Systems, devices, and methods for ablation and defunctioning of the gallbladder

Abstract

Provided herein are catheter devices, systems, and methods for ablating tissue locations. The devices, systems, and methods disclosed herein include ablation systems, including catheter systems including inner and outer shafts, that deliver an ablation medium (e.g., a cryogenic ablation medium) to a body lumen and eject the ablation medium from the body lumen. In some embodiments, the devices, systems, and methods disclosed herein include an expandable structure that facilitates nozzle positioning and / or ejection of the ablation medium from the body lumen.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the priority and benefit of U.S. Provisional Application No. 63 / 066,005, filed on August 14, 2020, entitled "SYSTEMS, DEVICES, AND METHODS FOR ABLATION AND DEFUNCITONALIZATION OF A GALLBLADDER", the disclosure of which is incorporated herein by reference in its entirety.

[0002] (Field of the Invention) The present disclosure relates to devices and methods for ablation and defunctionalization of the gallbladder.

Background Art

[0003] Medical ablation techniques, such as those used in cardiology, oncology, general surgery, gastroenterology, dermatology, and interventional radiology, are focused on local tissue targets and provide a high degree of ablation depth control, but may not be effective or practical for large high - surface area (HSA) tissue ablation targets within the body. Cryoablation techniques utilize common cryogen sprays to provide a platform for HSA tissue ablation, but have certain drawbacks associated with safely and effectively delivering energy into a closed lumen such as the gallbladder. For example, ice accumulation or other troublesome problems during an ablation procedure can lead to damage and / or ineffective ablation. Therefore, it is desirable to have systems, devices, and methods to address the drawbacks of existing ablation systems.

Summary of the Invention

[0004] This disclosure relates to devices and methods for ablation and defunctionalization of the gallbladder. In some embodiments, the device includes a shaft having a distal portion that defines a lumen and can be disposed within the body lumen of a target, and a nozzle disposed on the distal portion that defines a plurality of openings that are in fluid communication with the lumen and is configured to deliver an ablation medium into the body lumen; and an expandable structure disposed around the nozzle, configured to transition into an expanded state within the body lumen, and comprising a plurality of elongated members configured to (1) position the nozzle at least a predetermined distance away from tissue in the body lumen when the expandable structure is in the expanded state, and (2) allow the ablation medium to come into contact with and ablate the tissue in the body lumen through the expandable structure.

[0005] In some embodiments, the apparatus includes an outer shaft having a distal end that can be disposed within a body lumen of a target, wherein the outer shaft defines a first lumen and a plurality of discharge openings that are in fluid communication with the first lumen, and the plurality of discharge openings and the first lumen are collectively configured to discharge an ablation medium from the body lumen, and the outer shaft includes an expandable structure that (1) is disposed on the distal end of the outer shaft and (2) surrounds the plurality of discharge openings and is configured to transition to an expanded state to prevent debris from clogging the plurality of discharge openings; and an inner shaft having a nozzle that can be disposed within the first lumen and extends distally to the outer shaft, wherein the inner shaft defines a second lumen that is in fluid communication with the nozzle, and the second lumen is configured to deliver the ablation medium to the nozzle so that the nozzle can spray the ablation medium throughout the body lumen and ablate in contact with the tissue within the body lumen.

[0006] In some embodiments, the method includes: moving a first expandable structure, positioned on the distal end of the outer shaft of an ablation catheter, to an expanded state in order to hold the access sheath within the body lumen of a target, wherein the distal end of the outer shaft is positioned within the body lumen and the outer shaft defines a first lumen; advancing the distal end of the inner shaft through the first lumen into the body lumen, wherein the inner shaft defines a second lumen and includes a nozzle and a second expandable structure positioned on the distal end of the inner shaft; moving the second expandable structure to an expanded state so that the nozzle is positioned at least a predetermined distance from the tissue in the body lumen; delivering ablation fluid to the nozzle through the second lumen; and dispensing the ablation fluid from the nozzle so that the ablation fluid is transferred to an ablation gas that comes into contact with the tissue in the body lumen and ablates the tissue. [Brief explanation of the drawing]

[0007] [Figure 1] This is a schematic diagram of an ablation system (e.g., a cryoablation device) according to an embodiment. [Figure 2] This is a schematic diagram of the outer shaft of a catheter system according to an embodiment. [Figure 3] This is a schematic diagram of the inner shaft of a catheter system according to an embodiment. [Figure 4] This is a schematic diagram of a catheter system according to an embodiment. [Figure 5] This is a schematic diagram of the control unit of the ablation system according to an embodiment. [Figure 6A] This is a flowchart of a method for ablation and its monitoring according to an embodiment. [Figure 6B] This is a flowchart of a method for ablation and its monitoring according to an embodiment. [Figure 7A] This figure illustrates different percutaneous and endoscopic access approaches for an ablation system according to an embodiment. [Figure 7B] This figure illustrates different percutaneous and endoscopic access approaches for an ablation system according to an embodiment. [Figure 7C] This figure illustrates different percutaneous and endoscopic access approaches for an ablation system according to an embodiment. [Figure 8] This is a diagram of an ablation system according to an embodiment. [Figure 9] This is a detailed view of the outer and inner shafts of an ablation catheter according to an embodiment. [Figure 10] This is a diagram of an ablation catheter deployed in a body lumen according to an embodiment. [Figure 11] This is a diagram of the inner shaft of an ablation catheter including a fenestrated nozzle, according to an embodiment. [Figure 12A] This is a diagram of the outer shaft of an ablation catheter according to an embodiment. [Figure 12B] This is a diagram of the outer shaft of an ablation catheter according to an embodiment. [Figure 13A] This is a diagram of a portion of an ablation catheter, including an expandable structure, according to various embodiments. [Figure 13B] This is a diagram of a portion of an ablation catheter, including an expandable structure, according to various embodiments. [Figure 13C] This is a diagram of a portion of an ablation catheter, including an expandable structure, according to various embodiments. [Figure 14] This is a diagram of the inner shaft of an ablation catheter, including an expandable structure, according to an embodiment. [Figure 15] This is a diagram of an ablation catheter, including an opening for drainage, according to an embodiment. [Figure 16A] This is a cross-sectional view of an ablation catheter, including an excretion lumen, according to various embodiments. [Figure 16B] This is a cross-sectional view of an ablation catheter, including an excretion lumen, according to various embodiments. [Figure 17A]It is a diagram of an outer shaft of an ablation catheter including a discharge opening according to an embodiment. [Figure 17B] It is a diagram of an outer shaft of an ablation catheter including a discharge opening according to an embodiment. [Figure 18A] It is a diagram of an ablation catheter including an expandable mechanism and a discharge opening according to an embodiment. [Figure 18B] It is a diagram of an ablation catheter including an expandable mechanism and a discharge opening according to an embodiment. [Figure 19A] It is a diagram of an inner shaft of an ablation catheter including a spherical or round nozzle according to an embodiment. [Figure 19B] It is a diagram of an inner shaft of an ablation catheter including a spherical or round nozzle according to an embodiment. [Figure 20] It is a diagram of an inner shaft of an ablation catheter including a spherical or round nozzle deployed in a body cavity according to an embodiment. [Figure 21] It is a diagram of an ablation catheter including a movable nozzle having a free end according to an embodiment. [Figure 22] It is a diagram of an ablation catheter including a movable nozzle having a fixed end (e.g., fixed using an occluder) according to an embodiment. [Figure 23] It is a diagram of an ablation catheter including a curved nozzle according to an embodiment. [Figure 24] It is a diagram of an ablation catheter including a curved nozzle deployed in a body cavity according to an embodiment. [Figure 25] It is a diagram of an ablation catheter including a nozzle arm according to an embodiment. [Figure 26A] It is a cross-sectional view of a nozzle arm of an ablation catheter according to an embodiment. [Figure 26B] It is a cross-sectional view of a nozzle arm of an ablation catheter according to an embodiment. [Figure 27A] It is a diagram of an ablation catheter including a spiral nozzle according to an embodiment. [Figure 27B] This is a diagram of an ablation catheter including a spiral nozzle according to an embodiment. [Figure 28] This is a cross-sectional view of an ablation catheter including a catheter heating system according to an embodiment. [Figure 29A] This is a diagram of an ablation catheter including a catheter heating system according to an embodiment. [Figure 29B] This is a diagram of an ablation catheter including a catheter heating system according to an embodiment. [Figure 30A] This is a diagram of the outer shaft and dilator of an ablation catheter according to an embodiment. [Figure 30B] This is a diagram of the outer shaft and dilator of an ablation catheter according to an embodiment. [Figure 31A] This is a diagram of the outer shaft of an ablation catheter, including an expandable structure in both an un-deployed and de-deployed state, according to an embodiment. [Figure 31B] This is a diagram of the outer shaft of an ablation catheter, including an expandable structure in both an un-deployed and de-deployed state, according to an embodiment. [Figure 32A] This is a diagram of the inner shaft of an ablation catheter including an actuator, according to an embodiment. [Figure 32B] This is a diagram of the inner shaft of an ablation catheter including an actuator, according to an embodiment. [Figure 32C] This is a diagram of the inner shaft of an ablation catheter including an actuator, according to an embodiment. [Figure 33] This is a diagram of an assembled ablation catheter according to an embodiment. [Figure 34A] This is a diagram of an ablation catheter according to an embodiment. [Figure 34B] This is a diagram of an ablation catheter according to an embodiment. [Figure 35A] This is a diagram of the sheath of an ablation catheter according to an embodiment. [Figure 35B] This is a diagram of the sheath of an ablation catheter according to an embodiment. [Figure 36] This is a diagram of an ablation catheter according to an embodiment. [Figure 37A] This is a diagram of a nozzle assembly according to an embodiment. [Figure 37B] This is a diagram of a nozzle assembly according to an embodiment. [Figure 38A] This is a diagram of a catheter assembly according to an embodiment. [Figure 38B] This is a diagram of a catheter assembly according to an embodiment. [Figure 38C] This is a diagram of a catheter assembly according to an embodiment. [Figure 38D] This is a diagram of a catheter assembly according to an embodiment. [Figure 38E] This is a diagram of a catheter assembly according to an embodiment. [Figure 39] This is a description of the placement location of the temperature sensor in the gallbladder according to the embodiment. [Figure 40A] This is a diagram of an ablation system (e.g., a cryoablation device) including a pressure sensor, according to various embodiments. [Figure 40B] This is a diagram of an ablation system (e.g., a cryoablation device) including a pressure sensor, according to various embodiments. [Figure 40C] This is a diagram of an ablation system (e.g., a cryoablation device) including a pressure sensor, according to various embodiments. [Figure 40D] This is a diagram of an ablation system (e.g., a cryoablation device) including a pressure sensor, according to various embodiments. [Modes for carrying out the invention]

[0008] This disclosure relates to ablation systems, devices, and methods for ablating internal lumens, such as the lumen of the gallbladder. In some embodiments, the systems, devices, and methods described herein relate to cryoablation devices for tissue ablation. In some embodiments, the systems, devices, and methods described herein relate to ablation medium release valves for catheter-based cryoablation devices, for example, designed to safely, effectively, and uniformly disperse an ablation medium (e.g., a cryoablation medium) onto a target area (e.g., tissue lining the inside of the lumen of the gallbladder). In some embodiments, the systems, devices, and methods described herein relate to controlling the operation of an ablation system based on sensor data, such as pressure and / or temperature data. In some embodiments, the systems, devices, and methods described herein include and / or can be used with sensors (e.g., one or more probes) to track the characteristics or state of the internal lumen (e.g., the lumen of the gallbladder) and / or the ablation medium delivered into the internal lumen. Examples of preferred components of an ablation system including a cryoablation device are described in International Application US2019 / 017112, titled "GALLBLADDER DEFUNCITONALIZATION DEVICES AND METHODS," filed on 7 February 2019, and International Application US2020 / 045436, titled "SYSTEMS, DEVICES, AND METHODS FOR ABLATION AND DEFUNCTIONALIZATION OF A GALLBLADDER," filed on 7 August 2020, each incorporated in its entirety by reference.

[0009] Gallstones are one of the most common gastrointestinal disorders among Americans. Gallstones form when bile, a fluid secreted by the liver and stored in the gallbladder, becomes supersaturated. While gallstones do not cause problems for many people, they can block the cystic duct, i.e., the outlet for the gallbladder, preventing it from emptying. In some cases, the obstruction can lead to pain, inflammation, and infection. In otherwise healthy patients, cholelithiasis is treated by surgical removal of the gallbladder. However, the risks associated with surgical intervention are considerably higher in certain patient populations. For example, it has been shown that one in five Medicare patients will experience adverse outcomes. Non-surgical treatment options for these patients are limited and focus on alleviating acute symptoms without addressing the underlying cause of the disease. In some cases, the disease can recur, resulting in further clinical risks and significant costs. Currently, there are no long-term solutions for gallbladder disease in high-risk patients.

[0010] As shown in Figures 7A–7C, the gallbladder 2 is a small hollow organ in the gastrointestinal system. A blind-ended tubular sac of the biliary system, the gallbladder 2 is a pear-shaped organ with a storage capacity of 30 milliliters (mL) to 50 mL. The gallbladder is typically 2–3 centimeters (cm) wide and 7–10 cm in axial length. The gallbladder is typically divided into three parts: the base, the body, and the neck. The neck contains a mucosal fold known as Hartmann's capsule, which is a common site where gallstones can become lodged, leading to cholecystitis. As shown in Figures 7A–7C, the gallbladder 2 is connected to the liver 8 by the common hepatic duct 18, which opens into the cystic duct 14 and branches into the right and left hepatic ducts. The gallbladder 2 is connected to the small intestine 10 by the common bile duct 16.

[0011] Histologically, the gallbladder has four layers: the serosa (outermost layer), the muscular layer, the lamina propria, and the innermost mucosal layer. The mucosal layer of the gallbladder is the innermost layer of the gallbladder wall and concentrates bile. The serosa originates from the visceral peritoneum and covers the anterior base, body, and neck of the gallbladder. Inside the serosa, a single muscular layer covers the lamina propria. The mucosa lining the inside of the gallbladder lumen is composed of columnar epithelial cells that secrete mucin and dehydrate bile through the action of multiple ion channels. Occasionally, mucosal sacs (known as Rokitansky-Aschoff nodules) extend into deeper layers of the gallbladder wall.

[0012] The gallbladder stores and concentrates bile produced by the liver, releasing the stored bile into the small intestine, where it aids in the digestion of fats in food. Bile is produced by hepatocytes in the liver and then secreted into hepatic tubules that merge into the intrahepatic ducts. These tubules converge to form the left and right hepatic ducts, which then join the common bile duct. The common bile duct joins the pancreatic duct just proximal to the ampulla of Vater in the duodenal wall. Bile produced by hepatocytes flows through the biliary system into the duodenal lumen, aiding in digestion.

[0013] The flow of bile into the duodenal lumen is regulated at the level of the ampulla of Vater by the sphincter of Oddi. During non-feeding states when bile is not needed for digestion, the sphincter closes, resulting in the route of bile to the gallbladder for storage. During storage, the bile becomes supersaturated, providing a foci for the formation of gallstones and sludge (very small gallstones). The majority of gallstones are "brown stones" consisting mainly of cholesterol (typically >80%). These stones are brittle and tend to break easily. A small number of stones are mainly bilirubin ("black stones", <20% cholesterol) and are often harder. Mixed stones contain variable amounts of bilirubin and cholesterol.

[0014] Movable gallstones remaining in the lumen of the gallbladder can cause a variety of medical conditions. In some cases, gallstones can become lodged in the neck of the gallbladder, obstructing the cystic duct. This lodged gallstone can cause gallbladder distension and intermittent right upper abdominal discomfort (likely resulting from intramural muscle spasms in the organ trying to empty in response to the increased pressure gradient), a condition known as symptomatic cholelithiasis. In some cases, gallstones can become more persistently lodged at the gallbladder outlet, leading to inflammation and infection. This is a condition known as cholecystitis, which can progress to systemic infection and requires urgent intervention.

[0015] Alternatively, or in combination, gallstones or sludge can pass through the cystic duct and block the common bile duct, obstructing the flow of bile and leading to a potentially life-threatening condition known as ascending cholangitis. In some embodiments, debris can block the confluence of the pancreatic duct and common bile duct, causing stagnation of pancreatic juice secretion and leading to pancreatitis (inflammation of the pancreas).

[0016] In cholelithiasis, supersaturation of bile in the gallbladder leads to the formation of gallstones. In some cases, impacted gallstones cause inflammation, pain, and infection of the gallbladder. When the gallbladder is inflamed, the mucosal layer of the gallbladder becomes more prominent. In some cases, gallstones are diagnosed by ultrasound or other imaging methods. Provided herein are methods and devices configured to minimally invasively treat benign gallbladder disease in patients with symptomatic gallstones in order to reduce healthcare costs and patient morbidity.

[0017] Laparoscopic cholecystectomy is a common surgical procedure used to treat gallstone disease. During the procedure, small incisions are made in the lower abdomen, and a camera and small instruments are used to facilitate the removal of the gallbladder. This procedure is safe in otherwise healthy patients and often does not require hospitalization. In cases without complications, patients often return to work within two weeks.

[0018] In many patient populations, the surgical risks associated with laparoscopic cholecystectomy are considerably high. In some cases, these populations include patients with critical conditions, chronic diseases and intra-abdominal scarring from previous surgeries, and older patients who tend to have a higher incidence of medical comorbidities. One such population is the Medicare population, which in the United States includes approximately 200,000 laparoscopic cholecystectomies per year. 21 percent of these surgeries result in adverse outcomes, including prolonged hospital stays and readmissions, as well as other perioperative complications. In addition to the direct costs associated with these complications, many older patients are at risk of not returning to baseline levels of health, thereby incurring additional healthcare costs.

[0019] Non-surgical options exist for treating gallstones. These include the administration of antibiotics, or the placement of a gallbladder fistula to drain the contents of the gallbladder, or a combination of both. However, non-surgical options do not offer a long-term solution. These options are effective temporary measures and do not treat the underlying cause of the disease. During percutaneous gallbladder fistula placement, the gallbladder fistula is placed into the gallbladder through the thoracic cavity. Percutaneous cholecystostomy can be performed in an interventional radiology (IR) facility or at the patient's bedside, but it does not provide a clear cure for gallstone disease. In many cases, non-surgical options lead to recurrence and further hospitalization costs.

[0020] For patients with cholecystitis at high risk of surgical complications, treatment involves percutaneous decompression of the gallbladder (via a percutaneously inserted gallbladder fistula) in combination with antibiotics. This treatment provides a temporary measure (commonly referred to by medical professionals as a "cooling-off") to allow the patient to recover from the systemic effects of the ongoing infection (sepsis) and return to their baseline state of health. The gallbladder fistula remains in place until the patient recovers. Approximately 6-8 weeks after placement, cholangiography is performed under fluoroscopy by injecting radiopaque contrast agent through the tube to determine whether the cystic duct is patent (open). The gallbladder fistula is removed if the gallbladder is patent. Treatment involves interval cholecystectomy to reduce the recurrence rate of gallstone disease. If there is no communication between the cystic duct and the common bile duct, the tube remains in place until cholecystectomy is performed or until patency is demonstrated by subsequent cholangiography. There is no definitive treatment available for high-risk patients, and these patients are at risk of disease recurrence and are exposed to associated clinical risks and medical costs.

[0021] Ablation techniques have been used to treat other diseases. For example, ablation is used to treat esophageal metaplasia and endometrial hyperplasia. However, ablation techniques are not readily available for treating gallstone disease. Ablation techniques are often applied to small target areas such as nerves and are typically not used to apply to diffuse areas or tissues or organs. The systems, devices, and methods described herein relate to the ablation and denial of the gallbladder and are in particular designed to safely and efficiently ablate the gallbladder.

[0022] Figure 1 is a schematic diagram of an exemplary ablation system 100 according to an embodiment. The ablation system 100 includes a control unit 110, a catheter system or ablation catheter 150, and an ablation medium supply unit 120. The control unit 110 can control the operation of one or more components of the ablation system 100.

[0023] The control unit 110 can be operably coupled to an ablation medium supply unit 120 that provides the ablation medium. For example, the control unit 110 may be configured to control the delivery of the ablation medium into a body lumen (e.g., the lumen of the gallbladder). In some embodiments, the ablation medium is a cryogenic ablation medium. In some embodiments, the cryogenic ablation medium is a liquid. In some embodiments, the cryogenic ablation medium is a gas. In some embodiments, the cryogenic ablation medium undergoes a transition from liquid to gas when delivered using the systems and devices disclosed herein. In some embodiments, cryoablation is achieved via refrigerant properties due to a transition from liquid to gas from an ablation medium such as liquid nitrous oxide, carbon dioxide, and argon. In some embodiments, the cryogenic ablation medium is one or more of nitrous oxide, nitrogen, carbon dioxide, or argon. In some embodiments, the cryogenic ablation medium transitions from a first state (e.g., liquid) to a second state (e.g., gas), and during the transition, the volume of the cryogenic medium can increase to about 600 times its original volume. In some embodiments, the control unit 110 can control one or more of the following: the temperature and pressure of the ablation medium. In some embodiments, the ablation medium, such as a low-temperature ablation medium, is in the range of about -120°C to about 0°C, including all values ​​and partial ranges within that range, when the low-temperature ablation medium is used with the systems and devices disclosed herein. In some embodiments, the ablation medium supply unit 120 may be a cryogenic cartridge.

[0024] The control unit 110 may optionally be coupled to a vacuum source 140 (e.g., a vacuum or suction pump, suction device, etc.). In some embodiments, the control unit 110 can control the vacuum source 140 to apply a vacuum to the channel or lumen of the catheter system 150 to remove or discharge the ablation medium from, for example, a body lumen (e.g., the lumen of the gallbladder). For example, the control unit 110 can activate the vacuum source 140 to apply negative pressure to the lumen of the catheter system 150 to discharge a portion of the ablation medium, such as a cryoablation medium delivered to the body lumen. Alternatively, in some embodiments, the ablation system 100 may not include a vacuum source 140, and the ablation medium may be discharged from the body lumen via passive discharge driven by the pressure difference between the inside of the body lumen and the external environment. For example, when an ablation medium, such as a cryoablation medium, is delivered into a body lumen, the ablation medium can increase the pressure inside the body lumen relative to the external environment (e.g., the outside atmosphere), and this pressure difference can drive the discharge of a portion of the ablation medium from the body lumen through a lumen defined by, for example, the catheter system 150.

[0025] In some embodiments, the control unit 110 may include or be operably coupled to one or more sensors (e.g., pressure sensors, temperature sensors) and operate or control one or more components of the ablation system 100 based on data collected by the one or more sensors. For example, the control unit 110 may be coupled to a pressure sensor and, based on measurements from the pressure sensor, may control the delivery of the ablation medium (e.g., from the ablation medium supply unit 120) and the discharge of the ablation medium (e.g., using a vacuum source 140) to maintain the pressure in the body lumen within a predetermined pressure range. In other words, the control unit 110 may be configured to control the delivery of air into the body lumen so that the pressure in the lumen is maintained within a predetermined pressure range. In some embodiments, the predetermined pressure range is less than 50 mmHg or less than 100 mmHg. In some embodiments, the predetermined pressure range is about 0 mmHg to about 40 mmHg or about 30 mmHg to about 40 mmHg. In some embodiments, the control unit 110 may be operably coupled to one or more valves, and the control unit 110 may be controlled to enable and / or terminate the delivery or discharge of the ablation medium. Examples of suitable valves are described in International Application US2020 / 045436, which is incorporated herein by reference.

[0026] In some embodiments, the control unit 110 and / or other components of the ablation system 100 may optionally be coupled to one or more additional computing devices 190. The computing devices 190 may be any suitable processing devices configured to operate and / or perform specific functions. The one or more computing devices 190 may include, for example, a computer, laptop, portable device, mobile device, or other suitable computing devices including a processor, memory, and / or input / output devices. For example, the control unit 110 may be coupled to a remote computing device, such as a workstation, from which a user (e.g., a physician, administrator, etc.) can control one or more operating parameters of the ablation system 100. The control unit 110 and the one or more computing devices 190 may be configured to transmit and / or receive data from one or more other computing devices 190, for example, over a network. For example, the control unit 110 may transmit warnings and / or other information to a remote device (e.g., a display, mobile device) so that the remote device can present that information to a user (e.g., a physician). In some embodiments, the control unit 110 can transmit data such as patient information and the operating status of one or more components of the ablation system 100.

[0027] In some embodiments, the control unit 110, the ablation medium supply unit 120, and / or other components of the ablation system 100 may be integrated into a handheld device attached to the proximal end of the catheter system 150. The handheld device may include one or more input and / or output devices (e.g., buttons, switches, keyboards, touchscreens, displays, etc.) through which an operator of the ablation system 100 can control the operation of the ablation system 100 to perform an ablation procedure. In some embodiments, the control unit 110 may be remote from the catheter system 150, and a remote operator can control one or more components of the ablation system 100 to perform an ablation procedure.

[0028] The catheter system 150 can be percutaneously inserted into a body lumen (e.g., the gallbladder lumen) to scar and disable a portion of a biological structure (e.g., the gallbladder) without requiring surgical removal of the biological structure. The catheter system 150 can be used in interventional radiology (IR) facilities with local anesthesia, eliminating the risks associated with general anesthesia in high-risk surgical patients. Device placement can leverage existing IR workflows and be deployed in the same way as existing devices. For example, when placed in the gallbladder lumen, such placement may be similar to that of a gallbladder fistula or percutaneous gallbladder drainage tube.

[0029] Figures 2 to 4 provide schematic diagrams of exemplary parts of a catheter system 250 according to several embodiments. The catheter system 250 may be structurally and / or functionally similar to the catheter system 150. For example, the catheter system 250 may be configured to be coupled to a control unit (e.g., control unit 110) and / or to receive an ablation medium from an ablation medium supply unit (e.g., ablation medium supply unit 120). The catheter system 250 may include an outer shaft 260 and an inner shaft 270. The inner shaft 270 may also be referred to as the first shaft, and the outer shaft 260 may be referred to as the second shaft. In some embodiments, the outer shaft 260 and the inner shaft 270 may be separate components used together, for example, to perform an ablation procedure. For example, the outer shaft 260 may be implemented as an access sheath or introducer, and the inner shaft 270 may be implemented as a catheter that can be inserted into the lumen of the introducer. In some embodiments, the outer shaft 260 and the inner shaft 270 can be integrated into a single catheter device, for example, a device having two concentric shafts.

[0030] Figure 2 provides a detailed view of the outer shaft 260. The outer shaft 260 may be, for example, an access sheath. The outer shaft 260 can define a lumen 262. The lumen 262 may be configured to receive one or more instruments, including, for example, an inner shaft 270. The outer shaft 260 may be configured to provide access to a body lumen BL (e.g., the gallbladder lumen). For example, the distal end of the outer shaft 260 may be positioned within the body lumen BL, as schematically shown in Figure 4. Once positioned inside the body lumen BL, the outer shaft 260 can, for example, enable the delivery of one or more instruments into the body lumen BL via the lumen 262. For example, as shown in Figure 4, the inner shaft 270 may be inserted into the lumen 262 of the outer shaft 260 and navigated into the body lumen BL so that the distal end of the inner shaft 270 is positioned inside the body lumen BL.

[0031] In some embodiments, the lumen 262 may be configured to discharge or drain fluid (e.g., liquid or gas) and / or debris (e.g., gallstones or fragments thereof, tissue, etc.) from the body lumen BL. For example, the lumen 262 can allow an ablation medium (e.g., cryoablation medium) delivered to the body lumen BL to be discharged from the body lumen BL. In some embodiments, the lumen 262 may be operably coupled to a vacuum source 240, which may be activated to apply negative pressure within the lumen 262 to discharge fluid from the body lumen BL. Alternatively, the lumen 262 can function as a passive discharge passage for fluid to exit the body lumen BL. For example, when an ablation medium is delivered to the body lumen BL and the pressure increases within the body lumen BL relative to the outside of the shaft 260, such pressure can passively drive a portion of the ablation medium out of the body lumen BL through the lumen 262.

[0032] In some embodiments, the outer shaft 260 may define one or more additional lumens, for example, lumen 264, which may be structurally and / or functionally similar to lumen 262. For example, lumen 264 may also be configured to provide access to the internal lumen BL. In some embodiments, lumen 262 may be configured to receive the inner shaft 270, and lumen 264 may be configured to receive different surgical and / or monitoring devices (e.g., probes, second ablation devices, etc.). In some embodiments, one or more of the lumens 262, 264 may be fluidically coupled to a sensor (e.g., a pressure sensor) to enable pressure measurement of the internal lumen BL and / or other parts of the body. For example, a sensor integrated into a control unit (e.g., control unit 110) may be in fluid communication with one or more of the lumens 262, 264 to measure the environment (e.g., pressure measurement) within the outer shaft 260 and / or internal lumen BL.

[0033] In some embodiments, the outer shaft 260 optionally includes a sensor 263. In some embodiments, the sensor 263 may be located in the distal portion of the outer shaft 260, which is configured to be disposed within the internal lumen BL. Alternatively, the sensor 263 may be disposed at different locations along the outer shaft 260, including, for example, within the lumen (e.g., lumen 262, 264), or at the proximal end of the outer shaft 260. The sensor 263 may be configured to capture information about the environment within the internal lumen BL, or other environments within and / or surrounding the outer shaft 260. For example, the sensor may be configured to measure characteristics of the ablation medium being delivered to the internal lumen BL (e.g., pressure, temperature), characteristics of the internal lumen BL (e.g., pressure, temperature), or fluids within the internal lumen BL. The sensor 263 may include, for example, a pressure sensor (e.g., a pressure transducer, a strain gauge transducer, a diaphragm displacement sensor, an optical fiber pressure sensor, a solid-state sensor), a temperature sensor, an optical sensor, a gas sensor, and the like. In some embodiments, the sensor 263 may be coupled to a control unit (e.g., control unit 110) and / or other computing devices (e.g., computing device 190) via a wired connection, such as a wire coupled to and / or disposed within the outer shaft 260. In some embodiments, the sensor 263 may be configured to wirelessly transmit data indicating one or more measured characteristics of the body cavity BL to the control unit and / or another computing device.

[0034] In some embodiments, the outer shaft 260 may include a tapered portion or tapered end at its distal end. In some embodiments, the dilator can be inserted into the lumen (e.g., lumen 262) of the outer shaft 260 to assist in the insertion of the outer shaft 260 into the body lumen BL. The dilator may be positioned within the lumen such that its distal end extends distally from the outer shaft 260. In such cases, the tapered end of the outer shaft 260 can form a smooth transition from the outer shaft 260 to the outer surface of the dilator to assist in insertion into the body lumen BL, rather than having an abrupt step in the device's shape during insertion into the BL. Further details regarding the use of the dilator with the outer shaft 260 are provided with reference to Figures 6A-6B.

[0035] In some embodiments, the outer shaft 260 includes an expandable structure or body 266 that can be deployed within the body lumen BL, for example, transitioning from a non-deployed state or configuration to a deployed or expanded state or configuration. The expandable structure 266 may be configured to prevent movement between the outer shaft 260 and the body lumen BL and / or to create a seal. When in use, the outer shaft 260 can advance, for example, along a guidewire until the distal end of the outer shaft 260 is positioned within the body lumen BL through the opening. The expandable structure 266 can then be deployed (e.g., expanded, inflated) as schematically shown by arrow 290 in Figure 2. When deployed (e.g., in the deployed state), the expandable structure may have a diameter larger than the diameter of the opening into which the outer shaft 260 is implanted, and thus be configured to hold the outer shaft 260 within the body lumen BL. In some embodiments, the expandable structure 266 includes an inflatable balloon, a shape memory structure (e.g., an expandable nitinol structure), and the like. In some embodiments, the expandable structure 266 in the unfolded state may have an outer diameter about 1.5 to about 3 times larger than the outer diameter of the outer shaft 260.

[0036] In some embodiments, the expandable structure 266 can transition from a non-expanded state to an expanded state via compression of a portion of the outer shaft 260 and / or movement of the inner shaft relative to the outer shaft. For example, the expandable structure 266 may be bounded within a region along the length of the outer shaft 260 between two boundary rings, and the expandable structure 266 can be expanded (e.g., expanded) by bringing the two boundary rings closer together. In some embodiments, the outer shaft 260 may be formed from or include a plurality of concentric tubes or tubular members, and for example, the expandable structure 266 can be expanded (e.g., the expandable structure 266 is unfolded) by translating the inner tubular members relative to the outer tubular members to bring the ends of the expandable structure 266 closer together. In such embodiments, at least one end of the expandable structure 266 (e.g., the proximal end) may be coupled to an outer tubular member, and the other end of the expandable structure 266 (e.g., the distal end) may be coupled to an inner tubular member, and the translation of the inner tubular member relative to the outer tubular member may cause the expandable structure 266 to expand or unfold. In some embodiments, the expandable structure 266 may be pre-formed to expand to its unfolded state. For example, the expandable structure 266 may be held under tension (e.g., held in its unfolded state by an outer sleeve or tubular member, or stretched flat along the outer surface of the outer shaft 260 by a tubular member or pull wire) and, when released, self-expand to its unfolded state.

[0037] In some embodiments, the expandable structure 266 may include elongated members (e.g., bands, fibers, wires, splines) arranged in a woven or braided pattern. In some embodiments, the elongated members may be bent to form a spherical shape when the expandable structure 266 transitions from an un-expanded state to an expanded state. In some embodiments, the expandable structure 266 can be expanded outward by linearly compressing one end of the elongated member against the other end of the elongated member to produce a geometric shape with an expanded diameter. In some embodiments, the expandable structure 266 may have a larger diameter in the expanded state compared to the un-expanded state. This expansion can help prevent unintended removal of the expandable structure 266 from the body cavity BL. In some embodiments, the expandable structure 266 may be composed of nitinol, stainless steel, polymer, or any suitable material having high tensile relaxation. In some embodiments, the expandable structure 266 may be formed from a shape memory material, such as shape memory nitinol.

[0038] In some embodiments, the expandable structure 266 can function as a seal to seal the opening into which the ablation catheter 250 is disposed. Further details of a suitable expandable structure 266 implemented as a seal are described in International Application US2019 / 017112, incorporated herein by reference.

[0039] Although two lumens (e.g., lumens 262 and 264) are shown in Figure 2, it can be understood that the outer shaft 260 may include any number of lumens, including a single lumen and / or three or more lumens. The outer shaft 260 may also include additional sensors, expandable structures, etc., according to embodiments described herein.

[0040] Figure 3 provides a more detailed view of the inner shaft 270 disposed within the lumen 262. The inner shaft 270 can be deployed from the outer shaft 260 and the lumen 262 via axial movement (e.g., translation along the longitudinal axis of the outer shaft 260), as indicated by arrow 291. The inner shaft 270 may be, for example, an ablation delivery device or an ablation catheter. In some embodiments, the inner shaft 270 may form part of a cryoablation device and be configured to deliver a cryoablation medium into the body lumen BL. The inner shaft 270 may be configured to provide ablation energy or an ablation medium capable of killing cells in the body lumen BL. For example, the inner shaft 270 may be configured to provide ablation energy or an ablation medium capable of killing cells in the mucosal layer of the gallbladder lumen, killing cells lining the inside of the cystic duct, or any combination thereof. Ablation energy or medium may include, for example, chemical agents (e.g., antibiotics, liquid curing agents, sodium tetradecyl sulfate, acetic acid, ethanol, hypertonic sodium chloride solution, urea), low-temperature ablation mediums (e.g., low-temperature liquids or gases), thermal ablation, electroablation, etc. In some embodiments, the inner shaft 270 may be configured to deliver multiple types of ablation energy or medium. The inner shaft 270 may be configured to provide spatially diffusive ablation. In other words, the inner shaft 270 may be configured to provide ablation that ablates a large area of ​​the body lumen BL. In some embodiments, the inner shaft 270 may be configured to deliver ablation for the purpose of disabling the gallbladder mucosa, for ablation or hardening of the cystic duct, or for any combination thereof.

[0041] In some embodiments, the inner shaft 270 may be configured to deliver thermal ablation, cryoablation, chemical ablation, or any combination thereof. In some embodiments, cryoablation involves delivering a cryogenic fluid, such as liquid nitrogen, to the gallbladder wall. In some embodiments, cryoablation involves delivering an ablation medium, such as nitrous oxide or carbon dioxide, to the gallbladder wall, which induces low temperatures due to a phase change. In some embodiments, thermal ablation involves delivering a high-temperature fluid, such as hot water or steam, to the gallbladder wall. In some embodiments, the ablative medium is delivered in liquid form, gaseous form, aerosol form, gel form, or any combination thereof.

[0042] The inner shaft 270 can define a lumen 272. The lumen 272 may be configured to deliver, for example, an ablation medium from an ablation medium supply unit 120 to a nozzle 274 that can be disposed within the internal lumen BL. The nozzle 274 may be configured to release the ablation medium into the internal lumen BL. In some embodiments, the nozzle 274 may include a plurality of openings or windows for dispersing the ablation medium throughout the internal lumen BL. In some embodiments, the lumen 272 and the nozzle 274 may be configured to transport a liquid cryogenic ablation medium into the internal lumen BL. The lumen 272 and the nozzle 274 may be sized to maintain a set amount of pressure on the cryogenic ablation medium so that the medium does not undergo a transition from liquid to gas until it exits the opening of the nozzle 274. In other words, the lumen 272 and nozzle 274 may be configured to deliver a liquid cryoablation medium to the opening of the nozzle 274, at which point the release of the cryoablation medium into the internal lumen BL results in a change of the cryoablation medium from a liquid to a gaseous state. In some embodiments, the lumen 272 of the internal shaft 270 may have a diameter of about 0.001 inches to about 0.1 inches, including all values ​​and partial ranges in between.

[0043] In some embodiments, the inner shaft 270 may include an expandable structure or body 276. In some embodiments, the expandable structure may be arranged around the nozzle 274. In some embodiments, the expandable structure 276 can be expanded within the body lumen BL such that the nozzle 274 is centered within the body lumen BL. In other words, the expandable structure 276 can be expanded outward to a desired diameter such that the radial distance from the center of the nozzle 274 to the wall of the body lumen BL is consistent or substantially consistent in all radial directions. This consistent spacing or centering can ensure a minimum radial distance between the nozzle 274 and nearby tissue in the body lumen BL and / or more uniform distribution of the ablation medium through the body lumen BL. This allows for ablation of the lumen tissue while ensuring that the ablation medium is not too close to the range from the tissue section (e.g., creating a risk of adhesion or perforation) or too far from the range (e.g., reducing the effectiveness of the ablation).

[0044] In some embodiments, the external shape and / or thermal mass of the expandable structure 276 can be minimized to allow for more efficient passage of the ablation medium from the nozzle 274 to the surface of the body lumen BL. In other words, the efficiency of heat transfer during ablation can be improved by reducing or minimizing both the physical size and amount of thermal energy that the expandable structure 276 can absorb or radiate. In some embodiments, the expandable structure 276 may be made of nitinol, stainless steel, polymer, or any suitable material having high tensile relaxation. In some embodiments, the material of the expandable structure 276 can be selected based on the material's ability to withstand low temperatures without significantly altering the cooling performance of the catheter system 250. In some embodiments, the use of the expandable structure 276 can avoid the generation of significant juxtaposition forces between the expandable structure 276 and the body lumen BL, in contrast to cryoablation balloon catheters. This can produce a more effective cooling method that is less sensitive to the contents and geometric shape of the body lumen BL.

[0045] In some embodiments, the expandable structure 276 may be collapsible or retractable so that the inner shaft 270 can be removed from the internal lumen BL. In some embodiments, the expandable structure 276 may be radially symmetrical to ensure equidistant or nearly equidistant radial spacing of the walls of the internal lumen BL around the outside of the nozzle 274.

[0046] In some embodiments, the expandable structure 276 can transition from a non-expanded state (e.g., non-deployed state) to an expanded state (e.g., deployed state) via compression of a portion of the inner shaft 270 and / or movement of a portion of the inner shaft 270 relative to another portion of the inner shaft 270. In some embodiments, the expandable structure 276 may include elongated members (e.g., bands, wires, fibers, splines) arranged in a woven or knitted pattern or individually arranged along the length of the inner shaft 270. For example, the expandable structure 276 may include one or more elongated members that generally extend along the length of the inner shaft 270. In some embodiments, the expandable structure 276 may include a single expandable elongated member, while in other embodiments, the expandable structure may include 2 to 20 elongated members (including all values ​​and partial ranges in between). In some embodiments, the distal end of the expandable structure 276 can be moved toward a more proximal point of the expandable structure 276 to expand the expandable structure 276, i.e., to transition from a non-expanded state or configuration to an expanded state or configuration. In some embodiments, the inner shaft 270 can be moved relative to a sleeve or tubular member (not shown) to expand and contract the expandable structure 276. For example, a sleeve can be used to hold the expandable structure 276 in a non-expanded state, or the sleeve can move one end of the expandable structure 276 (e.g., the proximal end) relative to the other end (e.g., the distal end) of the expandable structure 276 to expand the expandable structure 276 to its expanded state. In some embodiments, the expandable structure 276 may include a plurality of wires or bands extending along the length of the inner shaft 270 so that the wires or bands can advance and retract from the proximal end of the ablation catheter 250. Such advance and retraction can be used to deploy and de-expand the expandable structure 276. Further details of the mechanism of the expandable structure 276 will be explained with reference to later figures, including, for example, Figures 13A-13C and Figures 32A-32C.

[0047] In some embodiments, the inner shaft 270 may optionally include a valve 278. The valve 278 may be configured to control the delivery of the ablation medium into the body cavity BL. For example, the valve 278 may be configured to turn on or shut off the supply of the ablation medium to the nozzle 274. In some embodiments, a control unit (e.g., control unit 110) may be configured to control the opening and / or closing of the valve 278. In some embodiments, a mechanical actuator (e.g., coupled to a handheld device as described above) may be used to open and / or close the valve 278. In some embodiments, the valve 278 may be configured to close (e.g., automatically and / or via control by the control unit) in response to the pressure in the body cavity BL being greater than a predetermined threshold. In some embodiments, sensors (e.g., sensors disposed on the inner or outer shafts 260, 270, and / or sensors coupled to the control unit 110) may be used to measure the pressure in the body cavity BL and control the opening and / or closing of the valve 278. In some embodiments, the valve 278 may be configured to close in response to a pressure difference between the internal lumen BL and the discharge lumen (e.g., lumen 262), for example, to indicate that an obstruction or blockage has formed along the discharge path. For example, multiple sensors may be configured to measure different pressures associated with the catheter system 250 and / or the internal lumen BL, and a control unit (e.g., control unit 110) may be configured to analyze when such pressure measurements determine that an unexpected obstruction has blocked any fluid flow path into and / or out of the internal lumen BL.

[0048] As described above, in some embodiments, the inner shaft 270 may be a cryoablation device or form part thereof, configured to deliver a cryoablation medium into the body cavity BL. The cryoablation device can leverage the phase-change properties of a particular cryoablation medium (e.g., liquid nitrous oxide) to induce a cryoablation temperature at the target tissue interface. When such a cryoablation medium transitions from liquid to gas, its volume expands, causing an increase in pressure within the body cavity BL. Therefore, one important consideration in designing the systems and devices disclosed herein is monitoring and controlling the intraluminal pressure within the body cavity BL during the ablation procedure. For example, the systems and devices disclosed herein may be configured to ensure that the intraluminal pressure does not increase above a predetermined threshold and / or remains within a predetermined range. If there is an increase in intraluminal pressure (e.g., pressure above a predetermined threshold, or a sudden change in pressure above a predetermined rate), the systems and devices disclosed herein may be configured to discharge air, gaseous cryoablation medium, and / or other fluids from the body cavity BL to reduce the intraluminal pressure. In such cases, it may be important to ensure that any cryoablation medium in the catheter system 250 (e.g., in the lumen 272 of the inner shaft 270) and / or in the supply line into the catheter system 250 does not escape from the catheter system 250 (e.g., the nozzle 274) into the body lumen BL, further contributing to the pressure increase. Therefore, it may be desirable to minimize or reduce the amount of residual cryoablation medium delivered into the BL in response to the detection of a pressure increase event (e.g., a pressure above a predetermined threshold, or a sudden change in pressure above a predetermined rate above the body lumen). In some embodiments, a valve 278 can be used to reduce the amount of residual cryoablation medium delivered into the body lumen 270. The valve 278 may be positioned at or near the nozzle 274 such that, when closed, the valve 278 prevents any residual or excess ablation medium in other passages leading to the lumen 272 and / or the nozzle 274 from being delivered into the body lumen BL.

[0049] The valve 278 may include any range of preferred mechanisms. In some embodiments, the valve may be closed in its resting state but open to allow the ablation medium to be delivered into the body lumen BL. Alternatively, the valve 278 may be open in its resting state and closed to prevent the delivery of additional ablation medium into the body lumen BL. In some embodiments, the valve 278 may be biased to be closed and / or open using a spring mechanism. The valve 278 may have any preferred geometric shape, including, for example, a cube, cone, cylinder, triangular prism, torus, helix, oval, or other three-dimensional body having a structure sufficient to obstruct the flow of ablation medium. In some embodiments, the valve 278 may be seated against a valve seat defined within the inner shaft 270 (e.g., within the lumen 272). In some embodiments, the valve 278 can be opened and / or closed manually or via a control device (e.g., control device 110) using a drive wire or rod, pneumatic or hydraulic, electromagnetic force, and / or motor. A suitable example of the valve is described in International Application US2020 / 045436, which is incorporated herein by reference.

[0050] In some embodiments, the inner shaft 270 optionally includes a sensor 273. In some embodiments, the sensor 273 may be located in the distal portion of the inner shaft 270, which is configured to be disposed within the internal lumen BL. Alternatively, the sensor 273 may be disposed at different locations along the inner shaft 270, including, for example, within the lumen (e.g., lumen 272), or at the proximal end of the inner shaft 270. The sensor 273 may be configured to capture information about the environment within the internal lumen BL. For example, the sensor 273 may be configured to measure characteristics of the ablation medium delivered to the internal lumen BL (e.g., pressure, temperature), characteristics of the internal lumen BL (e.g., pressure, temperature), or fluids within the internal lumen BL. The sensor 273 may include, for example, a pressure sensor (e.g., a pressure transducer, a strain gauge transducer, a diaphragm displacement sensor, an optical fiber pressure sensor, a solid-state sensor), a temperature sensor, an optical sensor, a gas sensor, and the like. The sensor 273 may be able to communicate data (e.g., sensor measurements) to a control unit (e.g., control unit 110) and / or other computing devices (e.g., computing device 190) via a wired or wireless connection.

[0051] In some embodiments, the inner shaft 270 may optionally include one or more additional lumens. In some embodiments, the lumens may be configured as passages for relaying pressure information or other conditions (e.g., temperature) from the body lumen BL and / or other parts of the catheter system 250. In some embodiments, the catheter system 250 may optionally include an occluder, as further described with reference to Figure 22. Although a single lumen (e.g., lumen 272) is shown in Figure 3, it can be understood that the inner shaft 270 may include any number of lumens, including a single lumen and / or three or more lumens. The inner shaft 270 may also include additional sensors, valves, nozzles, etc., according to embodiments described herein.

[0052] Figure 4 provides a detailed view of an inner shaft 270 and an outer shaft 260 positioned within the internal lumen BL. The inner shaft 270 can be disposed within the lumen 262 of the outer shaft 260. The space between the outer surface of the inner shaft 270 and the inner surface of the lumen 262 can define a discharge lumen or passage for removing gas and / or other fluids (e.g., ablation medium from the internal lumen BL) from the internal lumen BL.

[0053] The outer shaft 260 and / or inner shaft 270 can be formed from flexible and / or semi-flexible materials, thereby allowing each to be navigated, for example, along a guidewire into the body lumen BL. The material may be a medical-grade biocompatible material. The inner shaft 270 can be deployed into the body lumen BL in the axial direction indicated by arrow 294. The expandable structure 266 of the outer shaft 260 and the expandable structure 276 of the inner shaft 270 can be deployed radially, as indicated by arrow 292.

[0054] Figure 5 is a schematic diagram of an exemplary control unit 310 according to several embodiments. The control unit 310 may be structurally and / or functionally similar to the control unit 110, as described with reference to Figure 1. For example, the control unit 310 may be configured to control one or more components of an ablation system and / or a catheter system (e.g., ablation system 100, catheter system 250). The control unit 310 may include a processor 312, memory 314, and an input / output interface 319. In some embodiments, the control unit 310 may be coupled to the catheter system, for example, by being contained within a handheld device coupled to the proximal end of the catheter system. In some embodiments, the control unit 310 may be remotely located, for example, on a remote computer device or system, and may be used to remotely control the operation of the catheter system.

[0055] The processor 312 of the control unit 310 may be any suitable processing device configured to operate and / or perform functions associated with deploying one or more components of the catheter system (e.g., advancing or retracting a shaft, deploying an expandable structure, opening and / or closing a valve), delivering an ablation medium into a body lumen, analyzing sensor data associated with an ablation procedure involving the catheter system, controlling temperature and / or pressure within the body lumen, etc. The processor 312 may be configured to perform modules, functions, and / or processes. The processor 312 may be a general-purpose processor, a field programmable gate array (FPGA), an application-specific integrated circuit (ASIC), a digital signal processor (DSP), etc. In some embodiments, the processor 312 is part of a circuit, such as an integrated circuit. In some embodiments, one or more other components of the ablation system, such as one or more sensors, may be integrated into the circuit.

[0056] The input / output interface 319 may include a user interface and / or a communication interface for connecting the control unit 310 to one or more external computing devices. The user interface may include one or more components configured to receive inputs and transmit outputs to other devices and / or users who operate the devices, for example, a user who operates the catheter system. For example, the user interface may include a display device (e.g., a display, touchscreen, etc.), an audio device (e.g., a speaker or alarm), and one or more additional input / output devices configured to receive inputs and / or generate outputs to the user. The communication interface may include one or more wireless and / or wired interfaces for communicating with other computing devices (e.g., computing device 190) via one or more networks (e.g., a local area network (LAN), a wide area network (WAN), a virtual network, a telecommunications network).

[0057] Memory 314 may be, for example, random access memory (RAM), memory buffer, hard drive, database, erasable programmable read-only memory (EPROM), electrically erasable read-only memory (EEPROM), or read-only memory (ROM). In some embodiments, memory 314 stores instructions for the processor 312 to execute modules, processes, and / or functions associated with deploying one or more components of the catheter system (e.g., advancing or retracting a shaft, deploying an expandable structure, opening and / or closing a valve), delivering an ablation medium into a body lumen, analyzing sensor data associated with an ablation procedure involving the catheter system, or controlling the temperature and / or pressure within a body lumen. The methods described herein may be implemented by machine (e.g., computer processor) executable code stored, for example, in memory 314 or in an electronic storage location of the control unit 310, such as memory operably coupled to the control unit 310. In some embodiments, machine-executable code or machine-readable code is provided in the form of software. In operation, the code may be executed by processor 312. In some cases, the code is retrieved from memory 314 for access and / or execution by processor 312.

[0058] As shown in Figure 5, memory 314 stores instructions that cause the processor 312 to execute modules, processes, and / or functions indicated as the discharge control unit 315, the ablation medium supply control unit 316, optionally the sensor control unit 317, and / or optionally the nozzle control unit 318. The discharge control unit 315, the ablation medium supply control unit 316, the sensor control unit 317, and / or the nozzle control unit 318 may be implemented as one or more programs and / or applications tied to hardware components. For example, the discharge control unit 315, the ablation medium supply control unit 316, the sensor control unit 317, and / or the nozzle control unit 318 may be implemented by one or more components of an ablation system and / or catheter system (e.g., ablation system 100, catheter system 250). In some embodiments, the processor 312 executing the discharge control unit 315 can control the opening of a valve and / or the operation of a vacuum source to discharge gas or other fluid (e.g., ablation medium) from a body lumen. In some embodiments, a processor 312 running an ablation medium supply control unit 316 can control the opening of valves and / or the operation of the ablation supply source to deliver the ablation medium into a body lumen via the catheter system. In some embodiments, a processor 312 running a sensor control unit 317 can receive, process, and / or analyze data from one or more sensors and / or use such data to control the operation of one or more other components of the ablation system or the catheter system.

[0059] In some embodiments, the nozzle control unit 318 may be implemented to control the positioning or movement of one or more nozzles (e.g., nozzle 274) within a body lumen (e.g., body lumen BL). In some embodiments, the nozzle control unit 318 may be implemented to rotate the ablation catheter (e.g., inner shaft 270) along its central axis to increase the uniform or more dispersed delivery of the liquid cryogenic medium. In some embodiments, the nozzle control unit 318 can actuate the ablation catheter and / or nozzles to move axially or linearly to increase the dispersion of cryogenic material from the nozzles. In some embodiments, the nozzle control unit 318 may be implemented to open and close one or more nozzle openings.

[0060] Figures 6A and 6B illustrate exemplary methods 600 for controlling ablation and pressure and / or temperature during an ablation procedure according to embodiments. In some embodiments, the ablation procedure may be a cryoablation procedure implemented using an ablation system (e.g., ablation system 100) including a cryoablation device. In some embodiments, the ablation procedure is performed within the gallbladder to disable the gallbladder. Method 600 optionally includes, in 602, advancing the outer shaft (e.g., outer shaft 260) of the catheter system (e.g., catheter systems 150, 250) of the ablation system into a body lumen (e.g., gallbladder lumen). In some embodiments, ultrasound imaging may be used to visualize the body lumen. In some embodiments, a standard needle and guidewire may be used to access the body lumen via a transhepatic approach, for example, using the Seldinger technique. When the target body lumen is the gallbladder, visual return of bile through the needle and fluoroscopic confirmation of the guidewire curl inside the body lumen can help verify proper placement of the guidewire within the body lumen. In some embodiments, the outer shaft can be advanced along the guidewire with the dilator positioned within the lumen of the outer shaft (e.g., lumen 262). In some embodiments, a series of gradually increasing dilators can advance along the guidewire to expand the tube into the body lumen. After expanding the tube, the outer shaft (e.g., with the dilators inserted into it) can be advanced along the guidewire into the body lumen. In some embodiments, the outer shaft of the catheter system may be a separate tubular structure, such as an access sheath or introducer, which is first placed into the body lumen before the inner shaft is placed into the body lumen. Alternatively, in some embodiments, the outer and inner shafts may be placed into the body lumen simultaneously. In some embodiments, the placement of the outer shaft may be similar to that of a percutaneous drainage tube. Once the outer shaft is positioned within the body lumen, the dilator and guidewire may be removed to allow the placement of the inner shaft within the outer shaft, as will be further described below.

[0061] In some embodiments, the catheter system can be placed within the lumen of the gallbladder. Access to the gallbladder by the catheter system can be achieved by a percutaneous approach. In some embodiments, the access sheath or outer shaft 760 of the catheter system accesses the gallbladder 2 through a transhepatic percutaneous approach using ultrasound guidance, as shown in Figure 7A. In some embodiments, the access sheath 760 of the catheter device accesses the gallbladder 2 through a subhepatic percutaneous approach using ultrasound guidance, as shown in Figure 7B. In some embodiments, the percutaneous approach is similar to the method used to place a gallbladder fistula-forming drain. In some embodiments, the access sheath 760 provided herein provides endoscopic access to the gallbladder 2, as shown in Figure 7C. In some embodiments, the access sheath 760 accesses the gallbladder 2 by utilizing an innate biostructure by creating a transwall stoma that connects the lumen of the gallbladder to the lumen of the small intestine, as shown in Figure 7C. In some embodiments, percutaneous access is obtained using a hollow bore needle, thereby creating a tube to the desired access site (e.g., cystic duct, gallbladder, or a combination thereof) through which a guidewire is placed. In some embodiments, the access sheath 760 and the inner shaft or ablation catheter are configured with concentric lumens to allow the guidewire to pass through. In some embodiments, the access sheath 760 and the ablation catheter are configured with non-concentric lumens to allow the guidewire to pass through.

[0062] After positioning the distal end of the outer shaft of the catheter system within the body lumen, method 600 may optionally include, in 604, deploying an expandable structure of the outer shaft (e.g., expandable structure 266). Deploying the expandable structure within the body lumen ensures that the outer shaft (e.g., access catheter, introducer) remains within or is retained within the body lumen during the ablation procedure. In some embodiments, deploying the expandable structure may involve moving a first tubular member relative to a second tubular member to move the first end of the expandable structure toward the second end of the expandable structure, thereby expanding the expandable structure outward. In some embodiments, expanding the expandable structure may involve releasing tension applied to the expandable member (e.g., by releasing a sheath or pull wire) and allowing the expandable structure to automatically expand or self-expand into a pre-formed shape.

[0063] Method 600 may include advancing the inner shaft of the catheter system (e.g., inner shaft 270) into the body lumen in 606. In some embodiments, if the dilator is positioned within the outer shaft and the outer shaft is advanced into the body lumen, the inner shaft can be advanced after the dilator is removed. The inner shaft can be advanced until the nozzle of the inner shaft (e.g., nozzle 274) is positioned in the body lumen distal to the distal end of the outer shaft. The inner shaft can be advanced into the body lumen by inserting the inner shaft into the lumen defined by the outer shaft and advancing the inner shaft through that lumen until the distal portion of the inner shaft is positioned distal to the outer shaft. The distal portion of the inner shaft may include one or more openings (e.g., fenestrations) into which the ablation medium can be delivered into the body lumen. In some embodiments, Method 600 may optionally include, for example, the deployment of saline solution to wash and drain any contents in the body lumen via the inner and / or outer shafts. For example, a fluid such as saline solution may be delivered into the gallbladder via a first lumen (e.g., a lumen 272 defined by the inner shaft 270), and / or contents of the body lumen (e.g., gallbladder contents) may be discharged from the body lumen via a second lumen (e.g., a lumen 262 defined by the outer shaft 260).

[0064] Method 600, in 607, includes deploying an expandable structure of the inner shaft (e.g., expandable structure 276). In some embodiments, the expandable structure may include a plurality of wires or bands extending along the length of the inner shaft. Such wires may be deployed by advancing the wires distal to the sheath. In some embodiments, the expandable structure may be deployed by moving the inner and outer tubular members relative to each other. Once the expandable structure is deployed, it can ensure that the nozzle is centered within the body lumen or that the nozzle is at least a predetermined distance from the tissue surface. Method 600, in 608, may optionally include opening a supply lumen valve (e.g., valve 278). For example, as described above with reference to Figure 3, the valve may be positioned along the ablation medium delivery passage (e.g., along the lumen 272 defined by the inner shaft) to control the delivery of the ablation medium. An open valve can allow the ablation medium to flow through the valve into the body lumen, while a closed valve can block the flow of the ablation medium into the body lumen. In some embodiments, the valve may naturally be in a closed state, and therefore method 600 may include opening the valve so that the ablation medium can be delivered into the body lumen. In some embodiments, the valve may naturally be in an open state, and therefore 608 can be omitted.

[0065] Method 600 may include, in 610, delivering an ablation medium into a body lumen. In some embodiments, a cartridge (e.g., ablation medium supply unit 120, 220) of a cryoablation medium (e.g., nitrous oxide) or any other suitable ablation medium may be loaded into the handle of the ablation device (e.g., a handheld device). When using a cryoablation medium, in 610, one, two, three, four, five, six, seven, eight, nine, ten, or eleven or more freeze-thaw cycles may be delivered to the gallbladder to ensure complete hypothermic death of the gallbladder mucosa. While the ablation medium is being delivered, Method 600 may include, in 612, events and / or steps associated with pressure and / or temperature monitoring, as further described below with reference to Figure 6B. For example, a control unit (e.g., control unit 110, 310) may monitor pressure, temperature, and / or other conditions to ensure safe delivery of the ablation medium. After delivering the ablation medium, method 600 may optionally include removing the catheter system (e.g., the inner and outer shafts) from the body lumen in 614.

[0066] Figure 6B illustrates events and steps associated with temperature and pressure monitoring protocols performed during an ablation procedure, such as the ablation procedure described with reference to Figure 6A. A control unit of the ablation system or another computer device (e.g., control units 110, 310) may be configured at 620 to receive data from a temperature sensor and at 622 to determine the state of the ablation. In some embodiments, the state of the ablation may be determined by data received from the temperature sensor. In some embodiments, the temperature sensor may be integrated into one of the inner or outer shafts (e.g., as sensors 263, 273). In other embodiments, the temperature sensor may be operably coupled to a lumen extending into a body cavity, and the sensor may be used to measure the temperature associated with the body cavity. In yet another embodiment, the temperature sensor may be mounted on a probe that is separately insertable into a body cavity, for example, via a separate lumen (e.g., lumen 264) and / or the same lumen housing the inner shaft (e.g., lumen 262). In some embodiments, the temperature sensor may be embedded or inserted into tissue within a body cavity so that the temperature of the tissue can be measured.

[0067] Method 600 may optionally include generating information to be presented to the user in 626. In some embodiments, the information presented to the user may be presented via a computing device such as control units 110 and / or 310, or via another computing device (e.g., a tablet, smartphone, or any other suitable communication device) that is network-communicating with the ablation system. Based on the ablation status determined in 622, the supply of the ablation medium may be adjusted or terminated in 627. In some embodiments, the supply of the ablation medium may be reduced or terminated. In some embodiments, the supply of the ablation medium may be increased. In some embodiments, to evaluate the temperature of the tissue at a different location, the temperature sensor may optionally be moved to a new location in 628. For example, the temperature sensor may be retracted from the tissue at a first location, moved to a second location, and inserted into the tissue at the second location. In some embodiments, method 600 may include determining, for example, based on sensor data, whether the ablation is complete, and in response to determining that the ablation is complete, the supply of the ablation medium may be terminated (for example, by closing valve 278), and method 600 may follow 612 in which the catheter system is removed from the body lumen.

[0068] A control unit (e.g., control units 110, 310) or another computing device may also receive pressure data from one or more pressure sensors in 630. In some embodiments, the first pressure reading may be from inside the body lumen (e.g., measuring intraluminal pressure), and the second pressure reading may be from inside the outer shaft (e.g., measuring pressure in the discharge lumen (e.g., lumen 262)). In other embodiments, more or fewer pressure readings may be received in 630. In 632, at least one of the pressure measurements (e.g., intraluminal pressure in the body lumen) is evaluated to determine whether the pressure reading is within a desired pressure parameter (e.g., within a desired pressure range). If pressure readings are substantially different from each other (e.g., different pressure readings differ from each other by more than a predetermined amount or percentage, or have a certain percentage (e.g., 30%) increase or decrease from the nominal operating pressure), or if one or more pressure readings are not within one or more desired pressure parameters (632: No), then in 634, information (e.g., a warning) may be optionally presented to the user, and in 635, the supply of the ablation medium may be adjusted or terminated. The information presented to the user may indicate to the user that an error has occurred in the ablation delivery and / or the operation of the device. For example, a substantial difference (e.g., a difference exceeding a predetermined amount or percentage) between the intraluminal pressure in the body lumen and the pressure in the drainage lumen (e.g., intraluminal pressure exceeding drainage lumen pressure) may indicate that a blockage occurred at some point between the body lumen and the drainage lumen. In cryogenic delivery systems, such a thing may occur when ice or other solid contents block a portion of the drainage lumen. Such a blockage may cause an increase in pressure in the body lumen and may cause injury to the patient. Therefore, in such cases, the control unit or other computing device may terminate the supply of the ablation medium to the body lumen until the blockage is removed (e.g., via a heating coil). In some embodiments, when the pressure measurement is outside a specific pressure parameter (e.g., a predetermined threshold or range), the control unit may, in 636, control one or more valves and / or vacuum sources (e.g., vacuum source 130) to discharge the ablation medium from the body lumen to reduce the pressure rise in the body lumen.

[0069] In procedure 614, the catheter system (e.g., introduction device and ablation catheter) can be removed from the body lumen. For a period of time after removal of the ablation system (e.g., several weeks), the body's chronic inflammatory response may scar the ablated gallbladder tissue, leading to lumen regression and obstruction of the cystic duct. The flow of bile to the gallbladder may be blocked, but its blood supply remains intact, resulting in an inactive organ.

[0070] In some embodiments, as described above, the ablation procedures described herein utilize a cryoablation medium. In some embodiments, the cryoablation medium is a liquid. In some embodiments, the cryoablation medium is a gas. In some embodiments, the cryoablation medium undergoes a transition from liquid to gaseous phase when delivered using catheter devices and nozzles disclosed herein. In some embodiments, cryoablation is achieved via refrigerant properties due to a transition from liquid to gaseous phase from an ablation medium such as liquid nitrous oxide, carbon dioxide, and argon. In some embodiments, the phase change of the cryoablation medium is triggered by a rapid pressure drop. In some embodiments, the phase change of the cryoablation medium occurs when a liquid ablation medium comes into contact with the wall of a body lumen (e.g., the wall of the gallbladder). Thus, a liquid ablation medium can be delivered into a body lumen, come into contact with the wall of the body lumen, and undergo a phase change into a liquid ablation medium. Ablation can occur at the phase change interface.

[0071] Figures 8 and 9 show an ablation system implemented as a cryoablation device 800 according to an embodiment. The cryoablation device 800 may be configured to ablate or disable the gallbladder cavity. The cryoablation device 800 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., ablation system 100, catheter system 250, control unit 310, etc.). As shown, the cryoablation device 800 includes a handle assembly 801, an outer shaft 860, and an inner shaft 870. The outer shaft 860 includes an expandable structure 866. The inner shaft 870 includes a nozzle 874 and an expandable structure 876. In some embodiments, the handle assembly 801 may include or house a control unit (e.g., control unit 110). In some embodiments, the handle assembly 801 may include an actuator 801a (e.g., a button) or a plurality of actuators 801a. In some embodiments, actuators may be used to control the deployment of an expandable structure 866 on the outer shaft 860, an expandable structure 876 on the inner shaft 870, the deployment of the ablation medium through the nozzle 874, the operation of the nozzle 874 (e.g., translation of the rotation of the nozzle 874), and so on. In some embodiments, the handle assembly 801 may be fluidically coupled to an ablation medium supply unit (e.g., an ablation medium supply unit 120). In some embodiments, the handle assembly 801 may include a user interface (e.g., an input / output interface 319) for communicating information to and / or receiving input from the user.

[0072] Figure 9 is a detail view of the outer shaft 860 and inner shaft 870 of the cryoablation device 800 according to an embodiment. The outer shaft 860 and inner shaft 870 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., outer shaft 260 and inner shaft 270). As shown, the expandable structure 876 may be implemented as an expandable cage mechanism. As shown, the expandable structure 876 has a “closed” design, for example, the bands or wires forming the expandable structure 876 come together and close at both the proximal and distal ends of the expandable structure 876, so that the expandable structure 876 forms an enclosed basket or cage.

[0073] Figure 10 shows an ablation catheter 1050 deployed in the body lumen BL according to an embodiment. The ablation catheter 1050 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., ablation system 100, catheter system 250, control unit 310, cryoablation device 800, etc.). As shown, the ablation catheter 1050 includes an outer shaft 1060 including an expandable structure 1066, and an inner shaft 1070 including a nozzle 1074 and an expandable structure 1076. As shown, the expandable structure 1066 on the outer shaft 1060 is deployed to prevent the ablation catheter 1050 from unintentionally exiting the body lumen BL (e.g., being maintained in a fixed position within the body lumen BL). The expandable structure 1076 on the inner shaft 1070 is deployed to position the nozzle 1074 approximately in the center within the body lumen BL, for example, to ensure a uniform and / or minimum spacing (e.g., a predetermined amount) between the nozzle 1074 and the tissue wall of the body lumen BL. As described above, such placement of the nozzle 1074 increases the effectiveness of ablation delivery and reduces potential undesirable effects (e.g., damage, adhesion between the nozzle and tissue, etc.). Both the expandable structure 1066 and the expandable structure 1076 can be collapsed (e.g., transitioned back to a non-deployed state) to allow the ablation catheter 1050 to be retracted from the body lumen BL.

[0074] Figure 11 shows an example of an inner shaft 1170 comprising a lumen 1172 and a fenestrated nozzle 1174. The inner shaft 1170 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., inner shaft 270, inner shaft 870, etc.). In some embodiments, the inner shaft 1170 may include a proximal end 1171a and a distal end 1171b. In some embodiments, the lumen 1172 is small enough to keep the cryogenic liquid ablation medium 1122 in a liquid state, and the cryogenic liquid ablation medium 1122 transitions to a cryogenic gas ablation medium 1124 (i.e., a transition from liquid phase to gas phase) when it exits the inner shaft 1170 through a plurality of openings 1175 (e.g., due to a pressure drop between the inside of the lumen 1172 and the inside of the gallbladder), as shown in Figure 11. In some embodiments, the cryogenic gas ablation medium 1124 exits the fenestrated nozzle 1174 through a plurality of openings 1175, and when the cryogenic gas ablation medium 1124 comes into contact with tissue, it ablates the outer surface of the gallbladder lumen.

[0075] Figures 12A and 12B show an outer shaft 1260 of an ablation system (e.g., a cryoablation device) according to an embodiment. The outer shaft 1260 may include components that are structurally and / or functionally similar to other outer shafts of the ablation system described herein (e.g., outer shaft 260, outer shaft 860, outer shaft 1060, etc.). As shown, the outer shaft 1260 may include concentrically arranged outer tubular members 1261a and inner tubular members 1261b. Also shown are a lumen 1262 and an expandable structure 1266. Figure 12A shows the expandable structure 1266 in an un-deployed state, and Figure 12B shows the expandable structure 1266 in an deployed state. As shown, the expandable structure 1266 includes wires arranged in a braided configuration including a proximal ring 1267a and a distal ring 1267b. In some embodiments, at least one of the proximal ring 1267a and the distal ring 1267b can move toward the other to induce outward expansion (e.g., unfolding) of the expandable structure 1266. In some embodiments, the proximal ring 1267a and the distal ring 1267b can move by sliding the tubular members 1261a and 1261b.

[0076] In some embodiments, the rings 1267a, 1267b and / or wires of the expandable structure 1266 may be radiopaque to aid in visualizing the operation of the expandable structure 1266 under image guidance (e.g., fluoroscopy, ultrasound imaging). In some embodiments, the proximal ring 1267a and the distal ring 1267b may be moved via pull wires, springs, sheaths, and / or any other suitable mechanism. For example, one or more pull wires may be actuated to move at least one of the proximal ring 1267a and the distal ring 1267b toward the other. In some embodiments, the expandable structure 1266 may be under tension when in the unextended state (Figure 12A) and relaxed when in the extended state (Figure 12B). In particular, the expandable structure 1266 may be held under tension along the outer surface of the outer shaft 1260 and may be released (for example, by releasing the holding on one or both ends of the expandable structure 1266, such as by releasing a pull wire, sheath, etc.) to allow the expandable structure 1266 to self-expand into an unfolded state. In some embodiments, the expandable structure 1266 may be made of a shape memory material so as to maintain its shape in the unfolded state unless subjected to an external force. In some embodiments, the band may be under tension when in the unfolded state and relaxed when in the unfolded state. For example, the expandable structure 1266 can be transitioned from an unfolded state to an unfolded state by pushing or moving the outer tubular member 1261a distally relative to the inner tubular member 1261b. As another example, the expandable structure 1266 can be transitioned from an unfolded state to an unfolded state by pulling or moving the inner tubular member 1261b proximal relative to the outer tubular member 1261a.

[0077] Figures 13A to 13C show parts of an ablation device, including different arrangements of expandable structures and nozzles. The ablation devices described in Figures 13A to 13C may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., ablation system 100, catheter system 250, control unit 310, cryoablation device 800, cryoablation catheter 1050, etc.). Figure 13A shows an outer shaft 1360 including an expandable structure 1366, and an inner shaft 1370 including an expandable structure 1376. The inner shaft 1370 is slidable within the outer shaft 1360 so that the inner shaft 1370 can move axially in the direction along arrow 1391 (e.g., along the longitudinal axis of the outer shaft 1360). The expandable structure 1376 may be coupled to the distal portion of the inner shaft 1370. The inner shaft 1370 can advance through the outer shaft 1360 until its distal portion (including, for example, the expandable structure 1376) is positioned distal to the distal end of the outer shaft 1360. Once positioned in this manner, the expandable structure 1376 may be configured to expand to its expanded state, as shown in Figure 13A. Although not shown in Figure 13A, a nozzle can advance separately distal to the outer shaft 1360. For example, a separate shaft supporting the nozzle can advance through the lumen of the outer shaft 1360 into the space adjacent to the expandable structure 1376. The nozzle can advance separately from the expandable structure 1376 so that a user can manipulate the position of the nozzle relative to the expandable structure 1376. Alternatively, in some embodiments, the inner shaft 1370 may include a nozzle. The expandable structure 1376 may include a plurality of bands or wires. In some embodiments, the bands may be made of shape-memory material so as to maintain their shape in the expanded state unless subjected to external force. As described above, in some embodiments, the band may be under tension when in an unextended state and in a relaxed state when in an extended state.Alternatively, the band can be in a relaxed state when unextended and under tension when extended.

[0078] Figure 13B shows an ablation device comprising an outer shaft 1360', an inner shaft 1370', a nozzle 1374', an expandable structure 1376', and a hub 1379'. As shown, the expandable structure 1376' includes a plurality of wires or bands extending outward and distally from the inner shaft 1370' and coupled to the distal hub 1379'. In some embodiments, the bands extend through the length of the inner shaft 1370' so that the bands can advance and retract from the proximal end of the inner shaft 1370'. Advancement of the bands causes expansion of the expandable structure 1376', allowing the expandable structure 1376' to be unfolded, and retraction of the bands pulls the expandable structure 1376' back toward the inner shaft 1370, returning the expandable structure 1376' to its unfolded state. In some embodiments, the bands of the expandable structure 1376' may be under tension when unfolded and relaxed when unfolded. In other words, the band can be held under tension so that the expandable structure 1376' is held in a non-extended or non-expanded state, and by releasing the band, the band can self-extend to the extended state. In some embodiments, the band can be moved via an actuator located at the proximal end of the inner shaft 1370'. In some embodiments, the actuator can be activated by pressing a button, moving a slider, releasing a spring, or activating any other suitable mechanism. In some embodiments, the band of the expandable structure 1376' may be under tension when in the extended state and relaxed when in the non-extended state. In other words, the band can advance from or be pushed from the proximal end of the inner shaft 1370' to extend the expandable structure 1376' to its extended or unextended state. As shown, the nozzle 1374' may be located within the expandable structure 1376'. The nozzle 1374' may be coupled to a lumen extending through the inner shaft 1370' so that the nozzle 1374' can receive and deliver the ablation medium into the body lumen. The nozzle 1374' may terminate proximal to the hub 1379'.In some embodiments, the nozzle 1374' can advance independently of the expandable structure 1376' so that its position within the expandable structure 1376' can be adjusted.

[0079] In some embodiments, the sensor may be located within the hub 1379'. In some embodiments, the sensor may be a temperature sensor. In some embodiments, the sensor may be a pressure sensor. In some embodiments, when the inner shaft 1370' is positioned within the gallbladder lumen to deliver the ablation medium (e.g., a cryoablation medium), the hub 1379' may be positioned in or near the cystic duct to measure the temperature and / or pressure within the cystic duct. Such measurements may be used (e.g., for safety) to monitor the progress of the ablation procedure and / or operating conditions during the ablation procedure.

[0080] Figure 13C shows an ablation device (e.g., a cryocatheter) comprising an outer shaft 1360”, an inner shaft 1370”, a nozzle 1374”, and an expandable structure 1376”. The ablation device may include a sleeve 1371”, which defines a set of one or more lumens for receiving one or more bands or wires forming the expandable structure 1376”. The bands forming the expandable structure 1376”, may extend from the proximal end of the sleeve 1371”, beyond the distal end, so that the bands can advance and / or retract from the proximal end of the sleeve 1371”. In some embodiments, the bands of the expandable structure 1376”, may be under tension when in the non-expanded state and relaxed when in the expanded state. In other words, the expandable structure 1376”, can be flattened by pulling the bands from the proximal end of the sleeve 1371”, and can be self-expanded into the expanded state by releasing the bands. In some embodiments, the band can be pulled or released from the proximal end of the secondary inner shaft 1371” via an actuator. In some embodiments, the band of the expandable structure 1376” can be under tension when in the deployed state and slack when in the undeployed state. In other words, the band can be advanced or pushed from the proximal end of the secondary inner shaft 1371” to expand. In some embodiments, the movement of the band of the expandable structure 1376” can be caused by an actuator (e.g., a button, slider, motor, spring, etc.).

[0081] In some embodiments, the sleeve 1371” can move proximal and distally along line 1391. In some embodiments, the sleeve 1371” can act as a push mechanism to deploy, for example, an expandable structure 1376”. For example, in response to pushing the sleeve 1371” toward the distal end of the inner shaft 1370” the expandable structure 1376” can expand outward to an expanded state in a first direction along arrow 1392. In response to pulling the sleeve 1371” toward or proximal to the distal end of the inner shaft 1370” the expandable structure 1376” can contract inward to an unexpanded state in the opposite direction along arrow 1392.

[0082] Figure 14 shows an internal shaft 1470 of an ablation catheter or catheter system, including an alternative embodiment of the expandable structure 1476 according to the embodiment. The expandable structure 1476 may include a plurality of wires or splines that are coupled to a hub or shaft at a first end (e.g., proximal end) and uncoupled at a second opposite end (e.g., distal end). In other words, the expandable structure 1476 has an "open" configuration. The inner shaft 1470 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., inner shaft 270, inner shaft 870, inner shaft 1170, inner shaft 1370, 1370', 1370'', etc.). The inner shaft 1470 also includes a nozzle 1474 and a hub 1479. Bands of expandable structure 1476 may be coupled to the hub 1479 at their proximal ends. As shown, the hub 1479 is located proximal to the nozzle 1474. The hub 1479 is Although shown as being proximal to the nozzle 1474, it can be understood that in other embodiments, the hub 1479 may be located distal to the nozzle 1474. Like other expandable structures described herein, the expandable structure 1476 may be configured to self-expand (for example, after being released from tension or after the band has advanced distal to the hub 1479). In some embodiments, the expandable structure 1476 may be composed of a shape memory material so that the expandable structure 1476 remains expanded during cryoablation.

[0083] Figures 15 to 16B illustrate catheter systems, according to various embodiments, that include an excretion lumen for the discharge of fluid (e.g., gas, liquid) or smaller debris from a body lumen BL. Figure 15 shows an ablation catheter 1550 partially disposed within a body lumen BL according to an embodiment. The ablation catheter 1550 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., ablation system 100, catheter system 250, control unit 310, cryoablation device 800, ablation catheter 1050, etc.). The ablation catheter 1550 includes an outer shaft 1560 and an inner shaft 1570. The outer shaft 1560 includes an excretion port 1563 (e.g., an excretion opening) and an expandable structure 1566. In some embodiments, the discharge port 1563 may be inserted into the internal lumen BL during ablation so that fluid or smaller debris can exit the internal lumen BL through the discharge port 1563 and flow out of the internal lumen BL via the outer shaft 1560 along the passage indicated by arrow 1595. In some embodiments, an expandable structure 1566 may be arranged around the outside of the discharge port 1563 so that the expandable structure 1566 acts as a filter to prevent larger debris from clogging the discharge port 1563. In some embodiments, the expandable structure 1566 may have a mesh structure that can help filter debris (e.g., stones, sludge, bile) from entering the discharge pathway in the outer shaft 1560 and create a reliable pathway for releasing ablation gases and pressure in the internal lumen BL. In some embodiments, the debris exiting the internal lumen through the discharge port 1563 may be solid, liquid, and / or gas. In some embodiments, the discharge port 1563 may be fluidly coupled to lumens running along arrow 1595 inside the outer lumen 1560 and outside the inner lumen 1570. In some embodiments, an expandable structure 1566 can create a reliable pocket for the discharge of ablation gases.

[0084] Figures 16A and 16B show cross-sections of outer shafts 1660 and 1660' including discharge lumens according to various embodiments. Figure 16A includes an outer shaft 1660 and an inner shaft 1670. The outer shaft 1660 and inner shaft 1670 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., outer shaft 260, inner shaft 270, outer shaft 860, inner shaft 870, outer shaft 1060, inner shaft 1070, outer shaft 1260, etc.). As shown in Figure 16A, the outer shaft 1060 may include a lumen 1662 in which the inner shaft 1070 is disposed. During the ablation procedure, the space between the outer surface of the inner shaft 1070 and the inner surface of the outer shaft 1060 can define a discharge channel or passage. In some embodiments, the debris can flow into an outlet in the lumen (e.g., outlet 1563), pass through an outlet channel, and exit the body lumen.

[0085] Figure 16B shows an alternative arrangement of lumens within the outer shaft 1670' of an ablation catheter (e.g., a cryoablation device). As shown, the outer shaft 1670' may include a separate lumen 1664' designated for the drainage of contents (e.g., solids, fluids, etc.) from within the body lumen BL. In some embodiments, the lumen 1664' may be fluidically coupled to an drainage port (e.g., drainage port 1563) which may be located within the body lumen. In some embodiments, the lumen 1664' may provide a channel for fluids and / or debris to exit the body lumen. As with other outer shafts, the outer shaft 1660' may define a lumen 1662' that can receive the inner shaft 1670' and be used to guide the inner shaft 1670' into the body lumen.

[0086] Figures 17A and 17B show the outer shaft 1760 of an ablation catheter (e.g., a cryoablation device) including an expandable structure 1766 according to an embodiment. The outer shaft 1760 includes an outlet 1762a and an outlet lumen 1762. The outer shaft 1760 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., outer shaft 260, outer shaft 860, outer shaft 1060, inner shaft 1070, outer shaft 1660, etc.). Figure 17A shows the expandable structure 1766 in an undeployed (i.e., non-expanded) state, and Figure 17B shows the expandable structure 1766 in an expanded state. As shown, the expandable structure 1766 is disposed on the outer shaft 1760 such that the expandable structure 1766 covers the outlet 1762a. When the expandable structure 1766 is deployed, it expands outward in the direction indicated by arrow 1792. In some embodiments, the expandable structure 1766 may form a mesh or include perforations or openings so that, in its expanded state, it can act as a filter for fluid and / or debris entering the discharge port 1762a. In such cases, the expandable structure 1766 can act as a filter to prevent debris large enough to clog the discharge port 1762a from entering the discharge port 1762a.

[0087] Figures 18A and 18B show different arrangements of the expandable structure of the outer shaft of an ablation catheter according to an embodiment. Figures 18A and 18B show the outer shafts 1860 and 1860' of an ablation catheter (e.g., a cryoablation device) disposed within the body lumen BL. The outer shafts 1860 and 1860' may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., outer shaft 260, outer shaft 860, outer shaft 1060, inner shaft 1070, outer shaft 1660, outer shaft 1760, etc.). Figure 18A shows the outer shaft 1860 including an expandable structure 1866, an outlet 1862a, and an outlet pocket 1867. As shown, the outlet 1862a is disposed within the body lumen BL when the outer shaft 1860 is positioned for the ablation procedure. The expandable structure 1866 may be configured to expand in order to form a curved or concave structure that defines an discharge pocket 1867 around the discharge hole 1862a. In other words, the expandable structure 1866 may form an umbrella-like shape that prevents debris from entering the discharge hole 1862a.

[0088] Figure 18B shows an outer shaft 1860' including an expandable structure 1866', an outlet 1862a', and an outlet pocket 1867'. As shown, the outlet 1862a' is located within the body lumen BL. The expandable structure 1866' partially covers the outlet 1862a', forming the outlet pocket 1867'. As shown, the outlet pocket 1867' is expanded to have a flat or substantially flat proximal side. This shape allows for a secure engagement with the wall at the entrance point of the body lumen BL, stabilizing the outer shaft 1860' within the body lumen. This shape ensures better retention of the outer shaft 1860' within the body lumen, for example, in the gallbladder.

[0089] Figures 19A-19B and 20 illustrate exemplary diagrams of the inner shaft 1970, including a nozzle 1974 (e.g., a dispersion nozzle) located at the distal end of the inner shaft 1970, according to various embodiments. Figure 19A shows a perspective view of the inner shaft 1970, and Figure 19B shows a cross-sectional side view of the inner shaft 1970. The inner shaft 1970 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., inner shaft 270, inner shaft 870, inner shaft 1070, inner shaft 1670, etc.).

[0090] In some embodiments, the inner shaft 1970 may include a long catheter body containing at least one delivery lumen 1972 that carries a liquid ablation medium 1922 and terminates within a dispersion nozzle 1974. In some embodiments, the geometry of the dispersion nozzle 1974 is spherical and includes a series of holes 1975 extending from the outer diameter of the dispersion nozzle 1974 to the delivery lumen 1972. In some embodiments, the dispersion nozzle 1974 uses liquid nitrous oxide as the ablation medium that undergoes a phase transition, and the geometry of each hole 1975 intersects with the outer surface of the dispersion nozzle 1974 (phase transition interface 1975a). In other words, the liquid ablation medium 1922 is transferred to the gas ablation medium 1924 near the outer surface of the dispersion nozzle 1974. In some embodiments, the pores 1975 are sufficiently small in size (e.g., about 0.0005 inches to 0.004 inches) to withstand the high pressure required to keep the nitrous oxide in its liquid form until the cryogenic agent reaches the desired phase transition interface 1975a. In some embodiments, the phase transition interface 1975a is controlled by a pressure drop (e.g., atmospheric ventilation) relative to the supply pressure of the liquid ablation medium 1922. In some embodiments, the phase transition occurs when the liquid nitrous oxide is exposed to near-atmospheric pressure in the internal cavity BL or other desired ablation region. In some embodiments, the phase transition occurs at the wall of the internal cavity BL. Thus, the fluid ablation medium can be delivered into the internal cavity BL, come into contact with the wall of the internal cavity BL, and undergo a phase transition to a gas ablation medium. In such cases, ablation can occur at the liquid-gas phase transition interface. As shown, the hole 1975 located proximal to the nozzle 1974 is angled so that the gas ablation medium 1924 is dispensed at a certain angle toward the proximal region of the body lumen (for example, angled proximal to the longitudinal axis of the inner shaft 1970). The hole 1975 located distal to the nozzle 1974 is angled so that the gas ablation medium 1924 is dispersed at a certain angle toward the distal region of the body lumen (for example, angled distal to the longitudinal axis of the inner shaft 1970). This angled configuration of the hole 1975 may help increase the dispersal of the gas ablation medium 1924 throughout the body lumen.

[0091] Although shown as a spherical configuration, the geometry of the dispersion nozzle 1974 may be a cube, cone, cylinder, triangular prism, torus, spiral, oval, or any other three-dimensional (3D) body containing sufficient structure to allow delivery of the ablation medium. In some embodiments, the dispersion nozzle 1974 may be made from metal, polymer, ceramic, or other structural material. In some embodiments, the maximum diameter of the distal geometry is small enough to slide through the access catheter. In some embodiments, the dispersion nozzle 1974 may be expanded (e.g., inflated) to achieve a shape larger than the diameter of the access catheter.

[0092] Figure 20 shows how the gas ablation medium 1924 is uniformly distributed from the dispersion nozzle 1974 to the wall of the body cavity BL during use. In some embodiments, the inner shaft 1970 can move freely axially (i.e., along the axis indicated by line 1994) to adequately treat the wall of the body cavity BL with the gas ablation medium 1924 over the entire axial length of the body cavity BL.

[0093] Figure 21 shows an inner shaft 2170, according to an embodiment, including an operating nozzle 2174 located near the distal end of the inner shaft 2170. The inner shaft 2170 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., inner shaft 270, inner shaft 870, inner shaft 1070, inner shaft 1670, inner shaft 1970, etc.). In some embodiments, the gas ablation medium 2124 may be discharged through a hole 2175 on the operating nozzle 2174. In some embodiments, the inner shaft 2170 may include an inner shaft body 2170a and a linear rail component 2170b. In some embodiments, the operating nozzle 2174 can be mounted on the linear rail component 2170b. In some embodiments, the linear rail component 2170b allows the operating nozzle 2174 to move axially (i.e., along the line indicated by arrow 2194) in response to a driving force. In some embodiments, the linear rail component 2170b allows the operating nozzle 2174 to move nonlinearly along its central axis in response to a driving force.

[0094] In some embodiments, the driving force is applied either manually or automatically via a control unit (e.g., control unit 110). In some embodiments, the driving force may be applied manually or automatically using a rigid drive wire system, a flexible drive cable system, a meshing gear drive system, a rack and pinion system, a screw drive mechanism, a pneumatic actuator system, an electromagnetic coil system, a hydraulic actuator system, or any other type of system that can be understood. In some embodiments, the driving force is a user's gripping force, tensile force, torsional force, or compressive force. In some embodiments, the driving force may be electromechanical, such as the use of electric current or an electromagnetic field to drive an AC / DC motor.

[0095] In some embodiments, the linear rail component 2170b may be fixed or substantially fixed to the rail by distal and proximal features. In some embodiments, the linear rail component 2170b may be fixed or substantially fixed to the rail by the proximal feature alone. In some embodiments, the linear rail component 2170b may be fixed or substantially fixed to the rail by the distal feature alone. In some embodiments, the distal feature may be a cystic duct obstruction mechanism. In some embodiments, the proximal feature may be an access catheter lumen.

[0096] In some embodiments, the operating nozzle 2174 may be similar to the nozzles shown in Figures 19A, 19B, and 20, according to various embodiments. In some embodiments, the diameters of one or more holes 2175 located on the operating nozzle 2174 may vary relative to their positions. In some cases, the holes 2175 may be “tapered” along their geometry or increase / decrease in diameter to deliver a gas ablation medium 2124 at a constant mass flow rate and to address the effects of pressure drops in the ablation supply lumen.

[0097] In some embodiments, the size, shape, and number of holes 2175 emanating from the supply lumen determine the spray pattern, spray velocity, and spray uniformity of the ablation medium. In some embodiments, some of the holes 2175 are optimized to target nearby targets (e.g., 0–0.5 cm). In some embodiments, some of the holes 2175 are optimized to target distant targets (e.g., greater than 0.5 cm).

[0098] In some embodiments, the operating nozzle 2174 can spin along its central axis, rotating the holes 2175 relative to their starting positions. In some embodiments, the operating nozzle 2174 can rotate within a range of 0 to 360 degrees or any inclusive range. In some embodiments, the rotating operating nozzle 2174 allows for a wider range of application for ablation medium delivery.

[0099] In some embodiments, the operating nozzle 2174 can be fixed to the distal end of the linear rail component 2170b and can move along with the displacement of the linear rail component 2170b due to the driving force.

[0100] In some embodiments, the linear rail component 2170b can facilitate concentric or non-concentric movement of the operating nozzle 2174 over a range of about 0 to 10 cm or any other range in response to a driving force.

[0101] Figure 22 shows an inner shaft 2270, according to an embodiment, including an operating nozzle 2274 located near the distal end of the inner shaft 2270. The inner shaft 2270 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., inner shaft 270, inner shaft 870, inner shaft 1070, inner shaft 1670, inner shaft 1970, inner shaft 2170, etc.). In some embodiments, the gas ablation medium 2224 may be discharged through a hole 2275 on the operating nozzle 2274. In some embodiments, the inner shaft 2270 may include an inner shaft body 2270a and a linear rail component 2270b. In some embodiments, the operating nozzle 2274 may move axially along the linear rail component 2270b in response to a driving force (i.e., along the line indicated by arrow 2294). In some embodiments, the inner shaft 2270, the operating nozzle 2274, the hole 2275, the inner shaft body 2270a, and the linear rail component 2270b may be the same as or substantially the same as the inner shaft 2170, the operating nozzle 2174, the hole 2175, the inner shaft body 2170a, and the linear rail component 2170b, as described above with reference to Figure 21.

[0102] The inner shaft 2270 also includes an occluder 2279. The occluder 2279 may be configured to occlude or close an opening or lumen outlet from a body lumen to a nearby biological structure. For example, if the body lumen is the lumen of the gallbladder, the occluder 2279 may be configured to occlude the cystic duct. The occluder 2279 may be coupled to and / or detachable from the inner shaft 2270. During operation, the occluder 2279 may be coupled to the distal end of the inner shaft 2270. In some embodiments, the occluder 2279 may be coupled to a linear rail component 2270b. The inner shaft 2270 may be navigated into the body lumen. The inner shaft 2270 may be operated to position the occluder 2279 at an opening from the body lumen (e.g., an outlet lumen such as the cystic duct). The occluder 2279 can then be separated from or removed from the inner shaft 2270, and the occluder 2279 can be left in the opening. The occluder 2729 can then be fixed in place, for example, by volume expansion of the occluder 2279, by a male screw, friction fitting, bonding, or other suitable fixing mechanism. Further details of suitable occluders, such as plugs, are described in International Application US2019 / 017112, which is incorporated herein by reference.

[0103] Figures 23-24 show an inner shaft 2370 having a nozzle 2374 which includes a curved design that can increase the effective spray area of ​​the ablation medium. The inner shaft 2370 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., inner shaft 270, inner shaft 870, inner shaft 1070, inner shaft 1670, inner shaft 1970, inner shaft 2170, inner shaft 2270, etc.). In some embodiments, the nozzle 2374 has at least one curved segment including at least one hole 2375 emanating from a supply lumen. In some embodiments, the nozzle 2374 can rotate along its central axis 2395 (i.e., along arrow 2396) to uniformly deliver the ablation medium to the surface of the body lumen. Figure 24 shows the inner shaft 2370 disposed within the body lumen BL. As shown, the liquid ablation medium 2322 exits the nozzle 2374 through the hole 2375, undergoes a phase change, and becomes the gas ablation medium 2324.

[0104] In at least one embodiment, the diameters of one or more holes 2375 located on the nozzle 2374 may vary in diameter with respect to their distance along the nozzle 2374. In some cases, the holes may be “tapered” or increase / decrease in diameter between the proximal and distal ends of the nozzle 2374 to deliver an ablation medium at a constant mass flow rate and to address the effects of pressure drops in the supply lumen.

[0105] In some embodiments, the size, shape, and number of holes 2375 emanating from the supply lumen determine the spray pattern, spray velocity, and spray uniformity of the ablation medium. In some embodiments, the entire nozzle 2374 can rotate and / or slide longitudinally with respect to its central axis 2395. In some embodiments, some of the holes 2375 are optimized to target nearby targets. In some embodiments, some of the holes 2375 are optimized to target distant targets.

[0106] Figures 25 to 26B show an ablation catheter 2550, according to an embodiment, which includes a collapsible cryotherapy nozzle. The ablation catheter 2550 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., ablation system 100, catheter system 250, control unit 310, cryoablation device 800, ablation catheter 1050, etc.). The ablation catheter 2550 includes an outer shaft 2560, and a first inner shaft 2570a and a second inner shaft 2570b. In some embodiments, the ablation catheter 2550 may include an expandable structure 2576. In some embodiments, the inner shafts 2570a, 2570b (collectively referred to as inner shaft 2570) may be coupled to the expandable structure 2576. In some embodiments, the inner shafts 2570 may be uncoupled at their distal ends. In other words, the ablation catheter 2550 may not have an expandable structure 2576. The inner shaft 2570 includes a hole 2575 for the delivery of the ablation medium. In some embodiments, the inner shaft 2570a can move along the line indicated by arrow 2591. In some embodiments, the inner shaft 2570 can rotate around the central axis 2595 (i.e., along the path indicated by arrows 2592a, 2592b). As shown, the ablation catheter 2550 includes two inner shafts 2570. In some embodiments, the ablation catheter 2550 may include 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or more inner shafts 2570. As shown, the inner shaft 2570 extends to the partial length of the expandable structure 2576. In some embodiments, the inner shaft 2570 can extend along the entire length of the expandable structure 2576 so that the inner shaft 2570 is joined together with the distal end of the ablation catheter 2550.

[0107] In some embodiments, at least one of the inner shafts 2570 forms a curved shape along the central axis 2595, the curved shape extending to the maximum radial dimension, converging back toward the central axis 2595, and bringing the hole 2575 closer to the target ablation site. In some embodiments, the ablation catheter 2550 uses liquid nitrous oxide as the ablation medium, and is configured such that the phase change interface of the ablation medium is located on the outer surface of the inner shaft 2570.

[0108] In some embodiments, the inner shaft 2570 may be spring-loaded and can be deformed to be delivered through a delivery lumen with a smaller diameter compared to the nominal expanded diameter of the inner shaft 2570.

[0109] Figures 26A and 26B show the inner shaft 2570 in more detail. Figure 26A shows a cross-sectional view of the inner shaft 2570, and Figure 26B shows a side view of the inner shaft 2570. In some embodiments, the ablation catheter 2541 may be constructed using a pre-formed core 2571 within the inner shaft 2570 that exerts a return force when subjected to mechanical stress, thermal energy, electric current, or light. In some embodiments, the pre-formed core 2541 may be made from an alloy metal such as nitinol or spring steel. In some embodiments, the pre-formed core 2571 may be made from a polymer such as acrylonitrile butadiene styrene (ABS). In some embodiments, the inner shaft 2570 may be driven into an expanded form by a mechanical drive force such as a rack and pinion gear system, a cable drive system, or an electromechanical control system. In some embodiments, the inner shaft 2570 may be operated along a linear or radial path to increase the dispersion of the chilling agent from the inner shaft 2570.

[0110] Figures 27A and 27B show an inner shaft 2770 having a helical nozzle 2774 containing several holes 2775 emanating from at least one continuous supply lumen 2772. Figure 27A shows a side view of the inner shaft 2770, and Figure 27B shows a cross-sectional view of the inner shaft 2770. The inner shaft 2770 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., inner shaft 270, inner shaft 870, inner shaft 1070, inner shaft 1670, inner shaft 1970, inner shaft 2170, inner shaft 2270, etc.). The gas ablation medium 2724 is shown to exit the inner shaft 2770 through the holes 2775. In some embodiments, the helical nozzle 2774 may be mounted around a structure that holds the helical shape of the helical nozzle 2774. In some embodiments, the size, shape, and position of the holes 2775 may vary depending on the desired spray pattern. In some embodiments, the holes 2775 may be “tapered” along the nozzle 2774 with respect to their distance along the nozzle 2774 in order to maintain a desired mass flow rate along each of the holes 2775. In some embodiments, the aforementioned design allows for a minimum distance between the phase change surface and the supply lumen 2772 to minimize variability in the spray pattern between the holes.

[0111] Figure 28 shows an ablation catheter 2850 including an outer shaft 2860 and an inner shaft 2870. The ablation catheter 2850 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., ablation system 100, catheter system 250, control unit 310, cryoablation device 800, ablation catheter 1050, etc.). The ablation medium 2826 can be discharged from the body lumen through the outer shaft 2860. In some embodiments, a heating coil 2882 may be deployed around the outside of the outer shaft 2860. In some embodiments, a heating coil 2884 may be deployed around the outside of the inner shaft 2870. According to various embodiments of the present disclosure, the cryoablation device of the present disclosure is designed to utilize the phase change properties of liquid nitrous oxide (N2O or LN2O) to induce a cryoablation temperature (e.g., about -80°C) at the target tissue interface. N2O is a clear liquid at ambient temperature and high pressure (>650 psi), but under sufficient pressure reduction, it undergoes a phase change from liquid to gas, resulting in an endothermic reaction that produces refrigerant properties. Furthermore, while liquid nitrous oxide offers unique refrigerant properties that make it very suitable for cryoablation applications, it can raise safety concerns because the gas volume can increase by more than 600 times during the phase change, potentially creating a source of pressure increase in the lumen. To address this risk, the cryoablation devices of this disclosure may be designed to utilize a passive evacuation management system to evacuate the cryogenic gas from the body during the procedure. For example, the systems, devices, and methods described herein can enable the flow of ablation medium through the concentric tubular space between the inner shaft (e.g., inner shaft 2870) and the outer shaft (e.g., outer shaft 2860) of an ablation catheter. A pressure-driven flow can cause the ablation medium to enter the tubular space between the inner and outer shafts and be discharged through an evacuation port at the proximal end of the ablation catheter.

[0112] In addition, liquid nitrous oxide has a melting point within a few degrees Celsius of its boiling point, meaning there is a small margin between its gas and solid phases. This can lead to the accumulation of solid nitrous oxide ice if the pressure and temperature within the outer and inner shafts are not properly controlled. In relation to residual fluid in the gallbladder, the accumulation of solid nitrogen ice can lead to blockage of the drainage lumen under certain circumstances. This can cause an increase in pressure within the gallbladder lumen, which is a safety concern. To directly address ice formation in the drainage lumen, heating coils 2882 and 2884 can be applied to melt or evaporate the ice accumulation.

[0113] Figures 29A and 29B show diagrams of an ablation catheter 2950, ​​including a catheter heating system configured to address ice accumulation in the discharge lumen, according to various embodiments of the present disclosure. The ablation catheter 2950 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., ablation system 100, catheter system 250, control unit 310, cryoablation device 800, ablation catheter 1050, etc.). As shown, the ablation catheter 2950 includes an outer shaft 2960 and an inner shaft 2970. The inner shaft 2970 includes a nozzle 2974. In some embodiments, a heating coil 2982 may be wound around the outside of the outer shaft 2960 (e.g., arranged around it). In some embodiments, a heating coil 2984 may be wound around the outside of the inner shaft 2970 (e.g., arranged around it). In particular, Figure 29A shows an exemplary diagram of a catheter heating system designed to thaw the accumulation of cryogenic ice in the lumen. The catheter heating system in Figure 29A includes a multi-surface heating system in which the outer surfaces of the outer shaft 2960 and the inner shaft 2970 are heated to evaporate the ice accumulation and maintain the patency of the annular space between the two shafts. Figure 29B shows an ablation catheter 2950' that includes a single-surface heating system in which the outer surface of the outer shaft 2960 is heated via a heating coil 2982 to evaporate the ice accumulation and maintain the patency of the annular space between the inner shaft 2970 and the outer shaft 2960.

[0114] In some embodiments, the heating coils 2982, 2984 may include a resistive heating element, such as a resistive wire, which converts electrical energy into heat, thereby conductively heating a nearby body. In some embodiments, the resistive heating wire is wound around the outer circumference of the outer shaft 2960. In some embodiments, the resistive heating wire is wound around the inner circumference of the outer shaft 2960. In at least one embodiment, the resistive heating wire is embedded in the wall material of the outer shaft 2960.

[0115] In some embodiments, the resistive heating wire is wound in a helical coil configuration with a pitch spacing of approximately 0 to 1 inch, encompassing all partial ranges and values ​​in between. In some embodiments, the resistive heating wire is wound in a helical coil configuration with a fixed pitch. In another embodiment, the resistive heating wire is wound in a helical coil configuration with variable or "progressive fixed" pitches, such that sections with denser coil pitches are located closer to the distal end of the outer shaft 2960. In the above configurations, the denser pitch sections allow for greater heat density compared to the sparser pitch sections, thereby heating the body surrounding the denser pitch sections more. This allows for the localization of the heating energy of the coil, minimizing competing effects on the therapy.

[0116] In some embodiments, the outer shaft 2960 may be a polymer, metal, ceramic, or composite material, or any combination thereof. In some embodiments, a metal or highly thermally conductive material may extend to part or all of the wall thickness and circumference of the outer shaft 2960 to increase the heat transfer rate to the desired heating target. In some embodiments, the delivery lumen may have a metal segment near the distal end of the outer shaft 2960 to concentrate the effect of the heating coil 2982. In some embodiments, insulating material may be used to electrically and / or thermally insulate the heating coil 2982 from the body surrounding it.

[0117] Figures 30A to 33 show the ablation catheter 3050 at various stages of assembly. Figures 30A to 30B show the outer shaft 3060 and dilator 3068 according to embodiments. The ablation catheter 3250 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein (e.g., ablation system 100, catheter system 250, control unit 310, cryoablation device 800, ablation catheter 1050, etc.). The outer shaft 3060 includes a handle assembly 3002 and an expandable structure 3066. In some embodiments, the deployment of the expandable structure 3066 may be controlled by the handle assembly 3002. Figure 30A shows the outer shaft 3060 separated from the dilator 3068. Figure 30B shows the dilator 3068 fixed within the outer shaft 3060. In some embodiments, as described above with reference to Figures 6A-6B, the dilator 3068 can be used to securely fit the outer shaft around the guidewire during insertion into the body lumen. In some embodiments, the dilator 3068 can be fixed inside the outer shaft 3060 via threads.

[0118] Figures 31A and 31B show an outer shaft 3060 containing an expandable structure 3066 in an unextended state (Figure 31A) and an extended state (Figure 31B) according to an embodiment. As shown, the handle assembly 3002 includes a button 3002a and a handle 3002b. In some embodiments, pressing the button 3002a can release the mechanism that controls the extension of the expandable structure 3066. After the mechanism is released, the handle 3002b can be pulled to activate the expandable structure 3066 into the extended state. Once the expandable structure 3066 is extended, the button 3002a can be released to lock the expandable structure 3066 into the extended state.

[0119] Figures 32A to 32C show an inner shaft 3070 including an actuator handle assembly 3004 according to an embodiment. The actuator handle assembly 3004 includes an actuator handle 3004a. The inner shaft 3070 includes a nozzle 3074, an expandable structure 3076, and a hub 3079. The nozzle 3074 includes holes 3075a, 3075b, and 3075c (collectively referred to as holes 3075). As shown, the proximal hole 3075a is angled so that the ablation medium exits slightly proximal from the nozzle 3074. As shown, the distal hole 3075c is angled so that the ablation medium exits slightly distal from the nozzle 3074. The advantages of such an angled configuration of holes 3075 are described above with reference to holes 1975 in Figures 19A to 19B.

[0120] As shown, Figure 32A shows details of the expandable structure 3276, Figure 32B shows the actuator handle 3004a positioned so that the expandable structure 3076 is in an extended state, and Figure 32C shows the actuator handle 3004a positioned so that the expandable structure 3076 is in an unextended state. In some embodiments, the actuator handle 3004a may be fixed in place by magnets. For example, the actuator handle assembly 3004 may include magnets on both the proximal and distal sides, and the actuator handle 3004a may include magnets so that the actuator handle 3004a is attracted to the proximal and distal sides of the actuator handle assembly 3004. In such cases, the actuator handle 3004a may be more attracted to the side closer to the actuator handle assembly 3004.

[0121] Figure 33 shows the assembled ablation catheter 3050, where the inner shaft 3070 is disposed within and / or coupled to the outer shaft 3060. As shown, the expandable structure 3066 is in the unextended state, and the expandable structure 3076 is in the extended state. As shown, the actuator handle 3004a is coupled to the actuator handle assembly 3004. In some embodiments, the actuator handle 3004a may be coupled to the actuator handle assembly 3004. In some embodiments, the button 3002a may be disposed within the handle assembly 3002. In some embodiments, the button 3002a may be coupled to the handle assembly 3002. In some embodiments, the handle 3002b may be disposed within the handle assembly 3002. In some embodiments, the handle 3002b may be coupled to the handle assembly 3002.

[0122] Figures 34A and 34B show an ablation system 3150, including a handle assembly with multiple handles, according to an embodiment. Figure 34A shows the ablation system 3150, and Figure 34B shows the spray pattern of the nozzle of the ablation system 3150. As shown, the ablation system 3150 includes an outer shaft 3160, an expandable structure 3166 (e.g., a retaining mechanism), an inner shaft 3170, a nozzle 3174, an expandable structure 3176 (e.g., an expandable body or cage), an outer shaft (introducer or access sheath) handle 3180, an outer shaft (introducer or access sheath) handle button 3182, an discharge chamber port 3184, an discharge chamber collar 3185, an inner shaft (catheter) handle 3190, an inner shaft (catheter) handle button 3192, a wire end collar 3194, and a heated sheath plug 3196. In some embodiments, the outer shaft 3160, expandable structure 3166, inner shaft 3170, nozzle 3174, and expandable structure 3176 may be the same as or substantially the same as the outer shaft 3060, expandable structure 3066, inner shaft 3070, nozzle 3074, and expandable structure 3076, as described above with reference to Figure 33. Therefore, specific embodiments of the outer shaft 3160, expandable structure 3166, inner shaft 3170, nozzle 3174, and expandable structure 3176 are not described in further detail herein.

[0123] In some embodiments, the user can press the outer shaft handle button 3182 to advance the outer liner or sheath 3161 of the outer shaft 3160 distally. Advancement of the outer liner 3161 relative to the tip 3163 of the outer shaft 3160 can expand the expandable structure 3166 (e.g., transition to an expanded configuration) so that the expandable structure 3166 can hold the tip 3163 in a fixed position inside the gallbladder. In some embodiments, the outer shaft handle 3180 may include a locking mechanism (not shown) so that the liner 3161 of the outer shaft 3160 can be locked in a fixed position relative to the tip 3163. The discharge chamber port 3184 is in fluid communication with the interior of the outer shaft 3160. The cryoablation medium flows through the interior of the outer shaft 3160 and can exit the ablation system 3150 through the discharge chamber port 3184. In some embodiments, the discharge chamber port 3184 may be connected to a hose and / or vacuum line so that the cryoablation medium can be discharged from the outer shaft 3160 and handle assembly 3180 as needed.

[0124] The exhaust chamber collar 3185 fits around the outside of the inner shaft 3170. In some embodiments, the exhaust chamber collar 3185 can create a seal with the inner shaft 3170 so that the exhaust chamber collar 3185 can prevent liquids and / or gases (e.g., ablation medium) from leaking or flowing further along the inner shaft 3170.

[0125] The inner shaft handle 3190 includes an inner shaft handle button 3192. By pressing the inner shaft handle button 3192, a portion of the inner shaft 3170 can be advanced relative to the inner handle assembly 3190. In some embodiments, by pressing the inner shaft handle button 3192, one or more outer layers of the inner shaft 3170 can be advanced relative to the inner ablation lumen of the inner shaft 3170. In some embodiments, the inner handle assembly 3190 may include a locking mechanism (not shown) so that the advanced portion of the inner handle assembly 3180 can be locked in place relative to the other portion of the inner shaft 3170. This movement of the portion of the inner shaft 3170 can be used to deploy the expandable structure 3176.

[0126] The wire end collar 3194 is coupled to the inner shaft 3170 and can serve as a connection point between one or more heating elements, sensors, tubular lumen, etc., and an external source. Alternatively, in some embodiments, the collar 3194 may be omitted, and the connection may be formed between one or more components of the inner shaft 3170 and the external source via another section of the handle 3190. In some embodiments, the collar 3194 may be configured to couple one or more heating wires of the inner shaft 3170 to an external heat source. In some embodiments, the wire end collar 3194 can provide heat to the inner shaft 3170 via an internal heat source to prevent clogging due to freezing. A cryoablation medium can freeze material passing through the inner shaft 3170 and / or the outer shaft 3160, thereby potentially clogging the path through the inner shaft 3170. By initiating heating (for example, via an external heat source coupled to one or more electric heating wires extending along the inner shaft 3170), the heat applied to the inner shaft 3170 can melt the frozen material and allow flow through the inner shaft 3170 and / or the outer shaft 3160. In some embodiments, the wire end collar 3194 may be coupled to the inner handle assembly 3190. The collar 3194 may include a heating sheath plug 3196 used for coupling to the external heat source.

[0127] Although not shown in detail in Figures 34A and 34B, the inner shaft 3170 defines a lumen from which an ablation medium, such as a cryoablation medium, can be delivered to the opening of the nozzle 3174. In some embodiments, the nozzle 3174 may be rotatable to adjust the position of the opening of the nozzle 3174 and the location to which the ablation medium is delivered. In some embodiments, the nozzle 3174 may act independently of the expandable structure 3176 and be moved, for example, relative to the expandable structure 3174 to adjust the position of the opening of the nozzle 3174 and the location to which the ablation medium is delivered.

[0128] In some embodiments, a pressure-sensing lumen (not shown) may be located within one or more of the outer shaft 3160 and / or inner shaft 3170. In some embodiments, the pressure-sensing lumen may be fluidically coupled to a pressure sensor at the proximal end of the ablation system 3150 (not shown). In some embodiments, the pressure-sensing lumen may terminate at an orifice located within the gallbladder cavity, with the pressure sensor located outside the gallbladder cavity. In other words, the pressure-sensing lumen may be fluidly coupled to the pressure sensor within the gallbladder cavity. In some embodiments, the pressure-sensing lumen may be located around the inner shaft 3170. In some embodiments, the pressure-sensing lumen may be located around the outer shaft 3160. In some embodiments, the pressure-sensing lumen may be located within the inner shaft 3170. In some embodiments, the ablation system 3150 may include a plurality of pressure-sensing lumen.

[0129] Figure 34B shows the spray pattern of the ablation system 3150 according to an embodiment. As described above, the ablation system 3150 can be used to deliver an ablation medium, such as a cryoablation medium, through the opening of the nozzle 3174. In some embodiments, the medium may be delivered as a fluid. In some embodiments, the medium may be delivered as a gas. In some embodiments, the medium may be delivered as a fluid that transitions to a gas at points along the length of the ablation system 3150 and / or at points within the lumen of the gallbladder. As schematically shown in Figure 34B, the spray pattern of the ablation medium exiting the ablation catheter 3150 through the opening of the nozzle 3174 may be conical. In other words, the ablation medium may be delivered through multiple spray zones that may or may not overlap with each other.

[0130] Figures 35A and 35B provide more detailed illustrations of the outer shaft 3260 and outer shaft handle 3280 of the ablation system according to an embodiment. Figure 35A shows a side view of the outer shaft 3260 and outer shaft handle 3280, and Figure 35B shows a cross-sectional view of the outer shaft 3260 and outer shaft handle 3280. As shown, the outer shaft 3260 includes an expandable structure 3266 (e.g., a retaining mechanism). The outer shaft 3260 is coupled to the outer shaft handle 3280. The outer shaft handle 3280 includes an outer shaft handle button 3282 and an exhaust chamber port 3284. In some embodiments, the outer shaft 3260, expandable structure 3266, outer shaft handle 3280, outer shaft handle button 3282, and discharge chamber port 3284 may be the same as or substantially the same as the outer shaft 3160, expandable structure 3166, outer shaft handle 3180, outer shaft handle button 3182, and discharge chamber port 3184, as described above with reference to Figures 34A to 34B. Therefore, specific embodiments of the outer shaft 3260, expandable structure 3266, outer shaft handle 3280, outer shaft handle button 3282, and discharge chamber port 3284 are not described in further detail herein. The outer shaft 3260 can define a lumen 3265 that can receive an inner shaft (for example, the inner shaft of an ablation catheter such as any of those described herein).

[0131] The handle 3280 may have a button 3282 that can be moved distally (e.g., sliding) to advance the outer liner 3261 of the outer shaft 3260 relative to the tip 3263 of the outer shaft 3260. This advancement can be used to deploy the expandable structure 3266, for example, to transition the expandable structure 3266 from a collapsed state extending substantially parallel to the longitudinal axis of the outer shaft 3260 to an expanded state curving radially outward from the longitudinal axis. Once deployed, the expandable structure 3266 may be configured to hold the distal end of the outer shaft 3260 within the gallbladder lumen. In other words, in its expanded state, the expandable structure 3266 may be configured such that the distal end of the outer shaft 3260 has a larger diameter than the opening used to gain access to the gallbladder lumen. Thus, the expanded structure 3266 in its expanded state can abut against the gallbladder wall near its opening, holding the distal end of the outer shaft 3260 within the gallbladder lumen. Button 3282 can be locked by spring 3281. Button 3282 can be pressed to release it and then slid to advance the liner 3161. When the button has slid its maximum distance (e.g., along the track), button 3282 can be locked again via notch 3283 and spring 3282 which pushes button 3282 into the notch. Although the button is described as an example of an actuator (e.g., actuator 801a), it can be understood that any type of actuation mechanism may be used to advance and / or retract various components of the outer shaft 3260.

[0132] Figure 36 provides a more detailed diagram of the ablation catheter 3350 of the ablation system according to an embodiment. As shown, the ablation catheter 3350 includes an inner shaft 3370, a nozzle 3374, an expandable structure 3376 (e.g., an expandable cage), an inner shaft handle 3390 including an inner shaft handle button 3392, a wire end collar 3394, and an inner shaft plug 3396. In some embodiments, the inner shaft 3370, nozzle 3374, expandable structure 3376, inner shaft handle 3390, and inner shaft handle button 3392, wire end collar 3394, and inner shaft plug 3396 may be the same as or substantially the same as the inner shaft 3170, nozzle 3174, expandable structure 3176, inner shaft handle 3190, inner shaft handle button 3192, wire end collar 3194, and inner shaft plug 3196 as described above with reference to Figures 34A to 34B. Therefore, specific aspects of the inner shaft 3370, nozzle 3374, expandable structure 3376, inner shaft handle 3390, inner shaft handle button 3392, wire end collar 3394, and inner shaft plug 3396 are not described in further detail herein.

[0133] In some embodiments, the distal end of the ablation catheter 3350 may be inserted through the lumen of the outer shaft or the introducer, for example, as shown in Figure 34A. For illustrative purposes in Figure 36, the inner shaft 3370 is shown with a discontinuity to indicate that the length of the inner shaft is longer than that shown in Figure 36. The expandable structure 3376 can transition between a non-expanded configuration and an expanded configuration. When the expandable structure 3376 is in the non-expanded configuration, it may have an elongated member that extends substantially parallel to the longitudinal axis of the catheter 3350, in particular, the longitudinal axis of the shaft 3370. In such a configuration, the distal portion of the shaft 3370 (including the nozzle 3374 and the expandable structure 3376) may be inserted through the lumen of the outer shaft or the introducer, for example, into the lumen of the gallbladder. After the distal portion of shaft 3370 is inserted past the distal end of the outer shaft, the expandable structure 3376 can transition to an unfolded configuration, in which the elongated members of the expandable structure 3376 extend outward from the longitudinal axis (for example, curve outward radially).

[0134] Figures 37A and 37B are detail views of the distal portion of an ablation catheter including a heating element according to an embodiment. Figure 37A shows a cross-sectional view of the distal portion showing the internal parts, and Figure 37B shows an external view of the distal portion. As shown, the distal portion of the ablation catheter includes a nozzle 3474 including a plurality of nozzle openings or windows 3475, an expandable structure 3476 (e.g., an expandable cage), a hub 3479, and a heating sheath 3491. The heating sheath 3491 includes a jacket 3492, a liner 3493, a sensor wire or lead wire mounted as a thermocouple wire 3495, a heating element mounted as a heating wire 3497, and a ventilation opening or hole 3498. In some embodiments, the windows 3475 may be the same as or substantially the same as the windows 1175 described above with reference to Figure 11, or other nozzle openings described herein. In some embodiments, the expandable structure 3476 may be the same as or substantially the same as other expandable structures described herein, including, for example, the expandable structure 876 described above with reference to Figure 9, and / or the expandable structure 3176 described above with reference to Figure 34A. Therefore, specific embodiments of the opening window 3475 and the expandable structure 3476 are not described in further detail herein.

[0135] The expandable structure 3476 may be formed from a plurality of elongated members. The plurality of elongated members are transitionable between a non-expandable configuration in which the elongated members extend substantially parallel to the longitudinal axis of the catheter and an expandable configuration in which the elongated members extend outward from the longitudinal axis (e.g., curve outward radially). In some embodiments, each elongated member may have a proximal end connected to the distal end of the heating sheath 3491 and a distal end connected to the hub 3479. In such embodiments, the expansion of the elongated members can be performed by moving the hub 3479 or the heating sheath 3491 relative to the other of the hub 3479 and the heating sheath 3491. For example, the heating sheath 3491 can advance distally toward the hub, causing the elongated members to extend outward (e.g., curve outward radially), thereby expanding the expandable structure 3476.

[0136] The jacket 3492 and liner 3493 of the heating sheath 3491 insulate the thermocouple wire 3495 and the heating wire 3497. In some embodiments, the jacket 3492 and / or liner 3493 can be extruded onto the wires 3495 and 3497. The jacket 3492 is positioned outside the thermocouple wire 3495 and the heating wire 3497, while the liner 3493 is positioned inside the thermocouple wire 3495 and the heating wire 3497. In some embodiments, the thermocouple wire 3495 and the heating wire 3497 can be wound together. In some embodiments, the thermocouple wire 3495 can be placed directly beneath the heating wire 3497.

[0137] The vent 3498 is configured to connect the pressure-sensing lumen 3499 to the outside of the catheter so that it can communicate with the outside. Thus, the vent 3498 may be configured to connect the pressure-sensing lumen 3499 to the lumen of the gallbladder so that the intraluminal pressure of the gallbladder can be measured through the pressure-sensing lumen 3499. The pressure-sensing lumen 3499 may be an annular space located between an inner shaft defining a lumen for delivering the ablation medium and a heating sheath 3491. As shown, the catheter includes two vents 3498. Including multiple vents 3498 can allow the connection between the pressure-sensing lumen 3499 and the internal lumen to be maintained if one of the vents becomes blocked. In some embodiments, the catheter may include three, four, five, six, seven, eight, nine, ten, or eleven or more vents 3498.

[0138] The thermocouple wire 3495 may be configured to couple a temperature sensor (e.g., a thermocouple) to a control unit or processor (e.g., control unit 110) at the proximal end of the ablation catheter (or operably coupled to the proximal end of the ablation catheter). The temperature sensor may be positioned near the vent 3498 and / or outside the ablation catheter to measure the temperature near the distal portion of the ablation catheter.

[0139] Figures 38A to 38E show an ablation catheter assembly 3570 and its details according to an embodiment. Figure 38A shows the complete catheter assembly 3570, Figure 38B shows details of section B as shown in Figure 38A, Figure 38C shows details of section C as shown in Figure 38A, Figure 38D shows details of section D as shown in Figure 38A, and Figure 38E shows details of section E as shown in Figure 38E. As shown, the catheter assembly 3570 includes a nozzle 3574, an expansion structure 3576, a jacket 3592, a liner 3593, a wire end collar 3594, a thermocouple wire 3595, a heating wire 3597, and a vent 3598. In some embodiments, the nozzle 3574, extension structure 3576, jacket 3591, liner 3593, thermocouple wire 3595, heating wire 3597, wire end collar 3594, and vent 3598 may be the same as or substantially the same as similar components described in other embodiments of this specification, including, for example, the nozzle 3174, extension structure 3176, wire end collar 3194, and inner shaft plug 3196 as described above with reference to Figures 34A to 34B, and / or the nozzle 3474, extension structure 3476, jacket 3492, liner 3493, thermocouple wire 3495, heating wire 3497, and vent 3498 as described above with reference to Figures 37A to 37B. Therefore, specific embodiments of the nozzle 3574, extension structure 3576, jacket 3591, liner 3593, wire end collar 3594, thermocouple wire 3595, electric heating wire 3597, and vent hole 3598 will not be described in further detail herein. The electric heating wire 3597 and / or thermocouple wire 3595 can be wrapped around the sheath, shaft, and / or portions of the annular space between the sheath and the shaft to heat those portions.

[0140] In some embodiments, the thermocouple wire 3595 and / or the heating wire 3597 can be coupled to one or more connections within the wire end collar 3595. For example, the thermocouple wire 3595 may be configured to be coupled via the collar 3595 to an external processor or control unit (e.g., control unit 110) to monitor, for example, temperature, pressure, and / or other conditions, and / or to control the delivery and / or discharge of the ablation medium. The heating wire 3597 may be configured to be coupled via the collar 3595 to an external heat source to receive energy from an external heat source and generate heat for heating a portion of the ablation catheter. In some embodiments, the wire end collar 3595 may be coupled to a proximal handle for operating the ablation catheter, as described with reference to Figure 34A. In some embodiments, the collar 3595 may be omitted, and the thermocouple wire 3595 and / or the heating wire 3597 may be configured to be coupled to a handle (e.g., including any onboard components such as an onboard processor and / or microcontroller, power supply, etc.).

[0141] As shown in Figures 38D and 38E, the thermocouple wire 3595 and the heating wire 3597 are divided into a straight section 3570a, a coarse winding section 3570b, and a fine winding section 3570c. A denser pitch of the heating wire 3597 (i.e., a finer winding of the heating wire) can increase the energy density in a particular area. In some embodiments, the fine winding section 3570c may have a length of about 0.5 cm, about 1 cm, about 1.5 cm, about 2 cm, about 2.5 cm, about 3 cm, about 3.5 cm, about 4 cm, about 4.5 cm, or about 5 cm (including all values ​​and ranges in between). In some embodiments, the fine winding section 3570c may cover about 5%, about 10%, about 15%, about 20%, about 25%, or about 30% (including all values ​​and ranges in between) of the total length of the entire catheter assembly 3570. In some embodiments, the transition from the coarse winding section 3570b to the fine winding section 3570c may be gradual, or the spacing between the thermocouple wire 3595 and the heating wire 3597 may change as a gradient. In some embodiments, the transition from the coarse winding section 3570b to the fine winding section 3570c may be immediate.

[0142] In some embodiments, adjacent turns of wire may be spaced about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, or about 5 mm (including all values ​​and ranges in between). In some embodiments, wire may be spaced about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, or about 2 mm (including all values ​​and ranges in between).

[0143] The power delivered to the thermocouple wire 3595 and the heating wire 3597 may be a function of the operating voltage and the wire resistance. The operating voltage and wire resistance may be adjusted to achieve a desired energy density through the cross-sectional area of ​​the heating wire, and thus determine the temperature response to the heat flux and cooling generated by the heating wire 3597.

[0144] While a single heating element is shown in Figures 38A, it can be understood that any number of heating elements may be used. For example, multiple heating wires may extend along different parts of the ablation catheter (e.g., the sheath, shaft, or different parts of the annular space between them). In some embodiments, multiple heating wires may be selectively activated using a processor (e.g., control unit 110) to maintain a substantially uniform temperature along the entire length of the sheath, shaft, or annular space between them. A substantially uniform temperature may be, for example, a temperature along the entire length that does not deviate by more than 10% from the mean or median temperature. In some embodiments, one or more sensors (e.g., coupled to thermocouple wires) may be positioned at one or more locations along the length of the shaft and used to measure the temperature at different points along the length of the shaft. These measured temperatures may be received by a processor and used to control one or more heating elements (e.g., selectively activate or adjust the amount of power delivered to the heating elements).

[0145] In some embodiments, the thermocouple wire 3595 may be coupled to a temperature sensor positioned near the distal end of the ablation catheter. The thermocouple wire 3595 can carry a temperature signal to a processor (e.g., an onboard processor and / or an external processor) for temperature monitoring and / or temperature-based control of ablation delivery and / or discharge. In some embodiments, the ablation device and / or system described herein may be used in conjunction with an external temperature probe. Figure 39 shows, according to an embodiment, the placement of a temperature sensor (e.g., a probe or needle-type temperature sensor) along the entire length of the gallbladder. As shown, the gallbladder includes a cervical region, a body region, and a basal region. A temperature probe can be placed outside the wall of the gallbladder to monitor how the temperature changes along the length of the gallbladder (e.g., from the neck to the basal). The placement of the temperature probe can confirm that the temperature change is spreading from the inside to the outside of the gallbladder, which can facilitate the determination of the effectiveness of the ablation. In other words, the temperature probe can also help confirm that cryoablation has been performed, i.e., that the gallbladder wall has been ablated. In some embodiments, a first temperature probe T1 may be placed at the distal end of the gallbladder. By measuring the temperature at the base of the gallbladder, it can be confirmed that the cryoablation medium has penetrated to the base of the gallbladder. In some embodiments, the temperature probe may be placed at a point between the base and the neck of the gallbladder (e.g., temperature probe T2). In some embodiments, the temperature probe may be placed in the cervical region near the opening of the gallbladder into the cystic duct (e.g., temperature probe T3). In some embodiments, an additional temperature probe may be placed in the cervical region of the gallbladder (e.g., temperature probe T4). In some embodiments, an additional temperature probe may be placed at a point between the base and the neck of the gallbladder (e.g., temperature probe T5). In some embodiments, a combination of at least three temperature sensors (e.g., one placed in the neck, one in the body, and one in the base) may be used to measure the temperature of the tissue wall along the length of the gallbladder.In some embodiments, the position of the ablation catheter nozzle can be adjusted according to the temperature measurement, for example, by translating distally and / or proximal to a target area of ​​tissue with a higher temperature. Thus, the placement of the temperature probe can be used to confirm the uniform distribution of the ablation medium within the gallbladder and / or to provide feedback for controlling further delivery of the ablation medium.

[0146] Figures 40A to 40D are diagrams of an ablation system implemented as a cryoablation device 4000. The cryoablation device 4000 may be configured to ablate or disable the gallbladder cavity. The cryoablation device 4000 may include components that are structurally and / or functionally similar to other ablation systems and their components described herein. Figure 40A shows a side profile of the cryoablation device 4000, and Figures 40B to 40D show cross-sectional views of various configurations of the inner and outer shaft lumens of the cryoablation device 4000. The cryoablation device 4000 includes a control unit 4010, an outer shaft 4060, an inner shaft 4070, and a pressure-sensing lumen 4076. The control unit 4010 includes a processor 4012, a pressure sensor 4015, an input / output interface 4019, and a solenoid valve 4021. In some embodiments, an expandable structure 4079 can hold the inner shaft 4070 within the gallbladder cavity during the deployment of the ablation medium. A control unit 4010 is fluidically coupled to the ablation medium supply unit 4020. In some embodiments, the ablation medium can flow from the ablation medium supply unit to the inner shaft 4070 through a solenoid valve 4021.

[0147] In some embodiments, the pressure-sensing lumen 4076 can terminate at an orifice O located within the gallbladder cavity, while the pressure sensor 4015 is located outside the gallbladder cavity. In other words, the pressure-sensing lumen 4076 can be fluidly coupled to the pressure sensor 4015 within the gallbladder cavity. The pressure sensor 4015 can be located in and / or operably coupled to a control unit 4010. In such a configuration, the pressure sensor 4015 can measure the pressure inside the gallbladder cavity while being positioned outside the gallbladder cavity.

[0148] The pressure-sensing lumen 4076 may be arranged around the inner shaft 4070 or the outer shaft 4060 of the catheter system according to one of several different arrangements. In some embodiments, the pressure-sensing lumen 4076 may have a circular cross-section and be arranged on one side of the shaft. For example, in an embodiment, the pressure-sensing lumen 4076 may be attached to the inner shaft 4070, as shown in Figure 40B. Alternatively, the pressure-sensing lumen 4076' may be arranged or defined within the inner shaft 4070, as shown in Figure 40C. As yet another alternative, as shown in Figure 40D, the pressure-sensing lumen 4076” may be located outside the outer shaft 4060. As an additional alternative, in some embodiments, the pressure-sensing lumen 4076 may be an annular space formed outside the inner shaft 4070 and between the inner concentric sheath and / or shaft, as described with reference to Figure 37A. Pressure may be released from the gallbladder cavity through a ventilation path P that passes through the outer shaft 4060 to the outside of the cryoablation device 4000. The pressure-sensing lumen may also be referred to as the pressure lumen or sensor lumen.

[0149] Although not explicitly specified in Figures 40A to 40D, the cryoablation device 4000 includes lumens defined by an inner shaft 4060 and an outer shaft 4070 for the delivery of the ablation medium and / or the discharge of the ablation medium from the gallbladder cavity. For example, as with other catheter systems described herein, the inner shaft 4070 may define a lumen for delivering the cryoablation medium to the gallbladder cavity, for example, through one or more nozzle openings. The outer shaft 4060 may define a lumen for discharging the cryoablation medium from the gallbladder cavity.

[0150] The systems, devices, and methods described herein may implement passive discharge channels and cryogenic control systems to safely exhaust cryogenic gas from the gallbladder cavity while ensuring safe operating conditions. During cryogenic delivery, the cryogenic ablation medium (e.g., nitrous oxide) expands and is discharged to the external environment (e.g., the atmosphere) through the annular space between the inner surface of the outer shaft 4060 and the outer surface of the inner shaft 4070. Resistance within the discharge channel can expand the gallbladder cavity to facilitate exposure of tissues within the lumen to the cryogenic ablation medium. The solenoid valve 4021 may be configured to control or regulate, for example, the delivery of the ablation medium from the ablation medium supply unit 4020 into the gallbladder cavity. For example, the control unit 4010 can control the solenoid valve 4021 to transition from an open state in which the ablation medium can be delivered into the gallbladder cavity to a closed state in which the delivery of the ablation medium into the gallbladder cavity can be prevented. While a solenoid valve is provided herein as an exemplary valve, it should be understood that other types of valves, including mechanically operated valves and magnetically operated valves, may be used to control the delivery of the ablation medium into the gallbladder cavity. The control unit 4010, pressure sensor 4015, and solenoid valve 4021 can generate a closed-loop pressure feedback system to maintain a safe operating pressure in the gallbladder cavity. In particular, in response to detecting a pressure in the gallbladder cavity greater than a predetermined maximum threshold, the control unit 4010 can control the solenoid valve 4021 to terminate the supply of the ablation medium into the gallbladder cavity and / or discharge the ablation medium from the gallbladder cavity to the external environment via the outer shaft 4060. Additionally or alternatively, in response to detecting that the pressure in the gallbladder cavity is below a predetermined minimum threshold, the control unit 4010 can control the ablation medium supply unit 4020 and / or solenoid valve 4021 to provide additional ablation medium into the gallbladder cavity to adequately inflate the gallbladder for cryoablation.

[0151] It will be understood that this disclosure may include any one or all of the following embodiments.

[0152] Example 1: A cryoablation catheter comprising: a catheter body including at least one cryoablation lumen for delivering cryoablation to a tissue area; and a nozzle disposed at the distal end of at least one cryoablation lumen, the nozzle including a plurality of orifices extending between at least one cryoablation lumen and the outer surface of the nozzle, wherein each of the plurality of orifices is sized and shaped to uniformly disperse cryoablation onto a tissue area at a constant mass flow rate through each of the plurality of orifices.

[0153] Example 2: The cryoablation catheter according to Example 1, wherein the cryotherapy agent contains nitrous oxide.

[0154] Example 3: The cryoablation catheter according to Example 1, wherein the nozzle further includes phase change interfaces at the intersections of multiple orifices and the outer surface of the nozzle.

[0155] Example 4: The cryoablation catheter according to Example 3, wherein the multiple orifices are sized and shaped such that the cryoablation remains liquid until it reaches the phase change interface.

[0156] Example 5: The cryoablation catheter described in Example 3, wherein the diameter of each of the multiple orifices is in the range of approximately 0.0005 inches to 0.004 inches.

[0157] Example 6: The cryoablation catheter according to Example 3, wherein the phase change of the cryotherapy agent is caused by exposure of the cryotherapy agent to near atmospheric pressure associated with the target ablation region.

[0158] Example 7: The cryoablation catheter according to Example 3, wherein the phase change interface is controlled by a pressure drop relative to the cryogenic supply pressure.

[0159] Example 8: The cryoablation catheter according to Example 1, wherein the nozzle geometry of the nozzle is one of a sphere, cube, cone, cylinder, triangular prism, torus, spiral, or oval.

[0160] Example 9: The cryoablation catheter according to Example 1, wherein the geometric shape of the nozzle is spherical, and a plurality of orifices are arranged along the sphere of the nozzle, and each of the plurality of orifices extends from the outer diameter of the sphere to at least one cryotherapy delivery lumen.

[0161] Example 10: The cryoablation catheter described in Example 1, wherein the nozzle is sized to allow the nozzle to slide through the access catheter.

[0162] Example 11: The cryoablation catheter according to Example 1, wherein the nozzle is inflatable.

[0163] Example 12: The cryoablation catheter according to Example 1, wherein the nozzle includes a linear rail component and a nozzle geometric shape, the nozzle geometric shape is coupled to the linear rail component, and a plurality of orifices are arranged along the outer surface of the nozzle geometric shape.

[0164] Example 13: The cryoablation catheter according to Example 12, wherein the linear rail component can facilitate at least one of concentric or non-concentric movement of the nozzle geometry of about 0 to 10 cm in response to a driving force.

[0165] Example 14: The cryoablation catheter according to Example 12, wherein the nozzle geometry of the nozzle includes one of a sphere, cube, cone, cylinder, triangular prism, torus, spiral, or oval.

[0166] Example 15: The cryoablation catheter according to Example 12, wherein the nozzle geometry includes a sphere, and a plurality of orifices are arranged along the sphere of the nozzle, and each of the plurality of orifices extends from the outer diameter of the sphere to at least one cryotherapy delivery lumen.

[0167] Example 16: The cryoablation catheter according to Example 12, wherein the nozzle geometry is fixed to the distal end of a linear rail component.

[0168] Example 17: The cryoablation catheter according to Example 12, wherein the nozzle geometry is movable in response to the displacement of the linear rail components due to the driving force.

[0169] Example 18: The cryoablation catheter according to Example 12, wherein the nozzle geometry is movable along at least one axis of the linear rail component.

[0170] Example 19: The cryoablation catheter according to Example 12, wherein the nozzle geometry is movable along a linear rail component in response to a driving force.

[0171] Example 20. The cryoablation catheter according to Example 19, wherein the driving force is automated and further comprises a control unit, the control unit configured to initiate the driving force.

[0172] Example 21: The cryoablation catheter according to Example 19, wherein the driving force is caused by at least one of the following: a rigid drive wire system, a flexible drive cable system, a meshing gear drive system, a rack and pinion system, a screw drive mechanism, a pneumatic actuator system, an electromagnetic coil system, a hydraulic actuator system, or an electromechanical system.

[0173] Example 22: The cryoablation catheter according to Example 12, wherein the linear rail component is fixed by at least one of the proximal component or the distal component of the linear rail component.

[0174] Example 23: The cryoablation catheter according to Example 1, wherein the respective diameters of the individual orifices of the multiple orifices in the nozzle vary from one another, at least partially based on the location of the individual orifices on the nozzle.

[0175] Example 24: The cryoablation catheter according to Example 1, wherein the diameter along the length of each of the multiple orifices is tapered.

[0176] Example 25: The cryoablation catheter according to Example 1, wherein at least a subset of the orifices are shaped and sized to target an adjacent target.

[0177] Example 26: The cryoablation catheter according to Example 1, wherein at least a subset of the orifices are shaped and sized to target distant targets.

[0178] Example 27: The cryoablation catheter according to Example 1, wherein the nozzle includes a curved segment.

[0179] Example 28: The cryoablation catheter according to Example 27, wherein at least one of the multiple orifices is arranged along a curved segment.

[0180] Example 29: The cryoablation catheter according to Example 27, wherein the curved segment is rotatable around its central axis.

[0181] Example 30: The cryoablation catheter according to Example 27, wherein the curved segment is movable longitudinally with respect to its central axis.

[0182] Example 31: The cryoablation catheter according to Example 1, wherein the nozzle includes a helical nozzle, and a plurality of orifices are arranged along the helical nozzle lumen of the helical nozzle, extending from at least one cryotherapy delivery lumen to the outer surface of the helical nozzle lumen.

[0183] Example 32: The cryoablation catheter according to Example 31, further comprising a helical body structure, wherein a helical nozzle lumen is mounted on the helical body structure.

[0184] Example 33: The cryoablation catheter according to Example 1, wherein the nozzle can be crushed.

[0185] Example 34: The cryoablation catheter according to Example 1, wherein the nozzle includes at least one nozzle branch containing a plurality of orifices for delivering a cryotherapy agent.

[0186] Example 35: The cryoablation catheter according to Example 34, wherein at least one branch forms a curved shape along the central axis, the curved shape extending to the maximum radius dimension, converging back toward the central axis, and helping to bring the nozzle hole closer to the target ablation site.

[0187] Example 36: A cryoablation catheter according to Example 34, wherein at least one branch forms a curved shape along the central axis, the curved shape extending to a maximum radius dimension and terminating to help bring the nozzle hole closer to the target ablation site.

[0188] Example 37: The cryoablation catheter according to Example 34, wherein the nozzle is spring-loaded and can collapse to deliver through a delivery lumen of a smaller diameter compared to the nominal expanded diameter of at least one branch.

[0189] Example 38: A cryoablation catheter according to Example 34, wherein the nozzle is constructed using a pre-formed core within the nozzle branch and exerts a return force when subjected to mechanical stress, thermal energy, electric current, or light.

[0190] Example 39: The cryoablation catheter according to Example 38, wherein the pre-formed core is made from an alloy metal.

[0191] Example 40: The cryoablation catheter according to Example 38, wherein a pre-formed core is made from a polymer.

[0192] Example 41: The cryoablation catheter according to Example 34, wherein the nozzle can be driven into an extended form by a mechanical drive force such as a rack and pinion gear system, a cable drive system, or an electromechanical control system.

[0193] Example 42: The cryoablation catheter according to Example 1, wherein the nozzle can be operated along a linear or radial path to increase the spraying of the cryogen from at least one nozzle branch.

[0194] It should be emphasized that the embodiments described above in this disclosure are merely possible examples of implementations described for a clear understanding of the principles of this disclosure. Many changes and modifications can be made to the embodiments described above without substantially departing from the spirit and principles of this disclosure. All such changes and modifications are incorporated herein by reference within the scope of this disclosure and are intended to be protected by the following claims.

[0195] Furthermore, various concepts can be embodied in one or more ways, and examples of such are provided. The actions performed as part of the method may be ordered in any preferred way. Thus, while shown as sequential actions in the exemplary embodiments, embodiments can be constructed in which the actions are performed in a different order than those illustrated, which may include performing several actions simultaneously.

[0196] As used herein, the terms “about” and / or “approximately,” when used in conjunction with numbers and / or ranges, generally refer to numbers and / or ranges close to the listed numbers and / or ranges. In some cases, the terms “about” and “approximately” may mean within ±10% of the stated value. For example, in some cases, “about 100 [units]” may mean within ±10% of 100 (e.g., 90 to 110). The terms “about” and “approximately” may be used interchangeably.

[0197] Some embodiments described herein relate to computer storage products that include a non-temporary computer-readable medium (which may also be referred to as a non-temporary processor-readable medium) having instructions or computer code for performing various computer implementation operations. The computer-readable medium (or processor-readable medium) is non-temporary in the sense that it does not itself contain a temporary propagating signal (e.g., a propagating electromagnetic wave that carries information on a transmission medium such as space or a cable). The medium and the computer code (which may also be referred to as code or algorithm) may be designed and constructed for a particular purpose. Examples of non-temporary computer-readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tapes; optical storage media such as Compact Disc / Digital Video Disc (CD / DVD), Compact Disc-Read Only Memory (CD-ROM), and holographic devices; magneto-optical storage media such as optical discs; carrier signal processing modules; and hardware devices specifically configured to store and execute program code, such as application-specific integrated circuits (ASICs), programmable logic devices (PLDs), read-only memory (ROM), and random access memory (RAM) devices. Other embodiments described herein relate, for example, to computer program products which may include instructions and / or computer code disclosed herein.

[0198] The systems, devices, and / or methods described herein may be implemented by software (running on hardware), hardware, or a combination thereof. Hardware modules may include, for example, general-purpose processors (or microprocessors or microcontrollers), field-programmable gate arrays (FPGAs), and / or application-specific integrated circuits (ASICs). Software modules (running on hardware) may be expressed in various software languages ​​(e.g., computer code), including C, C++, Java®, Ruby, Visual Basic®, and / or other object-oriented, procedural, or other programming languages ​​and development tools. Examples of computer code include, but are not limited to, files containing microcode or microinstructions, machine instructions such as those generated by a compiler, code used to generate web services, and high-level instructions executed by a computer using an interpreter. Further examples of computer code include, but are not limited to, control signals, encryption code, and compression code.

Claims

1. an outer shaft having a proximal end and a distal end and defining a first lumen extending therebetween; an inner shaft defining a second lumen disposable within the first lumen, the inner shaft extending from a distal end of the outer shaft and having a distal portion configured to be disposed in a gallbladder lumen; a plurality of nozzle openings formed on the distal portion of the inner shaft, the plurality of nozzle openings in communication with the second lumen such that the second lumen and the plurality of nozzle openings are configured to deliver a cryoablation medium to the gallbladder lumen to contact and ablate at least a portion of a wall of the gallbladder lumen; an expandable body disposed about the plurality of nozzle openings, the expandable body being formed from a plurality of elongate members and configured to expand to a predetermined diameter to space the plurality of nozzle openings at least a minimal distance from the wall of the gallbladder lumen; an evacuation pathway defined at least in part by one or both of the outer shaft and the inner shaft and configured to evacuate cryogenic gases and fluids from the gallbladder lumen during delivery of a cryogenic ablation medium; and a pressure sensing lumen configured to terminate in the gallbladder lumen, the pressure sensing lumen fluidly coupled to a pressure sensor such that the pressure sensor can measure pressure in the gallbladder lumen via the pressure sensing lumen; The device comprises:

2. The device of claim 1, further comprising a handle including an actuator, the actuator configured to move the plurality of nozzle openings.

3. The device of claim 1 or 2, further comprising a handle including an actuator, the actuator configured to rotate the plurality of nozzle openings.

4. A sleeve configured to be disposed over at least a portion of the inner shaft; 10. The device of claim 1, further comprising: a handle including an actuator configured to be actuated to move at least one of the sleeve or the inner shaft relative to the other of the sleeve or the inner shaft to expand the expandable body.

5. The apparatus of claim 1, wherein the multiple nozzle openings are distributed around the inner shaft.

6. The device described in claim 5, wherein the plurality of nozzle openings includes at least three rows of nozzle openings arranged at different positions along the length of the distal portion of the shaft.

7. The device described in claim 1, wherein the plurality of elongated members includes at least three elongated members evenly distributed around the distal portion of the inner shaft.

8. The device described in claim 7, wherein each of the at least three elongated members is configured to extend substantially parallel to the inner shaft when the expandable body is not expanded.

9. The device described in claim 7 or 8, further comprising a hub disposed on the inner shaft distal to the plurality of nozzle openings, each of the at least three elongated members including a distal end coupled to the hub.

10. The method of claim 1, further comprising: a controller operably coupled to the pressure sensor, the controller comprising: receiving data from the pressure sensor indicative of pressure in the gallbladder lumen; detecting that the pressure in the gallbladder lumen is outside a predetermined pressure range based on the data; and and controlling delivery of the cryoablation medium to the gallbladder lumen by ceasing or reducing a supply of the cryoablation medium in response to detecting the pressure being outside the predetermined range. The apparatus of claim 1 , configured as follows:

11. The controller: Detecting that a drain path is clogged or frozen based on the data; and in response to detecting that the drain path is clogged or frozen, actuating a heating element to heat at least a portion of the drain path; The apparatus of claim 10 , configured to:

12. The device of claim 1, further comprising a temperature sensor disposed on the outer shaft, the temperature sensor configured to measure a temperature of the gallbladder cavity.

13. The method of claim 1, further comprising: providing a controller operably coupled to the temperature sensor, the controller comprising: receiving data indicative of a temperature in the gallbladder lumen from the temperature sensor; and monitoring a process of ablation of the portion of the wall of the gallbladder lumen based on the data. The apparatus of claim 12 configured to:

14. The device of claim 1, wherein the pressure sensing lumen is disposed within the outer shaft.

15. The device of claim 1, further comprising a handle coupled to the outer shaft and disposed outside the gallbladder cavity, the handle housing the pressure sensor.

16. The apparatus of claim 15, further comprising a handle coupled to the outer shaft, the handle including a seal into which the inner shaft can be positioned, the seal configured to seal around the inner shaft to prevent leakage of fluid around the inner shaft.

17. The expandable body is a first expandable body, and the apparatus comprises:

10. The device of claim 1, further comprising a second expandable body disposed at a distal end of the outer shaft, the second expandable body configured to expand to retain the outer shaft within the gallbladder lumen.

18. The device of claim 17, further comprising a handle coupled to the inner shaft, the handle including an actuator configured to be actuated to expand the second expandable body.

19. A temperature sensor disposed within the outer shaft and configured to measure a temperature at a point along the outer shaft. a heating element disposed on the outer shaft or the inner shaft and configured to heat at least a portion of the exhaust path; a controller configured to activate the heating element to heat at least a portion of the exhaust path based on a temperature measured by the temperature sensor; The apparatus of claim 1 further comprising:

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