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WO2025226991A1 - Ablation thérapeutique à la vapeur - Google Patents

Ablation thérapeutique à la vapeur

Info

Publication number
WO2025226991A1
WO2025226991A1 PCT/US2025/026291 US2025026291W WO2025226991A1 WO 2025226991 A1 WO2025226991 A1 WO 2025226991A1 US 2025026291 W US2025026291 W US 2025026291W WO 2025226991 A1 WO2025226991 A1 WO 2025226991A1
Authority
WO
WIPO (PCT)
Prior art keywords
nozzles
expandable
vapor
ablation
ablation catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/026291
Other languages
English (en)
Inventor
Yao Chen
Shibo Wang
Bochen JIANG
Ruihuan LUO
Linshanzi Pan
Cheng Zhang
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Medical Device Ltd
Boston Scientific Scimed Inc
Original Assignee
Boston Scientific Medical Device Ltd
Scimed Life Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Medical Device Ltd, Scimed Life Systems Inc filed Critical Boston Scientific Medical Device Ltd
Publication of WO2025226991A1 publication Critical patent/WO2025226991A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00541—Lung or bronchi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B2018/044—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
    • A61B2018/048—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid in gaseous form

Definitions

  • the present disclosure pertains to medical systems, medical devices, and methods for using the medical systems and devices for therapeutic vapor ablation. More particularly, the present disclosure pertains to medical systems, devices and methods that relate to the therapeutic vapor ablation treatment of airway related diseases.
  • a wide variety of medical devices have been developed for medical use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.
  • This disclosure provides design, material, manufacturing method, and use alternatives for medical devices.
  • a first example is a system comprising a console configured to produce water vapor; and an ablation catheter for vapor ablation of tissue, the ablation catheter comprising: an elongate shaft having a proximal end region and a distal end region and including a lumen extending between the proximal end region and the distal end region; an expandable device positioned adjacent to the distal end region of the elongate shaft and in fluid communication with the lumen, the expandable device configured to move between an unexpanded configuration and an expanded configuration; and nozzles extending through an outer surface of the expandable device and being configured to emit a vapor to ablate tissue proximate thereto, wherein the expandable device is configured to maintain a threshold distance between the tissue and the nozzles when the expandable device is in the expanded configuration.
  • threshold distance is in a range from about 0.5 millimeters to about 1.5 millimeters.
  • the expandable device comprises an expandable balloon.
  • the expandable balloon includes anchoring projections that extend radially from the outer surface.
  • anchoring projections are configured expand radially relative to the outer surface.
  • anchoring projections are positioned longitudinally along and circumferentially about the outer surface.
  • anchoring projections are elongate anchoring projections.
  • the anchoring projections are configured in substantially the same direction.
  • the nozzles are located about the outer surface at locations that are adjacent to the anchoring projections.
  • the nozzles extend a first distance from the outer surface, wherein the anchoring projections extend a second distance from the outer surface, and wherein the second distance is larger than the first distance.
  • a total quantity of the anchoring projections is less than or equal to a total quantity of the nozzles.
  • Another example is a method for therapeutic vapor ablation of tissue.
  • the method comprising providing an vapor ablation catheter including: an elongate shaft having a proximal end region and a distal end region and including a lumen extending between the proximal end region and the distal end region; an expandable device positioned adjacent to the distal end region of the elongate shaft and in fluid communication with the lumen, the expandable device configured to move between an unexpanded configuration and an expanded configuration; and nozzles in fluid communication with the lumen and extending through an outer surface of the expandable device, wherein the nozzles are configured to emit a vapor to ablate tissue in a target region that is proximate to the nozzles; advancing the vapor ablation catheter through a body lumen to a position adjacent to the target region; expanding the expandable device at the target region to maintain a threshold distance between the tissue in the target region and the nozzles when the expandable device is in the expanded configuration; and applying vapor in the target region
  • the method includes expanding the expandable device further comprises causing the nozzles to move from a first position that is a first distance away from the tissue in the target region to a second position that is a second distance away from the tissue, wherein the second distance is less than the first distance.
  • Another example is a method for therapeutic vapor ablation of tissue.
  • the method comprising providing an vapor ablation catheter including: an elongate shaft having a proximal end region and a distal end region and including a lumen extending between the proximal end region and the distal end region; an expandable device positioned adjacent to the distal end region of the elongate shaft and in fluid communication with the lumen, the expandable device configured to move between an unexpanded configuration and an expanded configuration; and nozzles in fluid communication with the lumen and extending through an outer surface of the expandable device, wherein the nozzles are configured to emit a vapor to ablate tissue in a target region that is proximate to the nozzles; advancing the vapor ablation catheter through a body lumen to a position adjacent to the target region; expanding the expandable device at the target region to maintain a threshold distance between the tissue in the target region and the nozzles when the expandable device is in the expanded configuration; receiving, via that lumen, heated
  • threshold distance is in a range from about 0.5 millimeters to about 1.5 millimeters.
  • threshold distance is configurable based upon a diameter of a vessel at the target region.
  • FIGS. 1A-1H show schematic representations of example systems for performing vapor ablation treatments within a body passageway
  • FIGS. 2A-2B show schematic representations of example ablation catheters disposed within a body passageway
  • FIGS. 3A-3B show schematic representations of side views of ablation catheters including example expandable devices configured to perform a vapor ablation treatment within a body passageway;
  • FIGS. 3C-3D show schematic representations of cross-sections of portions of an example vapor ablation catheter
  • FIGS. 4A-4D show schematic representations of side views of vapor ablation catheters including expandable devices configured to perform vapor ablation treatment within a body passageway;
  • FIG. 5 shows a schematic representation of a side view of an ablation catheter including an expandable device configured to perform a vapor ablation treatment within a body passageway;
  • FIG. 6 illustrates a section view of an example of an ablation catheter including a heated reinforcement layer
  • FIG. 7 illustrates an example of a method flow diagram for performing a vapor ablation treatment within a body passageway.
  • references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc. indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
  • proximal refers to the direction or location closest to the user (medical professional or clinician or technician or operator or physician, etc., such terms being used interchangeably herein without intent to limit, and including automated controller systems or otherwise), etc., such as when using a device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and/or closest to a delivery device, and “distal” refers to the direction or location furthest from the user, such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and/or closest to a delivery device.
  • Longitudinal means extending along the longer or larger dimension of an element.
  • a “longitudinal axis” extends along the longitudinal extent of an element, though is not necessarily straight and does not necessarily maintain a fixed configuration if the element flexes or bends, and “axial” generally refers to along the longitudinal axis.
  • reference to axial or longitudinal movement with respect to the above-described systems or elements thereof need not be strictly limited to axial and/or longitudinal movements along a longitudinal axis or central axis of the referenced elements.
  • Central means at least generally bisecting a center point and/or generally equidistant from a periphery or boundary
  • a “central axis” means, with respect to an opening, a line that at least generally bisects a center point of the opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a channel, a cavity, or a bore.
  • a “lumen” or “channel” or “passage” is not limited to a circular cross-section.
  • a “free end” or “distalmost end” of an element is a terminal end at which such element does not extend beyond.
  • the present invention relates to medical system, devices, and methods for treating obstructive and or inflammatory lung disease, and more specifically to minimally invasive medical systems, devices and methods for vapor ablating the inner wall of the airways to limit contraction and obstruction within airways.
  • COPD chronic obstructive pulmonary disease
  • COPD chronic obstructive pulmonary disease
  • asthma are lung inflammatory diseases and affect many people. Each disease is characterized by limited airflow, and interferes with normal breathing.
  • COPD includes a number of diseases including chronic bronchitis and emphysema, it is generally characterized by airflow obstruction. People with airflow obstruction may have a number of symptoms including smooth muscle contraction, chronic cough with excess sputum production, and general thickening of the airway wall, all of which result in obstruction of normal breathing.
  • COVID-19 affects the respiratory system, lung damage and loss of function associated with COPD can be exacerbated when patients contract COVID- 19.
  • an inhaled bronchodilator (short or long acting) may be administered (e.g., daily) to relax and temporarily open airways.
  • the side effects of the pharmacological agents include: nausea and vomiting, diarrhea, palpitations, a rapid heartbeat, an irregular heartbeat, headaches, and problems sleeping (insomnia), all of which are undesirable.
  • Interventional treatments include a variety of surgical and thermal ablation based interventional treatments have been described as therapies to treat diseased airways.
  • EBSs endobronchial valves
  • approaches are invasive and may be prone to surgical complications during or subsequent to the surgery, among other issues.
  • RF ablation techniques that deliver RF energy via electrodes to the airway wall to thermally ablate diseased tissue (e.g., to reduce excess smooth muscle in the airway).
  • BTVA Bronchoscopic Thermal Vapor Ablation
  • ELVR endoscopic lung volume reduction
  • BTVA tet al.
  • the vapor causes heat to be applied directly and uniformly across in wall tissue in a target region
  • tissue and volume decrease in the most diseased emphysematous segments As a result of the BTVA, the adjacent healthier lung segments may function better (e.g., manifested as a reduction in lung over inflation) thereby making breathing easier for the patient.
  • BTVA may improve the symptoms and lung function, and thus the patients' quality of life.
  • the systems and methods herein can treat smaller vasculatures (e.g., level 3-5 bronchi), as compared to other approaches which employ bulky ablation electrodes (e.g., RF electrodes).
  • bronchial hyperreactivity BHR
  • COPD chronic obstructive pulmonary disease
  • the expandable device herein can be deliverable via a bronchoscope or catheter, and may be inserted in an elongated configuration through a working channel of the bronchoscope or lumen of the catheter into the bronchus.
  • FIG. 1 A shows a system 10 for performing a vapor ablation treatment (e.g., a BTVA) within a body passageway.
  • the system 10 includes a console 40 and an ablation catheter 200 that is coupled to the console 40.
  • the ablation catheter 200 can be a vapor ablation catheter that is configured to emit vapor (e.g., heated water vapor) from nozzles included in the vapor ablation catheter 200, as detailed herein.
  • a catheter shaft 205 of the ablation catheter 200 has a proximal end region that may remain external to the patient’s body and a distal end region 216 adapted to be introduced inside the patient’s body.
  • the proximal end region of the catheter shaft 205 may include a hub attached to it for connecting other diagnostic and/or treatment devices.
  • the catheter shaft 205 may have an elongated configuration having a circular cross-section or other suitable cross-section.
  • an expandable device 230 as described herein, may have a substantially circular cross-section or other suitable crosssection.
  • Other suitable cross-sectional configurations such as, but not limited to, rectangular, oval, irregular or the like may also be contemplated.
  • the catheter shaft 205 (and the expandable device 230) may have a cross-sectional configuration adapted to be received in a desired body lumen, such as the bronchus (e.g., bronchus 104 as illustrated in FIGS. 2A-2B) via the trachea (e.g., trachea 102 as illustrated in FIGS. 2A- 2B).
  • a desired body lumen such as the bronchus (e.g., bronchus 104 as illustrated in FIGS. 2A-2B) via the trachea (e.g., trachea 102 as illustrated in FIGS. 2A- 2B).
  • the dimensions of the catheter shaft 205 can be manipulated to navigate it through any desired body lumen such as through the bronchioles.
  • the stiffness of the catheter shaft 205 may be modified to form the ablation catheter 200 for use in various vessel diameters.
  • the material used for manufacturing the catheter shaft 205 may include any suitable biocompatible material such as, but are not limited to, polymers, metals, alloys, either in combination or alone.
  • the material employed may have enough stiffness for use in various lumen diameters, and sufficient flexibility to maneuver through tortuous and/or stenotic lumens, avoiding any undesirable tissue injuries.
  • the catheter shaft 205 may further include one or more lumens (not shown) extending through it.
  • the catheter shaft 205 may include a guidewire lumen and/or one or more auxiliary lumens.
  • the lumens may be configured in any suitable way such as those ways commonly used for medical devices.
  • the guidewire lumen may extend the entire length of the catheter shaft 205 such as in an over-the-wire catheter or may extend only along a distal portion of the catheter shaft 205 such as in a single operator exchange (SOE) catheter.
  • SOE single operator exchange
  • the ablation catheter 200 may further include a temperature sensor/wire, an infusion lumen, radiopaque marker bands, fixed guidewire tip, a guidewire lumen, external sheath, and/or other components to facilitate the use and advancement of the ablation catheter 200 within the patient’s body.
  • catheters herein such as the ablation catheter 200 may be used for both mapping and ablation functions, catheters that are specifically suited for mapping are also contemplated.
  • the ablation catheter 200 can include an expandable device 230.
  • the expandable device 230 can be a compliant, non-compliant, or semi- compliant expandable balloon, an expandable basket, or expandable stent-like structure, as described herein.
  • the expandable device 230 generally has a first low-profile unexpanded delivery configuration (e.g., an uninflated configuration) and a second deployed, radially-expanded configuration (e.g., an inflated configuration) where a portion of the expandable device 230 contacts a wall of a vessel in which the ablation catheter 200 is deployed.
  • an individual expandable device 230 may be disposed along the ablation catheter 200.
  • Employing an individual expandable device 230 can promote aspects herein, such as providing accurate deliver of vapor to a target region while mitigating emission of vapor (e.g., water vapor) to locations other than the target region.
  • vapor e.g., water vapor
  • a greater quantity of expandable devices may be employed.
  • the ablation catheter 200 may also include other structures, such as a deflectable tip, anchoring projections, a handle, one or more sealing balloons located proximally and/or distally with respect to the expandable device 230, and/or a coiled structure or other anchoring structure such as those that may be used to bring or maintain the expandable device 230 in contact with and/or in close proximity to a desired treatment region.
  • the systems herein can include at least one thermistor (e.g., a thermistor assembly, a thermistor array, etc.) electrically coupled to the console 40 (e.g., the control unit).
  • Such thermistors can be electrically configured to have temperature sensing capability.
  • the systems can include a thermistor located in the console 40, in a handle (e.g., handle 220) located along the ablation catheter 200, and/or in the ablation catheter 200, among other possibilities.
  • the console 40 can include various components including an energy generator (e.g., a steam generator, etc.) for delivering energy (e.g., steam energy) to the ablation catheter 200. That is, the console 40 can be fluidically coupled with (e.g., be in fluid communication with) the ablation catheter 200. Additionally, the console can be communicatively coupled with the ablation catheter 200. Further details of the console 40 and the ablation catheter 200 are described herein.
  • an energy generator e.g., a steam generator, etc.
  • energy e.g., steam energy
  • the ablation catheters herein such as the ablation catheter 200 can be free of ablation electrodes (e.g., RF electrodes) that, in some other approaches, are disposed on an outer surface of a medical device (e.g., on an outer surface of an expandable balloon and/or expandable basket) and are configured to perform tissue ablation via the electrodes.
  • ablation electrodes e.g., RF electrodes
  • a medical device e.g., on an outer surface of an expandable balloon and/or expandable basket
  • vapor ablation catheters that are ablation electrode-free can mitigate issues (e.g., electrical short and/or unintended tissue destruction), typically associated with electrode-based ablation approaches and/or can yield ablation catheters with relatively smaller crosssections (e.g., as compared to electrode-based ablation catheters) at least when in a first (unexpanded configuration).
  • issues e.g., electrical short and/or unintended tissue destruction
  • FIG. IB shows a schematic representation of a system 20 for performing a vapor ablation treatment within a body passageway.
  • the console 40 can include a reservoir 50, a pump 52, and a heating element manifested as a first heating element 54 and a second heating element 56.
  • the console 40 can include an autoclave, as described herein.
  • the reservoir 50 can be a reservoir that is configured to store a liquid such as liquid water, liquid deionized water, liquid distilled water, among other types of liquids.
  • the reservoir 50 may be a tank or other vessel configured to store liquid deionized water.
  • the pump 52 can be a pump that is configured to pump the liquid stored in the reservoir 50 to a heating element such as the first heating element 54 and the second heating element 56.
  • the pump 52 can control a flow rate of the liquid supplied to the heating element and/or a flow rate of water vapor supplied to the ablation catheter 202.
  • water vapor generated from the console 40 will enter a lumen (e.g., vapor lumen 307 as illustrated in FIG. 3C) in the ablation catheter 202 and be released at the distal end region of the ablation catheter 202 via a distal tip of the ablation catheter 202 and/or via nozzles (e.g., via nozzles in an expandable device and/or in the ablation catheter 202).
  • all water vapor provided to the ablation catheter 202 is released via nozzles in the expandable device. However, in some instances a portion of the water vapor provided to the ablation catheter 202 can be released via nozzles in the expandable device and a remaining portion of the water vapor can be released via a distal tip of the ablation catheter 202, as described herein.
  • the heating elements 54, 56 can be configured to heat a liquid via conduction, convection, and/or radiation.
  • the first heating element 54 and the second heating element 56 can be resistive heating elements and/or tubular heating elements, among other types of heating elements.
  • the first heating element 54 and the second heating element 56 can be positioned along a flow path between the pump 52 and the ablation catheter 202.
  • the first heating element 54 and the second heating element 56 can be configured in parallel or can be configured in series on the flow path between the pump 52 and the ablation catheter 202.
  • the first heating element 54 and the second heating element 56 can be configured in series as illustrated in FIG. IB.
  • first heating element 54 and the second heating element 56 be configured in series can promote aspects herein such as providing a superheated vapor (e.g., superheated water vapor) to the ablation catheter 200.
  • a superheated vapor e.g., superheated water vapor
  • the system 20 can include fewer or additional heating elements.
  • additional or alternate heating elements may be included elsewhere in the system 20 such as being included along a length of an ablation catheter (e.g., along a catheter shaft and/or in a handle of the ablation catheter, etc.).
  • the ablation catheter 202 can include a handle such as the handle 220 illustrated in FIG. IB.
  • the handle 220 can include circuitry and/or otherwise be configured to permit a physician to move the ablation catheter 202 within a patient, alter a configuration of the expandable device (inflate or deflate the expandable balloon), and/or can permit the physical to control a rate of vapor supplied to the distal end region of the ablation catheter 202.
  • the handle 220 can include one or more controls (e.g., a control knob) configured to alter a flow rate of water vapor that is delivered from the console 40 via a vapor lumen in the ablation catheter 202 to the distal end region (e.g., to the nozzles in the expandable balloon) of the ablation catheter 202.
  • controls e.g., a control knob
  • the expandable device 230 can include a plurality of nozzles that are configured to emit a vapor.
  • the expandable device 230 and the nozzles can be located at a distal end region of the ablation catheter 202.
  • the expandable device 230 can be an expandable balloon or an expandable basket located at a distal end region 216 of the ablation catheter 202, as detailed herein, that is configured to emit a vapor to ablate tissue proximate to the nozzles.
  • FIG. 1A illustrates the presence of an expandable device 230
  • ablation catheters can be employed that do not include an expandable device (e.g., do not include an expandable device located at a distal end region of the ablation catheters).
  • ablation catheters may include nozzles located at a distal end region (e.g., along an outer surface of the ablation catheters and/or at a distal tip of the ablation catheters) in the absence of an expandable device.
  • Employing ablation catheters without an expandable device may further reduce a profile of the ablation catheters and thereby promote aspects herein such as permitting the emission of vapor to target regions that are located in relatively small vessels.
  • the expandable device 230 of FIG. 1 A can be manifested as an expandable balloon 231.
  • the expandable balloon 231 can include a plurality of nozzles 232 that are configured to emit a vapor (represented as element 209).
  • the expandable balloon 231 can be located in a distal end region 216 of an ablation catheter 202. Having the expandable device 231, and therefore the nozzles 232, be located in the distal end region 216 can promote aspects herein such as permitting the emission of vapor to target regions that are located in relatively small vessels.
  • the expandable device 230 can be located at a distal tip 210 of an ablation catheter, for instance, as is described herein.
  • an ablation catheter such as the ablation catheter 202 can include a nozzle or opening 208 located at a distal tip 210 thereof.
  • the nozzle or opening 208 can be in fluid communication with a vapor lumen in the ablation catheter.
  • nozzles such as the nozzles 232 and the nozzle or opening 208 can each be in fluid communication with a common (individual) lumen in the ablation catheter that is configured to provide the vapor to the nozzles and the nozzle or opening 208.
  • water vapor can be provided via a vapor lumen in the ablation catheter 202 to the nozzles 232 and a remaining portion of the water vapor can continue to travel distally via the vapor lumen until being emitted by the nozzle or opening 208.
  • FIG. 1C shows a schematic representation of a system 22 for performing a vapor ablation treatment within a body passageway.
  • the system 22 is similar to the system 20, with the difference that the ablation catheter 202 and the expandable balloon 231 are replaced with the ablation catheter 203 which includes nozzles 232.
  • the ablation catheter 203 does not include a nozzle or opening located at the distal tip 210 of the ablation catheter 203.
  • an entire amount of vapor 209 provided via a vapor lumen (e.g., not illustrated in FIG. 1C) in the ablation catheter 203 to the nozzles 232 can be emitted by the nozzles 232.
  • FIG. ID shows a schematic representation of a system 24 for performing a vapor ablation treatment within a body passageway.
  • the system 24 is the same as the system 22 with the difference that the system 24 includes a nozzle or opening 208 located at the distal tip 210 of the ablation catheter 204 instead of the nozzles 232.
  • a nozzle or opening 208 located at the distal tip 210 of the ablation catheter 204 instead of the nozzles 232.
  • an entire amount of vapor 209 provided via a vapor lumen, as described herein, in the ablation catheter 204 to nozzle or opening 208 can be emitted by the nozzle or opening 208.
  • FIG. IE shows a schematic representation of a system 25 for performing a vapor ablation treatment within a body passageway.
  • the system 25 is the same as the system 22 with the difference that the system 25 includes a retractable motor drive 83 configured to automatically retract the catheter shaft 205 of the ablation catheter.
  • the retractable motor drive 83 can be a variable speed motor configured to retract the elongate catheter at a given retraction rate e.g., as determined by a user via an input provided to a handle and/or at a predetermined retraction rate.
  • retraction of an elongate ablation catheter by the retractable motor drive 83 can occur at a predetermined retraction rate.
  • the distal end region 216 of the elongate catheter shaft 205 can be retracted within a vessel at the predetermined retraction rate while vapor is emitted from the nozzles 232 located in the distal end region 216, thereby uniformly treating a larger area within the vessel as compared to deploying the elongate catheter at a fixed location in the vessel.
  • the predetermined retraction rate can be fixed (e g., constant) or can be variable.
  • the predetermined retraction rate can be determined based on vessel diameter (e.g., internal diameter) such as a bronchi diameter, a flow rate of the vapor, a temperature of the vapor, a severity of disease progression or desired depth of penetration of heat from the vapor 209 into tissue, or any combination thereof.
  • vessel diameter e.g., internal diameter
  • the retraction rate may be progressively or incrementally reduced as the elongate catheter is retracted. That is, as the distal end region of the catheter is retracted the vessels that are adjacent to the distal end region may become larger (e.g., having progressively larger inner diameters).
  • the progressive or incremental reduction of the retraction rate may ensure a uniform impact on tissue along the vessel (e.g., tissue that is further away from the nozzles 232 is exposed to the vapor for a longer duration of time to ensure a uniform treatment of tissue along the retraction path).
  • Automatic retraction can occur responsive to an input to the handle 220. For instance, a physician can provide an input to initiate and/or cease automatic retraction of the elongate catheter.
  • the automatic retraction (e.g., longitudinally) of the elongate catheter can occur in combination with rotation of the elongate catheter about the longitudinal axis of the elongate catheter.
  • Employing automatic retraction of the elongate catheter in combination with automatic rotation (e.g., a fixed or variable angular speed) about the longitudinal axis of the elongate catheter can promote aspects herein such as promoting uniform application of the vapor along a length and circumference of a vessel.
  • FIG. IF shows a schematic representation of a system 29 for performing a vapor ablation treatment within a body passageway.
  • the system 29 is the same as the system 22 with the difference that the system 29 includes a coil 88 extending from (e.g., out of) the distal tip 210 of the ablation catheter 207.
  • the coil 88 can be used to bring the nozzles 232 within a threshold distance of a desired treatment region.
  • the coil 88 can have a diameter that is larger than a diameter of an elongate catheter shaft 205 of the ablation catheter 203 and thereby can contact a vessel wall to anchor the nozzles 232 of the ablation catheter 203 a threshold distance from tissue in the vessel wall.
  • the nozzles 232 can be micromachined into a tube or can otherwise be provided in the elongate catheter shaft 205 of an ablation catheter such as the ablation catheter 203.
  • the nozzles 232 can be micromachined as substantially circular or oval openings extending longitudinally and/or circumferentially about the elongate catheter shaft 205, as illustrated in FIG. IF.
  • the nozzles 232 can be elongate slits extending substantially circumferentially about a portion of the catheter shaft 205.
  • the nozzles can be formed of a series of elongate slits 237 positioned longitudinally along and extending substantially circumferentially about the elongate catheter shaft 205, as illustrated in FIG. 1G.
  • Employing the series of elongate slits 237 can permit application of vapor 209 via the elongate slits 237 and may also provide the catheter shaft 205 an added degree of flexibility thereby easing insertion of the ablation catheter.
  • an outer surface of the ablation catheters can have a hydrophilic and/or friction-reducing coating over the outer surface.
  • a hydrophilic coating and/or friction-reducing coating on an outer surface of a distal end region of an elongate shaft may facilitate insertion and advancement of the distal end region into the patient.
  • the use of a hydrophilic and/or friction-reducing coating may minimize discomfort and / or otherwise improve patient outcomes.
  • the ablation catheters herein can include a lumen (not illustrated in FIGS. 1A- 1H) extending between the proximal end region 214 and the distal end region 216 of the ablation catheters in FIGS. 1A-1H.
  • the lumen can include at least a vapor lumen, as described herein.
  • the vapor lumen can be in fluidic communication with the console 40 and nozzles (e.g., nozzles in a distal end region and/or distal tip of the ablation catheters and/or nozzles in an expandable device).
  • the nozzles can be configured to receive vapor via the vapor lumen and emit the vapor (e.g., superheated water vapor), for instance, to perform BTVA.
  • the lumen can include an inflation lumen that is fluidically coupled to the expandable balloon 231, as described herein.
  • FIGS. 1 A- 1G illustrate the presence of various elements (e.g., heating elements 54, 56) in the console 40
  • some or all of the elements in the console 40 may be replaced with an autoclave.
  • FIG. 1H shows a system 30 for performing a vapor ablation treatment within a body passageway.
  • the system 30 in FIG. 1H is the same as the system 20 in FIG. IB with the difference that the reservoir 50, the pump 52, and the heating element (e.g., the first heating element 54 and the second heating element 56) are replaced with an autoclave 60.
  • the autoclave 60 refers to a device configured to supply heated water vapor (steam) to an ablation catheter such as the ablation catheter 202.
  • the autoclave 60 can include a reservoir (not shown) configured to store a liquid (e.g., deionized water) and can include a heating element (not shown) configured to heat the liquid to form a heated water vapor.
  • FIG. 2A schematically illustrates an example ablation catheter (illustrated as ablation catheter 202 of FIG. IB including an expandable balloon 231 with nozzles (not illustrated) disposed along a body lumen.
  • FIG. 2B schematically illustrates an example ablation catheter (illustrated as ablation catheter 202 of FIG. 4A including an expandable basket 241 with nozzles (not illustrated)) disposed along the body lumen.
  • the ablation catheter 202 extends through a trachea 102 and into a bronchus 104. As illustrated in FIGS.
  • the systems and methods herein can treat smaller vasculatures (e.g., level 3-5 bronchi), as compared to other approaches such as those approaches which employ bulky ablation electrodes (e.g., RF electrodes).
  • the ablation catheter 202 may be used to identify a target nerve along the bronchus 104 for treatment of, for example, BHR to reduce the probability of acute exacerbations in COPD (AECOPD) events.
  • AECOPD COPD
  • the ablation catheter 202 may be used to treat the muscle and/or nerves along the bronchus 104 of the patient, it should be noted that the ablation catheter 202 may be used to identify and treat muscle and/or nerves along other body lumens including along the airways, blood vessels, or the like.
  • the ablation catheter 202 can be used to treat muscle and/or nerves disposed in other body regions such as kidney, heart, bladder, or the like.
  • the ablation may be performed using BTVA which is an endoscopic lung volume reduction (ELVR) treatment that helps to reduce hyperinflation and improve respiratory mechanics in patients with various conditions such as severe emphysema thereby make breathing easier for the patient.
  • BTVA endoscopic lung volume reduction
  • FIGS. 3A-3B show schematic representations of side views of ablation catheters 202 including expandable devices that are configured to perform an ablation treatment within a body passageway.
  • the expandable device can be manifested as the expandable balloon 231 .
  • the expandable balloon 231 can be coupled to a respective location on an outer surface of the catheter shaft 205 and can be configured to expand radially (e.g., relative to the outer surface of the catheter shaft 205) to an expanded configuration and thereby cause a portion of the expandable balloon 231 to contact tissue at a target region in a vessel.
  • the expandable devices herein may be configured to transition between a first (unexpanded) configuration and a second (expanded) configuration.
  • the expandable devices may remain in a straightened configuration (e.g., having anchoring projections, legs, and/or struts disposed substantially parallel along the length of the catheter shaft).
  • the expandable devices may switch to an expanded configuration (e.g., such that the anchoring projections, legs, and/or struts extend radially outwards, for instance, to take on an arcuate-shaped configuration such as an arcuate leg).
  • the expandable devices herein remain in the first straightened configuration in a delivery state, for example, when an ablation catheter such as the ablation catheter 202 is being traversed through the patient’s body, in particular, the body lumen such as the trachea 102 (as shown in FIGS. 2A-2B).
  • an ablation catheter such as the ablation catheter 202
  • the body lumen such as the trachea 102 (as shown in FIGS. 2A-2B).
  • a physician may cause the expandable device (e.g., the expandable balloon 231) to expand.
  • the physician can inflate the expandable balloon 231 with fluid conveyed via an inflation lumen and/or can manipulate the proximal region of an ablation catheter to switch an expandable basket, as described herein, from a first (unexpanded) configuration to the second (expanded) configuration.
  • the anchoring projections and/or the legs may be adjusted and arranged such that one or more nozzles are positioned a threshold distance away from but are not in contact with the airway wall of the bronchus.
  • the therapy may be provided to the target region to treat the one or more symptoms of the COPD patient.
  • the expandable balloon 231 can be positioned at a distal end region of an elongate shaft such as the elongate catheter shaft 205. In some instances, the expandable balloon 231 can be located at a distal tip 210 of the elongate catheter shaft 205. For example, as illustrated in FIGS. 3 A-3B, a distal tip of the expandable balloon 231 can be located at the distal tip 210 of the elongate catheter shaft 205.
  • the distal end of the expandable device e.g., the expandable balloon 231) and/or the distal end of the ablation catheter (e.g., a distal tip 210 of the ablation catheter) can be a blunt (e.g., generally rounded) and/or can be flexible. Having the distal end of the expandable device (e.g., expandable balloons and/or expandable baskets) and/or the distal end of the ablation catheters be blunt and/or flexible may promote aspects herein, such a prompting ease of navigation of the ablation catheters and/or mitigating any unintended damage to tissue that as compared to other approaches that employ sharp and/or rigid catheter tips.
  • An expandable device can include a number of nozzles disposed on an outer surface of the expandable device.
  • a number of nozzles can be disposed on legs of an expandable basket, as described herein, or can be disposed on an outer surface of an expandable balloon.
  • a number of nozzles 232 and a number of anchoring projections 236 can be disposed about an outer surface 270 of the expandable balloon 231.
  • a total quantity of the anchoring projections 236 can be less than or equal to a total quantity of the nozzles 232.
  • a total quantity of the anchoring projections 236 can be less than a total quantity of the nozzles 232, as illustrated in FIG. 3A.
  • a total quantity of the anchoring projections 236 can be equal to a total quantity of the nozzles 232, as illustrated in FIG. 3B.
  • a ratio of a total quantity of nozzles 232 to a ratio of a total quantity of the anchoring projections can be in a range from 20: 1, 10:1, 6: 1, 3: 1, 2: 1, or 1 : 1, among other possibilities.
  • the anchoring projections 236 and the nozzles 232 can be located at respective (different) locations on the outer surface 270 of an expandable device such as the expandable balloon 231. Each nozzle of the nozzles 232 can be located at a different respective location.
  • the anchoring projections 236 and the nozzles 232 can be positioned longitudinally along and/or circumferentially about the outer surface 270 of the expandable balloon 231. For instance, the anchoring projections 236 and the nozzles 232 can be positioned longitudinally along and circumferentially about the outer surface 270 of the expandable balloon 231 in a patterned array at different respective locations, as illustrated in FIGS. 3A-3B.
  • the anchoring projections 236 can be coupled to an inflation lumen (e.g., inflation lumen 311 as illustrated in FIG. 3C) in the elongate catheter shaft 205 of an ablation catheter.
  • inflation of the outer surface 270 of the expandable balloon 231 or inflation of the outer surface 270 and inflation of the anchoring projections 236 themselves (which are disposed on the outer surface 270) can cause the anchoring projections 236 to expand radially (e.g., relative to an outer surface of the elongate catheter shaft 205 and/or relative to the outer surface 270 of the expandable balloon 231).
  • having the anchoring projections expand radially relative to the outer surface 270 of the expandable balloon 231 can promote aspects herein such as promoting anchoring of the expandable balloon 231 at a target region in a vessel, maintaining the nozzles 232 a threshold distance away from tissue in the target region, and/or promoting navigation of an ablation catheter (e.g., when the anchoring projections and the expandable balloon are in an unexpanded configuration).
  • each of the anchoring projections 236 can be the same size and/or shape.
  • each of the anchoring projections 236 can be an elongate projections that are the same size and shape (e.g., each having tapered distal and proximal ends).
  • Employing anchoring projections that are the same size and shape can promote aspects herein such as promoting anchoring of the expandable balloon 231 at a target location, promoting uniform blood flow through gaps 296 between adjacent anchoring projections 236, and/or maintaining the nozzles 232 a threshold distance from tissue in the target region.
  • the anchoring projections 236 can be different sizes and/or shapes.
  • the anchoring projections 236 can include a patterned array of anchoring projections that are positioned longitudinally and circumferentially about the outer surface 270 of the expandable balloon 231. That is, a plurality of anchoring projections 236 can extend longitudinally along the outer surface 270 of the expandable balloon 231 and a plurality of anchoring projections can extend about a circumference of the outer surface of the expandable balloon 231. For instance, the anchoring projections 236 can be positioned circumferentially about the outer surface 270 of the expandable balloon 231 in a uniform pattern (e.g., having substantially equal distance between equivalent positions on adjacent anchoring projections of the anchoring projections 236), as illustrated in FIGS. 3A-3B.
  • anchoring projections 236 be positioned circumferentially about the outer surface 270 of the expandable balloon 231 in a uniform patterned array can promote aspects herein, such as promoting anchoring of the expandable balloon 231 at a target location, promoting uniform blood flow through the gaps 296 between adjacent anchoring projections, and/or maintaining the nozzles 232 a threshold distance from tissue in the target region.
  • the anchoring projections 236 can be positioned about the outer surface 270 of the expandable balloon in a non-uniform manner.
  • the anchoring projections 236 can be configured in substantially the same direction.
  • each of the anchoring projections 236 can be configured in a first direction, as illustrated in FIG. 3A, or can be configured in a second direction, as illustrated in FIG. 3B.
  • each of the anchoring projections 236 can be configured in a first direction that is substantially orthogonal to a longitudinal axis of the expandable balloon 231, as illustrated in FIG. 3 A.
  • each of the anchoring projections can be configured in a second direction that extends substantially along the longitudinal axis of the expandable balloon 231, as illustrated in FIG. 3B.
  • the nozzles 232 can be located on the outer surface 270 of the expandable balloon 231 at locations that are adjacent to the anchoring projections 236.
  • having the nozzles 232 be adjacent to the anchoring projections 236 refers to the nozzles 232 being in close proximity to, but not in contact with, the anchoring projections 236.
  • the nozzles 232 can be located adjacent to at least one anchoring projection 236, as illustrated in FIGS. 3A-3B.
  • Having the nozzles 232 be located adjacent to the anchoring projections 236 can promote aspects herein such as promoting the emission of vapor via the nozzles 232 to ablate tissue proximate thereto. That is, when the expandable balloon 231 is a second (expanded) configuration the anchoring projections 236 can anchor the expandable balloon 231 within a vessel inside a body of a patient.
  • the approaches herein can ensure that a threshold distance between the nozzles 232 and the inner wall 280 is maintained.
  • a threshold distance 290 can be maintained between the nozzles 232 on the outer surface 270 of an expandable device such as the expandable balloon 231 and the inner wall 280 in a target region (e.g., bronchus 104), as illustrated in FIG. 3D which shows a cross-section (taken at section line 252 in FIG. 3 A) of the expandable balloon 231.
  • the expandable balloon 231 can be configured to maintain the threshold distance 290 between tissue of the inner wall 280 and the nozzles (e.g., from the radial most tip of the nozzles 232) when the expandable balloon 231 is in the expanded configuration, as illustrated in FIG. 3C.
  • the nozzles 232 can be at a first position at which the nozzles 232 extend a first distance 292 from the outer surface 270 and the anchoring projections 236 can be at a second position at which the anchoring projections 236 extend a second distance 294 from the outer surface 270 with the second distance 294 being larger than the first distance 292, as illustrated in FIG. 3C.
  • Maintaining the threshold distance 290 when the expandable balloon 231 is in a second (expanded) configuration can promote aspects herein such as promoting a precise application of the vapor via the nozzles 232 to the inner wall 280 and yet avoiding the unintended application of the vapor to tissue surrounding the target region.
  • the threshold distance 290 can be in a range from about 0.5 millimeters to about 1.5 millimeters. All individual values and sub-ranges from about 0.5 millimeters to about 1.5 millimeters are included.
  • the threshold distance can be about 0.5 millimeters, about 0.6 millimeters, about 0.7 millimeters, about 0.8 millimeters, about 0.9 millimeters, about 1.0 millimeters, about 1.1 millimeters, about 1.2 millimeters, about 1.3 millimeters, about 1.4 millimeters, or about 1.5 millimeters.
  • a distance of at least about 0.1 millimeters, of at least about 0.2 millimeters, of at least about 0.3 millimeters, of at least about 0.4 millimeters, or at least about 0.5 millimeters can be maintained between the nozzles (e.g., between tissue of an inner wall of a vessel and a location on the nozzles that is most proximate (radially) to the tissue.
  • the expandable devices e.g., expandable balloon and/or expandable baskets
  • the expandable devices herein can in some embodiments be configured to permit blood flow past the expandable devices when the expandable devices are in the second (expanded) configuration.
  • anchoring projections 236 may contact tissue proximate to an outer surface of the expandable balloon 231 and blood may be permitted to flow longitudinally through gaps 296 between adjacent anchoring projections 236. Permitting blood flow when the expandable devices are in the second (expanded) configuration may improve the patient experience and/or reduce complications as compared to other approaches that employ sealing balloons to isolate an area within a vessel (e.g., as compared to surgical intervention such as that employ sealing balloons).
  • FIG. 3C shows a schematic representation of a cross-section (taken at section line 248 in FIG. 3A) of a portion of an ablation catheter (vapor ablation catheter).
  • the elongate catheter shaft 205 can include a lumen 310 extending between the proximal end region and the distal end region of the elongate catheter shaft 205.
  • the lumen 310 can include a vapor lumen 307 and an inflation lumen 311, as illustrated in FIG. 3C.
  • the vapor lumen 307 and an inflation lumen 311 can be separate and distinct respective lumens, as illustrated in FIG. 3C.
  • the vapor lumen 307 can be configured to permit vapor (represented as 309) to be conveyed from an outlet of a console (e.g., console 40 as illustrated in FIG. 1A) to nozzles (e.g., the nozzles 232) in an expandable device in an ablation catheter.
  • a console e.g., console 40 as illustrated in FIG. 1A
  • nozzles e.g., the nozzles 232
  • water vapor can be conveyed via the vapor lumen 307 to the nozzles 232 which emit the water vapor to ablate tissue adjacent to the nozzles.
  • the inflation lumen 311 can be configured to permit a fluid (represented as 313) to be conveyed from an outlet of the console to the anchoring projections 236.
  • the fluid 313 can be a gas such as compressed air or a liquid such as liquid water (e.g., liquid water at ambient room temperature or normothermia) having a sufficient volume and/or a sufficient pressure to cause the expandable balloon 231 to expand and/or to cause the anchoring projections 236 to expand, as described herein.
  • the nozzles 232 and the anchoring projections 236 can each be uniformly spaced about the circumference of the outer surface 270 of the expandable balloon 231.
  • nozzles 232 and the anchoring projections 236 each be uniformly spaced about the circumference of the outer surface 270 can promote aspects herein such as promoting anchoring of the expandable balloon 231 at a target region in a vessel, maintaining the nozzles 232 a threshold distance away from tissue in the target region, and/or promoting uniform and effective vapor ablation of tissue in the target region.
  • the expandable device 230 can be manifested as the expandable balloon 231. However, in some instances the expandable device 230 can be manifested as a different structure such as an expandable basket.
  • FIG. 4A shows a schematic representation of a side view of an ablation catheter 272 including an expandable device configured to perform a vapor ablation treatment within a body passageway.
  • the expandable device can be manifested as an expandable basket 241 coupled to a catheter shaft 205.
  • the expandable basket 241 may also be configured to switch between a first and a second configuration, where the expandable basket 241 may remain straightened in the first configuration and may switch to an expanded state in the second configuration.
  • the ablation catheter 272 may include a steering member or wire (not shown) that may be manipulated in order to cause the expandable basket 241 to shift from a first configuration (e.g., a generally straightened configuration) to a second (expanded) configuration that includes a curved portion.
  • the steering member or wire may be configured to impart a longitudinal force on a distal cap 211 and thereby cause the distal cap to longitudinally translate closer to the catheter shaft 205. The movement of the distal cap 211 can in turn cause legs 226 to deflect axially outwards thereby forming curved portions which can contact tissue at a target region.
  • the expandable basket 241 may include a plurality of legs 226 extending longitudinally along the expandable basket 241.
  • Each leg 226 may be an arcuate leg having an arcuate-shaped configuration such that a proximal end of each leg 226 may be coupled to a hub 219 in the distal end region 216 of the ablation catheter 202, while a distal end of the legs 226 may be coupled to a distal cap 211.
  • the arcuate legs can be substantially convex legs having a substantially convex shape (e.g., a sustainably convex arc) with respect to a longitudinal axis of the expandable basket 241, as illustrated in FIG. 4A.
  • the legs 226 may be coupled to catheter shaft 205 and the distal cap 211 using mechanisms such as, for example, gluing, welding, soldering, thermal bonding, mechanical bonding, or the like. While illustrated in FIG. 4A as having a distal end of the legs coupled to the distal cap 211 of the ablation catheter 272, in some instances, both the proximal end and the distal end of the legs 226 can be coupled to two different portions of the catheter shaft 205 (rather than having the distal end of the legs 226 be coupled to the distal cap 211).
  • One or more of the legs 226 can include one or more nozzles 232.
  • each leg 226 has four nozzles 232, which may be located in a uniform arrangement along the length of each leg 226.
  • the legs 226 may include any number of nozzles 232 located either uniformly or non-uniformly along the length of each leg 226.
  • each of the nozzles 232 may be configured in an outward direction to direct vapor outwardly (away from) each of the legs 226, as illustrated in FIG. 4A. Having at least some of the nozzles directed outwardly can promote aspects herein such as minimizing a distance between vapor existing the nozzles 232 and tissue at a target region (e.g., tissue that is a threshold distance from the nozzles 232).
  • the at least some of the nozzles 232 may be configured in an inward direction to direct vapor inwardly (toward at least one adjacent leg).
  • each of the nozzles 232 can be directed inwardly, as illustrated with the ablation catheter 274 in FIG. 4B. Having at least some of the nozzles directed inwardly can promote aspects herein such as ensuring that a threshold distance is maintained between the nozzles 232 and tissue that is adjacent to the nozzles.
  • the center or centermost nozzles can be configured inwardly, while other more distal or more proximal nozzles can be configured outwardly, as illustrated in FIG. 4C.
  • the legs 226 can secure the expandable basket 241 in place against a vessel wall (e.g., directly contact a tissue) at a target location and yet vapor can be emitted via each of the nozzles 232 which are each located a threshold distance away from the tissue at the target region (e.g., the tissue in contact with the legs 226) at least by virtue of having the center or centermost nozzles be configured inwardly.
  • a central portion 234 of the legs 226 can be nozzle-free.
  • a central portion 234 (e.g., which is radial -most region of the legs 226 when the expandable basket 241 is in a second configuration) can be nozzle-free.
  • the central portion 234 of the legs 226 can be configured to contact tissue at target region and the nozzles 232 which are disposed adjacent to (e.g., proximally or distally from) the central portion 234 can each be maintained a threshold distance away from the tissue at the target region.
  • each of the legs 226 can include nozzles 232, as illustrated in FIG. 4A-4C. However, in some embodiments a portion of (but not all of) the legs 226 can include nozzles 232. For instance, a first subset 226 of the legs 226 can include nozzles 232 while a second subset 229 of the legs does not include nozzles, as illustrated in FIG. 4D. For instance, as illustrated in FIG. 4D the legs can alternate between having nozzles and omitting nozzles such that every other leg (circumferentially about the longitudinal axis of an ablation catheter 278) includes nozzles 232.
  • the legs 226 without nozzle may be configured to extend a first (larger) distance from a longitudinal axis of the ablation catheter 202 and thereby may be in direct contact with tissue in target region, while the legs with nozzle 232 may be configured to extend a second (smaller) distance from the longitudinal axis of the ablation catheter 202 and thereby the nozzles 232 may be maintained a threshold distance from the tissue at the target region.
  • FIGS. 4A-4D illustrate ablation catheters including baskets with curved central portions
  • the baskets can include different configurations.
  • the expandable basket can include struts with a linear central portion, as illustrated in FIG. 5.
  • FIG. 5 illustrates an example ablation catheter 560 having a catheter shaft 205 with an expandable basket 555 formed of a plurality of struts 561.
  • the catheter shaft 205 may include a plurality of longitudinal struts 561 extending distally therefrom.
  • One or more of the struts 561 can have at least one nozzle 232 disposed thereon. Any quantity of struts, legs, balloons, baskets, and/or nozzles can be employed on the expandable devices herein.
  • each strut 561 can include a first angled section 582, a second angled section 584, and a linear central section 580 connecting a distal end of the first angled section 582 to proximal end of the second angled section 584, as illustrated in FIG. 5.
  • first angled section 582 can be a proximal most element of the strut
  • second angled section 584 can be a distal most section of the strut
  • the linear central section 580 can be located between the first angled section 582 and the second angled section 584.
  • the angled sections 582, 584 can extend at a non-zero angle (e.g., in a range from about 1 degree to about 60 degrees) with respect to a longitudinal axis of the expandable basket 555 when the expandable basket is in an expanded configuration, as shown in FIG. 5.
  • the linear central section 580 can extend substantially coaxially with or substantially parallel to a longitudinal axis of the expandable basket 555, as illustrated in FIG. 5.
  • the linear central section 580 can include one or more nozzles (e.g., one or more inwardly configured nozzles). However, in some embodiments the linear central section 580 can be nozzle-free (e.g., is without any nozzles), as illustrated in FIG. 5. In some embodiments, the linear central section 580 of a strut 561 can be nozzle-free (e.g., does not include a nozzle) and one or both of the angled sections 582, 584 can include a nozzle. In some embodiments, the nozzles 232 are located at least on the first angled section and the second angled section.
  • each of the first angled section 582 and the second angled section 584 of the strut 561 can include a plurality of nozzles 232 thereon and the linear central portion 580 can be nozzle-free, as illustrated in FIG. 5.
  • the first angled section 582 and the second angled section 584 of the strut 561 can include a plurality of nozzles 232 thereon that are configured in an outward direction (e.g., configured to emit vapor in a direction away from a longitudinal axis of the expandable basket 555) and the linear central portion 580 can be nozzle-free, as illustrated in FIG. 5.
  • one or more of the angled sections 582, 584 and/or the linear central portion 580 can include nozzles that are configured in an inward direction (e.g., configured to emit vapor in a direction toward the longitudinal axis of the expandable basket 555).
  • the angled sections 582, 584 can include nozzles configured in an outward direction and the linear central section 580 can include nozzles configured in an inward direction.
  • each of the angled sections 582, 584 and the linear central section 580 can include nozzles that are configured in an inward direction (e.g., only include nozzles that are configured in an inward directions.
  • each of the nozzles can be maintained a threshold distance away from tissue at a target region when the expandable basket 555 is in an expanded configuration. That is, the nozzles 232 can be located on an inside surface and/or an outside surface of the legs and/or struts of the expandable baskets herein.
  • the expandable baskets herein e.g., the expandable baskets 241 and/or 555
  • the expandable baskets herein can include at least some nozzles located on an inside surface of the expandable basket.
  • an inside surface of a leg or strut refers to a portion of a leg or strut that is most proximate to a longitudinal axis of the expandable basket. That is, the inside surface of the leg or strut may be oriented toward a longitudinal axis of the expandable basket.
  • each of the nozzles in an expandable basket herein can be located on an inside surface of a leg or a strut of the expandable basket.
  • the nozzles can be located on an inside surface of a leg or strut and be configured to emit a vapor in a direction that is substantially toward a longitudinal axis of the expandable basket.
  • one or more of the nozzles can be located on an outside surface of the expandable baskets herein.
  • an outside surface of a leg or strut refers to a portion of a leg or strut that is least proximate (or less proximate relative to an inside surface) to a longitudinal axis of the expandable basket. That is, the outside surface of the leg or strut may be oriented away from a longitudinal axis of the expandable basket.
  • each of the nozzles in an expandable basket herein can be located on an outside surface of a leg or a strut of the expandable basket.
  • the nozzles can be located on an outside surface of a leg or strut and be configured to emit a vapor in a direction that is substantially away from a longitudinal axis of the expandable basket.
  • the expandable basket 555 with the struts 561 may also be configured to switch between a first and a second configuration, where the expandable basket 555 may remain straightened in the first configuration and may switch to an expanded state in the second configuration.
  • the ablation catheter 560 may include a steering member or wire (not shown) that may be manipulated in order to cause the expandable basket 555 to shift from a first configuration (e.g., a generally straightened configuration) to a second (expanded) configuration that includes struts in an expanded configuration (e.g., extending axially from the expandable basket 555.
  • the steering member or wire may be configured to impart a longitudinal force on a distal cap 511 and thereby cause the distal cap 511 to longitudinally translate closer to the catheter shaft 205.
  • the movement of the distal cap 511 can in turn cause the struts 561 to deflect axially outwards thereby forming struts with linear central portions 580 which can contact tissue at a target region.
  • the linear central portions 580 may be in contact with tissue at a target region and angled sections such as a first angled section 582 and a second angled section 584 may be spaced away from the tissue.
  • the expandable basket 555 can be configured to maintain a threshold distance between the tissue and the nozzles when the expandable basket 555 is in the expanded configuration. While FIG. 5 illustrates the nozzles 232 as being in particular locations, other nozzle configurations such as those described with respect to the expandable basket 421 in FIGS. 4A-4D are possible.
  • FIG. 6 illustrates a section view of an example of a portion of an ablation catheter 200 including a heated reinforcement layer 670.
  • Having the heated reinforcement layer 670 present along at least a portion of or all of the catheter shaft (e.g., the catheter shaft 205 as illustrated in FIG. 1 A, FIG, 4A-4D, and/or FIG. 5) of the ablation catheter 200 can promote aspects herein.
  • the heated reinforcement layer 670 can be heated to a temperature that is above ambient temperature and/or that is above normothermia.
  • the heated reinforcement layer can be heated to a temperature that is greater than about 36.5 degrees or that is greater than about 37.5 degrees Celsius, among other possibilities.
  • the heated reinforcement layer 670 can be disposed between an inner layer 668 and an outer layer 676.
  • the heated reinforcement layer 670 can be disposed about an entire circumference of the inner layer 668, as illustrated in FIG. 6.
  • the inner layer 668 can define a lumen (e.g., the lumen 310 as described with respect to FIG. 3C).
  • the inner layer 668 can be formed of a thermally conductive material such as various polymers and/or metals.
  • the outer layer 676 can be disposed about an entire circumference of the heated reinforcement layer 670 as illustrated in FIG. 6.
  • the outer layer 676 can be formed of an insulative material that is configured to retain or reflect the heat from the heated reinforcement layer 670 within the catheter shaft.
  • the heated reinforcement layer 670 can be formed of a hybrid braided structure including at least two different materials.
  • a first material 672 can form a portion of the heated reinforcement layer 670 and a second material 674 can form a remaining portion of the heated reinforcement layer 670.
  • the first material 672 can be configured to be heated, while the second material 674 can be configured to provide structural integrity and/or flexibility to the ablation catheter.
  • the heated reinforcement layer 670 can be a carbon fiber based heat reinforcement layer where the first material 672, the second material 674, or both the first material 672 and the second material 674 are carbon fiber.
  • first material 672 and the second material 674 can promote aspects herein such as promoting heating of vapor in a lumen of the ablation catheter 200 and maintaining a relatively small diameter ablation catheter 200, and yet can promote the structural integrity and/or steerability of the ablation catheter 200.
  • the first material 672 can be formed of carbon fiber (e.g., is formed exclusively of carbon fiber) and the second material 674 can be formed of a metal such as stainless steel, a polymer (e.g., a doped polymer), and/or another material.
  • the first material 672 and the second material 674 can be present at a 1: 1 ratio, among other possible ratios.
  • the methods herein can include applying heat via the heated reinforcement layer 670 (e.g., a carbon fiber based heated reinforcement layer) to vapor in a lumen (e.g., a vapor lumen) of the ablation catheter 200.
  • the approaches can mitigate heat lost by the vapor during transmission of the vapor longitudinally along the ablation catheter (e.g., which can be in a range from 1.5 meters to 2.5 meters long and therefore would otherwise be prone to dissipation of heat from the vapor).
  • the first material 672 can be formed of carbon fiber which can be inductively heated (or otherwise heated) at a proximal end of the first material 672 and the heat may transfer longitudinally along the longitudinal axis of the ablation catheter 200 and may transfer radially at least from the first material 672 to the vapor in the vapor lumen along the longitudinal axis of the ablation catheter 200.
  • FIG. 7 illustrates an example of a flow diagram of a method 770 for therapeutic vapor ablation of tissue.
  • the method 770 is employed with the vapor ablation catheters described herein.
  • the method 770 includes providing a vapor ablation catheter.
  • the method 770 includes providing a vapor ablation catheter that is configured to emit a vapor via nozzles and is configured to maintain a threshold distance between the nozzles and tissue in a target region, as described herein.
  • the vapor ablation catheter can be provided that includes an expandable device.
  • the expandable device can be an expandable balloon or an expandable basket. The expandable device can be positioned adjacent to the distal end region of the elongate catheter shaft and have nozzles are located thereon.
  • the expandable device is an expandable balloon coupled to a distal end region of the elongate catheter shaft, where the expandable balloon includes anchoring projections, as described herein.
  • the expandable device is an expandable basket coupled to the distal end region of the elongate catheter shaft and including legs and/or struts having nozzles located thereon, as described herein.
  • the method 770 can include advancing the vapor ablation catheter through a body lumen to a position adjacent to the target region.
  • advancing the vapor ablation catheter through a body lumen includes advancing the vapor ablation catheter at least through a bronchus.
  • a distal end region of the ablation catheter may be advanced through the trachea to a position within the left bronchus.
  • the vapor ablation catheter can be advanced (e.g., from a position external to a patient to the target region in vivo) while in in a first (unexpanded) configuration.
  • the method can include expanding the expandable device.
  • the expandable device may be altered from the first (unexpanded) configuration to the second (expanded) configuration.
  • an operator may actuate the vapor ablation catheter to expand a balloon or basket and thereby anchor the balloon or basket at a target region and maintain the threshold distance between nozzles and tissue in the target region.
  • this includes shifting the expandable basket relative to the catheter shaft to cause expansion of at least one of the expandable legs and/or struts radially.
  • the method 770 can include applying vapor to tissue in the target region. For instance, while the expandable device is in the second configuration, at least one of the nozzles may be employed to stimulate a target region via the emission of heated water vapor for a therapeutic amount of time.
  • applying the vapor can be manifested as applying heated water vapor that is heated above a normothermia temperature (e.g., 36.5 to 37.5 degrees Celsius), as described herein.
  • the method 770 includes retracting the vapor ablation catheter while applying the vapor.
  • the method 770 includes automatically retracting the vapor ablation catheter at a predetermined retraction rate while applying the vapor, as described herein.
  • the predetermined retraction rate is based on a vessel diameter, a flow rate of the vapor, a temperature of the vapor, or any combination thereof, as described herein.
  • the predetermined retraction rate is reduced as the elongate catheter is retracted, as described herein.
  • the operator may actuate the catheter to contract the expandable device (e.g., shift an expandable basket from a second configuration to a first configuration) and then remove the ablation catheter (e.g., the distal end region of the ablation catheter) from the patient.
  • the materials that can be used for the various medical devices disclosed herein and/or the components thereof may include a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material.
  • suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate
  • suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel -titanium alloy such as linear- elastic and/or super-elastic nitinol; other nickel alloys such as nickel -chromium - molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKEL VAC® 400, NICORROS® 400, and the like), nickel-cobalt- chromium-molybdenum alloys (e.g., UNS: R3OO35 such as MP35-N® and the like), nickel-molybden
  • the linear elastic and/or non-super-elastic nickel -titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel.
  • a suitable nickeltitanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in U.S. Patent Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUMTM (available from Neo-Metrics) and GUM METALTM (available from Toyota).
  • a superelastic alloy for example a superelastic nitinol can be used to achieve desired properties.
  • portions or all of the devices disclosed herein may also be doped with, made of, or otherwise include a radiopaque material.
  • Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user in determining the location of the device within a patient.
  • Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the devices disclosed herein to achieve the same result.
  • a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the devices disclosed herein.
  • the devices disclosed herein and/or components thereof may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image).
  • Certain ferromagnetic materials may not be suitable because they may create artifacts in an MRI image.
  • the devices disclosed herein or portions thereof may also be made from a material that the MRI machine can image.
  • Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium- molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.
  • cobalt-chromium- molybdenum alloys e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like
  • nickel-cobalt-chromium-molybdenum alloys e.g., UNS: R30035 such as MP35-N® and the like
  • nitinol and the like, and others.

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Abstract

L'invention concerne des dispositifs médicaux, des systèmes et des procédés de traitement thérapeutique par ablation à la vapeur de maladies associées aux voies respiratoires.
PCT/US2025/026291 2024-04-26 2025-04-24 Ablation thérapeutique à la vapeur Pending WO2025226991A1 (fr)

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CN202410516816.3A CN120837189A (zh) 2024-04-26 2024-04-26 治疗性蒸汽消融
CN202410516816.3 2024-04-26

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5238004A (en) 1990-04-10 1993-08-24 Boston Scientific Corporation High elongation linear elastic guidewire
US6508803B1 (en) 1998-11-06 2003-01-21 Furukawa Techno Material Co., Ltd. Niti-type medical guide wire and method of producing the same
US20160310200A1 (en) * 2015-04-24 2016-10-27 Neurotronic, Inc. Chemical ablation and method of treatment for various diseases
US20220022932A1 (en) * 2012-08-09 2022-01-27 Fractyl Laboratories, Inc. Ablation systems, devices and methods for the treatment of tissue

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5238004A (en) 1990-04-10 1993-08-24 Boston Scientific Corporation High elongation linear elastic guidewire
US6508803B1 (en) 1998-11-06 2003-01-21 Furukawa Techno Material Co., Ltd. Niti-type medical guide wire and method of producing the same
US20220022932A1 (en) * 2012-08-09 2022-01-27 Fractyl Laboratories, Inc. Ablation systems, devices and methods for the treatment of tissue
US20160310200A1 (en) * 2015-04-24 2016-10-27 Neurotronic, Inc. Chemical ablation and method of treatment for various diseases

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