration. The dilation device in the deployment configuration may occlude the anatomical lumen at a second position along the anatomical lumen, different from the first position. The dilation device may also occlude at least one of a plurality of vessels adjacent to the anatomical lumen to reduce blood flow to the target tissue at the first position.

[0008] In some examples, a system may include a processor and a memory thereon storing computer-readable instructions. When executed by the processor, the computer-readable instructions may cause the system to expand a treatment device located at a first position along the length of the first anatomical lumen within the first anatomical lumen, and to apply heat using the treatment device to occlude a first blood vessel adjacent to the first anatomical lumen, thereby reducing blood flow to the target tissue. The target tissue may be located at a second position along the length of the first anatomical lumen, and the second position may be at a location different from the first position.

[0009] It should be understood that the foregoing general description and the following detailed description are illustrative and explanatory in nature and are intended to provide an understanding of this disclosure without limiting its scope. In this regard, additional aspects, features, and advantages of this disclosure will be apparent to those skilled in the art from the following detailed description. Attached Figure Description

[0010] Figure 1A It is a simplified diagram based on some examples of patient anatomy.

[0011] Figure 1B The illustrations are based on some examples. Figure 1A The area of ​​the patient's anatomical body.

[0012] Figure 1C It is based on some examples Figure 1A A cross-sectional view of the patient's anatomical region.

[0013] Figure 2 This is a flowchart illustrating, according to some examples, a method for applying thermal therapy to an intraluminal channel to occlude adjacent blood vessels.

[0014] Figure 3 It is based on some examples Figure 1A A detailed view of a portion of the patient's anatomy, with treatment instruments inside the anatomical lumen.

[0015] Figure 4 It is based on some examples Figure 3 A detailed view of a portion of the patient's anatomy, with dilated treatment instruments within the anatomical lumen.

[0016] Figure 5 This is a flowchart illustrating, according to some examples, a method for applying thermal energy therapy to the surface of an intracavitary channel.

[0017] Figure 6A and Figure 6B It is based on some examples Figure 1A A detailed view of a portion of the patient's anatomy, with treatment instruments inside the anatomical lumen.

[0018] Figure 7A-1and Figure 7A-2 These are cross-sectional views of anatomical regions of patients treated for chronic bronchitis, based on some examples.

[0019] Figure 7B-1 and Figure 7B-2 These are cross-sectional views of anatomical regions of patients treated for bronchiectasis, based on some examples.

[0020] Figure 7C-1 and Figure 7C-2 These are cross-sectional views of anatomical regions of patients treated for emphysema, based on some examples.

[0021] Figure 7D-1 and Figure 7D-2 These are cross-sectional views of anatomical regions of patients treated for emphysema, based on some examples.

[0022] Figure 7E-1 and Figure 7E-2 These are cross-sectional views of anatomical regions of patients treated for lung tumors, based on some examples.

[0023] Figure 8 The illustrations depict medical devices with expandable devices, based on some examples.

[0024] Figure 9 The illustrations depict medical devices with expandable devices, based on some examples.

[0025] Figure 10 The illustrations depict medical devices with expandable devices, based on some examples.

[0026] Figure 11 The illustrations depict medical devices with expandable devices, based on some examples.

[0027] Figure 12 The illustrations depict medical devices with expandable devices, based on some examples.

[0028] Figure 13 The illustrations depict medical devices with expandable devices, based on some examples.

[0029] Figure 14 The illustrations depict medical devices with expandable devices, based on some examples.

[0030] Figure 15 The illustration shows an expandable device based on some examples.

[0031] Figure 16 The illustrations depict medical devices with expandable devices, based on some examples.

[0032] Figure 17This is a flowchart illustrating, according to some examples, a method for occluding an artery by approaching via an adjacent bronchial passage.

[0033] Figure 18 The illustration shows an arterial occlusion device based on some examples.

[0034] Figure 19 The illustration shows an arterial occlusion device based on some examples.

[0035] Figure 20 The illustration shows an arterial occlusion device based on some examples.

[0036] Figure 21 The illustration shows an arterial occlusion device based on some examples.

[0037] Figure 22A and Figure 22B The illustration shows an arterial occlusion device based on some examples.

[0038] Figure 23 The illustrations show robot-assisted medical systems based on some examples.

[0039] The embodiments and advantages of this disclosure can be best understood by referring to the following detailed description. It should be understood that the same reference numerals are used to identify the same elements shown in one or more figures, wherein the illustrations in the figures are for illustrating embodiments of this disclosure and not for limiting the scope of this disclosure. Detailed Implementation

[0040] The techniques described herein provide techniques and treatment systems for intracavitary thermotherapy of diseased tissue. While the examples provided herein may relate to the treatment of lung tissue and lung diseases, it should be understood that the described techniques can be used to treat artificially created lumens or any intracavitary passage or cavity, including the patient's trachea, colon, intestines, stomach, liver, kidneys and renal calyces, brain, heart, circulatory system including the vascular system, fistulas and / or the like. In some examples, the treatments described herein may be referred to as intrabronchial thermotherapy and may be used in the surgical treatment of lung tumors and / or chronic obstructive pulmonary disease (COPD).

[0041] Figure 1A The illustration depicts an elongated medical device system 100 extending within a branching anatomical passage or airway 102 of an anatomical structure 104. In some examples, the anatomical structure 104 may be a lung and a passage 102 including a trachea 106, primary bronchi 108, secondary bronchi 110, and tertiary bronchi 112. The anatomical structure 104 has an anatomical reference frame (X). A Y A Z AThe distal end 118 of the medical device 100 can be advanced into an anatomical opening (e.g., the mouth) and through an anatomical passage 102 to perform medical procedures, such as thermal therapy, at or near a target tissue located in a region 113 of an anatomical structure 104. Figure 1B As shown, the distal region 111 of the branching anatomical pathway (which may be distal to the tertiary bronchus 112) may include small bronchioles 115 and lung parenchyma 117, including bronchioles 114 and alveoli 116, which are involved in gas exchange. The vascular system 119 extending along the bronchus 115 may include pulmonary arteries 138 and bronchial arteries 140. Pulmonary veins 142 transfer oxygenated blood from the lungs to the heart. Nerves 131 and lymphatic vessels 129 may also extend within region 111. Target tissue 127 (e.g., a tumor) may form in the parenchyma 117.

[0042] Figure 1C The illustration shows a cross-sectional view of a bronchus 115 including a lumen 122 defined by an internal bronchial wall 124. The inner diameter of the bronchial wall 124 may be lined by an epithelial layer 126 comprising goblet cells. Mucosal cilia 125 are fine hairs extending from the epithelium 126 into the lumen 122. The epithelium 126 may be surrounded by a lamina propria 128, which may be surrounded by a smooth muscle layer 130. A submucosa 121 surrounds the smooth muscle layer 130, and a layer of continuous or discontinuous cartilage 133 covers the submucosa. A connective tissue layer of the adventitia 120 may surround and support the bronchus 115. A vascular system including a bronchial artery 140, a pulmonary artery 138, and a pulmonary vein 142 may extend along the bronchus 115 to supply blood flow to and from the lung regions.

[0043] Lung tumors (e.g., tumor 127) can include ground-glass opacities, semi-solid tumors, or spiculated tumors. They typically occur in the outer third of the lung volume. Some of the lung tumor treatments and systems described in this article are particularly suitable for low-density peripheral areas of the lung. The tumor may be cancerous, and effective treatment for lung cancer can involve destroying the tumor core, the surrounding tumor, and the cancerous or non-cancerous areas at the tumor periphery. Conventional ablation therapy directly heats the tumor core without treating the tissue at the periphery. For some cancers, a more effective treatment may involve obstructing a segment of the lung, thereby destroying the tumor and surrounding tissue within the obstructed area. Figure 1BAs shown, arteries 140 and 138 can maintain and support the growth of tumor 127. Conventional ablation therapy can directly apply heat to tumor 127, leaving the parenchyma 117 and the surrounding vascular system and bronchial structures largely intact. As described in detail below, for some tumors or other lung diseases, occlusion of the segment 150 including tumor 127 by applying local heating to bronchus 115 and / or the surrounding vascular system (138, 140) can not only destroy tumor 127 but also destroy tissue at the tumor margin and the vascular system that delivers oxygen and supports tumor growth and potential regeneration. In some embodiments, reliable lung tumor ablation can be achieved by simultaneously occluding multiple supporting structures (including bronchus 115, pulmonary artery 138, and / or bronchial artery 140). For example, as described below, a heated balloon deployed at location 152 within the bronchial lumen can compress or reduce the diameter of pulmonary artery 138 at location 154 to restrict heat dissipation blood flow to location 158 including tumor 127. Additionally, the heated balloon can heat the bronchus 115 at location 154 to create scarring and occlusion at location 152. Furthermore, the heated balloon within the bronchus 115 can heat the bronchial artery 140 at location 156 to occlude the artery 140. The heated balloon can also compress the bronchial wall, thereby placing the heat source closer to the artery to more effectively deliver ablation heat to arterial locations 154 and 156. Conventional techniques that deliver endovascular treatment via arteries to directly ablate only the artery may not simultaneously occlude multiple structures, such as the pulmonary artery, bronchial artery, and bronchus. Occluding multiple structures with a single treatment allows for more efficient and effective infarction of the entire lung segment 150 surrounding the tumor 127.

[0044] The systems and techniques described herein can also be used to treat chronic obstructive pulmonary disease (COPD), which can include one or more of a variety of conditions, including chronic bronchitis, emphysema, and bronchiectasis. Chronic bronchitis is an inflammation of the bronchi and is characterized by increased mucus secretion, infection, and exacerbations due to goblet cell proliferation. Emphysema is a condition in which impaired gas exchange and alveolar overgrowth damage the alveoli distal to the bronchi, leading to decreased lung function. Bronchiectasis is a condition in which the bronchi become widened and thickened due to scarring. Sacs form on the bronchial walls, creating a breeding ground for bacterial biofilms, infection, and exacerbation of bronchiectasis.

[0045] Figure 2 This is a flowchart illustrating a method 200 for applying thermal energy therapy to an endovascular channel to occlude one or more adjacent blood vessels. Method 200 is shown as a set of operations or procedures that can be combined with... Figure 2 The shown order may be the same or different. In some embodiments of this method, one or more of the shown processes may be omitted. Additionally, Figure 2One or more processes not explicitly shown will be included before, after, between, or as part of the processes shown. In some embodiments, one or more processes of method 200 may be implemented at least in part by control system execution code stored on a non-transitory, tangible, machine-readable medium that, when run by one or more processors (e.g., a processor of the control system), causes said one or more processors to execute one or more of the processes. (Refer to...) Figures 3-4 To further illustrate the process of method 200.

[0046] In optional procedure 202, the treatment device is positioned at a first location within the anatomical lumen. For example, and referring to a detailed view of region 113 providing lung 104. Figure 3 The treatment device, in the form of a medical device 100, can be positioned at a first location 152 within the lumen 122 of the anatomical passage 102. Pulmonary blood vessels or vascular systems 119 may extend alongside the bronchial passage 102. For example... Figure 4 As shown in more detail, the pulmonary vascular system 119 extends along the bronchial wall 137 and may include a pulmonary artery 138 and a bronchial artery 140. For example, a target tissue 127, such as a lung tumor, may be located at a second location 158 distal to or downstream of the first location 152. In some embodiments, the lung tumor may have a diameter of about 2 cm or less, but the methods described herein can also be used for larger tumors. Positioning of the medical device 100 can be performed using a robot-assisted endovascular medical system or manually by a clinician using an endoscope. In some embodiments, the first location may be determined based on a predetermined treatment distance from the second location. In some embodiments, the robot-assisted endovascular medical system may use imaging data or user input to identify the second location, and then use imaging data or user input to determine the first location. For example, the first location may be identified based on a predetermined distance from the second location, analysis of blood supply to the second location, preoperative or intraoperative imaging, and / or based on the proximity of the vascular system and airway. In some embodiments, preoperative or intraoperative imaging can be used to measure or determine anatomical dimensions, such as the distance from the airway to the artery, the lumen diameter, and / or the radial or circumferential position of the artery relative to the airway orientation (e.g., at the 10 o'clock position). Anatomical dimensions can be used to select the size of an expandable device or to plan the extent of expansion of the expandable device. In some embodiments, blood flow sensor data from, for example, pressure sensors, force sensors, impedance sensors, and / or real-time imaging systems or other vision-based systems can be used to detect blood flow.

[0047] At process 204, the treatment device expands at the first location to inflate the anatomical lumen and compress the adjacent vascular system. For example, and referring to... Figure 4The medical device 100 may include a flexible catheter 139 having an expansion portion or expandable device 132 coupled to a distal end of the catheter. The expandable device 132 may be, for example, a balloon filled with liquid 136 or other incompressible fluid. Therefore, in this embodiment, the medical device 100 may be referred to as a heated balloon catheter system. The expandable device 132 may be expanded by introducing liquid into the expandable device, or by being expanded with an expansion fluid and subsequently filled with liquid 136 after expansion. The liquid may be supplied from a liquid source or reservoir coupled to the proximal end of the catheter. The liquid 136 within the expandable device 132 may be an incompressible fluid, such as water, saline, gel, or oil. In some embodiments, the expandable device may generally be compliant and conform to the airway walls of the anatomical passage 102. In other embodiments, the expandable device may generally be non-compliant and may maintain a predetermined expansion configuration that produces an expansion effect on channels with a diameter smaller than the diameter of the expandable device. In other embodiments, the expandable device may generally be semi-compliant and may produce a partial expansion effect on channels with a diameter smaller than the diameter of the expandable device. In some embodiments, the expandable device may include compliant, semi-compliant, and / or non-compliant regions. In other embodiments, the expandable device may be an expandable scaffold, a support, or other expansion device. In some embodiments, the expandable device may expand to a predetermined size and configuration. In some embodiments, a first position may be determined in real time during the procedure. For example, the device 100 may be positioned near a target tissue (e.g., tumor 127), and then, while monitoring blood flow, the device may retract from the tumor to a proximal position (e.g., the first position) as blood flow is monitored. Monitoring may be performed using a control system (e.g., control system 512) to detect blood flow upon receiving blood flow sensor data from, for example, pressure sensors, force sensors, impedance sensors, and / or real-time imaging systems or other vision-based systems.

[0048] In the dilatation configuration, the dilatational device 132 may have a generally rhomboid cross-section, including a ridge 135 that causes bronchial dilation and localized compression of the vascular system 119 near or adjacent to the first location 152. The bronchial wall 137, as well as surrounding connective tissue, lymphatic tissue, and nerve tissue, may also be compressed by the dilatational device. For example, the pulmonary artery 138 may be narrowed or compressed, thereby restricting or blocking blood flow through the compressed area and preventing or limiting distal blood flow to the target tissue 127 at the second location 158. This acute obstruction of blood flow can reduce or eliminate heat dissipation that occurs with the flowing blood. Because heat is not dissipated through the blood flow, the size of the heated area 144 can increase and may ultimately lead to obliterative neointimal hyperplasia. Because the dilatational device 132 dilates the lumen 122, the compression distance D1 between the bronchial wall 137 and the pulmonary artery 138 within the lumen 122 can be smaller than the distance D2 at the uncompressed location. In some embodiments, the degree of expansion of the expandable device can be controlled based on, for example, the diameter of the channel and the desired amount of compression on surrounding tissue. In some embodiments, the degree of expansion can be monitored and / or controlled by a control system (e.g., control system 512) of the robot-assisted medical system. For example, the control system can control expansion to detect arterial compression based on sensor feedback, including sensed pressure, sensed force, measured tissue contact resistance, and real-time imaging methods or other vision-based methods (e.g., fluorescence microscopy or CT imaging). Imaging methods and vision-based methods can also be used to monitor the expansion of the diameter of the expandable device. In some embodiments, when a non-compliant balloon is used as the expandable device, the measured fluid volume can be used to monitor and determine the expansion diameter of the expandable device.

[0049] In some embodiments, the uncompressed distance D2 between the bronchial wall and the vascular system can be determined based on sensor data including internal imaging source data (e.g., ultrasound sensor data, other imaging sensor data) or external imaging source data (e.g., preoperative or intraoperative CT data or MRI data), or it can be determined based on a predetermined normalized model estimate of the distance at a first location and at a specific airway generation. In some embodiments, if the diameter of the bronchus and the uncompressed distance D2 are determined, the expansion can be based on the ratio of the diameter to the distance D2. In some embodiments, the distance can be evaluated and determined by the control system of the robot-assisted medical system (e.g., control system 512). In some embodiments, the expansion configuration of the treatment device can be determined based on the determined uncompressed distance. For example, if the determined distance is relatively small (e.g., the artery is close to the airway), the expandable device can expand to a relatively narrow diameter, thus providing only slight compression. In contrast, if the determined distance is relatively large (e.g., the artery is farther from the airway), the expandable device can expand to a larger diameter, thus providing more compression. In some embodiments, the control system and one or more monitoring sensors may include a closed-loop system that prevents the expandable device from over-expanding. For example, expansion may be limited based on the monitored expansion diameter or based on measured pressure. In some embodiments, the expansion procedure may be paused if the measured distance D2 from the channel to the artery exceeds a threshold distance, or if the monitored expansion diameter exceeds a threshold diameter, or an instruction may be provided to the user or the control system to stop expansion, thereby preventing channel rupture.

[0050] At process 206, heat is applied using a therapeutic device to occlude an artery adjacent to the anatomical lumen. For example, a heating system 134 within an expandable device 132 can heat fluid 136. Heat can be conducted through the bronchial wall 137 to the vascular system 119, causing vascular occlusion. Within the heated area 144, the pulmonary artery 138 may, for example, develop arterial occlusion due to thrombosis, scar tissue, or collagen contraction, or other responses of the anatomical structure to the applied heat. In some examples, occlusion may occur entirely during the application of heat via thrombosis, while in others, occlusion may occur over a period of time as the anatomical structure responds to heat-induced damage. For example, neointimal hyperplasia is a type of scar formation that can occur four to six weeks after process 206. In some examples, heat can also cause scarring of the airway lumen 122, which may occlude or restrict airflow through the lumen 122. For example, the bronchial artery 140 within the heated area 144 may also be occluded. In some examples, heat can also destroy connective tissue, lymphatic tissue, parenchymal tissue, and / or nerves adjacent to or near location 152. In some embodiments, the temperature of the liquid 136 can be monitored and regulated using a control system (e.g., control system 512) of a robot-assisted medical system.

[0051] At optional procedure 208, blood flow to the target tissue at the second location can be reduced. For example, occlusion of the pulmonary artery 138 can lead to apoptosis, hypoxia, and infarction of distal (e.g., downstream) cells supplied by artery 138 to tissue distal to the first location (including the second location 158). Because tissue can be destroyed via hypoxia or non-thermal fixation, coagulative necrosis may occur over time in the infarcted tissue (including the target tissue 127 and surrounding margins), followed by removal of the necrotic tissue by macrophages. In contrast, thermal fixation caused by direct ablation may lead to necrosis, but the macrophage process may not be able to remove the necrotic tissue. Compared to direct ablation that leads to tissue thermal fixation (e.g., using radiofrequency ablation, microwave ablation, or stereotactic radiotherapy), hypoxia and infarction enable the immune system to recognize antigens of dead cancer cells and allow for an immunostimulatory effect that can stimulate the immune system to target other tumors in the body via ectopic effects.

[0052] In some embodiments, blood flow through artery 138 can be monitored at a first location or a downstream location to measure the effectiveness of the occlusion in reducing blood flow. Monitoring can be performed by a control system (e.g., control system 512) upon receiving blood flow sensor data from, for example, pressure sensors, force sensors, impedance sensors, and / or real-time imaging systems or other vision-based systems to detect blood flow.

[0053] In some embodiments, postoperative imaging (e.g., CT or MRI imaging) may be used to determine whether thrombosis has occurred. In some embodiments, intraoperative imaging (e.g., endobronchial ultrasound) may be used to measure anatomical dimensions, such as the distance from the airway to the artery or the diameter of the lumen.

[0054] In some embodiments, a second artery supplying blood to the target tissue and a second anatomical lumen adjacent to the second artery may be identified. Procedures 202-208 may be repeated within the second anatomical lumen to further reduce blood flow to the target tissue and promote local ischemia of the target tissue. Additional supplying arteries and adjacent anatomical lumen may be identified and treated with a heated, expandable device until blood flow to the target tissue is completely blocked.

[0055] In some embodiments, complete and permanent occlusion of the pulmonary artery may not be necessary to achieve pulmonary artery occlusion via complete acute collapse of the pulmonary artery caused by compression and heat from the expansion device. This is because heat applied to the inner diameter of the pulmonary artery closest to the heated expansion balloon may cause platelet activation and aggregation, which may be sufficient to cause acute occlusion.

[0056] In some embodiments, as described in method 200 and various alternative embodiments, reliable lung tumor removal can be achieved by occluding the bronchial lumen, pulmonary artery, and bronchial artery. In some embodiments, in addition to method 200, diffusion-heated liquid therapy can be used for ablation of the pulmonary artery, bronchial artery, and / or bronchial passages, as described in the PCT application filed July 7, 2020, entitled “Systems and Method for Diffuse Endoluminal Thermal Liquid Treatment,” which is incorporated herein by reference in its entirety (File No.: P02303-WO). In some embodiments, the expandable device 132 may not occlude all pulmonary arteries, bronchial arteries, and bronchial passages. For example, heat from the expandable device may cause occlusion of the bronchial arteries and bronchial passages, but may not cause pulmonary artery occlusion or may cause incomplete occlusion. Targeted ablation of the pulmonary artery can be performed by directly occluding the pulmonary artery by inserting an arterial occlusion device into the bronchial wall, as described in the following embodiments. In some embodiments, as described in method 200 and various alternative embodiments, the target tissue 127 can be ablated directly before or after occlusion of the bronchial lumen, pulmonary artery, and / or bronchial artery. Any one or combination of the bronchial access 102, vascular system 119, parenchyma 117, and / or target tissue 127 can be treated simultaneously or continuously using any of the methods, systems, or devices described herein.

[0057] In some embodiments, method 200 may be applicable to lung tumors having a diameter of approximately 2 millimeters (mm) or less. In other embodiments, method 200 may be applicable to larger tumors. Optionally, before, after, or during processes 204-208, the target tissue 127 may be directly ablated, for example by radiofrequency (RF) or microwave (MW) ablation probes, ultrasound, cryotherapy, chemical ablation, or direct heating. For example, an RF or MW ablation probe may directly ablate the core of the lung tumor 127 before, during, or after inducing segmental infarction at the second location 158. Optionally, an expandable device may be movable from the first location to the second location to directly ablate the target tissue. Optionally, the treatment device may be a telescopic device that compresses and occludes an artery at the first location and subsequently or simultaneously has an extension catheter component extending to the second location to directly ablate the target tissue.

[0058] Although method 200 has been described with reference to lung tumors as the target tissue, in other embodiments, the target tissue may be lung tissue with emphysema or other tissue with other diseases. Emphysematous segments of the lung may be unable to perform gas exchange and may become excessively inflated, causing the diseased segment to encroach on a healthier lung segment, thereby reducing lung function and quality of life. The methods described above for airway and arterial occlusion can be used to obstruct emphysematous lung segments and reduce emphysema in the lungs, thereby improving lung function and quality of life.

[0059] In some embodiments, liquid 136 can be heated to temperatures below 100 degrees Celsius at sea-level pressure to remain in liquid form without converting to a gaseous phase. In some embodiments, higher temperatures can be used to ensure that the vascular system (including the region furthest from the expandable device) is sufficiently heated to cause occlusion. Thus, in some embodiments, the temperature of the liquid in the expandable device can be greater than 100 degrees Celsius at pressures above sea level. For example, if the liquid is water and a pressure of 20 atm is reached in the expandable device, the temperature of the liquid can be heated to temperatures below 215 degrees Celsius before the water converts to vapor. In some embodiments, oil or other liquids can be used to achieve even higher temperatures at the expandable device. When the temperature of the liquid is greater than 100 degrees Celsius, secondary effects such as thermosetting may occur in the anatomical passage. This can be acceptable when the target is infarction of a lung segment including a lung tumor, such as in the case of lung tumor treatment.

[0060] In some embodiments, process 204 can be modified or omitted so that the treatment device does not compress the adjacent vascular system. For example, if the vascular system is close enough to the airway or if the airway walls are thin enough, the heated fluid within the expandable device can be conducted to the adjacent vascular system and can occlude the adjacent vascular system without compression. For example, the bronchial artery can be close enough to the bronchus and can have a sufficiently small diameter so that the expandable device can provide sufficient heat to induce platelet aggregation and subsequent occlusion.

[0061] Figure 5 This is a flowchart illustrating a method 250 for applying thermal energy therapy to ablate an intracavitary channel. Method 250 is shown as a set of operations or procedures that can be performed in conjunction with... Figure 5 The shown order may be the same or different. In some embodiments of this method, one or more of the shown processes may be omitted. Additionally, Figure 5 One or more processes not explicitly shown may be included before, after, between, or as part of the processes shown. In some embodiments, one or more processes of method 250 may be implemented at least in part by control system execution code stored on a non-transitory, tangible, machine-readable medium that, when run by one or more processors (e.g., the processor of the control system), causes said one or more processors to perform one or more of the processes. The processes of method 250 will be further illustrated with reference to Figures 6-7.

[0062] In optional procedure 252, the treatment device is positioned within the anatomical lumen at the first location. For example, and referring to a detailed view of region 113 providing lung 104. Figure 6A The treatment device, in the form of medical device 280, can be positioned at a first location 282 within the lumen 122 of the anatomical passage 102. In this example, target tissue 284 can be located throughout the region 113. Target tissue can be, for example, lung tissue suffering from chronic bronchitis, emphysema tissue, tissue suffering from bronchiectasis, parenchymal tissue, or hemorrhagic tissue. Positioning of the medical device 280 can be performed using a robot-assisted medical system or manually by a clinician. In some embodiments, the first location 282 can be distal to a planned second location 292.

[0063] At process 254, the treatment device expands at the first position. For example, and refer to... Figure 6AThe medical device 280 may include a flexible catheter 286 having an expansion portion or expandable device 288 coupled to a distal end of the catheter. The expandable device 288 may be, for example, a balloon filled with a liquid 289 or other incompressible fluid. The liquid may be an incompressible fluid, such as water, saline, gel, or oil. In some embodiments, the liquid 289 may be used to inflate the balloon, but in other embodiments, the balloon may be expanded mechanically or by introducing another fluid. In the expansion configuration, the expandable device 288 may physically contact the airway wall of the lumen 122. In some embodiments, the expandable device may be generally compliant and may conform to and radially contact the airway wall of the anatomical passage 102. In other embodiments, the expandable device may generally be non-compliant and may maintain a predetermined expansion configuration. In some embodiments, the expandable device may include compliant and non-compliant regions. In some embodiments, the expandable device may contact the anatomical passage wall without significant expansion of the passage. Alternatively, the expandable device may apply pressure to the anatomical passage wall to expand the lumen.

[0064] At process 256, heat is applied to the surface (and optionally subsurface) of the wall of the anatomical lumen using a heated treatment device. For example, a heating system 290 within expandable device 288 can heat liquid 289 and induce ablation of target tissue 284 in anatomical passage 102. The depth of ablation and the anatomical structures thus ablated and occluded (e.g., bronchial passage, bronchial artery, pulmonary artery, etc.) can be controlled based on the duration of application, the temperature of the expanded and heated device, and a defined distance between the heated expandable device and the anatomical structure. In some embodiments, the distance between the bronchial wall and the vascular system at the first location can be determined based on sensor data including internal imaging source data (e.g., ultrasound sensor data, other imaging sensor data) or external imaging source data (e.g., preoperative or intraoperative CT data or MRI data), or it can be determined based on a predetermined normalized model estimate of the distance between the airway progeny at the first location and a specific airway progeny.

[0065] Ablation can cause cellular and structural changes in the epithelium, and in some cases, the epithelium can extend to the subepithelial membrane. Ablation can result in tissue reduction, including destruction of goblet cells and cilia at the first site 282. In some embodiments, the cellular matrix may be preserved to allow for subsequent regrowth of healthy cells. The size of the ablation area, the ablation depth, and the tissue structures affected by ablation can vary based on the duration of contact with the expandable device 288, the amount of material interface between the expandable device 288 and the tissue, the contact pressure, and the temperature of the liquid and the expandable device. In some examples, the tissue response can occur entirely during the application of heat, while in other examples, tissue damage can occur over a period of time as the anatomy responds to heat-induced damage. As described above, in some examples, the liquid 289 can be heated to a temperature less than 100°C at sea level, but in other examples, the temperature of the liquid can be greater than 100°C.

[0066] In optional process 258, when in the expanded configuration, the treatment device can be moved from a first position within the anatomical lumen to a second position within the anatomical lumen. For example, and referring to... Figure 6B The medical device 280 can move from a first position 282 to a second position 292, thereby dragging the expandable device 288 along the anatomical channel 102. Using the expandable device 288 in its expanded configuration, heat from the heated liquid 289 can cause ablation of the walls of the anatomical channel 102, including the target tissue 284, between the first position 282 and the second position 292. Therefore, goblet cells, cilia, and other tissues along the channel length between the first and second positions 282 can be ablated as the expandable device 288 moves. In some embodiments, the movement of the treatment device from the first position to the second position can be performed manually. In some embodiments, the treatment device can be coupled to a manipulator of a robot-assisted medical system (e.g., system 500), and the movement of the treatment device from the first position to the second position can be performed by actuation of the manipulator.

[0067] In some embodiments and for some treatment plans, the expandable device may be applied at multiple discrete locations along the anatomical channel, rather than being pulled along the channel in an expanded configuration. In optional process 260, after heat is applied to the wall channel, the treatment device may collapse at a first location. For example, expandable device 288 may collapse from an expanded configuration to an unexpanded configuration, in which the expandable device typically does not radially contact the anatomical channel 102. When expandable device 288 collapses, some or all of the fluid 289 may be extracted from the expandable device.

[0068] In optional process 262, the collapsed treatment device can be moved from a first position to a sequential second position. For example, the expandable device 288 in the collapsed configuration can be moved from a first position 282 to a second position 292. While the expandable device 288 is moving, it may not be sufficiently heated to ablate the tissue and may have little or no contact with the walls of the airway 102, so the length of the airway between the first and second positions may not be ablated.

[0069] In optional process 264, the treatment device expands at the second location. For example, medical device 280 can be re-expanded to an expanded configuration and can be refilled with liquid 289. The liquid can be heated to induce ablation of airway 102 at the second location 292. In some embodiments, expandable device 288 can be placed in multiple airway regions, such as in fourth to fifteenth generation airways, to generate sequential heat delivery for each location of the targeted anatomy.

[0070] Method 200 described above can use a heated therapeutic device to compress adjacent vascular systems, thereby restricting heat dissipation of blood flow while applying heat to occlude the vascular system. Method 250, as described above, can use a heated therapeutic device to ablate bronchial passages while avoiding ablation of adjacent vascular systems or providing only minor ablation of adjacent vascular systems. Any of these methods, either alone or in combination, can be used to effectively treat a variety of disease conditions. The depth of ablation and the anatomical structures thus ablated and occluded (e.g., bronchial passages, bronchial arteries, pulmonary arteries, etc.) can be controlled based on the duration of application, the temperature of the dilated and heated device, the degree of dilation of the dilatational device, and a defined distance between the heated dilatational device and the anatomical structure.

[0071] Figure 7A-1 The illustration depicts the disease state of chronic bronchitis in bronchus 115. Bronchus 115 is surrounded by a vascular system 119 including pulmonary artery 138 and bronchial artery 140. Chronic bronchitis can lead to excessive goblet cell proliferation and cilia damage, which can result in excessive mucus production. Excessive mucus can lead to increased respiratory infections, decreased lung function, and reduced quality of life. Goblet cells can reside at a depth of approximately 0.05 mm to 0.10 mm. A heated balloon catheter system (e.g., medical device 100) can ablate cilia and excessive goblet cells while preserving the cellular matrix and allowing for the regrowth of healthier goblet cells and cilia. Healthy regrowth can reduce mucus production, improve lung function, and enhance quality of life. In chronic bronchitis, airway folds 700 may form. Figure 7A-2As shown, the expandable device 702 (e.g., expandable devices 132, 288) that expands in the lumen 122 of the bronchus 115 can inflate and open the folds 700, exposing the valleys of the folds and thus more goblet cells that secrete excessively to heat from the expandable device 702 and thereby improving the effectiveness of the treatment compared to treatments that do not inflate the airway.

[0072] These systems and methods for treating chronic bronchitis are effective for, for example, third to fifth generation bronchi and can be used on any or all lobes of the lung. For treating chronic bronchitis, a heated balloon catheter can be deployed several times during the treatment procedure. For example, approximately 9 to 54 ablations can be performed during the procedure at different locations. For treating chronic bronchitis, the temperature of the heated balloon during treatment can be approximately 60 to 70 degrees Celsius. The duration of each balloon deployment can be, for example, approximately 5 to 15 seconds, and can cause ablation to a depth of approximately 0.05 mm to 0.10 mm. For treating chronic bronchitis, bronchodilator dilation can be approximately 20% or in the range of approximately 10% to 30% (compared to an uninflated channel) to allow for appropriate fold exposure. The inflated balloon can temporarily compress the bronchial artery; however, by controlling the depth of airway ablation, heat does not reach the bronchial artery or pulmonary artery, and therefore thermal damage to the artery or subsequent permanent occlusion does not occur. In addition, by limiting the ablation depth of cilia and goblet cells, ablation of the airway endothelium was avoided, which would otherwise lead to unwanted obstructive neoendothelial hyperplasia and a reduction in airway diameter due to collagen contraction.

[0073] Figure 7B-1 The illustration depicts the disease state of bronchiectasis in bronchus 115. Bronchiectasis can lead to enlarged bronchial pockets and damaged cilia. This can result in excessive mucus, leading to increased respiratory infections, decreased lung function, and reduced quality of life. Heated balloon catheter systems (e.g., medical device 100) can ablate cilia and bronchial walls, resulting in the regrowth of healthier cilia and a reduction in bronchial pocket size due to collagen contraction and neointimal hyperplasia. The mucus load in the bronchial passage can be reduced, and mucus clearance can be increased, thereby reducing respiratory infections, improving lung function, and enhancing quality of life. During the treatment of bronchiectasis, the ablation of collagen in the airway may induce airway wall tightening to reduce the excessive expansion associated with the disease. Furthermore, ablation of biofilms in the bronchial pockets, which create a breeding ground for infection, can reduce exacerbation. Figure 7B-2 As shown, the expandable device 704 (e.g., expandable devices 132, 288) can expand within the lumen 122 of the bronchus 115 and can cause the lumen 122 to expand.

[0074] These systems and methods for treating bronchiectasis can be effective on, for example, third to fifth generation bronchi and can be used on any of the three lobes of the lung during the procedure. For treating bronchiectasis, a heated balloon catheter can be deployed several times during the treatment procedure. For example, approximately 3 to 21 ablations can be performed during the treatment procedure at different locations. For treating bronchiectasis, the temperature of the heated balloon can be approximately 70 to 90 degrees Celsius during treatment. The duration of each balloon deployment can be, for example, approximately 5 to 20 seconds, and can cause ablation to a depth of approximately 0.30 mm to 1.0 mm. For treating bronchiectasis, the heated balloon can be inflated within the bronchial channel, but the channel can be inflated very little (e.g., approximately 5% to 20% inflated) or not inflated at all, and with little or no compression of adjacent arteries. The duration, temperature, and depth of ablation can be selected based on the bronchial wall thickness. The thickness of the bronchial wall can vary from approximately 0.3 mm to 1.0 mm and can be determined based on imaging data (e.g., intraoperative or preoperative CT data). Once the wall thickness is determined, the time required for ablation through the bronchial wall but not through the bronchial artery can be determined.

[0075] Ablation of the radial segment of the bronchial passage can also be used to treat hemoptysis that may be caused by various disease conditions, including bronchiectasis. Ablation of the bleeding bronchial artery (often caused by bronchiectasis) can be life-saving. A thermo-expandable balloon (e.g., expandable devices 132, 288, 704) can include insulated and non-insulated (e.g., conductive) portions or radial rings that confine the ablation to the radial segment of the bronchial passage. Once the bleeding is located, the thermo-expandable balloon can be applied to the bronchial passage where the ruptured bronchial artery resides. Inflation can stop blood flow by compressing the ruptured artery, and the applied heat can constrict and occlude the artery via thrombus formation, followed by permanent occlusion via neointimal proliferation. By ablating only the radial segment of the airway, complete occlusion of the passage can be avoided and the airway remains open. This allows for the preservation of function in the lung segment distal to the ablation site.

[0076] Figure 7C-1 The illustration depicts the disease state of emphysema. Emphysema can cause uneven over-inflation of alveoli 116. These over-inflated lung segments may have poor gas exchange and may encroach on healthier areas of the alveoli. Reducing these dysfunctional, over-inflated lung segments can improve lung function and quality of life. A heated balloon catheter system (e.g., medical device 100) can ablate the bronchial wall 124, causing collagen contraction and neointimal hyperplasia. This can lead to occlusion of the passage 122 and subsequent reduction in lung volume of the over-inflated lung segments. This can improve lung function and quality of life. Figure 7C-1As shown, the expandable device 706 (e.g., expandable devices 132, 288) can expand within the lumen 122 of the bronchus 115.

[0077] These systems and methods for treating emphysema can be effective on, for example, third to fifth generation bronchi, and can be used on approximately 3 to 6 segments during the procedure. For treating emphysema, a heated balloon catheter can be deployed several times during the treatment procedure. For example, approximately 3 to 21 ablations can be performed during the treatment procedure at different locations. For treating emphysema, the temperature of the heated balloon can be approximately 70 to 90 degrees Celsius during treatment. The duration of each balloon deployment can be, for example, approximately 5 to 20 seconds, and can cause ablation to a depth of approximately 0.30 mm to 1.0 mm. For treating emphysema, the heated balloon can be inflated in the bronchial channel, but the channel can be inflated very little (e.g., approximately 5% to 20%) or not at all, and with little or no compression of adjacent arteries. Although the bronchial arteries 140 may be compressed due to the expansion of the bronchial wall, they may not be ablated because the ablation depth may only extend through the adventitia. Therefore, in some embodiments, no thermal damage or subsequent permanent occlusion of the arteries occurs. The duration, temperature, and depth of channel ablation can be selected based on bronchial wall thickness. Bronchial wall thickness can vary from approximately 0.3 mm to 1.0 mm and can be determined based on imaging data (e.g., intraoperative or preoperative CT data). Once the wall thickness is determined, the ablation time across the bronchial wall but not through the bronchial artery can be determined. Figure 7C-2 As shown, bronchus 115 can become occluded after ablation. This results in a reduction in excessive lung segmental expansion, such as a decrease in lung volume of 300 to 1000 cc, and a reduction in encroachment on adjacent alveoli.

[0078] like Figure 7D-1As shown, emphysema can also be treated, or alternatively, using the expandable device 706, thereby ablating not only the passage 122 of the bronchus 115 but also the adjacent bronchial artery 140. In some embodiments, the pulmonary artery 138 may not be ablated by heat from the expandable device 706. Ablation of the bronchial artery can result in partial infarction of the over-inflated segment, leading to additional volume reduction via alveolar infarction. In this embodiment, approximately one to six ablations can be performed during the treatment procedure. To treat emphysema including ablation of the bronchial artery, the temperature of the heated balloon during treatment can be approximately 85 to 95 degrees Celsius. The duration of each balloon deployment can be, for example, approximately 20 to 120 seconds, and can cause ablation to a depth of approximately 1.0 mm to 3.0 mm. In this embodiment, to treat emphysema, the heated balloon can be expanded in the bronchial passage to expand the passage by approximately 10% to 50%, thereby compressing the bronchial artery. Compression of the bronchial artery eliminates heat dissipation from blood flow in the bronchial artery. The balloon may not expand sufficiently to compress the pulmonary artery. Because blood can continue to flow through the uncompressed pulmonary artery, the heat from the balloon can be dissipated by the blood, thus preventing pulmonary artery ablation. Figure 7D-2 As shown, bronchus 115 can become occluded after ablation. This results in a reduction of segmental overinflation, partial parenchymal infarction, a decrease in lung volume of 300 to 1000 cc, and a reduction in encroachment on adjacent alveoli.

[0079] Figure 7E-1 The illustration depicts the disease state of a lung tumor. As mentioned above, complete ablation of the bronchi (e.g., airways), bronchial arteries, and pulmonary arteries can be used to treat one or more lung tumors. Lung tumors are often irregular in shape and composition, making complete ablation by direct heating of the tumor difficult. Failure to completely necrose all tumor cells can lead to tumor regrowth. Creating complete infarction in the lung segment containing the tumor can lead to complete tumor necrosis and can result in complete tumor removal via tissue replacement. Figure 7E-1As shown, the expandable device 708 (e.g., expandable devices 132, 288) can expand within the lumen 122 of the bronchus 115. The expandable device 708 can ablate the bronchial wall 124, bronchial artery 140, and pulmonary artery 138, resulting in complete infarction of the segment containing the tumor 127. This tumor-killing method may include destroying the tumor margins, which is associated with a low recurrence rate after surgical resection. Ablation of the bronchial wall 124 can lead to collagen contraction and neointimal hyperplasia. This can result in airway occlusion, thereby blocking the primary oxygen source of the lung segment. Ablation of the bronchial artery 140 can occlude the bronchial artery through neointimal hyperplasia and collagen contraction, thereby blocking the secondary oxygen source (oxygenated blood) of the lung segment. Ablation of the pulmonary artery 138 can occlude the artery through neointimal hyperplasia and collagen contraction, thereby blocking the tertiary oxygen source (oxygenated blood) of the lung segment. This technique for indirect thermal ablation of tumor necrosis can maximize the remote effect without altering the DNA of cancer cells.

[0080] These systems and methods for treating lung tumors can be effective on, for example, fourth- to sixth-generation bronchi. To treat the tumor, a heated balloon catheter can be deployed several times during the treatment procedure. For example, approximately one to three ablations can be performed during the procedure at different locations. To treat the lung tumor, the temperature of the heated balloon during treatment can be approximately 90 to 95 degrees Celsius. The duration of each balloon deployment can be, for example, approximately 120 to 300 seconds, and can cause ablation to a depth of approximately 3.0 mm to 5.0 mm. To treat the tumor, the bronchial channel can be inflated by 50% to 100% to compress the bronchial artery 140 and the pulmonary artery 138. Compression of the arteries eliminates heat loss from arterial blood flow. The duration, temperature, and depth of channel ablation can be selected based on the bronchial wall thickness. The bronchial wall depth and the thickness of the radial distance of the pulmonary artery can vary within a range of approximately 0.3 mm to 1.0 mm and can be determined based on imaging data (e.g., intraoperative or preoperative CT data). Once the wall thickness is determined, the time required for ablation to pass through the bronchial wall but not through the bronchial artery can be determined. For example... Figure 7E-2 As shown, after ablation, the bronchus 115, bronchial artery 140, and pulmonary artery 138 can become occluded. This leads to obstruction of oxygen supply to the alveoli in the segment where the tumor 127 is located, which can result in complete infarction of the diseased segment, tumor necrosis, and biological removal of necrotic tissue from the body.

[0081] Figures 8-14 Various embodiments of expandable or expandable devices that can be used to perform any of the above methods are illustrated. These expandable devices can be incorporated into a medical device system 100, which may be referred to as a heated balloon catheter system.

[0082] Figure 8The illustration shows an expandable device 300 (e.g., expandable devices 132, 288) coupled to the distal end of a flexible conduit 302. In this embodiment, the expandable device 300 is an elongated balloon that extends from a first position 282 to a second position 292, thereby ablating the surface (and optionally subsurface) along the wall of the airway 102 from the first position 282 to the second position 292. In some embodiments, the expandable device 300 may have a length between approximately 5 and 60 mm and a diameter between approximately 0.5 and 5 mm. In some embodiments, the expandable device may span multiple airway passages. In some embodiments, the fluid temperature in the expandable device 300 may be controlled at a temperature between approximately 38 and 99 degrees Celsius.

[0083] Figure 9 An expandable device 320 (e.g., expandable devices 132, 288, 300) is illustrated, attached to the distal end of a flexible conduit 322. In this example, fluid 328 may be heated proximally to the expandable device 320 and may circulate into the expandable device through a fluid inlet 324 and exit the expandable device through a fluid outlet 326. In some embodiments, the fluid may be an incompressible liquid or gel.

[0084] Figure 10 An expandable device 330 (e.g., expandable devices 132, 288, 300) is illustrated, coupled to the distal end of a flexible conduit 331. A heating system 332 (e.g., heating systems 134, 290) is located within the expandable device 330 or along the distal portion of the conduit 331 and includes a heating element 334 and a sensor 336. The heating element 334 may include, for example, a radio frequency heating element, a resistance heating element, a microwave heating element, an ultrasonic heating element, a magnetic heating element, or a light / laser-based heating element. The heating element 334 can heat a fluid 338 flowing within the expandable device 330. The sensor 336 may be, for example, a thermocouple, and can sense the temperature of the fluid 338 and provide feedback for controlling the power supplied to the heating element 334. Based on the sensed temperature, the power supplied to the heating element 334 can be cyclical to control the temperature of the expandable device 330.

[0085] Figure 11A medical device system 349 is illustrated, comprising an expandable device 350 (e.g., expandable devices 132, 288) within an anatomical channel 352 (e.g., channel 102). The expandable device 350 (e.g., a balloon) may have a generally cylindrical shape and may be coupled to the distal end of a flexible catheter 354. System 349 also includes a heating system 356 comprising bipolar radiofrequency electrodes, wherein electrodes 358 are positioned within the expandable device 350, for example, on the distal portion of the catheter 354, and electrodes 360 are positioned on the surface of the expandable device. In some embodiments, multiple electrodes may be placed within the expandable device and multiple electrodes may be placed on the surface of the expandable device. Heating system 356 may also include a temperature sensor 362, which may be substantially similar to sensor 336. Fluid may flow into the expandable device 350 through a fluid inlet 364 and out of the expandable device through a fluid outlet 366. In some embodiments, the expandable device 350 may have a length L1 between approximately 5 and 60 mm. In some embodiments, the fluid temperature in the expandable device 350 can be controlled between approximately 60 and 99 degrees Celsius. In some embodiments, the diameter D1 of the anatomical channel 352 and the expandable device 350 can be between approximately 2 and 10 mm, and in some embodiments can be approximately 4 mm. In some embodiments, the ablation zone 368 can have a depth D2 between approximately 1 and 5 mm. In some embodiments, the catheter 354 can have a diameter D3 of approximately 1.8 mm. In some embodiments, the system 349 can be adapted to treat emphysema and can induce airway obstruction and an inflammatory response that induces lung volume distal to the ablation zone 368.

[0086] When one electrode is placed on the surface of the expandable device and another electrode is placed on the conduit, such as Figure 11 As illustrated in the embodiments, a liquid (e.g., a saline solution) can become a conductor of radio frequency (RF) energy, and an electric current flowing through the liquid will heat the liquid. In an alternative embodiment, electrodes may be omitted from the surface of the expandable device; instead, at least two electrodes may be spaced apart along a conduit. In this embodiment, current can be conducted through the liquid to heat it, or current can flow along the conduit axis from one electrode to another to heat the axis and thus the surrounding liquid. Whether the current is conducted through the conduit or through the liquid depends on which path has the least resistance. In any of these embodiments, the heated liquid can conduct thermal energy to the tissue, while the electrodes heat the liquid but not directly heat adjacent tissue. In an alternative embodiment, RF energy can be applied so that current flows through the tissue to directly heat the tissue.

[0087] Figure 12The illustration shows a system 349 for creating an ablation zone 370, which may be shallower than an ablation zone 368 due to fluid temperature, duration of application, and / or pressure. In this embodiment, the ablation zone may have a depth D4 between approximately 0.1 and 1.5 mm and may be suitable for treating chronic bronchitis, particularly ablation of goblet cells.

[0088] Figure 13 The illustration shows a system 380 including an expandable device 382 (e.g., expandable devices 132, 288) within an anatomical channel 384 (e.g., channel 102). The expandable device 382 (e.g., a balloon) has a generally elliptical shape and is coupled to the distal end of a flexible catheter 386. System 380 also includes a heating system 388 comprising bipolar radiofrequency electrodes, wherein electrodes 390 are located within the expandable device 382, ​​for example, on the distal portion of the catheter 386, and electrodes 392 are positioned on the surface of the expandable device. In some embodiments, multiple electrodes may be placed within the expandable device and multiple electrodes may be placed on the surface of the expandable device. The heating system 388 may also include a temperature sensor 394, which may be substantially similar to sensor 336. Fluid may flow into the expandable device 382 through a fluid inlet 396 and out of the expandable device through a fluid outlet 398. In some embodiments, the expandable device 382 may have a length L1 between approximately 5 and 60 mm. In some embodiments, the fluid temperature in the expandable device 382 can be controlled between approximately 60 and 99 degrees Celsius. In some embodiments, the diameter D5 of the bronchial bag and the expandable device 382 can be between approximately 2 and 10 mm. In some embodiments, the ablation zone 400 can have a depth D6 between approximately 1 and 6 mm. In some embodiments, the catheter 386 can have a diameter D3 of approximately 1.8 mm. In some embodiments, the system 380 can be adapted to treat bronchiectasis by ablating collagen in the channel 384 and destroying biofilms within the bronchial bag that can create breeding grounds for infection.

[0089] Figure 14The illustration shows a system 450 that may be similar to medical device system 100, having the identified details or differences and being usable for performing method 200. System 450 may include an expandable device 452 (e.g., a balloon) having a generally rhomboid cross-section including a ridge 454 when expanded to an expanded configuration. Expandable device 452 may be coupled to the distal end of flexible catheter 456. System 450 also includes a heating system 458 comprising bipolar radiofrequency electrodes, wherein electrodes 460 are located within expandable device 452, for example on the distal portion of catheter 456, and electrodes 462 are positioned on a surface of expandable device. In some embodiments, multiple electrodes may be placed within expandable device and multiple electrodes may be placed on a surface of expandable device. Heating system 458 may also include a temperature sensor 464 that may be substantially similar to sensor 336. Fluid may flow into expandable device 452 through fluid inlet 466 and out of expandable device through fluid outlet 468. In some embodiments, the expandable device 452 may have a length L2 of approximately 7 mm and a diameter D7 of approximately 6.5 mm at the ridge 454. In alternative embodiments, the expandable device may have other shapes, including conical, biconical, asymmetrical, or multi-lobed. In some embodiments, the ablation zone 470 may have a depth D8 between approximately 3 and 5 mm. In some embodiments, the inner diameter D1 of the lumen 122 may be approximately 4 mm. In some embodiments, the catheter 456 may have a diameter D3 of approximately 1.8 mm.

[0090] In some embodiments, system 450 may be adapted to treat distal lung tumors or emphysema. For example, system 450 may reduce blood flow to target tissue at a more distal second location as described in method 200. For example, occlusion of pulmonary artery 138 may lead to apoptosis of distal (e.g., downstream) cells and infarction of tissue supplied by artery 138 distal to the first location. Over time, coagulative necrosis of the infarcted tissue (including the target tumor) and surrounding margins will occur, followed by removal of necrotic tissue by macrophages. In some embodiments, system 450 may be applied to multiple locations to infarct a larger downstream region or a target region where the infarction may have collateral blood flow.

[0091] Figure 15An expandable device 490, which can be positioned within a lumen 122, is illustrated. The expandable device 490, which may be an expandable ring, can be inserted through the lumen 122 in a compression configuration and can expand to an expansion configuration to compress the vascular system 119, as described in process 204 of method 200. The expandable device 490 can remain in the expansion configuration when heat is applied from within the lumen 122 to occlude the vascular system 119. Heat can be applied using any of a variety of techniques, including heated expandable devices, flowable heated liquids, RF or MW ablation probes, or other heat delivery tools. In some embodiments, the ring may have a narrow profile of approximately 1 mm to provide a sharp pressure zone. In alternative embodiments, additional mechanical retractors or other types of mechanical stretching tools at the catheter tip may be used within the lumen 122 to mechanically occlude the vascular system 119.

[0092] Figure 16 The illustration shows a system 492 that includes an expandable device 494 (e.g., expandable devices 132, 288) for use within an anatomical passage (e.g., passage 102). The expandable device 494 (e.g., a balloon) has a generally cylindrical shape and is coupled to the distal end of a flexible catheter 495. System 492 also includes a heating system 496 that includes a resistance heating element or bipolar radio frequency electrode within the expandable device 494 to heat a fluid 498. An RF housing 497 may be disposed on the surface of the expandable device 494. The RF housing may be, for example, a metal-plated or painted electrode. The RF housing 497 may be unipolar, such that heat from the heated fluid 498 is projected radially outward from the expandable device 494. Compared to some embodiments of heated expandable devices without an RF housing, system 492 can produce a larger ablation area, capable of completely ablating adjacent arteries.

[0093] In any of the above-described instrument systems, the fluid may be heated by a heating system at the distal portion of the treatment device before being released from the distal portion of the treatment device into the patient's anatomy.

[0094] In any of the aforementioned instrument systems, the liquid can be circulated to improve heat distribution. For example, the liquid can be circulated via impellers, through injection and aspiration, through vibration of the heating system in an expandable device, by contracting and expanding the expandable device, and / or by rotating, oscillating, or otherwise moving the heating system or components within the expandable device. In some embodiments, portions of the heating system may be vibrated to reduce bubble formation on the heating system.

[0095] In any of the aforementioned device systems, expandable devices can be reinforced with, for example, woven fabrics or metal coatings to maintain the balloon's temperature, which would otherwise reduce or alter the balloon's mechanical properties.

[0096] In some embodiments, reliable lung tumor removal can be achieved by occluding the bronchial lumen, pulmonary artery, and bronchial artery. In some embodiments, heated balloons or diffusion-heated liquid therapy can occlude the bronchial lumen, pulmonary artery, and bronchial artery. However, sometimes these treatments alone may not be sufficient to completely occlude all structures. For example, the elastic limit of the bronchial wall may be reached before the heated balloon can cause pulmonary artery collapse. Incomplete pulmonary artery collapse can allow continuous blood flow and blood flow-related heat dissipation. This continuous blood flow and heat dissipation can limit the extent of arterial ablation and subsequent neointimal hyperplasia, and may result in partial infarction or no infarction at all.

[0097] In some embodiments, complete and permanent occlusion of the pulmonary artery may not be necessary to achieve complete acute collapse of the pulmonary artery via a heated balloon. This is because heat to the arterial inner diameter closest to the heated balloon will cause platelet activation and aggregation, which may be sufficient to cause acute occlusion. Acute occlusion can produce hemostasis, thereby eliminating heat dissipation flow through the pulmonary artery, thus allowing heat conduction through static blood and resulting in ablation of the entire periphery of the pulmonary artery. Complete circumferential ablation of the pulmonary artery maximizes the likelihood of complete and permanent neointimal hyperplasia occlusion, thus leading to the greatest tendency for substantial infarction. However, if platelet activation and aggregation from a partially occluded pulmonary artery via a heated balloon device does not produce acute hemostasis, there may be blood flow within the pulmonary artery that could act as a heat sink, potentially preventing ablation of the entire periphery of the pulmonary artery. Failure to ablate the entire periphery of the pulmonary artery reduces the likelihood of permanent pulmonary occlusion via neointimal hyperplasia.

[0098] The following describes various systems and methods for using a bronchial passage as an initiation point, from which tools can be inserted into an adjacent artery to directly occlude it. Such systems and techniques can also be used to suppress bleeding from ruptured arteries. Figure 17The illustration depicts a method 600 for occluding a vascular system including a pulmonary artery extending along a bronchial passage to aid in the removal of infarction, necrosis, and subsequent lung tumors. At process 602, a medical device can be delivered to a location within the target bronchial passage. As previously described, the medical device can be coupled to a robot-assisted manipulator and navigated to the target location, or it can be manually positioned at the target location. At process 604, the medical device can be inserted into the bronchial wall using an arterial occlusion device. The arterial occlusion device can be moved from the bronchial passage, through the bronchial wall, and into an artery (e.g., the pulmonary artery) adjacent to the bronchial passage. At process 606, the arterial occlusion device can occlude the artery by creating an acute clot that blocks blood flow. The stagnation of blood prevents bleeding from the artery from entering the airway and allows heat conduction through the clot, thereby providing complete peripheral ablation of the artery. This maximizes the possibility of completely permanent neointimal hyperplasia occlusion. Optionally, the risk of bleeding between the airway puncture site and the pulmonary artery can be reduced by RF ablation, application of fibrin glue, application of heated expandable balloon packing, or application of unheated expandable balloon packing. Alternatively, other methods (e.g., locally heated expandable balloon ablation method 200 or the diffusion heated liquid ablation method as described in the PCT application filed July 7, 2020, entitled "Systems and Method for Diffuse Endoluminal Thermal Liquid Treatment" (File No.: P02303-WO), which is incorporated herein by reference) can also be used for ablation of the pulmonary artery, bronchial artery, and / or bronchial passage.

[0099] Figure 18 , Figure 19 , Figure 20 , Figure 21 and Figures 22A-22B An example of an arterial occlusion device that can be used to perform method 600 is illustrated. Figure 18The illustration shows a bronchus 610 with an adjacent pulmonary artery 612. A catheter 614 can deliver an arterial occlusion device 616 into the lumen 618 of the bronchus 610. The position of the pulmonary artery 612 relative to the bronchus 610 can be determined using, for example, intraoperative imaging. The catheter 614 can be rotated toward the pulmonary artery 612, and the arterial occlusion device 616 can be advanced through a distal opening 615 on one side of the catheter, through the bronchial wall 620, and into the pulmonary artery 612. In this embodiment, the arterial occlusion device can be an RF wire. After placement in the pulmonary artery 612, the RF wire can be activated to induce platelet aggregation and the formation of an occlusion clot. If blood flow in the pulmonary artery 612 is blocked by a blood clot, the RF wire can be removed from the artery and the catheter 614. After a blood clot has formed and the cooling effect of the blood flow has been terminated by the clot, a heated expansion balloon ablation technique can be performed to locally heat and ablate the pulmonary artery without causing complete collapse of the artery.

[0100] Figure 19 The illustration shows a bronchus 610 adjacent to a pulmonary artery 612. A catheter 614 can deliver an arterial occlusion device 630 into the lumen 618 of the bronchus 610. The position of the pulmonary artery 612 relative to the bronchus 610 can be determined using, for example, intraoperative imaging. The catheter 614 can be rotated toward the pulmonary artery 612, and the arterial occlusion device 630 can be advanced into the pulmonary artery 612 through the bronchial wall 620. In this embodiment, the arterial occlusion device can be a hollow needle catheter for delivering occlusion material 632. After placement in the pulmonary artery 612, the needle catheter can deliver the occlusion material into the artery 612 to create a clot. The occlusion material can be injected and may include fibrin glue, cyanoacrylate, a liquid containing microspheres, alcohol, heated liquids such as water, collagen, tranexamic acid, thromboxane, adenosine diphosphate, and / or gelatin sponge. The occlusion material can induce platelet aggregation leading to a blood clot, or the material itself can induce an occlusion clot. After a blood clot forms and the heat dissipation effect of blood flow is terminated by the clot, a heated expansion balloon ablation method can be performed to locally heat and ablate the pulmonary artery without causing the artery to completely collapse.

[0101] Figure 20The illustration shows a catheter 614 for delivering an arterial occlusion device 640 into the lumen 618 of a bronchus 610. The position of the pulmonary artery 612 relative to the bronchus 610 can be determined using, for example, intraoperative imaging. The catheter 614 can be rotated toward the pulmonary artery 612, and the arterial occlusion device 640 can be advanced into the pulmonary artery 612 through the bronchial wall 620. In this embodiment, the arterial occlusion device may include a delivery catheter for delivering an occlusion coil. The coil may be formed of an elastic material such as nitinol or an elastomer, which can be straightened to be deployed through the delivery catheter and can return to a coiled shape after being exposed from the delivery catheter and inserted into the artery 612. The coil can induce platelet aggregation, resulting in a blood clot. After the blood clot forms and the heat dissipation of blood flow is terminated by the clot, a heated expansion balloon ablation technique can be performed to locally heat and ablate the pulmonary artery without causing complete collapse of the artery.

[0102] Figure 21 The illustration shows a catheter 914 for delivering an arterial occlusion device 650 into the lumen 618 of a bronchus 610. The position of the pulmonary artery 612 relative to the bronchus 610 can be determined using, for example, intraoperative imaging. The catheter 614 can be rotated toward the pulmonary artery 612, and the arterial occlusion device 650 can be advanced into the pulmonary artery 612 through the bronchial wall 620. In this embodiment, the arterial occlusion device may include a delivery catheter for delivering a balloon. The balloon may be a silicone balloon extending over an opening in the delivery catheter. The balloon can be inflated with a high-viscosity liquid (e.g., fibrin glue). Once inflated, the delivery catheter can be withdrawn from the balloon, leaving the balloon to occlude the artery. After the balloon inflates and the cooling effect of blood flow is terminated by the balloon, a heated balloon ablation technique can be performed to locally heat and ablate the pulmonary artery without causing complete collapse of the artery.

[0103] Figure 22A and Figure 22B The illustration shows a catheter 660 for delivering an arterial occlusion device 670 into the lumen 618 of a bronchus 610. In this embodiment, the arterial occlusion device 670 may include an occlusion rod 672 pivotally coupled to an RF rod 674. A pull wire 676 coupled to the occlusion rod 672 may be activated by a pull wire 976 to remove the occlusion rod from an insertion configuration parallel to the catheter 660 (as shown in...). Figure 22A (middle) pivot to occlusion rod 672 generally transverse to the occlusion structure of catheter 660 (as in) Figure 22B(In the middle). The occlusion rod 672 in the occlusion configuration can compress the artery 612 to completely or partially occlude blood flow through the artery. RF energy from the RF rod 674 can heat the occlusion rod 672 to induce platelet aggregation, thereby forming a blood clot in the compressed artery 612. After the blood clot has formed and the heat dissipation of blood flow has been terminated by the clot, a heated expansion balloon ablation technique can be performed to further locally heat and ablate the pulmonary artery.

[0104] In some embodiments, in addition to blocking blood flow through the pulmonary artery, or as an alternative to blocking blood flow through the pulmonary artery, airflow through the bronchial passage can be blocked. During the healing process, airway ablation can induce neointimal hyperplasia and occlusion. However, this process can take several days and may be too slow. In some embodiments, a physical airway occlusion device can be inserted after an airway heating procedure. The airway occlusion device may include a plug (e.g., a silicone or plastic plug), a one-way valve device, glue, and / or foam. The plug may be temporarily placed and can be removed after the expected necrosis is complete. Alternatively, it may be absorbed by the body or may be permanently retained.

[0105] Any methods, techniques, or systems described in this disclosure may be used in combination or in series with each other, or in conjunction with the methods, techniques, or systems described in PCT application filed on July 7, 2020, entitled "Systems and Method for Diffuse Endoluminal Thermal Liquid Treatment" (File No.: P02303-WO), which is incorporated by reference.

[0106] In some embodiments, the systems and methods disclosed herein can be used in medical procedures utilizing robot-assisted medical systems, which are further described in detail below. Figure 23As shown, the robot-assisted medical system 500 may include a manipulator assembly 502 for operating a medical device 504 (e.g., medical device system 100 or any medical device having the aforementioned expandable device) to perform various procedures on a patient P located on an operating table T in a surgical environment 501. The manipulator assembly 502 may be a remotely operated, non-remotely operated, or hybrid remotely and non-remotely operated assembly having selected degrees of freedom of motion, which may be motorized and / or remotely operated, and selected degrees of freedom of motion, which may be non-motorized and / or non-remotely operated. A main assembly 506, which may be inside or outside the surgical environment 501, typically includes one or more control devices for controlling the manipulator assembly 502. The manipulator assembly 502 supports the medical device 504 and may optionally include a plurality of actuators or motors that drive inputs on the medical device 504 in response to commands from a control system 512. The actuators may optionally include a drive system that, when coupled to the medical device 504, can advance the medical device 504 into an anatomical opening created naturally or surgically. Other drive systems can move the distal end of a medical device with several degrees of freedom, which may include three linear motions (e.g., linear motion along the X, Y, Z Cartesian axes) and three rotational motions (e.g., rotation about the X, Y, Z Cartesian axes).

[0107] The robot-assisted medical system 1100 also includes a display system 510 for displaying images or representations of the surgical site and medical instrument 504 generated by a sensor system 508, which may include an endoscopic imaging system. The display system 510 and main component 506 can be oriented such that an operator O can use telepresent perception to control the medical instrument 504 and main component 506. Any previously described graphical user interface can be displayed on the display system 510 and / or the display system of a stand-alone planning workstation.

[0108] Sensor system 508 may include a position / positioning sensor system (e.g., an actuator encoder or electromagnetic (EM) sensor system) and / or a shape sensor system (e.g., a fiber optic shape sensor) for determining the position, orientation, speed, rate, posture, and / or shape of medical device 504. Sensor system 508 may also include a temperature sensor, such as temperature sensors 336, 362, 394, and 464.

[0109] The robot-assisted medical system 500 may also include a control system 512. The control system 512 includes at least one memory 516 and at least one computer processor 514 for implementing control between the medical device 504, the main component 506, the sensor system 508, and the display system 510. The control system 512 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement various operating modes of the robot-assisted medical system, including a navigation planning mode, a navigation mode, and / or a programmed mode. The control system 512 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement some or all of the processes described according to various aspects of the disclosure herein, including, for example, expanding an expandable device, adjusting the temperature of a heating system, controlling the insertion and retraction of a therapeutic device, controlling the actuation of the distal end of a therapeutic device, receiving sensor information, selecting a treatment location, and / or determining the size to which the expandable device can be expanded.

[0110] The control system 512 may optionally further include a virtual visualization system to provide navigational assistance to the operator O when controlling the medical device 504 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system may be based on a reference to a preoperative or intraoperative dataset of acquired anatomical access routes. The virtual visualization system uses imaging techniques to process images of the surgical site, such as computed tomography (CT), magnetic resonance imaging (MRI), fluorescence microscopy, temperature recording, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. As provided in the description of method 200 above, the control system 512 may use preoperative images to locate target tissue and create preoperative planning, including an optimal first location for bronchial access and vascular system occlusion. Preoperative planning may include, for example, the planned size of the expandable device, treatment time, and / or several deployment locations.

[0111] In the description, specific details describing some embodiments have been set forth. Numerous specific details have been set forth to provide a thorough understanding of the embodiments. However, it will be apparent to those skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are intended to illustrate and not limit. Those skilled in the art will recognize other elements that, while not specifically described herein, are within the scope and spirit of this disclosure.

[0112] Elements described in detail with reference to one embodiment, implementation, or application may optionally be included in other embodiments, implementations, or applications where they are not specifically shown or described, as long as practicable. For example, if an element is described in detail with reference to one embodiment and not with reference to a second embodiment, that element may still be claimed to be included in the second embodiment. Therefore, to avoid unnecessary repetition in the following description, one or more elements shown and described in association with one embodiment, implementation, or application may be incorporated into other embodiments, implementations, or aspects unless otherwise specifically described, unless the one or more elements render the embodiment or implementation ineffective, or unless two or more of the elements provide conflicting functionality. Not all illustrated processes can be performed in all embodiments of the disclosed methods. Furthermore, one or more processes not explicitly stated may be included before, after, between, or as part of the illustrated processes. In some embodiments, one or more of the processes may be performed by a control system or may be implemented at least in part in the form of executable code stored on a non-transitory, tangible, machine-readable medium, which, when run by one or more processors, causes the one or more processors to perform one or more of the processes.

[0113] Any changes and further modifications to the described apparatus, instruments, methods, and principles of this disclosure are fully considered and would normally occur to those skilled in the art to which this disclosure pertains. Furthermore, the dimensions provided herein are for specific examples, and it is contemplated that the concepts of this disclosure may be implemented using different sizes, dimensions, and / or ratios. To avoid unnecessary repetition of description, one or more components or actions described according to one illustrative embodiment may be used or omitted when applicable to other illustrative embodiments. For brevity, multiple iterations of these combinations will not be described separately. For simplicity, in some cases, the same reference numerals are used throughout the drawings to refer to the same or similar components.

[0114] The systems and methods described herein are applicable to imaging in any of a variety of anatomical systems via connection channels created naturally or surgically, including the lungs, colon, intestines, stomach, liver, kidneys and renal calyces, brain, heart, circulatory system including the vascular system, and / or the like. While some embodiments of medical procedures are provided herein, any reference to medical or surgical instruments and methods is non-limiting. For example, the instruments, systems, and methods described herein can be used for non-medical purposes, including industrial use, general robotic use, and sensing or manipulating non-tissue artifacts. Other example applications relate to cosmetic improvements, imaging of human or animal anatomy, data collection from human or animal anatomy, and training medical or non-medical personnel. Further example applications include surgery on tissue removed from human or animal anatomy (without returning to the anatomy) and surgery on human or animal cadavers. Furthermore, these techniques can also be used in surgical and non-surgical medical treatments or diagnostic procedures.

[0115] One or more elements of the embodiments of this disclosure can be implemented in software to execute on a processor of a computer system, such as a control processing system. When implemented in software, elements of the embodiments of this disclosure can be code segments performing various tasks. Programs or code segments can be stored in a processor-readable storage medium or device that can be downloaded via computer data signals carried on a carrier wave over a transmission medium or communication link. Processor-readable storage devices can include any medium capable of storing information, including optical media, semiconductor media, and / or magnetic media. Examples of processor-readable storage devices include: electronic circuits; semiconductor devices, semiconductor storage devices, read-only memory (ROM), flash memory, erasable programmable read-only memory (EPROM); floppy disks, CD-ROMs, optical disks, hard disks, or other storage devices. Code segments can be downloaded via computer networks such as the Internet, intranets, etc. Any of a variety of centralized or distributed data processing architectures can be employed. Programmed instructions can be implemented as multiple separate programs or subroutines, or they can be integrated into multiple other aspects of the system described herein. In some examples, the control system may support wireless communication protocols such as Bluetooth, Infrared Data Association (IrDA), HomeRF, IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), Ultra Wideband (UWB), ZigBee, and wireless telemetry.

[0116] Please note that the presented processes and displays may be inherently unrelated to any particular computer or other device. Various general-purpose systems may be used with the programs taught herein, or configuring more specialized devices to perform the described operations may prove convenient. The necessary structures for various such systems will appear as elements in the claims. Furthermore, embodiments of the invention are described without reference to any particular programming language. It will be understood that the teachings of the invention as described herein can be implemented using a variety of programming languages.

[0117] This disclosure describes various instruments, instrument parts, and anatomical structures based on their state in three-dimensional space. As used herein, the term position refers to the orientation of an object or part of an object in three-dimensional space (e.g., three translational degrees of freedom along Cartesian x-, y-, and z-coordinates). As used herein, the term orientation refers to the rotational placement of an object or part of an object (e.g., in one or more rotational degrees of freedom, such as roll, pitch, and / or yaw). As used herein, the term pose refers to the position of an object or part of an object in at least one translational degree of freedom and the orientation of the object or part of the object in at least one rotational degree of freedom (e.g., up to six total degrees of freedom). As used herein, the term shape refers to a set of poses, positions, or orientations measured along the object.

[0118] Although certain illustrative embodiments of the invention have been described and illustrated in the accompanying drawings, it should be understood that these embodiments are merely illustrative of the broad invention and not limiting, and that the embodiments of the invention are not limited to the specific constructions and arrangements shown and described, as various other modifications will be apparent to those skilled in the art.

[0119] The following numbered examples illustrate various aspects of the topics discussed in this article.

[0120] Example 1: A method for treating diseased target tissue causing chronic lung disease, comprising: expanding a treatment device positioned within a first airway at a first location along the length of a first airway; and applying heat using the treatment device at a certain temperature and for a certain time period to at least ablate the bronchial wall of the first airway.

[0121] Example 2: The method according to Example 1 further includes determining a distance, wherein the distance is based on the thickness of the bronchial wall at the first location.

[0122] Example 3: The method according to Example 1 further includes determining a distance, wherein the distance is between the inner surface of the bronchial wall and a plurality of bronchial arteries adjacent to the anatomical lumen.

[0123] Example 4: The method according to Example 2 or 3, wherein determining the distance includes receiving sensor data.

[0124] Example 5: The method according to Example 2 or 3, wherein determining the distance includes receiving a predetermined distance.

[0125] Example 6: The method according to one of Examples 2-5 further includes expanding the treatment device to an expanded configuration based on the determined distance.

[0126] Example 7: The method according to one of Examples 2-6, wherein the determined distance is used to reduce the diameter of at least one of the plurality of bronchial arteries.

[0127] Example 8: The method according to one of Examples 2-7, wherein the time period is further based on preventing the ablation of multiple bronchial arteries.

[0128] Example 9: The method described in one of Examples 2-8, wherein the time period is at least partially based on the distance.

[0129] Example 10: The method according to one of Examples 1-9, wherein the time period is at least partially based on the temperature.

[0130] Example 11: A method according to one of Examples 1-10, wherein expanding the treatment device includes expanding to a deployment size for expanding the airway by 5% to 20%.

[0131] Example 12: The method described in one of Examples 1-11, wherein the time period is between 5 and 20 seconds.

[0132] Example 13: The method described in one of Examples 1-12, wherein the temperature is between 70 and 90 degrees Celsius.

[0133] Example 14: The method described in one of Examples 1-13, wherein the chronic lung disease is bronchiectasis.

[0134] Example 15: The method described in one of Examples 1-14, wherein the chronic lung disease is emphysema.

[0135] Example 16: The method according to one of Examples 2 or 3, wherein the determined distance is used to maintain the diameter of the pulmonary artery adjacent to the anatomical lumen.

[0136] Example 17: The method according to any one of Examples 1-10 or 16, wherein expanding the treatment device includes expanding to a deployment size for expanding the airway by 10% to 50%.

[0137] Example 18: The method described in any of Examples 1-10 or 16-17, wherein the time period is between 20 and 120 seconds.

[0138] Example 19: The method according to any one of Examples 1-10 or 16-18, wherein the temperature is between 80 and 95 degrees Celsius.

[0139] Example 20: The method according to any one of Examples 1-10 or 16-19, wherein the chronic lung disease is emphysema.

[0140] Example 21: The method according to any one of Examples 1-10, wherein expanding the treatment device includes expanding to a deployment size for expanding the airway by 50% to 1000%.

[0141] Example 22: The method described in any of Examples 1-10 or 21, wherein the time period is between 120 and 300 seconds.

[0142] Example 23: The method according to any one of Examples 1-10 or 21-22, wherein the temperature is between 90 and 95 degrees Celsius.

[0143] Example 24: The method according to one of Examples 2 or 3, wherein the determined distance is used to reduce the diameter of a pulmonary artery adjacent to the first airway, wherein the pulmonary artery provides blood flow to the target tissue.

[0144] Example 25: The method of claim 24, wherein the treatment device is used to apply heat to occlude the pulmonary artery to block blood flow to the target tissue.

[0145] Example 26: The method according to Example 24 or 25, wherein the first position is located along the length of the first airway, proximal to the target tissue.

[0146] Example 27: The method according to one of Examples 24-26 further includes determining the first location for applying heat to the first airway.

[0147] Example 28: The method according to one of Examples 25-27 further includes monitoring fluid flow in the pulmonary artery to determine whether the pulmonary artery is occluded.

[0148] Example 29: The method according to one of Examples 24-28 further includes determining a second location along the length of the first airway, wherein the target tissue is located at the second location.

[0149] Example 30: The method according to Example 29 further includes ablation of the target tissue at the second location.

[0150] Example 31: The method according to Example 30 further includes: collapsing the treatment device; repositioning the treatment device at the second location; expanding the treatment device at the second location; and applying heat to ablate the target tissue.

[0151] Example 32: The method according to one of Examples 24-31 further includes identifying a blood vessel supplying blood to the target tissue, wherein the blood vessel is adjacent to the second airway.

[0152] Example 33: The method according to Example 32 further includes applying heat to the blood vessel when the treatment device is positioned within the second airway.

[0153] Example 32: The method according to Example 1 or any of 21-33, wherein the target tissue includes a cancerous tumor.

[0154] Example 33: The method according to Example 32, wherein the target tissue includes the periphery surrounding the cancerous tumor.

[0155] Example 34: A method for treating chronic lung disease, comprising: expanding a treatment device within an airway to a deployment configuration, wherein the deployment configuration expands folds along the wall of the airway; and applying heat using the treatment device, wherein the heat is applied at a certain temperature and for a certain time period to ablate goblet cells and cilia within the wall of the airway without damaging the bronchial arteries surrounding the airway.

[0156] Example 35: The method according to Example 34 further includes determining a distance, wherein the distance is based on the thickness of the bronchial wall at the first location of the airway.

[0157] Example 36: The method according to Example 34 further includes determining a distance, wherein the distance is between the inner surface of the bronchial wall of the airway and a plurality of bronchial arteries adjacent to the anatomical lumen.

[0158] Example 37: The method according to Example 35 or 36, wherein determining the distance includes receiving sensor data.

[0159] Example 38: The method according to Example 35 or 36, wherein determining the distance includes receiving a predetermined distance.

[0160] Example 39: The method according to one of Examples 35-38 further includes expanding the treatment device to an expanded configuration based on the determined distance.

[0161] Example 40: A method of one of Examples 35-39, wherein the determined distance is provided to reduce the diameter of at least one of the plurality of bronchial arteries adjacent to the airway.

[0162] Example 41: The method according to Example 40, wherein the time period is further based on preventing the ablation of multiple bronchial arteries.

[0163] Example 42: The method according to one of Examples 35-41, wherein the time period is at least partially based on the distance.

[0164] Example 43: The method according to one of Examples 35-42, wherein the time period is at least partially based on the temperature.

[0165] Example 44: The method according to one of Examples 35-43, wherein expanding the treatment device includes expanding to a deployment size for expanding the airway by 10% to 30%.

[0166] Example 45: The method described in one of Examples 35-44, wherein the time period is between 5 and 15 seconds.

[0167] Example 46. The method according to one of Examples 35-45, wherein the temperature is between 60 and 70 degrees Celsius.

[0168] Example 47. The method according to one of Examples 35-46, wherein the chronic lung disease is chronic bronchitis.

[0169] Example 48: A method for treating bronchiectasis, comprising: identifying a ruptured bronchial artery adjacent to an airway; expanding a device within the airway to a deployment configuration, wherein the deployment configuration compresses the ruptured bronchial artery; and applying heat using the device to occlude the ruptured bronchial artery, wherein the device includes an insulating portion and a conductive portion, and wherein the insulating portion is aligned toward the ruptured bronchial artery.

[0170] Example 49: The method according to one of Examples 1-48, wherein applying the heat includes operating a heating system to heat the liquid.

[0171] Example 50: According to the method of Example 49, the liquid is heated by the heating system at the distal portion of the treatment device before being released from the distal portion of the treatment device.

[0172] Example 51: The method according to Example 49 or 50, wherein the heating system heats the liquid using resistance energy.

[0173] Example 52: The method according to Example 49 or 50, wherein the heating system heats the liquid with radio frequency energy.

[0174] Example 53: The method according to one of Examples 1-48, wherein ablation of the target tissue includes applying heat generated by an RF heat source, a microwave heat source, or a resistive heat source.

[0175] Example 54: A system for treating target tissue, comprising: a catheter including a distal portion configured for deployment in an anatomical lumen; an expansion device coupled to the distal portion of the catheter; a processor; and a memory having computer-readable instructions stored thereon, the computer-readable instructions causing the system to perform one of the methods described in Examples 1-53 when executed by the processor.

Claims

1. A system for treating target tissue located at a first position along an anatomical lumen, the system comprising: A catheter, which includes a distal portion configured for deployment within the anatomical lumen; and An expansion device coupled to the distal portion of the catheter, the expansion device comprising a ridge and a rhomboid cross-section in a deployment configuration. The expansion device in the deployment configuration occludes the anatomical lumen at a second location along the anatomical lumen, different from the first location, and the ridge is configured to compress at least one of a plurality of blood vessels adjacent to the anatomical lumen to reduce blood flow to the target tissue at the first location.

2. The system of claim 1, wherein the expansion device in the deployment configuration expands the anatomical lumen and reduces the distance between the wall of the anatomical lumen and at least one of the plurality of blood vessels.

3. The system of claim 1, wherein the dilation device in the deployment configuration reduces the diameter of at least one of the plurality of blood vessels.

4. The system of claim 1, wherein the system further comprises a heating system configured to heat the dilation device to further occlude the anatomical lumen and at least one of the plurality of blood vessels.

5. The system of claim 4, wherein the heating system is located at the distal portion of the conduit, and wherein the heating system comprises at least one of a resistance heating element, an RF heat source, a microwave heat source, an ultrasonic heat source, or a laser heat source.

6. The system of claim 4, wherein the expansion device comprises a balloon.

7. The system according to claim 6, further comprising: A liquid source provides liquid to fill the balloon, thereby expanding the balloon into the deployment configuration.

8. The system of claim 7, wherein the heating system is further configured to heat the liquid.

9. The system of claim 8, wherein the liquid is heated by the heating system at the distal portion of the catheter after being released into the balloon.

10. The system of claim 7, wherein the heating system comprises two radio frequency electrodes, and wherein at least one of the radio frequency electrodes is coupled to the balloon.

11. The system of claim 10, wherein the heating system includes two radio frequency electrodes coupled to the conduit.

12. The system of claim 6, wherein the balloon includes a reinforcing member, and wherein the reinforcing member is configured to support the inflation of the balloon.

13. The system of claim 12, wherein the reinforcing member comprises a woven fabric or a metal coating.

14. The system of claim 4, wherein the expansion device comprises an expandable ring.

15. The system of claim 4, further comprising a processor configured to: Expand the expansion device and adjust the heating system.

16. The system of claim 15, wherein the expansion of the dilation device is based on the distance between the wall of the anatomical lumen and at least one of the plurality of blood vessels, the amount of compression of the at least one of the plurality of blood vessels, the diameter of the anatomical lumen, or the blood flow rate.

17. The system according to any one of claims 1-16, wherein the anatomical lumen is an airway; the target tissue comprises parenchymal tissue; and the plurality of blood vessels comprises bronchial arteries.

18. The system of claim 17, wherein the expansion device in the deployment configuration expands the airway by 10% to 50%.

19. The system of claim 17, wherein the plurality of blood vessels further comprises a pulmonary artery.

20. The system of claim 19, wherein the expansion device in the deployment configuration causes the airway to expand between 50% and 100%.

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