Systems, apparatus, and methods for gallbladder ablation and defunctionalization

Abstract

This document provides catheter devices, systems, and methods for ablation of tissue sites. The devices, systems, and methods disclosed herein include ablation systems comprising catheter systems having an inner shaft and an outer shaft that deliver and empties an ablation medium (e.g., cryoablation medium) into and from a body cavity. In some embodiments, the devices, systems, and methods disclosed herein include an expandable structure that facilitates nozzle positioning and / or emptying of the ablation medium from the body cavity.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority and benefit to U.S. Provisional Application 63 / 066005, filed August 14, 2020, entitled “Systems, Devices, and Methods for Ablation and Defunctionalization of a Gallbladder”, the entire disclosure of which is hereby incorporated by reference. Technical Field

[0003] This disclosure relates to apparatus and methods for ablation and defunctionalization of the gallbladder. Background Technology

[0004] Medical ablation techniques, such as those used in cardiology, oncology, general surgery, gastroenterology, dermatology, and interventional radiology, focus on localized tissue targets. While offering a high degree of control over ablation depth, they may be ineffective or impractical for large high surface area (HSA) tissue targets within the body. Cryoablation utilizes conventional cryotherapy jets to provide a platform for HSA tissue ablation, but it has certain drawbacks in safely and efficiently delivering energy within closed cavities (e.g., the gallbladder). For example, ice buildup or other complications during ablation can lead to damage and / or ineffective ablation. Therefore, systems, devices, and methods that address the shortcomings of existing ablation systems are desired. Summary of the Invention

[0005] This disclosure relates to apparatus and methods for ablation and defunctionalization of the gallbladder. In some embodiments, an apparatus includes a shaft defining a cavity and having a distal portion disposed within a body cavity of a subject, the shaft including: a nozzle disposed on the distal portion defining a plurality of openings in fluid communication with the cavity, the nozzle being configured to deliver an ablation medium into the body cavity; and an expandable structure disposed around the nozzle, the expandable structure being configured to transition into an expanded state within the body cavity, the expandable structure including a plurality of elongated members configured, when the expandable structure is in the expanded state, to (1) position the nozzle relative to tissue within the body cavity at at least a predetermined distance, and (2) allow the ablation medium to pass through the expandable structure to contact and ablate the tissue within the body cavity.

[0006] In some embodiments, an apparatus includes: an outer shaft having a distal end disposed within a body cavity of a subject, the outer shaft defining a first cavity and a plurality of drain openings in fluid communication with the first cavity, the plurality of drain openings and the first cavity being configured to drain an ablation medium from the body cavity, the outer shaft including an expandable structure (1) disposed at the distal end of the outer shaft and (2) configured to transition to an expanded state to surround the plurality of drain openings and prevent debris from clogging the plurality of drain openings; and an inner shaft disposed within the first cavity and having a nozzle extending distally to the outer shaft, the inner shaft defining a second cavity in fluid communication with the nozzle, the second cavity being configured to deliver the ablation medium to the nozzle such that the nozzle can distribute the ablation medium throughout the body cavity to contact and ablate tissue within the body cavity.

[0007] In some embodiments, a method includes: converting a first expandable structure disposed on a distal end of an outer shaft of an ablation catheter into an expanded state to retain a access sheath within a body cavity of a subject, the distal end of the outer shaft being disposed within the body cavity and the outer shaft defining a first cavity; advancing a distal end of an inner shaft through the first cavity into the body cavity, the inner shaft defining a second cavity and including a nozzle and a second expandable structure disposed on the distal end of the inner shaft; converting the second expandable structure into an expanded state to position the nozzle relative to tissue within the body cavity at at least a predetermined distance; delivering ablation fluid through the second cavity to the nozzle; and dispensing ablation fluid from the nozzle such that the ablation fluid is converted into an ablation gas, the ablation gas contacting and ablating tissue within the body cavity. Attached Figure Description

[0008] Figure 1 This is a schematic diagram of an ablation system (e.g., a cryoablation device) according to an embodiment.

[0009] Figure 2 This is a schematic diagram of the outer shaft of the catheter system according to an embodiment.

[0010] Figure 3 This is a schematic diagram of the inner shaft of the catheter system according to an embodiment.

[0011] Figure 4 This is a schematic diagram of a catheter system according to an embodiment.

[0012] Figure 5 This is a schematic diagram of the control unit of the ablation system according to an embodiment.

[0013] Figures 6A-6B This is a flowchart of a method for ablation and monitoring according to an embodiment.

[0014] Figures 7A-7C This is an illustration of various percutaneous and endoscopic-assisted access routes for an ablation system according to an embodiment.

[0015] Figure 8This is a diagram of an ablation system according to an embodiment.

[0016] Figure 9 This is a detailed view of the outer and inner axes of the ablation catheter according to an embodiment.

[0017] Figure 10 This is an illustration of an ablation catheter deployed into a body cavity according to an embodiment.

[0018] Figure 11 This is a diagram of the inner shaft of an ablation catheter with a vented nozzle according to an embodiment.

[0019] Figures 12A-12B This is a diagram of the outer axis of the ablation catheter according to an embodiment.

[0020] Figures 13A-13C This is an illustration of a portion of an ablation catheter with an expandable structure according to various embodiments.

[0021] Figure 14 This is a diagram of the inner shaft of an ablation catheter with an expandable structure according to an embodiment.

[0022] Figure 15 This is an illustration of an ablation catheter with an opening for drainage according to an embodiment.

[0023] Figures 16A-16B This is a cross-sectional view of an ablation catheter including a drainage cavity, according to various embodiments.

[0024] Figures 17A-17B This is a diagram of the outer shaft of an ablation catheter with a drainage opening according to an embodiment.

[0025] Figures 18A-18B This is an illustration of an ablation catheter including an expandable mechanism and a drain opening according to an embodiment.

[0026] Figures 19A-19B This is an illustration of the inner shaft of an ablation catheter having a spherical or circular nozzle according to an embodiment.

[0027] Figure 20 This is an illustration of the inner axis of an ablation catheter having a spherical or circular nozzle deployed into a body cavity, according to an embodiment.

[0028] Figure 21 This is an illustration of an ablation catheter with a free end and a movable nozzle, according to an embodiment.

[0029] Figure 22 This is an illustration of an ablation catheter with a movable nozzle that has a fixed end (e.g., fixed using a occluder) according to an embodiment.

[0030] Figure 23 This is an illustration of an ablation catheter with an arc-shaped nozzle according to an embodiment.

[0031] Figure 24 This is an illustration of an ablation catheter with an arc-shaped nozzle deployed in a body cavity, according to an embodiment.

[0032] Figure 25 This is an illustration of an ablation catheter with a nozzle arm according to an embodiment.

[0033] Figures 26A-26B This is a cross-sectional view of the nozzle arm of the ablation catheter according to an embodiment.

[0034] Figures 27A-27B This is an illustration of an ablation catheter with a spiral nozzle according to an embodiment.

[0035] Figure 28 This is a cross-sectional view of an ablation catheter with a catheter heating system according to an embodiment.

[0036] Figures 29A-29B This is an illustration of an ablation catheter with a catheter heating system according to an embodiment.

[0037] Figures 30A-30B This is a diagram of the outer shaft of the ablation catheter and the dilator according to an embodiment.

[0038] Figures 31A-31B This is a diagram of the outer axis of an ablation catheter having an expandable structure in an unexpanded state and an expanded state, according to an embodiment.

[0039] Figures 32A-32C This is a diagram of the inner shaft of an ablation catheter with an actuator according to an embodiment.

[0040] Figure 33 This is a diagram of an assembled ablation catheter according to an embodiment.

[0041] Figures 34A-34B This is a diagram of an ablation catheter according to an embodiment.

[0042] Figures 35A-35B This is a diagram of the sheath of the ablation catheter according to an embodiment.

[0043] Figure 36 This is a diagram of an ablation catheter according to an embodiment.

[0044] Figures 37A-37B This is an illustration of a nozzle assembly according to an embodiment.

[0045] Figures 38A-38E This is a diagram of a catheter assembly according to an embodiment.

[0046] Figure 39 This is an illustration of the placement of a temperature sensor in the gallbladder according to an embodiment.

[0047] Figures 40A-40D This is an illustration of an ablation system (e.g., a cryoablation device) with a pressure sensor according to various embodiments. Detailed Implementation

[0048] This disclosure relates to ablation systems, apparatus, and methods for ablating body cavities (e.g., gallbladder cavities). In some embodiments, the systems, apparatus, and methods described herein relate to cryoablation devices for tissue ablation. In some embodiments, the systems, apparatus, and methods described herein relate to ablation medium release valves, such as for catheter-based cryoablation devices, designed to safely, effectively, and uniformly distribute an ablation medium (e.g., cryoablation medium) onto a region of interest (e.g., the tissue lining of the gallbladder cavity). In some embodiments, the systems, apparatus, and methods described herein relate to controlling the operation of an ablation system based on sensor data (e.g., pressure and / or temperature data). In some embodiments, the systems, apparatus, and methods described herein include sensors and / or sensors (e.g., one or more probes) to track the properties or conditions of the body cavity (e.g., the gallbladder cavity) and / or the ablation medium delivered into the body cavity. International patent applications PCT / US2019 / 017112, filed February 7, 2019, entitled “GALLBLADDER DEFUNCITONALIZATION DEVICES AND METHOS”, and PCT / US2020 / 045436, filed August 7, 2020, entitled “SYSTEMS, DEVICES, AND METHODS FOR ABLATION AND DEFUNCITONALIZATION OF A GALLBLADDER”, describe examples of suitable components of an ablation system including a cryoablation device. The entire contents of these two patent applications are incorporated herein by reference.

[0049] Gallstones are one of the most common gastrointestinal disorders in Americans. Gallstones form when bile (the fluid secreted by the liver and stored in the gallbladder) becomes supersaturated. While gallstones don't cause problems for many people, occasionally they can block the cystic duct (the outlet of the gallbladder), preventing it from emptying. In some cases, this blockage can lead to pain, inflammation, and infection. In otherwise healthy patients, gallstone disease is treated by surgically removing the gallbladder. However, in certain patient groups, the risks associated with surgery are much higher. For example, one in five Medicare patients has been found to experience adverse outcomes. Non-surgical treatment options for these patients are limited and focused on relieving acute symptoms but do not address the underlying cause. In some cases, the disease is prone to recurrence, leading to additional clinical risks and significant costs. There is currently no long-term solution for gallbladder disease in high-risk patients.

[0050] like Figures 7A-7C As shown, gallbladder 2 is a small, hollow organ in the gastrointestinal system. As a blind-end tubular projection of the bile duct tree, gallbladder 2 is a pear-shaped organ with a storage capacity of 30-50 ml. The gallbladder is typically 2-3 cm wide and 7-10 cm long axially. The gallbladder is generally divided into three parts: the fundus, the body, and the neck. The neck contains mucosal folds called Hartmann's sac, a common location for impacted gallstones, leading to cholecystitis. Figures 7A-7C As shown, gallbladder 2 connects to the cystic duct 14 and is connected to the liver 8 via the common hepatic duct 18, which branches into the right and left hepatic ducts. Gallbladder 2 is connected to the small intestine 10 via the common bile duct 16.

[0051] Histologically, the gallbladder has four layers: the serosa (outermost layer), the muscular layer, the lamina propria, and the innermost mucosa. The gallbladder mucosa is the innermost layer of the gallbladder wall and concentrates bile. The serosa originates from the visceral peritoneum and covers the gallbladder fundus, body, and neck. Medial to the serosa, a single muscular layer encloses the lamina propria. The mucosa lining the gallbladder lumen is composed of columnar epithelial cells, which secrete mucin and dehydrate bile through the action of various ion channels. Occasionally, lateral protrusions of the mucosa (called Rokitansky-Aschoff nodes) extend into the deeper layers of the gallbladder wall.

[0052] The gallbladder stores and concentrates bile produced by the liver and releases the stored bile into the small intestine, where it helps digest fats in food. Bile is produced by hepatocytes in the liver and then secreted into the hepatic tubules, which converge into the intrahepatic ducts. The intrahepatic ducts merge to form the left and right hepatic ducts, which then merge into the common bile duct. The common bile duct joins the pancreatic duct near the ampulla of Vater in the duodenal wall. Bile produced by hepatocytes flows through the biliary system and into the lumen of the duodenum to aid digestion.

[0053] The flow of bile into the duodenum is regulated by the sphincter of Oddi at the ampulla of Vater. During periods of fasting, when bile is not needed for digestion, the sphincter closes, allowing bile to flow into the gallbladder for storage. During storage, the bile becomes supersaturated, providing a foci for the formation of gallstones and biliary sludge (very small gallstones). Most gallstones are “brown stones,” primarily composed of cholesterol (usually >80%). These stones tend to be brittle and easily crushed. A minority of stones are primarily bilirubin (“black stones”; <20% cholesterol), and are generally harder. Mixed stones contain varying amounts of bilirubin and cholesterol.

[0054] Mobile gallstones remaining in the gallbladder cavity have the potential to cause various pathologies. In some cases, gallstones can become lodged in the gallbladder neck, obstructing the cystic duct. Lodged gallstones can cause gallbladder distension and intermittent right upper quadrant discomfort (possibly due to intramural muscle spasms as the organ attempts to empty against an increased pressure gradient); this condition is known as symptomatic cholelithiasis. In other cases, gallstones can become lodged more persistently at the gallbladder outlet, leading to inflammation and infection. This condition, called cholecystitis, requires urgent intervention because it can develop into a systemic infection.

[0055] Alternatively or in combination, gallstones or biliary sludge can pass through the cystic duct and become lodged in the common bile duct, obstructing the flow of bile and causing a potentially life-threatening condition known as ascending cholangitis. In some embodiments, debris can become lodged at the junction of the pancreatic duct and the common bile duct, causing retention of pancreatic secretions and leading to pancreatitis (inflammation of the pancreas).

[0056] In cholelithiasis, the supersaturation of bile in the gallbladder leads to gallstone formation. In some cases, impacted gallstones cause inflammation, pain, and infection of the gallbladder. When the gallbladder is inflamed, the mucosal layer becomes more prominent. In some cases, gallstone disease is diagnosed using ultrasound or other imaging methods. This article provides methods and devices for the minimally invasive definitive treatment of benign gallbladder disease in patients with symptomatic gallstones, aiming to reduce healthcare costs and patient morbidity.

[0057] Laparoscopic cholecystectomy is a common surgical procedure used to treat gallstones. During the procedure, a small incision is made in the abdomen to allow for the removal of the gallbladder using a camera and small instruments. The surgery is safe for otherwise healthy patients and usually does not require hospitalization. Without complications, patients typically return to work within two weeks.

[0058] The surgical risks associated with laparoscopic cholecystectomy are significantly higher in many patient groups. In some cases, these groups include critically ill patients, patients with abdominal scarring due to chronic illness or previous surgeries, and elderly patients who tend to have a higher incidence of comorbidities. One such group is the Medicare group, which includes approximately 200,000 laparoscopic cholecystectomies performed annually in the United States. 21% of these surgeries result in adverse outcomes, including prolonged hospitalizations and readmissions, as well as other perioperative complications. In addition to the direct costs associated with these complications, many elderly patients face the risk of not being able to return to their baseline level of health, leading to additional healthcare costs.

[0059] There are several non-surgical options for treating gallstones. These include antibiotics, cholecystostomy to drain gallbladder contents, or a combination of both. However, non-surgical options do not provide a long-term solution. These are effective temporary measures but do not treat the underlying cause. In percutaneous cholecystostomy, a cholecystostomy tube is inserted into the gallbladder through the chest cavity. Percutaneous cholecystostomy can be performed in the interventional radiology (IR) room or at the patient's bedside, but it does not provide definitive treatment for gallstones. Often, non-surgical options lead to recurrence and additional hospitalization costs.

[0060] For patients with cholecystitis at high risk of surgical complications, treatment involves a combination of percutaneous cholecystodesthesia (through percutaneous insertion of a cholecystostomy tube) and antibiotics. This treatment provides a temporary measure to allow patients to recover from the systemic effects of persistent infection (sepsis) and return to baseline health (what healthcare professionals often refer to as "cooling down"). The cholecystostomy tube remains in place until the patient recovers. Approximately 6–8 weeks after placement, cholangiography is performed under fluoroscopy with radiopaque contrast agent injected through the tube to determine if the cystic duct is patent (open). If the cystic duct is patent, the cholecystostomy tube is removed. The next treatment option is septal cholecystectomy, as it reduces the recurrence rate of gallstone disease. If there is no connection between the cystic duct and the common bile duct, the bile duct remains in place until cholecystectomy is performed or until subsequent cholangiography shows patency. There is no definitive treatment for high-risk patients, leaving them at risk of disease recurrence and facing associated clinical risks and healthcare costs.

[0061] Ablation techniques have been used to treat other diseases. For example, ablation has been used to treat esophageal metaplasia and endometrial hyperplasia. However, ablation techniques are not readily available for treating gallstones. Ablation techniques are typically applied to small target areas (such as nerves) and are generally not used on diffuse areas or tissues or organs. The systems, apparatus, and methods described in this article relate to the ablation and defunctionalization of the gallbladder and are specifically designed to safely and effectively ablate the gallbladder.

[0062] Figure 1 This 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 source 120. The control unit 110 can control the operation of one or more components of the ablation system 100.

[0063] Control unit 110 may be operatively coupled to ablation medium supply source 120, which provides ablation medium supply. For example, control unit 110 may be configured to control the delivery of ablation medium into a body cavity (e.g., gallbladder cavity). In some embodiments, the ablation medium is a cryoablation medium. In some embodiments, the cryoablation medium is a liquid. In some embodiments, the cryoablation medium is a gas. In some embodiments, when delivered using the systems and apparatus disclosed herein, the cryoablation medium undergoes a liquid-to-gas phase transition. In some embodiments, cryoablation is achieved by means of refrigerant properties due to the liquid-to-gas phase change of the ablation medium (such as liquid nitrous oxide, carbon dioxide, and argon). In some embodiments, the cryoablation medium is one or more of nitrous oxide, nitrogen, carbon dioxide, or argon. In some embodiments, the cryoablation medium may transition from a first state (e.g., liquid) to a second state (e.g., gaseous) and increase in volume up to about 600 times the original volume of the cryoablation medium during the transition. In some embodiments, control unit 110 may control one or more of the temperature, pressure, etc., of the ablation medium. In some embodiments, when a cryoablation medium is used with the systems and apparatus disclosed herein, the range of an ablation medium, such as a cryoablation medium, is from about -120 degrees Celsius to about 0 degrees Celsius, including all values ​​and subranges therebetween. In some embodiments, the ablation medium supply source 120 may be a cryoprotectant cartridge.

[0064] Control unit 110 may optionally be coupled to vacuum source 140 (e.g., vacuum pump or suction pump, aspirator, etc.). In some embodiments, control unit 110 may control vacuum source 140 to apply a vacuum to the flow path or cavity of catheter system 150, for example, to remove or drain ablation medium from a body cavity (e.g., gallbladder cavity). For example, control unit 110 may activate vacuum source 140 to apply negative pressure within the cavity of catheter system 150 to drain a portion of the ablation medium (e.g., cryoablation medium) already delivered to the body cavity. Alternatively, in some embodiments, ablation system 100 may not include vacuum source 140, and ablation medium may be drained from the body cavity by passive evacuation driven by a pressure difference between the internal and external environments of the body cavity. For example, when ablation medium (such as cryoablation medium) is delivered to the body cavity, the ablation medium may increase the pressure within the body cavity relative to the external environment (e.g., the outside atmosphere), and this pressure difference may drive a portion of the ablation medium to drain from the body cavity (e.g., via the cavity defined by catheter system 150).

[0065] In some embodiments, the control unit 110 may include or be operatively coupled to one or more sensors (e.g., pressure sensors, temperature sensors), and may 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, control the delivery of the ablation medium (e.g., from an ablation medium supply source 120) and the evacuation of the ablation medium (e.g., using a vacuum source 140) to maintain the pressure within the body cavity within a predetermined pressure range. In other words, the control unit 110 may be configured to control the inflation of the body cavity such that the pressure within the body cavity 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 operatively coupled to one or more valves, and the control unit 110 may control the valves to allow and / or terminate the delivery or evacuation of the ablation medium. Examples of suitable valves are described in International Patent Application PCT / US2020 / 045436, which is incorporated herein by reference.

[0066] 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 device 190 may be any suitable processing device configured to run and / or perform certain functions. 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 (e.g., a workstation) through which a user (e.g., a doctor, administrator, etc.) can control one or more operating parameters of the ablation system 100. The control unit 110 and one or more computing devices 190 may be configured to send and / or receive data (e.g., via a network) from one or more other computing devices 190. For example, the control unit 110 may send alarms and / or other information to a remote device (e.g., a display, a mobile device) so that the remote device can present that information to a user (e.g., a doctor). In some embodiments, the control unit 110 may send data such as patient information, the operating status of one or more components of the ablation system 100, etc.

[0067] In some embodiments, the control unit 110, ablation medium supply source 120, and / or other components of the ablation system 100 may be integrated into a handheld device attached proximally to the catheter system 150. The handheld device may include one or more input and / or output devices (e.g., buttons, switches, keypads, touchscreens, displays, etc.) that an operator of the ablation system 100 can use to control the operation of the ablation system 100 to perform ablation. In some embodiments, the control unit 110 may be located remotely from the catheter system 150, and a remote operator may control one or more components of the ablation system 100 to perform ablation.

[0068] The catheter system 150 can be percutaneously inserted into a body cavity (e.g., the gallbladder cavity) to scar down and defunctionalize portions of anatomical structures (e.g., the gallbladder) without requiring surgical removal of the anatomical structures. The catheter system 150 can be used in the interventional radiology (IR) room and with local anesthesia, thereby eliminating the risks associated with general anesthesia for high-risk surgical patients. Device placement utilizes existing IR workflows and can be deployed in a manner similar to existing devices. For example, for placement in the gallbladder cavity, this placement can be similar to a cholecystostomy tube or a percutaneous gallbladder drainage tube.

[0069] Figures 2-4 A schematic diagram of portions of an exemplary catheter system 250 according to some embodiments is provided. Catheter system 250 may be structurally and / or functionally similar to catheter system 150. For example, catheter system 250 may be coupled to a control unit (e.g., control unit 110) and / or configured to receive ablation medium from an ablation medium supply source (e.g., ablation medium supply source 120). Catheter system 250 may include an outer shaft 260 and an inner shaft 270. The inner shaft 270 may also be referred to as a first shaft, and the outer shaft 260 may be referred to as a second shaft. In some embodiments, the outer shaft 260 and the inner shaft 270 may be separate components used together, for example, to perform ablation. For example, the outer shaft 260 may be implemented as a access sheath or guide, and the inner shaft 270 may be implemented as a catheter insertable into a guide lumen. In some embodiments, the outer shaft 260 and the inner shaft 270 may be integrated into a single catheter device, for example, a device having two concentric shafts.

[0070] Figure 2 A detailed view of the outer shaft 260 is provided. The outer shaft 260 may be, for example, a passage sheath. The outer shaft 260 may define a cavity 262. The cavity 262 may be configured to receive one or more instruments, said instruments including, for example, an inner shaft 270. The outer shaft 260 may be configured to provide access to a body cavity BL (e.g., the gallbladder cavity). For example, the distal end of the outer shaft 260 may be positioned within the body cavity BL, such as... Figure 4As schematically illustrated. Once positioned within the body cavity BL, the outer shaft 260 can, for example, deliver one or more instruments into the body cavity BL via cavity 262. For example, as... Figure 4 As shown, the inner shaft 270 can be inserted into the cavity 262 of the outer shaft 260 and navigated into the body cavity BL, so that the distal end of the inner shaft 270 is positioned within the body cavity BL.

[0071] In some embodiments, cavity 262 may be configured to empty or drain fluid (e.g., liquid or gas) and / or debris (e.g., gallstones or fragments thereof, tissue, etc.) from the body cavity BL. For example, cavity 262 may allow ablation media (e.g., cryoablation media) delivered to the body cavity BL to be emptied from the body cavity BL. In some embodiments, cavity 262 may be operatively coupled to vacuum source 240, which may be activated to apply negative pressure within cavity 262 to empty fluid from the body cavity BL. Alternatively, cavity 262 may serve as a passive evacuation channel for fluid to leave the body cavity BL. For example, as ablation media is delivered to the body cavity BL and the pressure within the body cavity BL increases relative to the outside of shaft 260, this pressure may passively drive a portion of the ablation media to be discharged from the body cavity BL via cavity 262.

[0072] In some embodiments, the outer shaft 260 may define one or more additional cavities, such as cavity 264, which may be structurally and / or functionally similar to cavity 262. For example, cavity 264 may also be configured to provide access to the body cavity BL. In some embodiments, cavity 262 may be configured to receive the inner shaft 270, and cavity 264 may be configured to receive various surgical and / or monitoring devices (e.g., probes, second ablation devices, etc.). In some embodiments, one or more cavities 262, 264 may be fluidly coupled to sensors (e.g., pressure sensors) to allow pressure measurement of the body cavity BL and / or other parts of the body. For example, sensors integrated into a control unit (e.g., control unit 110) may be in fluid communication with one or more cavities 262, 264 and measure the environment within the outer shaft 260 and / or the body cavity BL (e.g., pressure measurement).

[0073] In some embodiments, the outer shaft 260 may optionally include a sensor 263. In some embodiments, the sensor 263 may be located in a distal portion of the outer shaft 260, the distal portion being configured to be disposed within the body cavity BL. Alternatively, the sensor 263 may be disposed at different locations along the outer shaft 260, including, for example, within cavities (e.g., cavities 262, 264), at the proximal end of the outer shaft 260, etc. The sensor 263 may be configured to capture information about the environment within the body cavity BL or other environments within and / or around the outer shaft 260. For example, the sensor may be configured to measure the properties (e.g., pressure, temperature) of the ablation medium delivered to the body cavity BL, the properties (e.g., pressure, temperature) of the body cavity BL or fluid within the body cavity BL, etc. The sensor may include, for example, a pressure sensor (e.g., a pressure transducer, a strain gauge transducer, a diaphragm displacement sensor, a fiber optic pressure sensor, a solid-state sensor), a temperature sensor, a light sensor, a gas sensor, etc. In some embodiments, sensor 263 may be connected to a control unit (e.g., control unit 110) and / or other computing devices (e.g., computing device 190) via a wired connection (e.g., a wire coupled to outer shaft 260 and / or disposed within outer shaft 260). In some embodiments, sensor 263 may be configured to wirelessly transmit data to the control unit and / or other computing devices, such as data representing one or more measurement properties of the body cavity BL.

[0074] In some embodiments, the outer shaft 260 may include a tapered portion or tapered end located at the distal end of the outer shaft 260. In some embodiments, an expander may be inserted into a cavity (e.g., cavity 262) of the outer shaft 260 to aid in insertion of the outer shaft 260 into the body cavity BL. The expander may be positioned within the cavity such that its distal end extends distally from the outer shaft 260. In this case, the tapered end of the outer shaft 260 may form a smooth transition from the outer shaft 260 to the outer surface of the expander to aid in insertion into the body cavity BL, rather than having an abrupt step in the profile of the device. Reference Figures 6A-6B More details are provided regarding the use of the expander with the outer shaft 260.

[0075] In some embodiments, the outer shaft 260 includes an expandable structure or expandable body 266 that can deploy within the body cavity BL, for example, transitioning from an undeployed state or configuration to an deployed or expanded state or configuration. The expandable structure 266 can be configured to prevent displacement and / or to form a seal between the outer shaft 260 and the body cavity BL. In use, the outer shaft 260 can be advanced, for example, along a guidewire until the distal end of the outer shaft 260 is positioned within the body cavity BL through an opening. The expandable structure 266 can then be deployed (e.g., expanded, inflated), such as... Figure 2The middle arrow 290 schematically illustrates this. Once deployed (e.g., once in the deployed state), the diameter of the expandable structure can be larger than the diameter of the opening through which the outer shaft 260 is placed, thus the expandable structure is configured to hold the outer shaft 260 within the body cavity BL. In some embodiments, the expandable structure 266 includes an inflatable balloon, a shape memory structure (e.g., an expandable nitinol structure), etc. In some embodiments, the outer diameter of the expandable structure 266 in the deployed state can be about 1.5 to about 3 times the outer diameter of the outer shaft 260.

[0076] In some embodiments, the expandable structure 266 can transition from a non-expanded state to an expanded state by compressing a portion of the outer shaft 260 and / or by moving the inner shaft relative to the outer shaft. For example, the expandable structure 266 can be defined within a region between two boundary rings along the length of the outer shaft 260, and the expandable structure 266 can expand (e.g., inflate) when the two boundary rings are brought together. In some embodiments, the outer shaft 260 may be formed of or comprise a plurality of concentric tubes or tubular members, for example, the inner tubular member may translate relative to the outer tubular member to bring the two ends of the expandable structure 266 closer together, thereby causing the expandable structure 266 to inflate (e.g., unfold). In such embodiments, at least one end (e.g., the proximal end) of the expandable structure 266 may be coupled to the outer tubular member, the other end (e.g., the distal end) of the expandable member 266 may be coupled to the inner tubular member, and translation of the inner tubular member relative to the outer tubular member may cause the expandable structure 266 to inflate or unfold. In some embodiments, the expandable structure 266 may be pre-formed to expand into an unfolded state. For example, the expandable structure 266 may be held taut (e.g., held in an un-unfolded state by an outer sleeve or tubular member, or flattened along the outer surface of the outer shaft 260 by a tubular member or traction wire) and may self-inflate into an unfolded state when released.

[0077] In some embodiments, the expandable structure 266 may include elongated members (e.g., strips, filaments, fibers, strips) arranged in a woven or braided pattern. In some embodiments, the elongated members may bend to form a bulbous shape as the expandable structure 266 transitions from an unexpanded state to an expanded state. In some embodiments, linear compression of one end of the elongated member relative to the other end can cause the expandable structure 266 to expand outward, thereby forming a geometry with an expanded diameter. In some embodiments, the expandable structure 266 may have a larger diameter in the expanded state compared to the unexpanded state. This expansion may help prevent accidental 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, polymers, or any suitable material with high strain relief. In some embodiments, the expandable structure 266 may be formed of a shape memory material, such as shape memory nitinol.

[0078] In some embodiments, the expandable structure 266 can be used as a seal to seal the opening through which the ablation catheter 250 passes. Further details of a suitable expandable structure 266 implemented as a seal are described in International Patent Application PCT / US2019 / 017112, which is incorporated herein by reference.

[0079] Although Figure 2 Two cavities (e.g., cavities 262, 264) are shown, but it will be understood that the outer shaft 260 may include any number of cavities, including a single cavity and / or more than two cavities. According to the embodiments described herein, the outer shaft 260 may also include additional sensors, expandable structures, etc.

[0080] Figure 3A more detailed view of the inner shaft 270 disposed in cavity 262 is provided. The inner shaft 270 can be deployed from the outer shaft 260 and cavity 262 by axial movement (e.g., translation along the longitudinal axis of the outer shaft 260), as indicated by arrow 291. The inner shaft 270 can be, for example, an ablation delivery device or an ablation catheter. In some embodiments, the inner shaft 270 can form part of a cryoablation device and be configured to deliver cryoablation media into the body cavity BL. The inner shaft 270 can be configured to provide ablation energy or ablation media capable of killing cells within the body cavity BL. For example, the inner shaft 270 can be configured to provide ablation energy or ablation media capable of killing cells in the mucosal layer of the gallbladder cavity, killing cells lining the cystic duct, or any combination thereof. The ablation energy or media can include, for example, chemical reagents (e.g., antibiotics, liquid sclerosing agents, sodium tetradecyl sulfate, acetic acid, ethanol, hypertonic sodium chloride, urea), cryoablation media (e.g., frozen liquids or gases), thermal ablation, electroablation, etc. In some embodiments, the inner shaft 270 may be configured to deliver various types of ablation energy or media. The inner shaft 270 may be configured to provide spatially diffuse ablation. In other words, the inner shaft 270 may be configured to provide ablation over a large area of ​​the body cavity BL. In some embodiments, the inner shaft 270 may be configured to deliver ablation for defunctionalizing the gallbladder mucosa, for ablation or sclerotherapy of the cystic duct, or any combination thereof.

[0081] 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 to the gallbladder wall to induce cryogenicity due to a phase change, such as nitrous oxide or carbon dioxide. 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 ablation medium is delivered in liquid, gaseous, aerosol, gel, or any combination thereof.

[0082] The inner shaft 270 may define a cavity 272. The cavity 272 may be configured to deliver an ablation medium (e.g., from an ablation medium supply source 120) to a nozzle 274 disposed within a body cavity BL. The nozzle 274 may be configured to release the ablation medium into the body cavity BL. In some embodiments, the nozzle 274 may include multiple openings or windows for distributing the ablation medium throughout the body cavity BL. In some embodiments, the cavity 272 and nozzle 274 may be configured to deliver liquid cryoablation medium into the body cavity BL. The dimensions of the cavity 272 and nozzle 274 may be configured to maintain a predetermined pressure on the cryoablation medium such that the ablation medium does not undergo a liquid-to-gas transition until it exits the opening of the nozzle 274. In other words, the cavity 272 and nozzle 274 may be configured to deliver liquid cryoablation medium to the opening of the nozzle 274, at which point the release of the cryoablation medium into the body cavity BL causes the cryoablation medium to change from a liquid to a gaseous state. In some embodiments, the diameter of the cavity 272 of the inner shaft 270 can range from about 0.001 inches to about 0.1 inches, including all values ​​and subranges therein.

[0083] In some embodiments, the inner shaft 270 may include an expandable structure or expandable body 276. In some embodiments, the expandable structure may be disposed around the nozzle 274. In some embodiments, the expandable structure 276 may expand within the body cavity BL such that the nozzle 274 is centered within the body cavity BL. In other words, the expandable structure 276 may expand outward to a desired diameter such that the radial distance from the center of the nozzle 274 to the wall of the body cavity BL is consistent or approximately consistent in all radial directions. This consistent spacing or centering ensures a minimum radial distance between the nozzle 274 and the tissue near the body cavity BL and / or a more uniform distribution of the ablation medium throughout the body cavity BL. This allows for the ablation of tissue within the body cavity while ensuring that the ablation medium is not too close to the tissue portion (e.g., creating a risk of adhesion or perforation) or too far away (e.g., reducing the effectiveness of ablation).

[0084] In some embodiments, the profile and / or thermal mass of the expandable structure 276 can be minimized to allow the ablation medium to be delivered more effectively from the nozzle 274 to the surface of the body cavity BL. In other words, reducing or minimizing the physical dimensions of the expandable structure 276 and the amount of heat energy it can absorb or radiate can improve heat transfer efficiency during ablation. In some embodiments, the expandable structure 276 may comprise a composition of nitinol, stainless steel, polymer, or any suitable material with high strain relief. In some embodiments, the material of the expandable structure 276 may be selected based on the material's ability to withstand freezing temperatures without significantly altering the cooling performance of the catheter system 250. In some embodiments, the use of the expandable structure 276, as opposed to cryoablation balloon catheters, avoids significant adhesion forces between the expandable structure 276 and the body cavity BL. This can create a more efficient cooling method that is less sensitive to the contents and geometry of the body cavity BL.

[0085] In some embodiments, the expandable structure 276 may be retractable or collapsible, thereby allowing the inner shaft 270 to be removed from the body cavity BL. In some embodiments, the expandable structure 276 may be radially symmetrical to ensure equidistant or near-equidistant radial spacing of the body cavity BL walls around the outside of the nozzle 274.

[0086] In some embodiments, the expandable structure 276 can transition from an unexpanded state (e.g., an unexpanded state) to an expanded state (e.g., an expanded state) by compressing a portion of the inner shaft 270 and / or by moving 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., strips, filaments, fibers, slivers) arranged in a woven or braided pattern or arranged along the length of the inner shaft 270. For example, the expandable structure 276 may include one or more elongated members extending generally 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 between two and 20 elongated members, including all values ​​and subranges thereof. In some embodiments, the distal end of the expandable structure 276 may be moved toward a more proximal point of the expandable structure 276, thereby causing the expandable structure 276 to expand, i.e., transition from an unexpanded state or configuration to an expanded state or configuration. In some embodiments, the inner shaft 270 may be movable relative to a cannula or tubular member (not shown) to allow the expandable structure 276 to expand and contract. For example, a cannula may be used to hold the expandable structure 276 in an undeployed state, or a cannula may allow one end (e.g., the proximal end) of the expandable structure to be moved relative to the other end (e.g., the distal end) of the expandable structure 276 to expand the expandable structure 276 into an deployed state. In some embodiments, the expandable structure 276 may include a plurality of filaments or bands extending along the length of the inner shaft 270, such that the filaments or bands may advance and retract from the proximal end of the ablation catheter 250. This advance and retraction may be used to deploy and retract the expandable structure 276. Further details of the mechanism of the expandable structure 276 will be described with reference to the following figures, including, for example... Figures 13A-13C and Figures 32A-32C .

[0087] In some embodiments, the inner shaft 270 may optionally include a valve 278. The valve 278 may be configured to control the delivery of ablation medium to the body cavity BL. For example, the valve 278 may be configured to turn on or off the supply of 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 in response to a pressure within the body cavity BL exceeding a predetermined threshold (e.g., automatically and / or under the control of the control unit). In some embodiments, a sensor (e.g., a sensor disposed on the inner shaft 270 or the outer shaft 260 and / or a sensor coupled to the control unit 110) may be used to measure the pressure within 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 body cavity BL and the drainage cavity (e.g., cavity 262) (e.g., indicating a blockage or obstruction along the drainage path). For example, multiple sensors may be configured to measure different pressures associated with the catheter system 250 and / or the body cavity BL, and the control unit (e.g., control unit 110) may be configured to analyze when such pressure measurements are taken to determine when any fluid flow path into and / or out of the body cavity BL is accidentally blocked.

[0088] As described above, in some embodiments, the inner shaft 270 may be part of or form part of a cryoablation apparatus and may be configured to deliver a cryoablation medium into the body cavity BL. The cryoablation apparatus may utilize the phase change properties of certain cryoablation media (e.g., liquid nitrous oxide) to induce cryoablation temperatures at the target tissue interface. When such a cryoablation medium changes from liquid to gas, its volume expands, resulting in an increase in pressure within the body cavity BL. Therefore, an important consideration in designing the systems and apparatuses disclosed herein is monitoring and controlling the intracavitary pressure within the body cavity BL during the ablation procedure. For example, the systems and apparatuses disclosed herein may be configured to ensure that the intracavitary pressure does not increase above a predetermined threshold and / or ensure that the intracavitary pressure remains within a predetermined range. In the event of an increase in intracavitary pressure (e.g., pressure exceeding a predetermined threshold, or pressure abruptly exceeding a predetermined ratio), the systems and apparatuses disclosed herein may be configured to evacuate air, gaseous cryoablation medium, and / or other fluids from the body cavity BL to reduce the intracavitary pressure. In this context, it is important to ensure that any cryoablation media within the catheter system 250 (e.g., within the lumen 272 of the inner shaft 270) and / or within the supply line entering the catheter system 250 does not exit the catheter system 250 (e.g., nozzle 274) into the body cavity BL to avoid further increasing pressure. Therefore, it is preferable to minimize or reduce the amount of residual cryoablation media delivered to the body cavity BL in response to the detection of a pressure increase event (e.g., pressure exceeding a predetermined threshold, or a pressure spike exceeding a predetermined rate). In some embodiments, a valve 278 may be used to reduce the amount of residual cryoablation media delivered to the body cavity 270. The valve 278 may be positioned at or near the nozzle 274 such that, when closed, the valve 278 prevents any residual or excessive ablation media within the lumen 272 and / or other channels leading to the nozzle 274 from being delivered into the body cavity BL.

[0089] Valve 278 may include any suitable mechanism. In some embodiments, the valve may be closed in a resting state but open to allow delivery of ablation medium into the body cavity BL. Alternatively, valve 278 may be open in a resting state and closed to prevent additional delivery of ablation medium into the body cavity BL. In some embodiments, a spring mechanism may be used to bias valve 278 to close and / or open. Valve 278 may have any suitable geometry, including, for example, a cube, cone, cylinder, triangular prism, toroidal body, helix, ovoid, or other three-dimensional body with a structure sufficient to impede the flow of ablation medium. In some embodiments, valve 278 may sit on a valve seat defined within an inner shaft 270 (e.g., within cavity 272). In some embodiments, valve 278 may be actuated manually or via a control device (e.g., control device 110) to open and / or close using a drive wire or drive rod, pneumatic or hydraulic pressure, electromagnetic force, and / or an electric motor. Examples of suitable valves are described in International Patent Application PCT / US2020 / 045436, which is incorporated herein by reference.

[0090] In some embodiments, the inner shaft 270 may optionally include a sensor 273. In some embodiments, the sensor 273 may be located at a distal portion of the inner shaft 270, which is configured to be disposed within the body cavity BL. Alternatively, the sensor 273 may be disposed at different locations along the inner shaft 270, including, for example, within a cavity (e.g., cavity 272), at the proximal end of the inner shaft 270, etc. The sensor 273 may be configured to capture information about the environment within the body cavity BL. For example, the sensor 273 may be configured to measure the properties (e.g., pressure, temperature) of the ablation medium delivered to the body cavity BL, the properties (e.g., pressure, temperature) of the body cavity BL or the fluid within the body cavity BL, etc. The sensor 273 may include, for example, a pressure sensor (e.g., a pressure transducer, a strain gauge transducer, a diaphragm displacement sensor, a fiber optic pressure sensor, a solid-state sensor), a temperature sensor, a light sensor, a gas sensor, etc. The sensor 273 is capable of transmitting data (e.g., sensor measurement results) 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.

[0091] In some embodiments, the inner shaft 270 may optionally include one or more additional lumens. In some embodiments, the lumens may be configured as channels for transferring pressure information or other conditions (e.g., temperature) from the body cavity BL and / or other portions of the catheter system 250. In some embodiments, the catheter system 250 may optionally include an occluder, as referenced Figure 22 Further description. Although Figure 3A single cavity (e.g., cavity 272) is shown, but it will be understood that the inner shaft 270 may include any number of cavities, including a single cavity and / or more than two cavities. According to the embodiments described herein, the inner shaft 270 may also include additional sensors, valves, nozzles, etc.

[0092] Figure 4 Detailed views of the inner shaft 270 and outer shaft 260 located within the body cavity BL are provided. The inner shaft 270 may be disposed within the cavity 262 of the outer shaft 260. The gap between the outer surface of the inner shaft 270 and the inner surface of the cavity 262 may define a venting cavity or venting channel for removing gas and / or other fluids (e.g., ablation medium from the body cavity BL) from the body cavity BL.

[0093] The outer shaft 260 and / or inner shaft 270 can be formed of flexible and / or semi-flexible materials to enable both to be navigated into the body cavity BL, for example, along a guidewire. The material can be a medical-grade biocompatible material. The inner shaft 270 can be deployed into the body cavity BL along 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 radially deployed, as indicated by arrow 292.

[0094] Figure 5 This is a schematic diagram of an example control unit 310 according to some embodiments. The control unit 310 may be structurally and / or functionally similar to the referenced figure. Figure 1 The control unit 110 is described above. 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, a 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 included in a handheld device connected proximally to the catheter system. In some embodiments, the control unit 310 may be remotely located, for example, on a remote computing device or system, and may be used to remotely control the operation of the catheter system.

[0095] The processor 312 of the control unit 310 can be any suitable processing device configured to operate and / or perform functions related to deploying one or more components of the catheter system (e.g., advance or retract shaft, deploy expandable structure, open and / or close valves), delivering ablation media into the body cavity, analyzing sensor data related to ablation involving the catheter system, controlling intracavitary temperature and / or pressure, etc. The processor 312 can be configured to execute modules, functions, and / or processes. The processor 312 can be a general-purpose processor, a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), and / or a digital signal processor (DSP), etc. In some embodiments, the processor 312 is part of a circuit (e.g., an integrated circuit). In some embodiments, one or more other components of the ablation system can be integrated into the circuit, including, for example, one or more sensors.

[0096] Input / output interface 319 may include a user interface and / or a communication interface for connecting control unit 310 to one or more external computing devices. The user interface may include one or more components configured to receive input and send output to other devices and / or users operating the devices (e.g., users operating a conduit system). For example, the user interface may include a display device (e.g., a monitor, touchscreen, etc.), an audio device (e.g., a speaker or alarm), and one or more additional input / output devices configured to receive input and / or generate output to the user. The communication interface may include one or more wireless and / or wired interfaces, for example, for communicating with other computing devices (e.g., computing device 190) via one or more networks (e.g., local area network (LAN), wide area network (WAN), virtual network, telecommunications network).

[0097] Memory 314 may be, for example, random access memory (RAM), a memory buffer, a hard disk drive, a database, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), and / or a read-only memory (ROM). In some embodiments, memory 314 stores instructions for causing processor 312 to perform modules, processes, and / or functions related to deploying one or more components of the catheter system (e.g., advance or retract shafts, deploying expandable structures, opening and / or closing valves), delivering ablation media into the body cavity, analyzing sensor data related to ablation procedures involving the catheter system, and controlling intracavitary temperature and / or pressure, etc. The methods described herein may be implemented by machine-executable code (e.g., a computer processor) stored at an electronic storage location (e.g., on memory 314) of control unit 310 or operatively coupled to the memory of control unit 310. In some embodiments, machine-executable or machine-readable code is provided in software form. In operation, the code may be executed by processor 312. In some cases, code is retrieved from memory 314 for access and / or execution by processor 312.

[0098] like Figure 5 As shown, memory 314 stores instructions for enabling processor 312 to execute modules, processes, and / or functions, exemplified as venting control 315, ablation medium supply control 316, optional sensor control 317, and / or optional nozzle control 318. Venting control 315, ablation medium supply control 316, sensor control 317, and / or nozzle control 318 can be implemented as one or more programs and / or applications bound to hardware components. For example, venting control 315, ablation medium supply control 316, sensor control 317, and / or nozzle control 318 can 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, processor 312 executing venting control 315 can control the opening of valves and / or the activation of a vacuum source to vent air or other fluids (e.g., ablation medium) from body cavities. In some embodiments, the processor 312 performing ablation medium supply control 316 may control the opening of valves and / or the operation of the ablation supply source to deliver ablation medium into the body cavity via the catheter system. In some embodiments, the processor 312 performing sensor control 317 may receive, process, and / or analyze data from one or more sensors and / or use this data to control the operation of one or more other components of the ablation system or catheter system.

[0099] In some embodiments, nozzle control 318 may be implemented to control the positioning or movement of one or more nozzles (e.g., nozzle 274) within a body cavity (e.g., body cavity BL). In some embodiments, nozzle control 318 may be implemented to rotate an ablation catheter (e.g., inner shaft 270) along a central axis to increase the uniform or more distributed delivery of the liquid cryoprotectant medium. In some embodiments, nozzle control 318 may actuate the ablation catheter and / or nozzles to move axially or linearly to increase the distribution of cryoprotectant from the nozzles. In some embodiments, nozzle control 318 may be implemented to open and close one or more nozzle openings.

[0100] Figures 6A-6B An example method 600 for ablation and management of pressure and / or temperature during an ablation procedure, according to an embodiment, is illustrated. In some embodiments, the ablation procedure may be a cryoablation performed using an ablation system (e.g., ablation system 100) that includes a cryoablation device. In some embodiments, ablation is performed in the gallbladder to defunctionalize it. Method 600 optionally includes advancing the outer axis (e.g., outer axis 260) of the catheter system (e.g., catheter systems 150, 250) of the ablation system into a body cavity (e.g., the gallbladder cavity) at 602. In some embodiments, ultrasound imaging may be used to visualize the body cavity. In some embodiments, a standard needle and guidewire may be used to enter the body cavity via a transhepatic approach (e.g., using the Seldinger technique). When the target body cavity is the gallbladder, visual observation of bile, confirmation of guidewire spiral advance within the body cavity via needle return and fluoroscopy can help verify proper guidewire placement within the body cavity. In some embodiments, the outer axis may be advanced along the guidewire with the dilator located within a cavity (e.g., cavity 262) of the outer axis. In some embodiments, a series of progressively larger dilators can be advanced along a guidewire to dilate the passage into the body cavity. After the passage is dilated, an outer shaft (e.g., with dilators inserted) can be advanced along the guidewire into the body cavity. In some embodiments, the outer shaft of the catheter system can be a separate tubular structure, such as a access sheath or guide, which is placed in the body cavity before the inner shaft is placed. Alternatively, in some embodiments, the outer and inner shafts can be placed into the body cavity simultaneously. In some embodiments, the placement of the outer shaft can be similar to percutaneous drainage catheter placement techniques. Once the outer shaft has been positioned in the body cavity, the dilators and guidewire can be removed to allow the inner shaft to be placed within the outer shaft, as further described below.

[0101] In some embodiments, the catheter system may be placed in the gallbladder cavity. Access to the gallbladder using the catheter system can be achieved percutaneously. In some embodiments, such as Figure 7A As shown, the access sheath or outer shaft 760 of the catheter system enters the gallbladder 2 via an ultrasound-guided transhepatic percutaneous approach. In some embodiments, such as Figure 7BAs shown, the access sheath 760 of the catheter device is inserted into the gallbladder 2 via an ultrasound-guided subhepatic percutaneous approach. In some embodiments, the percutaneous approach is similar to a method for placing a cholecystostomy drainage tube. In some embodiments, such as Figure 7C As shown, the access sheath 760 provided here facilitates access to the gallbladder 2 via an endoscope. In some embodiments, such as Figure 7C As shown, the access sheath 760 accesses the gallbladder 2 using native anatomical structures by creating a transmural stoma connecting the gallbladder lumen to the small bowel lumen. In some embodiments, a percutaneous access is obtained using a hollow needle, thereby allowing a guidewire to be inserted through the needle to create a channel to the desired access site (e.g., the cystic duct, the gallbladder, or a combination thereof). In some embodiments, the access sheath 760 and the inner shaft or ablation catheter are configured with concentric cavities that allow the guidewire to pass through. In some embodiments, the access sheath 760 and the ablation catheter are configured with non-concentric cavities that allow the guidewire to pass through.

[0102] After positioning the distal end of the outer shaft of the catheter system within the body cavity, method 600 may optionally include deploying an expandable structure of the outer shaft (e.g., expandable structure 266) at 604. Deploying the expandable structure within the body cavity ensures that the outer shaft (e.g., access catheter, guide) remains or is retained within the body cavity during ablation. In some embodiments, deploying the expandable structure may involve moving a first tubular member relative to a second tubular member to bring a first end of the expandable structure close to a second end of the expandable structure, thereby causing the expandable structure to expand outward. In some embodiments, expanding the expandable structure may involve releasing tension acting on the expandable member (e.g., by releasing a sheath or traction wire) and allowing the expandable structure to expand automatically or self-expand into a pre-formed shape.

[0103] Method 600 may include advancing the inner shaft of the catheter system (e.g., inner shaft 270) into the body cavity at 606. In some embodiments, the inner shaft may be advanced after the dilator has been removed, provided that a dilator has been previously positioned in the outer shaft to advance the outer shaft into the body cavity. The inner shaft may be advanced until a nozzle (e.g., nozzle 274) of the inner shaft is positioned within the body cavity distal to the distal end of the outer shaft. The inner shaft may be advanced into the body cavity by inserting the inner shaft into a cavity defined by the outer shaft and advancing the inner shaft through the cavity until a 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) for delivering ablation media into the body cavity. In some embodiments, method 600 may optionally include deploying saline to irrigate and drain any contents within the body cavity, e.g., via the inner shaft and / or the outer shaft. For example, fluids such as saline solution can be delivered to the gallbladder via a first cavity (e.g., cavity 272 defined by inner shaft 270), and / or contents within the body cavity (e.g., gallbladder contents) can be emptied from the body cavity via a second cavity (e.g., cavity 262 defined by outer shaft 260).

[0104] Method 600 includes deploying an expandable structure (e.g., expandable structure 276) of the inner shaft at 607. In some embodiments, the expandable structure may include a plurality of filaments or strips extending along the length of the inner shaft. The filaments can be deployed by advancing such filaments distally outside the sheath. In some embodiments, the expandable structure can be deployed by moving the inner tubular member and the outer tubular member relative to each other. Once the expandable structure is deployed, it allows the nozzle to be centered within the body cavity or ensures that the nozzle is at least a predetermined distance from the tissue surface. Method 600 may optionally include opening a supply chamber valve (e.g., valve 278) at 608. For example, as referenced above. Figure 3 The valve discussed can be positioned along an ablation medium delivery channel (e.g., along cavity 272 defined by an inner shaft) to control the delivery of the ablation medium. A valve in the open state allows the ablation medium to flow through the valve and into the body cavity, while a valve in the closed state prevents the ablation medium from flowing into the body cavity. In some embodiments, the valve can be in a naturally closed state, so method 600 may include opening the valve to allow the ablation medium to be delivered into the body cavity. In some embodiments, the valve can be in a naturally open state, so 608 can be omitted.

[0105] Method 600 may include delivering an ablation medium into a body cavity at 610. In some embodiments, a cartridge (e.g., an ablation medium supply source 120, 220) of 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, at 610 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more than 10 freeze-thaw cycles may be applied to the gallbladder to ensure complete hypothermic death of the gallbladder mucosa. When delivering the ablation medium, method 600 may include at 612 events and / or steps associated with pressure and / or temperature monitoring, as referenced below. Figure 6B Further described. 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 delivery of the ablation medium, method 600 may optionally include removing the catheter system (e.g., inner and outer shafts) from the body cavity at 614.

[0106] Figure 6B It shows the connection with ablation (e.g., see reference). Figure 6AThe events and steps associated with the temperature and pressure monitoring protocol performed during the described ablation procedure. A control unit (e.g., control unit 110, 310) of the ablation system or other computing device may be configured to receive data from a temperature sensor at 620 and determine the ablation status at 622. In some embodiments, the ablation status can 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 sensor 263, 273). In other embodiments, the temperature sensor may be operatively coupled to a cavity extending into the body cavity, which the sensor can use to measure temperatures associated with the body cavity. In other embodiments, the temperature sensor may be mounted on a probe that can be inserted separately into the body cavity, e.g., through a separate cavity (e.g., cavity 264) and / or the same cavity accommodating the inner shaft (e.g., cavity 262). In some embodiments, the temperature sensor may be implanted or inserted into tissue within the body cavity, thereby allowing the temperature of the tissue to be measured.

[0107] Method 600 may optionally include generating information to be presented to a user at 626. In some embodiments, the information presented to the user may be presented via a computing device such as control unit 110 and / or 310 or other computing device (e.g., a tablet, smartphone, or any other suitable communication device) that communicates with the ablation system via a network. Based on the ablation status determined at 622, the supply of ablation medium may be adjusted or terminated at 627. In some embodiments, the supply of ablation medium may be reduced or terminated. In some embodiments, the supply of ablation medium may be increased. In some embodiments, to assess tissue temperature at different locations, at 628, a temperature sensor may optionally be moved to a new location. For example, the temperature sensor may be retracted from tissue at a first location, moved to a second location, and inserted into tissue at the second location. In some embodiments, method 600 may include determining whether ablation is complete (e.g., based on sensor data), and in response to determining that ablation is complete, the supply of ablation medium may be terminated (e.g., by closing valve 278), and method 600 may continue to 612, where the catheter system is removed from the body cavity.

[0108] At 630, a control unit (e.g., control unit 110, 310) or other computing device may also receive pressure data from one or more pressure sensors. In some embodiments, the first pressure reading may be from inside a body cavity (e.g., measuring intracavitary pressure), while the second pressure reading may be from inside an external shaft (e.g., measuring pressure within a venting cavity (e.g., cavity 262)). In other embodiments, at 630, more or fewer pressure readings may be received. At 632, at least one pressure measurement (e.g., intracavitary pressure within a body cavity) is evaluated to determine whether the pressure reading is within a desired pressure parameter range (e.g., within the desired pressure range). If the pressure readings are significantly different from each other (e.g., the difference between the different pressure readings is greater than a predetermined amount or percentage, or there is an increase or decrease of a percentage relative to the nominal working pressure (e.g., 30%)), or if one or more pressure readings are not within one or more desired pressure parameter ranges (632: No), then at 634, information (e.g., an alarm) may optionally be presented to the user, and at 635, the supply of ablation medium may be adjusted or terminated. The information presented to the user can indicate that an error has occurred in the ablation delivery and / or device operation. For example, a significant difference (e.g., a difference greater than a predetermined amount or percentage) between the intracavitary pressure and the pressure in the emptied cavity (e.g., intracavitary pressure greater than emptied cavity pressure) can indicate a blockage at some point between the body cavity and the emptied cavity. In the case of cryo-delivery systems, this occurs when ice or other solid contents block a portion of the emptied cavity. This blockage causes pressure buildup within the body cavity and can lead to patient injury. Therefore, in this situation, the control unit or other computing device can terminate the supply of ablation media to the body cavity until the blockage is cleared (e.g., by a heating coil). In some embodiments, when the pressure measurement is outside a certain pressure parameter (e.g., a predetermined threshold or range), at 636, the control unit can control one or more valves and / or a vacuum source (e.g., vacuum source 130) to evacuate the ablation media from the body cavity, thereby reducing pressure buildup within the body cavity.

[0109] In 614, the catheter system (e.g., guide and ablation catheter) can be removed from the body cavity. For some time after removal of the ablation system (e.g., several weeks), the body's chronic inflammatory response can cause scarring of the ablated gallbladder tissue, leading to lumen degeneration and obstruction of the cystic duct. The flow of bile to the gallbladder is cut off, while the gallbladder's blood supply remains unimpaired, resulting in an inert organ.

[0110] In some embodiments, as described above, the ablation technique described herein uses a cryoablation medium. In some embodiments, the cryoablation medium is a liquid. In some embodiments, the cryoablation medium is a gas. In some embodiments, when delivered using the catheter device and nozzle disclosed herein, the cryoablation medium undergoes a liquid-to-gas phase transition. In some embodiments, cryoablation is achieved through refrigerant properties due to the liquid-to-gas phase change from the 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 sudden pressure drop. In some embodiments, the phase change of the cryoablation medium occurs when the liquid ablation medium contacts the body cavity wall (e.g., the gallbladder wall). Thus, the liquid ablation medium can be delivered into the body cavity and contact the body cavity wall, undergoing a phase transition to a liquid ablation medium. Ablation may occur at the phase transition interface.

[0111] Figures 8-9 An ablation system, implemented as a cryoablation device 800 according to an embodiment, is illustrated. The cryoablation device 800 can be configured to ablate or defunctionalize the gallbladder cavity. The cryoablation device 800 may include components 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 one actuator 801a (e.g., a button) or multiple actuators 801a. In some embodiments, the actuator may be used to control the deployment of the expandable structure 866 on the outer shaft 860, the deployment of the expandable structure 876 on the inner shaft 870, the deployment of the ablation medium through the nozzle 874, and the actuation of the nozzle 874 (e.g., translation or rotation of the nozzle 874). In some embodiments, the handle assembly 801 may be circumferentially coupled to an ablation medium supply source (e.g., ablation medium supply source 120). In some embodiments, the handle assembly 801 may include a user interface (e.g., an input / output interface 319) to transmit information to and / or receive input from the user.

[0112] Figure 9This is a detailed view of the outer shaft 860 and inner shaft 870 of the cryoablation apparatus 800 according to an embodiment. The outer shaft 860 and inner shaft 870 may include components structurally and / or functionally similar to other ablation systems and their components described herein (e.g., outer shaft 260 and inner shaft 270, etc.). As shown, the expandable structure 876 may be implemented as an expandable cage mechanism. As shown, the expandable structure 876 has a “closed” configuration; for example, the strips or filaments forming the expandable structure 876 are gathered together and closed at both the proximal and distal ends of the expandable structure 876, such that the expandable structure 876 forms a closed basket or cage.

[0113] Figure 10 An ablation catheter 1050 deployed in a body cavity BL according to an embodiment is shown. The ablation catheter 1050 may include components 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 having an expandable structure 1066 and an inner shaft 1070 having a nozzle 1074 and the expandable structure 1076. As shown, the expandable structure 1066 on the outer shaft 1060 is in an deployed state to prevent the ablation catheter 1050 from unintentionally leaving the body cavity BL (e.g., maintaining its position within the body cavity BL). The expandable structure 1076 on the inner shaft 1070 is in an deployed state to substantially center the nozzle 1074 within the body cavity BL, for example, to ensure uniform and / or minimal spacing (e.g., a predetermined spacing amount) between the nozzle 1074 and the tissue wall of the body cavity BL. As described above, this 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). Both the expandable structures 1066 and 1076 are retractable (e.g., convertible back to an unexpanded state), allowing the ablation catheter 1050 to retract from the body cavity BL.

[0114] Figure 11 An example of an inner shaft 1170 is shown, which includes a cavity 1172 and a vented nozzle 1174. The inner shaft 1170 may include components 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 cavity 1172 is small enough to keep the cryo-liquid ablation medium 1122 in a liquid state, wherein the cryo-liquid ablation medium 1122 transforms into a cryo-gas ablation medium 1124 (i.e., a liquid-to-gas phase transition) as it exits the inner shaft 1170 via a plurality of vents 1175, such as... Figure 11As shown (e.g., due to the pressure drop between the interior of cavity 1172 and the interior of the gallbladder). In some embodiments, the cryo-gas ablation medium 1124 exits the ventilated nozzle 1174 via a plurality of windows 1175 and ablates the outer surface of the gallbladder cavity once the cryo-gas ablation medium 1124 comes into contact with tissue.

[0115] Figures 12A-12B This is an illustration of the outer shaft 1260 of an ablation system (e.g., a cryoablation device) according to an embodiment. The outer shaft 1260 may include components structurally and / or functionally similar to the outer shafts of other ablation systems described herein (e.g., outer shaft 260, outer shaft 860, outer shaft 1060, etc.). As shown, the outer shaft 1260 may include a concentrically arranged outer tubular member 1261a and an inner tubular member 1261b. A cavity 1262 and an expandable structure 1266 are also shown. Figure 12A The expandable structure 1266 in its unexpanded state is shown, while Figure 12B An expandable structure 1266 in an unfolded state is shown. As shown, the expandable structure 1266 includes filaments arranged in a braided configuration, having a proximal loop 1267a and a distal loop 1267b. In some embodiments, at least one of the proximal loop 1267a and the distal loop 1267b can be moved toward the other to cause outward expansion (e.g., unfolding) of the expandable structure 1266. In some embodiments, the proximal loop 1267a and the distal loop 1267b can be moved by sliding tubular members 1261a and 1261b.

[0116] In some embodiments, the loops 1267a, 1267b and / or filaments of the expandable structure 1266 may be radiopaque to aid in visualizing the actuation of the expandable structure 1266 under image guidance (e.g., fluorescence imaging, ultrasound imaging). In some embodiments, the proximal loop 1267a and distal loop 1267b can be moved by a traction wire, spring, sheath and / or any other suitable mechanism. For example, one or more traction wires can be actuated to move at least one of the proximal loop 1267a and distal loop 1267b toward the other. In some embodiments, when in the unexpanded state ( Figure 12A When inflatable structure 1266 is in a tensioned state, it can be in an expanded state. Figure 12BThe expandable structure 1266 is in a relaxed state. Specifically, the expandable structure 1266 can be held taut along the outer surface of the outer shaft 1260 and can be released (e.g., by releasing the holdings on one or both ends of the expandable structure 1266, such as by releasing the traction wire, sheath, etc.) to allow the expandable structure 1266 to self-inflate into an unfolded state. In some embodiments, the expandable structure 1266 may be made of a shape memory material, thereby maintaining its shape in the unfolded state unless subjected to external force. In some embodiments, the belt may be taut when in the unfolded state and relaxed when in the unfolded state. For example, pushing or moving the outer tubular member 1261a relative to the inner tubular member 1261b in a distal direction can cause the expandable structure 1266 to change from an unfolded state to an unfolded state. As another example, pulling or moving the inner tubular member 1261b relative to the outer tubular member 1261a in a proximal direction can cause the expandable structure 1266 to change from an unfolded state to an unfolded state.

[0117] Figures 13A-13C Parts of an ablation device with different arrangements of expandable structures and nozzles are shown. Figures 13A-13C The ablation device described herein 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 An outer shaft 1360 with an expandable structure 1366 and an inner shaft 1370 with an expandable structure 1376 are shown. The inner shaft 1370 is slidable within the outer shaft 1360, such that the inner shaft 1370 is axially movable in the direction of arrow 1391 (e.g., along the longitudinal axis of the outer shaft 1361). The expandable structure 1376 is coupled to a distal portion of the inner shaft 1370. The inner shaft 1370 can advance through the outer shaft 1360 until the distal portion of the inner shaft 1376 (e.g., including the expandable structure 1376) is positioned distal to the distal end of the outer shaft 1366. When thus positioned, the expandable structure 1376 can be configured to expand into an expanded state, such as... Figure 13A As shown. Although in Figure 13ANot shown, but the nozzle can advance distally from the outer shaft 1360 independently. For example, a separate shaft supporting the nozzle can advance through a cavity of the outer shaft 1360 and into a space adjacent to the expandable structure 1376. The nozzle can advance separately from the expandable structure 1376, allowing a user to manipulate the position of the nozzle relative to the expandable structure 1376. Alternatively, in some embodiments, the inner shaft 1370 may include the nozzle. The expandable structure 1376 may include multiple belts or filaments. In some embodiments, the belts may be made of a shape memory material, such that they retain their shape in the unfolded state unless subjected to external force. As described above, in some embodiments, the belts may be taut when in the unfolded state and slack when in the unfolded state. Alternatively, the belts may be slack when in the unfolded state and taut when in the unfolded state.

[0118] Figure 13BAn ablation device having an outer shaft 1360', an inner shaft 1370', a nozzle 1374', an expandable structure 1376', and a hub 1379' is shown. As shown, the expandable structure 1376' includes a plurality of filaments or strips extending outward and distally from the inner shaft 1370' and coupled to the distal hub 1379'. In some embodiments, the strips extend along the entire length of the inner shaft 1370', such that the strips can advance and retract from the proximal end of the inner shaft 1371'. Advancing of the strips can cause the expandable structure 1376' to expand to deploy the expandable structure 1366', and retraction of the strips can pull the expandable structure 1336' back toward the inner shaft 1370 to return the expandable structure 1346' to an undeployed state. In some embodiments, the strips of the expandable structure 1376' may be taut when in the undeployed state and slack when in the deployed state. In other words, the belt can remain taut, keeping the expandable structure 1376' in an unexpanded or uninflated state, and releasing the belt can allow the belt to expand to the expanded state. In some embodiments, the belt can be moved by 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 actuating any other suitable mechanism. In some embodiments, the belt of the expandable structure 1376' can be taut when in the expanded state and slack when in the unexpanded state. In other words, the belt can be advanced or pushed from the proximal end of the inner shaft 1370' to inflate the expandable structure 1376' to the expanded or expanded state. As shown, a nozzle 1374' can be located within the expandable structure 1376'. The nozzle 1374' can be coupled to a cavity extending through the inner shaft 1370', such that the nozzle 1374' can receive and deliver the ablation medium into the body cavity. The nozzle 1374' can terminate proximally to the hub 1379'. In some embodiments, the nozzle 1374' can advance independently of the expandable structure 1376', thereby allowing adjustment of the nozzle's position within the expandable structure 1376'.

[0119] In some embodiments, a sensor may be disposed within 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 inner shaft 1370' is positioned within the gallbladder cavity to deliver ablation medium (e.g., cryoablation medium), hub 1379' may be positioned at or near the cystic duct and may measure temperature and / or pressure within the cystic duct. Such measurements may be used to monitor the progress of the ablation procedure and / or operating conditions during the ablation procedure (e.g., for safety).

[0120] Figure 13CAn ablation device (e.g., a cryoablation catheter) is illustrated, having an outer shaft 1360”, an inner shaft 1370”, a nozzle 1374”, and an expandable structure 1376”. The ablation device may include a cannula 1371”, which defines a group of one or more lumens for receiving one or more strips or filaments forming the expandable structure 1376”. The strip forming the expandable structure 1376” may extend from the proximal end of the cannula 1371” to the distal end beyond the cannula 1371”, such that the strip may advance and / or retract from the proximal end of the cannula 1371”. In some embodiments, the strip of the expandable structure 1376” may be tensioned when in an unexpanded state and relaxed when in an expanded state. In other words, pulling the strip from the proximal end of the cannula 1371” can flatten the expandable structure 1376”, and releasing the strip can allow the strip to self-expand to the expanded state. In some embodiments, the strip may be pulled or released from the proximal end of a second inner shaft 1371” by an actuator. In some embodiments, the belt of the expandable structure 1376” can be tensioned when in the unfolded state and slack when in the unfolded state. In other words, the belt can be advanced or pushed to expand from the proximal end of the second inner shaft 1371”. In some embodiments, the movement of the belt of the expandable structure 1376” can be caused by an actuator (e.g., a button, slider, motor, spring, etc.).

[0121] In some embodiments, the sleeve 1371” can be moved along a straight line 1391 in both proximal and distal directions. In some embodiments, the sleeve 1371” can act as a pushing mechanism, for example, to deploy the 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 in the first direction along arrow 1392 to the deployed state. In response to pulling the sleeve 1371” away from the distal end of the inner shaft 1370” or pulling it proximal, the expandable structure 1376” retracts inward in the opposite direction along arrow 1392 to the undeployed state.

[0122] Figure 14An inner shaft 1470 of an ablation catheter or catheter system with an expandable structure 1476, according to an embodiment, is shown. The expandable structure 1476 may include a plurality of filaments or strips coupled to a hub or shaft at a first end (e.g., proximal end) and disengaged 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 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. The strip of the expandable structure 1476 may be coupled to the hub 1479 at its proximal end. As shown, the hub 1479 is located proximal to the nozzle 1474. Although the hub 1479 is shown... While the hub 1479 is located proximal to the nozzle 1474, it will be understood that in other embodiments the hub 1479 may be located distal to the nozzle 1474. Similar to other expandable structures described herein, the expandable structure 1476 may be configured to self-expand (e.g., after release from tension or after the belt has been advanced distal to the hub 1479). In some embodiments, the expandable structure 1476 may be made of a shape memory material, such that the expandable structure 1476 remains in an expanded state during cryoablation.

[0123] Figures 15-16B A catheter system with a drain cavity is shown according to various embodiments, the drain cavity being used to drain fluid (e.g., gas, liquid) or smaller debris from the body cavity BL.

[0124] Figure 15An ablation catheter 1550, partially disposed in a body cavity BL according to an embodiment, is shown. The ablation catheter 1550 may include components structurally and / or functionally similar to other ablation systems and 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 a drain hole 1563 (e.g., a drain opening) and an expandable structure 1566. In some embodiments, the drain hole 1563 may be inserted into the body cavity BL during ablation, allowing fluid or smaller debris to exit the body cavity BL through the drain hole 1563 and flow out of the body cavity BL via the outer shaft 1560 along the channel indicated by arrow 1595. In some embodiments, the expandable structure 1566 may be disposed around the outside of the drain hole 1563, such that the expandable structure 1566 acts as a filter to prevent larger debris from clogging the drain hole 1566. In some embodiments, the expandable structure 1566 may have a mesh structure that facilitates the filtering of debris (e.g., gallstones, sludge, bile) and prevents it from entering the venting channel in the outer shaft 1560, thereby creating a reliable channel for releasing ablation gas and pressure in the body cavity BL. In some embodiments, debris exiting the body cavity via the venting hole 1563 may be solid, liquid, and / or gaseous. In some embodiments, the venting hole 1563 may be orifice-connected to a cavity extending along arrow 1595 inside the outer cavity 1560 and outside the inner cavity 1570. In some embodiments, the expandable structure 1566 may create a reliable bag for venting ablation gas.

[0125] Figures 16A-16B Cross-sectional views of the outer shafts 1660, 1660' having vent cavities according to various embodiments are shown. Figure 16A This includes an outer shaft 1660 and an inner shaft 1670. The outer shaft 1660 and inner shaft 1670 may include components 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.). Figure 16A As shown, the outer shaft 1060 may include a cavity 1662, and the inner shaft 1070 is disposed within the cavity 1662. During ablation, the space between the outer surface of the inner shaft 1070 and the inner surface of the outer shaft 1060 may define a drainage channel or passage. In some embodiments, debris may flow into a drainage hole (e.g., drainage hole 1563) located within the body cavity and flow through the drainage channel to exit the body cavity.

[0126] Figure 16BAn alternative arrangement of the cavity within the outer shaft 1670' of an ablation catheter (e.g., a cryoablation device) is illustrated. As shown, the outer shaft 1670' may include a separate cavity 1664' designated for draining contents (e.g., solids, fluids, etc.) from the body cavity BL. In some embodiments, the cavity 1664' may be orifice-connected to a drain orifice (e.g., drain orifice 1563) that may be disposed in the body cavity. In some embodiments, the cavity 1664' may provide a flow path for fluids and / or debris to exit the body cavity. Similar to other outer shafts, the outer shaft 1660' may define a cavity 1662' that may receive the inner shaft 1670' and may be used to guide the inner shaft 1672' into the body cavity.

[0127] Figures 17A-17B An outer shaft 1760 of an ablation catheter (e.g., a cryoablation device) having an expandable structure 1766 according to an embodiment is shown. The outer shaft 1760 includes a vent hole 1762a and a vent cavity 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 The expandable structure 1766 is shown in its unexpanded (i.e., unexpanded) state, while Figure 17B An expandable structure 1766 in its deployed state is shown. As shown, the expandable structure 1766 is disposed on an outer shaft 1760 such that it covers a drain hole 1762a. When deployed, the expandable structure 1766 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, such that in its expanded state, the expandable structure 1766 can act as a filter to prevent fluid and / or debris from entering the drain hole 1762a. In this case, the expandable structure 1766 can act as a filter and prevent any debris large enough to clog the drain hole 1762a from entering the drain hole 1762b.

[0128] Figures 18A-18B Different arrangements of the expandable structure of the outer shaft of the ablation catheter according to embodiments are shown. Figures 18A-18B The outer shafts 1860 and 1860' of an ablation catheter (e.g., a cryoablation device) disposed in a body cavity BL are shown. 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 18AThe outer shaft 1860 is shown to have an expandable structure 1866, a drainage hole 1862a, and a drainage pouch 1867. As shown, when the outer shaft 1860 is positioned for ablation, the drainage hole 1862a is disposed in the body cavity BL. The expandable structure 1866 can be configured to expand to form a curved or concave structure, thereby defining a drainage pouch 1867 surrounding the drainage hole 1862a. In other words, the expandable structure 1866 can be formed into an umbrella-like shape to prevent debris from entering the drainage hole 1862a.

[0129] Figure 18B The diagram shows an outer shaft 1860' having an expandable structure 1866', a drainage hole 1862a', and a drainage pouch 1867'. As shown, the drainage hole 1862a' is disposed within the body cavity BL. The expandable structure 1866' partially covers the drainage hole 1862a' to form the drainage pouch 1867'. As shown, the drainage pouch 1867' expands to have a flat or substantially flat proximal side. This shape allows for a strong engagement with the wall at the entrance point of the body cavity BL, stabilizing the outer shaft 1860' within the body cavity. This shape ensures better retention of the outer shaft 1860' within the body cavity (e.g., the gallbladder).

[0130] Figures 19A-19B and Figure 20 An example view of an inner shaft 1970 according to various embodiments is shown, with a nozzle 1974 (e.g., a dispersion nozzle) located at the distal end of the inner shaft 1970. Figure 19A A perspective view of the inner axis from 1970 is shown, while Figure 19B A cross-sectional side view of the inner shaft 1970 is shown. 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.).

[0131] In some embodiments, the inner shaft 1970 may include a long conduit body having at least one delivery chamber 1972 carrying a liquid ablation medium 1922 and terminating at a dispersing nozzle 1974. In some embodiments, the dispersing nozzle 1974 is spherically shaped and includes a series of orifices 1975 extending from the outer diameter of the dispersing nozzle 1974 into the delivery chamber 1972. In some embodiments, the dispersing nozzle 1974 uses liquid nitrous oxide as the phase-change ablation medium, wherein the geometry of each orifice 1975 intersects with the outer surface of the dispersing nozzle 1974 (phase change interface 1975a). In other words, the liquid ablation medium 1922 transforms into a gaseous ablation medium 1924 near the outer surface of the dispersing nozzle 1974. In some embodiments, the orifices 1975 are small enough (e.g., approximately 0.0005”–0.004”) to withstand the high pressure required to keep the nitrous oxide in a liquid state until the refrigerant reaches the desired phase change interface 1975a. In some embodiments, the phase change interface 1975a is controlled by a pressure drop relative to the supply pressure of the liquid ablation medium 1922 (e.g., venting to the atmosphere). In some embodiments, a phase change occurs when liquid nitrous oxide is at near atmospheric pressure in the body cavity BL or other desired ablation region. In some embodiments, the phase change occurs at the wall of the body cavity BL; thus, the fluid ablation medium can be delivered into the body cavity BL and contact the wall of the body cavity BL, and the phase change occurs to a gaseous ablation medium. In this case, ablation can occur at the liquid-to-gas phase change interface. As shown, the orifice 1975 located proximal to the nozzle 1974 is tilted (e.g., tilted proximal relative to the longitudinal axis of the inner axis 1970) such that the gaseous ablation medium 1924 is dispensed at an angle toward the proximal region of the body cavity. The orifice 1975 located distal to the nozzle 1974 is tilted (e.g., tilted distal relative to the longitudinal axis of the inner axis 1970) such that the gaseous ablation medium 1924 is dispersed at an angle toward the distal region of the body cavity. This tilted configuration of the orifice 1975 can help enhance the distribution of the gas ablation medium 1924 throughout the body cavity.

[0132] Although shown as a spherical configuration, the geometry of the dispersing nozzle 1974 can be a cube, cone, cylinder, triangular prism, toroidal, helical, oval, or any other three-dimensional (3D) body with a structure sufficient to achieve delivery of the ablation medium. In some embodiments, the dispersing nozzle 1974 can be made of metal, polymer, ceramic, or other structural materials. In some embodiments, the maximum diameter of the distal geometry is small enough to slide through the access conduit. In some embodiments, the dispersing nozzle 1974 can expand (e.g., inflate) to achieve a shape larger than the diameter of the access conduit.

[0133] Figure 20This illustrates how the gas ablation medium 1924 is uniformly dispersed from the dispersion nozzle 1974 to the walls of the body cavity BL during use. In some embodiments, the inner shaft 1970 can move freely in the axial direction (i.e., along the axis shown by the straight line 1994) to adequately treat the walls of the body cavity BL with the gas ablation medium 1924 over the entire axial length of the body cavity BL.

[0134] Figure 21 An inner shaft 2170 according to an embodiment is shown, with an actuated nozzle 2174 located near the distal end of the inner shaft 2170. The inner shaft 2170 may include components 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, a gas ablation medium 2124 may be discharged via an orifice 2175 on the actuated nozzle 2174. In some embodiments, the inner shaft 2170 may include an inner shaft body 2170a and a linear track component 2170b. In some embodiments, the actuated nozzle 2174 may be attached to the linear track component 2170b. In some embodiments, the linear track component 2170b allows the actuated nozzle 2174 to move axially (i.e., along the straight line indicated by arrow 2194) in response to a driving force. In some embodiments, the linear track component 2170b allows the actuated nozzle 2174 to move non-linearly along its central axis in response to a driving force.

[0135] In some embodiments, the driving force is applied manually or automatically, for example, 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 mating 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, pulling force, torsional force, or squeezing force. In some embodiments, the driving force may be electromechanical, such as using electric current to drive an AC / DC motor or using an electromagnetic field.

[0136] In some embodiments, the linear track component 2170b may be fixed or approximately fixed to the linear track component 2170b by means of distal and proximal features. In some embodiments, the linear track component 2170b may be fixed or approximately fixed to the track by means of only the proximal feature. In some embodiments, the linear track component 2170b may be fixed or approximately fixed to the linear track component 2170b by means of only the distal feature. In some embodiments, the distal feature may be a cystic duct occlusion mechanism. In some embodiments, the proximal feature is a passage catheter lumen.

[0137] In some embodiments, according to various implementations, the actuated nozzle 2174 may be similar to Figure 19A , Figure 19B and Figure 20 The nozzle described herein. In some embodiments, the diameter of the orifice 2175 located on the actuated nozzle 2174 may vary in diameter relative to the position of the orifice. In some cases, the orifice 2175 may be geometrically tapered or have an increased / decreased diameter to deliver a constant mass flow rate of gaseous ablation medium 2124 and counteract the effects of pressure drop in the ablation supply chamber.

[0138] In some embodiments, the size, shape, and number of orifices 2175 originating from the supply chamber determine the spray pattern, spray velocity, and spray uniformity of the ablation medium. In some embodiments, some orifices 2175 are optimized to target nearby targets (e.g., 0-0.5 cm). In some embodiments, some orifices 2175 are optimized to target distant targets (e.g., greater than 0.5 cm).

[0139] In some embodiments, the actuated nozzle 2174 is rotatable along its central axis, thereby rotating the orifice 2175 relative to its orifice starting position. In some embodiments, the actuated nozzle 2174 is rotatable between 0 and 360 degrees or any range included therein. In some embodiments, the rotating actuated nozzle 2174 allows for a greater coverage area of ​​the ablation medium delivery.

[0140] In some embodiments, the actuated nozzle 2174 may be fixed relative to the distal end of the linear track member 2170b and may be moved by a driving force as the linear track member 2170b is displaced.

[0141] In some embodiments, the linear track component 2170b can be facilitated by the actuated nozzle 2174 to move concentrically or non-concentrically in a range of about 0-10 cm or any range included therein in response to a driving force.

[0142] Figure 22An inner shaft 2270 according to an embodiment is shown, with an actuated nozzle 2274 located near the distal end of the inner shaft 2270. The inner shaft 2270 may include components 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, a gas ablation medium 2224 may be discharged via an orifice 2275 on the actuated nozzle 2274. In some embodiments, the inner shaft 2270 may include an inner shaft body 2270a and a linear track component 2270b. In some embodiments, the actuated nozzle 2274 may be axially (i.e., along the straight line indicated by arrow 2294) along the linear track component 2270b in response to a driving force. In some embodiments, the inner shaft 2270, the actuated nozzle 2274, the orifice 2275, the inner shaft body 2270a, and the linear track component 2270b may be referenced. Figure 21 The inner shaft 2170, the actuated nozzle 2174, the hole 2175, the inner shaft body 2170a, and the linear track component 2170b are the same or substantially similar as described above.

[0143] The inner shaft 2270 also includes an occluder 2279. The occluder 2279 can be configured to block or close openings or cavity exits from the body cavity to nearby anatomical structures. For example, in the case where the body cavity is a gallbladder cavity, the occluder 2279 can be configured to block the cystic duct. The occluder 2279 can be coupled to and / or detached from the inner shaft 2270. In operation, the occluder 2279 can be coupled to the distal end of the inner shaft 2270. In some embodiments, the occluder 2279 can be coupled to a linear track component 2270b. The inner shaft 2270 can be navigated into the body cavity. The inner shaft 2270 can be manipulated to position the occluder 2279 at an opening exiting the body cavity (e.g., an oral cavity, such as the cystic duct). The occluder 2279 can then be detached from or ejected from the inner shaft 2270, thereby allowing the occluder 227 to be placed in the opening. Subsequently, the occluder 2729 can be secured in place, for example by the volume expansion of the occluder 2279, external threads, friction fit, adhesion, or other suitable securing mechanism. Further details of suitable occluders (e.g., plugs) are described in International Patent Application PCT / US2019 / 017112, which is incorporated herein by reference.

[0144] Figures 23-24An inner shaft 2370 is shown, with a nozzle 2374 in an arcuate design to increase the effective spray area of ​​the ablation medium. The inner shaft 2370 may include components 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 arcuate segment containing at least one orifice 2375 originating from the supply cavity. In some embodiments, the nozzle 2374 may be rotated along its central axis 2395 (i.e., along arrow 2396) to uniformly deliver the ablation medium to the surface of the body cavity. Figure 24 The inner shaft 2370 disposed in the body cavity BL is shown. As shown, the liquid ablation medium 2322 exits the nozzle 2374 through the orifice 2375 and undergoes a phase change to become the gaseous ablation medium 2324.

[0145] In at least one embodiment, the diameter of one or more orifices 2375 located on nozzle 2374 may vary relative to the distance of the orifice along nozzle 2374. In some cases, the orifice may taper or increase / decrease in diameter between the proximal and distal ends of nozzle 2374 to deliver a constant mass flow rate of ablation medium and counteract the effects of pressure drop in the supply chamber.

[0146] In some embodiments, the size, shape, and number of orifices 2375 originating from the supply chamber determine the spray pattern, spray velocity, and spray uniformity of the ablation medium. In some embodiments, the entire nozzle 2374 may rotate and / or slide longitudinally relative to its central axis 2395. In some embodiments, some orifices 2375 are optimized to target nearby targets. In some embodiments, some orifices 2375 are optimized to target distant targets.

[0147] Figures 25-26BAn ablation catheter 2550 with a retractable cryotherapy dispersion nozzle is shown according to an embodiment. The ablation catheter 2550 may include components 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, 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 and 2570b (collectively referred to as inner shaft 2570) may be coupled to the expandable structure 2576. In some embodiments, the inner shaft 2570 may be detached at its distal end. In other words, the ablation catheter 2550 may be without the expandable structure 2576. The inner shaft 2570 includes an orifice 2575 for delivering the ablation medium. In some embodiments, the inner shaft 2570a can move along a straight line as indicated by arrow 2591. In some embodiments, the inner shaft 2570 can rotate about a 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 shafts 2570 extend over a portion of the length of the expandable structure 2576. In some embodiments, the inner shafts 2570 can extend over the entire length of the expandable structure 2576, such that the individual inner shafts 2570 are joined together at the distal end of the ablation catheter 2550.

[0148] In some embodiments, at least one inner shaft 2570 forms an arc along a central axis 2595, the arc extending to its maximum radial dimension and converging toward the central axis 2595 to bring the orifice 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.

[0149] In some embodiments, the inner shaft 2577 may be spring-loaded and may contract relative to the nominal expansion diameter of the inner shaft 2570 to deliver through a smaller diameter delivery cavity.

[0150] Figures 26A-26B The inner shaft 2570 is shown in more detail. Figure 26A A sectional view of the inner shaft 2570 is shown, while Figure 26BA side view of the inner shaft 2570 is shown. In some embodiments, the ablation conduit 2550 may be configured to have a preformed core 2571 within the inner shaft 2570, which exerts a restoring force when subjected to mechanical stress, heat, current, or light. In some embodiments, the preformed core 2541 may be made of an alloy metal, such as nitinol or spring steel. In some embodiments, the preformed core 2571 may be made of a polymer, such as acrylonitrile-butadiene-styrene (ABS). In some embodiments, the inner shaft 2570 may be driven to an expanded configuration by a mechanical driving force (e.g., a rack and pinion system, a cable drive system, or an electromechanical control system). In some embodiments, the inner shaft 2570 may be actuated along a linear or radial path to increase the distribution of cryoprotectant from the inner shaft 2572.

[0151] Figures 27A-27B An inner shaft 2770 with a spiral nozzle 2774 is shown, the spiral nozzle having a plurality of holes 2775 originating from at least one continuous supply chamber 2772. Figure 27A A side view of the inner shaft 2770 is shown, while Figure 27B A cross-sectional view of the inner shaft 2770 is shown. The inner shaft 2770 may include components 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 exiting the inner shaft 2770 via orifice 2775. In some embodiments, the helical nozzle 2774 may be mounted around a structure for maintaining the helical configuration of the helical nozzle 2774. In some embodiments, the size, shape, and position of the orifice 2775 may vary depending on the desired injection pattern. In some embodiments, the orifice 2775 may “taper” or increase / decrease along the nozzle 2774 relative to the distance of the orifice along the nozzle 2774 to maintain the desired mass flow rate along each orifice 2775. In some embodiments, the above design allows for a minimum distance between the phase change surface and the supply chamber 2772, thereby minimizing the variability of the injection pattern of the individual orifices.

[0152] Figure 28An ablation catheter 2850 with an outer shaft 2860 and an inner shaft 2870 is shown. The ablation catheter 2850 may include components 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.). Ablation medium 2826 can be drained from the body cavity through the outer shaft 2860. In some embodiments, a heating coil 2882 may be deployed around the outer side of the outer shaft 2860. In some embodiments, a heating coil 2884 may be deployed around the outer side of the inner shaft 2870. According to various embodiments of this disclosure, the cryoablation device of this 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 colorless, transparent liquid at ambient temperature and high pressure (>650 psi), but it undergoes a phase change from liquid to gas when subjected to a sufficient pressure drop, resulting in an endothermic reaction with refrigerant properties. Furthermore, while liquid nitrous oxide offers unique refrigerant properties well-suited for cryoablation applications, it can pose safety concerns because the gas volume increases by 600 times or more during the phase change, creating a pressure buildup source within the cavity. To counteract this risk, the cryoablation apparatus of this disclosure can be designed with a passive venting management system to expel the refrigerant gas during ablation. For example, the systems, apparatus, and methods described herein can allow the ablation medium to flow through a concentric cavity space between the inner axis (e.g., inner axis 2870) and outer axis (e.g., outer axis 2860) of the ablation catheter. Pressure-driven flow can cause the ablation medium to enter the cavity space between the inner and outer axes and exit from an outlet at the proximal end of the ablation catheter.

[0153] Furthermore, the melting point of liquid nitrous oxide is within a few degrees Celsius of its boiling point, meaning there is a small margin of error between the gas and solid phases. If the pressure and temperature within the outer and inner shafts are not properly controlled, this can lead to the accumulation of solid nitrous oxide ice. In some cases, the accumulation of solid nitrous oxide ice, along with residual fluid within the gallbladder, can cause blockage of the drain cavity. This can lead to pressure buildup within the gallbladder cavity, a safety concern. To directly combat icing in the drain cavity, heating coils 2882 and 2884 can be used to melt or evaporate the ice buildup.

[0154] Figures 29A-29BA view of an ablation catheter 2950 with a catheter heating system according to various embodiments of the present disclosure is shown. The catheter heating system is configured to counteract ice buildup in a venting cavity. The ablation catheter 2950 may include components 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 (e.g., arranged around) around the outer side of the outer shaft 2960. In some embodiments, a heating coil 2984 may be wound (e.g., arranged around) around the outer side of the inner shaft 2970. In particular, Figure 29A An exemplary view of a conduit heating system is shown, which is designed to thaw the refrigerant ice buildup within the cavity. Figure 29A The conduit heating system includes a multi-surface heating system, wherein the outer surface of the outer shaft 2960 and the outer surface of the inner shaft 2970 are heated to allow ice to accumulate and evaporate and to maintain the unobstructed annular space between the two shafts. Figure 29B An ablation conduit 2950' with a single-surface heating system is shown, wherein the outer surface of the outer shaft 2960 is heated by a heating coil 2982 to cause ice buildup to evaporate and to keep the annular space between the inner shaft 2970 and the outer shaft 2960 open.

[0155] In some embodiments, heating coils 2982, 2984 may include a resistance heating element, such as a resistance wire, which converts electrical energy into heat to conduct heat to a nearby object. In some embodiments, the resistance heating wire is wound around the outer periphery of the outer shaft 2960. In some embodiments, the resistance heating wire is wound around the inner periphery of the outer shaft 2960. In at least one embodiment, the resistance heating wire is embedded within the wall material of the outer shaft 2960.

[0156] In some embodiments, the resistance heating wire is wound into a helical coil configuration with a pitch of approximately 0-1”, including all subranges and values ​​therebetween. In some embodiments, the resistance heating wire is wound into a helical coil configuration with a fixed pitch. In another embodiment, the resistance heating wire is wound into a helical coil configuration with a variable or “gradually fixed” pitch, such that a more compact coil pitch portion is closer to the distal end of the outer shaft 2960. In the above configurations, the more compact pitch portion achieves a greater heat density compared to a looser pitch portion, thereby heating the object surrounding the more compact pitch portion to a greater extent. This allows the heating energy of the coil to be localized and minimizes conflicting effects on treatment.

[0157] 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 high thermal conductivity material may cover part and 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 cavity may have a metal section near the distal end of the outer shaft 2960 to concentrate the effect of the heating coil 2982. In some embodiments, an insulating material may be used to electrically and / or thermally insulate the heating coil 2982 relative to surrounding objects.

[0158] Figures 30A-33 The ablation catheter 3050 is shown at various stages of assembly. Figures 30A-30B An outer shaft 3060 and an expander 3068 according to an embodiment are shown. The ablation catheter 3250 may include components 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 The outer shaft 3060 is shown separated from the expander 3068. Figure 30B The expander 3068 is shown secured within the outer shaft 3060. In some embodiments, the expander 3068 can be used to securely assemble the outer shaft around a guidewire during insertion into the body cavity, as referenced above. Figures 6A-6B In some embodiments, the expander 3068 can be threaded into the outer shaft 3060.

[0159] Figures 31A-31B An outer shaft 3060 according to an embodiment is shown, having a non-deployed state. Figure 31A ) and unfolded state ( Figure 31B The expandable structure 3066 is shown in the figure. The handle assembly 3002 includes a button 3002a and a handle 3002b. In some embodiments, pressing the button 3002a unlocks a mechanism for controlling the deployment of the expandable structure 3066. After the mechanism is unlocked, pulling the handle 3002b actuates the expandable structure 3066 to the deployed state. Once the expandable structure 3066 is in the deployed state, the button 3002a can be released to lock the expandable structure 3066 in the deployed state.

[0160] Figures 32A-32CThis is an illustration of an inner shaft 3070 having 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 orifices 3075a, 3075b, and 3075c (collectively referred to as orifices 3075). As shown, orifice 3075a in a proximal position is tilted such that the ablation medium exits the nozzle 3074 in a slightly proximal direction. As shown, orifice 3075c in a distal position is tilted such that the ablation medium exits the nozzle 3074 in a slightly distal direction. References above. Figures 19A-19B The advantages of this inclined structure of hole 3075 are described in hole 1975.

[0161] As shown in the figure Figure 32A Details of the expandable structure 3276 are shown, while Figure 32B The actuator handle 3004a is shown positioned such that the expandable structure 3076 is in the deployed state. Figure 32C The actuator handle 3004a is positioned such that the expandable structure 3076 is in an undeployed state. In some embodiments, the actuator handle 3004a can be fixedly positioned by magnets. For example, the actuator handle assembly 3004 may include magnets on its proximal and distal sides, and the actuator handle 3004a may include magnets that attract the actuator handle 3004a towards the proximal and distal sides of the actuator handle assembly 3004. In this case, the actuator handle 3004a may be more strongly attracted towards the side of the actuator handle assembly 3004 that is closer to it.

[0162] Figure 33 An assembled ablation catheter 3050 is shown, with an inner shaft 3070 disposed within and / or connected to an outer shaft 3060. As shown, the expandable structure 3066 is in an undeployed state, while the expandable structure 3076 is in an deployed state. As shown, an actuator handle 3004a is connected to an actuator handle assembly 3004. In some embodiments, the actuator handle 3004a may be connected to the actuator handle assembly 3004. In some embodiments, a button 3002a may be disposed in the handle assembly 3002. In some embodiments, the button 3002a may be connected to the handle assembly 3002. In some embodiments, a handle 3002b may be disposed in the handle assembly 3002. In some embodiments, the handle 3002b may be connected to the handle assembly 3002.

[0163] Figures 34A-34B An ablation system 3150 according to an embodiment is shown, having a handle assembly including a plurality of handles. Figure 34A The ablation system 3150 is shown, while Figure 34BThe spray pattern of the nozzle of the ablation system 3150 is shown. As shown, the ablation system 3150 includes an outer shaft 3160, an expandable structure 3166 (e.g., a holding mechanism), an inner shaft 3170, a nozzle 3174, an expandable structure 3176 (e.g., an expandable body or expandable cage), an outer shaft (guide or access sheath) handle 3180, an outer shaft (guide or access sheath) handle button 3182, a venting chamber port 3184, a venting 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 referenced above. Figure 33 The outer shaft 3060, expandable structure 3066, inner shaft 3070, nozzle 3074, and expandable structure 3076 are the same or substantially similar. Therefore, certain aspects of the outer shaft 3160, expandable structure 3166, inner shaft 3170, nozzle 3174, and expandable structure 3176 are not described in more detail here.

[0164] In some embodiments, a user can press the outer shaft handle button 3182 to advance the outer bushing or sheath 3161 of the outer shaft 3160 distally. Advancement of the outer bushing 3161 relative to the front end 3163 of the outer shaft 3160 can cause the expandable structure 3166 to expand (e.g., change to an expandable configuration) so that the expandable structure 3166 can hold the front end 3163 in position within the gallbladder. In some embodiments, the outer shaft handle 3180 may include a locking mechanism (not shown) such that the bushing 3161 of the outer shaft 3160 can be locked in position relative to the front end 3163. A drain port 3184 is in fluid communication with the interior of the outer shaft 3160. Cryoablation medium can flow through the interior of the outer shaft 3160 and exit the ablation system 3150 via the drain port 3184. In some embodiments, the drain port 3184 may be connected to a hose and / or vacuum line so that the cryoablation medium can be drained from the outer shaft 3160 and handle assembly 3180 as needed.

[0165] The vent chamber collar 3185 is fitted around the outer side of the inner shaft 3170. In some embodiments, the vent chamber collar 3185 may form a seal with the inner shaft 3170, such that the vent chamber collar 3185 can prevent leakage of liquids and / or gases (e.g., ablative media) or further flow along the inner shaft 3175.

[0166] The inner shaft handle 3190 includes an inner shaft handle button 3192. Pressing the inner shaft handle button 3192 advances a portion of the inner shaft 3170 relative to the inner handle assembly 3190. In some embodiments, pressing the inner shaft handle button 3192 advances one or more outer layers of the inner shaft 3170 relative to the inner ablation cavity of the inner shaft 3170. In some embodiments, the inner handle assembly 3190 may include a locking mechanism (not shown) such that the advanced portion of the inner handle assembly 3180 can be locked in position relative to other portions of the inner shaft 3170. Movement of this portion of the inner shaft 3170 can be used to deploy the expandable structure 3176.

[0167] A 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, cavities, etc., and an external source. Alternatively, in some embodiments, the collar 3194 may be omitted, and a connection may be formed between one or more components of the inner shaft 3170 and the external source via other portions 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 may provide heat to the inner shaft 3170 via an internal heat source to prevent blockage due to freezing. A freezing ablation medium can cause material passing through the inner shaft 3170 and / or the outer shaft 3160 to freeze, thereby blocking the path through the inner shaft 3170. By initiating heating (e.g., via an external heat source coupled to one or more heating wires extending along the inner shaft 3170), heat applied to the inner shaft 3172 can melt the frozen material, thereby allowing flow through the inner shaft 3171 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 heated sheath plug 3196 for coupling to an external heat source.

[0168] Although Figure 34A and Figure 34B Not shown in detail, but the inner shaft 3170 defines a cavity that delivers an ablation medium (e.g., a cryoablation medium) to the opening of the nozzle 3174. In some embodiments, the nozzle 3174 may be rotatable to adjust the position of the nozzle 3174 opening and the position to which the ablation medium is delivered. In some embodiments, the nozzle 3174 may be actuated independently of the expandable structure 3176, for example, moved relative to the expandable structure 3174 to adjust the position of the nozzle 3174 opening and the position to which the ablation medium is delivered.

[0169] In some embodiments, a pressure sensing cavity (not shown) may be disposed within one or more of the outer shaft 3160 and / or the inner shaft 3170. In some embodiments, the pressure sensing cavity may be orally coupled to a pressure sensor (not shown) at the proximal end of the ablation system 3150. In some embodiments, the pressure sensing cavity may terminate at an orifice disposed in the gallbladder cavity, while the pressure sensor is located outside the gallbladder cavity. In other words, the pressure sensing cavity may orally couple the interior of the gallbladder cavity to the pressure sensor. In some embodiments, the pressure sensing cavity may be disposed around the inner shaft 3170. In some embodiments, the pressure sensing cavity may be disposed around the outer shaft 3160. In some embodiments, the pressure sensing cavity may be disposed within the inner shaft 3170. In some embodiments, the ablation system 3150 may include a plurality of pressure sensing cavities.

[0170] Figure 34B A jetting configuration of the ablation system 3150 according to an embodiment is shown. As described above, the ablation system 3150 can be used to deliver an ablation medium, such as a cryoablation medium, via an opening in a nozzle 3174. In some embodiments, the medium can be delivered as a fluid. In some embodiments, the medium can be delivered as a gas. In some embodiments, the medium can be delivered as a fluid that is converted into a gas at points along the length of the ablation system 3150 and / or within the gallbladder cavity. Figure 34B As schematically shown, the ablation medium exiting the ablation conduit 3150 through the opening of the nozzle 3174 can be sprayed in a conical pattern. In other words, the ablation medium can be delivered through multiple spray zones that may or may not overlap.

[0171] Figures 35A-35B More detailed views of the outer shaft 3260 and outer shaft handle 3280 of the ablation system according to an embodiment are provided. Figure 35A A side view of the outer shaft 3260 and the outer shaft handle 3280 is shown. Figure 35B A cross-sectional view of the outer shaft 3260 and the outer shaft handle 3280 is shown. 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 a vent port 3284. In some embodiments, the outer shaft 3260, the expandable structure 3266, the outer shaft handle 3280, the outer shaft handle button 3282, and the vent port 3284 may be associated with the components referenced above. Figures 34A-34BThe outer shaft 3160, expandable structure 3166, outer shaft handle 3180, outer shaft handle button 3182, and empty chamber port 3184 are identical or substantially similar. Therefore, certain aspects of the outer shaft 3260, expandable structure 3266, outer shaft handle 3280, outer shaft handle button 3282, and empty chamber port 3284 are not described in further detail here. The outer shaft 3260 may define a cavity 3265, which may receive an inner shaft (e.g., the inner shaft of an ablation catheter, such as any of those described herein).

[0172] The handle 3280 may have a button 3282 that is movable distally (e.g., sliding) to advance the outer bushing 3261 of the outer shaft 3260 relative to the front end 3263 of the outer shaft 3260. This advancement can be used to deploy the expandable structure 3266, for example, to change the expandable structure 3266 from a contracted state extending generally parallel to the longitudinal axis of the outer shaft 3260 to an expanded state that bends 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 cavity. In other words, the expandable structure 3266 may be configured such that its diameter in the expanded state is larger than the opening through which the distal end of the outer shaft 3260 was previously used to enter the gallbladder cavity. Thus, the expanded structure 3266 in the expanded state can rest against the gallbladder wall near the opening to hold the distal end of the outer shaft 3260 within the gallbladder cavity. The button 3282 may be locked by a spring 3281. Button 3282 can be pressed to unlock button 3282, and then slid to advance bushing 3161. Once the button has slid to its maximum distance (e.g., along the track), button 3282 can be locked again by slot 3283 and spring 3282 that presses button 3282 into the slot. Although the button is described as an example of an actuator (e.g., actuator 801a), it is understood that any type of actuation mechanism can be used to advance and / or retract the various parts of outer shaft 3260.

[0173] Figure 36 A more detailed view of an ablation catheter 3350 according to an embodiment of an ablation system is provided. 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 with 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, inner shaft handle button 3392, wire end collar 3394, and inner shaft plug 3396 may be associated with the components referenced above. Figures 34A-34BThe inner shaft 3170, nozzle 3174, expandable structure 3176, inner shaft handle 3190, inner shaft handle button 3192, thread end collar 3194, and inner shaft plug 3196 are the same or substantially similar. Therefore, certain aspects of the inner shaft 3370, nozzle 3374, expandable structure 3376, inner shaft handle 3390, inner shaft handle button 3392, thread end collar 3394, and inner shaft plug 3396 will not be described in more detail here.

[0174] In some embodiments, the distal end of the ablation catheter 3350 can be inserted through the lumen of an external shaft or guide, for example, as... Figure 34A As shown. In order to Figure 36 For illustrative purposes, the inner shaft 3370 is shown as having a discontinuity to indicate that the length of the inner shaft is longer than... Figure 36 The length is shown. The expandable structure 3376 can transition between an unexpanded configuration and an expanded configuration. When the expandable structure 3376 is in the unexpanded configuration, it can have an elongated member extending generally parallel to the longitudinal axis of the conduit 3350 (particularly the longitudinal axis of the shaft 3370). In this configuration, the distal portion of the shaft 3370 (including the nozzle 3374 and the expandable structure 3376) can be inserted through the lumen of the outer shaft or guide, for example, into the gallbladder cavity. After the distal portion of the shaft 3370 has been inserted beyond the distal end of the outer shaft, the expandable structure 3376 can transition to an expanded configuration in which the elongated member of the expandable structure 3376 extends outward from the longitudinal axis (e.g., bends radially outward).

[0175] Figures 37A-37B This is a detailed view of the distal portion of an ablation catheter with a heating element according to an embodiment. Figure 37A A cross-sectional view of the distal portion is shown, revealing the internal parts, while Figure 37B This is an external view of the distal portion. As shown, the distal portion of the ablation catheter includes a nozzle 3474 (the nozzle 3474 includes a plurality of nozzle openings or windows 3475), an expandable structure 3476 (e.g., an expandable cage), a hub 3479, and a heated sheath 3491. The heated sheath 3491 includes an outer sheath 3492, an inner liner 3493, a sensor wire or lead implemented as a thermocouple wire 3495, a heating element implemented as a heating wire 3497, and an exhaust port or vent 3498. In some embodiments, the windows 3475 may be as described above. Figure 11 The window 1175 described herein is the same as or substantially similar to other nozzle openings described herein. In some embodiments, the expandable structure 3476 may be the same as or substantially similar to other expandable structures described herein, including, for example, those referenced above. Figure 9 The expandable structure 876 and / or the above references Figure 34AThe expandable structure 3176 is described above. Therefore, certain aspects of the window 3475 and the expandable structure 3476 will not be described in more detail here.

[0176] The expandable structure 3476 may be formed of a plurality of elongated members. The plurality of elongated members may transition between an unexpanded configuration in which the elongated members extend generally parallel to the longitudinal axis of the conduit and an expanded configuration in which the elongated members extend outward from the longitudinal axis (e.g., bend radially outward). In some embodiments, the proximal end of each elongated member may be coupled to the distal end of a heated sheath 3491, and the distal end of each elongated member may be coupled to a hub 3479. In such embodiments, the expansion of the elongated members can be achieved by moving either the hub 3479 or the heated sheath 3491 relative to the other. For example, the heated sheath 3491 may advance distally toward the hub to cause the elongated members to extend outward (e.g., bend radially outward) and expand the expandable structure 3476.

[0177] The outer sheath 3492 and inner liner 3493 of the heated sheath 3491 insulate the thermocouple wire 3495 and the heating wire 3497. In some embodiments, the outer sheath 3492 and / or the inner liner 3493 may be extruded onto the wires 3495 and 3497. The outer sheath 3492 is located outside the thermocouple wire 3495 and the heating wire 3497, while the inner liner 3493 is located inside the thermocouple wire 3495 and the heating wire 3497. In some embodiments, the thermocouple wire 3495 and the heating wire 3497 may be wound together. In some embodiments, the thermocouple wire 3495 may be directly positioned below the heating wire 3497.

[0178] Vent 3498 is configured to connect the pressure sensing chamber 3499 in communication with the outside of the catheter. Thus, vent 3498 can be configured to connect the pressure sensing chamber 3499 to the gallbladder cavity, allowing measurement of the intracavitary pressure via the pressure sensing chamber 3499. The pressure sensing chamber 3499 may be an annular space disposed between an inner axis defining a cavity for delivering the ablation medium and a heated sheath 3491. As shown, the catheter includes two vents 3498. Including multiple vents 3498 allows the connection between the pressure sensing chamber 3499 and the body cavity to be maintained even if one vent is blocked. In some embodiments, the catheter may include 3, 4, 5, 6, 7, 8, 9, 10, or more than about 10 vents 3498.

[0179] Thermocouple wire 3495 can be configured to connect (or operatively connect to) 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. The temperature sensor can be located near the vent 3498 and / or outside the ablation catheter to measure the temperature near the distal portion of the ablation catheter.

[0180] Figures 38A-38E The ablation catheter assembly 3570 according to an embodiment is shown, along with its details. Figure 38A The complete catheter assembly 3570 is shown, while Figure 38B As shown Figure 38A Details of the marked part B, Figure 38C It shows Figure 38A Details of the marked part C, Figure 38D As shown Figure 38A Details of the marked part D, Figure 38E As shown Figure 38E Details of the marked portion E. As shown, the conduit assembly 3570 includes a nozzle 3574, an expansion structure 3576, an outer sleeve 3592, an inner 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, expansion structure 3576, outer sleeve 3591, inner liner 3593, thermocouple wire 3595, heating wire 3597, wire end collar 3594, and vent 3598 may be the same as or substantially similar to similar components in other embodiments herein, including, for example, those referenced above. Figures 34A-34B The nozzle 3174, expandable structure 3176, wire end collar 3194, and inner shaft plug 3196 and / or the above references Figures 37A-37B The nozzle 3474, expansion structure 3476, outer jacket 3492, inner liner 3493, thermocouple wire 3495, heating wire 3497, and vent 3498 are described. Therefore, certain aspects of the nozzle 3474, expansion structure 3576, outer jacket 3591, inner liner 3593, wire end collar 3594, thermocouple wire 3595, heating wire 3597, and vent 3598 are not described in further detail here. The heating wire 3597 and / or thermocouple wire 3595 may be wound around a portion of the sheath, shaft, and / or the annular space between the sheath and shaft to heat these portions.

[0181] In some embodiments, the thermocouple wire 3595 and / or the heating wire 3597 may be coupled to one or more connections in 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), for example, to monitor temperature, pressure, and / or other conditions and / or control the delivery and / or evacuation of the ablation medium. The heating wire 3597 may be configured to be coupled via the collar 3595 to an external heat source, for example, to receive energy from the external heat source and generate heat for heating various portions of the ablation catheter. In some embodiments, as referenced Figure 34AAs described, the wire end collar 3595 can be coupled to a proximal handle for manipulating the ablation catheter. In some embodiments, the collar 3595 can be omitted, and the thermocouple wire 3595 and / or heating wire 3597 can be configured to be coupled to the handle (including any built-in components, such as a built-in processor and / or microcontroller, power supply, etc.).

[0182] like Figure 38D and Figure 38E As shown, the thermocouple wire 3595 and the heating wire 3597 are divided into a straight section 3570a, a coarse-pitch wound section 3570b, and a fine-pitch wound section 3570c. A tighter pitch (i.e., a finer-pitch wound heating wire) in the heating wire 3597 can increase the energy density in a specific region. In some embodiments, the fine-pitch wound section 3570c can 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 therein. In some embodiments, the fine-pitch wound section 3570c can cover about 5%, about 10%, about 15%, about 20%, about 25%, or about 30% of the total length of the entire conduit assembly 3570, including all values ​​and ranges therein. In some embodiments, the transition from the coarse-pitch winding section 3570b to the fine-pitch winding section 3570c may be gradual, or the spacing between the thermocouple wire 3595 and the heating wire 3597 may vary in a gradient. In some embodiments, the transition from the coarse-pitch winding section 3570b to the fine-pitch winding section 3570c may be abrupt.

[0183] In some embodiments, adjacent turns of the wire in the coarse-pitch winding section may be spaced apart by 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 therein. In some embodiments, the wires in the fine-pitch winding section 3570c may be spaced apart by 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 therein.

[0184] The power supplied to thermocouple wire 3595 and heating wire 3597 can be a function of the operating voltage and wire resistance. The operating voltage and wire resistance can be adjusted to achieve a desired energy density over the cross-sectional area of ​​the heating wire, thereby determining the heat flux generated by the heating wire 3597 and the temperature response to cooling.

[0185] Although Figure 38A-Figure 38A A single heating element is shown, but it will be understood that any number of heating elements can be used. For example, multiple heating wires extending along different portions of the ablation catheter (e.g., sheath, shaft, or different portions of the annular space between them). In some embodiments, multiple heating wires can be selectively activated, for example 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 can be, for example, a temperature along the entire length that deviates from an average or median temperature by no more than 10%. In some embodiments, one or more sensors (e.g., coupled to thermocouple wires) can be positioned at one or more locations along the shaft length and used to measure the temperature at various points along the shaft length. These measured temperatures can be received at the processor and used to control one or more heating elements (e.g., selectively activate or regulate the amount of power delivered to the heating elements).

[0186] In some embodiments, the thermocouple wire 3595 may be coupled to a temperature sensor located near the distal end of the ablation catheter. The thermocouple wire 3595 can transmit the temperature signal to a processor (e.g., an integrated processor and / or an external processor) for temperature-based monitoring and / or control of ablation delivery and / or evacuation. In some embodiments, the ablation apparatus and / or system described herein may be used in conjunction with an external temperature probe. Figure 39This illustration shows the placement of a temperature sensor (e.g., a probe or needle-shaped temperature sensor) along the entire length of the gallbladder according to an embodiment. As shown, the gallbladder includes a neck region, a body region, and a fundus region. A temperature probe can be placed on the outer side of the gallbladder wall to monitor how temperature changes along the length of the gallbladder, for example, from the neck to the fundus. The placement of the temperature probe can confirm whether temperature changes have diffused from the interior to the exterior of the gallbladder, which can help determine the effectiveness of ablation. In other words, the temperature probe can also help confirm whether cryoablation has occurred, i.e., whether the gallbladder wall has been ablated. In some embodiments, a first temperature probe T1 can be placed at the distal end of the gallbladder. Measuring the temperature at the fundus of the gallbladder can confirm whether the cryoablation medium has penetrated to the fundus. In some embodiments, a temperature probe can be placed at a point between the fundus and the neck of the gallbladder (e.g., temperature probe T2). In some embodiments, a temperature probe can be placed in the gallbladder neck region near the opening of the gallbladder to the cystic duct (e.g., temperature probe T3). In some embodiments, an additional temperature probe (e.g., temperature probe T4) can be placed in the gallbladder neck region. In some embodiments, an additional temperature probe (e.g., temperature probe T5) may be placed at a point between the gallbladder fundus and the gallbladder neck. In some embodiments, a combination of at least three temperature sensors (e.g., one placed in the gallbladder neck, one in the gallbladder body, and one in the gallbladder fundus) may be used to measure the temperature of the tissue wall along the length of the gallbladder. In some embodiments, depending on the temperature measurement results, the position of the nozzle of the ablation catheter may be adjusted, for example, translated distally and / or proximally to a target area of ​​tissue with a higher temperature. In this way, 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.

[0187] Figures 40A-40D This is an illustration of an ablation system implemented as a cryoablation device 4000. The cryoablation device 4000 can be configured to ablate or defunctionalize the gallbladder cavity. The cryoablation device 4000 may include components that are structurally and / or functionally similar to other ablation systems and components described herein. Figure 40A A side view schematic diagram of the cryoablation device 4000 is shown, while Figures 40B-40DCross-sectional views of various configurations of the cavities of the inner and outer shafts of the cryoablation device 4000 are shown. The cryoablation device 4000 includes a control unit 4010, an outer shaft 4060, an inner shaft 4070, and a pressure sensing cavity 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 in the gallbladder cavity during deployment of the ablation medium. The control unit 4010 is in circulation connected to an ablation medium supply source 4020. In some embodiments, the ablation medium can flow from the ablation medium supply source through the solenoid valve 4021 to the inner shaft 4070.

[0188] In some embodiments, the pressure sensing cavity 4076 may terminate at an orifice O within the gallbladder cavity, while the pressure sensor 4015 is located outside the gallbladder cavity. In other words, the pressure sensing cavity 4076 can be oriented in a flow-through manner to the interior of the gallbladder cavity and the pressure sensor 4015. The pressure sensor 4015 may be located at and / or operatively coupled to the control unit 4010. In this configuration, the pressure sensor 4015 can measure the pressure inside the gallbladder cavity even when located outside the gallbladder cavity.

[0189] According to one of several different arrangements, the pressure sensing cavity 4076 may be disposed around the inner shaft 4070 or the outer shaft 4060 of the conduit system. In some embodiments, the pressure sensing cavity 4076 may have a circular cross-section and be disposed on one side of the shaft. For example, in one embodiment, the pressure sensing cavity 4076 may be attached to the inner shaft 4070, such as... Figure 40B As shown. Alternatively, as Figure 40C As shown, the pressure sensing cavity 4076' can be disposed or confined within the inner shaft 4070. Alternatively, the pressure sensing cavity 4076' can be disposed outside the outer shaft 4060, as shown... Figure 40D As shown. Alternatively, the pressure sensing cavity can be integrated into the wall of the inner or outer shaft, connected to both the inner and outer shafts, etc. In some embodiments, the pressure sensing cavity 4076 can be an annular space formed between the inner and outer concentric sheaths and / or shaft of the inner shaft 4070, for example, referring to... Figure 37A As described, pressure can be released from the gallbladder cavity via an exhaust path P that passes through the outer shaft 4060 and reaches the exterior of the cryoablation device 4000. The pressure sensing cavity may also be referred to as a pressure chamber or sensor chamber.

[0190] Although Figures 40A-40DUnless explicitly identified, the cryoablation device 4000 includes lumens defined by an inner shaft 4070 and an outer shaft 4060 for delivering and / or draining ablation media from the gallbladder cavity. For example, similar to other catheter systems described herein, the inner shaft 4070 may define a lumen for delivering cryoablation media into the gallbladder cavity, for example, via one or more nozzle openings. The outer shaft 4060 may define a lumen for draining cryoablation media from the gallbladder cavity.

[0191] The systems, apparatus, and methods described herein enable a passive venting channel and refrigerant control system to safely vent refrigerant gas from the gallbladder cavity while ensuring safe operating conditions. During refrigerant delivery, the cryoablation medium (e.g., nitrous oxide) expands and vents to the external environment (e.g., atmosphere) via an annular space between the inner surface of the outer shaft 4060 and the outer surface of the inner shaft 4070. Resistance in the venting channel causes the gallbladder cavity to expand, allowing the tissue within the gallbladder cavity to be exposed to the cryoablation medium. A solenoid valve 4021 can be configured to control or regulate the delivery of the ablation medium (e.g., from an ablation medium supply source 4020) to the gallbladder cavity. For example, a control unit 4010 can control the solenoid valve 4021 from an open state, allowing the delivery of the ablation medium to the gallbladder cavity, to a closed state, preventing the delivery of the ablation medium to the gallbladder cavity. While a solenoid valve is provided herein as an example valve, it will be understood that other types of valves, including mechanically actuated valves, magnetically actuated valves, etc., can also be used to control the delivery of the ablation medium to the gallbladder cavity. Control unit 4010, pressure sensor 4015, and solenoid valve 4021 can establish a closed-loop pressure feedback system to maintain a safe operating pressure within the gallbladder cavity. Specifically, in response to detecting that the pressure within the gallbladder cavity exceeds a predetermined maximum threshold, control unit 4010 can control solenoid valve 4021 to terminate the supply of ablation medium to the gallbladder cavity and / or drain the ablation medium from the gallbladder cavity to the external environment via outer shaft 4060. Additionally or alternatively, in response to detecting that the pressure within the gallbladder cavity is less than a predetermined minimum threshold, control unit 4010 can control ablation medium supply source 4020 and / or solenoid valve 4021 to provide additional ablation medium to the gallbladder cavity, thereby allowing the gallbladder to fully expand for cryoablation.

[0192] It should be understood that this disclosure may include any and all of the following examples.

[0193] Example 1: A cryoablation catheter includes: a catheter body including at least one cryoprotectant delivery chamber for delivering cryoprotectant to a tissue region; and a nozzle disposed at a distal end of the at least one cryoprotectant delivery chamber, the nozzle including a plurality of orifices extending between the at least one cryoprotectant delivery chamber and an outer surface of the nozzle, and the size and shape of each of the plurality of orifices are determined to uniformly disperse cryoprotectant at a constant mass flow rate onto the tissue region via each of the plurality of orifices.

[0194] Example 2: The cryoablation catheter according to Example 1, wherein the cryoprotectant includes nitrous oxide.

[0195] Example 3: According to the cryoablation catheter described in Example 1, the nozzle further includes a phase change interface located at the junction of the plurality of orifices and the outer surface of the nozzle.

[0196] Example 4: The cryoablation catheter according to Example 3, wherein the size and shape of the plurality of orifices are determined such that the cryopropellant remains liquid until the cryopropellant reaches the phase change interface.

[0197] Example 5: The cryoablation catheter according to Example 3, wherein the diameter of each of the plurality of orifices is in the range of about 0.0005 inches to 0.004 inches.

[0198] Example 6: The cryoablation catheter according to Example 3, wherein the cryoprotectant undergoes a phase change when exposed to near atmospheric pressure associated with the target ablation area.

[0199] Example 7: The cryoablation catheter according to Example 3, wherein the phase change interface is controlled by a pressure drop relative to the cryo-refrigerant supply pressure.

[0200] Example 8: According to the cryoablation catheter described in Example 1, the nozzle geometry is one of a sphere, cube, cone, cylinder, triangular prism, toroidal body, spiral or oval shape.

[0201] Example 9: The cryoablation catheter according to Example 1, wherein the nozzle geometry is a sphere, and the plurality of orifices are arranged along the sphere of the nozzle, each of the plurality of orifices extending from the outer diameter of the sphere to the at least one cryoprotectant delivery chamber.

[0202] Example 10: The cryoablation catheter according to Example 1, wherein the size of the nozzle is determined to allow the nozzle to slide through the access catheter.

[0203] Example 11: The cryoablation catheter according to Example 1, wherein the nozzle is inflatable.

[0204] Example 12: The cryoablation catheter according to Example 1, wherein the nozzle includes a linear track component and a nozzle geometry, the nozzle geometry being connected to the linear track component, and the plurality of orifices being arranged along the outer surface of the nozzle geometry.

[0205] Example 13: According to the cryoablation catheter described in Example 12, the linear track component can help the nozzle geometry to move at least one of concentric and non-concentric movement between about 0-10 cm in response to the driving force.

[0206] Example 14: The cryoablation catheter according to Example 12, wherein the nozzle geometry includes one of a sphere, cube, cone, cylinder, triangular prism, toroidal body, spiral or oval shape.

[0207] Example 15: The cryoablation catheter according to Example 12, wherein the nozzle geometry includes a sphere, the 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 the at least one cryoprotectant delivery chamber.

[0208] Example 16: The cryoablation catheter according to Example 12, wherein the nozzle geometry is fixed relative to the distal end of the linear track component.

[0209] Example 17: The cryoablation catheter according to Example 12, wherein the nozzle geometry is capable of moving in response to the displacement of the linear track component caused by the driving force.

[0210] Example 18: The cryoablation catheter according to Example 12, wherein the nozzle geometry is movable along at least one axis of the linear track component.

[0211] Example 19: The cryoablation catheter according to Example 12, wherein the nozzle geometry is capable of moving along a linear track component in response to a driving force.

[0212] Example 20: The cryoablation catheter according to Example 19, wherein the driving force is automatic, and the cryoablation catheter further includes a control unit configured to activate the driving force.

[0213] 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 paired gear drive system, a gear and rack system, a screw drive mechanism, a pneumatic actuator system, an electromagnetic coil system, a hydraulic actuator system, or an electromechanical system.

[0214] Example 22: The cryoablation catheter according to Example 12, wherein the linear track component is fixed by at least one of the following: a proximal component of the linear track component, a distal component of the linear track component.

[0215] Example 23: The cryoablation catheter according to Example 1, wherein the diameter of each of the plurality of orifices in the nozzle is at least partially different from each other based on the position of each orifice on the nozzle.

[0216] Example 24: The cryoablation catheter according to Example 1, wherein the diameter tapers along the length of each of the plurality of orifices.

[0217] Example 25: The cryoablation catheter according to Example 1, wherein the shape and size of the orifice of at least a subset are determined to target a nearby target.

[0218] Example 26: The cryoablation catheter according to Example 1, wherein the shape and size of the orifice of at least a subset are determined to be aimed at a distant target.

[0219] Example 27: The cryoablation catheter according to Example 1, wherein the nozzle includes an arc-shaped segment.

[0220] Example 28: The cryoablation catheter according to Example 27, wherein at least one of the plurality of orifices is provided along the arcuate segment.

[0221] Example 29: The cryoablation catheter according to Example 27, wherein the arcuate segment is rotatable about its central axis.

[0222] Example 30: The cryoablation catheter according to Example 27, wherein the arcuate segment is capable of longitudinal movement relative to its central axis.

[0223] Example 31: The cryoablation catheter according to Example 1, wherein the nozzle includes a helical nozzle, the plurality of orifices being disposed along the helical nozzle cavity of the helical nozzle and extending from the at least one cryoprotectant delivery cavity to the outer surface of the helical nozzle cavity.

[0224] Example 32: According to the cryoablation catheter described in Example 31, the cryoablation catheter further includes a helical structure, and the helical nozzle cavity is installed on the helical structure.

[0225] Example 33: The cryoablation catheter according to Example 1, wherein the nozzle is retractable.

[0226] Example 34: The cryoablation catheter according to Example 1, wherein the nozzle includes at least one nozzle branch having a plurality of orifices for delivering cryoprotectant.

[0227] Example 35: The cryoablation catheter according to Example 34, wherein the at least one nozzle branch forms an arc along the central axis, the arc extending to the maximum radial dimension and converging back toward the central axis to help bring the nozzle orifice closer to the target ablation site.

[0228] Example 36: The cryoablation catheter according to Example 34, wherein the at least one nozzle branch forms an arc along the central axis, the arc extending to the maximum radial dimension and terminating thereafter, to facilitate bringing the nozzle orifice closer to the target ablation site.

[0229] Example 37: The cryoablation catheter according to Example 34, wherein the nozzle is spring-loaded and capable of contracting relative to the nominal expansion diameter of the at least one nozzle branch for delivery via a smaller diameter delivery chamber.

[0230] Example 38: The cryoablation catheter according to Example 34, wherein the nozzle is configured to have a pre-shaped core within a nozzle branch and to exert a restoring force when subjected to mechanical stress, heat, current or light.

[0231] Example 39: The cryoablation catheter according to Example 38, wherein the preformed core is made of an alloy metal.

[0232] Example 40: The cryoablation catheter according to Example 38, wherein the preformed core is made of a polymer.

[0233] Example 41: The cryoablation catheter according to Example 34 can drive the nozzle to the expansion configuration by mechanical driving force (e.g., rack and pinion system, cable drive system or electromechanical control system).

[0234] Example 42: The cryoablation catheter according to Example 1, wherein the nozzle can be actuated along a linear or radial path to increase the distribution of cryoprotectant from the at least one nozzle branch.

[0235] It should be emphasized that the above embodiments of this disclosure are merely possible examples of implementation methods proposed for the purpose of clearly understanding the principles of this disclosure. Many variations and modifications can be made to the above embodiments without substantially departing from the spirit and principles of this disclosure. All such modifications and variations should be included within the scope of this disclosure and protected by the following claims.

[0236] Furthermore, the various concepts can be embodied in one or more methods as exemplified in the examples provided. Actions performed as part of a method can be ordered in any suitable manner. Therefore, embodiments can be constructed that perform actions in a different order than those shown, which could include performing some actions simultaneously, even those shown sequentially in the illustrative embodiments.

[0237] As used herein, the terms “approximately” and / or “approximately” when used with numerical values ​​and / or ranges generally refer to those numerical values ​​and / or ranges that are close to the stated value and / or range. In some cases, the terms “approximately” and “approximately” can mean within ±10% of the stated value. For example, in some cases, “approximately 100 [units]” can mean within ±10% of 100 (e.g., from 90 to 110). The terms “approximately” and “approximately” are used interchangeably.

[0238] Some embodiments described herein relate to computer storage products having a non-transitory computer-readable medium (also referred to as a non-transitory processor-readable medium) having instructions or computer code on it for performing various computer-implemented operations. A computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not itself include transiently propagating signals (e.g., propagating electromagnetic waves carrying information over a transmission medium such as space or cable). The medium and computer code (also referred to as code or algorithm) can be code designed and constructed for a particular purpose. Examples of non-transitory 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 compressed optical discs / digital video optical discs (CD / DVD), optical disc read-only memories (CD-ROMs), 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 memories (ROMs), and random access memories (RAMs). Other embodiments described herein relate to computer program products that may include, for example, instructions and / or computer code disclosed herein.

[0239] The systems, apparatus, and / or methods described herein may be implemented in software (executing 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 (executing on hardware) may be expressed in various software languages ​​(e.g., computer code), including C, C++, etc. Ruby, Visual And / or other object-oriented, procedural, or other programming languages ​​and development tools. Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions (e.g., generated by a compiler), code for generating web services, and files containing higher-level instructions executed by a computer using an interpreter. Other examples of computer code include, but are not limited to, control signals, encryption code, and compression code.

Claims

1. A cryoablation device, comprising: An outer shaft having a proximal end and a distal end, and defining a first cavity extending between the proximal end and the distal end; An inner shaft is disposed within a first cavity and defines a second cavity. The inner shaft has a distal portion that is configured to extend from the distal end of an outer shaft and is disposed within the gallbladder. A first expandable body is disposed at the distal end of the outer shaft, the first expandable body being configured to expand to retain the outer shaft within the gallbladder; A second expandable body is disposed around the distal portion of the inner axis. The second expandable body is formed by a plurality of elongated members. The second expandable body is configured to change from a non-deployed configuration to a deployed configuration in response to actuation from a proximal actuator. The plurality of elongated members are configured to extend substantially parallel to the longitudinal axis of the inner axis in the non-deployed configuration and to extend outward from the longitudinal axis in the deployed configuration. and Multiple nozzle openings are formed on the distal portion of the inner shaft, located between the two ends of the second expandable body. These nozzle openings communicate with a second cavity, such that the second cavity and the multiple nozzle openings are configured to deliver cryoablation medium from the proximal end of the inner shaft into the gallbladder. The second expandable body in the unfolded configuration is configured such that the plurality of nozzle openings are spaced apart relative to the gallbladder wall to facilitate the distribution of the cryoablation medium; A pressure sensing chamber is disposed in the outer and / or inner shaft and configured to terminate in the gallbladder; and A pressure sensor is configured to be disposed outside the gallbladder, and the pressure sensor is inflowably connected to a pressure sensing chamber and configured to measure the pressure of the gallbladder.

2. The cryoablation device of claim 1, wherein, The plurality of nozzle openings are movable relative to the second expandable body.

3. The cryoablation apparatus according to claim 2, wherein, The plurality of nozzle openings are rotatable about the longitudinal axis of the inner shaft.

4. The cryoablation apparatus according to claim 2, wherein, The plurality of nozzle openings are capable of translation along the longitudinal axis of the inner shaft.

5. The cryoablation apparatus according to claim 1, wherein, The proximal end of each of the plurality of elongated members is connected to the distal end of the outer shaft, and the distal end of each of the plurality of elongated members is connected to the distal end of the inner shaft, such that the relative translation of the outer shaft with respect to the inner shaft causes the second expandable body to transform into an unfolded configuration.

6. The cryoablation device of claim 1, further comprising a handle including the proximal actuator configured to slide distally to advance the outer axis relative to the inner axis, thereby transforming the second expandable body into an unfolded configuration.

7. The cryoablation apparatus according to claim 1, wherein, Each of the plurality of nozzle openings is configured to deliver the cryoablation medium into the gallbladder in a jetting manner.

8. The cryoablation apparatus according to claim 1, wherein, The plurality of nozzle openings surround the circumference of the distal portion of the inner shaft and are distributed along the axial length of the distal portion of the inner shaft.

9. The cryoablation apparatus according to claim 1, wherein, The second chamber and the plurality of nozzle openings are configured to deliver a liquid cryoablation medium into the gallbladder, where the cryoablation medium changes into a gaseous state in response to a decrease in pressure from the plurality of nozzle openings to the gallbladder.

10. A cryoablation device, comprising: An outer shaft having a proximal end and a distal end, and defining a first cavity extending between the proximal end and the distal end; An inner shaft is disposed within a first cavity and defines a second cavity. The inner shaft has a distal portion that extends distal to the outer shaft and can be positioned within the gallbladder. An expandable body is disposed on the distal part of the inner shaft. The expandable body is formed by a plurality of elongated members. The expandable body is configured to change from a non-expanded configuration to an expanded configuration. In the non-expanded configuration, the plurality of elongated members extend substantially parallel to the longitudinal axis of the inner shaft. In the expanded configuration, the plurality of elongated members bend radially outward from the longitudinal axis. Multiple nozzle openings are formed on the distal portion of the inner shaft, between the two ends of the expandable body, and the multiple nozzle openings communicate with a second chamber such that the second chamber and the multiple nozzle openings are configured to deliver cryoablation medium from the proximal end of the inner shaft into the gallbladder. A heating element is disposed in the outer shaft and configured to generate heat along at least a portion of the annular space between the outer shaft, the inner shaft, or the outer shaft and the inner shaft; A pressure sensing chamber is disposed in the outer and / or inner shaft and configured to terminate in the gallbladder; and A pressure sensor is configured to be disposed outside the gallbladder, and the pressure sensor is inflowably connected to a pressure sensing chamber and configured to measure the pressure of the gallbladder.

11. The cryoablation apparatus according to claim 10, wherein, The outer shaft includes an inner liner and an outer sleeve, and the heating element is disposed between the inner liner and the outer sleeve.

12. The cryoablation apparatus according to claim 10, wherein, The heating element is a coil wound around the periphery of the outer shaft.

13. The cryoablation apparatus according to claim 11, wherein, The coil has a first pitch along a first portion of the outer shaft and a second pitch along a second portion of the outer shaft, the second portion being near the first portion, and the first pitch being smaller than the second pitch.

14. The cryoablation apparatus according to claim 10, wherein, The heating element is configured to generate heat, with a greater heat flux along a first portion of the outer shaft, which is located distal to a second portion of the outer shaft.

15. The cryoablation apparatus of claim 10, further comprising a temperature sensor disposed at or near the distal end of the outer shaft, the temperature sensor being configured to measure the temperature within the gallbladder during delivery of the cryoablation medium.

16. The cryoablation apparatus according to claim 10, wherein, The outer shaft has at least one exhaust port located at or near the distal end of the outer shaft, the exhaust port being in communication with a first chamber, the first chamber and the at least one exhaust port forming a pressure sensing chamber, the pressure sensing chamber being configured to be coupled to a pressure sensor, such that the pressure sensor is able to measure the intracavitary pressure of the gallbladder.

17. The cryoablation apparatus according to claim 10, wherein, The heating element is a first heating element, and at least a portion of the annular space between the outer shaft, the inner shaft, or the outer shaft and the inner shaft is a first portion of the annular space between the outer shaft, the inner shaft, or the outer shaft and the inner shaft. The cryoablation device further includes: A second heating element is disposed in the outer shaft and configured to generate heat along a second portion of the annular space between the outer shaft, the inner shaft, or the outer shaft and the inner shaft, the second portion being different from the first portion.

18. The cryoablation apparatus of claim 17, further comprising one or more temperature sensors disposed along the length of an outer axis, an inner axis, or an annular space between the outer and inner axes, the one or more temperature sensors being configured to measure the temperature at various points along the length of the outer axis, the inner axis, or the annular space between the outer and inner axes.

19. The cryoablation apparatus of claim 18, further comprising a processor operatively coupled to the one or more temperature sensors and a first heating element and a second heating element, the processor being configured to control the first heating element and the second heating element based on temperatures measured by the one or more temperature sensors to maintain substantially uniform heating over the length of the annular space between the outer shaft, the inner shaft, or the outer shaft and the inner shaft.

20. An ablation system, comprising: A guide, defining a first cavity, the guide including a distal end configured to pass through a passage opening in the gallbladder wall and be inserted into the gallbladder; A retaining mechanism, located near the distal front end of the guide, is configured to shift to an inflatable configuration to retain the distal front end of the guide within the gallbladder; An ablation catheter, configured to pass through the first lumen and be inserted into the gallbladder, has a distal portion comprising: Multiple nozzle openings are configured to deliver the ablation medium into the gallbladder; and An expandable body, formed of multiple elongated members, is arranged around the plurality of nozzle openings and configured to transition between an undeployed configuration and an deployed configuration. In the undeployed configuration, the multiple elongated members extend generally parallel to the longitudinal axis of the ablation catheter, while in the deployed configuration, the multiple elongated members extend outward from the longitudinal axis. The expandable body in its unexpanded configuration allows the ablation catheter to be inserted through the first lumen. The expandable body in an unfolded configuration spaces the plurality of nozzle openings relative to the gallbladder wall to facilitate the distribution of the ablation medium within the gallbladder; and A pressure sensing cavity, disposed within the guide and / or ablation catheter, is configured to terminate in the gallbladder; and A pressure sensor is configured to be disposed outside the gallbladder, and the pressure sensor is inflowably connected to a pressure sensing chamber and configured to measure the pressure of the gallbladder.

21. The ablation system according to claim 20, wherein, The first chamber of the guide is configured to empty at least a portion of the ablation medium from the gallbladder after the ablation medium has been delivered into the gallbladder via the plurality of nozzle openings.

22. The ablation system according to claim 21, wherein, The ablation medium is a cryoablation medium, and the ablation catheter also includes a heating element configured to heat the space between the inner surface of the guide and the outer surface of the ablation catheter to prevent the formation of ice that could interfere with the evacuation of the cryoablation medium.

23. The ablation system according to claim 22, wherein, The heating element is a coil located inside the outer shaft of the ablation catheter.

24. The ablation system according to claim 20, wherein, The pressure sensor is located in the handle that is attached to the proximal end of the ablation catheter.

25. The ablation system of claim 24, further comprising the handle, the handle including a connection port configured to connect a pressure sensing chamber to a pressure sensor.

26. The ablation system of claim 21, further comprising a handle assembly including a plurality of actuators, the plurality of actuators including a first actuator and a second actuator, the first actuator being actuated to convert a holding mechanism into an deployed configuration, and the second actuator being actuated to convert an expandable body into an deployed configuration.

27. The ablation system according to claim 26, wherein, The handle assembly includes: A first handle, coupled to the guide and including a first actuator; and The second handle is connected to the ablation catheter and includes a second actuator.

28. The ablation system according to claim 26, wherein, The handle assembly includes a drain port connected to the first chamber for draining the ablation medium.

29. The ablation system according to claim 26, wherein, The plurality of actuators further includes a third actuator configured to perform at least one of the following: rotating the plurality of nozzle openings about the longitudinal axis of the ablation conduit; or translating the plurality of nozzle openings along the longitudinal axis of the ablation conduit.

30. The ablation system according to claim 21, wherein, The mechanism is configured to surround the opening in the first cavity leading to the gallbladder to prevent debris from clogging the first cavity.

31. The ablation system according to claim 21, wherein, The ablation medium is a cryoablation medium, and the second chamber and the plurality of nozzle openings are configured to deliver the cryoablation medium in a liquid state to the gallbladder, where the cryoablation medium changes to a gaseous state in response to a decrease in pressure from the ablation catheter to the gallbladder.

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