EP2677953A2 - Dispositif de cathéter d'ablation par radiofréquence - Google Patents

Dispositif de cathéter d'ablation par radiofréquence

Info

Publication number
EP2677953A2
EP2677953A2 EP12764009.2A EP12764009A EP2677953A2 EP 2677953 A2 EP2677953 A2 EP 2677953A2 EP 12764009 A EP12764009 A EP 12764009A EP 2677953 A2 EP2677953 A2 EP 2677953A2
Authority
EP
European Patent Office
Prior art keywords
wire frame
catheter
renal artery
electrodes
nerve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP12764009.2A
Other languages
German (de)
English (en)
Other versions
EP2677953A4 (fr
Inventor
Steven HIMMELSTEIN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tidal Wave Technology Inc
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 EP2677953A2 publication Critical patent/EP2677953A2/fr
Publication of EP2677953A4 publication Critical patent/EP2677953A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
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    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
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    • 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
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    • 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
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    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
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    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00357—Endocardium
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    • A61B2018/00345—Vascular system
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    • A61B2018/00375—Ostium, e.g. ostium of pulmonary vein or artery
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    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • 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
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    • 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
    • A61B2018/00505—Urinary tract
    • A61B2018/00511—Kidney
    • A—HUMAN NECESSITIES
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    • 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
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    • A61B2018/00696—Controlled or regulated parameters
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    • A61B2018/00791—Temperature
    • A61B2018/00815—Temperature measured by a thermistor
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    • A61B2018/00773—Sensed parameters
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    • 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
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    • 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
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    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

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 aorta which is a complex structure that performs multiple functions, houses a network of nerves that are helpful in maintaining vascular tone throughout the entire body and each individual organ, 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. These afferent and efferent nerves traverse via the aorta to their destination end-organ site.
  • renal ischemia ischemia
  • hypoxia oxidative stress
  • uremic toxins such as urea
  • 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.
  • Denervation of the kidney can be accomplished via the renal artery ostium of the aorta, namely the orifice of the branch off the aorta that opens into the renal artery.
  • Ablation of nerve activity at the renal artery ostium will not affect blood flow from the aorta into the renal artery but will cause the desired effect of denervation of the kidney.
  • One problem in the art is the providing of a treatment surface that can reach all of the desired treatment areas, such as the area circumferentially surrounding the renal artery ostium. While the use of a catheter to deploy energy may be known, it has been difficult to provide ablation about the entire opening of the ostium of an aortic branch blood vessel, such as the renal artery, so as to provide optimal uniform treatment.
  • electrical energy such as RF (radiofrequency) energy
  • electrical energy such as RF (radiofrequency) energy
  • the present invention is directed to a device, system and method for delivering radiofrequency energy, to the inner layer of a body lumen, particularly the aorta, specifically to the renal artery ostium of the aorta, using a nonconductive catheter.
  • the device comprises a wire frame or stent, e.g., cylindrically shaped, bearing one or more electrodes that are capable of conducting RF energy and that comes in contact with the body tissue.
  • the one or more electrodes have a circular configuration at one side of the wire frame. If more than one electrode is used, then the circular electrodes are positioned concentrically.
  • the wire frame is contacted against the inner surface of the aorta at the renal artery ostium, such that the circular electrodes ablate the nerve activity circumferentially around the renal artery ostium.
  • the wire frame or stent is movable between a non-deployed position and a deployed position.
  • the wire frame In the non-deployed position, the wire frame is unexpanded, i.e., collapsed.
  • the collapsed wire frame in its non-deployed position at the end of a catheter may be encapsulated within a sheath.
  • the device is advanced longitudinally through the blood vessel, e.g., over a guide wire, to the relevant location within the body lumen, such as within the aorta, and into the desired position within the inner circumference of the vessel, such as at the renal artery ostium of the aorta.
  • the sheath is then withdrawn, exposing the wire frame or stent member and allowing the wire frame to be expanded 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 wire frame in one embodiment in which the wire frame can be expanded into the deployed position, is formed from a material with a shape memory.
  • the natural shape of the wire frame is in an expanded, generally cylindrical configuration, and the wire frame is positioned within the sheath in a collapsed configuration.
  • the constraint on the wire frame keeping it in its collapsed configuration is released, allowing the wire frame to spontaneously expand to its remembered expanded configuration, in which it contacts the wall of the aorta.
  • a mechanism is provided in the catheter design for positioning and securing the catheter at the desired location within the vessel, e.g., the aorta, such that the electrodes can operate at the precise location, namely around the renal artery ostium.
  • This mechanism will properly center the circularly-configured RF electrodes circumferentially around the opening to the renal artery. If the device is not properly positioned, the electrodes can ablate tissue that is not intended to be harmed, causing irreversible damage to other aortic or arterial structures.
  • the positioning mechanism comprises an imaging catheter that allows the user to properly center and position the RF electrodes circumferentially around the opening to the renal artery.
  • the imaging catheter allows the user to view exactly where the renal artery ostium is located.
  • the distal end of the imaging catheter extends from the proximal direction into the wire frame and passes out through the hole of the circularly- configured RF electrodes.
  • the circularly-configured RF electrodes can be positioned at the renal artery ostium by inserting the distal end of the imaging catheter at least partially into the entrance of the renal artery, to allow the device to hold its position within the aorta relative to the renal artery.
  • the wire frame When the device is so positioned, the wire frame can be expanded to the inner surface of the aorta, allowing the RF electrodes to be centered about the renal artery ostium while they perform their ablative function. Additionally, a balloon can be placed through the imaging catheter into the proximal segment of the renal artery for improved positioning and stabilization of the aortic device as discussed below.
  • the sheath that envelopes the device has a longitudinal cut out to allow the imaging catheter/positioning device to protrude out of the wire frame and into the renal artery to position the device at the renal artery ostium, even while the wire frame is still in its collapsed, non-deployed configuration within the sheath and even while the sheath has not yet been withdrawn from over the wire frame.
  • the positioning mechanism comprises a balloon catheter with an inflatable balloon at its distal end that projects through the imaging catheter and into the entrance to the renal artery.
  • This balloon catheter passes through the imaging catheter and the wire frame from the distal direction and passes through the hole of the circularly- configured RF electrodes, and is inserted at least partially into the entrance of the renal artery.
  • the catheter sheath is then withdrawn and the balloon is then inflated, to allow the device to hold its position within the aorta relative to the renal artery.
  • the device sheath When the device is so positioned by virtue of the inflatable balloon, the device sheath is retracted so that the wire frame can be expanded to the inner surface of the aorta, allowing the RF electrodes to be positioned against the renal artery ostium so that they may perform their ablative function.
  • Renal nerve activity will be measured through the same electrode mechanism as that required for energy delivery at the level of the renal artery ostium, but also along the renal artery positioning balloon.
  • the device comprises a mechanism for cooling the aortic wall in order to limit potential damage to the endothelial surface of the aorta while ablative energy is effectively transmitted to the adventitial layer.
  • the present invention is also directed to a method for radio-frequency (RF) heat ablation of tissue through the use of one or more circularly-shaped RF electrodes, which are mounted on one side of a cylindrically-shaped wire frame or stent that is mounted in a compressed configuration at the distal end of a catheter within a sheath.
  • RF radio-frequency
  • 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.
  • the device In the next step, the device must be positioned at the renal artery ostium of the aorta. This positioning can be done via a positioning mechanism, as discussed herein.
  • an imaging catheter may extend out of the wire frame so as to assist the user in determining where the renal artery ostium is.
  • a balloon catheter may extend out of the wire frame, and the balloon is inflated and centers the circular RF elements circumferentially around the ostium of the renal artery.
  • the wire frame is expanded so as to position the wire frame or stent and the RF electrodes that are mounted thereon against the inner surface of the aorta, at the ostium of the desired branch artery.
  • the RF electrodes are positioned about the opening of the renal artery so as to surround the renal artery ostium.
  • 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 inner surface of the vessel wall. This coolant function may provide a form of protection or insulation to the inner vessel wall surface during RF energy activation and heat transfer.
  • the ablation is performed for the ablation of aortic nerve activity that leads specifically to the kidney.
  • Figure 1 shows a first embodiment of a device for delivering radiofrequency energy to the renal artery ostium
  • Figure 2 shows a cross-sectional exploded perspective view of the first embodiment of the device for delivering radiofrequency energy to the walls of a body lumen; and [0043] Figure 3 shows a further cross-sectional view of the first embodiment of the device for delivering radiofrequency energy to the walls of a body lumen; and
  • Figure 4 shows a further cross-sectional view of the first embodiment of the device for delivering radiofrequency energy to the walls of a body lumen
  • Figure 5 shows a perspective view of a sheath for use in the first embodiment of the device for delivering radiofrequency energy to the walls of a body lumen.
  • 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 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 1 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.
  • the device 1 includes a substantially tubular catheter (not shown), namely a long, thin, tube-like device, having proximal and distal openings, preferably constructed from a nonconductive material.
  • the catheter 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 is nonconductive.
  • the catheter is used as a delivery system for delivering a device containing radiofrequency electrodes to the desired site for nerve ablation.
  • a guide wire 11 such as one having 0.035" thickness, may first be inserted into the patient's vascular system via a natural orifice, a stoma or a surgically created opening that is made for the purpose of inserting the catheter, e.g. through the groin, and advanced to the desired location.
  • a catheter is inserted into the patient and threaded over the guide wire to the desired location.
  • the device 1 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.
  • Radiographic contrast media may be injected at the beginning of the procedure, e.g., through the imaging catheter port, in order to assist in manipulation of the instruments.
  • the device 1 comprises a wire frame or stent 3 bearing one or more electrodes 8 that are capable of conducting RF energy and that come in contact with the body tissue.
  • the one or more electrodes 8 have a generally circular configuration at one side of the wire frame 3. If more than one electrode 8 is used, then the circular electrodes 8 are positioned concentrically.
  • the wire frame 3 is expanded so as to contact against the inner surface of the aorta at the juncture of the renal artery, such that the circular electrodes 8 are situated about the renal artery ostium.
  • the wire frame or stent 3 is generally cylindrically shaped, so that, when positioned within the aorta, its outside surfaces rest against the inner surface of the aorta.
  • the structure of the wire frame or stent 3 has two or more elongated supports 5 that are connected to two or more circular rings 7.
  • the structure of the wire frame or stent 3 has two to four elongated supports 5, although more or fewer elongated supports 5 can be used, as necessary.
  • the structure of the wire frame or stent 3 has two to four circular rings 7 positioned substantially transverse to the elongated supports 5, although more or fewer circular rings 7can be used, as necessary.
  • the elongated supports 5 are connected to the circular rings 7 by any method, e.g., welding.
  • Fig. 2 shows these elongated supports 5 and circular rings 7 in an exploded configuration.
  • the wire frame 3 is formed from a material that is flexible and has a shape memory, e.g., nitinol.
  • the natural shape of the wire frame 3 is in an expanded, generally cylindrical configuration, as shown in Fig. 1.
  • the elongated supports 5 have a natural straight configuration
  • the transverse rings 7 have a natural circular configuration.
  • the elongated supports 5 and circular rings 7 of the wire frame 3 are formed from a material that is sufficiently flexible and elastic so as to allow them to be flexed and deformed into other shapes, such as a collapsed configuration, upon application of an external force.
  • the material of the wire frame 3 has a sufficient shape memory such that the elongated supports 5 and circular rings 7 of the wire frame 3 will return to their natural configurations when the external force is released.
  • the wire frame or stent 3 is selectively movable between a non-deployed position and a deployed position. In the non-deployed position, the wire frame 3 is stored unexpanded, i.e., in a collapsed configuration. The collapsed wire frame 3 in its non- deployed position may be positioned or encapsulated within a sheath 10 at the end of the catheter.
  • a guide wire 11 may first be inserted into the patient' s vascular system via a natural orifice, e.g. through the groin, and advanced to the desired location.
  • a cap 13 at the distal end of the guide wire 11 facilitates entrance through the skin, and the cap and guide wire may be later separated from the sheath 10 for later deployment of the ablative elements.
  • the catheter comprising the sheath 10 is advanced longitudinally through the blood vessel, e.g., over the guide wire 11, to the relevant location within the body lumen, such as within the aorta, and into the desired position within the inner circumference of the vessel, such as at the renal artery ostium of the aorta.
  • the sheath 10 is then withdrawn, thereby removing the constraint that kept the wire frame 3 in its collapsed configuration. Withdrawing the sheath 10 exposes the wire frame 3 or stent member 3 and allows the wire frame 3 to spontaneously expand into its natural cylindrical configuration, i.e., the deployed position, wherein it conforms to the walls of the lumen.
  • the wire frame or stent 3 is also movable between the deployed, expanded position and a non-deployed, collapsed position. It is desirable for the wire frame 3 to be collapsible back to its non-deployed position for retraction back into the catheter sheath 10 after ablation is complete and when it is desired to withdraw the catheter from the patient.
  • the wire frame 3 comprises at least one electrode 8 that is capable of conducting RF energy and that comes in contact with the body tissue.
  • RF electrodes 8 are attached to the wire frame 3 as a means to deliver RF energy to the body lumen, as well as temperature and nerve activity sensing.
  • the electrodes 8 positioned on the outside of one side of the wire frame 3.
  • the electrodes 8 are attached to two elongated supports 5 on one side of the wire frame 3.
  • the purpose of positioning the electrodes 8 on one side of the wire frame 3 is so that, when the wire frame 3 is expanded within the aorta and the against the insides of the aorta, the electrodes 8 would be situated on one specific side of the aorta, e.g., the side that branches off to the renal artery for more effective ablation of, e.g., the renal nerve, called the renal artery ostium.
  • the elongated supports 5 to which the RF electrodes 8 are attached are adapted to conduct RF energy from the RF control unit to the RF electrodes 8.
  • these two elongated supports 5 serve to house connections from the RF control unit and the attached RF electrodes for temperature control and ablative energy.
  • the electrodes 8 that are positioned on the wire frame directly contact the lumen wall. If the wire frame 3 has been properly positioned before the withdrawal of the sheath 10, then the electrodes 8 contact the lumen wall at the desired location, e.g., the renal artery ostium. Heat is then generated to the electrodes 8 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 device 1 has a positioning element or mechanism for positioning and securing the device at the desired location within the vessel, e.g., the aorta.
  • a positioning element or mechanism for positioning and securing the device at the desired location within the vessel, e.g., the aorta.
  • Such a mechanism is necessary so that the electrodes can operate at the precise location, namely around the renal artery ostium. Otherwise, if the device is not properly positioned, the electrodes 8 can ablate tissue that is not intended to be harmed, causing irreversible damage.
  • the positioning mechanism should properly center the electrodes circumferentially around the renal artery ostium, namely the opening to the renal artery.
  • the positioning element or mechanism includes an imaging catheter 15 that allows the user to view exactly where the renal artery ostium is and to properly position the device 1, and specifically the RF electrodes 8, through use of visual means.
  • the imaging catheter 15 comprises a proximal end that is external to the patient and manipulated by the user along with the operating end of the device 1, and also comprises a distal end that is situated within the wire frame 3 of the device 1.
  • the distal end of the imaging catheter 15 extends from the proximal direction into the wire frame 3 and passes out of the wire frame 3 in a direction transverse to the longitudinal direction of the wire frame 3.
  • the distal end of the imaging catheter 15 passes out of the wire frame 3 through the center hole 9 of the circularly-configured RF electrodes 8, as shown in Fig. 3.
  • the positioning element or mechanism includes a catheter that comprises an inflatable balloon 16 at its distal end that is projected into the entrance to the renal artery.
  • This inflatable positioning balloon 16 passes through the imaging catheter 15 and the wire frame 3 from the distal direction and passes through the hole 9 of the circularly-configured RF electrodes 8, in the manner of the imaging catheter.
  • the balloon catheter comprises a proximal end that is external to the patient and manipulated by the user along with the operating end of the device 1 , and also comprises a distal end that is situated within the wire frame 3 of the device 1.
  • the distal end of the balloon catheter 16 extends from the proximal direction into the wire frame 3 and passes out of the wire frame 3 in a direction transverse to the longitudinal direction of the wire frame 3. In one embodiment, the distal end of the balloon catheter 16 passes out of the wire frame 3 through the center hole 9 of the circularly-configured RF electrodes 8, as shown in Fig. 3.
  • the inflatable positioning balloon 16 is situated at the distal end of the balloon catheter.
  • the balloon catheter 16 may be inserted at least partially into the entrance of the renal artery, and the catheter sheath 10 is then withdrawn, exposing the balloon 16 at the end thereof.
  • the balloon is then inflated against the inner walls of the renal artery, to allow the device 1 to hold its position within the aorta relative to the renal artery.
  • the diameter of the balloon 16, when expanded, is dependent upon the internal diameter of the branch artery at which positioning is desired. Generally, a balloon 16 with an expanded diameter of approximately 4 to 5 mm is sufficient.
  • the wire frame can be expanded to the inner surface of the aorta, such as by retraction of the device sheath, allowing the RF electrodes 8 to be positioned against the renal artery ostium so that they may perform their ablative function.
  • the imaging catheter 15 and the balloon catheter 16 may both comprise an outer sheath 10 that is inserted into the wire frame 3 using a guide wire 11, through which sheath 10 the imaging device and the balloon device may be inserted.
  • an imaging catheter 15 may be inserted and used and then removed, leaving the sheath therefrom remaining within the patient and extending through the wire frame 3 and into the renal artery ostium.
  • the balloon 16 may be advanced through the sheath (e.g., over a guide wire 11) and into the renal artery ostium for anchoring of the device therein. Radiographic contrast media injected at the beginning of the procedure may assist in manipulation of the instruments.
  • the positioning element or mechanism operates to position the circularly-configured RF electrodes 8 at the renal artery ostium, and specifically around the opening to the branch renal artery off the ostium. This is accomplished by insertion of the distal end of the imaging catheter 15 or balloon catheter 16 that has exited the wire frame 3 of the device through the center hole 9 of the circularly-configured RF electrodes 8 at least partially into the entrance of the renal artery so as to serve, either by itself or by inflation of the balloon 16 that is exposed from within, as an anchor for the device 1 within the aorta.
  • the device 1 When the distal end of the imaging catheter 15 or the balloon 16 that is exposed from the distal end of the balloon catheter 16 is so positioned, the device 1 is able to hold its position within the aorta relative to the renal artery, and the wire frame 3 can be expanded to abut against the inner surface of the aorta.
  • the RF electrodes 8 When the wire frame 3 is expanded against the inner surface of the aorta, the RF electrodes 8 can be centered circumferentially around the opening to the renal artery, i.e., the renal artery ostium, so that the RF electrodes 8 can perform their ablative function.
  • the distal end of the positioning mechanism is inserted at least partially into the entrance of the renal artery so as to serve as an anchor even before the wire frame 3 has been expanded.
  • the wire frame 3 is comprised of shape memory material such that the wire frame 3 expands spontaneously when released from the constraints that keep it in the collapsed position, the wire frame 3 cannot expand until and unless the sheath 10 covering the entire device is withdrawn.
  • the positioning mechanism protrude out of the wire frame 3 and device 1 and extend into the entrance of the renal artery so as to position the device 1 at the renal artery ostium, even while the wire frame 3 is still in its collapsed, non-deployed configuration within the sheath 10 and even while the sheath 10 has not yet been withdrawn from over the wire frame 3.
  • the sheath 10 that envelopes the device has a longitudinal cut out 20 from its distal-most edge.
  • This cut out 20 should be wide enough to allow the positioning device to pass through to allow the imaging catheter 15 or the balloon catheter 16 to be positioned within the entrance of the renal artery even while the sheath 10 is still in position around the wire frame 3 and keeping the wire frame in a collapsed and non-deployed position.
  • the imaging catheter 15 or the balloon catheter 16 may be manipulated to that it is positioned within the wire frame 3 but just behind the circularly-configured RF electrodes 8, as shown in cross- sectional view in Fig. 3.
  • the sheath is rotated about its longitudinal axis so that the cut out 20 is oriented over the center hole 9 of the circularly-configured RF electrodes 8. This exposes the center hole 9 of the circularly-configured RF electrodes 8, allowing the imaging catheter 15 or balloon catheter 16 to be pushed through the center hole 9 of the circularly-configured RF electrodes 8 and into the entrance of the renal artery.
  • the device 1 is considered to be properly positioned within the aorta once the imaging catheter 15 is positioned at least partially within the entrance of the renal artery.
  • the positioning mechanism comprises a balloon catheter 16
  • the device 1 is not considered to be properly positioned within the aorta until the sheath of the balloon catheter 16 is withdrawn and the balloon 16 is expanded. Once the balloon 16 is expanded within the entrance of the renal artery, the balloon catheter 16, as well as the device from which the balloon catheter 16 protrudes, is held securely therein.
  • the sheath 10 is withdrawn or retracted, and the wire frame 3 and its attached RF electrode(s) 8 are exposed, allowing the wire frame 3 to be expanded. Then, if the device has been properly positioned, expansion of the wire frame 3 will result in its outer surface resting against the inside surface edges of the aorta.
  • the imaging/positioning catheter 15 has passed through the center hole 9 of the circularly-configured RF electrodes 8 and into the entrance of the renal artery, expansion of the wire cage 3 will cause the RF electrodes 8 to be positioned directly against the renal artery ostium.
  • the catheter includes at least one port.
  • This port 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.
  • RF Radiofrequency
  • the electrodes 8 are electrically coupled to the RF energy source through this port.
  • the catheter 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 catheter may also be connected to a second port for connection to an air source.
  • This port would be used when it is needed for inflation and deflation of a balloon, such as in an embodiment when a balloon 16 is used in a positioning mechanism.
  • This port can be pneumatically coupled to a pump or other apparatus to inflate or deflate the balloon. This same port may be used to circulate coolant to the inside of the balloon for the purpose of cooling the balloon during RF energy activation.
  • the RF electrodes 8 operate to provide radiofrequency energy for heating of the desired location during the nerve ablation procedure.
  • Electrodes 8 may be constructed of any suitable conductive material, as is known in the art. Examples include stainless steel and platinum alloys.
  • RF electrode 8 may operate in either bipolar or monopolar mode, with a ground pad electrode.
  • a monopolar mode of delivering RF energy a single electrode 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 are used, such a two concentric electrodes.
  • Electrodes 8 can be attached to an electrode delivery member, such as the wire frame 3, by the use of soldering or welding methods which are well known to those skilled in the art.
  • the diameter of the circular RF electrodes 8 is determined by the width of the aortic artery branch for which denervation is desired. If the diameter of the RF electrode 8 is smaller than the diameter of the aortic artery branch for which denervation is desired, the RF electrode 8 would not actually be in contact with tissue, and no ablation would occur. For example, when denervation is desired for the renal artery, which is approximately 6-7 mm in diameter at the ostium of the aorta, the diameter of the circular RF electrodes 8 must be at least that distance, i.e., 7 mm, in order to properly provide ablation at the renal artery ostium.
  • the spacing between the two RF electrodes 8 determines the depth in the tissue to which ablation is accomplished. The father apart the electrodes 8 are, the deeper the tissue denervation that is accomplished. For denervation of the renal artery, a spread of approximately 2-6 mm between the electrodes 8 provides sufficient depth of penetration into the tissue to accomplish the desired level of ablation such that denervation occurs. For example, in one embodiment, if the inner RF electrode 8 has a diameter of approximately 10 mm, then the outer RF electrode 8 would have a diameter of approximately 12-17 mm.
  • the diameter of the RF electrodes 8 may be calculated with reference to the imaging catheter 15. For example, for an imaging catheter 15 whose distal end has a diameter of approximately 2 mm, the RF electrodes 8 that surround the imaging catheter 15 may be centered at 5 mm and 10 mm, respectively, from the center location of the imaging catheter 15.
  • Each electrode 8 can be disposed to treat tissue by delivering Radiofrequency (RF) energy.
  • the radiofrequency energy delivered to the electrode 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 8 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.
  • An electrode selection and control switch may include an element that is disposed to select and activate individual electrodes.
  • RF power source may have multiple channels, delivering separately modulated power to each electrode. This reduces preferential heating that occurs when more energy is delivered to a zone of greater conductivity and less heating occurs around electrodes 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 8 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 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 comprises an insulation pad 19 that is situated between each RF electrode 8 and the wire frame 3, for example so as to protect the wire frame 3 from the direct effects of the RF energy.
  • This insulation pad 19 may also avoid potential damage to the body to the subject's blood while ablative energy is effectively transmitted to the vessel surface and the blood that has passes through the wire frame.
  • kidney spastic nerve activity is also included in this design.
  • a means to measure renal nerve afferent activity prior to and following RF nerve ablation 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 and electrodes on the renal artery placed positioning balloon.
  • 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 positioned within the proximal segment of the renal artery.
  • Action potentials will be measured from the segment of the catheter 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 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 operate 8 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 8 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.
  • the catheter can be coupled to a visualization apparatus, such as a fiber optic device, a fluoroscopic device, an anoscope, a laparoscope, an endoscope or the like.
  • a visualization apparatus such as a fiber optic device, a fluoroscopic 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.
  • the catheter may be constructed with markers that assist the operator in obtaining a desired placement, such as radio-opaque markers, etchings or microgrooves.
  • the catheter 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 through an injection port, thereby enabling localization by fluoroscopy or angiography.
  • the invention herein also comprises a method for ablation of renal artery nerve function within the aorta using the device described hereinabove.
  • the method is performed by a system including a catheter 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.
  • electrical energy port is coupled to a source of electrical energy.
  • the patient is positioned on a treatment table in an appropriate position for the insertion of a catheter.
  • the visualization port is coupled to the appropriate visualization apparatus, such as a fluoroscope, 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 so that the catheter balloon may be later be inflated.
  • the most distal end of the treatment balloon is lubricated and introduced into the patient.
  • the balloon is completely deflated during insertion.
  • the catheter 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 f the catheter, including the wire frame and positioning device, i.e., imaging or balloon catheter, is threaded through the vessel until the wire frame is situated entirely within the vessel to be treated.
  • An introducer sheath or guide tube may also be used to facilitate insertion.
  • step g the position of the catheter is checked using visualization apparatus coupled to the visualization port.
  • This apparatus can be continually monitored by medical professionals throughout the procedure.
  • a positioning mechanism is positioned such that it protrudes through the circular electrodes into the ostium of the renal or another artery.
  • step i the irrigation and aspiration control port is manipulated so as to inflate the balloon of the positioning mechanism, causing the catheter top be rendered stable in its position within the lumen.
  • step j the device sheath is retracted, causing the wire frame to revert to its expanded configuration, in which the wire frame expands to fit within the vessel interior
  • a step k electrodes are selected using the electrode selection and control switch. In a preferred embodiment, all electrodes are deployed at once. In another preferred embodiment, electrodes may be individually selected. This step may be repeated at any time prior to step j.
  • the therapeutic energy port is manipulated so as to cause a release of energy from the electrodes.
  • the duration and frequency of energy are responsive to judgments by medical personnel. This release of energy creates a circular pattern of lesions at the renal artery ostium.
  • a step m the device sheath is advanced over the wire frame so as to cause the wire frame to revert to its collapsed state.
  • a step n the irrigation and aspiration control port is manipulated so as to cause the positioning device balloon to deflate.
  • a step o the positioning device, either the balloon catheter or the imaging catheter, is withdrawn from the renal artery ostium, into the device.
  • the balloon and the imaging/positioning catheters are withdrawn into the sheath, the device is available for positioning at another location within the patient, e.g., the contralateral (or accessory) renal artery, and the steps above may be repeated for each ablation site.
  • a step p the catheter is withdrawn from the patient.

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Abstract

Selon l'invention, un treillis de forme cylindrique portant une ou plusieurs électrodes RF configurées de manière circulaire peut être mis en contact contre la surface interne de l'aorte, par exemple, au niveau de l'ostium de l'artère rénale, de telle sorte que les électrodes circulaires enlèvent l'activité nerveuse de manière circonférentielle autour de l'ostium de l'artère rénale. Le treillis a une mémoire de forme et peut être positionné dans une position pliée, non déployée, au niveau de l'extrémité d'un cathéter et encapsulé à l'intérieur d'une gaine puis avancé longitudinalement à travers le vaisseau sanguin, par exemple, sur un fil guide, jusqu'à l'emplacement pertinent à l'intérieur de la lumière corporelle. La gaine est ensuite retirée, permettant au treillis d'être déployé dans sa position déployée dans laquelle il se conforme aux parois de la lumière, de façon à permettre aux électrodes de venir en contact avec la paroi de lumière afin de réaliser l'ablation. Les éléments RF circulaires peuvent être positionnés autour de l'ouverture dans l'artère rénale à l'aide d'un cathéter d'imagerie qui est passé à travers le trou de l'électrode RF circulaire et au moins partiellement dans l'entrée de l'artère rénale, et un ballonnet peut être placé à travers le cathéter d'imagerie dans le segment proximal de l'artère rénale pour un positionnement amélioré et une stabilisation améliorée. La gaine peut également avoir une découpe longitudinale pour permettre au cathéter d'imagerie de faire saillie à l'extérieur du treillis et dans l'artère rénale pour positionner le dispositif au niveau de l'ostium de l'artère rénale, même alors que le treillis est toujours dans sa configuration pliée, non déployée, à l'intérieur de la gaine. Une fois que le dispositif a été positionné correctement, la gaine est retirée et le treillis est déployé de telle sorte que les électrodes RF sont positionnées contre l'ostium de l'artère rénale.
EP12764009.2A 2011-03-31 2012-03-30 Dispositif de cathéter d'ablation par radiofréquence Withdrawn EP2677953A4 (fr)

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WO2012135703A3 (fr) 2012-11-22
JP2014516608A (ja) 2014-07-17
EP2677953A4 (fr) 2014-10-08
KR20140013045A (ko) 2014-02-04
WO2012135703A2 (fr) 2012-10-04

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