WO2016040056A1 - Appareil à cathéter à ballonnet avec émetteur de micro-ondes - Google Patents

Appareil à cathéter à ballonnet avec émetteur de micro-ondes Download PDF

Info

Publication number
WO2016040056A1
WO2016040056A1 PCT/US2015/047954 US2015047954W WO2016040056A1 WO 2016040056 A1 WO2016040056 A1 WO 2016040056A1 US 2015047954 W US2015047954 W US 2015047954W WO 2016040056 A1 WO2016040056 A1 WO 2016040056A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
tissue
microwave
emitter
ablation system
Prior art date
Application number
PCT/US2015/047954
Other languages
English (en)
Inventor
Daniel KASPRZYK
Justin PRESTON
Seth Crozier
Sohail DESAI
Roger D. Watkins
Balamurugan Sundaram
Sureshbabu SUNDARAM
Original Assignee
Symple Surgical 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
Priority claimed from US14/483,148 external-priority patent/US10076384B2/en
Application filed by Symple Surgical Inc. filed Critical Symple Surgical Inc.
Publication of WO2016040056A1 publication Critical patent/WO2016040056A1/fr

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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • 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
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A61B2018/00648—Sensing and controlling the application of energy with feedback, i.e. closed loop control using more than one sensed parameter
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A61B2018/00708—Power or energy switching the power on or off
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00779—Power or energy
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • A61B2018/1861—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument inserted into a body lumen or cavity, e.g. a catheter

Definitions

  • phase shifting and/or sweeping feature disclosed herein allows for a balloon catheter system of the type herein described to deliver microwave energy to tissue at different radial depths, while avoiding dielectric-related thermal peaks in RF absorbing tissue or fluids.
  • WO 2012/061 150 further limits its target tissue at a depth less than 5 millimeter radially from the center of the renal artery.
  • an embodiment of a balloon catheter apparatus and associated system disclosed herein targets tissue in the range of about 0.5 mm to about 12 mm radially from the inner surface of the artery wall.
  • an embodiment of a balloon catheter apparatus and associated system disclosed herein is configured to operate in any vessel - not only the renal artery as described in WO 2012/061 150.
  • a method of renal denervation of a targeted tissue of a patient comprising the steps of: intravascularly positioning a catheter having an emitter within an artery of the patient; activating the emitter such that microwave energy is produced and transferred from the emitter to the targeted tissue; and treating the targeted tissue with a balloon catheter apparatus and with enough microwave energy to therapeutically impair one or more renal nerves of the patient.
  • treating targeted tissue with microwave energy results in a functional impairment of the treated targeted tissue such that the functional impairment has a therapeutic benefit for the patient.
  • a microwave ablation system comprising: a balloon catheter apparatus and a control system.
  • the balloon catheter apparatus comprises (1 ) a catheter configured to house a coaxial cable and one or more coolant channels, (2) an inflatable balloon located at the distal end of the catheter, and (3) an antenna positioned in the inflatable balloon and in communication with the coaxial cable.
  • the inflatable balloon comprises a length of 10 to 45 millimeters.
  • the antenna is configured to emit microwave energy to a target tissue zone located within a range from 0.5 millimeters to 12.0 millimeters radially from an inner wall of an artery, where tissue within the target tissue zone is heated by the emitted microwave energy to a temperature from 40°C to 100°C, and where the one or more coolant channels are configured to cool one or more elements of the microwave ablation system and/or non-targeted tissue lying outside the target tissue zone that may be heated as a consequence of emitting microwave energy from the antenna.
  • the control system comprises (1 ) a fluid pump configured to introduce fluid into a proximal end of the catheter, (2) a power amplifier capable of generating microwave energy for delivery to the target tissue zone for at least one energy application cycle ranging from 60 seconds to 600 seconds at a frequency ranging from 2.4 GHz to 2.5 GHz, and (3) a computer system configured to monitor and/or regulate the delivery of microwave energy to the target tissue, the fluid pump, at least one sensor, and antenna reflected power, wherein the computer system comprises a safety algorithm to ensure the microwave ablation system operates within acceptable temperature and power ranges.
  • the one or more coolant channels may include at least two coolant channels to form a circulation loop to continuously cool the balloon catheter apparatus and/or non-targeted tissue.
  • saline may be conveyed by the one or more coolant channels.
  • carbon dioxide may be conveyed by the one or more coolant channels.
  • Ringers solution may be conveyed by the one or more coolant channels.
  • the at least one application cycle may contain more than one pulse of microwave energy.
  • the computer system may be configured to monitor a pressure of fluid in the one or more coolant channels and adjust a flow rate and/or fluid volume output of the fluid pump.
  • the one or more coolant channels may be in communication with an irrigation port configured to deliver fluid to the patient's vasculature after the fluid has cooled elements of the balloon catheter apparatus and/or non-targeted tissue.
  • a distal portion of the catheter may be more flexible than a proximal portion of the catheter.
  • a distal portion of the coaxial cable may be more flexible than a proximal portion of the coaxial cable.
  • the catheter may include one or more sensors connected to one or more sensor cables and the one or more sensor cables may be in communication with the control system.
  • the catheter may include a radiometer.
  • the antenna may be configured to receive reflected radiation information from the target tissue zone, and transmit the radiation information to the control system via the coaxial cable.
  • the target tissue zone may be located within a range from 0.75 millimeters to 5.0 millimeters radially from the inner wall of the artery.
  • the control system may be capable of phase shifting the emitted microwave energy.
  • the control system may be capable of frequency sweeping the emitted microwave energy.
  • the antenna may be a slot antenna, a multi-slot antenna, or a choked slot antenna.
  • the control system may be configured to permit selection of a predetermined dose amount of microwave energy from among a plurality of predetermined dose amounts of microwave energy to be emitted by the antenna.
  • a method of treating a patient via ablation of a targeted tissue comprising the steps of: (1 ) intravascularly positioning a catheter having an emitter within an artery of the patient, (2) emitting microwave energy from the emitter to the targeted tissue, and (3) treating the targeted tissue with a microwave ablation system described herein and with enough microwave energy to therapeutically impair the targeted tissue of the patient while not damaging non-targeted tissue.
  • the patient may suffer from pulmonary embolism
  • Fig. 5 illustrates a side view of the inflatable balloon of the balloon catheter apparatus shown in Fig. 3.
  • Fig. 1 1 illustrates an embodiment of an emitter in accordance with the disclosure herein.
  • Fig. 12 illustrates an embodiment of an emitter in accordance with the disclosure herein.
  • Fig. 13 illustrates an embodiment of an emitter in accordance with the disclosure herein.
  • Fig. 16 illustrates another embodiment of an emitter in accordance with the disclosure herein.
  • Fig. 17 illustrates another embodiment of an emitter in accordance with the disclosure herein.
  • Fig. 18 illustrates another embodiment of an emitter in accordance with the disclosure herein.
  • Fig. 19 illustrates another embodiment of an emitter in accordance with the disclosure herein.
  • Fig. 20 illustrates a representative thermal gradient map resulting from microwave emissions applied to tissue from an emitter associated with one embodiment of a balloon catheter apparatus and associated system.
  • Fig. 21 illustrates a representative thermal gradient map resulting from microwave emissions applied to tissue from the emitter associated with the embodiment of Fig. 17 in combination with a cooling mechanism.
  • Fig. 23 illustrates a thermal gradient map resulting from microwave emissions applied to tissue from the emitter associated with the embodiment of Fig. 19 in combination with a cooling mechanism.
  • Fig. 26A, 26B, and 26C illustrate another embodiment of a non-symmetrical inflatable balloon, a tapered inflatable balloon, of the balloon catheter apparatus.
  • Fig. 27 illustrates a cross section of an embodiment of the inflatable balloon catheter apparatus along the catheter shaft.
  • Fig. 28 illustrates a cross section of another embodiment of the inflatable balloon catheter apparatus along the catheter shaft.
  • a percutaneous transluminal balloon catheter apparatus and associated system is disclosed for treating disease.
  • the balloon catheter apparatus and associated system can be used for treating cardiovascular hypertension.
  • the balloon catheter apparatus and associated system may be implemented as part of a renal denervation procedure on a patient.
  • such apparatus and associated system comprises a balloon catheter comprising an emitter to emit electromagnetic waves in the microwave frequency spectrum in close proximity to one or more renal neural fibers and thermally disrupt the fibers sufficient to block neurological signals from passing therethrough - while causing no unintended damage or injury, or at most only inconsequential damage or injury, to the patient's renal or cardiovascular vasculature and surrounding organs or tissue.
  • the balloon catheter apparatus and associated system may be used for treating Hypertension, including Pulmonary Hypertension, Insulin Resistance, Diabetes, Diabetic Nephropathy, Chronic Kidney Disease, Congestive Heart Failure, Hepatorenal Syndrome, End-Stage Renal Disease, and Acute Renal Disease.
  • a modified balloon catheter apparatus and associated system may be used to treat Atrial Fibrillation, Sleep Apnea, Obesity, Polycystic Ovary Syndrome, Sarcomas, Carcinomas, COPD, and Lymphomas.
  • one or more diseases can be treated by delivering microwave energy from the balloon catheter apparatus and associated system to the upper and/or lower Renal Sympathetic Nerve Plexus. Whether to target the upper, lower, or a combination of both Renal Sympathetic Nerve Plexus depends on the desired amount of ablation and degree of desired disruption of renal sympathetic nerve activity. One of ordinary skill would appreciate when total ablation is desired in certain diseases and/or patient populations and when less than total ablation is desired.
  • the balloon catheter apparatus and associated system as described herein can be adapted to treat a particular disease for a given patient by varying the degree of the ablation and by targeting a variety of tissue.
  • the balloon catheter apparatus and associated system can target tissue at various depths as needed to treat a particular disease for a particular patient.
  • Treating in the present disclosure includes alleviating symptoms, arresting, slowing, retarding, or stabilizing progression of a condition or a physiological or morphological marker thereof, and/or improvi clinical outcome, for example as measured by blood pressure, quality of life, incidence or severity of adverse cardiac events, or survival time.
  • eGFR estimated glomerular filtration rate
  • energy in the form of electromagnetic waves is delivered via a balloon catheter apparatus and associated system to sympathetic nerves associated with a renal artery.
  • the electromagnetic waves are emitted at a predetermined frequency range from an emitter positioned in or on the balloon portion of a balloon catheter apparatus.
  • the emitter may include one or more emitters. Each emitter may include an antenna or an antenna array.
  • the emitter is configured to provide radiation symmetry 360° about a central axis of the artery to allow energy in the form of electromagnetic waves to treat a predetermined radial depth at a particular longitudinal location in the artery.
  • This radiation pattern avoids the need to rotate the balloon or emitter to emit energy multiple times to complete an ablation procedure and minimizes exposure to the patient of unnecessary radiation.
  • the electromagnetic waves radiate radially in all directions about the central axis to create a volumetric field of electromagnetic radiation that excite tissue at a predetermined radial depth from the inner wall of an artery.
  • the excited tissue locally increases in temperature due to the presence of the electromagnetic radiation.
  • the excited tissue includes renal nerves.
  • the renal nerves absorb the microwave energy from the emitter, the signal transduction of the nerves is altered and the patient receives a therapeutic benefit therefrom.
  • conduction of thermal energy may begin at the focused location and proceed radially inward, radially outward, and longitudinally along the artery wall as the case may be.
  • the emitter is capable of delivering energy in broad band frequencies.
  • the emitter is advanced into the renal artery before activating the emitter. In another embodiment, the emitter is advanced into the aorta, in cranial proximity to the renal artery, before activating the emitter.
  • the balloon catheter apparatus may have the emitter located on the centerline of the catheter or extended to a desired position within the inflated balloon during energy delivery.
  • the emitter can deliver energy from a static location or while traversing longitudinally along either a linear or a spiral path.
  • the emitter may be advanced in one or more emitter channels formed into the balloon surface for precision delivery.
  • the emitter channels may also be formed by materials within the balloon.
  • the emitter channel forms a linear path for the emitter along the longitudinal centerline axis of the balloon.
  • the emitter channel is a path off-center the centerline axis of the balloon.
  • the path off-center the centerline axis of the catheter is a spiral path.
  • an emitter comprising an antenna includes multiple antenna segments, patches, rings, or other simple or complex shapes to focus the radiated energy to a predetermined radial depth to target the distribution of energy to an intended tissue or portion thereof.
  • the antenna may include design features that spread its useable frequency range to allow adjusting, phasing, or sweeping the frequency of the antenna feed signal while maintaining the antenna efficiency and impedance matching.
  • This adjusting, phasing, or sweeping enables the ablation catheter system to treat tissue at different radial depths while minimizing exposure to untargeted tissue. Treating tissue at different radial depths can allow the user to ablate a larger amount of desired targeted tissue in a controlled manner.
  • a further benefit of frequency sweeping includes minimizing hot spots along the cable by distributing energy along the length of the catheter. Another benefit of frequency sweeping is to improve the life and efficiency of the cable. Another benefit of frequency sweeping is a reduction in reflected power due to physiologic variables, for example, tissue impedance.
  • the antenna may comprise two or more emitting elements with methods to phase relate each emitting element's radiated electromagnetic waveform to allow steering or focusing of the transmitted energy, in order to concentrate heating effects of the emitted energy at targeted tissue depths.
  • the antenna may comprise cylindrical, conical, biconical, planar, triangular, slot, multi-slot, choked slot, or multilayer geometries and structures where adjacent layers have different shapes and are separated by dielectric layers.
  • the antenna may also include complex curvatures rather than being simple cones or triangles, for example.
  • a plurality of antennas can be contained within the balloon. These antennas could be arranged in a particular array which may be ideal for a particular procedure.
  • the antenna may include a printed circuit board, a Low (or High) Temperature Cofired Ceramic (LTCC or HTCC), micro-machined structures, molded or over-molded structures, swaged structures, structures plated on or laminated over elastomer or plastic substrates, and/or small die cast or die formed structures.
  • LTCC Low (or High) Temperature Cofired Ceramic
  • the antenna may include features or structures surrounding the antenna to create focusing or "slotting type” effects.
  • Slotting type refers to slots formed within the balloon that focus or target the RF energy radiation or circumferential RF energy radiation.
  • one or more portions of the balloon may also include a coating that is configured to shield electromagnetic waves emitted from the antenna to directionally configure the microwave transmission pattern to tissue outside of the balloon. Either the interior or exterior of the balloon may be coated with material designed to shield RF energy, effectively prohibiting RF energy to be transmitted except through the slots formed by the absence of shielding material. These slots may be designed according to the needs of a particular procedure.
  • Portions of the shielding material can be removed in a desired pattern to allow RF energy to pass through tissue outside the balloon in accordance with the removed designed pattern.
  • shielding material may be placed in a configuration to avoid heating blood passing therethrough.
  • the shielding material is positioned to avoid heating cooling fluids or contrast media or agents passing therethrough.
  • the shielding material may include reflective or absorptive materials, or a combination of both.
  • Shielding materials as described may include dielectric, semi-conducting, or conducting materials, which encompass cast material, coated material, encapsulated material, or formed material. Such material may be composed of metal, ceramic, glass, ferrite, plastic, elastomer, or other suitable materials, including chemical compounds and mixtures of diverse materials.
  • the antenna and associated balloon catheter apparatus may accommodate a broad range of artery sizes to prevent requiring the operator to use structurally different antennae with different patients.
  • the balloon for use in renal denervation procedures where the balloon catheter apparatus is advanced into the renal artery can have a diameter in the range or about 2.0 to about 12.0 millimeter and a length in the range of about 10 to about 45 millimeter.
  • the balloon for use in renal denervation procedures where the balloon catheter apparatus is advanced into the aorta can have a diameter in the range or about 22 to about 46 millimeter and a length in the range of about 10 to about 60 millimeter. This may or may not still require different catheters having different, selectable inflated balloon size to account for differences in artery anatomy or geometry between patients.
  • the balloon catheter apparatus and associated system disclosed herein contemplates the use of coolant and heat transfer mechanisms to promote blood circulation past the balloon and/or minimize thermal damage to untargeted tissue.
  • the emitter may be immersed in an appropriate dielectric agent.
  • dielectric agents include, but are not limited to, non- ionic contrast media, Carbon Dioxide (C0 2 ) or other deionized fluid or gas having a low dielectric constant.
  • a nonionic, dielectric cooling fluid may be circulated to, from, and within the balloon to cool the inner artery walls and to maintain a desired temperature range during operation.
  • the dielectric agent may comprise some or all of the desirable effects of a "contrast media," such as the contrast media or agents used in X-ray procedures.
  • the C0 2 gas may be chilled to supercritical temperatures before introduction into the balloon catheter apparatus. When supercritical C0 2 is utilized, the emitter may deliver higher frequency microwave energy ranging from 8 to 10 GHz to optimize the ablation depth and rate of ablation.
  • a non-ionic contrast media or other dielectric agent having lower conductivity and lower dielectric constant than tissue or blood may be used to inflate the balloon and/or circulate in the balloon.
  • the balloon may also be attached to a fluid or gas pump which circulates the dielectric agent within the lumen of the balloon to act as a cooling mechanism for the interior wall of the artery.
  • a gas When a gas is used as a dielectric agent, the gas will be contained within the balloon catheter apparatus and will not be introduced into the patient's vasculature.
  • a fluid When a fluid is used as a dielectric agent, the fluid optionally can be introduced into the patient's vasculature through irrigation ports.
  • more than one dielectric agent can be employed, including, but not limited to, one gas and one fluid or two fluids.
  • a dielectric agent may be circulated to, from, and within the walls of the balloon to achieve the desired cooling effect of the adjacent tissue.
  • the dielectric agent would not contact the emitter.
  • the dielectric agent may be introduced into the lumen of the balloon, contacting the emitter, as well as in cooling channels within the balloon walls.
  • a dielectric agent in the form of a fluid can be injected into the bloodstream via irrigation ports positioned on or near the balloon of the balloon catheter apparatus to protect the arterial wall against thermal damage by directly cooling the arterial wall and serving as a heat transfer mechanism to pull the heat away from the procedure site following the bloodstream.
  • irrigation ports may be located at the distal tip of the balloon catheter apparatus, on the balloon of the balloon catheter apparatus, at the junction formed between the distal tip and the balloon of the balloon catheter apparatus, or proximal of the inflatable balloon of the balloon catheter apparatus. Irrigation ports may be terminated with a one-way valve or open to the bloodstream without a valve. In some embodiments, the lumen carrying the dielectric agent that serves as a coolant may also receive a guide wire for use in positioning the balloon within a patient. The irrigation port is located in vivo once the balloon catheter apparatus is in place and the emitter is adjacent the target tissue.
  • the irrigation ports form an exit to allow the dielectric agent to transport heat away from the emitter that is generated during operation.
  • the irrigation ports serve as an exit for a dielectric agent that has cooled the balloon catheter apparatus as the balloon catheter apparatus can increase in temperature while or soon after delivering energy as described herein.
  • a dielectric agent passes through the catheter in a lumen shared by or adjacent to the cable whereby the dielectric agent cools the cable throughout the catheter.
  • the cable of the balloon catheter apparatus can operate at power capacities above the rated capacity.
  • dielectric agents can include saline, Ringer's solution, or other medical-grade hydration or contrast agents with low ionic strength provided that the inflatable balloon catheter apparatus and associated system functions in ablation procedures described herein and is not hindered by the presence of low concentration ions.
  • the cable comprises an inner electrical conductor configured in the shape of a tube, the inner diameter of which forming a central lumen.
  • the central lumen is configured to transport fluid or gas therethrough to the balloon for: (1 ) cooling a microwave emitter, such as an antenna, positioned in or on a wall of the balloon, (2) cooling the wall of the central lumen, which wall is formed by an inner electrical conductor, and (3) inflating the balloon.
  • the central lumen is also configured to (1 ) receive a guide wire therethrough for positioning the catheter in a vessel, and (2) receive pressure and temperature devices therethrough for communicating pressure and temperature data from or in the vicinity of the balloon and/or along the lumen to the proximal end of the catheter.
  • the inner diameter surface of the inner conductor is not covered with any material and is configured to directly contact the cooling fluid or gas that is transported therethrough to the balloon.
  • the flow rate through the central lumen is 10 ml/min to 150 ml/min.
  • the flow of a dielectric agent through the balloon catheter apparatus can be a consistent infusion, a bolus controlled by the user, or a combination thereof.
  • a dielectric agent would be cooled to an external temperature of 0°C to 37°C before introduction into the balloon catheter apparatus and associated system.
  • the C0 2 may be cooled to subzero temperatures.
  • the dielectric agent would be circulated for constant cooling of the dielectric agent.
  • a dielectric agent may be cooled to an external temperature less than 0°C before introduction into the balloon catheter apparatus and associated system.
  • a dielectric agent as a coolant in the embodiments described herein prevents inflammation and other adverse events associated with prior existing artery stenosis, plaque, or other conditions that may be exacerbated by local increased temperature.
  • the balloon may also have a spiral configuration with channels that form a passage for blood to pass through and bypass the balloon when the balloon is inflated in a vessel.
  • the blood passing between the vascular wall and through the balloon channels effectively acts as a heat transfer mechanism to draw heat away from the balloon catheter apparatus while energy is being delivered by the emitter.
  • Use of flowing blood to transport heat away from the vascular wall protects the non-targeted tissue, such as the vessel inner wall, from thermal damage associated with any ablation procedure, whether by RF, thermal, microwave, or any other form of energy radiation.
  • a blood pass-through channel may also be incorporated into the lumen of the catheter body.
  • the emitter and associated system may be tuned and/or calibrated to radiate electromagnetic waves at a frequency among a range of frequencies in, for example, the microwave spectrum.
  • the specific emitted frequency and the range of desirable frequencies that may be emitted to disrupt the sympathetic nerves in a renal denervation procedure may be determined by balancing the amount of energy that will be absorbed by tissue at a desired range of target radial distances from the emitter while accounting for a patient's body to act as a shield to prevent unwanted emissions in, for example, the microwave spectrum to other untargeted tissues in the body or externally to the body.
  • the choice of emitted frequency helps determine the physical size of the emitter for electromagnetic wave emissions as well as the predicted bulk absorption rate by the arterial wall and surrounding tissue of the emitted frequency.
  • Microwave frequencies in tissue are absorbed at rates determined by tissue characteristics and by microwave frequencies. In general, higher microwave frequencies are absorbed in a shorter distance than lower microwave frequencies.
  • the desired energy heating penetration depth in tissue may be achieved in order to ablate targeted tissue or disrupt targeted nerves in the desired volume while minimizing the effect on non-targeted nerves and other non-targeted tissue outside the treatment volume.
  • microwave frequencies in the range of about 500 MHz to about 50 GHz, and more particularly of about 500 MHz to about 30 GHz, may be used to thermally disrupt or ablate sympathetic nerves without incurring unintended damage or injury, or at most only inconsequential damage or injury, to the patient's vasculature and surrounding tissue.
  • a predetermined frequency range causes the electromagnetic wave energy emitted to be absorbed by tissue in the first several millimeters of tissue radially from the position of the antenna.
  • the depth of energy absorption will depend on frequency, relative permittivity of the tissue, power of the microwave energy, and tissue temperature (indirectly by changing relative permittivity of the tissue).
  • the balloon catheter apparatus and associated system emits microwave energy at frequencies at about 500 MHz to about 30 GHz, more particularly at about 5.0 GHz to about 19.5 GHz, to thermally disrupt sympathetic nerves in local tissue nominally located approximately 0.5 millimeter to approximately 10 millimeter radially from the inner wall of an artery.
  • the balloon catheter apparatus and associated system emits microwave energy at frequencies at about 500 MHz to about 30 GHz, more particularly at about 5.0 GHz to about 19.5 GHz, to thermally disrupt sympathetic nerves in local tissue nominally located approximately 0.5 millimeter to approximately 10 millimeter radially from the inner wall of the renal artery when positioned within the renal artery in the vicinity of a patient's kidney.
  • the balloon catheter apparatus and associated system emits microwave energy at frequencies at about 500 MHz to about 30 GHz to thermally disrupt sympathetic nerves in local tissue nominally located approximately 0.5 millimeter to approximately 10 millimeter radially from the inner wall of the aorta when positioned within the aorta proximal to the patient's renal artery.
  • a user determines and selects an initial frequency to be emitted. In another embodiment, the initial frequency to be emitted is not user- selectable. In one embodiment, a user configures a plurality of the parameters that are desired for a denervation or ablation dose. In another embodiment, a plurality of the parameters for a desired denervation or ablation dose are predetermined or are configured automatically by a computer algorithm.
  • Other means of renal denervation may include selectively heating the sympathetic nerves cells while having minimal effect on the surrounding tissue in the presence of microwave energy. This can be achieved by selecting a frequency, phase, and power setting, or combination thereof to correlate to the specific dielectric properties of the nerve tissue as opposed to the surrounding tissue.
  • the dielectric loss factor and/or energy absorption characteristics of the two different types of tissues will determine the degree to which microwave energy will be converted to heat at the target site.
  • the dielectric loss factor and/or energy absorption characteristics are frequency, phase, and power dependent and peak heating of the tissue can be achieved by selecting the appropriate parameters which correspond to the target tissue exhibiting the highest dielectric loss.
  • Microwave energy radiates from the emitter outward through the balloon and into tissue, where tissue absorbs the energy at some percentage per travel distance, and the radiated waves expand roughly radially from the emitter.
  • Choice of frequency and emitter configuration may allow either a non-symmetrical or a symmetrical wave energy absorption pattern around the balloon axis of symmetry.
  • the desired thermal effect zone i.e., the targeted tissue
  • the desired thermal effect zone is approximately 0.5 millimeter to approximately 10.0 millimeter radially outward from the inner wall of an artery.
  • the desired thermal effect zone is approximately 0.5 mm to approximately 12.0 mm, or 0.75 mm to 5.0 mm, radially outward from the inner wall of the artery.
  • Frequency, power, transmit duty cycle, internal coolant application, and treatment period may be varied to obtain target temperatures in tissue in this targeted depth region.
  • the targeted tissue is the core density of nerves, which are located about 2.0 millmeters to about 4.0 millimeters radially outward from the inner wall of an artery.
  • the core density of nerves may lie outside the range of about 2.0 millimeters to about 4.0 millimeters.
  • an adjustment of at least one of the frequency, power, transmit duty cycle, internal coolant application, and treatment period may be made to accommodate the unique anatomy of a given patient.
  • substantially all of the electromagnetic wave energy is transferred to and absorbed by tissue within the first few millimeters of tissue radially outward from the balloon, thereby minimizing adverse effects on other body organs or tissue.
  • a computer control unit may alter generated frequencies within a 100 MHz bandwith of an initial frequency of 2.45 GHz (i.e., 2.4 Ghz to 2.5 Ghz).
  • a computer control unit may shift the phase of the waveform of the microwave energy, once or several times, thereby transposing and/or broadening the peak energy delivery in the target tissue area and reducing the impact on non-targeted tissue. This phase shifting can minimize hot spots along the cable by reducing standing waves that may develop along the length of the cable due to non-uniformities in cable manufacturing and reflected power due to variable physiological properties, for example impedance mismatches caused by variable tissue dielectric properties. This leads to improved life and efficiency of the cable.
  • a computer control unit may both shift the phase and alter the frequency of the waveform of the microwave energy, once or several times, thereby transposing and/or broadening the peak energy delivery in the target tissue area and reducing the impact on non-targeted tissue.
  • Frequency sweeping or phase shifting implemented during the procedure can be done to minimize reflected power not absorbed by the target tissue due to environmental factors, for example, tissue impedance.
  • Memory can include any one or a combination of volatile memory elements (e.g., random access memory (RAM), such as DRAM, SRAM, SDRAM, etc.) and nonvolatile memory elements (e.g., EEPROM, FLASH, FRAM, ROM, hard drive, tape, CDROM, etc.). Memory may also include electronic, magnetic, optical, and/or other types of storage media. Memory can be distributed among various components remote from yet interconnected with one another, or can reside on a single component.
  • RAM random access memory
  • SRAM static random access memory
  • SDRAM static random access memory
  • Memory may also include electronic, magnetic, optical, and/or other types of storage media. Memory can be distributed among various components remote from yet interconnected with one another, or can reside on a single component.
  • Disease characteristics that may be considered in selecting an operational mode include, but are not limited to the severity of disease, for example, severity of hypertension; the presence or absence of hyperactive sympathetic activity, which can be identified by at least muscle sympathetic nerve activity and/or intravascular nerve activity, among others; and clinical data demonstrating or suggesting optimized treatment regimens.
  • Other variables that may be considered in selecting an operational mode include, but are not limited to the physician's experience and equipment operating requirements.
  • certain operational modes may be selected by the user or physician prior to emitting microwave energy from the emitter.
  • the operational modes are preprogrammed settings that allow a user or physician to select a certain dose amount of microwave energy along with other parameters.
  • operational modes that could be selected are "High”, “Medium”, and “Low”.
  • the "High” operational mode would contain software that delivers an increased amount of microwave energy compared to the "Medium” and “Low” operational modes.
  • Each operational mode is associated with software controlling the different parameters described herein, including, but not limited to vessel wall temperature, tissue temperature inferred at some depth radial from the center of the vessel, power input, power output, cooling flow level, frequency, phase, power on time, power alteration rate, cooling flow volume/rate, time the microwave ablation apparatus dwells in vessel, and balloon inflation/deflation rates.
  • the user selects the operational mode through one or more knobs, keyboards, mouses, touch screens, PLCs, or any other user interfaces or input devices.
  • the balloon catheter apparatus and associated system may include a control system.
  • the balloon catheter apparatus and associated system may be configured to measure the forward and reflected energy delivered to the cable and to the emitter.
  • the balloon catheter apparatus and associated system may also include a feedback signal originating at or near the emitter to permit the control unit to modulate or otherwise control the amount and/or frequency of electromagnetic energy emitted from the antenna.
  • Low frequency signals derived from detectors configured for transmitted and reflected power measurement may be provided as control inputs to allow proper management of frequency and/or power output control signals from the control unit.
  • Sensors to measure the real-time temperature at or near the emitter, the inside of the balloon, the wall of the balloon, or in the tissue may be included to provide the control unit with data sufficient to help modulate or adjust, in real-time, the frequency, phase, and amplitude of the emitted energy and/or flow rate of the dielectric agent.
  • Sensors to measure electromagnetic field can be located on the distal end of the inflatable balloon catheter apparatus.
  • the electromagnetic field measurements serve as an indicator of energy generated and, in turn, temperature of the surrounding environment, including, but not limited to, a targeted tissue, a non-targeted tissue, a vessel wall, and a balloon catheter apparatus.
  • Temperature feedback to the user may be employed in several embodiments of this invention, where such temperature feedback includes detection of temperature at the balloon end of the catheter at one or more locations, and such detection includes one or more detection devices.
  • temperature detection devices are known in the art, and some examples of possibly suitable devices include fiber optic sensors, liquid crystal light capturing or colorimetric sensors, thermistors, resistance-temperature-detectors, semiconductor junction characteristic temperature sensors, microwave radiometer, acoustic reflectivity sensors, and numerous others.
  • non-conductive devices such as fiber optic and liquid crystal based, since the effect of microwave radiation on the sensor and the effect of the sensor and wiring on the emitter radiation pattern is minimized. It is also contemplated to incorporate very small and high resistance sensors of the conductive devices into the balloon catheter apparatus and associated system.
  • the sensors of the inflatable balloon catheter apparatus provide direct measurements.
  • the control system can be configured to calculate, estimate, or infer data from those direct measurements.
  • temperature measurements from an arterial wall can be used to calculate, estimate, or infer temperature values for tissue at some radial depth from the arterial wall.
  • Pressure sensors internal to the balloon catheter apparatus and/or at the proximal end near the fluid pump may also be utilized to monitor and/or permit manual or automatic adjustments of the performance of the balloon catheter apparatus and associated system.
  • one or more sensors may be in communication with a computer system configured to monitor a pressure of fluid in the one or more coolant channels and adjust a flow rate and/or fluid volume output of the fluid pump.
  • the balloon catheter apparatus and associated system may monitor and/or adjust one or more operating parameters associated with the delivery of electromagnetic energy to a patient.
  • the balloon catheter apparatus and associated system may include one or more temperature sensors, one or more fluid flow sensors, one or more timers, one or more electrical power consumption meters, one or more voltage sensors, one or more current sensors, one or more pressure transducers, and any other sensor or measurement device to measure and/or report measurement data to one or more CPU's configured to perform one or more computer algorithms according to one or more predefined rules.
  • the one or more predefined rules may include predefined operating ranges for each parameter being monitored or measured. Such operating ranges can be preprogrammed and stored in memory.
  • the one or more CPU's may be housed in a housing electrically connected to the balloon catheter.
  • the balloon catheter apparatus and associated system may be configured to transmit data to a remote computer.
  • the balloon catheter apparatus and associated system may be configured to receive data from a remote computer via a wired link such as RS232, CAN bus, Ethernet, Firewire, USB or a wireless link such as Bluetooth, Zigbee, 802.1 1 a/b/c/n.
  • one or more aspects of the balloon catheter apparatus and associated system may monitor the amount of energy provided by the emitter to the patient's arterial walls. If, for example, should detected temperature be outside a desired temperature range or limit, the system will initiate a fail-safe mode to cease or reduce delivery of microwave energy to tissue. For example, if the balloon catheter apparatus and associated system is operating at 100 percent duty cycle and/or at 100 percent microwave power amplifier output level, and the system determines that the measured temperature falls outside of a predetermined temperature range or limit, a control algorithm may reduce the duty cycle for microwave power delivery and/or reduce the microwave power amplifier output level to a value that is less than 100 percent to reduce the temperature to be within desired limits.
  • the control unit may be configured to provide a predetermined, nominal energy delivery at a rate sufficient to bring the target tissue up to the desired temperature range or band in a reasonable time, then using one or more feedback control system, or predetermined energy levels which correlate to resulting temperature levels provide for the delivery of energy to maintain the temperature in a desired temperature band or range for a desired period of time.
  • the target tissue will be heated to at least 40°C. In other preferred embodiments, the target tissue will be heated up to a range of 40°C to 100°C.
  • the target tissue will be heated to a range of 40°C to 60°C. In other preferred embodiments, the target tissue will be heated to a range of 48°C to 75°C.
  • the energy application cycle will be at least 15 seconds. In other preferred embodiments, the energy application cycle will range between 15 seconds to 600 seconds.
  • One or more pulses of energy may be applied per application cycle.
  • a wall temperature of 46°C to 50°C as measured or inferred at the inner diameter of the vessel may be coupled with an application cycle of 120 to 180 seconds.
  • the balloon catheter apparatus and associated system is designed to optimize therapy by varying the energy application cycle and target tissue temperature.
  • the optimal dose for a given patient may require manipulations of the balloon catheter apparatus and associated system as described herein after monitoring vessel wall temperature and target tissue temperature. Achieving the optimal dose for a given may be accomplished through manipulation of power input, power output, cooling flow rate, coolant temperature, frequency, phase, power on time, power alterative rate, cooling flow volume or rate, balloon catheter apparatus dwell time, balloon inflation/deflation rate, among others.
  • a balloon catheter and associated system to emit microwave energy to excite and thermally disrupt or ablate one or more sympathetic nerves.
  • Thermal disruption or ablation of one or more sympathetic nerves would have therapeutic benefits for patients suffering from Cardiovascular Hypertension, Insulin Resistance, Diabetes, Diabetic Nephropathy, Chronic Kidney Disease, Congestive Heart Failure, Hepatorenal Syndrome, End-Stage Renal Disease, Atrial Fibrillation, Ventricular Tachycardia, Pulmonary Hypertension, COPD, and Acute Renal Disease.
  • Fig. 1 shows an exemplary balloon catheter apparatus comprising modular catheter 20 removably connectable to steerable catheter handle 30, a guide wire port 50, ports for fluid or gas introduction 60, an inflatable balloon 40 housing a microwave emitter, which is associated with a system comprising a power source 80, and a control unit 70 which includes an RF generator, and display.
  • the steerable catheter handle 30 is connected to a guide wire port 50.
  • a guide wire can be removably inserted into the shaft of the catheter 20 from the guide wire port 50 and used to advance the balloon catheter apparatus through the vasculature.
  • the steerable catheter handle 30 is also connected to an inflation port 60 used to inflate the balloon 40 with fluid or gas.
  • the steerable catheter handle 30 is further connected to a control unit 70, which includes a display and a RF generator.
  • the display such as a touch screen display, comprises a user interface for user data entry or commands to, for example, calibrate or otherwise operate the balloon catheter and associated system 10.
  • the control unit 70 may include connections to user interface, power conversion circuitry for converting input power from alternating current to direct current and vice versa, and sensing circuitry and software for monitoring sensors, interpreting data received from sensors, and for adjusting the signal delivered to emitter 41.
  • the control unit 70 may be configured to execute computer executable instructions to perform the functions described above, including phase sweeping.
  • the control unit 70 is connected to a power source 80, which may include alternating current line power provided by an electrical utility provider (i.e., 120 volt, 60 Hz in the U.S.) or power provided by a portable battery or fuel cell system.
  • a power source 80 which may include alternating current line power provided by an electrical utility provider (i.e., 120 volt, 60 Hz in the U.S.) or power provided by a portable battery or fuel cell system.
  • the balloon catheter apparatus is designed to be introduced into the patient's body whereas the associated system will remain outside the patient's body.
  • control unit 70 Upon completion of a desired exposure or dose of energy to a target tissue in an artery, control unit 70 causes delivery of such energy to cease. Catheter 20 and balloon 40 may then be maneuvered as needed for additional dosing of the same or opposite artery, or extracted from the patient's body.
  • Balloon catheter apparatus and associated system 10 is configured to be sterilized before use on a patient. Acceptable methods for disinfection of the various components of balloon catheter apparatus and associated system 10 include sterilizing for required duration at a required temperatures, concentrations, and pH's.
  • cooling channels 42 may comprise a lumen extending from the proximal end of the balloon catheter apparatus (located ex vivo when the balloon catheter is in place) through the distal tip of the balloon catheter apparatus. These cooling channels 42 may be configured to allow a dielectric agent to cool the balloon catheter apparatus, the emitter 41 , the balloon wall, the untargeted tissue, or a combination thereof. The path the cooling channels 42 form will be dependent on what cooling is desired. If it is desired that the emitter 41 be cooled, the dielectic agent delivered by the cooling channels contacts the emitter or is in close proximity to the emitter 41 to effectively cool the emitter 41.
  • Figs. 1 1-19 show several alternate embodiments for emitter 41.
  • the emitter can be an antenna 43 or a plurality of antennas.
  • An antenna 43 can be formed in the shape or geometry as shown in Figs. 1 1-19.
  • the optimal antenna design will enable the balloon catheter apparatus and associated system to deliver microwave energy in a desired orientation and to a targeted tissue of a specific depth.
  • Fig. 12 depicts an exemplary conical antenna configuration
  • Fig. 13 depicts an exemplary dipole antenna configuration
  • Fig. 14 depicts an exemplary patch antenna
  • Fig. 15 depicts an exemplary bow-tie antenna configuration
  • Fig. 16 depicts an exemplary helical coil antenna configuration
  • Fig. 17 depicts an exemplary planar antenna configuration
  • Fig. 12 depicts an exemplary conical antenna configuration
  • Fig. 13 depicts an exemplary dipole antenna configuration
  • Fig. 14 depicts an exemplary patch antenna
  • Fig. 15 depicts an exemplary bow-tie antenna configuration
  • Figs. 20-23 illustrate examples of the effect the operation of the balloon catheter apparatus and associated system 10 may have on adjacent tissue when the emitter is operational and emitting microwave energy.
  • Figs. 20-23 depict temperature gradients at an isolated timepoint after the emitter has been emitting microwave energy for a given time.
  • FIG. 22 depicts an example of the effect the balloon catheter apparatus and associated system 10 may have on adjacent tissue when the balloon catheter apparatus and associated system 10 is targeting tissue at a radial depth of 2.0 mm to 4.0 mm from the inner surface of an arterial wall while the various cooling and heat transfer mechanisms described herein are not employed.
  • Fig. 23 depicts an example of the effect the balloon catheter apparatus and associated system 10 may have on adjacent tissue when the balloon catheter apparatus and associated system 10 is targeting tissue at a radial depth of 2.0 mm to 4.0 mm from the inner surface of an arterial wall while the various cooling and heat transfer mechanisms described herein are employed. As demonstrated by Figs.
  • the use of the various cooling and heat transfer mechanisms described herein result in less thermal damage to the arterial wall and, instead, enable the balloon catheter apparatus and associated system 10 to focus the thermal heat generated by the microwave emission on the targeted tissues.
  • one set of operational variables e.g., frequency selection, pulse duration, time of treatment, emitter design, etc.
  • Numerous variables including, but not limited to, patient anatomy, bioimpedance, and the type of targeted tissue, needs to be taken into account when selecting the proper variables to operate the balloon catheter apparatus and associated system.
  • Additional tissue temperature gradients are contemplated to achieve the desired ablation as described herein, and Fig. 20-23 are presented solely as examples and are not meant to suggest that the balloon catheter apparatus and associated system 10 is incapable of alternate tissue temperature gradients that can accomplish the desired ablation of targeted tissue and achieve the associated therapeutic benefit.
  • Figs. 24-26 depict various embodiments of the inflatable balloon 40 of the balloon catheter apparatus. Particularly, Figs. 24-26 show non-symmetrical balloon geometries that are apparent when the balloon 40 is inflated.
  • Figs. 24A, 24B, and 24C are perspective, side, and end views, respectively, of a non-symmetrical inflatable balloon 40 when inflated.
  • the inflatable balloon 40 is non-symmetrical with respect to the longitudinal axis.
  • Figs. 25A, 25B, and 25C are perspective, side, and end views, respectively, of another non-symmetrical inflatable balloon 40 when inflated.
  • the inflatable balloon 40 is symmetrical with respect to the longitudinal axis, but as shown in Fig.
  • Fig. 27 depicts one embodiment of a cross-section of the catheter 20 shaft proximal to the inflatable balloon 40.
  • a coolant channel 42 is located within a cable 90.
  • the guide wire 92 may be housed within a central lumen that may function as a coolant channel 42.
  • the central lumen serves as both a coolant channel 42 and a guide wire 92 lumen, the latter to permit advancement of the balloon within the patient's vasculature.
  • the inner conductor 95 of the cable 90 forms the boundaries of the central lumen.
  • a dielectric material 94 surrounds the inner conductor.
  • the dielectric material 94 comprises a dielectric material found in coaxial cables, which is known by those of ordinary skill in the art.
  • the dielectric material 94 differs from the dielectric agents described above that traverse through one or more coolant channels 42. Surrounding the dielectric material 94 is an outer conductor 93. A cable outer jacket 96 surrounds the outer conductor 93. The area or annulus between the cable 90 and the catheter 20 forms another coolant channel 42'.
  • a dielectric agent would be introduced from a port into the balloon catheter apparatus. The port would carry the dielectric agent into coolant channel 41 ". The dielectric agent would flow through the coolant channel 42" into the balloon. A return aperture or apertures would be located at some location distal to the cross-section depicted in Fig. 27.
  • the one or more return apertures would allow the dielectric agent to inflate the balloon and be circulated towards the proximal end of the balloon catheter apparatus.
  • One or more return apertures may be connected to coolant channels 42' to return the dielectric agent to the proximal end of the balloon catheter apparatus in order for the dielectric agent to be cooled or disposed.
  • the dielectric agent may exit the distal end of the balloon through one or more irrigation ports described above.
  • Fig. 28 depicts one embodiment of a cross-section of the catheter 20 shaft proximal to the inflatable balloon 40.
  • a coaxial cable 90 is located within the catheter 20 shaft.
  • the coaxial cable comprises an inner conductor 95, a dielectric material 94 (as described in Fig. 27), an outer conductor 93, and a cable outer jacket 96.
  • a guide wire lumen 51 houses a guide wire 92. The space in the catheter 20 not occupied by the cable 90 or the guide wire lumen 51 forms a coolant channel 42.
  • balloon catheter apparatus and associated system described herein may be used in any number of different ways and in different applications not necessarily involving procedures for treating cardiovascular hypertension. Accordingly, the disclosure herein is meant to be illustrative only and not limiting as to its scope and should be given the full breadth of the appended claims and any equivalents thereof.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Electromagnetism (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Otolaryngology (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un système et un procédé d'ablation à micro-ondes qui comprennent un appareil à cathéter à ballonnet et un système de commande. L'appareil à cathéter à ballonnet comprend un cathéter conçu pour loger un câble coaxial et un ou plusieurs canaux de fluide de refroidissement, un ballonnet gonflable situé au niveau de l'extrémité distale du cathéter et une antenne positionnée dans le ballonnet gonflable et en communication avec le câble coaxial. Le système de commande comprend une pompe à fluide conçue pour introduire un fluide dans une extrémité proximale du cathéter, un amplificateur de puissance susceptible de générer une énergie à micro-ondes pour administration à la zone tissulaire cible pendant au moins un cycle d'application d'énergie allant de 60 secondes à 600 secondes, à une fréquence comprise entre 2,4 GHz et 2,5 GHz et un système informatique configuré pour surveiller et/ou réguler l'administration d'énergie à micro-ondes au tissu cible, la pompe à fluide, au moins un capteur et une puissance d'antenne réfléchie.
PCT/US2015/047954 2014-09-10 2015-09-01 Appareil à cathéter à ballonnet avec émetteur de micro-ondes WO2016040056A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/483,148 2014-09-10
US14/483,148 US10076384B2 (en) 2013-03-08 2014-09-10 Balloon catheter apparatus with microwave emitter

Publications (1)

Publication Number Publication Date
WO2016040056A1 true WO2016040056A1 (fr) 2016-03-17

Family

ID=55459427

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/047954 WO2016040056A1 (fr) 2014-09-10 2015-09-01 Appareil à cathéter à ballonnet avec émetteur de micro-ondes

Country Status (1)

Country Link
WO (1) WO2016040056A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111050679A (zh) * 2017-08-31 2020-04-21 柯惠有限合伙公司 使用多个光纤传感器在微波天线的不同位置感测温度的系统和方法
EP3714828A1 (fr) * 2019-03-25 2020-09-30 Covidien LP Dénervation pulmonaire à l'aide d'un élément chauffant diélectrique centré sur les bronches
WO2021183890A1 (fr) * 2020-03-13 2021-09-16 Biocompatibles Uk Limited Systèmes de détermination d'un score d'ablation et de test de pré-ablation

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5861021A (en) * 1996-06-17 1999-01-19 Urologix Inc Microwave thermal therapy of cardiac tissue
US20070185554A1 (en) * 2006-02-07 2007-08-09 Angiodynamics, Inc. Interstitial microwave system and method for thermal treatment of diseases
US20070219548A1 (en) * 2006-03-16 2007-09-20 Carr Kenneth L Microwave apparatus for controlled tissue ablation
US20120116486A1 (en) * 2010-10-25 2012-05-10 Medtronic Ardian Luxembourg S.A.R.L. Microwave catheter apparatuses, systems, and methods for renal neuromodulation
US20120157988A1 (en) * 2005-03-28 2012-06-21 Vessix Vascular, Inc. Tuned rf energy for selective treatment of atheroma and other target tissues and/or structures
US20140021197A1 (en) * 2008-09-30 2014-01-23 Covidien Lp Microwave ablation generator control system
US20140081254A1 (en) * 2012-09-19 2014-03-20 Denervx LLC Cooled microwave denervation

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5861021A (en) * 1996-06-17 1999-01-19 Urologix Inc Microwave thermal therapy of cardiac tissue
US20120157988A1 (en) * 2005-03-28 2012-06-21 Vessix Vascular, Inc. Tuned rf energy for selective treatment of atheroma and other target tissues and/or structures
US20070185554A1 (en) * 2006-02-07 2007-08-09 Angiodynamics, Inc. Interstitial microwave system and method for thermal treatment of diseases
US20070219548A1 (en) * 2006-03-16 2007-09-20 Carr Kenneth L Microwave apparatus for controlled tissue ablation
US20140021197A1 (en) * 2008-09-30 2014-01-23 Covidien Lp Microwave ablation generator control system
US20120116486A1 (en) * 2010-10-25 2012-05-10 Medtronic Ardian Luxembourg S.A.R.L. Microwave catheter apparatuses, systems, and methods for renal neuromodulation
US20140081254A1 (en) * 2012-09-19 2014-03-20 Denervx LLC Cooled microwave denervation

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111050679A (zh) * 2017-08-31 2020-04-21 柯惠有限合伙公司 使用多个光纤传感器在微波天线的不同位置感测温度的系统和方法
EP3714828A1 (fr) * 2019-03-25 2020-09-30 Covidien LP Dénervation pulmonaire à l'aide d'un élément chauffant diélectrique centré sur les bronches
WO2021183890A1 (fr) * 2020-03-13 2021-09-16 Biocompatibles Uk Limited Systèmes de détermination d'un score d'ablation et de test de pré-ablation
US11759247B2 (en) 2020-03-13 2023-09-19 Biocompatibles Uk Limited Systems and methods for determining an ablation score and for pre-ablation testing

Similar Documents

Publication Publication Date Title
US10076384B2 (en) Balloon catheter apparatus with microwave emitter
US20140257266A1 (en) Balloon catheter apparatus with microwave emitter
US20200360076A1 (en) Devices for thermally-induced renal neuromodulation
JP6437585B2 (ja) 流体冷却されるアンテナアセンブリへの熱フィードバック制御された流量の流体流のためのシステムおよびそれを用いて組織にエネルギーを導く方法
US9707036B2 (en) Devices and methods for nerve modulation using localized indifferent electrodes
US8414570B2 (en) Microwave coagulation applicator and system
EP3453354B1 (fr) Système de surveillance de la taille d'ablation
CN106377312B (zh) 用于肾神经调节的微波导管设备、系统和方法
EP1998698B1 (fr) Ligne de transmission avec capacité de transfert de chaleur
US20140249524A1 (en) System and method for performing renal nerve modulation
US20130274731A1 (en) Helical tubing devices and methods for fluid renal nerve modulation
US20140067029A1 (en) Renal nerve modulation and ablation catheter electrode design
US20110208180A1 (en) System and Method for Monitoring Ablation Size
WO2016040056A1 (fr) Appareil à cathéter à ballonnet avec émetteur de micro-ondes
EP4096547A1 (fr) Systèmes et procédés d'ablation de tissu et mesures se rapportant à ceux-ci
US20210212763A1 (en) Microwave ablation systems and methods having adjustable ablation parameters and modes of operation
JP2023517254A (ja) アブレーションスコアを特定するため、及びアブレーション事前試験を行うためのシステム
CN115605154A (zh) 用于消融设备的斜升功能
CN115605153A (zh) 消融设备的循环

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 15840653

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 15840653

Country of ref document: EP

Kind code of ref document: A1