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WO2024260683A1 - Distribution d'écoulement de fluide dans des ballonnets de cathéter de dénervation occlusif - Google Patents

Distribution d'écoulement de fluide dans des ballonnets de cathéter de dénervation occlusif Download PDF

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Publication number
WO2024260683A1
WO2024260683A1 PCT/EP2024/064532 EP2024064532W WO2024260683A1 WO 2024260683 A1 WO2024260683 A1 WO 2024260683A1 EP 2024064532 W EP2024064532 W EP 2024064532W WO 2024260683 A1 WO2024260683 A1 WO 2024260683A1
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WO
WIPO (PCT)
Prior art keywords
catheter
refrigerant
flow diverter
balloon interior
exhaust opening
Prior art date
Application number
PCT/EP2024/064532
Other languages
English (en)
Inventor
Eanna P. CONNOLLY
Conor J. CASEY
Cian Walsh
Carlos H. LIMA
Alessandro Fisher
Gergo EDES
David J. Hobbins
Daniel M. King
Original Assignee
Medtronic Ireland Manufacturing Unlimted Company
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 Medtronic Ireland Manufacturing Unlimted Company filed Critical Medtronic Ireland Manufacturing Unlimted Company
Publication of WO2024260683A1 publication Critical patent/WO2024260683A1/fr

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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
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • 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
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • 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
    • 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
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid
    • 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
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid
    • A61B2018/0268—Characteristics of handpieces or probes using a circulating cryogenic fluid with restriction of flow

Definitions

  • Cryoablation therapy is used to treat a number of conditions, including uncontrolled hypertension and cardiac arrhythmias, for example, through vascular denervation.
  • treatment elements on the distal end of a transcutaneous catheter deliver a pressurized refrigerant to a treatment area of a vessel to damage targeted nerves.
  • the flow of refrigerant causes an occlusive balloon of the treatment element to expand within the vessel. This occludes the vessel while thermal transfer from the tissue to the refrigerant creates a circumferential lesion at the treatment site.
  • Cryoablation therapy suppresses vascular nerves through rapid freezing. It is important during treatment that a sufficient ablation depth to cause nerve death is achieved, while minimizing excessive inflammation to the surrounding tissue and organs.
  • refrigerant e.g., N 2 O gas
  • aspects and embodiments are provided herein for improving refrigerant distribution within occlusive balloons.
  • cryoablation catheters and cryoablation systems which provide for more uniform distribution of refrigerant in cryocatheter balloons.
  • the techniques described herein relate to a catheter for ablating tissue, the catheter including: a balloon including an inner surface defining a balloon interior; an inflow lumen positioned within the balloon interior, the inflow lumen including: an exhaust opening, through which a refrigerant is delivered to the balloon interior; and a flow diverter positioned distally to the exhaust opening, wherein the flow diverter is configured such that the retrigerant is dispersed substantially annularly from the exhaust opening into the balloon interior.
  • the techniques described herein relate to a catheter, wherein the flow diverter is configured such that the refrigerant is also dispersed toward a distal end of the balloon interior.
  • the techniques described herein relate to a catheter, wherein: the inflow lumen further includes a skive defining a channel in fluid communication with the exhaust opening; and the flow diverter is positioned within the channel.
  • the techniques described herein relate to a catheter, wherein the flow diverter is secured in the channel using one selected from the group consisting of an adhesive, a polymer reflow process, or a press fit.
  • the techniques described herein relate to a catheter, wherein the flow diverter includes a cylindrical body and a proximal end.
  • the techniques described herein relate to a catheter, wherein an outer profile of the proximal end has either one of a conical shape or a wedge shape.
  • the techniques described herein relate to a catheter, wherein an outer profile of the proximal end has an asymmetric face such that configured such that it induces a helical flow of the refrigerant from the exhaust opening into the balloon interior.
  • the techniques described herein relate to a catheter, wherein: the flow diverter has a spherical shape; and the flow diverter is coupled to the inflow lumen to form a gap between the exhaust opening and the flow diverter sufficient to allow the flow of refrigerant into the balloon interior.
  • the techniques described herein relate to a catheter, further including: a hypotube; and a bridge wire coupled to the hypotube, wherein the inflow lumen is attached to the bridge wire using either one of a weld or an adhesive.
  • the techniques described herein relate to a catheter, wherein the flow diverter is a cap including: a cylindrical body including a wall defining a central cavity, an open end, and a closed end; a plurality of orifices disposed circumferentially in the wall between the open end and the closed end; and a semispherical depression defined by the wall of the closed end, wherein the cap is configured to attach to the inflow lumen such that the cap covers the exhaust opening, the central cavity is in fluid communication with the balloon interior via the plurality of orifices, and the semispherical depression is positioned such that the refrigerant is dispersed through the plurality of orifices into the balloon interior in a substantially annular flow.
  • the techniques described herein relate to a catheter, wherein the cap is secured to the inflow lumen using one selected from the group consisting of an adhesive, a weld, or a press fit.
  • the techniques described herein relate to a catheter, further including: a hypotube; and a bridge wire coupled to the hypotube, wherein the inflow lumen is attached to the bridge wire using either one of a weld or an adhesive.
  • the techniques described herein relate to a catheter, wherein the flow diverter is made from a radiopaque material.
  • the techniques described herein relate to a catheter, further including: an outflow lumen for removing the refrigerant from the balloon interior, the outflow lumen positioned at a proximal end of the balloon.
  • the techniques described herein relate to a system including the catheter and a console for operating the catheter, the console including: an electronic controller configured to control a delivery of the refrigerant to the balloon interior.
  • the techniques described herein relate to a system, further comprising a refrigerant source configured to provide the refrigerant to the balloon interior.
  • a catheter that includes a balloon comprising an inner surface defining a balloon interior, wherein the catheter includes an inflow lumen positioned within the balloon interior, wherein the inflow lumen includes an exhaust opening, through which a refrigerant is delivered to the balloon interior, wherein the catheter includes a flow diverter positioned distally to the exhaust opening, and wherein the flow diverter is configured such that the refrigerant is dispersed substantially annularly from the exhaust opening into the balloon interior.
  • FIG. 1 is schematic illustration of an example vascular denervation system in accordance with some embodiments.
  • FIG. 2 is a block diagram that illustrates an electronic controller of the system of FIG. 1 in accordance with some embodiments.
  • FIGS. 3A-3C illustrate an example treatment element of the vascular denervation system of FIG. 1 in accordance with some embodiments.
  • FIG. 4A & FIG. 4B illustrate an example treatment element of the vascular denervation system of FIG. 1 in accordance with some embodiments.
  • FIGS. 5A-5C illustrate an example treatment element of the vascular denervation system of FIG. 1 in accordance with some embodiments.
  • distal and proximal are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” or “distally” are a position distant trom or in a direction away from the clinician. “Proximal” and “proximally” are a position near or in a direction toward the clinician.
  • FIG. 1 illustrates an example system 10 that is suitable for performing vascular denervation.
  • the system 10 nay be configured to perform denervation in the renal arteries, as and/or in other vessels, including the celiac trunk and its branches, the splenic artery and its branches, the common hepatic artery and its branches, the left gastric artery and its branches, and the superior and inferior mesenteric arteries and their branches.
  • the system 10 may also be configured to perform denervation two or more vessels (e.g., in the renal artery and the common hepatic artery and its branches).
  • the system 10 is for applying cryotherapy to an area of target tissue (e.g., an area of tissue within the hepatic artery, a pulmonary vein ostium, etc.) to cause denervation.
  • the system 10 may generally include a treatment device, such as a medical device 12, and a console 14 for operating, monitoring, and regulating the operation of the device 12 (for example, with the electronic controller 33), and a fluid supply reservoir 16 for delivering fluid (for example, a sterile coolant or refrigerant) to the device 12.
  • the medical device 12 includes a highly flexible treatment device that is suitable for passage through the vasculature.
  • the device 12 may be adapted for use with the fluid supply reservoir 16 to supply a coolant or refrigerant to denervate portions of a blood vessel.
  • the device 12 has an elongate body 18 having a proximal portion 20 and a distal portion 22.
  • the distal portion 22 includes a treatment element 23.
  • the proximal portion 20 of the device 12 is mated to a handle 24 that can include an element such as a lever or knob for manipulating the elongate body 18 and the treatment element 23.
  • the distal portion 22 may also define a distal tip 29 defining an aperture (not shown) sized to allow for the passage of a guidewire 30 through the elongate body 18 and through the aperture.
  • the elongate body 18 is sized and configured to be passable through a patient’s vasculature and/or positionable proximate to the area of target tissue, and may include one or more lumens (for example, the inflow lumen 27 and the outflow lumen 28) disposed within the elongate body 18 that provide mechanical, electrical, and/or fluid communication between the proximal portion 20 of the elongate body 18 and the distal portion 22 of the elongate body 18.
  • the elongate body 18 includes a guidewire lumen through which a sensing device, mapping device, the guidewire 30, or other system component may be located and extended from the distal portion 22 of the medical device 12.
  • the elongate body 18 may be rigid and/or flexible to facilitate the navigation of the device 12 within a patient’s body.
  • the distal portion 22 of the elongate body 18 is relatively more flexible to allow for more desirable positioning proximate to an area of target tissue (e.g., positioning within a renal artery, a hepatic artery, the splanchnic bed, the pulmonary artery, the aortic root, the carotid body, and the like), which the proximal portion is relatively more rigid to transmit a pushing and/or pulling force from the handle 24 to the distal portion 22.
  • target tissue e.g., positioning within a renal artery, a hepatic artery, the splanchnic bed, the pulmonary artery, the aortic root, the carotid body, and the like
  • the device 12 may be inserted through one or more blood vessels, such as, for example, one or more brachial arteries, one or more radial arteries, one or more femoral arteries, or other points of access including venous access (e.g., for greater splanchnic nerve denervation or through the jugular vein for carotid body ablation).
  • blood vessels such as, for example, one or more brachial arteries, one or more radial arteries, one or more femoral arteries, or other points of access including venous access (e.g., for greater splanchnic nerve denervation or through the jugular vein for carotid body ablation).
  • the medical device 12 does not include a guidewire 30.
  • the embodiments and aspects presented herein may be used with or without a guidewire.
  • 1 he treatment element 23 includes an expandable element 26 (for example, an occlusive balloon), to which fluid from the fluid supply reservoir 16 is provided.
  • fluid from the fluid supply reservoir 16 is circulated through the expandable element 26.
  • a fluid inflow lumen 27 is in fluid communication with the fluid supply reservoir 16 in the console 14 to supply fluid to the expandable element 26 in response to console commands and other control input.
  • a vacuum pump 34 (electronically coupled to and controlled by the electronic controller 33) in the console 14 creates a low pressure environment in an outflow lumen 28 so that the fluid is drawn into the outflow lumen 28, away from the expandable element 26, towards the proximal portion 20 of the elongate body 18, and into the fluid recovery reservoir 40 within the console 14.
  • the treatment element 23 includes one or more temperature sensors positioned on or in the treatment element to continuously measure temperature values within, on, or proximate to the expandable element 26.
  • the one or more temperature sensors transmit temperature signals to the electronic controller 33 of the console 14.
  • the console 14 includes one or more pressure sensors 42 to continuously record the instantaneous pressure values within the expandable element 26.
  • the pressure sensors 42 may then generate and transmit a pressure signal to the electronic controller 33 of the console 14.
  • the device 12 may also include a pressure sensor 42 within the expandable element 26 (not shown) or a pressure monitoring tube (enclosed in the elongate body 18) in fluid communication with the pressure sensor 42 (housed in the console 14) and the expandable element 26.
  • the system 10 may also include the use of one or more flow sensors (not shown) to monitor how much fluid is flowing into the expandable element 26.
  • the flow sensor may be positioned to sense flow in the inflow lumen 27 or the outflow lumen 28 and is configured to measure the rate or speed of fluid at a certain location and report the rate or speed to the electronic controller 33.
  • each of the inflow lumen 27 or the outflow lumen 28 is monitored by a dedicated flow sensor.
  • the console 14 includes an electronic controller 33 (described more particularly with respect to FIG. 2) programmed or programmable to execute the automated or semi-automated operation and performance of the features, sequences, calculations, or procedures described herein.
  • the electronic controller 33 is communicatively coupled to the temperature sensors, pressure sensors, flow sensors, and other components of the device 12, including the vacuum pump 34.
  • the console 14 may include one or more user input devices, controllers, speakers, and/or electronic displays 35 (each coupled to and controllable by the electronic controller 33) for collecting and conveying information from and to the user.
  • the treatment element 23 includes ultrasonic transducers (not shown) to record the reflected, refracted, scattered, and/or attenuated ultrasound signals from the target tissue.
  • the transducers record the ultrasound signals, they begin to vibrate and the mechanical vibrations are converted into electric current signals that are transmitted back to the console 14 or an external ultrasound control unit 37 which processes the signals to generate a sonogram or ultrasonogram showing the patient’s tissue, organs, and/or a location of the device 12 within the patient’s body.
  • the sonogram may then be relayed to a clinician via a display 35 of the console 14, or via a display 39 of the external ultrasound control unit 37, to assist the physician in positioning the device 12 near or proximate to a desired treatment location.
  • treatment element 23 includes a flow diverter.
  • the flow diverter is positioned within the expandable element 26 distally to an exhaust opening of the inflow lumen 27.
  • the flow diverter is configured such that fluid (e.g., refrigerant) provided through the inflow lumen 27 is dispersed substantially annularly from the exhaust opening of the inflow lumen 27 into the interior of the expandable element 26.
  • fluid e.g., refrigerant
  • the flow diverter may distribute refrigerant in a desired flow profile (e.g., annularly) within the expandable element 26.
  • FIG. 2 illustrates an example embodiment of the electronic controller 33, which includes an electronic processor 205 (for example, a microprocessor, application specific integrated circuit, etc.), a memory 210, and an input/output interface 215.
  • the electronic processor 205, the memory 210, and the input/output interface 215, as well as the other various modules are coupled directly, by one or more control or data buses (e.g., the bus 230), or a combination thereof.
  • the memory 210 may be made up of one or more non-transitory computer-readable media and includes at least a program storage area and a data storage area.
  • the program storage area and the data storage area can include combinations of several types of memory, such as read-only memory (“ROM”), random access memory (“RAM”) (for example, dynamic RAM (“DRAM”), synchronous DRAM (“SDRAM”), etc.), electrically erasable programmable read-only memory (“EEPROM”), flash memory, or other suitable memory devices.
  • the electronic processor 205 is coupled to the memory 210 and the input/output interface 215.
  • the electronic processor 205 sends and receives information (for example, from the memory 210 and/or the input/output interface 215) and processes the information by executing one or more software instructions or modules, capable of being stored in the memory 210, or another non-transitory computer readable medium.
  • the software can include firmware, one or more applications, program data, filters, rules, one or more program modules, and other executable instructions.
  • the electronic processor 205 is configured to retrieve from the memory 210 and execute, among other things, software for performing methods as described herein.
  • the input/output interface 215 transmits and receives information from devices external to the electronic controller 33 (for example, over one or more wired and/or wireless connections), for example, components of the system 10.
  • the input/output interface 215 receives input (for example, from a human machine interface of the console 14), provides system output or a combination of both.
  • the input/output interface 215 may also include other input and output mechanisms, which for brevity are not described herein and which may be implemented in hardware, software, or a combination of both.
  • FIG. 2 illustrates only a single electronic processor 205, memory 210, and input/output interface 215, alternative embodiments of the electronic controller 33 may include multiple processors, memory modules, and/or input/output interfaces.
  • the system 10 may include other electronic controllers, each including similar components as, and configured similarly to, the electronic controller 33.
  • the electronic controller 33 is implemented partially or entirely on a semiconductor (for example, a field-programmable gate array [“FPGA”] semiconductor) chip.
  • the various modules and controllers described herein may be implemented as individual controllers, as illustrated, or as components of a single controller. In some embodiments, a combination of approaches may be used.
  • FIG. 3 A illustrates an example 300 of the treatment element 23.
  • the 300 includes, in addition to the components illustrated and described above, a skive 302 and a flow diverter 304.
  • the skive is cut into the inflow lumen 27 to form a channel 303 and an exhaust opening 305.
  • the flow diverter 304 is positioned within the channel 303.
  • the flow diverter 304 may have any suitable shape for diverting flow of fluid (e.g., a refrigerant) from the inflow lumen 27 into the interior of the expandable element 26.
  • the flow diverter 304 has a cylindrical body with a conically shaped proximal end. The proximal end of the flow diverter 304 faces the exhaust opening 305.
  • the refrigerant As the refrigerant is delivered through the inflow lumen 27 through the exhaust opening 305, it contacts the proximal end of the flow diverter 304 and is dispersed.
  • the refrigerant is dispersed substantially annularly from the exhaust opening 305 into the balloon interior.
  • the flow diverter 304 is configured such that the refrigerant is also dispersed toward a distal end of the balloon interior.
  • the proximal end of the flow diverter 304 may have another shape.
  • the proximal end may be a wedge shape.
  • the proximal end may have an asymmetric face to induce a helical flow of the refrigerant from the exhaust opening 305 into the balloon interior.
  • the flow diverter is secured in the channel 303, for example, using an adhesive, a polymer reflow process, a press fit, or combinations thereof.
  • the flow diverter is made from a radiopaque material, allowing it to act as a radiopaque marker, which may reduce or eliminate the need for a separate marker band 310, reducing cost and complexity of the catheter.
  • the outflow lumen 28 of the treatment element 300 is positioned at the proximal end of the balloon, inducing a flow of the refrigerant from the distal end of the balloon to the proximal end of the balloon, in a substantially annular fashion.
  • FIG. 4A illustrates another example 400 of the treatment element 23.
  • Treatment element 400 includes, in addition to the components illustrated and described above, a bridge wire 404 and a flow diverter 406.
  • the bridge wire 404 is welded to a hypotube of the elongate body 18 to provide column strength to the expandable element 26 (e.g., a balloon).
  • the inflow lumen 27 is attached to the bridge wire, for example, using a weld or an adhesive.
  • the flow diverter 406 is configured such that the refrigerant is also dispersed toward a distal end of the balloon interior. In other examples, as shown in FIG. 4B, the flow diverter 406 is configured such that the refrigerant is directed in a distal-radial direction, a substantially radial direction, and/or a proximal-radial direction (with respect to a major axis of the catheter).
  • the cap 502 is configured to attach to the inflow lumen 27 such that the cap covers the exhaust opening 503, causing the central cavity to be in fluid communication with the inflow lumen 27 and the balloon interior via the plurality of orifices 514.
  • the semispherical depression 516 is positioned to form a gap between it and the exhaust opening 503 of the inflow lumen 27.
  • the gap is sized sufficiently to allow the flow of refrigerant such that the refrigerant is dispersed through the plurality of orifices 514 into the balloon interior in a substantially annular flow.
  • the plurality of orifices 514 and the semispherical depression 516 are configured such that the refrigerant is also dispersed toward a distal end of the balloon interior.
  • the treatment element 500 includes a bridge wire (as described herein), to which the inflow lumen 27 is attached (e.g., using a weld or an adhesive).
  • FIG. 5B illustrates a perspective view of the treatment element 500.
  • FIG. 5C illustrates a facing view of the end cap 502.
  • the electronic based aspects of the invention may be implemented in software (e.g., stored on non-transitory computer-readable medium) executable by one or more processors.
  • software e.g., stored on non-transitory computer-readable medium
  • processors e.g., one or more processors.
  • a plurality of hardware and software-based devices, as well as a plurality of different structural components may be utilized to implement the invention.
  • control units” and “controllers” described in the specification can include one or more processors, one or more application specific integrated circuits (ASICs), one or more memory modules including non-transitory computer-readable media, one or more input/output interfaces, and various connections (e.g., a system bus) connecting the components.
  • ASICs application specific integrated circuits
  • memory modules including non-transitory computer-readable media
  • input/output interfaces e.g., a system bus
  • some embodiments may be comprised of one or more electronic processors such as microprocessors, digital signal processors, customized processors, and field programmable gate arrays (FPGAs) and unique stored program instructions (including both software and firmware) that control the one or more processors to implement, in conjunction with certain non-processor circuits, some, most, or all of the functions of the method and/or apparatus described herein.
  • electronic processors such as microprocessors, digital signal processors, customized processors, and field programmable gate arrays (FPGAs) and unique stored program instructions (including both software and firmware) that control the one or more processors to implement, in conjunction with certain non-processor circuits, some, most, or all of the functions of the method and/or apparatus described herein.
  • FPGAs field programmable gate arrays
  • unique stored program instructions including both software and firmware
  • some embodiments may be implemented as a computer-readable storage medium having computer readable code stored thereon for programming a computer (for example, comprising an electronic processor) to perform a method as described and claimed herein.
  • Examples of such computer-readable storage media include, but are not limited to, a hard disk, a CD-ROM, an optical storage device, a magnetic storage device, a ROM (Read Only Memory), a PROM (Programmable Read Only Memory), an EPROM (Erasable Programmable Read Only Memory), an EEPROM (Electrically Erasable Programmable Read Only Memory) and a Flash memory.
  • Example 1 A catheter for ablating tissue, the catheter comprising: a balloon comprising an inner surface defining a balloon interior; an inflow lumen positioned within the balloon interior, the inflow lumen comprising: an exhaust opening, through which a refrigerant is delivered to the balloon interior; and a flow diverter positioned distally to the exhaust opening, wherein the flow diverter is configured such that the refrigerant is dispersed substantially annularly from the exhaust opening into the balloon interior.
  • Example 2 The catheter of example 1, wherein the flow diverter is configured such that the refrigerant is also dispersed toward a distal end of the balloon interior.
  • Example 3 The catheter of any of examples 1 and 2, wherein: the inflow lumen further comprises a skive defining a channel in fluid communication with the exhaust opening; and the flow diverter is positioned within the channel.
  • Example 4 The catheter of example 3, wherein the flow diverter is secured in the channel using one or at least one selected from the group consisting of an adhesive, a polymer reflow process, or a press fit.
  • Example 5 The catheter of example 3, wherein the flow diverter comprises a cylindrical body and a proximal end.
  • Example 6 The catheter of example 5, wherein an outer profile of the proximal end has either one of a conical shape or a wedge shape.
  • Example 7 The catheter of example 5, wherein an outer profile of the proximal end has an asymmetric face such that it induces a helical flow of the refrigerant from the exhaust opening into the balloon interior.
  • Example 8 The catheter of example 1, wherein: the flow diverter has a spherical shape; and the flow diverter is coupled to the inflow lumen to form a gap between the exhaust opening and flow diverter sufficient to allow the flow of refrigerant into the balloon interior.
  • Example 9 The catheter of example 8, further comprising: a hypotube; and a bridge wire coupled to the hypotube, wherein the inflow lumen is attached to the bridge wire using either one of a weld or an adhesive.
  • Example 10 The catheter of example 1, wherein the flow diverter is a cap comprising: a cylindrical body comprising a wall defining a central cavity, an open end, and a closed end; a plurality of orifices disposed circumferentially in the wall between the open end and the closed end; and a semispherical depression defined by the wall of the closed end, wherein the cap is configured to attach to the inflow lumen such that the cap covers the exhaust opening, the central cavity is in fluid communication with the balloon interior via the plurality of orifices, and the semispherical depression is positioned such that the refrigerant is dispersed through the plurality of orifices into the balloon interior in a substantially annular flow.
  • the flow diverter is a cap comprising: a cylindrical body comprising a wall defining a central cavity, an open end, and a closed end; a plurality of orifices disposed circumferentially in the wall between the open end and the closed end; and a semispherical depression defined
  • Example 11 The catheter of example 10, wherein the cap is secured to the inflow lumen using one or at least one selected from the group consisting of an adhesive, a weld, or a press fit.
  • Example 12 The catheter of any of examples 9 and 10, further comprising: a hypotube; and a bridge wire coupled to the hypotube, wherein the inflow lumen is attached to the bridge wire using either one of a weld or an adhesive.
  • Example 13 The catheter of any of examples 1 through 12, wherein the flow diverter is made from a radiopaque material or wherein the flow diverter comprises a radiopaque material.
  • Example 14 The catheter of any of examples 1 through 13, further comprising: an outflow lumen for removing the refrigerant from the balloon interior, the outflow lumen positioned at a proximal end of the balloon.
  • Example 15 A system comprising the catheter of any of examples 1 through 14 and a console for operating the catheter, the console comprising: an electronic controller configured to control a delivery of the refrigerant to the balloon interior.
  • Example 16 The system of example 15, further comprising a refrigerant source configured to provide the refrigerant to the balloon interior.

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Abstract

L'invention concerne des cathéters et des systèmes de cryoablation. Un exemple de cathéter comprend un ballonnet comprenant une surface interne définissant un intérieur de ballonnet. Le cathéter comprend une lumière d'entrée positionnée à l'intérieur du ballonnet. La lumière d'entrée comprend une ouverture de sortie, par l'intermédiaire de laquelle un fluide frigorigène est administré à l'intérieur du ballonnet. Le cathéter comprend un déflecteur d'écoulement positionné de manière distale par rapport à l'ouverture de sortie. Le déflecteur d'écoulement est conçu de telle sorte que le fluide frigorigène est dispersé de manière sensiblement annulaire à partir de l'ouverture d'échappement dans l'intérieur du ballonnet.
PCT/EP2024/064532 2023-06-21 2024-05-27 Distribution d'écoulement de fluide dans des ballonnets de cathéter de dénervation occlusif WO2024260683A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363509401P 2023-06-21 2023-06-21
US63/509,401 2023-06-21

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US20150157391A1 (en) * 2012-04-22 2015-06-11 Newuro, B.V. Bladder tissue modification for overactive bladder disorders
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EP4268744A1 (fr) * 2022-04-27 2023-11-01 Cryovasc GmbH Appareil médical de cryothérapie pourvu de corps de transfert de chaleur

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US20020026182A1 (en) * 1997-12-02 2002-02-28 James Joye Apparatus and method for cryogenic inhibition of hyperplasia
US20130197500A1 (en) * 2008-11-21 2013-08-01 C2 Therapeutics, Inc. Cryogenic Ablation System and Method
US20120245574A1 (en) * 2011-03-25 2012-09-27 Medtronic Cryocath Lp Spray nozzle design for a catheter
US20190209230A1 (en) * 2011-10-28 2019-07-11 Medtronic Cryocath Lp Systems and methods for variable injection flow
US20150157391A1 (en) * 2012-04-22 2015-06-11 Newuro, B.V. Bladder tissue modification for overactive bladder disorders
EP4268744A1 (fr) * 2022-04-27 2023-11-01 Cryovasc GmbH Appareil médical de cryothérapie pourvu de corps de transfert de chaleur

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