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WO2012122157A1 - Cathéter d'ablation par radiofréquence - Google Patents

Cathéter d'ablation par radiofréquence Download PDF

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Publication number
WO2012122157A1
WO2012122157A1 PCT/US2012/027849 US2012027849W WO2012122157A1 WO 2012122157 A1 WO2012122157 A1 WO 2012122157A1 US 2012027849 W US2012027849 W US 2012027849W WO 2012122157 A1 WO2012122157 A1 WO 2012122157A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
electrodes
balloon catheter
catheter
nerve
Prior art date
Application number
PCT/US2012/027849
Other languages
English (en)
Inventor
Steven HIMMELSTEIN
Original Assignee
Tidal Wave Technology, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tidal Wave Technology, Inc. filed Critical Tidal Wave Technology, Inc.
Publication of WO2012122157A1 publication Critical patent/WO2012122157A1/fr
Priority to US14/020,275 priority Critical patent/US20140012251A1/en
Priority to US14/946,424 priority patent/US20160074112A1/en

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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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart 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
    • A61B2018/00005—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
    • 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
    • A61B2018/00059—Material properties
    • A61B2018/00089—Thermal conductivity
    • A61B2018/00101—Thermal conductivity low, i.e. thermally insulating
    • 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
    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • 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
    • A61B2018/00434—Neural system
    • 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
    • A61B2018/00773—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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance
    • 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
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6862—Stents

Definitions

  • the present invention generally relates to a medical apparatus and method for treating vascular tissues through application of radiofrequency energy, and more particularly to an ablation apparatus for treating tissues in a patient by delivering therapeutic radiofrequency energy through a catheter and/or stent to a specific lesion site for nerve or atherosclerotic ablation.
  • Arteries are the tube-shaped blood vessels that carry blood away from the heart to the body's tissues and organs and are each made up of outer fibrous layer, smooth muscle layer, connecting tissue and the inner lining cells (endothelium).
  • Certain arteries comprise complex structures that perform multiple functions.
  • the renal artery houses a network of nerves that are helpful in maintaining renal vascular tone, sodium and water excretion or reabsorption, and blood pressure control. The electrical activity to these nerves originates within the brain and the peripheral nervous system.
  • the kidneys have a dense afferent sensory and efferent sympathetic innervation and are thereby strategically positioned to be the origin as well as the target of sympathetic activation. Communication with integral structures in the central nervous system occurs via afferent sensory renal nerves. Renal afferent nerves project directly to a number of areas in the central nervous system, and indirectly to the anterior and posterior hypothalamus, contributing to arterial pressure regulation. Renal sensory afferent nerve activity directly influences sympathetic outflow to the kidneys and other highly innervated organs involved in cardiovascular control, such as the heart and peripheral blood vessels, by modulating posterior hypothalamic activity.
  • renal ischemia ischemia
  • hypoxia oxidative stress
  • oxidative stress results in increased renal afferent activity.
  • Stimulation of renal afferent nerves which may be caused by metabolites, such as adenosine, that are formed during ischemia, uremic toxins, such as urea, or electrical impulses, increases reflex in sympathetic nerve activity and blood pressure.
  • An increase in renal sympathetic nerve activity increases renin secretion rate, decreases urinary sodium excretion by increasing renal tubular sodium reabsorption, and decreases renal blood flow and glomerular filtration rate.
  • nervous activity to the kidney is increased, sodium and water are reabsorbed, afferent and efferent arterioles constrict, renal function is reduced, and blood pressure rises.
  • Renin release may be inhibited with sympatholytic drugs, such as clonidine, moxonidine, and beta blockers.
  • sympatholytic drugs such as clonidine, moxonidine, and beta blockers.
  • Angiotensin receptor blockers substantially improve blood pressure control and cardiovascular effects.
  • these treatments have limited efficacy and adverse effects.
  • many hypertensive patients present with resistant hypertension with uncontrolled blood pressure and end organ damage due to their hypertension.
  • elevated temperature is used to ablate tissue.
  • temperatures exceed 60°C cell proteins rapidly denature and coagulate, resulting in a lesion.
  • the lesion can be used to resect and remove the tissue or to simply destroy the tissue, leaving the ablated tissue in place.
  • Heat ablation can also be performed at multiple locations to provide a series of ablations, thereby causing the target tissue to die and necrose. Subsequent to heating, the necrotic tissue is absorbed by the body or excreted.
  • Radiofrequency ablation is a high temperature, minimally invasive technique in which an active electrode is introduced in the undesirable tissue and a high frequency alternating current of up to 500 kHz is used to heat the tissue to coagulation.
  • Radiofrequency (RF) ablation devices work by sending alternating current through the tissue, creating increased intracellular temperatures and localized interstitial heat.
  • RF treatment exposes a patient to minimal side effects and risks, and is generally performed after first locating the tissue sites for treatment.
  • RF energy when coupled with a temperature control mechanism, can be supplied precisely to the apparatus-to-tissues contact site to obtain the desired temperature for treating a tissue.
  • RF power applied through electrode tips emerging from a controlled radio-frequency (RF) instrument, the tissue is ablated.
  • RF radio-frequency
  • RF therapeutic protocol has been proven to be highly effective when used by electrophysiologists for the treatment of tachycardia, by neurosurgeons for the treatment of Parkinson's disease, and by neurosurgeons and anesthetists for other RF procedures such as Gasserian ganglionectomy for trigeminal neuralgia and percutaneous cervical cordotomy for intractable pains.
  • One problem in the art is the providing of a treatment surface that can reach all of the desired treatment areas, such as the entire interior surface of an artery or other blood vessel. While the use of a catheter to deploy energy may be known, it has been difficult to provide ablation across the entire interior surface of a blood vessel so as to provide optimal uniform treatment. [0016] There is an urgent need in the art to develop an approach to effectively ablate the nerve function within the kidney. Such an approach would provide the advantage of improving volume status within the body and reducing blood pressure.
  • electrical energy such as RF (radiofrequency) energy
  • the present invention is directed to a device, system and method for delivering radiofrequency energy, to the walls of a body lumen, particularly the renal artery, using a nonconductive catheter.
  • the device comprises a wire frame or stent bearing one or more electrodes that are capable of conducting RF energy.
  • the one or more electrodes are positioned in a helical arrangement about the wire frame, which is positioned about an expandable balloon contained within a catheter, e.g., at the end thereof.
  • the device is advanced over a guidewire within a sheath to the relevant location, such as within the renal artery, and positioned within the inner circumference of the vessel, such as the renal artery ostium.
  • the sheath is then withdrawn to expose the balloon and wire frame on the catheter, and the wire frame or stent is then expanded by inflating the balloon at the end of the catheter.
  • the wire frame or stent structure comprises at least one electrode that comes in contact with the body tissue when the system is expanded by the balloon.
  • the wire frame or stent is movable between a non-deployed position and a deployed position.
  • the balloon and wire frame are unexpanded, i.e., collapsed.
  • the unexpanded balloon and wire frame in their non-deployed positions at the end of a catheter may be encapsulated within a sheath and advanced longitudinally through the blood vessel into the desired position, at which point the sheath may be withdrawn, exposing the unexpanded balloon and wire frame or stent member.
  • the balloon is then expanded, thereby also expanding the wire frame into the deployed position, wherein it conforms to the walls of the lumen, so as to thereby allow the electrodes that are positioned about the wire frame to contact the lumen wall.
  • Heat is then generated to the electrodes by supplying a suitable RF energy source to the apparatus, and the ablation is performed for the ablation of nerve activity, such as nerve activity that leads specifically to the kidney.
  • the invention provides an apparatus comprising one or more ablation elements arranged in a helical fashion along the length of the expandable wire frame or stent that is positioned around the balloon catheter.
  • two or more, e.g., four, ablation elements are arranged in a helical fashion along the length of the expandable wire cage or stent that is positioned around the balloon catheter.
  • one linear array element is arranged in a helical fashion along the length of the expandable wire cage or stent that is positioned around the balloon catheter.
  • two linear array elements separated from each other by a predetermined distance are arranged in a helical fashion along the length of the expandable wire cage or stent that is positioned around the balloon catheter.
  • a mechanism is provided in the catheter design for positioning and securing the catheter at the desired position within the vessel.
  • the device is a nonconductive flexible catheter for introduction into the lumen of a blood vessel, wherein the catheter has, near its remote end, an inflatable balloon that is connected to a balloon inflation and deflation source.
  • a conductive wire is formed into a frame or stent and is situated in a collapsed position around the balloon when the balloon is in its deflated, non-deployed position.
  • the wire frame may be made of a memory material such that the wire frame is in a collapsed state when the balloon is not inflated but assumes a generally cylindrical or helical shape when the balloon is advanced out of the catheter through a port and inflated.
  • the wire frame may comprise interlocking or interwoven strands that are loosely interlocked or interwoven when the balloon is not inflated such that the wire frame is in a collapsed state and that, when the balloon is advanced out of the sheath and inflated, become more tightly interlocked or interwoven such that the wire frame assumes a generally cylindrical or helical shape and conforms to the walls of the lumen when the wire frame is in its deployed position.
  • kidney spastic nerve activity is also included in this design.
  • a means to measure renal nerve afferent and effenert nerve activity prior to and following RF nerve ablation is also included in this design.
  • Renal nerve activity will be measured through the same electrode mechanism as that required for energy delivery.
  • the device comprises a mechanism protecting the expandable balloon from high temperatures that might otherwise damage the integrity of the balloon.
  • the device could have an insulation pad that is situated between each RF electrode and the surface of the balloon for insulating the balloon from the high temperatures of the RF electrode. This insulation pad avoids potential damage to the catheter balloon while ablative energy is effectively transmitted to the vessel surface. This insulation pad also avoids heating of the blood vessel and the blood flowing within it.
  • the present invention is also directed to a method for radio-frequency (RF) heat ablation of tissue through the use of one or more RF electrodes, which are positioned in a helical arrangement around a wire frame or stent that is mounted about a balloon positioned at the distal end of a catheter.
  • RF radio-frequency
  • the catheter is deployed in the body at the relevant location, such as the renal artery.
  • the catheter may be inserted into the body via a natural orifice, a stoma or a surgically created opening that is made for the purpose of inserting the catheter, and insertion of the catheter may be facilitated with the use of a guide wire or a generic support structure or visualization apparatus.
  • a second step of the invention once the catheter is at the relevant location, the balloon is inflated so as to position the wire frame or stent and the RF electrodes that are mounted thereon against the inner surface of the vessel.
  • RF energy is applied to the RF electrodes that are mounted on the wire frame or stent in order to effect changes in the target tissue.
  • Heat is generated by supplying a suitable energy source to the apparatus, which is comprised of at least one electrode that is in contact with the body tissues through the wire frame or stent.
  • coolant either stagnant or circulating may be employed to cool the inflated balloon and the inner surface of the vessel wall. This coolant function may provide a form of protection or insulation to the expanded balloon during RF energy activation as well as protection to the inner vessel wall surface during heat transfer.
  • the balloon centers the RF elements within the vessel, and is inflated. In this fashion, more selective ablation of nerve activity leading to the kidney can be accomplished.
  • the ablation is performed for the ablation of renal nerve activity that leads specifically to the kidney.
  • Figure 1 shows a first embodiment of a device for delivering radiofrequency energy to the walls of a body lumen
  • Figure 2 shows a second embodiment of a device for delivering radiofrequency energy to the walls of a body lumen
  • Figure 3 shows a process flow drawing of a method for ablation of nerve function.
  • proximal refers to a portion of an instrument closer to an operator, while “distal” refers to a portion of the instrument farther away from the operator.
  • a wire includes one or more wires and can be considered equivalent to the term “at least one wire.”
  • subject or patient refers in one embodiment to a mammal including a human in need of therapy for, or susceptible to, a condition or its sequelae.
  • the subject or patient may include dogs, cats, pigs, cows, sheep, goats, horses, rats, and mice and humans.
  • FIG. 1 is a drawing of one embodiment of a device for delivering radiofrequency energy to the walls of a body lumen.
  • radiofrequency energy is delivered to the walls of the renal artery or aorta.
  • radiofrequency energy is delivered using a nonconductive catheter 11.
  • the device includes a substantially tubular catheter 11, namely a long, thin, tube-like device, having proximal and distal openings, preferably constructed from a nonconductive material.
  • the catheter 11 can be any type of catheter, as are well known to those in the art, having a proximal end for manipulation by an operator and a distal end for operation within a patient. The distal end and proximal end preferably form one continuous piece.
  • the catheter 11 is nonconductive.
  • the catheter 11 is used as a delivery system for delivering a device containing radiofrequency electrodes 15,16 to the desired site for nerve ablation.
  • a guide wire 12 may first be inserted into the patient' s vascular system and advanced to the desired location, and a catheter 11 is inserted into the patient and threaded over the guide wire 12 to the desired location.
  • the catheter 11 has a positioning element.
  • the positioning element includes an inflatable balloon 13, of a type that is well known to those in the art, situated at the distal end of the catheter 11.
  • the balloon 13 is pneumatically connected to a port at the proximal end of the catheter 11 and is thereby connected to a balloon inflation and deflation source for inflation and deflation of the balloon 13.
  • the catheter 11 is a compliant balloon design that is advanced to the desired location within the patient's vascular system with, e.g., a rapid exchange (RX) or over-the-wire wire (OTW) delivery system.
  • the uninflated balloon 13 may be situated within an outer catheter sleeve or sheath during insertion into the vessel, so as to prevent inadvertent inflation of the balloon 13 prior to placement at the desired site within the patient.
  • the catheter 11 also has a thermal electric field delivery apparatus.
  • the thermal electric field delivery apparatus comprises a wire frame 14 or stent positioned about the catheter's expandable balloon 13.
  • the wire frame 14 is bonded to the balloon 13, and in other embodiments it is not.
  • the wire frame 14 is conductive so as to be able to provide current to RF electrodes and temperature sensing functions.
  • the wire frame 14 is preferably situated in a collapsed position around the balloon 13 when the balloon 13 is in its deflated, non-deployed position.
  • the wire frame 14 may be situated within an outer catheter sleeve during insertion into the vessel, so as to prevent inadvertent inflation of the balloon 13 and deployment of the wire frame 14.
  • the wire frame 14 may be made of a memory material such that the wire frame 14 is in a collapsed state when the balloon 13 is not inflated but assumes a generally cylindrical shape when the balloon 13 is advanced out of the catheter 11 through a port and inflated.
  • the wire frame 14 may also comprise interlocking or interwoven strands that are loosely interlocked or interwoven when the balloon 13 is not inflated such that the wire frame 14 is in a collapsed state. Then, when the balloon 13 is advanced out of the sheath and inflated, the interlocking or interwoven strands of the wire frame 14 or stent become more tightly interlocked or interwoven such that the wire frame 14 assumes a generally cylindrical or helical shape. The wire frame 14 conforms to the walls of the lumen when the wire frame 14 and balloon 13 are in their deployed position.
  • the wire frame 14 or stent is thus movable between a non-deployed position when the balloon 13 is unexpanded and a deployed position when the balloon 13 is expanded. It is also preferable that the wire frame 14 be collapsible, along with the balloon 13, back to its non- deployed position for retraction back into the catheter sheath along with the deflated balloon 13 after ablation is complete and when it is desired to withdraw the catheter 11 from the patient.
  • the wire frame 14 comprises at least one electrode 15,16 means that is capable of conducting RF energy and that comes in contact with the body tissue when the system is expanded by the balloon 13.
  • Other preferred embodiments may have more or fewer than four electrodes 15.
  • the individual electrodes 15 that are positioned along the wire frame 14 or stent are known as spot electrodes because they deliver thermal energy to a specific spot, as opposed to a larger area.
  • RF electrodes 15 are attached to the balloon 13 by means of the wire frame 14 that imparts support to the catheter 11 structure as well as providing a means to deliver RF energy and temperature and nerve activity sensing.
  • the electrodes 15 contained in the set of electrodes are evenly spaced around the circumference of the catheter balloon 13.
  • the RF electrodes 15 are positioned in a helical fashion around the outside of the balloon 13.
  • the purpose of positioning the electrodes 15 about the circumference of the catheter balloon 13 is so that the electrodes 15 would be situated along the circumference of the inside surface of the vessel, e.g., the renal artery, when the balloon 13 is expanded and the electrodes 15 are positioned against the vessel, for more effective ablation of, e.g., the renal nerve.
  • the electrode is in the form of a ribbon-shaped electrode 16 that is positioned in a helical fashion around the outside of the balloon 13.
  • another electrode is positioned outside the subject's body, e.g., on the subject's skin.
  • the electrode is in the form of two ribbon-shaped electrodes 16 that are positioned in a double-helical fashion around the outside of the balloon 13 (similar to a DNA strand).
  • the two ribbon-shaped electrodes 16 are separated by a predetermined distance.
  • the catheter 11 includes at least two ports.
  • a first port 17 is for connection to an air source for inflation and deflation of the balloon 13 and can be coupled to a pump or other apparatus to inflate or deflate the balloon 13 of the catheter 11.
  • the balloon positioning device is pneumatically connected to the air source through the first port 17. This same port 17 may be used to circulate coolant to the inside of the balloon 13 for the purpose of cooling the balloon 13 during RF energy activation.
  • Another port 18 is for connection to a source of radiofrequency (RF) power and can be coupled to a source of Radiofrequency (RF) energy, such as RF in about the 300 kilohertz to 500 kilohertz range.
  • the electrodes 15,16 are electrically coupled to the RF energy source through the second port 18.
  • the catheter 11 may also be connected to a control unit for sensing and measurement of other factors, such as temperature, conductivity, pressure, impedance and other variables, such as nerve energy.
  • the RF electrodes 15,16 operate to provide radiofrequency energy for heating of the desired location during the nerve ablation procedure. Electrodes 15,16 may be constructed of any suitable conductive material, as is known in the art. Examples include stainless steel and platinum alloys.
  • RF electrode 15,16 may operate in either bipolar or monopolar mode, as discussed above, with a ground pad electrode.
  • a monopolar mode of delivering RF energy a single electrode 15,16 is used in combination with an indifferent electrode patch that is applied to the body to form the other electrical contact and complete an electrical circuit.
  • Bipolar operation is possible when two or more electrodes 15,16 are used, either spot electrodes 15 or ribbon electrodes 16. Electrodes 15,16 can be attached to an electrode delivery member by the use of soldering methods which are well known to those skilled in the art.
  • the RF electrodes 15,16 also function to measure afferent and efferent nerve activity before and after vessel and nerve ablation.
  • Each electrode 15,16 can be disposed to treat tissue by delivering Radiofrequency (RF) energy.
  • the radiofrequency energy delivered to the electrode 15,16 has a frequency of about 5 kilohertz (kHz) to about 1 GHz.
  • the RF energy may have a frequency of about 10 kHz to about 1000 MHz; specifically about 10 kHz to about 10 MHz; more specifically about 50 kHz to about 1 MHz; even more specifically about 300 kHz to about 500 kHz.
  • the electrodes 15,16 can be operated separately or in combination with each other as sequences of electrodes disposed in arrays. Treatment can be directed at a single area or several different areas of a vessel by operation of selective electrodes. Different patterns of lesions, ablated, bulked, plumped, desiccated or necrotic regions can be created by selectively operating different electrodes 15,16. Production of different patterns of treatment makes it possible to remodel tissues and alter their overall geometry with respect to each other. In addition, varying the placement distance between bipolar electrodes will generate electrical fields allowing for temperature penetration of varying depths through the tissue.
  • An electrode selection and control switch may include an element that is disposed to select and activate individual electrodes 15,16.
  • RF power source may have multiple channels, delivering separately modulated power to each electrode 15,16 or array. This reduces preferential heating that occurs when more energy is delivered to a zone of greater conductivity and less heating occurs around electrodes 15,16 that are placed into less conductive tissue. If the level of tissue hydration or the blood infusion rate in the tissue is uniform, a single channel RF power source may be used to provide power for generation of lesions relatively uniform in size.
  • RF energy delivered through the electrodes 15,16 to the tissue causes heating of the tissue due to absorption of the RF energy by the tissue and ohmic heating due to electrical resistance of the tissue. This heating can cause injury to the affected cells and can be substantial enough to cause cell death, a phenomenon also known as cell necrosis.
  • cell injury will include all cellular effects resulting from the delivery of energy from the electrodes 15,16 up to, and including, cell necrosis.
  • Cell injury can be accomplished as a relatively simple medical procedure with local anesthesia. In one embodiment, cell injury proceeds to a depth of approximately 1-5 mms from the surface of the mucosal layer of sphincter or that of an adjoining anatomical structure.
  • the catheter 11 comprises an insulation pad 19 that is situated between each RF electrode 15,16 and the surface of the balloon 13 for insulating and protecting the balloon 13 from the high temperatures of the RF electrode 15,16.
  • This insulation pad 19 avoids potential damage to the catheter balloon 13 while ablative energy is effectively transmitted to the vessel surface.
  • the insulation pad 19 also avoids potential damage to the subject's blood due to heating of the blood that has pooled behind the expanded balloon 13.
  • the device comprises a cooling pad 19 between the RF electrodes 15,16 and the wire cage 14, for example so as to chill the surface of the balloon 13, thus protecting this surface from the direct effects of the RF energy, or the blood that has pooled behind the expanded balloon 13, thus protecting the subject's blood from the direct effects of the RF energy.
  • a means to measure renal nerve afferent activity prior to and following RF nerve ablation is also included in this design. By measuring renal nerve activity post procedure, a degree of certainty is provided that proper nerve ablation has been accomplished. Renal nerve activity will be measured through the same mechanism as that required for energy delivery.
  • Nerve activity may be measured by one of two means.
  • Proximal renal nerve stimulation will occur by means of transmitting an electrical impulse to the catheter 11 positioned within the proximal segment of the renal artery.
  • Action potentials will be measured from the segment of the catheter 11 situated within the more distal portion of the renal artery.
  • the quantity of downstream electrical activity as well as the time delay of electrical activity from the proximal to distal electrodes 15,16 will be provide a measure of residual nerve activity post nerve ablation.
  • the second means of measuring renal nerve activity will be to measure ambient electrical impulses prior to and post nerve ablation within a site more distal within the renal artery.
  • the RF electrodes 15,16 operate to provide radiofrequency energy for both heating and temperature sensing.
  • the RF elements can be used for heating during the ablation procedure and can also be used for sensing of nerve activity prior to ablation as well as after ablation has been done.
  • Each electrode 15,16 may be coupled to at least one sensor or control unit capable of measuring such factors as temperature, conductivity, pressure, impedance and other variables.
  • the device may have a thermistor that measures temperature in the lumen, and a thermistor may be a component of a microprocessor-controlled system that receives temperature information from the thermistor and adjusts wattage, frequency, duration of energy delivery, or total energy delivered to the electrode 15,16.
  • the catheter 11 can be coupled to a visualization apparatus, such as a fiber optic device, a flouroscopic device, an anoscope, a laparoscope, an endoscope or the like.
  • a visualization apparatus such as a fiber optic device, a flouroscopic device, an anoscope, a laparoscope, an endoscope or the like.
  • devices coupled to the visualization apparatus are controlled from a location outside the body, such as by an instrument in an operating room or an external device for manipulating the inserted catheter 11.
  • the catheter 11 may be constructed with markers that assist the operator in obtaining a desired placement, such as radio-opaque markers, etchings or microgrooves.
  • the catheter 11 may be constructed to enhance its imageability by techniques such as ultrasounds, CAT scan or MRI.
  • radiographic contrast material may be injected through a hollow interior of the catheter 11 through an injection port, thereby enabling localization by fluoroscopy or angiography.
  • Figure 3 is a process flow drawing of a method for ablation of nerve function within the kidney using the device described hereinabove.
  • the method is performed by a system including a catheter 11 and a control assembly.
  • the steps of the method can be performed by separate elements in conjunction or in parallel, whether asynchronously, in a pipelined manner, or otherwise. There is no particular requirement that the method be performed in the same order in which this description lists the steps, except where so indicated.
  • First (step 301), the patient is positioned on a treatment table in an appropriate position for the insertion of a device, and the device is prepared.
  • electrical energy port is coupled to a source of electrical energy.
  • the visualization port is coupled to the appropriate visualization apparatus, such as a flouroscope, an endoscope, a display screen or other visualization device.
  • the appropriate visualization apparatus such as a flouroscope, an endoscope, a display screen or other visualization device.
  • the choice of visualization apparatus is responsive to judgments by medical personnel.
  • the therapeutic energy port is coupled to the source of RF energy.
  • suction and inflation apparatus is coupled to the irrigation and aspiration control ports 17 so that the catheter balloon 13 may be later be inflated.
  • the most distal end of the treatment balloon 13 is lubricated and introduced into the patient.
  • the balloon 13 is completely deflated during insertion.
  • the catheter 11 may be inserted into the body lumen through its outer surface, and insertion may be percutaneous or through a surgically created arteriotomy or during an open surgical procedure.
  • step 303 the catheter 11 is threaded through the vessel until the balloon 13 is situated entirely within the vessel to be treated.
  • An introducer sheath or guide tube may also be used to facilitate insertion.
  • step 304 the position of the catheter 11 is checked using visualization apparatus coupled to the visualization port.
  • This apparatus can be continually monitored by medical professionals throughout the procedure.
  • step 305 the irrigation and aspiration control port 17 is manipulated so as to inflate the balloon 13, causing the wire frame 14 to revert to its expanded configuration, in which the wire frame 14 expands to fit within the vessel interior
  • electrodes 15,16 are selected using the electrode selection and control switch. In a preferred embodiment, all electrodes 15,16 are deployed at once. In another preferred embodiment, electrodes 15,16 may be individually selected. This step may be repeated at any time prior to step 306.
  • a step 307 the therapeutic energy port 18 is manipulated so as to cause a release of energy from the electrodes 15,16.
  • the duration and frequency of energy are responsive to judgments by medical personnel. This release of energy creates a pattern of lesions in the lumen.
  • Steps 306 and 307 are repeated as many times as necessary.
  • a step 308 the irrigation and aspiration control port 17 is manipulated so as to cause the balloon 13 to deflate and the wire frame 14 to revert to its collapsed state.
  • a step 309 the catheter 11 is withdrawn from the patient.

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Abstract

Dispositif d'ablation de nerfs, qui comporte une structure en fil métallique portant une ou plusieurs électrodes capables de conduire de l'énergie RF. Les électrodes peuvent être placées de manière circonférentielle ou hélicoïdale autour de la structure en fil métallique qui est placée autour d'un ballonnet dilatable contenu dans un cathéter, par ex. à l'extrémité de ce dernier, et qui est mobile entre une position rétractée et une position déployée. Le dispositif, comprenant le ballonnet écrasé et la structure en fil métallique enfermée dans un fourreau, est avancée sur un fil-guide dans le vaisseau sanguin jusqu'à l'endroit concerné, tel que l'artère rénale, et placé dans la circonférence interne du vaisseau, telle que l'ostium de l'artère rénale. Le fourreau est ensuite retiré pour mettre à nu le ballonnet et la structure en fil métallique sur le cathéter, et la structure en fil métallique ou le stent est alors déployé par gonflage du ballonnet à l'extrémité du cathéter.
PCT/US2012/027849 2011-03-07 2012-03-06 Cathéter d'ablation par radiofréquence WO2012122157A1 (fr)

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US14/020,275 US20140012251A1 (en) 2011-03-07 2013-09-06 Ablation devices and methods
US14/946,424 US20160074112A1 (en) 2011-03-07 2015-11-19 Ablation catheters and methods of use thereof

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US201161450016P 2011-03-07 2011-03-07
US61/450,016 2011-03-07

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US14/020,275 Continuation-In-Part US20140012251A1 (en) 2011-03-07 2013-09-06 Ablation devices and methods

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WO2014159538A1 (fr) * 2013-03-14 2014-10-02 Kyphon SÀRL Catheter diffuseur d'ondes rf pour cibler le ligament jaune
WO2014164445A1 (fr) * 2013-03-13 2014-10-09 Kyphon SÀRL Dispositif gonflable à radiofréquence
US8986294B2 (en) 2002-04-08 2015-03-24 Medtronic Ardian Luxembourg S.a.rl. Apparatuses for thermally-induced renal neuromodulation
US20150173830A1 (en) * 2013-12-23 2015-06-25 Eric Johnson Treatment structure and methods of use
US9138281B2 (en) 2002-04-08 2015-09-22 Medtronic Ardian Luxembourg S.A.R.L. Methods for bilateral renal neuromodulation via catheter apparatuses having expandable baskets
CN105683730A (zh) * 2013-10-25 2016-06-15 光纳株式会社 光纤式生物体诊断用传感器系统及血管插入式分布压力测定装置
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US10004557B2 (en) 2012-11-05 2018-06-26 Pythagoras Medical Ltd. Controlled tissue ablation
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US10478249B2 (en) 2014-05-07 2019-11-19 Pythagoras Medical Ltd. Controlled tissue ablation techniques
US10588682B2 (en) 2011-04-25 2020-03-17 Medtronic Ardian Luxembourg S.A.R.L. Apparatus and methods related to constrained deployment of cryogenic balloons for limited cryogenic ablation of vessel walls
US10709490B2 (en) 2014-05-07 2020-07-14 Medtronic Ardian Luxembourg S.A.R.L. Catheter assemblies comprising a direct heating element for renal neuromodulation and associated systems and methods
CN113679399A (zh) * 2020-05-14 2021-11-23 上海悦灵医疗科技有限公司 一种三叉神经半月节压迫装置
US11678932B2 (en) 2016-05-18 2023-06-20 Symap Medical (Suzhou) Limited Electrode catheter with incremental advancement
CN116899131A (zh) * 2023-08-09 2023-10-20 江苏霆升科技有限公司 肾动脉去交感神经超声消融导管

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US10376311B2 (en) 2002-04-08 2019-08-13 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for intravascularly-induced neuromodulation
US9827040B2 (en) 2002-04-08 2017-11-28 Medtronic Adrian Luxembourg S.a.r.l. Methods and apparatus for intravascularly-induced neuromodulation
US8774922B2 (en) 2002-04-08 2014-07-08 Medtronic Ardian Luxembourg S.A.R.L. Catheter apparatuses having expandable balloons for renal neuromodulation and associated systems and methods
US8818514B2 (en) 2002-04-08 2014-08-26 Medtronic Ardian Luxembourg S.A.R.L. Methods for intravascularly-induced neuromodulation
US8721637B2 (en) 2002-04-08 2014-05-13 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for performing renal neuromodulation via catheter apparatuses having inflatable balloons
US10420606B2 (en) 2002-04-08 2019-09-24 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for performing a non-continuous circumferential treatment of a body lumen
US8740896B2 (en) 2002-04-08 2014-06-03 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for performing renal neuromodulation via catheter apparatuses having inflatable balloons
US9023037B2 (en) 2002-04-08 2015-05-05 Medtronic Ardian Luxembourg S.A.R.L. Balloon catheter apparatus for renal neuromodulation
US9757193B2 (en) 2002-04-08 2017-09-12 Medtronic Ardian Luxembourg S.A.R.L. Balloon catheter apparatus for renal neuromodulation
US10105180B2 (en) 2002-04-08 2018-10-23 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for intravascularly-induced neuromodulation
US8986294B2 (en) 2002-04-08 2015-03-24 Medtronic Ardian Luxembourg S.a.rl. Apparatuses for thermally-induced renal neuromodulation
US9138281B2 (en) 2002-04-08 2015-09-22 Medtronic Ardian Luxembourg S.A.R.L. Methods for bilateral renal neuromodulation via catheter apparatuses having expandable baskets
US9827041B2 (en) 2002-04-08 2017-11-28 Medtronic Ardian Luxembourg S.A.R.L. Balloon catheter apparatuses for renal denervation
US9919144B2 (en) 2011-04-08 2018-03-20 Medtronic Adrian Luxembourg S.a.r.l. Iontophoresis drug delivery system and method for denervation of the renal sympathetic nerve and iontophoretic drug delivery
US10588682B2 (en) 2011-04-25 2020-03-17 Medtronic Ardian Luxembourg S.A.R.L. Apparatus and methods related to constrained deployment of cryogenic balloons for limited cryogenic ablation of vessel walls
US9770593B2 (en) 2012-11-05 2017-09-26 Pythagoras Medical Ltd. Patient selection using a transluminally-applied electric current
US10004557B2 (en) 2012-11-05 2018-06-26 Pythagoras Medical Ltd. Controlled tissue ablation
US9861431B2 (en) 2013-03-13 2018-01-09 Kyphon SÀRL Radiofrequency inflatable device
WO2014164445A1 (fr) * 2013-03-13 2014-10-09 Kyphon SÀRL Dispositif gonflable à radiofréquence
WO2014159538A1 (fr) * 2013-03-14 2014-10-02 Kyphon SÀRL Catheter diffuseur d'ondes rf pour cibler le ligament jaune
US9028488B2 (en) 2013-03-14 2015-05-12 Kyphon Sarl Radio frequency catheter to target ligamentum flavum
WO2014150204A1 (fr) * 2013-03-15 2014-09-25 Kyphon SÀRL Dispositif gonflable, activé par rf, pour bourrer un os
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CN105683730A (zh) * 2013-10-25 2016-06-15 光纳株式会社 光纤式生物体诊断用传感器系统及血管插入式分布压力测定装置
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US20150173830A1 (en) * 2013-12-23 2015-06-25 Eric Johnson Treatment structure and methods of use
US10478249B2 (en) 2014-05-07 2019-11-19 Pythagoras Medical Ltd. Controlled tissue ablation techniques
US10709490B2 (en) 2014-05-07 2020-07-14 Medtronic Ardian Luxembourg S.A.R.L. Catheter assemblies comprising a direct heating element for renal neuromodulation and associated systems and methods
US9913649B2 (en) 2014-05-28 2018-03-13 Boston Scientific Scimed, Inc. Catheter with radiofrequency cutting tip and heated balloon
US10383685B2 (en) 2015-05-07 2019-08-20 Pythagoras Medical Ltd. Techniques for use with nerve tissue
US11678932B2 (en) 2016-05-18 2023-06-20 Symap Medical (Suzhou) Limited Electrode catheter with incremental advancement
CN113679399A (zh) * 2020-05-14 2021-11-23 上海悦灵医疗科技有限公司 一种三叉神经半月节压迫装置
CN116899131A (zh) * 2023-08-09 2023-10-20 江苏霆升科技有限公司 肾动脉去交感神经超声消融导管

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