Classifications

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  • A61B18/0218—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip
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  • A61B2018/0212—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
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  • A61B2018/0231—Characteristics of handpieces or probes
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  • A61B2018/0293—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument interstitially inserted into the body, e.g. needle
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  • A61B18/1206—Generators therefor
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  • A61B90/06—Measuring instruments not otherwise provided for
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  • A61M25/00—Catheters; Hollow probes
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  • A61M2025/0002—Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
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  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/06—Body-piercing guide needles or the like
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  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector

Definitions

• the catheter located within the first lumen of the access sheath, and being extendable beyond the first distal end of the access sheath; the catheter comprising: a plurality of fenestrations located at the second distal end of the catheter, the plurality of fenestrations defining a plurality of ablation medium flow paths out of the second tubular body of the catheter and extending along a surface of the catheter in a circumferential pattern; and a connection to an ablation medium supply, the connection providing a fluid communication of an ablation medium with the plurality of fenestrations; a pressure sensor configured to detect an intraluminal pressure in the gallbladder; an extracorporeal control unit operatively connected to the pressure sensor and to the evacuator, the extracorporeal control unit configured to selectively direct an evacuation of the ablation medium through the first lumen of the access sheath upon reaching a pressure threshold.
• the plurality of fenestrations extends the surface of the catheter for a length ranging from about 1 centimeter to about 10 centimeters. In some embodiments, the diameter of each of the fenestrations ranges from about 0.001 centimeters to about 0.5 centimeters.
• the cystic duct occluder is a permanent cystic duct occluder. In some embodiments, the permanent cystic duct occluder is an ablation medium. In some embodiments, the permanent cystic duct occluder is an ablation balloon. In some embodiments, the permanent cystic duct occluder is a radiofrequency ablater. In some embodiments, the system further comprises an ablation balloon. In some embodiments, the ablation balloon comprises an ablation medium. In some embodiments, the ablation medium is a thermal conductive ablation medium or a cryogenic conductive ablation medium. In some embodiments, the ablation balloon is configured to conductively ablate a surrounding tissue.
• systems for defunctionalization of a gallbladder in a subject in need thereof comprising: an access sheath having a first proximal end, a first distal end, a first tubular body therebetween, and a first lumen therein, the first lumen of the access sheath in fluid communication with an evacuator; the access sheath comprising: a seal extending along the circumference of the access sheath at the first distal end of the access sheath; and a catheter having a second proximal end, a second distal end, a second tubular body therebetween, and a second lumen therein, the catheter located within the first lumen of the access sheath, and being extendable beyond the first distal end of the access sheath; the catheter comprising: a plurality of fenestrations located at the second distal end of the catheter, the plurality of fenestrations defining a plurality of ablation medium flow paths
• the pattern is pattern is a linear pattern, a hexagonal pattern, a rectangular pattern, a triangular pattern, a square pattern, a circular pattern, a spiral pattern, or any combination thereof.
• the first plurality of fenestrations extends the surface of the ablation balloon for a length ranging from about 1 centimeter to about 10 centimeters.
• the diameter of each of the fenestrations in the first plurality of fenestrations ranges from about 0.001 centimeters to about 0.5 centimeters.
• the system further comprises a radiofrequency ablater located at the second distal end of the catheter, the radiofrequency ablater configured to ablate a tissue via heat transfer.
• the radiofrequency ablater comprises at least one electrode that generates heat when energized.
• the system further comprises a temperature sensor is located at the first distal end of the system, in fluid connection with a lumen of the gallbladder, when in use.
• the temperature sensor is configured to detect a temperature of the ablation medium in the gallbladder, of a fluid in the gallbladder, or a combination thereof.
• the pressure threshold ranges from about 30 mmHg to about 40 mmHg.
• systems for defunctionalization of a gallbladder in a subject in need thereof comprising: an access sheath having a first proximal end, a first distal end, a first tubular body therebetween, and a first lumen therein, the first lumen of the access sheath in fluid communication with an evacuator; the access sheath comprising: a seal extending along the circumference of the access sheath at the first distal end of the access sheath; and a an ablation balloon having a surface, a second expandable body, and a second lumen; the ablation balloon comprising: a first plurality of fenestrations located at the surface of the ablation balloon, the first plurality of fenestrations defining a plurality of ablation medium flow paths out of second lumen of the ablation balloon and extending along the surface of the ablation balloon in a circumferential pattern; and a connection to an ablation medium supply, the connection
• the system further comprises a pressure sensor configured to detect an intraluminal pressure in the gallbladder.
• the system further comprises an extracorporeal control unit that is operatively connected to the pressure sensor.
• the extracorporeal control unit is configured to display the intraluminal pressure.
• the extracorporeal control unit comprises a connection for a visual output for a user.
• the visual output is a digital output or an analog output.
• the visual output comprises a temperature measurement, a pressure measurement, or a combination thereof.
• the extracorporeal control unit further comprises a fluid collection system configured to collect the ablation medium, a body fluid, a gallstone, a gallstone fragment, or any combination thereof.
• the extracorporeal control unit is operatively connected to the ablation medium supply.
• an evacuation of the ablation medium is a passive evacuation that is not selectively directed by the extracorporeal control unit.
• the passive evacuation of the ablation medium comprises draining of the ablation medium caused by a pressure gradient, wherein the ablation medium in gallbladder is at a higher pressure than atmospheric pressure, thereby generating the pressure gradient.
• the first plurality of fenestrations extends along the surface of the ablation balloon in a longitudinally directed pattern.
• the pattern is pattern is a linear pattern, a hexagonal pattern, a rectangular pattern, a triangular pattern, a square pattern, a circular pattern, a spiral pattern, or any combination thereof.
• the first plurality of fenestrations extends the surface of the ablation balloon for a length ranging from about 1 centimeter to about 10 centimeters.
• the diameter of each of the fenestrations in the first plurality of fenestrations ranges from about 0.001 centimeters to about 0.5 centimeters.
• the phase change interface of the catheter is an area of the catheter where the second lumen of the catheter decreases in diameter size.
• the extracorporeal control unit comprises a connection for a visual output for a user.
• the visual output is a digital output or an analog output.
• the visual output comprises a temperature measurement, a pressure measurement, or a combination thereof.
• the extracorporeal control unit further comprises a fluid collection system configured to collect the ablation medium, a body fluid, a gallstone, a gallstone fragment, or any combination thereof.
• the extracorporeal control unit is operatively connected to the ablation medium supply.
• the extracorporeal control unit is configured to selectively direct delivery of the ablation medium through the plurality of fenestrations upon reaching a temperature threshold or a pressure threshold.
• the catheter is located within the first lumen of the access sheath. In some embodiments, the catheter is extendable beyond the first distal end of the access sheath. In some embodiments, the catheter comprises a plurality of fenestrations located at the second distal end of the catheter. In some embodiments, the plurality of fenestrations defines a plurality of ablation medium flow paths out of the third tubular body of the catheter and extending along a surface of the catheter in a circumferential pattern. In some embodiments, the catheter comprises a connection to the ablation medium supply, the connection providing a fluid communication of the ablation medium with the plurality of fenestrations.
• the diameter of each of the fenestrations in the plurality of fenestrations ranges from about 0.001 centimeters to about 0.5 centimeters.
• the treatment is percutaneous decompression of the gallbladder (via a percutaneously inserted cholecystostomy tube) in conjunction with antibiotics.
• This treatment provides a temporizing measure to allow the patient to recover from the systemic effects of the ongoing infection (sepsis) and return to their baseline state of health (commonly referred to as“cooling off’ by healthcare professionals).
• the cholecystostomy tube remains in place until the patient has recovered. About 6-8 weeks following placement, a cholangiography by injection of radiopaque contrast through the tube under fluoroscopy is performed to determine if the cystic duct is patent (open).
• the gallbladder defunctionalization device comprises an extracorporeal control unit. In some embodiments, the gallbladder defunctionalization device comprises a cystic duct occluder. In some embodiments, the device access sheath is used to navigate and deliver therapy. In some embodiments, the extracorporeal control unit is used to regulate power requirements. In some embodiments, the extracorporeal control unit is connected to the proximal end of the device access system. In some embodiments, the extracorporeal control unit is connected to the proximal end of the ablation delivery system. In some embodiments, the device access system comprises a catheter configured to percutaneously access the gallbladder. In some embodiments, the device is a handheld device.
• an ablation delivery system located within the main body of the gallbladder, is deployed to defunctionalize the mucosal layer of gallbladder.
• the device is removed, and an integrated drainage catheter (not shown in the figures) is left in place while healing occurs over the next few weeks.
• the device access sheath is left in place and act as a drainage catheter while healing occurs over the next few weeks.
• the ablation delivery system 22 comprises a catheter device 4, an extracorporeal control unit 20, and a cystic duct occluder 26.
• the catheter device 4 comprises a catheter and a device access sheath 6.
• the catheter comprises a fenestrated nozzle 44, as shown in FIG. 2A.
• the fenestrated nozzle 44 is an area of the catheter that comprises a plurality of fenestrations.
• the catheter device 4 is deployed to defunctionalize the mucosal layer of gallbladder.
• the device access sheath lumen 96 having a diameter that is greater than the diameter of the catheter allows for the collection of an ablation medium, for the passive evacuation of an ablation medium, for the active evacuation of an ablation medium, or any combination thereof by serving as a conduit or channel in which the ablation medium located in the gallbladder can flow through in the direction of the arrows shown in FIG. 2B and exit the gallbladder.
• the device access sheath lumen 96 has a diameter sufficiently large to accommodate three catheters. In some embodiments, the device access sheath lumen 96 has a diameter sufficiently large to accommodate about 1 catheter to about 10 catheters.
• the device access sheath lumen 96 has a diameter sufficiently large to accommodate about 1 catheter to about 2 catheters, about 1 catheter to about 3 catheters, about 1 catheter to about 4 catheters, about 1 catheter to about 5 catheters, about 1 catheter to about 6 catheters, about 1 catheter to about 7 catheters, about 1 catheter to about 8 catheters, about 1 catheter to about 9 catheters, about 1 catheter to about 10 catheters, about 2 catheters to about 3 catheters, about 2 catheters to about 4 catheters, about 2 catheters to about 5 catheters, about 2 catheters to about 6 catheters, about 2 catheters to about 7 catheters, about 2 catheters to about 8 catheters, about 2 catheters to about 9 catheters, about 2 catheters to about 10 catheters, about 3 catheters to about 4 catheters, about 3 catheters to about 5 catheters, about 3 catheters to about 6 catheters, about 3 catheters to about 7 catheters, about 3 catheters to about 8 catheters, about 3 catheters to about 9 catheters, about 3 catheters to about 10 catheters, about 3 catheters to
• the device access sheath lumen 96 has a diameter sufficiently large to accommodate at most about 2 catheters, about 3 catheters, about 4 catheters, about 5 catheters, about 6 catheters, about 7 catheters, about 8 catheters, about 9 catheters, or about 10 catheters.
• the catheter device comprises a display screen (not shown in the figures).
• the display screen is operatively connected to the extracorporeal control unit 20.
• the extracorporeal control unit 20 comprises a display screen.
• the display screen provides visual information to a user.
• the display screen is operatively connected to the catheter device.
• the display screen displays a sensor reading to a user.
• the display screen displays a sensor reading to a user in real time.
• the display screen displays a temperature sensor reading to a user in real time.
• the display screen displays a pressure sensor reading to a user in real time.
• the display screen is a computer screen, a mobile device screen, or a portable device screen.
• the display screen is a tablet screen.
• the display screen is a mobile phone screen.
• the display screen is a touch screen.
• the display screen is a liquid crystal display (LCD).
• the display screen is a thin film transistor liquid crystal display (TFT-LCD).
• the display screen is an organic light emitting diode (OLED) display.
• an OLED display is a passive-matrix OLED (PMOLED) or an active-matrix OLED (AMOLED) display.
• the user controls the supply pressure of cryogen being delivered to the lumen of a gallbladder or a cystic duct using the catheter devices disclosed herein.
• the user controls the supply flow rate of a cryogen being delivered to the lumen of a gallbladder or a cystic duct using the catheter devices disclosed herein.
• the catheter device 4 comprises a device access sheath 6.
• the device access sheath 6 envelops, covers, encases, or surrounds one or more catheters to be inserted into a tissue of an individual in need thereof.
• the tissue is a gallbladder, a liver, adipose tissue, skin, pancreas, stomach, spleen, small intestine, large intestine, a blood vessel, or any combination thereof.
• the device access sheath 6 comprises at least one lumen.
• one or more catheters to be inserted into a tissue of an individual in need thereof are placed within the at least one lumen of the device access sheath 6.
• the device access sheath 6 provides access to the gallbladder lumen and allows for additional tools, procedures, or any combination thereof to be performed throughout.
• the device access sheath 6 acts as a channel to drain an ablation medium from the lumen of a gallbladder.
• the device access sheath 6 provides access to drain an ablation medium from the lumen of a gallbladder.
• the ablation medium is drained or passively evacuated from the lumen of a gallbladder via the device access sheath 6.
• the ablation medium is passively evacuated from the lumen of a gallbladder by having the ablation medium exit the lumen of the gallbladder, enter the lumen of the device access sheath 6, flow away from the gallbladder, and collected extracorporeally (by a fluid collection system, for example).
• the ablation medium is actively evacuated from the lumen of a gallbladder via the device access sheath 6.
• the ablation medium is actively evacuated from the lumen of a gallbladder via the device access sheath 6 by operatively connecting a vacuum source to the device access sheath 6.
• the device access sheath is a tube having a distal end 84, a proximal end 82, and at least one lumen (not shown in the figures), as shown in FIG. 3.
• the distal end 84 of the device access sheath 6 is placed within the gallbladder lumen 24.
• the distal end 84 of the device access sheath 6 has a deployable geometry that prevents dislodgement and creates a seal 30 between the access lumen and the gallbladder 2, as seen in FIG. 3.
• the seal 30 has a shape that resembles the shape of a Malecot catheter.
• the deployable geometry located on the distal end 84 of the device access sheath 6, comprises a balloon.
• the balloon is an inflatable balloon.
• the balloon is a compliant balloon.
• the compliant balloon expands as internal pressure increases.
• the compliant balloon is used to occlude a tissue, to expand a tissue, to hold the catheter device in position, or any combination thereof.
• the balloon is a semi-compliant balloon.
• the balloon is a non-compliant balloon. In some embodiments the semi-compliant balloon and the non-compliant balloon expand to a specific size or size range, even as internal pressure increases.
• the semi-compliant balloon and the non-compliant balloon are used to apply force or occlude.
• the balloon can inflate radially to achieve a ring conformation, whereby the diameter of the balloon is larger than the diameter of the access sheath. [0089] In some embodiments, the diameter of the balloon is about 1.1 times to about 5 times larger than the diameter of the device access sheath.
• the diameter of the balloon is about 1.1 times to about 1.2 times, about 1.1 times to about 1.3 times, about 1.1 times to about 1.4 times, about 1.1 times to about 1.5 times, about 1.1 times to about 1.6 times, about 1.1 times to about 1.7 times, about 1.1 times to about 1.8 times, about 1.1 times to about 1.9 times, about 1.1 times to about 2 times, about 1.1 times to about 3 times, about 1.1 times to about 5 times, about 1.2 times to about 1.3 times, about 1.2 times to about 1.4 times, about 1.2 times to about 1.5 times, about 1.2 times to about 1.6 times, about 1.2 times to about 1.7 times, about 1.2 times to about 1.8 times, about 1.2 times to about 1.9 times, about 1.2 times to about 2 times, about 1.2 times to about 3 times, about 1.2 times to about 5 times, about 1.3 times to about 1.4 times, about 1.3 times to about 1.5 times, about 1.3 times to about 1.6 times, about 1.2 times to about 1.7 times, about 1.2 times to about
• 1.5 times to about 1.9 times about 1.5 times to about 2 times, about 1.5 times to about 3 times, about 1.5 times to about 5 times, about 1.6 times to about 1.7 times, about 1.6 times to about 1.8 times, about 1.6 times to about 1.9 times, about 1.6 times to about 2 times, about 1.6 times to about 3 times, about 1.6 times to about 5 times, about 1.7 times to about 1.8 times, about 1.7 times to about 1.9 times, about 1.7 times to about 2 times, about 1.7 times to about 3 times, about 1.7 times to about 5 times, about 1.8 times to about 1.9 times, about 1.8 times to about 2 times, about 1.8 times to about 3 times, about 1.8 times to about 5 times, about 1.9 times to about 2 times, about 1.9 times to about 3 times, about 1.9 times to about 2 times, about 1.9 times to about 3 times, about 1.9 times to about 5 times, about 1.9 times to about 2 times, about 1.9 times to about 3 times, about 1.9 times to about 5 times, about 2 times to about 3 times, about 2
• the diameter of the balloon is about 1.1 times, about 1.2 times, about 1.3 times, about 1.4 times, about 1.5 times, about 1.6 times, about 1.7 times, about 1.8 times, about 1.9 times, about 2 times, about 3 times, or about 5 times larger than the diameter of the device access sheath. In some embodiments, the diameter of the balloon is at least about 1.1 times, about 1.2 times, about 1.3 times, about 1.4 times, about 1.5 times, about 1.6 times, about 1.7 times, about 1.8 times, about 1.9 times, about 2 times, or about 3 times larger than the diameter of the device access sheath.
• the diameter of the balloon is at most about 1.2 times, about 1.3 times, about 1.4 times, about 1.5 times, about 1.6 times, about 1.7 times, about 1.8 times, about 1.9 times, about 2 times, about 3 times, or about 5 times larger than the diameter of the device access sheath.
• the inflatable balloon is composed of a non-compliant, a semi- compliant, or a compliant material.
• a non-compliant material include polyethylene terephthalate (PET), polyester, and nylon.
• PET polyethylene terephthalate
• a semi- compliant material include polyether block amide (PEBA) and high durometer polyurethane.
• PEBA polyether block amide
• a compliant material include silicone, latex, liquid silicone rubber, polyolefin copolymer (POC), and polyurethane.
• the balloon has a compliance of at least about 0% to about 500%.
• the non-compliant balloon has a compliance ranging from about 0 %, about 1 %, about 2 %, about 3 %, about 4 %, about 5 %, about 6 %, or about 7 %. In some embodiments, the non-compliant balloon has a compliance ranging from at least about 0 %, about 1 %, about 2 %, about 3 %, about 4 %, about 5 %, or about 6 %. In some embodiments, the non-compliant balloon has a compliance ranging from at most about 1 %, about 2 %, about 3 %, about 4 %, about 5 %, about 6 %, or about 7 %.
• the semi-compliant balloon has a compliance ranging from about 5 % to about 10 %. In some embodiments, the semi -compliant balloon has a compliance ranging from about 5 % to about 6 %, about 5 % to about 7 %, about 5 % to about 8 %, about 5 % to about 9 %, about 5 % to about 10 %, about 6 % to about 7 %, about 6 % to about 8 %, about 6 % to about 9 %, about 6 % to about 10 %, about 7 % to about 8 %, about 7 % to about 9 %, about 7 % to about 10 %, about 8 % to about 9 %, about 8 % to about 10 %, or about 9 % to about 10 %.
• the semi-compliant balloon has a compliance ranging from about 5 %, about 6 %, about 7 %, about 8 %, about 9 %, or about 10 %. In some embodiments, the semi- compliant balloon has a compliance ranging from at least about 5 %, about 6 %, about 7 %, about 8 %, or about 9 %. In some embodiments, the semi -compliant balloon has a compliance ranging from at most about 6 %, about 7 %, about 8 %, about 9 %, or about 10 %.
• the compliant balloon has a compliance ranging from about 10 %, about 50 %, about 100 %, about 150 %, about 200 %, about 250 %, about 300 %, about 350 %, about 400 %, about 450 %, or about 500 %. In some embodiments, the compliant balloon has a compliance ranging from at least about 10 %, about 50 %, about 100 %, about 150 %, about 200 %, about 250 %, about 300 %, about 350 %, about 400 %, or about 450 %.
• the inflatable balloon is filled with a gas, such as carbon dioxide (C0 2 ), to achieve its final conformation.
• a gas such as carbon dioxide (C0 2 )
• the balloon is filled with a liquid, such as a saline solution, a dextrose solution, or any combination thereof, to achieve its final conformation.
• the debris comprises cholesterol. In some embodiments, the debris comprises bacteria. In some embodiments, the debris comprises infected tissue. In some embodiments, the mammalian cells originate from a tissue in the individual in need thereof. In some embodiments, the tissue is a gallbladder, a liver, adipose tissue, skin, pancreas, stomach, spleen, small intestine, large intestine, a blood vessel, or any combination thereof. In some instances, said debris includes gallstones. In some instances, the debris includes parts or fragments of gallstones. In some instances, the debris includes saline. In some instances, the debris includes a lavage medium. In some instances, the debris includes an ablation medium. In some instances, the debris includes gas.
• the active evacuation disclosed herein is controlled by a feedback loop.
• the access sheath is coupled to an active evacuation mechanism to prevent pressure build-up in the gallbladder lumen via a close loop feedback system.
• the access sheath is coupled to a passive evacuation system to prevent pressure from building up in the gallbladder lumen
• the feedback loop consists of a process whereby the active evacuation is automatically applied to the system when the pressure within the gallbladder lumen (as detected by the pressure sensor 28 described above) exceeds a certain threshold pressure.
• the pressure within the gallbladder lumen is detected by the pressure sensor 28 from the present disclosure.
• the threshold pressure ranges from at most about 10 mmHg, about 50 mmHg, about 75 mmHg, about 100 mmHg, about 150 mmHg, about 200 mmHg, about 250 mmHg, about 300 mmHg, about 350 mmHg, about 400 mmHg, or about 500 mmHg.
• the material of the delivery access sheath 6 is flexible or semi-flexible, relatively non-distensible and is able to return substantially to its original configuration and orientation.
• the material is biocompatible and is one or more medical grade materials.
• the catheter device provided herein comprises a guidewire.
• the device access sheath 6 comprises a guidewire.
• a catheter of the catheter device comprises a guidewire.
• the distal tip of the guidewire, the distal end 84 of the access delivery sheath 6, or any combination thereof comprises a marker to aid tracking of the movement of the catheter-based device.
• the distal end of the ablation catheter comprises at least one market to aid in the placement of device.
• the marker is a radiopaque marker or a metal marker.
• the device access sheath 6 minimizes or reduces blood loss, induces coagulation, alleviates or stops refractory bleeding, or any combination thereof of the liver 8 or tissues that are injured or damaged when accessing the gallbladder 2 via a transhepatic route by deploying a balloon tamponade 34, as shown in FIG. 4A.
• the device access sheath 6 minimizes or reduces blood loss, induces coagulation, alleviates or stops refractory bleeding, or any combination thereof of the liver 8 or tissues that are injured or damaged when accessing the gallbladder 2 via a subhepatic route or any other suitable access route known by the skilled artisan by deploying a balloon tamponade 34.
• the access delivery sheath 6 has a highly compliant outer covering of the elongated body.
• the outer covering has a port on the extracorporeal end that facilitates filling of the space between the outer covering and outside of the access lumen with air or fluid (including, but not limited to water, saline, or contrast agent) to increase the capillary pressure at the tissue interface with the access lumen, establishing tamponade and promoting coagulation and sealing of the disrupted surface of tissue and organs such as the liver 8, as seen in FIG. 4A.
• the device access sheath 6 comprises a balloon tamponade 34.
• the elongated body of the device access sheath 6 is coated with or embedded with a procoagulant material.
• the surface of the balloon tamponade 34 is coated with or embedded with a procoagulant material.
• the procoagulant material includes fibrin, thrombin, or other activating clotting factor.
• contact between the tissue interface and the treated surface of the device access sheath 6 promotes clotting on the surface of the disrupted tissue.
• contact between the tissue interface and the treated surface of the balloon tamponade 34 promotes clotting on the surface of the disrupted tissue.
• the first electrode 36a and the second electrode 36b are multipolar RF electrodes.
• the device access sheath 6 comprises at least one electrode to deliver an ablation energy.
• a device access sheath 6 with an embedded electrode(s) connects to an extracorporeal energy source.
• the energy source utilized includes RF, conductive heating, microwave, high frequency ultrasound, high intensity light (laser), or any combinations thereof.
• activation or energization of the electrode induces coagulation at the disrupted tissue surface leading to sealing of disrupted surfaces.
• the catheter device 4 comprises an ablation delivery system 22, as shown in FIGs. 2A-2B.
• the ablation delivery system 22 provides an ablative energy or an ablative agent capable of killing cells in a mucosal layer of the gallbladder, killing the cells lining the cystic duct, or any combination thereof.
• the ablative agent comprises a chemical agent, where the chemical agent is capable of killing cells in a mucosal layer of the gallbladder, killing the cells lining the cystic duct, or any combination thereof.
• the catheter 66 comprises a catheter lumen 92 in which a cryogenic liquid ablation medium 98 is located and flows therethrough.
• the catheter 66 comprises a catheter lumen 92 that is sufficiently small as to induce the cryogenic liquid ablation medium 98 to change into a cryogenic gas ablation medium 100 (i.e., a liquid-to-gas phase transition) at a phase change interface 3, as shown in FIG. 13.
• the fenestrated nozzle 44 comprises a proximal end 5 and a distal end 7.
• the cryogenic gas ablation medium 100 exits the fenestrated nozzle 44 via the plurality of fenestrations 45. In some embodiments, the cryogenic gas ablation medium 100 exits the fenestrated nozzle 44 via the plurality of fenestrations 45 and ablates the outer surface of the gallbladder lumen once the cryogenic gas ablation medium 100 upon contact with the tissue.
• 0.004 inches to about 0.009 inches about 0.004 inches to about 0.1 inches, about 0.005 inches to about 0.006 inches, about 0.005 inches to about 0.0625 inches, about 0.005 inches to about 0.007 inches, about 0.005 inches to about 0.008 inches, about 0.005 inches to about 0.009 inches, about
• the ablation balloon 40 in the inflated configuration fills more than 50%, 60%, 70%, 80%, 90%, 95%, or 99% of the interior volume of the gallbladder 2. In some embodiments, the ablation balloon 40, in the inflated configuration, fills about 50 % to about 99 % of the interior volume of the gallbladder 2.
• the ablation balloon 38 comprises an ablation medium.
• the ablation medium is a fluid.
• the ablation medium is a gas.
• the ablation medium is a thermal ablation medium.
• Non-limiting examples of the thermal ablation medium include saline, water, air, glycerin, steam, and dextrose.
• the temperature of the thermal ablation medium is controlled by the extracorporeal control unit 20. [00120] In some embodiments, the temperature of the thermal ablation medium ranges from about 37 degrees Celsius to about 100 degrees Celsius when the thermal ablation medium is used with the catheter devices disclosed herein.
• the temperature of the thermal ablation medium ranges from about 37 degrees Celsius to about 38 degrees Celsius, about 37 degrees Celsius to about 40 degrees Celsius, about 37 degrees Celsius to about 45 degrees Celsius, about 37 degrees Celsius to about 50 degrees Celsius, about 37 degrees Celsius to about 55 degrees Celsius, about 37 degrees Celsius to about 60 degrees Celsius, about 37 degrees Celsius to about 70 degrees Celsius, about 37 degrees Celsius to about 80 degrees Celsius, about
• the temperature of the thermal ablation medium ranges from at most about 38 degrees Celsius, about 40 degrees Celsius, about 45 degrees Celsius, about 50 degrees Celsius, about 55 degrees Celsius, about 60 degrees Celsius, about 70 degrees Celsius, about 80 degrees Celsius, about 90 degrees Celsius, or about 100 degrees Celsius when the thermal ablation medium is used with the catheter devices disclosed herein.
• the ablation medium is a cryogenic ablation medium.
• the cryogenic ablation medium is a liquid.
• the cryogenic ablation medium is a gas.
• the cryogenic ablation medium undergoes a liquid-to-gas phase transition when being delivered using the catheter devices disclosed herein.
• cryoablation is achieved via the refrigerant property due to the liquid to gas phase change from an ablation medium, such as liquid nitrous oxide, carbon dioxide, and argon.
• the phase change of the cryogenic ablation medium is triggered by
• the plug is a tissue ingrowth plug 58, as shown in FIG. 10D.
• the tissue ingrowth plug 58 comprises a profibrotic surface 72.
• the tissue ingrowth plug 58 is made from a bioresorbable, dissolvable, or biodegradable material, such as, but not limited to polyglycolic acid (PGA), polylactic acid (PLA), polylactic-co-glycolic acid (PLGA), a proteoglycan, or any combination thereof.
• the tissue ingrowth plug 58 is bioresorbable or biodegradable.
• the cystic duct occluder is delivered or applied to a patient after the gallbladder is ablated. In some embodiments, the cystic duct occluder is delivered or applied to a patient before the gallbladder is ablated.
• the ablation balloon 38 disclosed herein includes a temperature sensor that is embedded into the walls of the ablation balloon 38. In yet another embodiment, the temperature sensor is located at the neck of the ablation balloon 38. In some instances, the ablation balloon 38 includes a pressure sensor that is embedded into the walls of the ablation balloon 38. In yet another embodiment, the pressure sensor is located at the neck of the ablation balloon 38. In some embodiments, the temperature sensor, the pressure sensor, or any combination thereof are removably located in the ablation balloon 38 or are removably connected to the ablation balloon 38. For example, in some embodiments, the temperature sensor, the pressure sensor, or any combination thereof are introduced into the lumen of the ablation balloon 38 via the catheter.
• the cystic duct occluder comprises an elongated tapered end that is delivered sufficiently far into the cystic duct to create a seal.
• the catheter has a broad shaped terminus that seats against the narrow neck region of the gallbladder with a nipple-like protrusion that occupies the cystic duct.
• the ablation medium is extruded from this tapered tip 80, promoting ablation by direct contact.
• the cystic duct occluder is an RF ablater 48 comprising a first electrode 36a and a second electrode 36b that induce ablation by RF ablation, as seen in FIG. 11C.
• the RF ablater 48 is energized to deliver heat, ablate, and
• tissue necrosis in the tissue that comes in contact with the RF ablater 48 e.g., the cystic duct.
• the RF electrodes are spaced apart by about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 3 mm, about 0.5 mm to about 3.5 mm, about 0.5 mm to about 4 mm, about 0.5 mm to about 4.5 mm, about 0.5 mm to about 5 mm, about 0.5 mm to about 10 mm, about 0.5 mm to about 20 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, about 1 mm to about 3 mm, about 1 mm to about 3.5 mm, about 1 mm to about 4 mm, about 1 mm to about 4.5 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 20 mm, about 1.5 mm to about 2 mm, about 1 mm to about 2.5 mm
• the RF is delivered for about 1 second to about 5 seconds, about 1 second to about 15 seconds, about 1 second to about 30 seconds, about 1 second to about 45 seconds, about 1 second to about 60 seconds, about 1 second to about 120 seconds, about 1 second to about 300 seconds, about 1 second to about 600 seconds, about 1 second to about 900 seconds, about 1 second to about 1,800 seconds, about 1 second to about 3,600 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 30 seconds, about 5 seconds to about 45 seconds, about 5 seconds to about 60 seconds, about 5 seconds to about 120 seconds, about 5 seconds to about 300 seconds, about 5 seconds to about 600 seconds, about 5 seconds to about 900 seconds, about 5 seconds to about 1,800 seconds, about 5 seconds to about 3,600 seconds, about 15 seconds to about 30 seconds, about 15 seconds to about 45 seconds, about 15 seconds to about 60 seconds, about 15 seconds to about 120 seconds, about 15 seconds to about 300 seconds, about 15 seconds to about 600 seconds, about 15 seconds to about 900 seconds, about 15 seconds to about 1,800 seconds, about 5 seconds to about 3,600 seconds
• the RF is delivered at a power of about 10 W, about 20 W, about 40 W, about 60 W, about 80 W, about 100 W, about 200 W, or about 500 W. In some embodiments, the RF is delivered at a power of at least about 10 W, about 20 W, about 40 W, about 60 W, about 80 W, about 100 W, or about 200 W. In some embodiments, the RF is delivered at a power of at most about 20 W, about 40 W, about 60 W, about 80 W, about 100 W, about 200 W, or about 500 W.
• the computer system 101 includes a central processing unit (CPU, also“processor” and “computer processor” herein) 105.
• the CPU 105 is a single core or multi core processor.
• the computer system 101 includes a plurality of processors for parallel processing.
• the computer system 101 also includes memory or memory location 110 (e.g., random-access memory, read-only memory, flash memory), electronic storage unit 115 (e.g., hard disk), communication interface 120 (e.g., network adapter) for communicating with one or more other systems, and peripheral devices 125, such as cache, other memory, data storage, electronic display adapters, or any combination thereof.
• the memory 110, storage unit 115, interface 120 and peripheral devices 125 are in communication with the CPU 105 through a communication bus (solid lines), such as a motherboard.
• the storage unit 115 is a data storage unit (or data repository) for storing data.
• the computer system 101 is operatively coupled to a computer network (“network”) 130 with the aid of the communication interface 120.
• the network 130 is the Internet, an internet, an extranet, or any combination thereof, or an intranet that is in communication with the Internet, an extranet that is in communication with the Internet, or any combination thereof.
• the network 130 in some cases is a telecommunication network, a data network, or any combination thereof.
• the storage unit 115 stores files, such as drivers, libraries and saved programs.
• the storage unit 105 stores user data, e.g., user preferences and user programs.
• the computer system 101 in some cases includes one or more additional data storage units that are external to the computer system 101, such as located on a remote server that is in communication with the computer system 101 through an intranet or the Internet.
• the computer system 101 communicates with one or more remote computer systems through the network 130.
• the computer system 101 communicates with a remote computer system of a user.
• remote computer systems include personal computers (e.g., portable PC), slate or tablet PC’s (e.g., Apple® iPad, Samsung® Galaxy Tab), telephones, Smart phones (e.g., Apple® iPhone, Android-enabled device, Blackberry®), or personal digital assistants.
• the user accesses the computer system 101 via the network 130.
• common forms of computer-readable media therefore include for example: a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD or DVD-ROM, any other optical medium, punch cards paper tape, any other physical storage medium with patterns of holes, a RAM, a ROM, a PROM and EPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wave transporting data or instructions, cables or links transporting such a carrier wave, or any other medium from which a computer may read programming code, data, or any combination thereof.
• many of these forms of computer readable media are involved in carrying one or more sequences of one or more instructions to a processor for execution.
• Examples of UTs include, without limitation, a graphical user interface (GUI) and web-based user interface.
• GUI graphical user interface
• Methods and systems of the present disclosure are implemented by way of one or more algorithms.
• an algorithm is implemented by way of software upon execution by the central processing unit 105.
• the algorithm for example, calculates a real time projected subcutaneous needle location prior to insertion, acquires a plurality of voltage signals, and converts them into a pressure sensor array.
• an ablation balloon catheter is used to deploy an ablation balloon to the lumen of the gallbladder of the individual.
• the ablation balloon is inflated with a thermal conductive ablation medium within the gallbladder.
• the thermal conductive ablation medium is heated to about 80 °C and the outer surface of the ablation balloon comes in contact with the superficial surface of the gallbladder for about 8 minutes, thus ablating mucosal layer of the gallbladder.
• the ablation balloon is deflated, and the gallbladder defunctionalization device is withdrawn from the gallbladder and the individual.
• a 78 year old individual presents with severe pain and tenderness in the upper right quadrant of her abdomen that has lasted for several hours.
• the physician diagnoses the individual with cholelithiasis, but given his age, the physician determines the individual is at high risk of surgical complications.
• the physician therefore chooses to percutaneously defunctionalize the gallbladder of the individual using the catheter device disclosed herein, instead of surgically removing the gallbladder.
• the gallbladder defunctionalization device disclosed herein is used treat the gallbladder of the individual affected with gallstones.
• a catheter comprising a fenestrated nozzle comprising a plurality of fenestrations is introduced into the lumen of the gallbladder of the individual.
• the fenestrated nozzle is used to circumferentially spray nitrous oxide, a cryogenic ablation medium, within the gallbladder for three cycles, each cycle lasting about 1 to 3 minutes at a temperature of about -80 degrees Celsius.
• the nitrous oxide ablates mucosal layer of the gallbladder.
• the catheter is retracted and withdrawn from the gallbladder and the individual.

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