CN108289657A - It is melted with the carotid body of transvenous ultrasonic imaging and ablation catheter - Google Patents

Abstract

The method and apparatus for reducing the patient that the disease that the sympathetic nerve to assess and treat the sympathetic tone for reflecting and increasing with the peripheral chemoreceptor for being related to enhancing mediates is inputted to the chemical sensor of nervous system by carotid body ablation.Supersonic melting conduit can be used to carry out for method.Method may also include to be imaged using at least one ultrasound imaging catheter.

Description

It is melted with the carotid body of transvenous ultrasonic imaging and ablation catheter

It is incorporated by reference into

The application is the part continuation application for the U. S. application the 15/069th, 531 submitted on March 14th, 2016, the U.S. State's application requires the priority for the U.S. Provisional Application No. 62/132,459 submitted on March 12nd, 2015, the disclosure of which logical Reference is crossed to be fully incorporated herein.

U. S. application the 15/069,531st be the U. S. application the 14/656,635th submitted on March 12nd, 2015 part after Continuous application, the priority of the following U.S. Provisional Application of the U.S.Application claims：The application number 61/ that on March 12nd, 2014 submits 952,015；The application number 62/017,148 that on June 25th, 2014 submits；The application number 62/ submitted for 12nd with September in 2014 049,980.The disclosure of above-mentioned application is fully incorporated herein by reference.

The application also requires the equity of following U.S. Provisional Application, both the disclosure of which to be incorporated herein by reference： The application number 62/217,570 that September in 2015 is submitted on the 11st；The application number 62/219,595 submitted for 16th with September in 2016.

Apply below also by being incorporated herein by reference：The U.S. Patent number 9,283,033 that on March 15th, 2016 authorizes；With Announce 2014/0350401 in the U.S. that on November 27th, 2014 announces.

The all publications and patents application mentioned in the present specification is incorporated herein by reference, and is incorporated by reference into The degree of this paper like each independent publication or patent application are specifically and individually indicated be incorporated by reference into it is identical Degree.

Technical field

Present disclosure is related generally to by melting a carotid body, two carotid bodies and god associated there Through at least one for the treatment of with being reflected at least partly with the peripheral chemoreceptor of enhancing or the sympathetic nerve that increases is lived Change the system and method for the patient for the disease that associated sympathetic nerve mediates.

Background

It is known that autonomic nerves system is unbalance associated with various disease states.The recovery of autonomic balance has become a variety of The target of therapeutic treatment, the plurality of medical treatment includes such as pharmacy, form based on equipment and electro photoluminescence.Example Such as, Bextra (beta blockers) is a kind of for reducing sympathetic nerve activity to treat cardiac arrhythmia and height The drug of blood pressure；Gelfand and Levin (US 7,162,303), which is described, be used to reduce renal sympathetic nerve discharge to treat the heart The device-based treatment of force failure, hypertension and kidney failure；Yun and Yuarn-Bor (US 7,149,574；US 7,363, 076；US 7,738,952) it describes and restores autonomic balance by increasing parasympathetic activity to treat and parasympathetic nerve damage Consume the method for associated disease；Kieval, Burns and Serdar (US 8,060,206) are described to be stimulated in response to hypertension Pressoreceptor increases the electric pulse generator of parasympathetic activity；Hlavka and Elliott (US 2010/0070004) Describe be connected to the afferent nerve path of chemical receptor of carotid body with by electric nerve adjusting control is dyspneic can The egersimeter of implantation.Recently, carotid body ablation (CBA) is contemplated for the disease that treatment sympathetic nerve mediates.

It summarizes

This disclosure relates to for reducing the conduction of the input signal between peripheral chemoreceptor and central nervous system Methods, devices and systems.Present disclosure include the method melted for the targeted energy of carotid body or its related neural, Device and system.In particular, for melting (CBA) catheter ablation group with the intravascular carotid body with imaging and ablation instruments Knit such as carotid body, arteria carotis diaphragm or the method with the nerve of carotid body relevant close blood vessel such as vein or artery And device.

Following ablation carotid body can be passed through：Oriented energy transmitter is disposed adjacent to interested carotid body It is placed in the wall in one of jugular vein or its tributary or against the wall, then aims at and activate oriented energy transmitter, to Increase comprising carotid body or its nerve vein week space temperature, until be enough to melt arteria carotis diaphragm, carotid body or its The degree of the tissue of nerve and duration.

In exemplary process, then the position of identification and carotid body relevant vein week space is sent out oriented energy The inner wall of emitter against the jugular vein in neighbouring identified position is placed or is placed within the inner wall, then selection orientation Energy ablation parameter and activate oriented energy transmitter to melt carotid body, thus the orientation of oriented energy transmitter and The selection of position and oriented energy ablation parameter provides the ablation to carotid body and nothing is substantive to adjacent functional structure The collateral damage of property.

In other exemplary process, the position of identification and the relevant extravascular compartments of carotid body then will orientation Energy emitter close to identify position placement, then selection oriented energy ablation parameter and activate oriented energy transmitter from And carotid body is melted, the thus selection of the position of oriented energy transmitter and oriented energy ablation parameter provides dynamic to neck The ablation of arteries and veins body and without the collateral damage to adjacent functional structure substance.

The one side of present disclosure is configured for leading with imaging catheter such as intravascular ultrasound (" IVUS ") imaging The supersonic melting conduit of echocardiography (ICE) conduit interaction, the supersonic melting conduit include in pipe or heart： Remote area and proximal end region；Imaging catheter chamber, for proximally region to extend to the imaging of remote area and leads by its receiving Pipe；In the anechoic room of remote area；And the indoor supersonic melting energy converter of echoless, wherein imaging catheter chamber are configured to Imaging catheter is located in the sighted direction of supersonic melting energy converter in unfolded state and leaves aiming side in retracted mode To.

The one side of present disclosure is configured for mutual with the ultrasound imaging catheter with ultrasonic imaging energy converter The supersonic melting conduit of effect, the supersonic melting conduit include：Remote area and proximal end region；It is configured to accommodate by it Proximally region extends to the imaging catheter chamber of the imaging catheter of remote area；In the anechoic room of remote area；And nothing is returned The indoor supersonic melting energy converter of sound, wherein imaging catheter chamber are configured to the ultrasonic imaging energy converter of imaging catheter being located in The distal end of supersonic melting energy converter so that when ultrasonic imaging energy converter transmission and received wave to provide ablation when image when, surpass Sound melts energy converter and can transport ablation energy.

Present disclosure is a kind of supersonic melting conduit on one side, and the supersonic melting conduit includes：Distal component, The distal component includes supersonic melting energy converter, echoless shell and ablation directional reference marker, echoless shell at least portion Boundary of a piece of land Dingyuan end room, supersonic melting energy converter is divided to be located remotely interior, distal component is suitable for accommodating ultrasonic imaging wherein Energy converter, ablation directional reference marker is positioned and adapted to relative to supersonic melting energy converter, when ultrasonic imaging energy converter is remote It when positioning and activate in the component of end, is created on the image created by ultrasonic imaging energy converter and aims at artifact, aimed at artifact and be suitable for It is used to indicate ablation direction；And the elongated sheath proximally extended from distal component.

This paper present disclosures are a kind of supersonic melting conduit on one side, and the supersonic melting conduit includes：Distally Component, the distal component include supersonic melting energy converter and echoless shell, and echoless shell defines distal end room at least partly, Supersonic melting energy converter is located remotely interior, and distal component is suitable for accommodating ultrasonic imaging energy converter wherein, wherein without returning Sound shell has first thickness at the first axial position of ablation ultrasonic transducer, and far from ablation ultrasonic transducer There is the second thickness bigger than first thickness at the second axial position of distal tip；And proximally extend from distal component Elongated sheath.

This paper present disclosures are a kind of supersonic melting conduit on one side, and the supersonic melting conduit includes：Distally Component, the distal component include supersonic melting energy converter and echoless shell, and echoless shell defines distal end room at least partly, Supersonic melting energy converter is located remotely interior, and distal component is suitable for accommodating ultrasonic imaging energy converter wherein；Fluid cavity, should Fluid cavity is in fluid communication with supersonic melting energy converter, and fluid cavity further includes the electric connector being electrically connected with ablation ultrasonic transducer； And the elongated sheath proximally extended from distal component.

This paper present disclosures are a kind of supersonic melting conduit on one side, and the supersonic melting conduit includes：Distally Component, the distal component include supersonic melting energy converter and echoless shell, and echoless shell defines distal end room at least partly, Supersonic melting energy converter is located remotely interior, and distal component is suitable for accommodating ultrasonic imaging energy converter wherein；From distal end group The elongated sheath that part proximally extends；And it is fixed at least part of elongated sheath and from least one of elongated sheath Divide the ablation energy converter supporter extended to distal end, ablation ultrasonic transducer, which is mounted on, to be melted on energy converter supporter.

In any ablation catheter of this paper, conduit can also include for coolant treatment agent or ablation ultrasonic transducer Cooling fluid chamber, can be contained in anechoic room.It is additionally provided with to the space trandfer fluid around ultrasonic transducer Acoustic coupling medium.In any ablation catheter of this paper, the sighted direction of supersonic melting conduit may be in unfolded state The radial direction of conduit is left in the imaging plane generated by imaging catheter.In any ablation catheter of this paper, conduit may be used also To be included in the mating feature part for being coupled with imaging catheter of proximal end region, wherein mating feature part and imaging catheter is existed The actuator of transition between unfolded state and retracted mode is associated.In any ablation catheter of this paper, conduit can be constructed For the controllable deflection of remote area, wherein deflection plane and supersonic melting energy converter is coplanar.It is led in any ablation of this paper Guan Zhong, conduit can also include the chamber for being configured to accommodate seal wire.

In any ablation catheter of this paper, conduit can also include acoustic insulation body to shield the logical of supersonic melting energy It crosses, wherein acoustic insulation body includes the air microballoon in embedded epoxy resin.Acoustic insulation body can be micro- with about 200 to 300 The thickness of rice, and include microballoon with the diameter in the range of about 15 to 25 microns and with about 180 to 210 microns of model The microballoon of diameter in enclosing.

In any ablation catheter of this paper, conduit can also include fiducial marker, which has opposite In the positioning of imaging transducer and the sighted direction of ablation energy converter.Fiducial marker can be the hollow tube filled with air.When When ultrasonic imaging energy converter is in activated positon in distal component, fiducial marker can be axially right with ultrasound imaging catheter Together.Fiducial marker can be arranged relative to supersonic melting energy converter so that can be determined based on the position indicated on image The direction of the ablation energy emitted from supersonic melting energy converter.Fiducial marker can be fixed on echoless shell.Echoless Shell may include the first film and the second film, and fiducial marker can be fixed between the first film and the second film.Reference mark Utensil has the construction of bending, such as part tubular component.Fiducial marker can be neighbouring ablation directional reference marker setting Support member extension.Fiducial marker can be impermeable echogenic material such as stainless steel or radiopaque material such as platinum- Iridium.

In any ablation catheter of this paper, ablation catheter can be configured to the jugular vein for being inserted through patient and wherein surpass Sound ablation energy converter can be configured to be placed on the target ablation near sites including carotid body.

In any ablation catheter of this paper, conduit may include distal component, the distal component further include wherein by It is configured to accommodate the chamber of ultrasound imaging catheter by it.

In any ablation catheter of this paper, ablation energy converter can be flat energy converter, be in directly with being parallel to The axis of the longitudinal axis of the elongated sheath of construction.Flat energy converter can be arranged in the outer radius portion in distal end of catheter region.

In any ablation catheter of this paper, echoless shell can have at the first axial position of ablation ultrasonic transducer There is first thickness, and there is the second thickness more than first thickness at the second axial position of ablation ultrasonic transducer distal end Degree.Echoless shell may include at least the first and second film sections, and the first and second films section is solid in the second axial position It is scheduled on together.

In any ablation catheter of this paper, conduit may also include fluid cavity, fluid cavity and supersonic melting energy converter fluid Connection, fluid cavity further include the electric connector being electrically connected with ablation ultrasonic transducer.

In any ablation catheter of this paper, conduit may also include at least part for being fixed to elongated sheath and from thin The ablation energy converter supporter that at least part of long sheath extends to distal end, and melt ultrasonic transducer and may be mounted to that ablation On energy converter supporter.Conduit, which may also include, is fixed on putting down between ablation ultrasonic transducer and ablation energy converter supporter Plate.Ablation energy converter supporter may include the chamber for being suitable for accommodating ultrasound imaging catheter wherein.Melt energy converter supporter also May include that chamber is discharged at least one fluid of catheter proximal end regional connectivity.It may include by lateral edges to melt energy converter supporter The recess defined with backer board, recess be suitable for wherein accommodate supersonic melting energy converter, wherein ablation energy converter be fixed on it is recessed In falling into so that lateral edges extend radially outwardly relative to ablation energy converter, to allow cooling fluid free on ablation energy converter Flowing.Ablation energy converter supporter can be configured to the turbulent flow for causing cooling fluid on ablation energy converter.

Present disclosure is a kind of method in computer system on one side, the method includes：It receives based on super The image of sound is as input, based on the image of ultrasound come since ultrasonic imaging energy converter received signal；It determines based on ultrasound The position of artifact in image, the artifact is by the fiducial marker on supersonic melting energy converter in response to by ultrasonic imaging energy converter The ultrasonic wave of generation creates；Based on artifact position, the sighted direction of the ablation energy from supersonic melting energy converter is determined；And The image based on ultrasound for creating enhancing is used as output to show over the display, and the image based on ultrasound of the enhancing includes The sighted direction of image based on ultrasound and the ablation energy from supersonic melting energy converter.

Present disclosure is computer implemented method on one side, the method includes：It receives by being received and dispatched from ultrasound The video at the target ablation position for carotid body ablation that the ultrasonic signal of device transmission creates or the image based on ultrasound, should Video or based on ultrasound image supersonic melting energy converter be located at for carotid body ablation target ablation near sites when It captures；Enhance video by one or more visions auxiliary, animation or message or the image based on ultrasound, one of them or More visions auxiliary, animation or message include about the ablation energy for carotid body ablation from supersonic melting energy converter The information of the sighted direction of amount；And the video of enhancing or the image based on ultrasound are shown on a user interface.

Present disclosure is computer implemented method on one side, the method includes：It receives by being received and dispatched from ultrasound The video at the target ablation position for carotid body ablation that the ultrasonic signal of device transmission creates or the image based on ultrasound, should Video or based on ultrasound image supersonic melting energy converter be located at for carotid body ablation target ablation near sites when It captures；Enhance video by one or more visions auxiliary, animation or message or the image based on ultrasound, one of them or More visions auxiliary, animation or message include about the ultrasound positioned at the target ablation near sites melted for carotid body Melt the information of the estimated location of the ablation areas of energy converter；And the video of enhancing is shown on a user interface or is based on ultrasound Image.

Present disclosure is the system for being imaged and melting carotid body with image enhancement on one side, described System includes：Conduit, the conduit have ultrasonic imaging energy converter and ablation；Melt console；Ultrasonic imaging console, The ultrasonic imaging console is configured for signal to be transported to imaging transducer and receives signal from imaging transducer；Meter The algorithm that calculation machine executes creates the image based on ultrasound from imaging transducer received signal；Image enhancing unit utilizes Create image of the computerized algorithm processing based on ultrasound of the image of enhancing；And the display of the image of display enhancing.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, determine that the position of the artifact in the image based on ultrasound may include the part for identifying the image based on ultrasound, the base In ultrasound image a part when the orientation of image based on ultrasound changes in response to the movement of ultrasonic imaging energy converter, Not substantially change shape.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, one or more of vision auxiliary, animation or message may include the estimation position of the ablation areas about supersonic melting energy converter The information set.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, the information of the estimated location about ablation areas may include supersonic melting energy converter towards direction and/or supersonic melting Energy converter will convey the direction of ablation energy.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, the information of the estimated location about ablation areas may include the ablation areas of supersonic melting energy converter estimating depth and/or Width.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, the information of the estimated location about ablation areas may include the estimation profile of ablation areas.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, the information of the estimated location of the ablation areas about supersonic melting energy converter can be by considering the user-defined of ablation procedure And/or the parameter that is arranged automatically determines.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, the estimated location of the ablation areas of supersonic melting energy converter can be based at least partially on the ablation energy spectrum of selection to determine.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, one kind or more that the estimated location of the ablation areas of supersonic melting energy converter can be by consideration for the candidate of ablation process A variety of anatomical parameters determine.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, the estimated location of the ablation areas of supersonic melting energy converter can be by considering about the concrete kind for carrying supersonic melting energy converter The information of the Ablation characteristic of the conduit of type determines.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, the information of the Ablation characteristic about a type of conduit for carrying supersonic melting energy converter may include the damage that will be estimated depth The ablation energy and duration associated information of degree and/or width and the conduit of the concrete type.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, one or more of vision auxiliary, animation or message may also include is used for arteria carotis about from supersonic melting energy converter The information of the sighted direction of the ablation energy of body ablation.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, the information of the sighted direction about the ablation energy for carotid body ablation from supersonic melting energy converter can be by making It is determined with the position of fiducial marker or video or based on the aiming artifact in the image of ultrasound.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, fiducial marker can be disposed in the scheduled position of sighted direction relative to the ablation catheter for carrying supersonic melting energy converter It sets.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, fiducial marker may include the band or pipe or when being placed close to target ablation position and all of impermeable echogenic material or structure Closed structure and/or surrounding tissue compare the structure with apparent high echo or low echogenic material or structure.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, fiducial marker may include piezoelectric element.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, fiducial marker is located on the ablation catheter for carrying supersonic melting energy converter, to be indicated on the image based on ultrasound Convey the opposite direction of ablation energy.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, the information of the sighted direction about the ablation energy for carotid body ablation from supersonic melting energy converter can be by making It is determined with the position of multiple (multiple) fiducial markers or video or based on the aiming artifact in the image of ultrasound.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, video or the image based on ultrasound can be created with ultrasound imaging catheter such as IVUS conduits or ICE conduits.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, ultrasound imaging catheter can be placed in the jugular vein close to carotid bifuracation of the candidate melted for carotid body.

Any method or system that can create and/or show this paper of the video of enhancing or the image based on ultrasound may be used also Include that the visible known dimensions for aiming at artifact determine video or base based on conduit or in video or based on the image of ultrasound In the scale of the image of ultrasound.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, one or more of visions auxiliary, animation or message may include one between the anatomical features at target ablation position or The information of more distances.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, one or more distances may include one or more below：Jugular vein, arteria carotis diaphragm, internal carotid, outside neck Artery or arteria carotis diaphragm boundary are to the relative position of reference point, artery diameter, the variation of artery diameter, anatomical features The size and relative position of the ablation of variation, the estimation of relative position or the ablation of establishment.

Any method or system that can create and/or show this paper of the video of enhancing or the image based on ultrasound may be used also Include that one or more distances between the anatomical features based on target ablation position provide ablation therapy guidance to the user Or suggest.

Present disclosure is computer system for monitoring arteria carotis ablation procedure on one side, is configured to hold The operation of row any method herein.Computer system may include being configured to the video of display enhancing or based on ultrasound The display of image and the input interface for being configured to receive the video from supersonic imaging apparatus or the image based on ultrasound. Computer-readable medium may include the behaviour for allowing computer system to execute any method herein when being executed by computer system The instruction of work.

The video that can create and/or show enhancing or based on ultrasound image this paper any method or system In, the image of enhancing can be covered on the image based on ultrasound, and indicated the conveying direction of ablation energy, arteria carotis, estimated The ablation locations of the establishment of the ablation profile of meter, the depth of ablation of estimation and estimation.Computerized algorithm can use estimation The calculating of ablation locations and the relative position of arteria carotis controls ablation console.

Present disclosure be on one side parameter for determining carotid body ablation procedure computer implemented side Method, this method include：Receive the information of the size of the expectation ablated volume of the ultrasonic carotid body ablation procedure of characterization；With based on connecing The information of receipts automatically determines one or more of supersonic melting transportation parameters；And it is supplied to ultrasound to disappear using transportation parameters as output Melt transport system.

Present disclosure is method in computer system on one side, and this method includes：Receive from jugular wall to The distance of the line of the part of internal carotid and external carotid artery is connected as input, which, should from the image measurement based on ultrasound Image based on ultrasound from the ultrasonic transducer received signal being positioned in jugular vein by obtaining；It is determined based on transmission range super Sound melts transportation parameters；And it is supplied to supersonic melting transport system using transportation parameters as output.

It is one or more of in any method or system that can determine this paper of parameter of carotid body ablation procedure Supersonic melting transportation parameters may include composing the ablation energy used by ablation transport system.

In any method or system that can determine this paper of parameter of carotid body ablation procedure, ablation energy spectrum can To convey the overview of the acoustical power and the amount of duration of ablation energy during indicating processing routine.

It is one or more of in any method or system that can determine this paper of parameter of carotid body ablation procedure Supersonic melting transportation parameters can be determined by considering one or more of anatomical parameters for the candidate of ablation process.

It is one or more of in any method or system that can determine this paper of parameter of carotid body ablation procedure Supersonic melting transportation parameters can be by considering the ablation transducer characteristics about the specific conduit for carrying supersonic melting energy converter Information determines.

It is ultrasonic about carrying in any method or system that can determine this paper of parameter of carotid body ablation procedure The information for melting the ablation transducer characteristics of the conduit of energy converter may include that the lesion depths that will be estimated and/or width are specific with this The electrical power of ablation catheter and duration associated information.

In any method or system that can determine this paper of parameter of carotid body ablation procedure, ultrasonic carotid body The desired ablated volume of ablation procedure can be based on by the ultrasonic transduction from the target ablation position melted for carotid body The video that the ultrasonic signal of device transmission creates or the image based on ultrasound automatically determine.

In any method or system that can determine this paper of parameter of carotid body ablation procedure, automatically determining can wrap Include the position of one or more of anatomical features or size in assessment target ablation position.

It is one or more of in any method or system that can determine this paper of parameter of carotid body ablation procedure Anatomical features may include arteria carotis diaphragm, carotid body, internal carotid and external carotid artery and jugular vein.

In any method or system that can determine this paper of parameter of carotid body ablation procedure, determine a kind of or more A variety of supersonic melting transportation parameters may include using the information retrieved from previous ablation procedure and/or assess the number of simulation program Model.

It can determine that any method of this paper of the parameter of carotid body ablation procedure or system may further include certainly The body of dynamic monitoring patient or the movement on head；Identification meets predetermined effectively (significance) standard of instruction patient risk Movement；And it generates instruction movement and has reached the signal for being predefined with criterion standard.

It is one or more of in any method or system that can determine this paper of parameter of carotid body ablation procedure Supersonic melting transportation parameters may include energy conveying duration and acoustical power, wherein acoustic power range 2 watts and 25 watts it Between, and duration ranges are between 3 seconds and 25 seconds.

Present disclosure is computer system for monitoring arteria carotis ablation procedure on one side, is configured to hold The operation of any one of row this paper methods.Computer-readable medium may include allowing calculating when being executed by computer system Machine system executes the instruction of the operation of any method herein.

Present disclosure is supersonic melting conduit on one side comprising at least one surface of engagement ablation energy converter Insulating component, which will melt at least one pole of energy converter and is electrically isolated with the conductor fluid in anechoic room.

Present disclosure is supersonic melting conduit on one side comprising the cooling fluid inlet of ablation energy converter proximal end The cooling fluid outlet port of port and ablation energy converter distal end.

Present disclosure is supersonic melting conduit on one side comprising film is (for example, in ablation energy converter supporter Outer surface extend, melt energy converter supporter proximal end and distal tip it is at least one).In one aspect, ultrasound disappears Melt conduit include film (for example, ablation energy converter supporter outer surface extend, melt energy converter supporter proximal end and Distal tip it is at least one), combined with the insulating component at least one surface of engagement ablation energy converter, the insulating component At least one pole for melting energy converter is electrically isolated with the conductor fluid in anechoic room.

Present disclosure is supersonic melting conduit on one side comprising ablation energy converter supporter.

Present disclosure is supersonic melting conduit on one side comprising at least partly around the setting of conduit circumference The ultrasonic imaging energy converter (for example, three or more ultrasonic imaging energy converters) of more than one (a plurality of). On one side, supersonic melting conduit includes the more than one ultrasonic imaging energy converter being arranged at least partly around conduit circumference (for example, three or more ultrasonic imaging energy converters), with the insulating component at least one surface for engaging ablation energy converter At least one pole for melting energy converter is electrically isolated by combination, the insulating component with the conductor fluid in anechoic room, and/or with Film (for example, extending in the outer surface of ablation energy converter supporter, melts the proximal end and distal tip of energy converter supporter It is at least one) combination.

Present disclosure is supersonic melting conduit on one side comprising the depressed area in supersonic melting conduit cross section Domain.In one aspect, wherein supersonic melting energy converter is disposed in sunk area and ultrasonic imaging energy converter is not disposed in In sunk area.

Present disclosure is supersonic melting conduit on one side comprising by catheter sheath tube outer surface carry ultrasound at As energy converter.

Present disclosure is supersonic melting conduit on one side comprising relative to supersonic melting energy converter in proximal end Ultrasonic imaging energy converter or more than one ultrasonic imaging energy converter.

Present disclosure is supersonic melting conduit on one side comprising be arranged ablation energy converter behind, with disappear Melt the opposite guidewire lumen of the sighted direction of energy converter.In one aspect, supersonic melting conduit includes being arranged in ablation energy converter Below, the guidewire lumen opposite with the ablation sighted direction of energy converter, is more than with what is be arranged at least partly around conduit circumference One ultrasonic imaging energy converter (for example, three or more ultrasonic imaging energy converters) and with engage ablation energy converter at least The insulating component combination on one surface, the insulating component is by least one pole for melting energy converter and the conduction in anechoic room Fluid is electrically isolated.

Present disclosure is supersonic melting conduit on one side comprising the ablation energy converter with width, and conduit With conduit diameter, the wherein ratio of conduit diameter and width is no more than 2.5.

Present disclosure is supersonic melting conduit on one side comprising imaging transducer further includes in side view Cover the radiopaque marker of imaging transducer.

Present disclosure is that supersonic melting conduit and conduit are arranged on sheath therein on one side, which is included in far Sheath radiopaque marker on end regions.

Present disclosure is supersonic melting conduit on one side comprising the radiopaque on the remote area of conduit Lid.

Present disclosure is supersonic melting conduit on one side comprising is configured to generate the image of tissue plane Imaging transducer or more than one energy converter, the center about 1 to 15mm of the transmission surface of tissue plane distance ablation energy converter, Optionally about 3 to 12mm.

Present disclosure is supersonic melting conduit on one side, is adapted so that it can be conveyed without the use of conveying Sheath, the conduit further include the deflectionable part close to ultrasonic imaging energy converter and supersonic melting energy converter.

Present disclosure is medical apparatus on one side, is suitable for limited use, and wherein medical apparatus is not limited to herein It is described those, and can be can from console receive signal any medical apparatus.Medical apparatus may be adapted to instruction dress Set whether from console receive signal, optional seismic electrical signal.Medical apparatus can also be suitable to indicate that since device stops from control Platform receives signal (for example, if medical apparatus is pulled up from console or if console is closed), and the time of specified amount is It is no to pass by.As an example, medical apparatus may include with byte nonvolatile memory storage (such as EEPROM), if device once receives the signal (for example, being inserted into console) from console, which is set It sets.Memory for digits memory may include the second byte, if having passed through specified amount after the energy blackout from console to device Time, then the second byte be set.If medical apparatus is again insertable into same or different console, (or console is in device Opened after being closed when remaining inserted into), then console may be adapted to read memory for digits memory, and if two bytes all It is set, console can prevent medical apparatus from being used, such as by preventing signal from being sent to medical apparatus from console.Doctor Learning device can also be suitable for only indicating stopping receiving signal from console since device, and whether the time of specified amount passes by, i.e., Medical apparatus is set to be unsuitable for whether instruction device has received signal from console.Present disclosure further includes that can read medicine dress The console of memory in setting, with determine since medical apparatus receive the signal from console rise whether have passed through it is specified Period.If console determination has already been through the specified period, console may be adapted to anti-stop signal and be sent to medicine Device, to prevent it from being used.For example, console can read the memory for digits memory on medical apparatus, and determine word Whether section has been set due to have passed through the specified period after medical apparatus receives signal from console.

Brief description

Fig. 1 is depicted in simplified schematic form is placed in intravascular oriented energy ablation catheter via femoral venous puncture Patient's body.

Fig. 2 be show some characteristic sizes by arteria carotis spacer film (intercarotid septum) and surrounding group The schematic diagram for the cross section knitted.

Fig. 3 A, 3B, 3C, 3D and 3E are the schematic diagrames of the embodiment of ultrasonic transducer.

Fig. 4 A and 4B are the schematic diagrames for the Ultrasonic C BA conduits for being transported to jugular vein.

Fig. 5 A, 5B, 6A, 6B, 7A, 7B, 7C, 8A, 8B, 8C and 8D are the ultrasounds for having one or more diagnostic catheters The schematic diagram of CBA conduits, the diagnostic catheter with the vessel landmarks for being transported to jugular vein for being aligned.

Fig. 9 A and 9B are the schematic diagrames of the Ultrasonic C BA conduits with adjustable focusing distance.

Figure 10 is the schematic diagram of the Ultrasonic C BA conduits with adjustable focusing distance.

Figure 11 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of individual ultrasound imaging catheter.

Figure 12 A, 12B, 12C, 12D, 12E, 12F, 12G, 12H and 12I are configured for receiving individual ultrasonic imaging leading The schematic diagram of the Ultrasonic C BA conduits of pipe.

Figure 13 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of individual ultrasound imaging catheter.

Figure 14 A and 14B are configured for receiving the schematic diagram of the Ultrasonic C BA conduits of individual ultrasound imaging catheter.

Figure 15 A are the schematic diagrames of the component of conduit shown in Figure 15 B.

Figure 15 B are configured for receiving the schematic diagram of the Ultrasonic C BA conduits of individual ultrasound imaging catheter.

Figure 16 is the schematic diagram of the ultrasonoscopy generated in transvenous carotid body ablation procedure.

Figure 17 is the schematic diagram of deflectable ultrasound catheter.

Figure 18 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of individual ultrasound imaging catheter.

Figure 19 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of individual ultrasound imaging catheter.

Figure 20 A and 20B are configured for receiving the schematic diagram of the Ultrasonic C BA conduits of individual ultrasound imaging catheter.

Figure 21 A, 21B and 21C are the schematic diagrames of the CBA conduits and deflectable sheath that manipulate venous locations.

Figure 22 A are configured for the schematic diagram of ablation and the transducer assemblies being imaged.

Figure 22 B are the ablation of transducer assemblies and the electrode of imaging pattern shown in Figure 22 A and the table that frequency is constituted.

Figure 23 is configured for the schematic diagram of the conduit comprising the transducer assemblies for being imaged and melting the two.

Figure 24 A, 24B are figure of the lesion depths relative to energy.

Figure 24 Ci, 24Cii, 24Ciii and 24Civ represent the example of the algorithm from the dosimeter for determining unique conduit Data.

Figure 25 is damage dose look-up table.

Figure 26 is the video based on ultrasound shot by the conduit being positioned towards in the jugular vein of carotid bifuracation One frame.

Figure 27 is the block diagram of the system for being imaged and melting.

Figure 28,29,30 and 31 are the schematic diagrames of the video based on ultrasound of enhancing.

Figure 32 is the schematic diagram of the pin type ablation catheter of ultrasonoscopy guiding.

Figure 33 is the schematic diagram of the pin type ablation catheter of ultrasonoscopy guiding.

Figure 34 A, 34B, 34C, 35 and 36 are the signals of the Ultrasonic C BA conduits with integrated ultrasonic imaging transducer array Figure.

Figure 37 A are the schematic diagrames of the video based on ultrasound shot from the jugular vein close to arteria carotis diaphragm.

Figure 37 B are the schematic diagrames of the video based on ultrasound shot from the jugular vein close to arteria carotis diaphragm, and display comes from Melt the aiming transmitting of converter.

Figure 37 C are the schematic diagrames of the video based on ultrasound shot from the jugular vein close to arteria carotis diaphragm, and display comes from Melt the aiming transmitting of converter.

Figure 38 is the schematic diagram of the Ultrasonic C BA conduits with integrated ultrasonic imaging energy converter.

Figure 39 is the schematic diagram of the Ultrasonic C BA conduits with the multiple deflectionable parts for being configured to multi-direction deflection.

Figure 40 is the multiple deflectionable parts deflected with the different location being configured in the length along conduit The schematic diagram of Ultrasonic C BA conduits.

Figure 41 A, 41B and 41C are showing for the Ultrasonic C BA conduits with the passive flexible portion for being configured with adjustable length It is intended to.

Figure 42 is the schematic diagram of the Ultrasonic C BA conduits comprising integrated sheath.

Figure 43 A, 43B, 43C and 43D are the schematic diagrames of the Ultrasonic C BA conduits with protection cap.

Figure 44 A, 44B and 44C are configured for the schematic diagram of the ablation energy converter cooled down with saline solution.

Figure 45 A, 45B, 45C, 45D and 45E are the schematic diagrames of ablation catheter and system with integrated imaging array.

Figure 46 A are the simplified electrical circuit diagrams using limiter.

Figure 46 B and 46C are the flow charts using limiter algorithm.

Detailed description

This disclosure is related to melting for carotid body suffers from the periphery by enhancing at least partly to treat The sympathetic god for learning receptor reflection (for example, peripheral chemoreceptor hypersensitive, peripheral chemical sensor hyperactive) or increasing Disease (such as heart, kidney, metabolism or pulmonary disease such as hypertension, CHF, the sleep mediated through sympathetic nerve caused by activation Apnea, sleep disordered breathing, diabetes, insulin resistance, asthma, COPD) patient systems, devices and methods.Such as Carotid body used herein ablation typically refer to melt completely or partially one or two carotid body, carotid body nerve, Arteria carotis spacer film or peripheral chemoreceptor.Main therapy approach is to reduce peripheral chemoreceptor reflection or reduce to come from The afferent nerve signals of carotid body (CB) conduct, and lead to the reduction of central sympathetic anxiety.For the purpose of the application, it is passed to Carotid body nerve is considered as that the chemistry of enhancing is felt (regardless of its cause) higher than normal long-term or interval sexuality Receiver reflects.Other important benefits, such as parasympathetic is nervous, vagal tone and especially baroreflex and pressoreceptor are lived Dynamic increase, the reduction of expiratory dyspnea, hyperventilation and respiratory rate, can be expected in certain patients.Secondary to breathing speed The additional increase of the reduction of rate, parasympathetic anxiety can be expected in certain cases.The peripheral chemoreceptor of enhancing reflects (such as carotid body activation) leads to the increase of stomodaeal nervous system activity, this then mainly causes to see in target patient population The progress and debilitating symptom and adverse events of the chronic disease arrived.Carotid body includes sensitive to oxygen and carbon dioxide thin Born of the same parents.Carotid body also makes a response to blood flow, pH value of blood, blood glucose level and its possible dependent variable.Even if therefore chemistry Sensitive cell is not activated, and carotid body ablation can also become the therapeutic scheme to patient, such as with hypertension, heart disease Or the patient of diabetes.

Target：

In order to inhibit or suppress peripheric receptor chemoreceptor reflex, anatomic targets to be ablated (also referred to as target Tissue, target ablation position or target site) may include at least part below：At least one carotid body, aorta Body, neural (for example, carotid body is neural, carotid sinus nerve, carotid plexus) associated with peripheral chemoreceptor, Support peripheral chemoreceptor small blood vessel, carotid body essence, chemical-sensitive cell (for example, blood vessel glomus cell), Tissue, arteria carotis in carotid body resident site (such as site based on preoperative imaging or anatomy possibility) under a cloud Sizable a part of (a substantial part) of spacer film, a part for arteria carotis spacer film, arteria carotis spacer film Or combinations thereof.As used herein, the ablation of carotid body can refer to any one position in these target ablation positions Ablation.

Arteria carotis spacer film is being also known as arteria carotis diaphragm herein, and be defined herein as tissue has with following The wedge shape on boundary or the section of triangle：The tail portion pattern that the saddle (saddle) of carotid bifuracation defines arteria carotis diaphragm (pushes up Point)；The aspectant wall of internal carotid and external carotid artery defines the both sides of arteria carotis diaphragm；The cranium lateral boundaries of arteria carotis diaphragm exist Extend and can be defined as the cranium side of carotid body between these arteries, but may be in this region it is any important non- The caudal of target nerve structure (such as hypoglossal nerve), for example, cranium lateral boundaries can be the about 10mm of the saddle away from carotid bifuracation extremely About 15mm；The madial wall and lateral wall (medial and lateral walls) of arteria carotis diaphragm are generally by approximatively tangential It is defined in the plane of internal carotid and external carotid artery；A lateral wall for being tangential to internal carotid and external carotid artery in the plane And another plane is tangential to the madial wall of these arteries.Arteria carotis spacer film is arranged between madial wall and lateral wall.Neck Artery spacer film can include completely or partially carotid body, and important non-targeted structure can be not present, such as be confused Walk nerve or sympathetic nerve or hypoglossal nerve.Arteria carotis spacer film may include certain pressoreceptors or pressoreceptor god Through.Arteria carotis spacer film may also include neuropile nerve, thin vessels and fat between arteria carotis.Arteria carotis spacer film can be ablation Target.Even if carotid body or carotid body nerve easily cannot visually be identified specifically to target, arteria carotis Spacer film can be targeted, and had ablation carotid body and safely avoided the high probability of non-targeted nerve.Can arteria carotis every Multiple ablations are generated in film to cover the tissue for increasing volume to increase the ablation probability of carotid body.Multiple ablations can be overlapped Or it is discontinuous in arteria carotis diaphragm.

Carotid body nerve is anatomically defined herein as carotid plexuses nerve and carotid sinus nerve.Neck is dynamic Arteries and veins somatic nerves is functionally defined herein as information to be conducted from carotid body to the nerve of central nervous system.Neck is dynamic Arteries and veins somatic nerves is properly termed as one or more nerves associated with carotid body herein.

Ablation can be concentrated exclusively on the target tissue, or concentrated on destination organization while safely being melted close to target group The tissue (for example, to ensure that destination organization is ablated to or as acquisition to the approach of the access of destination organization) knitted.Ablation areas Can be equally big with peripheral chemoreceptor (such as carotid body or aortic body) itself, it smaller or bigger and can slightly wrap Include one or more tissues around chemocepter, such as blood vessel, tunica adventitia of artery, fascia, perfusion chemocepter is small Blood vessel and the nerve that is connected to blood vessel glomus cell and blood vessel glomus cell is made to innervate.Understand certain pressure experiences Device nerve will jointly be melted with carotid body nerve, then clump or carotid sinus nerve can be the mesh melted between arteria carotis Mark.Pressoreceptor is distributed in human arterial and the redundancy with high level.

Tissue can be ablated to the chemoreceptor reflex of the only one of two carotid bodies to inhibit or suppress patient. Other embodiments include ablation tissue to inhibit or suppress the chemoreceptor reflex of two carotid bodies of patient.At some In embodiment, the first carotid body is melted, is then assessed to determine whether melt another carotid body. For example, therapy may include being melted to carotid body, measure obtained chemosensitivity, sympathetic activity, Breathing or with the relevant other parameters of carotid body hyperactive, and unilateral side melt after if it is desire to being further reduced The ablation of the second carotid body can then be carried out by learning sensibility.

The pressure that the embodiment for the treatment of can substantially reduce chemoreceptor reflex and not excessively reduce patient is anti- It penetrates.Proposed ablative surgery can be being moved with substantially avoiding carotid sinus, being distributed in arteria carotis especially neck for targeting At least some of carotid sinus nerve of the signal of pressoreceptor and conduction from the pressoreceptor in the wall of arteries and veins. For example, baroreflex can substantially be avoided below targeting：The possibility of limited bulk surrounds being ablated to for carotid body Tissue, the tissue comprising large number of carotid body nerve, the inside segment at carotid bifuracation tunica adventitia of artery Tissue in all spaces (periadventitial space) or the tissue at the attachment position of carotid body and artery. The ablation of the targeting by by the region or carotid body itself the Visual Implementation, such as by CT, CT angiography, MRI, ultrasonography, fluoroscopy, by blood flow visualization or the injection of contrast agent and instrument is located in neck It positions, while is avoided to arteria carotis, pressoreceptor, carotid sinus nerve or other weights in artery body or close to carotid body The excessive damage that the non-targeted nerve wanted for example is predominantly located at vagus nerve or sympathetic nerve on the outside of arteria carotis diaphragm (such as wears Hole, narrow, thrombosis).Therefore, may be helpful in the following areas to carotid body imaging before ablation：(a) it selects Candidate is selected, if there is carotid body, sufficiently large and if being identified to, and (b) guiding treatment, by for operator It is tight to arteria carotis diaphragm, the center of arteria carotis diaphragm, carotid body nerve, blood vessel ablation instrument is guided to provide mark collection of illustrative plates Region adjacent to carotid body or it is contemplated that the region of carotid body itself or carotid body nerve.Its row of may also help in Except wherein carotid body is located substantially on the outside of arteria carotis diaphragm, in position close to vagus nerve, hypoglossal nerve, jugular vein or Certain others can be ablated to the patient of the structure injured.In one embodiment, only carotid body is located substantially on Patient in arteria carotis spacer film is selected for ablation therapy.

One embodiment of therapy may include only melting one of right carotid body and left neck artery body.With ablation Two carotid bodies are compared, this can reduce program time and cost and security risks, while generating desired treatment effect Fruit.Further, since such as vascular diseases or abnormal only tool there are one can and carotid body patient, can be the candidate of program Person.When carrying out unilateral treatment, ablation right carotid artery body ratio left side can be advantageous.For example, right side can be than left side more It is easy, is faster or more safely close, or can be with the therapeutic effect of bigger.

Once carotid body is ablated to, removes or denervation, carotid body function (such as carotid body chemoreception Device reflects) it basically can not restore in the mankind, partially due to aortic chemoreceptor is considered as not filling in the mankind What distribution was educated.On the contrary, once carotid sinus pressure reflection is removed, usually by aorta after several weeks or several months Or the pressoreceptor baroreflex compensation of other arteries.Therefore, if carotid chemoreceptor reflection and baroreflex two Person is removed or significantly reduces, such as by cutting off neuropile nerve, baroreflex between carotid sinus nerve or arteria carotis It can be finally recovered, and chemoreceptor reflex cannot.The consequence of temporary removal or the reduction of baroreflex is at certain It may be relatively serious in the case of a little and need to be hospitalized and control using drug, but they are not usually threat to life , it is not controlling or permanent.It will be understood, therefore, that although the selective removal and pressure of chemical receptor of carotid body reflection are anti- The reservation penetrated may be desired, but may not be indispensable in some cases.

Ablation：

Term " ablation ", which can refer to, changes tissue so that for good and all or persistently the extended period (is greater than 3 weeks, is more than 6 A month, be more than 1 year, continue several years or continue patient's remaining years) compacting or inhibit its biological function or activity in response to stimulation. The denervation of selectivity can relate to, for example, interrupt the afferent nerve from carotid body substantially retains conduction pressure simultaneously The neural such as hypoglossal nerve, laryngeal nerve and fan that the nerve from carotid sinus of ergoreceptor signal is adjacent with other are absent-minded Through.Selectivity denervation another example can relate to interrupt carotid sinus nerve or with carotid body and certain pressures Clump between the arteria carotis of both ergoreceptors connection, wherein the chemoreceptor reflex from carotid body for good and all or is persistently prolonged The long period (such as several years) is reduced and baroreflex is substantially extensive within the short period (such as a few days or several weeks) It is multiple.As used herein, term " ablation " or its derivative refer to suppressing or inhibiting natural chemocepter or afferent nerve The Invasive procedures of function, this is adjusted with electric nerve or reversibly inactivation and reactivation chemoreceptor function are contrasted.

Carotid body ablation (" CBA ") used herein refers to such destination organization ablation, and wherein desired effect is It reduces or removes the afferent nerve signals conduction from chemical sensor (such as carotid body) or reduce chemoreceptor reflex. Since chemoreceptor reflex or afferent nerve activity cannot directly be measured with practical way, can transfer to make sometimes With the index such as chemosensitivity of chemoreceptor reflex.Chemoreceptor reflex is reduced usually by the reduction of blood pressure, ventilation Indicated by reduction, saturation pressure or the partial pressure change that increase is made great efforts with the ventilation of per unit blood gas concentration or by that can survey indirectly The movable reduction instruction of central sympathetic of amount.Sympathetic activity can by blood pressure, lead to the peripheral nerve of muscle (MSNA) measurement activity, heart rate (HR), heart rate variability (HRV), hormone such as feritin, adrenaline and angiotensin It generates and the reduction of peripheral vascular resistance is assessed.All these parameters are measurable and can lead directly to health Improve.In the case of CHF patient, blood pH, blood PCO₂, hyperventilation degree and metabolism exercise test parameter such as peak Value VO₂And VE/VCO₂Slope is also important.It is believed that as being for example short of breath and low blood CO₂As a result, with raised The patient of chemoreceptor reflex has low VO₂With high VE/VCO₂Slope (index of the effciency of respiratory).These parameters also with movement Limit related, these movement limitations further speed up state deteriorating of the patient towards morbidity and dead direction.It should be understood that all These indexs be indirect and faulty, and be intended to instruct successful to the technology for being most possibly benefited or obtaining ablation The treatment of the patient of instruction, without being intended to prove the accurate measurement to effect or ensureing successfully.It has been observed that heart patient In certain tachyarrhythmias be sympathetic nerve mediate.Therefore, reversible auricular fibrillation is being treated in carotid body ablation It may be helpful in ventricular tachycardia.

Carotid body ablation may include by thermal heat mechanism (thermal heating mechanism) for heat The method and system of ablation tissue.Due to the direct effect to tissue and structure of thermal stress induction, heating ablation can be implemented.Separately Other places or selectively, calorifics destruction may be at least partly due to blood vessel or circumvascular structure (such as artery, petty action Arteries and veins, capillary or vein) change caused by, these structures perfusion carotid body and surround carotid body and make carotid body by The nerve fibre (such as afferent message being transmitted to from chemical receptor of carotid body the nerve of brain) of innervation.Additionally Or selectively, caused by calorifics destroys and can be scabbing after agglutination, fibrosis or group are woven in thermal damage, Especially when it is expected to prevent the regrowth and regeneration of active mass.As used herein, the calorifics mechanism for being used for ablation can be with Including both thermal necrosis and thermal damage or damage (for example, passing through continuous heating, Convective Heating, resistance heating or its any group It closes).Thermal heat mechanism may include that destination organization, such as nerve fibre, chemosensitive cell, whole or a large amount of neck is dynamic The temperature of arteries and veins body cell and the thin vessels of perfusion carotid body or its nerve is elevated above desired threshold value, for example, being higher than About 37 DEG C of body temperature for example, to realize thermal damage or damage, or is elevated above about 45 DEG C of temperature (such as greater than about 60 DEG C), it is persistently known to cause the time of essentially non-reversible ablation to realize thermal necrosis at a temperature of gained.

Other than increasing temperature during heating ablation, influence heat can be designated as on the time span of thermostimulation exposure and disappeared The degree or degree for the effect of melting.In some embodiments, the time span for being exposed to thermostimulation be about 1 second and about 60 seconds it Between, between for example, about 5 seconds and about 30 seconds.In some embodiments, the time span of thermostimulation exposure can be longer than or is waited It is longer than in about 30 seconds or even or is equal to about 2 minutes.In addition, exposure time span can less than or equal to about 10 minutes, but It is the upper limit that this is not construed as exposure duration section.Temperature threshold or thermal dose can continue as to thermostimulation exposure The function of time is determined.Additionally or alternatively, exposed time span can be as the function of desired temperature threshold It is determined.The parameter of these and other can be designated or be calculated to realize and control desired heating ablation.The ablation of thermal induction It can be by indirect to destination organization, such as nerve fibre, chemosensitive cell and whole or a large amount of carotid body cell It generates or applies thermal energy to realize, such as by being focused to target neural fiber application high intensity focused ultrasound (HIFU), part Ultrasound or high-strength directional ultrasound.

Carotid body ablation may include whole body conveying medicament and by energy such as ultrasonic energy be directed to carotid body or Related neural causes carotid body or related neural impaired to activate the medicament.

In addition and selectable method and apparatus can be used for realizing ablation.

Oriented energy embodiment

Fig. 1 is depicted blood vessel interior orientation in simplified schematic form with femoral venous puncture device 17 through intravascular method Energy ablation conduit 13 is placed in the optional embodiment in 1 body of patient.The distal end of intravascular oriented energy ablation catheter 13 is (with void Line is shown) it is depicted in left jugular vein 12 (shown in dotted line), at the horizontal plane of left neck artery bifurcated 2, it is arranged to It is melted convenient for the oriented energy of arteria carotis.As shown, by the inserting near groin of intravascular oriented energy ablation catheter 13 Enter inserted into the patient at position 17, into femoral vein 16 and to advance through inferior caval vein 15, superior vena cava 14, left neck always quiet Arteries and veins 11 simultaneously enters left jugular vein 12.It is alternatively possible to select insertion site to be obtained across brachial vein, subclavian vein, neck The venous channel of total vein 11 or any suitable peripheral vein.In addition, the specific blood vessel depending on patient 1 and neurotomy It learns, the distal end of intravascular oriented energy ablation catheter 13 can be positioned for carotid body ablation, but delocalization is quiet in neck In one (for example, facial vein, is not shown) in arteries and veins 12 or its tributary.Further depict the optional blood in arteria carotis communis 3 Pipe angiography catheter 97, the arterio-angiography image in the region for generating carotid bifuracation 2, to allow the visualization in the region And the oriented energy of carotid body is melted for guiding from jugular vein 12.As shown, use standard angiographic skill Angiography catheter 97 is inserted by insertion position 9 in groin in femoral artery 8 by art, then advance through abdominal aorta 7, The arch of aorta 6 simultaneously enters left common carotid artery 3.Intravascular intervention techniques field the skilled person will understand that, it means that arteria carotis Means other than angiography can be used for guiding being melted through vein oriented energy for carotid body.For example, can independent or group It closes using the external supersonic imaging of neck and intravascular ultrasound, computer tomography angiography and other known Mode.It is also understood that although Fig. 1 shows that left carotid artery body melts, can be carried out in embodiments herein Right carotid artery melts or bilateral carotid arteries ablation.

Ultrasonic examination can help to instruct percutaneous and endovascular surgeries.It can be from skin surface (such as neck), from vascular Internal system, from inside vascular system via imaging transducer in ablation catheter or thereon, or from the day of such as esophagus Right cavity carries out ultrasonography.

Oriented energy device used herein refers to having the elongated dress for the energy emitter for being configured as emitted energy It sets, and wherein the device is configured to the energy of orientation being transported to destination organization.In some embodiments, which includes Therapeutic ultrasound transducer (also referred herein as energy emitter), can be located in the remote area of device.In application method In, which can be positioned in patient body, close to the carotid body or related neural of patient.Then activation therapeutic ultrasound Energy converter, and will the acoustic energy of heating ablation tissue be transported to destination organization, ablation targets tissue such as carotid body.Usually It is expected that oriented energy in the direction that energy is launched to cause to penetrate in a manner of the volume-heated to the tissue of a volume Tissue.It is expected that as the distance away from emitter increases, oriented energy is deposited, and is converted into heat and metaplasia, and thereby subtracted It is weak.Due to the decaying in tissue, the boundary that will not be penetrated in a manner of biologically significant there are oriented energy or distance.When The volume of the destination organization occurred when using therapeutic ultrasound ablation energy as described herein heats (volumic Heating), it is different from the conductive heater of tissue, the conduction heating of tissue needs to heat from contact point, passes through group between It knits and reaches destination organization.However, may exist a degree of conduction heating with volume heating.However, using directional energy Amount, intended volume heating are the main means that destination organization is heated.In addition, oriented energy such as therapeutic ultrasound energy is not required to It will be with the close contact of target effectively to convey.Ultrasound can be by blood born, than the absorption in carotid body region Low about ten times, such as energy is allowed to be conveyed in the case where not being in close contact vascular wall (such as arteria carotis or jugular vein), or Distance of the even half-hearted consideration from transmitter to the wall.When vascular wall is irregular or easily damaged, this may be important.

Ultrasonic acoustic energy is in elongated devices (such as conduit) or surrounding super by being electrically excited setting by ultrasonic transducer Pinger generates.In some embodiments, ultrasonic transducer can be energized, in about 10MHz to about 30MHz Range in from transducer face generate orientation acoustic energy.Energy converter can in the range of for example about 10% to about 100% It is energized under duty ratio.The much higher energy density for navigating to small volume of focus can be had by focusing ultrasound, but will usually be used The shorter time for exposure or duty ratio.In the case where heating tissue, temperature of the energy converter usually in making tissue is increased to greatly It is energized under conditions of about 45 degrees Celsius of tissue temperature.In this case, cooling elongated devices are located in therein Cavity surface may be desired, to reduce the risk of damage.

This document describes the embodiments of the ultrasonic transducer for being placed on patient's body for supersonic melting carotid body. This ultrasonic transducer can be used in any carotid body ultrasonic ablation device described herein.For example, herein is any super Sonic transducer can be incorporated into carotid body ablation catheter, which has deployable or expansible structure (for example, ball Capsule, cage, basket, net or coil), with positioning, alignment and keep energy converter steady in blood vessel such as external carotid artery or jugular vein Positioning is set.

Fig. 3 A show the exemplary implementation scheme of ultrasonic transducer.As shown in Figure 3A, ultrasonic transducer can be poly- with right and wrong Coke, planar unit mode part energy converter, two main surface are substantially parallel to one another.Transducer hole shape can be rectangle, or Alternatively it can be round, ellipse or be designed to be suitble to appointing for ablating device (for example, conduit or detector (probe)) What other shapes.The width of transducer hole can be limited by the size (for example, diameter) of ablating device, for example, to 2F, 3F, 4F, 5F、6F、7F、8F、9F、10F、11F.By increasing the length of device distal component, the length of transducer hole can be more than its width Degree.4 to 6mm length has been proposed as required surface area and guiding-tube bend and has been navigated through between the ability of anatomical structure Reasonable tradeoff.In order to ensure the convergence of the beam of ultrasound energy of transmitting, the substantially flat transducer face of rectangle can be made It is slightly convex.

It is generally desirable to energy converter is placed in emitter facet surface towards target.Such as by using by sensing internal carotid The low intensity ultrasound Doppler of interior blood flow guides, including the distal component of the ultrasound transducer element of ablating device can be drawn Lead the appropriate location in such as external carotid artery.Along supersonic beam axis, it is more impulse wave can be adjusted in length and position The sampling volume of general Le.It is preferably set to coverage distance energy converter planar about 2 along the position of the sample volume of beam axis To the range of 15mm (for example, about 2mm to 9mm).Supersonic beam can be directed at by means of Doppler to cover arteria carotis to be ablated Body.Once it is determined that energy converter is correctly aligned, then high intensity continuous wave or high duty ratio (preferably greater than 30%) pulse can be used Wave ultrasound melts carotid body and other desired object constructions.Impulse ultrasound has cools down energy converter and blood by blood flow The advantages of managing, while being heated further from the continuation of the arteria carotis diaphragm of carotid artery flow.Ultrasonic Doppler guides and supersonic melting Identical element of transducer can be used, or individual element of transducer is alternatively used to execute.Optionally, ultrasound is changed Energy device can be made of annular array, such as used with the spider melted for high intensity and for low-intensity Doppler The two-element array of outer ring.

The energy converter of this paper can be configured as realization heating ablation, and wherein maximum heating region is concentrated on along supersonic beam axis In tissue apart from energy converter planar about 2mm to 9mm.In some embodiments, energy converter is configured as realizing heating ablation, wherein Maximum heating region concentrates in the tissue apart from energy converter planar about 5mm to 8mm.As described elsewhere herein, far from transducing Ablation in the so remote tissue of device can allow selective carotid body to melt, while minimize and other non-targeted group of ablation Knit relevant risk.The shadow of tissue mechanical energy dissipative of supersonic beam in by blood cooling and tissue is heated by intravascular ultrasound It rings.The position in maximum heating region depends on transducer designs, and specifically, aperture size and operating frequency, which define companions Decaying with distance and ultrasound beam shape.In general, the ultrasonic wave of upper frequency its by organize to advance and when being absorbed Decaying in shorter distance.Maximum heating zone position can be fixed with one-element transducers.Alternatively, phased array can be used The energy converter of technology (phased array technology), acoustic lens or geometric focusing by ultrasonic beam turn to needed for most Big heating zone position.The device can be designed to realize about 8mm³To 300mm³(for example, about 154+/- 146mm³) ablation tissue Volume.The combination of the energy of conveying, the shape of ultrasonic beam, direction and application time sequence can determine the body of ablation tissue Product.It can be conveyed using energy, such as power setting and operation mode (for example, impulse wave is to continuous application time sequencing) increase Heating in strong target location or region and realize target tissue temperature repeatable at any time.In example embodiment, For being about 2mm with width and energy converter that length is about 4mm, ultrasound procedure frequency can be selected as to about 10MHz to about 30MHz (for example, 15MHz to 25MHz).In some embodiments, ultrasound is conveyed with the frequency between about 10-25MHz.One In a little embodiments, ultrasound is conveyed with the frequency between about 10-20MHz.In some embodiments, between about 10-15MHz Frequency conveying ultrasound.In some embodiments, ultrasound is conveyed with the frequency between about 15-30MHz.In some embodiments In, ultrasound is conveyed with the frequency between about 15-25MHz.In some embodiments, it is conveyed with the frequency between about 15-20MHz Ultrasound.In some embodiments, ultrasound is conveyed with the frequency between about 20-30MHz.In some embodiments, with about 20- Frequency conveying ultrasound between 25MHz.In some embodiments, ultrasound is conveyed with the frequency between about 25-30MHz.

Ultrasonic transducer can be operated with thickness resonance mode, that is, operating frequency is substantially by piezoelectric transducer element Half-wavelength thickness determines.Element of transducer can by PZT-4 (Navy I) or PZT-8 (Navy III) type piezoceramic materials or Low-loss equivalent is shown under high power drive condition to be made, and can be incorporated into that in Piezoelectric anisotropy structure.It is high-strength Degree, high duty ratio, operating mode can lead to the self-heating of element of transducer and surrounding structural elements.Therefore, temperature can be used The temperature of sensor (for example, thermocouple) monitoring transducer or adjacent elements.If temperature is considered too high, can by The electrical power for reducing duty ratio during use or being output in energy converter, or flushing or circulation of fluid cooling, energy converter is cooled down Get off.It is alternatively possible to enhance transducer efficiency by electrical impedance and acoustic impedance match to reduce energy converter spontaneous heating.Example Such as, (inductive tuning) can be tuned by inductance to eliminate or reduce the capacitive reactance of electric transducer impedance.If transducing Device executes imaging or Doppler's sensing function, and the acoustic impedance of usually used piezoelectric material (is defined as multiplying for the velocity of sound and density Product) it is far above the acoustic impedance (for example, about 20x) of soft tissue.Therefore, the coupling of acoustic energy and soft tissue from element of transducer is not It is ideal.The means for improving acoustic energy coupling can be in transducer face between element of transducer and tissue use work frequently The about matching layer of quarter-wave thickness or multiple matching layers under rate.Theoretically, the acoustic impedance of matching layer should be close to source, piezoelectricity Element of transducer (about 30MRayl) and loaded article, the geometrical mean of soft tissue (about 1.5MRayl).It should be appreciated that raising sound The certain methods of effect may be more related to high-energy conveying, and some are more related to imaging and Doppler's sensing.

In some embodiments, can by include by acoustic impedance less than soft tissue or water acoustic impedance (about 1.5MAyal) divided by matching layer made of the material of energy converter mechanical quality factor (being measured as between 0 and 100 in water) is next excellent Change the validity of the therapeutic high-energy mode transducers to work in a continuous mode at resonant frequency or close under resonant frequency. Improve the common method of the conveying of the power between water and the acoustically ceramics of hard by being inserted into quarter-wave matching layer The case where being not practicable for undergoing the planar transducer of big displacement in resonance.It can be for example by by polyester, polyurethane or poly- The thin layer of imide polymer is directly bonded to the emitting surface of ceramic transducer to build thin treatment matching layer.Optionally, Treatment matching layer can be built by polyvinylidene fluoride (PVDF), and PVDF may be used as being directly connected to treatment transducer face Image-forming component or multicomponent imaging array.PVDF is the piezopolymer for having low acoustic impedance, is highly suitable for ultrasonic imaging. Depositions of the PVDF on the emitting surface of high impedance hard treatment ceramics can help to Miniaturization Design and optimize under treatment mode Power transmission, and in same folded energy converter obtain ultrasonic imaging function.

Fig. 3 A show that the exemplary piezoelectric with top (or front) electrode 151 and bottom (or rear portion) electrode 152 changes It can device element 150.Element of transducer 150 can be by PZT-4 (Navy I) or PZT-8 (Navy III) type piezoceramic material system At.PZT-4 and PZT-8 proximate matter material are referred to as " hard PZT ", and with relatively high mechanical quality factor, (for example, about 500 to about 1000) high intensity and high duty ratio application are very suitable for and high-curie temperature (for example, be more than 300 DEG C), and therefore.Energy converter The top 151 of element and 152 electrode of bottom can be welding, to provide reliable electrical connection to transducer face.Have The electrode of negative polarity is preferably located on the external radiation surface of energy converter, towards organizational goal.It is top in this embodiment Portion's electrode 151.

Fig. 3 B show exemplary piezoelectric element of transducer 153, have size undersize on the element back side Electrode 154.The purpose of the undersize electrode of size be avoid undesirably being electrically connected to transducer housing component it is (i.e. short Road) possibility.Top (or front) electrode 155 can substantially cover the entire surface of element of transducer 153.

Fig. 3 C show the example being installed to element of transducer 150 in housing unit 157, wherein illustrating only for saying The partial view of bright purpose.Element of transducer 150 can be located substantially at or close to ablating device (for example, conduit or detector) Sheath axis at, to allow maximum transducer width.Element of transducer 150 rests on the sky of the backing on acoustic insulation body 159 On chamber 158, which is, for example, O-ring or frame made of soft biddability material.The purpose of insulator be by The acoustic vibration of element of transducer is kept apart with housing unit.The side of element of transducer 150 can use offer gas-tight seal Filler 164 seals.At the back side of element of transducer, backing cavity 158 can use gaseous state or the foamed material filling of low acoustic impedance. Low acoustic impedance can be defined as speed of sound and the product of density of material.Backing cavity be hermetically sealed with environment (not shown) every From to prevent the rear-face contact of any liquid and element of transducer 150.Electrical connection may include being connected to preceding transducer electrode 162 cathode 160, and it is connected to the anode 161 of rear transducer electrode 163.Electrical connection can be for example soldered or welded.

It is alternatively possible to prevent energy from being diffused up in the side in addition to target using the material with acoustic impedance. Backing can be made of fine and close and high-sound-velocity material, the metal of the material such as reflection of the acoustic energy, such as stainless steel.Usually have Transition position (transition) or interface between the material of dramatically different acoustic characteristic (for example, velocity of sound) are by reflection of the acoustic energy.

Fig. 3 D show the vertical view or front surface of energy converter distal component.Spool chamber 165 can be provided for arriving transducing The electric wiring path of device, the path are connected to the Pulsed-Wave Doppler circuit and RF signals that may include for ablation in the proximal end of device The controller in source.Identical spool chamber 165 can be used for for thermocouple wire being connected to the distal end positioned at element of transducer or device Thermocouple 166 on component.

The embodiment that Fig. 3 E show the distal portions of supersonic melting conduit comprising be located in conduit sheath 167 Rectangle ultrasonic transducer 150 at axis or near it (as shown in Fig. 3 A, 3C and 3D).Conduit, which can be configured as, passes through application Tension controllably deflects, with actuator pulls wire in handle.Bracing wire can pass through sheath and be anchored on conduit Near distal portions.

From positioned at intravenous catheter in blood vessel supersonic melting carotid body

This disclosure is transported to one of jugular vein or its tributary including wherein ultrasound ablation conduit With the embodiment that ablation energy is directed to arteria carotis diaphragm.Compared with through artery instrument, may have through intravenous devices excellent Gesture, because they have lower cerebral embolism risk.In addition, the instrument of bigger can be used for transvenous method.

Present disclosure be on one side carotid body ablation method comprising the elongated devices of such as conduit are drawn In the venous system for entering patient, the distal end of conduit is promoted to one of jugular vein or its tributary of arteria carotis near diaphragm, wherein Remote area includes the directional transmitter for the high-energy ultrasonic that can convey ablation acoustic energy, and transmitter is aligned with arteria carotis diaphragm, And energy is directed in diaphragm with ablation targets tissue (such as tissue in carotid body, arteria carotis diaphragm, carotid body god Through).

Fig. 4 A and 4B show the exemplary implementation scheme through jugular vein supersonic melting conduit.If Fig. 4 A are as it can be seen that jugular vein With the close chance provided with the device ablation carotid body being located in jugular vein of arteria carotis diaphragm and carotid body.Such as figure Shown in 4A and 4B, conduit 313 includes ultrasonic transmitter 230 and optional receiver.Transmitter can be in selected direction (example Such as, the unfocused ultrasonic beam of the high-energy of orientation) on transmit high energy ultrasonic.Backing 231 is reflected (for example, by for example empty Acoustic insulation body made of gas, foam or compact metal) reflect ultrasonic wave 232 or ensure they largely be directed into it is desired Direction.It calculates or experimentally determined frequency, power, duration and aperture (its Consideration is described in detail above) is to melt Tissue in arteria carotis diaphragm 205, but prevent ablation energy from penetrating and be more than diaphragm, such as more than the centre of arteria carotis diaphragm Boundary 233.For example, transmitter may be configured so that transmitted ablation energy can deposit to tissue from transmitter 230 In no more than about 12mm, 11mm, 10mm, 9mm, 8mm, 7mm, 6mm, 5mm, 4mm or 3mm.In some embodiments, transmitter It is configured such that high-energy ablation ultrasonic wave is penetrating into soft tissue about 3mm to about 12mm, such as about into soft tissue 3mm, into soft tissue about 4mm, into soft tissue about 5mm, into soft tissue about 6mm, into soft tissue about 7mm, into soft group About 8mm is knitted, into soft tissue about 9mm, into soft tissue about 10mm, into soft tissue about 11mm, or enters soft tissue about 12mm Ablation power will be lost later.There may be certain variability different because of patient for the size of diaphragm, and therefore in ablation The preceding visualization for obtaining diaphragm, obtains the estimation size of diaphragm, and the use of transportation parameters can have based on the size of estimation Benefit.

It is expected that the stimulating frequency (for example, about 10MHz to about 20MHz) within the scope of about 10 to about 30MHz generates expectation Effect, including enough ablation energy penetration depths and simultaneously control needed for zone of ablation.Outside internal carotid 90 and neck The cooling of blood flow in artery 91 can help to ablative thermal energy or zone of ablation being limited in arteria carotis diaphragm.Therefore, it comes from The heat distribution of ablation ultrasonic beam can be shaped additionally by the uneven heat transfer in region, and uneven heat transfer is moved by neck Heating caused by the blood flow and ultrasound of the cooling in object space (i.e. arteria carotis diaphragm 205) between arteries and veins 90 and external carotid artery 91 Associated biomolecule effects.Since high blood flow and the thing followed are to the effective heat dissipation (thermal cooling) of blood vessel, Ultrasonic energy in selected frequency range is by vascular wall and blood without significant biological action, therefore only diaphragm will be by Selectivity heating.Present disclosure is ultrasonic to the conveying high intensity ablation of arteria carotis diaphragm on one side, while using in neck The cooling effect of blood in artery and external carotid artery selectively only melts the method for diaphragm tissue.It is expected that certain logical Cross scattering decaying reduce after ultrasonic effect and protect the subsequent non-targeted structure of artery.The principle can be classified as passing through The ultrasonic beam being formed in three-dimensional vascular space forms damage using heating (thermal heating).In some embodiment party In case, the ultrasonic energy emitted melts diaphragm tissue by the temperature of diaphragm tissue is increased to about 45 degrees Celsius, so And the tissue of exterior remains less than about 45 DEG C, therefore be not ablated to.Ablation is the function of temperature and time, and longer ground is sudden and violent It is exposed to lower energy and temperature can also ablation tissue.Present disclosure is primarily upon temperature, and includes lasting about 5 to about 60 The processing of second.However, the temperature being mentioned herein is not necessarily to be construed as stringent limitation.

Ultrasonic therapy parameter such as power, frequency, the choosing of time and mode (such as (pulsed) of pulse or continuous) It selects and may insure that ultrasonic beam will not be deeper (for example, no more than about 9mm is deep) than away from jugular vein about 15mm to the ablation of tissue.It is right The exemplary ultrasonic of 1dB/cm/MHz is decayed in musculature, and the depths of features of the unfocused ultrasonic penetration in tissue is decaying system The inverse of number divided by frequency.For example, in 10MHz, feature penetration depth is 7.7mm, and in 20MHz, feature penetration depth For 3.8mm, an example of target range range in across jugular vein catheter configurations is corresponded roughly to.

Fig. 4 B show the conduit 313 that (for example, via femoral vein access) introduces from below.Intravascular method hereafter can To include the femoral vein in patient's groin and pass through vena cave to enter desired jugular vein in conduit, such as shown in Fig. 1. Such as from other alternatives of jugular vein and jugular branch and other veins such as subclavian vein of body be also possible , and may have advantage in some clinical settings.

Acoustic beam is directed to from jugular vein 12 in the diaphragm between two carotid artery bifurcations and is conducive to through the cold of arteria carotis But effect makes damage shape.As shown in Figure 4 A, energy beam 232 is limited between two carotid artery bifurcations, these branches are high Blood flow is protected from thermal damage.Therefore, the anatomical structure in the region provides inherent advantage, is, if acoustic beam is slightly Misalignment and it is directed toward slightly wrong angle, then it will encounter internal carotid or external carotid artery, will be supported by cooling effect Close to the heating of tissue around anti-.Less cooling will be subjected to by being directed to the part of the acoustic beam or acoustic beam between branch, and will Lead to the ablation of tissue, it is contemplated that target organ such as carotid body 89 and associated nerve are located in the tissue (that is, in neck In artery diaphragm).As a result, arteria carotis diaphragm is selectively heated and heating ablation, this is one of aspect of present disclosure.Such as Upper described, present disclosure further includes the method for selectively ablation targets tissue, by the way that high intensity ultrasonic energy to be transported to In the region of anatomical structure so that blood flow will provide cooling effect and therefore promote the tissue of ablation being restricted to desired Region.In the case of the present embodiment, the tissue of ablation is comprised in arteria carotis diaphragm.

Vascular system such as arteria carotis communis 3,90 and of internal carotid are detected by using diagnostic ultrasound such as doppler ultrasound External carotid artery 91 and carotid bifuracation 2 can help guiding and targeted ultrasound out of jugular vein to melt beam 232 to target site At such as arteria carotis diaphragm 205.This diagnostic ultrasound can be by including at least one in manipulation (for example, rotation and translation operation) Blood flow velocity, flow direction, Pulsating Flow (pulsations of flow) and rapids are detected while the conduit of a ultrasonic transducer (turbulence) is flowed to provide the instruction (for example, visual pattern, acoustics or electric signal) of vascular system.

In some embodiments, it can incite somebody to action by detecting carotid bifuracation saddle 2 and relative to carotid bifuracation saddle Ultrasonic therapy energy converter (also referred herein as supersonic melting energy converter or supersonic melting transmitter) run-home position is realized Translation aims at (aligned therewith in some cases).In some embodiments, ultrasonic therapy energy converter is aimed at away from bifurcated saddle Cranium end about 5 to about 15mm, the cranium end about 10 away from bifurcated saddle is to about 15mm in some embodiments, at some The cranium end about 10 of embodiment middle-range bifurcated saddle is to about 12mm, and the cranium in some embodiments away from bifurcated saddle End about 5 to about 10mm.Carotid bifuracation saddle can represent arteria carotis communis from the position of the length along jugular vein 12 The strong blood flow velocity signal of one of 3 is separated at the position in two arteries (internal carotid 90 and external carotid artery 91) and is detected suddenly It measures.By promoting or retraction conduit, supersonic melting beam can aim at the about 5mm to about 15mm above the horizontal plane of bifurcated saddle Position.By acoustic beam aim at bifurcated saddle tail end about 5 to the position of about 15mm by acoustic beam aim at enter arteria carotis diaphragm so as to In the ablation of carotid body.

In some embodiments, the method for ablation includes detection one or two of internal carotid and external carotid artery. They can be detected by rotational diagnostic energy converter, and diagnostic transducer can exist together with conduit or sacculus, or in conduit Or in sacculus.Treating energy converter then can be relative to internal carotid and external carotid artery run-home position.In some embodiment party In case, external carotid artery and internal carotid are detected, and treat energy converter and rotatably substantially aim in internal carotid and external carotid artery Between.With the orientation relative to two kinds of arteries, ultrasonic therapy energy converter is intended to ablation diaphragm tissue and thus melts arteria carotis Body.In other embodiments, aiming sound is assisted by such as other of MRI, CTA or fluoroscopic examination visualization technique Beam.Ultrasonic transducer can also can be conveyed optionally and reception can be used for arteria carotis imaging, doppler imaging or pulse it is how general Strangle the low power ultrasound of imaging.This document describes the examples of the energy converter constructed by this respect.Operation to control energy conveying The Doppler signal of person or computer feedback is not necessarily image.It can be for example curve, number, voice signal, LED strip or The instruction of the color or intensity of indicator light.

Optionally or additionally, ultrasonic imaging can be applied and be used for from the outer transducer being placed on patient's skin of neck Guiding treatment.The ultrasonic imaging that outside applies can be incorporated to biplane imaging and the imaging of Doppler's flow enhuancement.It is alternatively possible to Other ultrasonic transmitter and receiver are incorporated in catheter design.

Optionally or additionally, single or multiple ultrasonic transducers can be positioned on the distal portions through jugular vein conduit, So that with the ultrasonic reverberation between electrical impedance or the outside and ultrasonic transducer that pass through ultrasonic imaging sensing neck surface, to Allow conduit to be aligned relative to the lateral mark of neck, effectively treatment energy converter is directed toward towards the interior side of neck inner septum To.It is laterally reflected into catheter-based ultrasound energy converter and acoustics guiding is provided, when catheter-based ultrasound imaging transducer becomes and external collar surface When substantially coplanar (this can be overlapped with the expectation rotation position relative to carotid bifuracation), effect maximizes.It is optional Ground, can be by the way that the reecho device of substantially flat or active low power ultrasound energy converter to be placed on the surface of neck come real Now similar is laterally guided.

In some embodiments of this paper, ablation catheter can from groin, under clavicle, from brachial vein or use with For biopsy or central corridor conduit those of place the slightly similar method of method traveled by Direct perforantes it is quiet in neck Arteries and veins.In some cases, facial vein or from other veins of jugular vein branch can provide closer to arteria carotis diaphragm with Just the placement of the energy delivery element of conduit.Therefore, the jugular vein of the venous locations of conduit is merely illustrative.

As described in methods herein, conduit can be moved up and down in jugular vein, until being clearly detected right over it Arteria carotis communis bifurcated and arteria carotis diaphragm.If using external ultrasound, conduit can be made to become ultrasound by adding echo coating It can be seen that.This can be confirmed by Doppler pulse speed signal or ultrasonic imaging.It is big with high pulsatile flow amount at two Between blood vessel, it should can be easy to detect the space of instruction arteria carotis diaphragm.It can select in the pre- of 3 to 10mm (such as 3 to 5mm) Select the pulse Doppler of depth to avoid the interference to venous blood flow.

In some embodiments, the conduit being located in jugular vein, which can enclose, to be rotated about the axis thereof, until melting transducing Device treats the hole of energy converter towards the arteria carotis diaphragm in the inwardly directed gap between outer arteries.Optionally, it is fixed to have It can be rotated in conduit to the energy converter of transmitter.It is placed in jugular vein if Doppler transmitter and receiver are located at In the distal portions of conduit, then certain advantages may be implemented.Low energy Doppler acoustic beam can towards with high-energy melt acoustic beam Identical direction.It then can be by Doppler signal for targeting and guiding ablation beam to enter diaphragm.Diaphragm can be located at two The lowest point of low-speed region between peak or high-speed region.It is alternatively possible to which several Doppler's transducers are incorporated into remote tip In, make acoustic beam silently aim at the angled place in hole face direction of high energy beam, will pass through the high speed of two arteria carotis It flows to detect two arteria carotis.Vein can be expanded, and catheter tip being maneuvered to suitable position so that high Energy emitter aims at the centre for representing the gap between internal carotid and the two strong Doppler signal of external carotid artery.Computer Algorithm can help or automate this aiming.

During ablation, ultrasonic energy emissions device may heating, and may need to cool down.Conduit can be configured as by Energy converter is located in jugular vein so that it will not contact jugular wall, while convey high-energy for ablation purpose.Example Such as, as illustrated in figures 4 a and 4b, conduit may include the protective film of such as sacculus 145.Sacculus 145 is by energy converter 146 and vascular wall 147 separate, while the tissue of the cooling for energy beam and energy converter, the blood in vein 12 and jugular wall provides pipe Road.Sacculus 145 can be made of thin polymer film, can be submissive or non-compliant, but can bear some pressures Power, provide with the rigid contact of vascular wall and in selected frequency range conduct ultrasound without significantly decaying, reflecting Or heating.Sacculus can be filled with circulation of fluid 148, such as sterile water or brine, be biocompatibility and pass well Ultrasonic wave is led without absorbing significant energy.Fluid can be cooling by outside, by the recycling of external pump (not shown) across leading Pipe sheath, or can only with it is relatively little of, be enough fluid and submergence transmitter in a fluid keeping desired low temperature Amount inject and be discharged into blood flow.

Protective film can surround the distal end of conduit completely, form sacculus around ultrasonic transducer, or such as Fig. 9 A and 9B institutes Show, protective film 250 can partly surround selected ultrasonic transducer 251.Protective film can surround therapeutic energy converter shape As convex, the shape of spill or Fresnel acoustic lens, and it is filled with liquid coolant 252, such as with basic with blood The Fluorinert of different acoustic characteristics.Ultrasonic beam can be scheduled focusing or defocusing by protectiveness film forming lens Pattern obtains the therapeutic dose of conveying so as to the sensitivity of acquisition selection area in doppler imaging or in ablation areas. Optionally, the energy converter with the expansible protective film of predefined thin-walled can form directional transmitter, and directional transmitter can quilt It manipulates to form the directed beams that can be targeted to different depth.The target depth of Doppler transmitter and receiver can be configured as So that realizing ultrasonic beam forming when the substantially different anatomical structure in jugular vein and arteria carotis complex and focusing The advantages of.

Conduit can be by being placed in jugular vein and being manipulated lens interior Fluid pressure come real by depth of ablation control It is existing, so that with scheduled repeatable shape propagation protective film, which generates acoustics convergence to ultrasonic beam or divergent lens is imitated It answers, and ultrasonic beam is preferentially targeted in the bifurcated of arteria carotis and the specific objective depth of arteria carotis diaphragm.For example, such as Fig. 9 A It is shown, so that film 250 is extended with coolant 252, generates the lens shape focused on ultrasonic beam 253 on target area 254.Phase Than under, as shown in Figure 9 B, film 250 can be made to extend with the coolant 252 of different pressures, to change lens shape, will be surpassed Beam of sound 253 focuses on the target area of different distance.Expandable membrane can be formed by various submissive polymer materials, example Such as Kraton (styrene blend), polyethylene, polypropylene, Pebax or Latex.Optionally, expandable membrane can be used for relatively Conduit is controlled in intrajugular positioning in the distance to arteria carotis complex.

As shown in Figure 10, the distal end of an embodiment of carotid body ablation catheter includes being located at conduit sheath 258 The ultrasonic transducer 255 and PVDF imaging arrays 256 of proximate distal ends.The acoustic insulation body 257 of such as stainless steel can be determined Position is on the back side of energy converter 255, to ensure that imaging or ablation acoustic beam are guided in the side for the front surface for being orthogonal to energy converter 255 To on 259.Expandable membrane 250 surrounds the cavity before energy converter.The liquid of such as coolant can be injected into the cavity of film, The intended shape of ultrasonic beam can be focused or guide by so that film 250 is expanded into across expansion chamber or pipe 260.

In an alternate embodiment, including supersonic melting energy converter and expandable membrane (that in such as Fig. 9 A, 9B or 10 Any conduit a bit) can also include installation to conduit any diagnostic transducer as described herein (such as Fig. 5 A-B, 6A-B, Those of in 7A-C), it can be used for helping positioning ablation energy converter and being aligned with one or more vessel landmarks, such as Carotid bifuracation, internal carotid, external carotid artery or combinations thereof will melt ultrasonic beam vector tissue volume, such as neck Position in artery diaphragm or arteria carotis diaphragm.

Ablation catheter may include supersonic melting energy converter and expandable membrane, such as film 250 shown in Fig. 9 A, 9B or 10, Wherein supersonic melting energy converter can be used for diagnostic ultrasound such as Doppler.These conduits can be positioned in external carotid artery simultaneously And rotated while assessing diagnostic signal, this can be used for finding the blood vessel of such as internal carotid or jugular vein.In fluorescope With the help of imaging, energy converter can be placed on the desired distance in external carotid artery middle-range carotid bifuracation cranium side, and for example, about 5 to about At 15mm, or about 5 to about 10mm.For example, conduit can have and be disposed close to the desired distance of energy converter (for example, about 5mm be extremely About 15mm, or about 5mm to about 10mm) at radiopaque marker；Contrast agent transport can be sent to arteria carotis communis (for example, from Delivery sheath), the radiography image of the distal portions of arteria carotis and conduit can be obtained, and radiopaque marker can To be aligned with carotid bifuracation.When diagnostic transducer is aimed in internal carotid or substantially in the center of internal carotid and energy converter position When at away from carotid bifuracation cranium side desired distance, it is contemplated that energy converter is aimed at across arteria carotis diaphragm.Melt ultrasonic beam It may be directed in the destination organization in arteria carotis diaphragm.Optionally, conduit can also include close to the deflectable of energy converter Partly (for example, about 5mm and about 30mm between) near energy converter, deflectionable part can be used for guiding ultrasonic beam relative to The angle of external carotid artery, this can be used for the tune to for example narrow or wide bifurcation angle of geometry of various arteria carotis vascular systems It is whole.Optionally, conduit can also include being located at the extensible structure far from energy converter on conduit, such as sacculus, cage, net or spiral shell Rotation can be used for engaging simultaneously distal portions of the stabilizing catheter in external carotid artery.Extensible structure can be launched into suitable for connecing The size of external carotid artery is closed, such as with about 4 to about 6mm diameter.Extensible structure can retract so that it can be assembled In delivery sheath, the delivery sheath is for example with the diameter less than about 3mm (for example, between about 2mm and about 2.4mm).

This disclosure further includes the methods, devices and systems for ablation targets position：By the way that ablation needle is determined Position inserts a needle into across vein and enters around the blood vessel comprising target site in the tube chamber of the vein adjacent with target site In space, perivascular space is delivered by agent is melted by using needle, and needle is withdrawn into vein from perivascular space In.Compared with through artery method, arteria carotis body ablation procedure is by the way that through vein method positioning device, there may be potential benefits. For example, compared with arteria carotis, there is jugular vein thinner wall, the wall can be easier that ablation needle is made to pass through；Jugular vein is can to expand It is opening and flexible, and can be by realize construction variation from internal blood vessel or external force, this is advantageously possible for promoting The placement of conduit or close to target ablation position；Jugular vein does not have atherosclerosis or an arteriosclerosis disease, and blood is from brain Portion is flowed out, and eliminates the risk for causing cerebral embolism (this may be a problem of arteria carotis program)；It can be from through jugular vein approach Side is close to arteria carotis spacer film；Compared with arteria carotis, due to the compressibility of vein blood vessel, pass through vein (for example, neck is quiet Arteries and veins, facial vein) wall is threaded a needle or conduit, the risk with lower complication such as hemotoncus；It is reduced with the flow of internal carotid It compares, the blood flow in jugular vein is likely to reduced with the smaller risk for limiting the flowing to brain.

Include the distance between AA- arteria carotis (for example, in the range of about 3 to 5mm) with exemplary feature size, The distance between BB- jugular veins and arteria carotis diaphragm center (for example, in the range of about 5 to 15mm), in CC- arteria carotis diaphragms The generation of the distance between the important non-targeted structure on the inside of the heart and arteria carotis diaphragm (for example, in the range of about 5 to 10mm) The exemplary anatomical structure of table is shown in FIG. 2.Embodiments described here, which can be configured as, safely and effectively will To enclose vein defeated to destination organization such as carotid body or arteria carotis diaphragm from such as jugular vein or facial vein close for ablation energy It send.

Supersonic melting conduit with imaging transducer

In some embodiments, carotid body supersonic melting conduit includes at least one diagnostic ultrasound transducer and ultrasound Energy converter is treated, wherein these energy converters are positioned relative to each other on conduit so that when diagnostic ultrasound transducer and vascular system When system mark alignment, treatment energy converter is aligned with target ablation position (such as arteria carotis diaphragm).Arteria carotis blood used herein Pipe mark includes internal carotid, external carotid artery, carotid bifuracation and arteria carotis communis.The configuration allows diagnostic transducer and mark Alignment, with the alignment of instruction treatment energy converter and destination organization.In some embodiments, when diagnostic transducer is aligned with mark When, treatment energy converter by appropriate location to be activated without additional movement with successfully ablation targets tissue. In Fig. 5 A, 5B, 6A and 6B, diagnostic ultrasound transducer 125 can be located at the preset distance of neighbouring treatment ultrasonic transducer on conduit, For example, about 5 to about 15mm so that when diagnostic transducer 125 is aligned with mark 2 (being in this case carotid bifuracation), control Treat energy converter 126 apart from bifurcated preset distance 127 (for example, about 5 to about 15mm), and with the ablation targets 128 in arteria carotis diaphragm Alignment.Diagnostic transducer 125 can provide material of the signal as the ultrasonic wave in the capture region 129 to Reflection Transducer The feedback of (such as tissue, blood flow).It can be by rotation or translational movement conduit or by electrically or mechanically manipulating energy converter To create scanning motion with search sign such as arteria carotis communis or carotid bifuracation.The feedback for carrying out self diagnosis converter 125 can be with It is processed into image 130, sound, waveform or electric signal as shown in Figure 6B.

Fig. 7 A-C show the exemplary ablation catheter including the first and second diagnostic ultrasound transducers.As shown in Figure 7 A, Conduit, which may also include, is configured as detection internal carotid 90 and the first diagnostic ultrasound transducer 132 and second of external carotid artery 91 is examined Disconnected ultrasonic transducer 133.Energy converter can be configured as image 134, acoustical signal or the electric signal of capture as shown in figures 7 b and 7 c. Fig. 7 B and 7C show the cross section of two arteries.Second opinion ultrasonic transducer 133 is positioned on conduit, thus its aim at Treat 137 identical direction of energy converter.When as shown in Figure 7 B, conduit rotate to wherein second opinion energy converter in internal carotid and When the position 136 at the center between external carotid artery, and as seen in figure 7 c, the first diagnostic transducer 132 is aimed in arteria carotis point When pitching 2, in the diaphragm at ultrasonic therapy energy converter 137 and the center substantially between internal carotid and external carotid artery and higher than point The target location 128 for pitching preset distance is aligned, the preset distance for example, about 5 to about 15mm, and about 5 to about 10mm, about 8 to about 10mm, or about 10mm to about 15mm.

Fig. 8 A-D show tool, and there are three the exemplary ablations of diagnostic ultrasound transducer and a treatment ultrasonic transducer to lead Pipe.As shown in Fig. 8 A-D, conduit includes that the first diagnostic transducer 140 being aligned with carotid bifuracation 2, setting is arranged on conduit Transducing is diagnosed with the second opinion energy converter 141 being aligned with internal carotid 90 and the third being aligned with external carotid artery 91 on conduit Device 142.Conduit further includes ultrasonic therapy energy converter 143, is located on conduit with when diagnosis relative to three diagnostic transducers When energy converter is aligned, ablation beam is aimed between internal carotid and external carotid artery and away from carotid bifuracation cranium side preset distance, Such as about 5 to about 15mm, about 5 to about 10mm, about 8 to about 10mm or about 10 to about 15mm target site.Alternatively, one or More diagnostic transducers can be moveable relative to conduit sheath.For example, 141 He of diagnostic transducer shown in Fig. 8 A 142 can mechanically move (for example, using transmission mechanism) to adjust the angle between two energy converters, while will treat transducing Device 143 is maintained at the center between two mobile diagnostic transducers.This can allow alignment to adapt to different diaphragm width. In use, all conduits shown in Fig. 4 A-8D and method generate the damage being substantially contained in arteria carotis diaphragm, and from And avoid non-target tissues.In addition, the combination of venous blood flow cooling and the selection of ultrasonic therapy scheme can help cooling operating The vein and emitter that period may become hot, while enhancing the Ultrasonic Heating of arteria carotis diaphragm.

It is configured to receive the supersonic melting conduit of individual imaging catheter

Catheter in blood vessel for carotid body ablation can be configured as using therapeutic ultrasound ablation targets tissue With in order to target purpose to imaging of tissue.Conduit may include that supersonic melting energy converter (also referred to as treats energy converter or therapeutic Energy converter), it is configured and is adjusted to receive imaging catheter；Suitable for treating transducing according to the image recognition generated by imaging catheter The sighted direction of device, and suitable for energy is directed to the target identified by imaging transducer from treatment energy converter.

There are many ultrasound imaging catheters for being imaged from patient's body, including intravascular ultrasound (IVUS) conduit in the market With echocardiography in heart (ICE) conduit.For example, VolcanoPV.035, for endovascular Lesion vessels are imaged；The UltraICETM of Boston Scientific, for during intravascular cardiology program at Picture.ICE conduits can work for the imaging in heart in application as described herein.Such imaging catheter can To be configured as creating the video based on ultrasound, it is illustrated in about 50- around the imaging transducer on the remote area of conduit The cross-sectional slices of the tissue of 60mm radiuses.The console that the ultrasonic signal for transmitting and receiving from imaging catheter passes through patient-external It is controlled and is handled, and can generate and show image to help user to identify other objects in tissue or the visual field.Separately Outer processing can help to identify such as feature of the presence of blood flow, patch or tissue differentiation.Existing ultrasound imaging catheter can be with Diameter with for example, about 8 to 10F (for example, 8.2F, 9F).In some embodiments of ablation catheter, can by it is existing at Imaging catheter as conduit or with those similar customizations as known in the art is inserted into carotid body supersonic melting conduit, with Help identifies target ablation position (such as carotid body, arteria carotis diaphragm, carotid body nerve), and identification target ablation position Position relative to treatment energy converter or its sighted direction.

Ablation energy converter before imaging transducer

As shown in figure 11, for the embodiment configuration for the supersonic melting conduit 305 that ultrasonic imaging adjusts and configures There is the ablation energy converter 300 positioned at 301 front of imaging catheter chamber.In this case, position refers to, and in front, can be determined Justice transmits the direction 302 of supersonic melting energy for direction from the side of ablation energy converter or conduit run-home.It can will be existing Ultrasound imaging catheter (for example, IVUS or ICE conduits) 303 be inserted through imaging catheter chamber with by it is one or more imaging change Energy device 304 is far from ablation energy converter positioning, and wherein imaging catheter chamber is after melting energy converter.Ablation catheter 305 can have There is within the scope of about 11FR to 13FR the diameter of (for example, about 12F) and is conveyed by deflectable sheath.For example, compatible sheath can be with It is that 12F is compatible with, the outer diameter with about 16F can deflect and make together with expander (dilator) at least one direction With.Ablation catheter may include supersonic melting energy converter 300, such as ablation energy converter as described herein, such as melt energy converter Can be substantially flat, width is about 2mm, and length is about 6mm.Energy converter can be configured as with about 15MHz to about 25MHz Frequency resonance in range (for example, about 20MHz).Ablation energy converter can be installed on back lining materials 306, back lining materials 306 It is reflected or shielded ultrasonic wave, therefore ablation energy is directed only to desired conveying direction.Back lining materials can be by herein to similar Embodiment description is made, such as by the dense material or air of such as stainless steel or the epoxy resin filled with air microballoon Sorptive material be made.As shown, imaging catheter chamber can pass through back lining materials, or optionally, if back lining materials It is thin and be installed to ablation energy converter support part, then imaging catheter chamber can pass through ablation energy converter support part.Imaging is led Tube chamber 301 can pass through the sheath 307 of ablation catheter to reach the proximal end region of conduit, and sheath 307 can be squeezing for such as Pebax Compression polymer.Ultrasound imaging catheter can be conveyed by imaging catheter chamber, and one or more imaging transducers 304 are positioned In the anechoic room 308 far from ablation energy converter.For example, one or more imaging transducers can be with about 0mm to 5mm The imaging of (for example, about 2mm, about 1mm, about .5mm) to ablation energy converter distance 309 is placed.Imaging plane is aligned to by the configuration It is roughly parallel to the conveying direction of ablation energy, and can be used at the same time or when continuous imaging conveys ablation energy, without It needs mobile imaging transducer or melts energy converter.Anechoic room 308 can be the space in echoless shell 312, allow Imaging or ablation ultrasonic wave pass through without generating notable echo.Echoless shell can be made of the thin polymer of such as nylon, And it can also be visually transparent or semitransparent, to allow user to observe the property of anechoic room for example to position imaging Energy converter ensures that coolant correctly flows or go bubble removing.Anechoic room can be sealed airtightly to accommodate the cooling of flowing Agent.In this embodiment, coolant can be conveyed by coolant Delivery lumen 314, recycle disappeared with cooling in the chamber Melt energy converter 300 and leaves the room along imaging catheter chamber 301.Ablation catheter can also include aiming artifact as shown (aiming artifact) 310 can be positioned at behind imaging catheter chamber 301 or indicate the conveying of ablation energy The position of relative direction.For example, aim at artifact component can be the hypotube (hypotube) for including air and being sealed at both ends, The either differentiable alternate design of ultrasonic wave such as the embodiment described herein.As shown in figure 11, aiming at artifact component can Can be that aiming puppet is for example made and adhered to of polymer or metal to support remote pointed member 311, remote pointed member 311 The half spherical pieces of shadow component or echoless shell 312.Remote pointed member can work as to be pressed against on vascular wall and allow to be inserted into simultaneously Wound is prevented when across sheath.User will can be conveyed based on ultrasonic video and by acquisition understanding ablation energy Include the ablation catheter of imaging catheter to placing in the case of the preset distance close to imaging plane, and the conduit is placed on example In jugular vein or facial vein such as near target carotid body.For example, ablation energy can begun approximately even with close to imaging The imaging of plane conveys in the range of starting to ablation energy converter distance 309, and height is about to melt the height of energy converter 313.For example, if the distance of imaging to ablation energy converter is 0.5mm, and it is 6mm to melt transducer height, then can manage Solution, ablation energy by 0.5 near imaging plane between 6.5mm and with aim at the opposite direction of artifact (for example, phase Negative direction) conveying.Conduit may include electric conductor 315, all from sensor to convey electrical current to ablation energy converter or conveying Such as temperature or the signal of pressure sensor.

Optionally, similar configuration may include the imaging transducer or energy converter of the part manufacture as ablation catheter Group is inserted into not as individual device in the imaging catheter tube chamber of ablation catheter.

In an alternate embodiment, conduit can be configured as determining the imaging transducer of imaging catheter close to ablation energy converter Position.

With the embodiment for the ablation catheter that imaging catheter is used together

It is configured to receive the ablation catheter of ultrasound imaging catheter that can have the distal component as shown in Figure 12 A to 12F 510.Distal component may be coupled to as the Pebax pipes of the elongated tubular 511 of conduit sheath, such as extruding.Distal component includes It is connected to the ablation energy converter support part 512 of sheath, the ablation energy converter 513 for being installed to ablation energy converter support part, limit Determine room 515 and be connected to the echoless shell 514 of ablation energy converter supporter, (it is oriented offer pair to fiducial marker 516 Melt the instruction of the sighted direction 517 of energy converter) and radiopaque tip 518.

Figure 12 E show the cross section of the conduit sheath of the embodiment.Extruded tube (for example, Pebax extrusions) 520 wraps The intensity containing increase and the line braided fabric 521 and chamber for improving torsion capacity (torqueability).Line braided fabric can such as co-extrusion Press or be laminated to extruded tube.Two PTFE linings are inserted into the chamber of extrusion 520 to form two independent chambers.It is optional Ground, Pebax extrusions can be extruded as carrying two or more chambers.First PTFE linings 523, which define, to be exclusively used in accommodating line 525 and conveying coolant chamber 542.It is cold that coolant for cooling ablation energy converter passes through the conveying of the chamber comprising line that can have But the additional benefits of line.Line can be that high-frequency current is for example transmitted to ablation energy converter from console, and will be with ablation transducing The temperature sensor (for example, thermocouple) of device thermal communication is connected to the conductor of console.In the figure, three conducting wires include generating It is welded to the constantan line and copper wire of the T-type thermocouple of ablation energy converter, and conveys electrical current to the copper wire of energy converter.A piece copper wire It can be the common conductor for completing Thermocouple Circuit and ablation energy circuit.It can be provided such as in container (such as bag, bottle) The coolant fluid of sterile water or brine, and it is pumped into through pipeline by peristaltic pump the coolant on the proximal end region of ablation catheter Ingress port, the coolant entrance port are in fluid communication with the first lining or fluid conveying chamber 542.It can be by pressure relief valve (not shown) is positioned to consistent with coolant entrance pipeline, prevents to cool down unintentionally if blocked along the somewhere of coolant channel Agent is flowed, then discharges coolant.When the pressure in pipeline is, for example, about 30psi, pressure reducing valve can be opened.It is optionally possible to Pressure sensor is incorporated into conduit or pipeline group to monitor coolant pressure and send out signal to console to adjust or stop Only coolant flowing or offer warning.2nd PTFE linings 524 limit the second chamber for being exclusively used in conveying ultrasound imaging catheter 526 543 and coolant outlet.Second chamber can have be enough to allow imaging catheter 526 and coolant by shape and diameter (example Such as, as shown) (it can be for example, about 8FR to 10FR (for example, about 8.5FR to 9FR)), while making the resistance of coolant flow It is minimum.Optionally, imaging catheter chamber can be ellipse, have the minor diameter for being enough to slidably engage imaging catheter.It is optional Ground, conduit sheath may include individual coolant return cavity.In the proximal end of conduit sheath, imaging catheter can pass through hemostasis Valve enters the second chamber, and to prevent coolant from being leaked from chamber, and coolant outlet port can be connected to the second chamber, will be cooled down Agent is discharged into draining container from conduit or returns it to coolant supply container.Sheath can have in about 11FR to 14FR Diameter in the range of (for example, about 12.5FR) and it is enough to reach the length of destination organization from vascular system introduce region.For example, It is configured to be introduced into the femoral vein of patient and be transported to close to the right internal jugular vein of arteria carotis diaphragm or leading for left jugular vein Pipe can have the length within the scope of about 90cm to 130cm (for example, about 110cm).

As shown in Figure 12 C and 12D, the first and second chamber linings 523 and 524 extend to from extruded tube and melt energy converter branch Component 512 is held to engage.Line 525 and coolant conveyor chamber 542 are transported to the special of ablation energy converter support part by the first lining For accommodate 528 ablation energy converters 513 a parts, including wire management frame 527, for install melt transducer assemblies it is recessed Shell 528, solder flux release aperture 529 and protection ridge 530.The imaging catheter chamber of second lining 524 and ablation energy converter support part 531 are connected to the coolant return slot 532 of ablation energy converter support part.It is carried through the imaging of the chamber 543 of the second lining 524 Conduit can pass through the imaging catheter chamber 531 of ablation energy converter support part go forward side by side and enter the room 515.Coolant in room can pass through Chamber 531 or coolant return slot 532 leave and across the chambers 543 of the second lining 524, to be moved from conduit in the proximal end region of conduit It removes.

Ablation energy converter support part 512 is connected to conduit sheath 511 and is configured as supersonic melting energy converter 513 It is maintained at the suitable position relative to imaging transducer 533, and guides the coolant fluid for stopping ablation energy converter overheat Flowing.As ablation transducer vibrations generate heat.Coolant is by melting energy converter removal heat and keeping the temperature at pre- Fixed maximum value (for example, about 90 DEG C) is below.Melt the too high other component that may cause to energy converter or conduit of transducer temperature Damage or uncontrolled heat transfer to blood, blood vessel or its hetero-organization.Temperature sensor can with monitoring transducer temperature, To ensure coolant liquid proper flow.If temperature is increased to predetermined maximum or more, console can be disappeared by sending out mistake Breath stops the conveying of ablation energy or adjusts the conveying of ablation energy to respond.

As shown in Figure 12 B, shown in decomposition diagram of the ablation energy converter support part 512 with ablation transducer assemblies, line 525 It can be soldered to energy converter 513.For example, two conducting wires of high-frequency current circuit can be soldered to the opposite side of energy converter, and Constantan line can be welded to the inside side of energy converter, to create thermocouple with one of copper wire.Melting energy converter can example It is such as adhered on energy converter backing 534 with cyanoacrylate 535, and backing can be for example viscous with cyanoacrylate 536 It is attached to the ablation transducer housing of ablation energy converter support part.UV adhesives 537 can be applied to the edge of transducer assemblies To further strengthen the engagement of itself and ablation energy converter support part.Once transducer assemblies are adhered to ablation energy converter to support For component to be packed into welding point, then solder flux release aperture 529 receives welding point outstanding, and can be for example with UV adhesives 538 fillings, generate and are electrically insulated and mechanically reinforce welding point.Protection ridge 530, which is defined, to be flowed through ablation for coolant and changes Energy device keeps the space between ablation energy converter and echoless shell layer 539 to the channel of echo imaging chamber 515.If Conduit is pressed against the inner wall of blood vessel, such as by deflecting the delivery sheath that can be turned to, then protects ridge by preventing echoless shell Soft thin layer collapse to keep space.Energy converter can be flat, Rectangular piezoelectric energy converter is (for example, about for ablation 0.004 " thickness, 2mm wide, 6mm long).Ablation energy converter alternate embodiment illustrate herein, such as the energy converter of bending or Transducer array.Ablation energy converter backing can be made of thickness of about 0.008 " stainless steel.The backing design of replacement is at this It is illustrated in text, such as with the epoxy resin of the glass microsphere filling filled with air.Melt the bonding between energy converter and backing Agent can have the thickness with the consistent wavelength of ablation energy converter, and can be consistent thickness, to allow repeatable change Can device assembly performance, such as energy converter and backing uncoupling.For example, for the resonance within the scope of about 20MHz to 21MHz The energy converter of frequency, the space between energy converter and backing can be greater than about 0.0013 " (for example, about 0.002 ").The space can be with It is filled with adhesive.In an alternate embodiment, material (such as polyimides) thin layer lower than backing density can be placed on It melts between energy converter and backing, with the interval being consistent, to ensure that the vibration for melting energy converter will not be shown by back lining materials Write ground containment.

In an alternate embodiment, ablation energy converter support part can be configured as on ablation energy converter and around it Generate the turbulent flow of coolant.For example, ablation energy converter supporter can have and melt energy converter support part shown in Figure 12 B 512 similar features, but it can also include ridge in coolant flow fields, such as on the side of Protect edge information 530 Or raised (not shown), or in the side of Protect edge information include chamber (not shown), to promote coolant in the side of ablation energy converter It is more flowed in region in face.

Gas-tight seal room is defined to echoless housing parts shown in Figure 12 A, and be configured as allow ultrasonic wave with Minimum interference passes through it.Echoless shell may include multiple layers, such as internal layer 540 can have about 0.005 " thickness Nylon extrudate, this can provide enough intensity for distal component.Internal layer can adhere to ablation energy converter support part Frame 541.Second outer layer 539 can be thin PET or nylon sleeve of such as thickness in about 0.00025 " to 0.0008 " range. In including the embodiment of internal layer and outer layer made of nylon, these layers can be melted together, this can be between eliminating layer Air or needs to adhesive.The other materials of the first layer or the second layer that can be used for echoless shell include PET or LDPE or with other biocompatible materials compared with low acoustic impedance.As illustrated in fig. 12, outer layer is in ablation energy converter support part Upper extension and with adhesive bonding to sheath 511.In the configuration, ultrasonic imaging wave is by internal layer and outer layer, and ultrasound Ablation wave only passes through outer layer.Remote tip 518 is connected to the distal end of echoless shell, and can have circular distal in order to pass The frame by sheath and blood vessel and the diameter reduction for being conveniently attached to shell is sent, the concordant transition on outer surface is allowed.Remote point End can be made of soft radiopaque Pebax, and when using X-ray or fluoroscopy, it can be visualized.

In the alternate embodiment as shown in Figure 12 H, outer layer 550 can have to be located at 552 front of ablation energy converter The sacculus (such as nylon) of protrusion 551 can allow to melt between energy converter and vascular wall compared with the shell without protrusion The fixed range of bigger and preferably cooling.Protrusion can deviate about 1mm.

In alternate embodiment as shown in figure 12i, echoless shell may include outer layer 566, and outer layer 566 can be The thin layer of the substantially anechoic material (for example, nylon, PET, LDPE) of 0.001 " (for example, about 0.008 ") can be less than, And internal layer may include two layers 567 and 568 for clipping fiducial marker 569.Two layers 567 and 568 can be about 0.0025 " is thick, and can be made of the material of such as nylon, and can emit the imaging transducer of imaging catheter 526 Ultrasonic wave is that substantially anechoic outer layer 566 combines.

In an alternate embodiment, anechoic room can include supersonic melting energy converter, but not include imaging transducer.At It melts near energy converter as catheter lumen may be configured to the ultrasonic imaging energy converter of imaging catheter being placed on, but is connect with blood flow It touches.Fiducial marker can be located in the visual field of imaging transducer, and can be such as seal wire.

Fiducial marker 516 can be placed on to the precalculated position of the sighted direction 517 relative to ablation energy so that Artifact, relative boresight side of the instruction ablation energy relative to the anatomical structure of imaging are generated on image or video based on ultrasound To.As shown in Figure 12 A and 12F, fiducial marker 516 can be impermeable echogenic material strip (for example, it is about 0.080 " wide, 0.002 " thick and 0.5 " long bent-strip, and be cut by laser from stainless steel tube), it is sandwiched in the internal layer 540 of echoless shell Between outer layer 539 and it is positioned to diametrically opposite with the sighted direction of ablation energy.A kind of alternate design includes about 0.0025 " Two thick nylon inner layers, one of fiducial marker is located between two internal layers, and two internal layers are consequently flowed together, embedded Fiducial marker.This can prevent reference mark from damaging relatively thin outer layer.Disclosed herein is the implementations of the replacement of fiducial marker Scheme.

In the proximal end region of ablation catheter, sheath may be coupled to proximal end ablation energy converter supporter, and proximal end ablation is changed Energy device supporter is also used as handle 544 as shown in fig. 12g.Handle can have will be used to melt energy converter and sensor The electric wire of (for example, temperature sensor) is connected to the electric connector 545 of ablation console 546 by interconnecting cable 547, has hemostasis Imaging catheter port 548, coolant input port 549 and the coolant output port for being connected to coolant hose group 556 of valve 555.Pipe group can be connected to coolant supply 561 by pump (such as peristaltic pump) 562 and coolant abandons container 563.It can Ultrasound imaging catheter (such as IVUS conduits) 526 to be inserted into imaging catheter port 548 and is connected to imaging control console 559, imaging control console 559 can be optionally coupled to image enhancement algorithm and display 560 or ablation console 546.Handle 544 can promote the rotation process of ablation catheter.Nonvolatile memory memory element 557 (such as comprising with time and work( The EEPROM of unique lesion depths table of rate setting) can in the handle and electric connector be connected to logical with ablation console Letter.Handle may include being electrically connected for managing and including EEPROM and the equipment that such as connects detects, using limitation (example Such as, recycling prevents, is limited using duration, the use of limited quantity) and minimize the reflected energy made in system Electric match circuit circuit board 558.Ablation catheter 544 is inserted into deflectable delivery sheath 564.

Optionally, ablation catheter can be configured with, for the device by seal wire into horizontal deflection or conveying, such as passing through this Illustrated by embodiment disclosed in text.

The imaging beam being aligned with ablation beam

The embodiment of carotid body supersonic melting conduit may include being transported to the distal area of the vascular system of patient Domain and the proximal end region being retained in outside body.Remote area be suitable for from supersonic melting energy converter transmit ablation ultrasonic energy and from Ultrasound imaging catheter transmits ultrasonic imaging signal.The conduit is configured to provide the organization chart picture close to remote area, the distal end Region is aligned and orients with the sighted direction of ablation energy converter.User can be to the imaging of tissue around remote area to search for simultaneously It identifies target ablation region (for example, arteria carotis spacer film), directional catheter so that ablation energy converter run-home ablation areas, And ablation ultrasonic energy is transported to target ablation region.In fig. 13, remote area 320 includes echoless shell 321, can To be such as thin polymer or sacculus.Cavity in shell, which defines, to be filled out with coolant (such as circulating brine or sterile water) The anechoic room 322 filled.For example, coolant can convey via coolant conveyor chamber 332 and 333 row of chamber is discharged via coolant Go out.It is ultrasonic barrier material to have the supersonic melting energy converter 323 for being installed to backing 324, backing 324 in anechoic room, such as Stainless steel or epoxy resin containing air microballoon.Supersonic melting energy converter aims in generally radial direction so that when disappearing When melting ultrasonic energy and being launched, it is transmitted along sighted direction 325.Supersonic melting energy converter or backing can be installed to sheath On bar (such as hypotube) on 326, such as in the chamber that is inserted into ablation catheter sheath of as shown being installed to or it is mounted on It melts on energy converter support part (not shown).

Carotid body supersonic melting conduit may include elongated sheath 326, and elongated sheath 326 can be by the polymer that squeezes It is made, and can be with long enough (for example, about 100 to 120cm), with quiet from stock when being transported to jugular vein 12 by vena cave Arteries and veins is to reach the neck of patient.The jugular vein general diameter of the mankind is about 8 to 20mm.Sheath may be configured to be suitable for neck Vein, such as with the diameter less than or equal to about 18French (for example, between about 9 and 11French).Conduit can pass through Delivery sheath 327, the delivery sheath that can be turned to are conveyed by seal wire 328.Sheath may include imaging catheter chamber 329, imaging Catheter lumen 329 slideably receives imaging catheter 330.The nothing that chamber can extend to distal end regions from the proximal end region of conduit is returned Sound chamber.Imaging catheter can be inserted into (for example, in the handle) in imaging catheter chamber in the proximal end region of ablation catheter, and be led to It crosses imaging catheter chamber and is advanced to remote area.Imaging catheter chamber can be oriented so that imaging catheter in echoless shell chamber Imaging transducer 331 is positioned along the sighted direction of ablation energy converter.

As shown in Figure 14 A, in the proximal end of conduit 334, imaging catheter chamber 329 can by imaging catheter 330 for example using Including the port 335 of haemostatic valve enters, and may include coordinating with the mating feature part 337 on the proximal end of imaging catheter Mating feature part 336 so that when imaging catheter is fully inserted into, the distal end of the cooperation of mating feature part and imaging catheter is suitably fixed Position is in the remote area 338 of supersonic melting conduit.Mating feature part on imaging catheter can be attached on conduit or it It can be located in the sheath of imaging catheter and be fastened on desired position for use as the individual suitable of depth stop Orchestration.The mating feature part of ablation catheter can move between the retracted position shown in extended position shown in figure 14 A and Figure 14 B It is dynamic so that in extended position, imaging transducer is aligned with ablation energy converter and prepares to target imaging；And in retracted position, Imaging transducer is pulled to the proximal end of ablation catheter with being enough to remove the distal end of imaging catheter the sighted direction of ablation catheter.Hand Actuator 339 on handle can be used for promoting or imaging catheter of retracting.Optionally, imaging catheter can manually advance and retract.

Supersonic melting conduit can also include the echoless that coolant such as brine or sterile water are transported to remote area The device of room 322.For example, sheath may include coolant conveyor chamber 332 and coolant return cavity 333.Coolant conveyor chamber and The coolant delivery port 339 and coolant that return cavity may be coupled at the proximal end region of ablation catheter return to port 340. Coolant can pass through container including coolant source such as brine or sterile water, pipeline such as pipeline and pump such as peristaltic pump Coolant system is supplied to conduit.Coolant system can also include flowing pulsation damper or flowmeter.Coolant system can It with by user's control, or can be automatically controlled by console 341, console 341 coordinates conveying and the ultrasonic energy of coolant Conveying.For example, coolant can start the cycle over before ablation energy conveying, speed and time are enough to ensure that coolant exists Ablation energy is recycled before transmitting in anechoic room, and at least continues until that ablation energy stops.Other signals also may be used For controlling coolant, such as the temperature of supersonic melting energy converter or anechoic room.

Supersonic melting conduit can also include that will melt energy converter to be connected at the proximal end region of conduit (for example, in handle On) electric connector electric conductor.Conductor can be maintained in the chamber of sheath or the chamber of hypotube (not shown).May exist Other conductors, such as sensor conductor.Temperature sensor can be positioned in anechoic room (for example, in echoless surface of shell Above, in ablation transducer face), it can be with measuring temperature.Temperature measurement may be used to indicate enough power, excessive power Or overheat.Temperature signal can be used for controlling the power conveying to ablation energy converter.

Alternate embodiment as shown in fig. 15b may include the (figure of ablation energy converter support part 345 of mechanical processing Shown in 15A), it can be made of the dense material of such as stainless steel for use as ablation energy converter backing, or ablation energy converter Support part can be made of plastics such as PEEK, and can add thin energy converter backing.Melting energy converter support part can To be the cylinder with cut-out, is combined with echoless shell 346 and define anechoic room.By echoless shell (such as Polymer casing, film or sacculus of the thickness in about 0.0002 " to 0.009 " range) it is placed on around cut-out, to be formed Anechoic room simultaneously accommodates circulating coolant.Ablation energy converter support part is adhered to polymer sheath with such as flange 347 Device, flange 347 can have be attached to sheath 348 or hole barb or windowing to receive the reflux of sheath tube material.Ablation Energy converter support part includes the imaging catheter chamber 349 being connected to the imaging catheter chamber in sheath.As shown, melt energy converter 350 can be installed to ablation energy converter support part 345, and melt energy converter support part and can have recessed shell 351 or profile, ablation energy converter is placed wherein in order to manufacture.Ablation energy converter support part can also include when connection disappears The coolant conveyor chamber 352 and return cavity 353 being connected to the coolant cavity in sheath when melting energy converter support part.Melt transducing Device support part can also be with chamber to carry electric conductor (for example, to be connected to ablation energy converter or such as temperature sensor Sensor conductor).The distal tip 354 for melting energy converter support part can be circular.Imaging catheter chamber can be positioned at In machined piece so that the center of chamber is located on the sighted direction of ablation energy converter, and the direction is considered from ablation The line perpendicular to ablation energy converter planar that the center of energy converter planar is sent out.In the expanded state, the imaging transducing of imaging catheter 358 The height of device 355 can be aligned with the sighted direction of ablation energy converter, as shown in fig. 15b.

Optionally, supersonic melting conduit may include the device that will be transmitted by seal wire 356.As shown in Figure 13,15A or 15B, Conduit may include guidewire lumen 357 that can be on the side of sheath or optionally in sheath.

The example for the image that the ultrasound imaging catheter being deployed in supersonic melting conduit provides is shown in Figure 16.Scribing line is cloudy The dark space of shadow zone domain representation ultrasonoscopy includes the wedge-shaped shade 360 projected by ablation energy converter or back lining materials, receiving conduit Blood vessel 361 (for example, jugular vein, facial vein), internal carotid 90 and external carotid artery 91.Melt the sighted direction of energy converter The center of 362 artifacts opposite with the shade projected by ablation energy converter and across ultrasound imaging catheter 363.As shown, disappear The sighted direction 362 for melting energy converter is placed towards arteria carotis diaphragm 205 by the orientation for melting conduit, and arteria carotis diaphragm 205 is in neck And it can be in about 7 or 10mm above carotid bifuracation between interior artery and internal carotid.When conduit travels across blood vessel (example Such as, jugular vein, facial vein) and internal carotid and external carotid artery can recognize carotid bifuracation when merging.Away from arteria carotis The distance of bifurcated can for example determine that the distance can be disappeared by carotid body ultrasound by promoting conduit in about 7mm Melt and is measured with the associated sounding mark of delivery sheath (not shown) in the sheath of conduit.Once orientation and the position of ablation catheter The sighted direction that target area is directed to according to ablation energy converter is desirably placed, then ultrasound imaging catheter regracting, to So that the distal tip of ultrasound imaging catheter is removed from anechoic room, or do not stop ablation signal at least, and supersonic melting energy It can be transmitted to target area from ablation energy converter.

Supersonic melting conduit can be adapted to that remote area articulated type is made to move.Articulated type movement can promote to melt transducing The positioning of device and target alignment extends ablation by generating with the relevant multiple ablation sites in multiple articulated type shift positions Area.For example, ablation catheter may include controllable deflection, wherein deflectable length 366 (for example, about 1 to 3cm) is from a lateral bending Song is to the other side, up to deflectable distance 367 (for example, about 0.5 to 3cm).As shown in figure 17, deflection can with ablation transducing In the coplanar plane of device.It can be by being connected to the bracing wire of remote area 368 (for example, to ablation energy converter support part) come real Now controllable deflection, the chamber being drawstring through in sheath to proximal end region, they may be connected to inclined on handle 370 at this Linear actuator 369, deflected actuators 369 apply tension to deflect remote area to bracing wire.Deflectable catheter may include rotation The device of conduit sheath, such as revolving actuator 371.

Deflection can be configured in and melt the plane of energy converter substantially orthogonal to plane in, or can be configured in The placement for potentially contributing to treatment energy converter, the generation repeatedly melted, the ablation for generating bigger are manipulated or are deformed comprising conduit Blood vessel (for example, vein, jugular vein, facial vein) any other direction on, supersonic melting energy converter is placed on suitable When position to deliver energy to target or place ultrasonic imaging energy converter in place to identify target or the target area Tissue in domain.

Ablation energy converter with angle

As shown in figure 18, the alternate embodiment for being configured to the ablation catheter 375 of ultrasonic imaging and treatment may include Be configured as receiving the imaging catheter chamber 376 of individual ultrasound imaging catheter (for example, IVUS or ICE conduits) 377, wherein at The anechoic room 379 in the remote area of ablation catheter is advanced to as energy converter 378；And ablation energy converter 380, positioning In the anechoic room far from imaging transducer and at making emitted supersonic melting energy be guided through imaging plane 381 angle.Imaging plane can be approximately perpendicular to the disk of the axis of imaging catheter.Alternatively, imaging catheter can be with It is configured as making imaging transducer slightly (for example, about 85 degree from imaging catheter axis rather than perpendicular to axis) angled, Generate slightly conical imaging section (slice).In figure 18, ablation energy converter 380 is located in the distal end of imaging transducer And it is directed into the angle intersected with imaging plane or section at generated zone of ablation 382 is made.Optionally, transducing is melted Device can be positioned at the proximal end of imaging transducer and at making zone of ablation be directed into the angle intersected with imaging plane or section Degree.It can be rectangle to melt energy converter, have fillet or egg shape or circular shape.For example, being configured as ablation carotid body Or in the embodiment of arteria carotis diaphragm, zone of ablation can with the surface away from imaging catheter about 3 to 8mm (for example, about 5mm) at Image plane intersects, which can be the suitable distance from the conduit in jugular vein 12 or facial vein to target area 205. Exemplary configuration may include the ablation energy converter of 4mm long and 2mm wide.Ablation energy converter can be placed as with axis into about 40 ° Between to 50 ° the angle 383 of (for example, about 45 °) and imaging plane distal end at a distance of about 3 to 10mm (for example, about 5mm) distance 384.The ablation areas of the elongated shape extended with the surface substantially perpendicular to ablation energy converter can be generated.The embodiment party The advantages of case, may include, to the ability of target area imaging while transmitting ablation energy, or is first imaged to target area Ablation energy is then transported on without mobile imaging catheter, this can be left by the mobile ablation energy of reduction the risk of target come Improve safety and effect.In addition, the angled ablation in target area can surround the more volume of target area simultaneously Target area is not extended off.Reduced conduit can be allowed by being placed on the angled ablation energy converter of imaging transducer distal end Diameter.In similar embodiment, imaging transducer is desirably integrated into ablation catheter, is promoted not as independent conduit Into ablation catheter.

In the embodiment illustrated, ablation catheter 375 includes the sheath made of pressure polymerization object (such as with about The outer diameter of 11F), hardness flexible (soft durometer) is carried, is had for improving torque response (torque Response braided sheath layer).Sheath includes for accommodating the imaging catheter chamber 376 of 377 conduit of ultrasonic imaging (for example, about 9.5F).The tube chamber can also be used for coolant and pass through.Ablation catheter can also include the guidewire lumen 385 that conduit conveys on line (for example, with the lumen diameter for slidably receiving 0.018 " seal wire).Guidewire lumen can be in pipe (for example, polyimide tube) Tube chamber, pass through sheath in chamber and pass through the distal end of anechoic room to conduit.Ablation catheter may include coolant conveyor chamber, It can be the chamber in coolant delivery pipe, and the coolant of such as brine or sterile water is stored in anechoic room (for example, separate Melt energy converter) in.Coolant in anechoic room and can flow cocurrent and go out coolant discharge chamber, and chamber is discharged in the coolant It can be imaging catheter conveyor chamber.Temperature sensor (for example, thermocouple, thermistor) can be placed in anechoic room (example Such as, on ablation energy converter, on locular wall), with monitoring temperature and ensure that enough coolants are conveyed to avoid overheat.It aims at Label 386 can be positioned in imaging plane, adjacent with imaging catheter conveyor chamber, and the direction phase conveyed with ablation energy Instead.Point of aim mark device can be only to be generated on the video based on ultrasound by being made with the material of imaging ultrasound wave interaction Special image.For example, point of aim mark device can be by absorption ultrasonic wave material or strong reflection object for ultrasonic wave material system At.The unique image or artifact of the displaying point of aim mark device shown on video based on ultrasound can be instruction ablation energy converter courts The shade or bloom that opposite direction aims at.It is contemplated that creating the other configurations clearly identified to sighted direction.

One example of application method may include that sheath 387 is advanced to by the region of close-target；By ablation catheter 375 It is advanced to the intracavitary of sheath；Imaging catheter is advanced in the chamber of ablation catheter, until imaging transducer is located in anechoic room In；The ablation catheter containing imaging catheter is disposed from the distal end of sheath；While imaging using imaging catheter, using by sheath with Including the combination that the ablation catheter of imaging catheter is promoted and retracted together, and sheath is deflected and reversed to obtain relative to ablation mesh Target suitable position；Ablation catheter is reversed while imaging, energy converter run-home will be melted.It is alternatively possible to use Seal wire.For example, seal wire can be first transmitted, and sheath and conduit can transmit on seal wire.

Imaging transducer with angle

Alternate embodiment includes the imaging transducer 390 being angularly positioned with ablation catheter sheath 391.Individually ablation Energy converter 392 can be parallel to ablation catheter sheath or at angle as shown in figure 19.Melt energy converter and imaging transducer edge It conduit axis and is spaced from each other a distance placement, and they are at an angle to each other so that ablation areas 393 and imaging region 394 radial to one of ablation catheter, apart from upper overlapping, which is suitble to melt 395 targets (for example, from vein from blood vessel 12 Such as jugular vein or facial vein ablation carotid body target).In the embodiment illustrated, imaging catheter 396 is advanced through Chamber in ablation catheter.In the remote area of conduit, chamber is pierced by conduit lateral bend and by the port of the conduit side 397. The imaging catheter pass-out port, and the imaging transducer 390 on imaging catheter is positioned to the sheath of ablation catheter into one jiao Degree.The imaging of overlapping and ablation areas allow simultaneously to target imaging and ablation.Between imaging transducer and ablation energy converter Angle can be determined by ablation catheter diameter, ablation the distance between energy converter and imaging transducer and expected ablation size It is fixed.The angle can be for example between about 90 ° and 150 °.The embodiment can allow ablation catheter to have than having ablation to change Energy device and imaging transducer position and adjacent to each other in the design less diameter of substantially the same axial position.The implementation Scheme can also allow for that imaging catheter, the imaging catheter is used to have the long part far from its imaging transducer, and imaging is inhibited to change The appropriate alignment of energy device and ablation energy converter.Long distal portions can protrude from tube chamber outlet.

Since the distance between vein and target area may change, it is suitable to realize vein can be manipulated as described herein When position and distance.Optionally, ablation catheter may be configured to that ablation energy converter is made to tilt to realize at suitable distance Ablation.For example, multiple conduits can be provided, it is disposed for generate ablation with the different distance and angle of ablation catheter.

Pivot ablation energy converter

Be configured as receive imaging catheter 358 supersonic melting conduit 400 embodiment can have can pivot with Change the ablation energy converter 401 of the angle 402 relative to axis, as seen in figs. 2 oa and 2 ob.User can be closely last by conduit Actuator (for example, the lever, driver plate, button on handle or knob) on end controls pivot (pivot), such as by tension Being applied to makes energy converter from an angle be pivoted to another angle or to the bracing wire of multiple positions therebetween.As shown in FIG. 20 A, Melt 355 side of imaging transducer that energy converter 401 is located at stretching, extension.In this arrangement, according to the position of anatomical structure and conduit It sets, device can use in many ways.Optionally, as shown in fig. 20b, ablation energy converter can be located at the imaging transducing of stretching, extension The distal end of device.Pivot may include the hinge or pivot hinge 403 in the proximal end of energy converter backing.Spring can will change Can device be pushed to first position (for example, with angle with about 45 degree of axis).It is slidably retained in the chamber of conduit and connects The conducting wire for the actuator being connected on catheter proximal end can be pushed with engage and stretch pivot energy converter or be pulled with release with The engagement of energy converter allows it to be bound to its angled configuration.Can adjust ablation energy converter angle or ablation energy converter and The relative position of imaging transducer is with the intersection point of mobile ablation beam 404 and imaging plane 405.

Imaging catheter compatibility

Ablation catheter can be configured to be used in combination with individual imaging catheter, and imaging catheter can help user to identify mesh The tissue for marking the tissue and surrounding target zone of ablation of zone of ablation, to which ablation energy to be safely and effectively transported to ablation mesh Mark.Individual imaging catheter can be the ultrasonic heart in such as ultrasound imaging catheter such as intravascular ultrasound (IVUS) conduit or heart Dynamic cardiotokography (ICE) conduit.Imaging catheter may include enhancing technology, such as optoacoustic or thermal acoustic imaging.Other medical imaging technologies Can be suitable.

There are many available IVUS and ICE conduits in the market.It is configured as receiving the ablation catheter of ultrasound imaging catheter can To be specifically configured to receive available imaging catheter in the market, such as VolcanoPV.035 IVUS are led The UltraICE of pipe or Boston Scientific Corporation^TMConduit.

Visions PV.035 IVUS conduits have imaging transducer in its remote area.Imaging plane is apart from the distal end About 13.5mm.The bore of energy converter is 8.2FR and length is about 6.5mm.From the proximal end of energy converter to the distal end of conduit away from From for about 18.5mm.Conduit sheath is 7.0FR, and active length is about 90cm.Imaging transducer is made of 64 yuan of cylindrical-arrays. Conduit has the guidewire lumen that proximal end is extended to from its remote tip.It is configured to receive disappearing for Visions PV.035 IVUS conduits It may include the imaging catheter chamber for having minimum diameter about 8.5FR to melt conduit, and preferably in the identical of IVUS surrounding catheters There is the exceptional space returned for coolant in chamber.Space in anechoic room can with long enough with accommodate imaging transducer and Part of the conduit far from energy converter.For example, can be from the distance of remote edge to the end pieces of ablation energy converter support part At least 18.5mm (for example, about 19mm).The length of ablation catheter can allow imaging transducer to be located in anechoic room, simultaneously Y-connection on the proximal end of IVUS conduits extends from the proximal end (for example, proximally handle on region) of ablation catheter.Example Such as, ablation catheter from distal end to the length of the ports IVUS on proximal end can be no more than about 90cm but long enough is with from introducing position (for example, femoral vein) reaches target area (for example, in jugular vein near carotid body), while being inserted through deflectable Delivery sheath.Valve such as haemostatic valve on the ports IVUS of ablation catheter should be configured to permit 8.5FR energy converters logical It crosses, while around 7FR sealings to prevent the coolant under the pressure for being for example up to about 30psi from leaking.The seal wire of IVUS conduits Chamber can be perfused with coolant, and be sealed with Rule cap to prevent coolant leakage or air from entering in proximal end.

UltraICE^TMConduit has the single 9MHz imaging transducers being mounted in rotation driving sheath, rotation driving Sheath passes through the sheath of conduit to its proximal end region, it is connected to motor with rotatable transducer at this.Energy converter is at slightly Towards the angle of distal end.Imaging plane is apart from the distal end about 5.5mm.However, since energy converter is angled, so image is slightly The cone of distal end rather than transverse plane.The bore of energy converter is 9FR and length is about 2mm.From the proximal end of energy converter to conduit The distance of the distal end be about 9.5mm.Conduit sheath is 9FR and active length is about 110cm.It is configured to receive UltraICE^TMThe ablation catheter of conduit can be with the imaging catheter chamber of the minimum diameter of about 9FR, and is preferably led in ICE There is the exceptional space returned for coolant in same chamber around pipe.Space in anechoic room can be with long enough to accommodate The part of imaging transducer and conduit far from energy converter.For example, from the remote edge of ablation energy converter support part to end pieces Distance can be at least 9.5mm (for example, about 10mm).The angle of imaging transducer is considered as how relative to image modification mesh Target position.The length of ablation catheter can allow imaging transducer to be located in anechoic room, while on the proximal end of ICE conduits Connector from the proximal end (for example, proximally handle on region) of ablation catheter extend.For example, ablation catheter is from distal end to close The length of imaging catheter port on end can be no more than about 110cm (for example, about 104.5cm+/- 2cm) but long enough is in quilt When being inserted through the deflectable delivery sheath length available of about 93.5cm+/- 2cm (for example, with) from introduce position (for example, Femoral vein) reach target area (for example, in jugular vein near carotid body).On the imaging catheter port of ablation catheter Valve such as haemostatic valve 9FR sheaths should be configured to permit to pass through, while around its sealing to prevent for example be up to about Coolant leaks under the pressure of 30psi.Since imaging transducer rotates on the driving shaft, it should be noted that avoiding grasp drive shaft Or prevent its rotation.For example, ablation catheter can be configured with minimum bending radius or curvature.Relative to ablation catheter Proximal end region, the component of the proximal end region comprising motor (motor drive) and ICE conduits can be provided to avoid torsion Knot.

System

The system of support ablation catheter may include interconnection cable, delivery sheath, coolant hose group, coolant pump and ablation control Platform processed.Embodiment for being configured as receiving individual imaging catheter, the system may include that imaging catheter and imaging are controlled Platform processed or these can be provided separately.For being configured to the embodiment with integrated imaging transducer, imaging control console It can be integrated with ablation console or individual unit.The other assemblies used in a program, for example, coolant (such as IV bags or Sterile water or brine in bottle), introducer, scene prepare supply (site preparation supplies) and dressing, can To provide in kit or be obtained from the source of supply of software.System can also include for handling trouble relative to trunk The head of person and the holder of neck.Embodiment for being configured to be used together with seal wire, system may include a seal wire Or one group of seal wire is (for example, the seal wire with 0.018 " diameter or 0.035 " diameter, the seal wire with preforming bending, deflectable Seal wire).

Interconnection cable can be configured as is connected to ablation console by ablation catheter, such as with coordinating fast coupling connector With suitable conductor.It can be suitable length (for example, about 8 ') to interconnect cable, will melt console and be detached with aseptic area, and Conduit operability is not interfered during program.

Delivery catheter can deflect at least one direction.It can have soft (for example, about 35D hardness), It is atraumatic tip, the tube chamber with the diameter (for example, about 0.174 ") suitable for slidably engaging ablation catheter, corresponding outer Diameter (for example, about .210 ") and allow ablation catheter by valve (for example, Tuohy-Borst valves).

Coolant hose group can be mutually compatible with coolant pump, for example, with by peristaltic pump carry out feed and and peristaltic pump The part worked together.Coolant hose group may include luer lock connection, with commercially available IV solution managements set group and expansion Open up set group compatibility.Pipe group may include the coolant delivery port that coolant is transported to ablation catheter handle from pump line part Pipe.The part of pipe can also include pressure relief valve, to be beaten in the case where being for example not intended to the high pressure caused by catheter blockage It opens.The part can also include pulsation damper.Coolant hose group further includes the coolant of ablation catheter handle to be connected to Return to the coolant recurrent canal of port.Coolant can be returned to coolant storage container or be abandoned by coolant recurrent canal. In one embodiment, coolant storage container only includes to be sufficient to enough coolants of limited amount ablation, and return It returns coolant to be dropped, therefore in the case of tube leaks, only limited amount coolant is transported in the blood flow of patient.

Ablation console can be the electric signal generator of computerization, and high frequency (example is transmitted to supersonic melting energy converter Such as, in the range of about 10 to 25MHz, about 20MHz) alternating current.Energy-delivering parameter can be selected by user or can be with It automatically determines.For example, console can read data from the memory in conduit, and correspondingly convey energy or with expectation Parameter for example lesion depths combine.Console can also coordinate coolant pumping or imaging capability.Console can identify instruction The condition of catheter malfunction or undesirable program simultaneously reminds user or adjustment energy conveying to mitigate problem.Console can by with It is set to and nerve stimulation signal is delivered to conduit.For example, mechanically or thermally stimulating the ultrasonic signal of nerve can be in not ablation tissue In the case of transmit, to determine effective or safe aiming of the ablation energy converter before conveying ablation energy and confirm after ablation Successful ablation.Optionally, conduit may include one or more stimulating electrodes, and console can convey electrical nerve stimulation Signal is to assess the degree of approach with nerve.

Vein is manipulated to obtain suitable ablation locations

The configuration of vein near target site can be different due to different patients, can also be different because of the not homonymy of patient. The ablation catheter 411 of any embodiment of all supersonic melting conduits as disclosed herein can be transported to close to target site 205 and the vein 12 in the suitable position for carotid body ablative surgery.For example, the condition of suitable position may include From the inner surface of wall of vein to the distance 410 on the target site such as boundary of arteria carotis spacer film in about 0 to 5mm, and it is quiet Arteries and veins 12 is with target alignment to allow ablation energy to convey and accessible or unsafe interference.The condition of replacement of suitable position is desirable Certainly in the construction of ablation catheter.Among the patients, in place in may there is no vein, however, ablation catheter can be with The vein of suitable position can be being maneuvered to by being transported to.Vein or intravenous catheter steering can be wrapped to suitable position Include technology such as below：Stereognosis neck, rotatable head deflect deflectable ablation catheter, and the knot from ablation catheter is unfolded For example extensible line of structure, deflects deflectable sheath or these combination.

As shown in Figure 21 A to 21B, deflectable sheath 412 can be configured to, for deflecting at least one direction, have The outer diameter of about 9FR to 16FR, and with inner cavity to slidably engage ablation catheter 411.Sheath can have elongated portion 413 and the deflectionable part 414 that is passed through with central lumen.Elongated portion can be surrounded to improve torque response by weaving chuck. Actively deflection can be realized by bracing wire, and the handle of the bracing wire tube chamber being drawstring through in sheath proximally reaches deflectable portion The anchoring piece of the far-end divided.Tension can be applied to bracing wire by the actuator on handle.Handle can also promote twisting to grasp Make, and includes chamber to receive ablation catheter with the clamp adapter of such as Tuohy-Borst connector.Sheath can be in sheath Remote area nearby or in its distal end regions include deflectionable part 414.Deflectionable part can with for example, about 1 to 5cm it Between long (for example, about 3cm long), and as shown in figures 21a and 21b be located at sheath distal end.

Figure 21 A show that the deflectable sheath 412 by non-deflected state is transported to the ablation catheter 411 of jugular vein 12, Wherein destination organization 205 is insufficient to close to ablation energy converter 415.Figure 21 B show the deflectable sheath in deflection state 412, ablation catheter 411 is pressed against wall of vein and manipulates extendable vein to obtain between destination organization and ablation energy converter Suitable distance 410.In such configuration, ablation catheter 411 can have bendable portion 416, the bendable portion 416 curved Song to allow the conduit far from bendable portion 416 to be aligned with vascular wall, but it is hard enough with to vein applied force to manipulate it Position.For example, bendable portion 416 can be with the hardness (for example, about 50D) within the scope of about 40D to 55D.Optionally, bendable Bent portions be characterized by when across 50mm and when deflecting into -2.5mm (the 5% of length of span), have about 1.25N+/- The bending stiffness of 0.38N, without imaging catheter in place.It during use, can be by making conduit 411 from conveying Sheath 414 promotes or retracts the length for adjusting bendable portion.By reducing the length of bendable portion, it is rigid that bending can be increased Degree allows the pressure for applying bigger to chamber wall, or the rigidity for allowing adjustment to include ablation energy converter 415 and imaging transducer Partial inclination.

Optionally, as shown in fig. 21 c, deflectionable part 421 can near the remote area of deflectable sheath 420, and And soft passive deflectionable part 422 can be in the far-end of sheath.Soft, passive flexible portion can provide and wall of vein Hurtless measure contacts, while the deflected wall that is pressed against of sheath by vein to be manipulated to the appropriate location melted for carotid body.Soft Passive flexible portion can also allow for the distal openings of sheath to be aligned with vein so that the ablation catheter such as institute conveyed by sheath Leave sheath with being parallel to wall of vein enough with showing.Soft passive flexible portion can by than elongated portion (for example, about 63D is hard Degree) and softer (for example, about 35D hardness) polymer of deflectionable part (for example, about 50D hardness) hardness be made.Passive flexible part The length divided can be in the range of about 1 to 3cm (for example, about 2cm).The length of deflectionable part 421 can be about 2 to 5cm In the range of (for example, about 3cm).

Method using the deflectable sheath with ablation catheter may include, and the entrance of sheath from such as femoral vein is quiet Arteries and veins is transported to the vein by close-target, such as quiet in jugular vein, facial vein or the neck that is connected near carotid body Other veins of arteries and veins.The embodiment of all ablation catheters as described herein of conduit is configured to be used together with imaging catheter Ablation catheter can be conveyed by deflectable sheath.Imaging mold (imaging modality) is such as located in ablation catheter In ultrasound imaging catheter or with ablation catheter integrate imaging transducer or be configured as be imaged and melt both transducing Device can be used for being imaged the tissue for melting surrounding catheter, and identify the relative position of target.If necessary to manipulate vein with Reach the suitable position for target ablation, can follow the steps below or the combination of step：The deflectionable part of sheath can be with It is deflected by controlling actuator；Sheath can be twisted to the deflectable end in torsion distal end at proximal end or handle；Ablation catheter It can be pushed into or retract in sheath to obtain from the deflectionable part of sheath to the suitable distance of ablation energy converter；Ablation is led Pipe can be twisted to the sighted direction of rotation ablation at its proximal end or at handle；And if ablation catheter be configured to it is deflectable , then it can be deflected.It can continue to be imaged when manipulating vein, or can intermittently execute imaging, until being enabled The position of people's satisfaction.It can be carried out during or after vein is satisfactorily manipulated to the position of ablation and sighted direction Adjustment.For example, ablation catheter can by rotation, propulsion, retraction or deflection, in imaging by ablation energy run-home.

It is configured as the transducer element for both being imaged and melting

Supersonic melting conduit may include the transducer assemblies for being configured for both being imaged and melting.As shown in fig. 22, It may include first transducer 425, second transducer 426, the back of the body to be configured to permit imaging and melt the transducer assemblies of ability Lining component 427 and electric conductor A, B and the C as shown for being connected to the first and second energy converters.As shown in Figure 22 B, can pass through Apply RF signals to electrode A and B to realize the high power of first transducer with the frequency (for example, about v/2a) proportional to 1/a Ablation vibration, wherein v is the velocity of sound in first transducer and a is the thickness of first transducer.Can be one or more change The second transducer of energy device is sandwiched between first transducer and backing member, and backing member provides the work(of installation first transducer Energy and imaging capability.The lower frequency proportional to 1/ (a+b) is (for example, about v/2 (a+b) or imaging v/2b) by passing through respectively The vibration of transducer assemblies is sensed to AC or BC to realize by electrode, wherein b is the thickness of second transducer.The backing of thickness c Reflector that component (wherein c be more than a or b) is mainly used as in ablation mode and as the absorber in imaging pattern.Backing structure The outer surface of part, which has, scatters and redirects surface characteristics (such as texture, angulation of the input signal far from imaging transducer region The ridge of degree), to reduce the ringing effect inside backing member.The inner surface of backing member can be flat and by minute surface Polishing is to enhance the reflectivity at the ablation operation frequency of about v/2a.Backing member is not (otherwise by second transducer Being accommodated) optional gap between first transducer can use air or liquid to fill.

For example, embodiment such as Fig. 5 A of the supersonic melting conduit with integrated imaging transducer, 5B, 6A, 6B, 7A, 7B、7C、8A、8B、8C、8D、34A、34B、34C、35、36、38、39、40、41A、41B、41C、42、43A、43B、43C、43D、 May include one group of imaging transducer as shown those of shown in 44A, 44B, 44C, 45A, 45B, 45C, 45D or 45E, but It is to replace ablation energy converter, which can have the transducer assemblies that both can be imaged and be melted.This can allow The place being guided accurately is generated the image of tissue by transducer assemblies in ablation.It is configured as receiving individual ultrasonic imaging The similar embodiment of the supersonic melting conduit (such as Figure 11,12A are to those of shown in 20) of conduit may include being configured to use In the transducer assemblies of ablation and imaging the two.

Optionally, as shown in figure 23, ablation catheter 430 can be not present one group of imaging transducer or for receiving individually The device of ultrasound imaging catheter and only have be configured for be imaged and melt both transducer assemblies (Figure 22 B) 424. In this configuration, compared with the embodiment with individual imaging capability, it may be more difficult to observe the tissue of surrounding target, but Advantage can be had in terms of cost and ease for use by being such configuration.Due to the embodiment phase with surrounding imaging capability Than, single transducer component has the ability for generating amplitude modes linear image (amplitude mode line image), because This user can manipulate conduit for example transducer assemblies from side to the other side are swung or are promoted by reversing conduit or Retraction conduit obtains multiple line images of surrounding tissue.Optionally, conduit can be configured as remains stationary, while have into Picture and the transducer assemblies of ablation functionality aim at the different directions in conduit.It is worn for example, transducer assemblies can be installed to The bar of conduit sheath is crossed, can be rotated by 360 °, or in predetermined hole, such as is tilted in an angle of 90 degrees.Optionally, transducing Device assembly can move (such as tilt, deflection, rotate) in multiple planes in conduit.This movement can be used for catching The image of the tissue of surrounding target is obtained, it is either that transducer assemblies run-home or mobile transducer assemblies is multiple to carry out Ablation, or transducer assemblies are swung to expand ablation.There is the energy converter for both being imaged and being melted shown in Figure 23 Embodiment is optionally configured to convey along seal wire or by deflectable conveying sheath；It is configured to manipulate blood vessel (example Such as, jugular vein or facial vein) position, as shown in figures 21a and 21b；It is configured to use sterile water or brine-cooled, wherein Energy converter can be electrical isolation, as be described herein with shown in Figure 44 A, 44B and 44C；It is configured to make without conveying sheath With, such as with multiple deflection or rotatory power, for manipulating vessel position relative to target area and changing imaging and ablation Energy device and boundary mark or target alignment, as shown in Figure 39,40,41A, 41B, 41C and 42, or for example including retractible energy converter Protector, as shown in Figure 43 A, 43B, 43C and 43D；It is constructed and carries expansible echoless film, as shown in figure 35；Quilt Construction carries sagging film, as shown in figure 36.

Supersonic melting dosimetry and deep-controlled

Laboratory and zooscopy has been carried out in author, is the transducing of about 2mm wide and 4mm to 6mm long to use size Device assesses the dosimetry of supersonic melting energy.Power between 3 to 8 sound watt, the frequency in the range of about 10MHz to 25MHz Time range between rate and 5 seconds to 20 seconds can allow 2mm between 9mm rational controllable trauma depth and by transducing What device width and length determined is suitable for from jugular vein targeting arteria carotis diaphragm (for example, positioned at away from jugular vein inner wall about 2-9mm's Tissue) lateral dimension.

It controls the effect of ability of depth of ablation is for clinical operation and safety is most important.It is dynamic in view of arteria carotis, neck The notable anatomical variations of arteries and veins body and jugular relative position, depth of ablation control for effective ablation targets tissue (such as Arteria carotis diaphragm), while safely limitation ablation areas is to avoid the iatrogenic injury to important non-targeted nerve or tissue Important.It is formed according to damage theoretical, humidity index is defined as at any time by thermocoagulation region caused by Ultrasonic Heating Integrate [Sapareto S.A., Dewey W.C.Thermal dose determination in cancer therapy Int.J.Radiat.Oncol.Biol.Phys.1984.V.10.№Bi P.787–800].It is generated by flat rectangular element Damage starts to travel to away from the farther deeper tissue of energy converter near energy converter and at any time along supersonic beam depth.It uses Thermal dose defines, and theoretical lesion depths can pass through integral rough estimate at any time：

Wherein d is the depth of damage, and T is tissue temperature, and t is the time.Based on finite element modelling, with the group of time change It is substantially proportional to the product of the acoustical power of application and ablation time to knit temperature：

T~Pt^β (2)

Wherein β is the dimensionless coefficient that tissue and energy converter rely on, and is less than or equal to 1.(it is suitable in simplest β=1 Active ultrasonic power deposition (active ultrasound power deposition) with insignificant volume heat transfer) In the case of composite equation (1) and (2), lesion depths provide as the acoustical power and the function of ablation time applied：

Assuming that β deviates 1, can derive the lesion depths of more complicated form with the growth of time, this correspond to by compared with For a long time with the ablation of lower-wattage composition, wherein heat-conduction effect is very important.The finite element modeling that damage is formed carries Gross data has been supplied to assess different beta coefficients, and has derived the trend between the acoustic energy of application and lesion depths.It was found that damage Depth and the acoustic energy of application are preferably described by hyperbolic cosine function：

Wherein damage growth parameter α is the minimum acoustic energy started needed for damage nucleation, and γ is to depend on energy converter geometry Shape, frequency and the anatomical Characteristic injury of surrounding tissue are against depth (lesion inversed depth) parameter.

Author determines that about 2mm to the target ablation depth bounds between 9mm may adapt to by anatomical research Ablation energy is transported to arteria carotis diaphragm from the conduit being placed in jugular vein.It is ground based on above-mentioned theory, laboratory and animal Study carefully, author is it has been proved that in first consistent with equation (3) is approximate, from the ultrasound of the resonant frequency with about 21+/- 2MHz The conduit for melting energy converter conveying ablation energy is big for the lesion depths of the energy acquisition about 1mm of every 10 acoustics joule.Energy Amount is acoustical power and the product of duration, therefore it is deep to control ablation using the kinds of schemes of control energy transportation parameters Degree.For example, energy transportation parameters can be selected to optimize multiple variables, such as：The duration is minimized to reduce patient's movement Risk；Utilize the substantially uniform duration-power bracket of wherein lesion width or height；For security reason, using pair It it is not too fast duration to needing the time for adjusting energy delivery to make a response in user or console；Using not being too high And with the power of increased overheat incidence；Use the rational transducer temperature liter for causing to be controlled by coolant flow High power；The duration is minimized to minimize the conduction heating to adjacent tissue；It is arrived using allowing to control lesion depths The parameter of about 0.5mm precision.

User can be for example by assessing come free imaging transducer establishment that can be with reference dimension based on ultrasound The image of video determine desired depth of ablation, and on ablation console select desired depth of ablation.Optionally, The video data that computerized Algorithm can for example be based on ultrasound automatically assesses desired depth of ablation, and will be desired Depth of ablation is passed to the ablation control algolithm of ablation console.Optionally, it is all can to assess anatomical features for computerized Algorithm Such as the relative position of internal carotid and external carotid artery and jugular vein and ablation energy converter, and to be input to can be confirmed or adjust The user for melting the expectation depth of ablation of control algolithm suggests the desired depth of ablation.Ablation control algolithm can use be suitable for It generates and it is expected the energy transportation parameters of depth of ablation to convey ablation energy.

Using computer finite element modeling, author have calculated that multigroup ablation time (for example, energy conveying it is lasting when Between) and apply acoustical power static temperature curve.The theory that the impairment parameter of calculating is indicated with experimental result and equation (4) becomes Gesture is consistent.Figure 24 A show the result 571 of the finite element modeling of lesion depths and energy.Line 570 is shown to be increased with damage The theoretical trend of the equation (4) of parameter alpha=3 joule and γ=0.5mm-1.

The accumulative effect of temperature is derived from the thermal dose of the amount of the energy of deposition, this is related with damage Cambium periodicity. It is mainly determined by transducer dimensions, the dimension (such as length and width) of injured side relatively quickly increases and when damage is deep Tranquilization when degree increases slower.For controlling lesion depths multigroup power and ablation duration for considering in the time In range (for example, in the range of about 5 seconds to 25 seconds), it is believed that lesion width and length are substantial constants.2mm depths Damage is considered to have the minimum controllable trauma depth of desired lateral dimension, and the desired lateral dimension is horizontal with energy converter It is consistent to size (such as 2mm wide and 4-6mm long).For every group of ablation time and power, lesion depths are modeled, are created Indicate the figure and equation (4) of the relationship between lesion depths and the acoustic energy of application, as shown in fig. 24b.

It is emulated using the polyacrylamide gel for the data point for generating the lesion depths for multigroup power against time (phantom) confirm the General Theory relationship between lesion depths and acoustic energy using laboratory research, the data point by with In generating relationship of the lesion depths as the function of energy, the relationship is very similar to theory relation.In general, by equation (4) theory relation indicated is provided to the accurate of both simulation (dotted line 573) and experiment (circle 574 and solid line 572) data Fitting.Computer simulation predict nucleation energy α=3J and depths of features constant inverse γ=0.5mm-1, and experimental data generate compared with Big α=17J and smaller γ=0.3mm-1.The difference of the damage growth parameter(s) of derivation reflects the thermit powder assumed in simulation Measure the difference formed relative to the damage that can be visually detected in polyacrylamide gel.Gel is in 70 DEG C of slightly higher temperature The protein of typical 42 DEG C of beginnings in the biological tissue for becoming opaque under degree, and being perfused with the non-zero assumed in simulation Denaturation temperature is compared, and has zero perfusion.Each conduit can have slightly different ablation energy converter to convey electrical power Response, and can be calibrated using acoustic measurement, to identify the relationship of its specific electrical power and total acoustic power.Based on disappearing Melt depth and the calibration of multigroup acoustical power and the relationship of time and the electrical power of each conduit to acoustical power, can create each The exclusive dosimetry table of conduit, the dosimetry table match desired depth and one group of ablation time and electrical power.

The example of dosimetry table-processing algorithm is shown in Figure 24 Ci, 24Cii, 24Ciii and 24Civ.The algorithm is false If the multinomial correlation (polynomial dependence) of injured depth and the acoustic energy of application.In the segment of Figure 24 Ci (panel) reference contours that the equation (4) of different lesion depths in acoustical power-ablation time space obtains are shown on 575.It is right The segment of side includes the total acoustic power measured value (Figure 24 Cii) of conduit 576, the control power index derived and ablation time 577 The depth residual error (depth residue) (Figure 24 Civ) of (Figure 24 Ciii) and target depth 578.Acoustics work(derived from experience The spatio-temporal ablation track of rate-is indicated by line 579.White diamond 580 shows one group of discrete, conduit specificity power And time value.The discrete setting of acoustical power and time have due to the ability that generator system controls electrical power and ablation time Limit.When the resolving power (resolution) of ablation time is limited to one second interval, the discretization of acoustical power depends on conduit spy Anisotropic acoustical power performance and generator is before amplification by the ability of controlling electric energy to 1dB.The algorithm is related to special in conduit It finds among property, the discretization power of generator and the time value of suitable optimum sound power against time track and is most connect with desired depth Close matching.Optimum trajectory is defined as the parabola of the origin at point A and the tangent line at point B, and midpoint A corresponds to 2 watts or more of minimum acoustical power at 3 seconds, and point B corresponds to the highest acoustical power at 25 seconds less than 6 watts.The algorithm uses Two inputs：First, the general lesion depths acoustic energy dependence value of experiment and theory deduction, second, conduit specificity acoustical power pair The dependence value of generator system control characteristic.The algorithm meets selected ablation track by minimizing function F to find The optimal generator power index of each desired depth and time pair：

Wherein δ P and δ t are acoustical power deviation and time deviation away from optimum trajectory, and δ d are inclined with optimum depth Difference, α=4, β=1, γ=1 are constants.

The example of the dosimetry table for particular catheter is shown in Figure 25.The first row of dosimetry table forms target Lesion depths, secondary series, which lists, is conveyed to the corresponding electrical power control that the electrical power of energy converter is converted by generator system software Index processed, third row are one group of corresponding ablation times (duration).In addition row are listed for verifying and quality control mesh Auxiliary information.Unique ablation dosimetry table can be programmed in the memory unit in particular catheter such as In EEPROM.In use, when particular catheter is electrically connected to ablation console, computerized Algorithm in console is from storage Device storage unit reads the unique depth of ablation table of the conduit, and when depth of ablation is selected either automatically or manually, algorithm choosing It selects corresponding power-ablation time setting and delivers energy to conduit using the setting to generate desired ablation deeply Degree.

Increase ablation size

It is usually related to depth of ablation to melt width.Controllably creating broader ablation can cause deeper to melt.From The conduit being located in vein (for example, jugular vein) conveys and the ablation energy for aiming at arteria carotis diaphragm can have from arteria carotis The outside (lateral) of the diaphragm depth dimensions that inwardly lateral boundaries are orientated.The depth of ablation can be optimized to cover these boundaries The distance between, and it can be desirable to avoid ablation beyond inboard boundary to reduce the risk for melting important non-targeted structure.Profit With the depth of ablation of optimization, the anatomical structure of patient is depended on, width can only cover a part for arteria carotis diaphragm width.It can It is expected to melt greater percentage of arteria carotis diaphragm to increase curative effect.Ablation size (for example, width or height) can pass through It is mobile to melt energy converter and optionally move together imaging transducer with ablation energy converter and increase, without increasing depth of ablation. For example, the movement of ablation energy converter can be realized by following：The side offside of the remote area of ablation catheter deflects (side- To-side deflection), the energy converter in rotary guide pipe or conduit, along blood vessel length translational movement conduit or change It can device.It can execute mobile to generate multiple independent ablations or be produced with being extended in the volume of bigger during energy conveys Raw ablation.Movement can be carried out in imaging, and wherein user can identify the boundary of desired target area, or ablation can be with By detecting target area boundaries and applying ablation energy only in boundary come computer control.Boundary may include for example solving Cut open structure, such as the boundary of arteria carotis diaphragm.The movement of energy converter in the catheter can manually be realized by user, or by even The servomotor (servomotor) for being connected to rotatable energy converter mounting base realizes that the servomotor is by computer automatically Control may include the feedback signal of such as edge detecting information to identify target area for required speed and distance Domain.The alternative for increasing ablation size can be by lens by ablation energy guiding to spread or diffraction energy.Lens can To be filled with liquid such as water or brine to adjust required diffusion or diffraction.Another alternative solution for generating wider ablation can Include conveying supersonic melting energy from the energy converter with convex surface.According to the anatomical structure of patient, user can select for Desired ablation width has the conduit of suitable flexible transducer.Optionally, conduit can with convex surface energy converter and Cover with the hole for being adjustable to custom ablated width.

Bubble is eliminated

The embodiment of anechoic room described herein comprising the coolant with flowing may be adapted to reduce or eliminate Bubble in coolant.Bubble may be unintentionally included in the source of supply of liquid coolant (such as brine or water).Pass through Surface tension, bubble may keep being trapped in anechoic room or be formed in ultrasonic transducer nearby or on ultrasonic transducer Energy is formed during conveying.This may have a negative impact to ablation or imaging performance.In the manufacture of conduit, carries surface and live The solution (such as isopropanol) of property agent can cycle through coolant transfer passage and anechoic room, and solution can be discharged and lead Pipe is allowed to stand for drying.Surfactant can be retained in fluid contact surfaces so that all surface is all wettable, that is, has drop Low surface tension is conducive to remove bubble.

The ultrasonic imaging of radiography enhancing is to check carotid body

Any application method of this paper may include ultrasonic contrast enhancing imaging, can improve to carotid body at As ability.For example commercially available SonoVue of acoustic contrast agent may contain microvesicle.Differential image analysis can by it is following come into Row：Using ultrasonic imaging energy converter (for example, on imaging catheter or external ultrasound is changed before and after injecting acoustic contrast agent Can be on device) image in photographic subjects region, and movement images are to protrude the tissue of radiography and non-radiography.Contrast agent can pass through note It was shot through sheath and was injected into the vascular system of patient, sheath can have the pad around ablation catheter sealing in proximal end Circle sealing, the injection port such as Luer lock with plug valve can be by contrast agent or other injections by the injection port It is injected into the chamber of the sheath in the space of ablation catheter to be deposited on except the distal end of sheath.Region containing contrast agent The typically region with blood flow, including carotid body.If the exact position of carotid body can such as be made with imaging technique Shadow enhances ultrasonic imaging, CT or MRI to identify, then target ablation region can focus on carotid body.If unidentified arrive neck The exact position of artery body, then target ablation region may include larger region, such as arteria carotis spacer film.

Melt energy converter backing

Ablation catheter may include ablation energy converter audio insulator or backing assembly.Melting energy converter can be in multiple directions Upper transmission ultrasonic wave.For example, what plate shaped energy converter was either substantially flat or was bent, it can be from the two of energy converter A face conveys ultrasonic energy.Backing assembly can be used for shielding the propagation of ablation energy, therefore ablation energy is only from ablation energy converter A face be guided, and backing assembly can be additionally used in reduce acoustic losses.

Backing can be sound absorption properties or reflexive.It is the such as empty of at least about 1mm that back member, which can be comprising thickness, The component of the thin layer gas of gas or carbon dioxide.Acoustic insulation body can be for example at least about 0.006 " (for example, about 0.008 ") dense material of thickness, such as stainless steel.

Including the embodiment of the acoustic insulation body of gas includes the air microballoon being embedded in the matrix of such as epoxy resin. When energy converter and audio insulator contact, compared with the acoustic insulation body made of brass or stainless steel, by embedded gas filled microsphere Epoxy resin made of audio insulator can have smaller mechanical couplings effect.In other words, when energy converter be positioned to it is micro- When ball insulator contacts, the vibration of energy converter may be suppressed than when its fine and close rigidity with such as stainless steel or brass is exhausted Edge body notable smaller when being placed into contact with.Therefore, it is positioned in the embodiment contacted with audio insulator in energy converter, gas filled microsphere Audio insulator may be more suitable.This design may have such as easily fabricated, less frangible energy converter, smaller conduit straight Diameter or before energy converter more coolant flowing spaces benefit.The combination of microballoon with various diameters can increase absolutely Volume of air in edge body.For example, smaller microballoon can take up the space between larger microballoon.Audio insulator can have The thickness of (for example, about 250 microns) in about 200 to 300 micron ranges, and can include to have diameter at about 15 to 25 microns In range the microballoon of (for example, about 20 microns) and with diameter for example in the range of about 180 to 210 microns (for example, about 200 Micron) microballoon combination.

Create the fiducial marker for aiming at artifact

It, can be by fiducial marker for the embodiment described herein for including one or more imaging transducers It is located in ablation catheter pseudo- to provide differentiable aiming on the video based on ultrasound with imaging ultrasound wave interaction Shadow aims at position of the artifact identification relative to the conveying direction of ablation energy.Due to rotation of the imaging catheter in ablation catheter Positioning can be variable, this can be particularly useful to being configured to accommodate the ablation catheter of individual imaging catheter.Fiducial mark Note device, which can have, is for example markedly different from the acoustic characteristic of surrounding tissue, thus echo than surrounding tissue bigger (high echo) or Smaller (low echo).The material of fiducial marker or surface can be sound wave high reflection or height relative to the surrounding tissue being imaged It absorbs.Compared with the surrounding tissue being imaged, fiducial marker can have more consistent echo.Fiducial marker can be determined Position is at the negative direction that instruction ablation energy conveys on the video based on ultrasound.In the configuration, the image (example of artifact is aimed at Such as, shade) it will not interfere with the image of target area and surrounding tissue.The image of aiming artifact on video based on ultrasound can To be differentiable shape, such as wedge shape or in one direction from the black that sends out of center of the video based on ultrasound or white Lines, and user is appreciated that ablation energy aims at opposite direction.

It is contemplated that other relative directions or arrangement of fiducial marker.Disappear for example, two fiducial markers can be located at Melt on the either side of energy converter, between indicating that ablation energy is conveyed the aiming artifact generated at two.Optionally, two thin Fiducial marker can be positioned in close, should to generate the image for being similar to two bright wisp bands and being close to a narrow strips Image may be more accurate and detectable aiming artifact.Alternatively, as long as taking aim at for fiducial marker and ablation energy is illustrated Fiducial marker can be placed on the other positions of the circumference around conduit by the relative position in quasi- direction.

Compared with the typical organization in target area, fiducial marker may include with imaging ultrasound wave interaction, with The material for absorbing or reflecting ultrasonic wave with the differentiable mode of typical organization in target area.For example, the material can be caused Close material, such as stainless steel or the pneumatic element for inhibiting transonic.In some embodiments, fiducial marker can be also The component of back lining materials as ablation energy converter, the back lining materials also inhibit the conveying of ablation energy.In other embodiments In, fiducial marker can be individual component, or can provide other functions, such as distal component, guidewire lumen or The structural support of echoless Housign support.

One embodiment of fiducial marker includes having containing receiving gas filled microsphere tube chamber in air or epoxy resin Stainless steel hypotube.Hypotube can at both ends with adhesive seal to accommodate air or microballoon.Hypotube can have for example About 0.028 " to 0.038 " outer diameter.

The another embodiment of fiducial marker includes line such as round wire (for example, with about 0.028 " to 0.038 " Diameter) or flat belt-like line (for example, with about 0.005 " multiply 0.030 " section).Line can be stainless steel.Optionally Ground, line can be sealed by the component further to interact with ultrasonic imaging wave, for example, wire coil can be wound online On or line can be coated in the epoxy resin of the microballoon containing air.

Fiducial marker can have the increased echogenicity compared with surrounding tissue, to increase its specific characteristic.Example Such as, fiducial marker may include the rough surface of reflectivity or the groove of linearity pattern or with texture for improving ultrasonic wave Surface.When imaging transducer is not parallel to reference mark, this can be particularly useful.Some ultrasound imaging catheters include with The energy converter that the axis of conduit is positioned at minute angle.Although angle can make wave reflection go out base with very little with incidence angle Fiducial mark is remembered, the ability of energy converter capture echo is reduced.

Fiducial marker may include the piezoelectric element vibrated when applying high-frequency current, and transmitting can be examined by imaging transducer The acoustical signal of survey is to provide the robust image of fiducial marker.

Image enhancement

The system of tissue for being imaged to target area and in ablation targets region can provide digital video or Video based on the video of ultrasound, the digital video or based on ultrasound is reflected tissue from what ultrasonic imaging energy converter emitted And the ultrasonic signal received by imaging transducer generates.It is shown in FIG. 30 in the jugular vein being placed near carotid bifuracation IVUS conduits generate based on ultrasound video frame example.

Can be assisted by vision, animation or message further enhance the video based on ultrasound, with provide a user can It can help to understand the video based on ultrasound, planning or the information for carrying out carotid body ablation procedure.

With image enhancement may include conduit for being imaged and melting the embodiment of the system of carotid body, described Conduit has ultrasonic imaging energy converter and ablating device；Melt console；Ultrasonic imaging console, the ultrasonic imaging console With for signal to be transported to imaging transducer and receives the device of signal from imaging transducer；The calculation executed with computer Method creates the video based on ultrasound from imaging transducer received signal；Image enhancing unit utilizes the figure for creating enhancing Video of the computerized algorithm processing based on ultrasound of picture；And the display of the image of display enhancing.It is shown in FIG. 27 and is The schematic diagram of system.Image enhancing unit hardware may include image or frame grabber, RAM, CPU, memory such as hard drive Device and graphics card.Imaging control console can (a) ultrasonic imaging signal is sent to imaging transducer 435, (b) from energy converter receive Echo signal, and the vision signal based on ultrasound (c) is sent to image enhancing unit.Ablation console can (d) will disappear Melt energy and be sent to ablation 436 (for example, supersonic melting energy converter), (e) from such as temperature sensing of the sensor in conduit Device receive feedback, (f) send information (for example, ablation state, energy transportation parameters, user interface control, display will be shown in Information on device) arrive image enhancing unit, and (g) from image enhancing unit receive information (for example, to control ablation state, To control energy transportation parameters).Image enhancing unit can send the video to display with (h).

Conduit can be an embodiment of ablation catheter described herein, the ablation catheter be configured to accommodate ultrasound at It is integrated as conduit or with imaging transducer, and can also be including aiming at artifact to identify the ablation energy on the video based on ultrasound The direction of transfer of amount.Ablating device may include supersonic melting energy converter or pass through vascular wall with RF energy or chemical agent is defeated It send to other ablation energy conveying device such as needles of ablation targets tissue.The system can also include being suitble to ablating device for example The ablation energy console of ultrasonic generator or RF generators.

Imaging transducer or energy converter can be for example positioned at ablation (for example, supersonic melting energy converter, RF needles, use In the needle, RF electrodes, laser emitter of injected chemical medicament) remote area of neighbouring ablation catheter or piezoelectricity thereon or electricity Hold energy converter.Imaging transducer can by the space around the remote area of Acoustic Wave Propagation to conduit, and receive in the space from The echo of Tissue reflectance.

Ultrasonic imaging console, which can generate electric signal and control, is converted into the signal of sound wave to the biography of imaging transducer It send.The echo received by imaging transducer can be converted into electric signal, which is transferred back to imaging control console.Some realities The scheme of applying can use individual transmitter and receiver component or console.In some embodiments, imaging transducer can To be located in ultrasound imaging catheter (for example, Volcano Corporation0.035 conduit or Boston The UltraICE of Scientific^TMConduit) on, and ultrasonic imaging console can be the system compatible with imaging catheter.It can To be separately provided imaging catheter and compatible imaging control console with system, system can be configured as accommodating the imaging catheter and at As console.In another embodiment, imaging transducer can be integrated in ablation catheter, imaging control console can with disappear Melt energy hole platform to separate or be desirably integrated into individual unit, and both imaging transducer and imaging control console can be made For a part for system.

By shock energy converter echo generate and passed back to imaging control console electric signal can be used for create can be displayed in it is aobvious Show the image or video (video i.e. based on ultrasound) on device.For example, signal can be with algorithm process performed by computer and defeated Go out to the display or video-out port on ultrasonic imaging console.

Image-capture hardware for capture images or video is known in the art, and can be regarded by capture single frames Frequently, the analogue value is converted into number and the hardware interface that result is fed to computer forms.For example, Image grabber can connect The video-out port being connected on ultrasonic imaging console, and can the number of video being explained to, being sent to image enhancement calculates Machine, image enhancement computer can be incorporated to supersonic melting console either individual unit.

Image enhancement computer can run the algorithm for enhancing video.The algorithm can handle each video in real time Frame, the video frame use the orientation of reference mark or aiming artifact tracking ablation catheter in image.The algorithm can pass through It finds and or not any unique label of shape when orientation changes to identify aiming artifact.It can be by base to the input of algorithm In the video, ablation console (for example, console state, energy feed status, depth parameter) or user interface (example of ultrasound Such as, the identification, setting of anatomical features, scaling, translation, contrast, feature to be shown) it provides.Output can be to display (for example, the image of enhancing, the original video based on ultrasound, the enhancing being superimposed upon on the video based on ultrasound image) or to disappearing Melt console (for example, signal of the signal of control energy conveying, control energy transportation parameters such as power and time).

Other than the video of capture, user can control the input to algorithm.For example, user can select desired disappear Melt depth or identifies a part for anatomical structure, such as internal carotid or internal carotid.User input can by can comprising On the unit (for example, ablation console) of image enhancement computer user interface (for example, knob, driver plate, touch screen, mouse, Voice control) it controls.Before conveying ablation energy, user can adjust depth of ablation on ablation console, for example, such as The superimposed image of the ablation of fruit estimation presents long and extends beyond the boundary or too short without filling of arteria carotis diaphragm Divide ground filling arteria carotis diaphragm, and the superimposed image for the ablation estimated can reflect the depth of adjustment.It is super in ablation Sound melts in the embodiment of energy converter, and depth of ablation can pass through the parameter such as power and time of automatic adjustment given frequency To control.

Algorithm for image enhancement can output signals to display.For example, if algorithm is physically included in ablation control On computer in platform, output can be to output port (for example, VGA, S-video, the port DVI, HDMI) or to outside being connected to The cable of portion's display melts the display on console to connection.External display can provide together with system, or A part as catheterization lab equipment is provided separately.Other than the video based on ultrasound with strong image superposition, Display can also show other information such as fluorescopy or X-ray, patient information or physiological parameter.

The black and white version of the embodiment of the video frame of enhancing is shown in Figure 28 to 31.The algorithm can identify that imaging is led The expection image (image usually can be the black circles 440 of picture centre) of pipe and aim at artifact (its usually can be from Uniqueness (for example, black or white) wedge 441 of image center location radiation.Such as it is sent out by fiducial marker or synchronous aim at Individual imaging catheter is being inserted into the embodiment in the imaging catheter chamber of ablation catheter by the aiming artifact that emitter generates Can be particularly useful.Optionally, the embodiment integrated for wherein imaging transducer and ablation catheter, can be by benchmark Marker synchronizes and aims at transmitter or by omitting imaging transducer on the opposite direction in the sighted direction with ablation energy It generates aiming artifact, or replaces with aiming at artifact, sighted direction may be programmed into imaging algorithm and be shown in and is based on On the video of ultrasound.User can use fluoroscopy imaging guiding that the conduit containing imaging transducer is transported through vascular system It unites to the region close to carotid bifuracation.In the example shown in Figure 28 to Figure 31, conduit is transported to neck by intravenous route and moves Region near arteries and veins bifurcated.Can be that anatomical structure is expected based on conduit carrying method by arithmetic programming.The example shown in In, algorithm it is contemplated that the black circular shape 442 around the imaging catheter of the heart is jugular vein 12 in the picture, and Two black circles 443 and 444 in region in about 3 to 8mm size range may be arteria carotis.If imaging system energy Enough to other anatomical features such as carotid body or carotid nerve or non-targeted neuroimaging, then they can also be known Not.As shown, the image of enhancing may include the image of the superposition on the video based on ultrasound, such as arteria carotis is (for example, neck Total artery, internal carotid 445, external carotid artery 446) profile, the profile 447 of ablation catheter indicates the sender of ablation energy To or ablation towards or direction that ablation energy will be conveyed arrow 448.In the embodiment illustrated, ablation Can be supersonic melting energy converter, and the image enhanced includes the estimation damage for indicating to project on ablation energy conveying direction The line 449 of width.The estimation ablation site that the image of enhancing also includes in the position that expected estimation ablation site 450 is created 450 profile.If the ablation profile of estimation is located in inappropriate region (for example, if it is not or not the side of arteria carotis diaphragm In boundary, if it contacts or be too close to arteria carotis, or if it is in the position previously melted), can be 451 (for example, red, to be shown with dotted outline in Figure 31) that can be identified.If the ablation profile of estimation is located at ideal The position of ablation is generated, such as between arteria carotis in arteria carotis spacer film, can be identified (for example, green, such as Figure 28 In dotted outline 450 shown in).

In order to confirm the identification of internal carotid and internal carotid, it may may require that conduit is slided disengaging by user at leisure Several centimetres, this may create two arteria carotis with conduit is pulled out and converge at arteria carotis communis and as conduit is pushed into and It is branched into the video of internal carotid and external carotid artery.

As shown in figure 30, when ablation energy is transmitted, the image of enhancing can show animation to indicate energy conveying, example Such as the colourama (being shown as line 452 in Figure 30) of bounce.It can show animation of the instruction through the time course of ablation duration, Such as the ablation profile that the color-bar (being shown in FIG. 30 as line 453) of growth can fill estimation, it is indicated without profile Time=0s and integrity profile instruction complete duration.

After having generated ablation, the image of the ablation 453 for arteria carotis can be shown, such as with unique face Color for example white, the ablation and ongoing second ablation that display is completed as shown in figure 33.

The information calculated by algorithm for image enhancement can feed back to energy and convey console.If conveying the phase in ablation energy Between exist unintentionally move, then the image algorithm enhanced can to ablation console send signal to suspend or interrupt ablation energy Conveying, and the image enhanced can not may have with the ablation profile of such as red color display portion filling with instruction There are the right times for reaching and generating desired depth of ablation, and user can select to carry out another ablation in same position.

If conduit pushes or pulls on back forward, algorithm for image enhancement can use the distance between internal carotid and external carotid artery Variation calculate translational movement.

Information from other imaging sources such as fluoroscopy, MRI, CT or the second ultrasonic imaging energy converter can input Into algorithm for image enhancement, and it can be used for creating the image of the position of carotid body or nerve, to calculate angle of forking, with wound 3D rendering is built, or to calculate the height of the ultrasonic imaging plane higher than carotid bifuracation.

The distance away from carotid bifuracation can be identified (for example, leading to carotid bifuracation more using another standard Distance on advantageous direction).For example, fiducial marker can be the slidable line of intracavitary in conduit.Line standard can be with With the differentiable echo label that can be aligned with carotid bifuracation.When conduit is pushed into, line standard can be maintained at Position appropriate.Line standard can have another at away from the first label preset distance (such as away from first label about 6mm) Diacritic label.When conduit is pushed into when seeing the second label, it is possible to understand that imaging plane is apart from bifurcated preset distance (such as 6mm).Line standard can have multiple labels (for example, per 2mm) of instruction increment.Line standard can also have not The label of radioparent can show in fluoroscopy.

Algorithm can control the rotation of image so that can for example show the image of enhancing, wherein sighted direction always to On.

Algorithm for image enhancement can use known dimensions such as conduit diameter or aim at artifact width as scale, and The distance between and calculate anatomical features, such as jugular vein, arteria carotis diaphragm, internal carotid, external carotid artery, arteria carotis diaphragm The relative position on boundary, artery diameter, the variation of artery diameter, the variation of the relative position of anatomical features, the ablation of estimation or The size and relative position of generated ablation.The distance of calculating may be displayed on the superimposed image of enhancing, for example, as row Table or label.Algorithm can provide instruction or suggestion to the user based on the distance of calculating, for example, how to reverse or deflectable catheter with The blood vessel (for example, jugular vein) of receiving conduit is manipulated, reverses the how many distances of conduit and where to disappear to torsion conduit to adjust The aiming for melting element, on depth of ablation or influence depth of ablation parameter adjustment, how by conduit into and out blood vessel with Realize suitable position.

Algorithm for image enhancement can be to ablation console input information.For example, the measurement calculated by algorithm for image enhancement Value and relative position can be used for adjust automatically parameter (for example, power and time) to control depth of ablation, to disappearing for estimation Melt size in the space most preferably between the inner side and outer side boundary of arteria carotis diaphragm and fills the space.Algorithm for image enhancement The apparent motion during ablation can be detected, signal can be sent to ablation console to suspend or terminate the defeated of ablation energy It send.It can be melted with weave mode, wherein ablation energy melts energy converter to swing in mobile target such as rotary ultrasonic It is transmitted from an arteria carotis to while another arteria carotis across arteria carotis diaphragm.Algorithm for image enhancement can indicate to the user that When move or how fast movement aims at, and when a large amount of energy is transmitted to position, ablation console can be transmitted Number with suspend energy conveying, then continue when algorithm for image enhancement, which detects, is moved to appropriate location convey energy.Optionally, The movement that ablation aims at can be controlled by mechanism such as servomotor, and the mechanism passes through measured value and phase based on calculating To position to the input control from algorithm for image enhancement.

Mobile detection

Ablation energy, especially supersonic melting energy can be less than about 30 seconds (for example, less than about 25 by the transmission duration Second is less than about between 20 seconds, about 7 to 23 seconds).When ablation energy is transmitted, the sighted direction of ablation energy may be unintentionally It is moved from desired target direction.This can cause to generate ineffective ablation in desired destination organization or damage non-target tissues Risk.Disclose some methods for mitigating these risks.

Orientation ablation energy can be for example by patient's movement (for example, moving-head, cough, beat from the movement of destination organization Sneeze, shrink back caused by it is unexpected or slowly moving) or the movement of the component for being connected to conduit of conduit or patient-external draw It rises.

It may include following that detection orientation ablation energy is moved from the possibility of destination organization：Manually or automatically by user The movement of patient body or head is monitored using the sensor of picture charge pattern or such as accelerometer；Imaging algorithm can be programmed Or algorithm for image enhancement is identified for increasing the important movement of risk；It can be by such as accelerometer or multiple accelerometers Sensor is placed in the ablation catheter of all ablation catheters as disclosed herein；It can be using for example being examined using magnetic field or electric field 3D orientations and the tracing system of the magnetic coil or electrode that are located in ablation catheter are surveyed to track the device of patient's body.

It reduces mobile risk and may include following methods：If detecting movement, user can manually cut off energy conveying； Can require user that actuator is maintained at on-position with convey energy and can by discharging actuator it is rapidly right Movement is made a response；Automatic patient, which moves detection, can be input to energy conveying console to stop or adjust energy conveying；Inspection Console can be conveyed to energy and send signal by surveying the imaging significantly moved or algorithm for image enhancement, it is made to stop or adjust energy Conveying.

When stopping or adjusting energy conveying, energy conveying console can be shown to user due to potentially moving risk And the message for cutting off the conveying of energy.The number that the message can further display process is completed.

Ultrasonic image-guided interstitial ablation needle

Many embodiments disclosed herein include high energy ultrasonic as ablation energy.Blood vessel with imaging capability The alternate embodiment of inner catheter may include the mesh of the ablation energy of other forms nearby with ablation vessels (such as jugular vein) Mark tissue (for example, tissue in arteria carotis diaphragm).Ultrasonic image-guided pin type ablation catheter can be used in combination in detection mesh Mark and by the intravascular ultrasound imaging energy converter of ablation needle target goal.Ablation needle can transmit ablation agent or other ablation energy Amount, such as radio frequency or cooled RF.As shown in figure 32, ultrasonic image-guided interstitial ablation needle catheter 460 may include surpassing Acoustic imaging energy converter and extensible needle.Imaging transducer 461 can lead on individual conduit (for example, IVUS conduits) The chamber 462 crossed in ablation catheter is advanced to the remote area of ablation catheter.Imaging transducer can be located at optional anechoic room In 463, anechoic room 463 includes the fiducial marker 464 for aiming, and fiducial marker 464 reflects or absorb ultrasonic wave, with Differentiable artifact is generated on the video based on ultrasound, which represents the relative direction that extensible needle 465 will be pushed into. Extensible needle can have tip 466 to pass through vascular wall (for example, jugular vein 12) to promote.As shown, blunting probe 467 It can be released from sharp syringe needle to pass through destination organization.Blunting probe can pass through such as fatty group in target area It knits, and reduces the risk for puncturing artery (such as arteria carotis) or the non-targeted nerve of damage.Probe 467 can be configured as conveying Ablation energy.For example, it may include RF electrodes 468, cooling RF electrodes or the chamber for conveying ablation agent.Probe can wrap Such as temperature sensor containing sensor 469 (such as thermocouple), to monitor or control energy conveying.Extensible prong or probe There can be echo coating to improve ultrasonic imaging.Conduit can be deflectable or be conveyed by deflectable sheath to help Positioning manipulates vein to obtain suitable ablation locations.Multiple needles can be disposed in bipole arrangement for example to be penetrated by transmission Frequency generates larger ablation.Carotid body stimulant (such as adenosine) can pass through injecting cavity 470 before and after ablation Or extensible needle or probe are transported to target area, to confirm whether carotid body has inactivated.

As shown in figure 33, the alternate embodiment of ultrasonic image-guided pin type ablation catheter 471 may include and melt The integrated imaging transducer 472 of conduit.Compared with embodiment shown in Figure 32, which can have relatively narrow diameter (such as in the range of about 8 to 10FR, about 9FR), and lacking for imaging catheter chamber provide more spaces for needle cavity 473. The relative direction that one group of integrated imaging transducer 472 can allow needle to be unfolded is programmed into the video based on ultrasound and generates software In, so as to the direction of the indicator expansion on the video based on ultrasound.Optionally, the integrated imaging transducer of the group can be with Including in energy converter spacing gap or fiducial marker, with generate identification relative to needle expansion direction relative direction it is distinguishable The image of knowledge.

It is transported in the embodiment of destination organization in wherein chemical ablation agent, chemical agent can be in the medium of low viscosity It is conveyed in such as gel, therefore it keeps being local to destination organization.

Ablation catheter with integrated imaging transducer

The embodiment that Figure 34 A, 34B, 34C, 35 and 36 show ablation catheter comprising be located at ablation energy converter distal end Integrated imaging transducer.These embodiments, which can lead to sheath, which to be crossed, can turn to sheath conveying shown in such as Figure 25 A to 25C To in the vein of close-target arteria carotis diaphragm (for example, jugular vein).Sheath can be turned to and can be used for manipulating vein relative to mesh The position of arteria carotis diaphragm is marked, or helps to position and aim at ablation energy converter.These embodiments can have about 8.5FR extremely The diameter of 9FR.

Figure 34 A show the distal component 480 of ultrasound catheter comprising it is (such as described herein to be installed to back lining materials 482 Those of) ablation energy converter 481, back lining materials 482 are mounted to ablation energy converter supporter 483.Energy converter is melted to support Part is machined into including cavity 484, with (for example, about 0.0008 " the thick PET or about 0.0003 " of thin polymer shell 485 Thick nylon) it combines and defines anechoic room.Polymeric shells around anechoic room and be sealed to ablation energy converter supporter with Airtightly seal the room.Coolant can be transported to anechoic room by the coolant conveyor chamber in conduit sheath, there it Chamber is left from coolant delivery port 487.Conduit be constructed such that coolant in ablation energy converter on by keep suitable Transducer temperature, therefore it will not be overheated.Overheat may be damaged energy converter, conduit or vascular tissue, or lead to blood clotting. Coolant can leave room via coolant discharge port 486, and coolant outlet port 486 connects with fluid discharge 488 fluid of chamber Logical, fluid discharge chamber 488 makes coolant be transmitted along conduit sheath, and it is external to release into patient.By comprising along sheath and disappearing Melt the guidewire lumen 490 (referring to Figure 34 B and 34C) of energy converter supporter or in the fast exchange guidewire port in distal end of catheter region (for example, fast exchange guidewire port can be positioned at ultrasonic transducer distal end, being not shown), conduit can be optionally configured to It is conveyed on seal wire 489.Conduit includes a series of imaging transducers 491.As shown in the cross section B-B of Figure 34 C, imaging transducer can With around the circumferential registration of conduit, in addition to position 492 opposite with the ablation sighted direction 493 of energy converter on circumference.It is from this The video based on ultrasound that the imaging transducer of row generates can show the artifact of the energy converter from the missing, provide ablation The instruction of the sighted direction of energy converter.Optionally, imaging transducer can surround the whole circumference positioning of conduit, and can disable For the program segment of the array to provide image artifacts, which provides the instruction of the sighted direction of ablation energy converter.Optionally, The whole circumference that imaging transducer can surround conduit positions, and stops that the imaging artefacts of imaging ultrasound can be positioned in for example The direction opposite with the ablation sighted direction of energy converter, with the aiming side of the identification ablation energy converter on the video based on ultrasound To.Optionally, ablation energy converter may be programmed into generation based on ultrasound relative to a series of sighted direction of imaging transducers Video software in, so as to based on ultrasound video on indicate sighted direction.

Embodiment shown in Figure 35 include around ablation energy converter 496 fluid filling sacculus 495, with accommodate such as without The flowing coolant of bacterium water or brine.Sacculus can be conveyed with non-unfolded state in sheath, and worked as and pushed away from sheath When going out, coolant the cavity in sacculus can be transported to by coolant Delivery lumen with increase pressure and by sacculus be deployed into as There is increased diameter unfolded state shown in figure.Unfolded state can allow the coolant volume of bigger to surround ablation transducing Device, or the energy converter for melting embodiment shown in energy converter ratio Figure 34 can be allowed big.

Embodiment shown in Figure 36 includes with the small perforation for allowing coolant (such as brine) 502 to be leaked from room 501 leakage polymeric shells 500.Leakage shell can prevent blood heat up or be agglomerated to treatment ultrasonic energy be passed Conduit.

Embodiment shown in Figure 35 and 36 can optionally include other features of Figure 34 A, 34B and 34C descriptions, example Such as catheter lumen and the device for being used to indicate the sighted direction for melting energy converter.

Embodiment shown in Figure 38 includes ablation energy converter 585, is oriented mainly laterally to emit from conduit and disappears Melt ultrasonic energy.The distal end of ablation energy converter is mounted to the rotation imaging transducer 587 of drive shaft 588, and drive shaft 588 can To reach the proximal end of conduit by conduit sheath, rotated by motor in the proximal end drive shaft 588.Fiducial marker 589 can be with In the visual field of imaging transducer, the relative direction of the sighted direction 586 relative to ablation energy converter is provided.Rotary-type imaging Energy converter can generate the image or video based on ultrasound of almost plane, and the plane transverse is far from (for example, far from about 2mm, far between about 1mm and 3mm, far from being less than about 4mm) conduit of ablation energy converter.Fiducial marker can be stainless steel Other embodiments of band or such as seal wire of the component with multiple functions or fiducial marker as described herein.

Optional embodiment, which can have, to be positioned at ablation energy converter proximal end or is positioned at ablation energy converter proximally and distally One or more imaging transducers of the two, such as shown in this paper Fig. 6 A, 6B, 7A, 7B, 7C, 8A, 8B, 8C and 8D. These figures show that the conduit with imaging transducer 125,133,132,140,141 and 142, these imaging transducers generate generation Wedge-shaped image of the table around the part in the tissue cross section of conduit.In other embodiments, imaging transducer can be by cloth Multiple energy converters or rotatable transducer are set to (for example, see embodiment party shown in Figure 34 A, 34B, 34C, 35,36,38,45A-E Case) to generate the complete cross section of the tissue around conduit or the major part in cross section are represented (for example, more than 75%, being more than 85%) image.This arrangement of multiple energy converters or rotatable transducer can be positioned at the remote of supravasal ablation energy converter End, proximal end or both proximally and distally.It is a kind of to use the imaging transducer or one group of imaging transducing that include ablation energy converter proximal end The illustrative methods of the conduit of device may include：Mobile conduit until imaging transducer by relative to target ablation position (for example, neck Artery diaphragm) positioning with provide target site image or with the relevant anatomic marker of target site (for example, internal carotid, External carotid artery, carotid bifuracation), and the position of conduit is adjusted so that imaging transducer to be moved to the position of target ablation position proximal end It sets, so that energy converter and target ablation position positioned in alignment will be melted.For example, imaging transducer or more than one energy converter can To generate the image of tissue plane, the tissue plane is apart from the center about 1 for transmitting covering weave of ablation energy converter to 15mm (examples Such as, about 5mm, about 10mm, about 3 to 12mm).Conduit can be moved until obtaining anatomic marker such as carotid bifuracation protuberantia Image, this may indicate that ablation energy converter is positioned in desired locations so that ablation energy is transported to range image known distance (for example, about 1 to 15mm, about 5mm, about 10mm, about 3 to 12mm), which can further be aligned with destination organization with safety Effectively ablation targets tissue.Other exemplary application methods above for Fig. 6 A-8D descriptions can also be executed.Conduit can Be further configured to provide ablation energy converter sighted direction instruction, it is all as described herein those (for example, fiducial mark Remember device, the instruction in relative boresight direction of the ablation energy converter on the ultrasonoscopy generated by imaging transducer is provided, or The group of imaging transducer can be configured to create the artifact consistent with the ablation sighted direction of energy converter).

The integrated imaging including being positioned at 703 proximal end of ablation energy converter is shown in Figure 45 A, 45B, 45C, 45D and 45E The distal tip 700 of the embodiment of the ablation catheter of transducer array 702.Above for the embodiment in Figure 34 A-34C Any disclosure appropriate, including relevant application method can be similarly incorporated embodiment party shown in Figure 45 A-45E In case.

The method for manufacturing imaging transducer or array is known in the art.For example, imaging transducer arrays 702 can root It is manufactured according to method is transferred disclosed in 6776763 B2 of US of Volcano Therapeutic Inc., and it is by drawing With being incorporated herein.

As shown, in the present embodiment, ablation catheter includes guidewire lumen 718, is constructed such that guidewire lumen 718 can To be conveyed by seal wire 705.Seal wire can be in order to being transported to the small blood vessel of especially diameter or across the bending of racing by conduit Conveying, such as when conduit is transported to jugular tributary such as facial vein.Conduit can also be defeated by conveying sheath 706 It send.Figure 45 B show the side view of the embodiment of Figure 45 A, and illustrate the construction of guidewire lumen.Conduit sheath 706 can be by having about 40D is to 55D hardnessIt is made and there is center cavity 708.Sheath 706 is connected with imaging array 702, imaging array 702 ablation energy converter supporters 710 are connected.Echoless membrane material 711 partly defines the echoless for including ablation energy converter 703 Room 712.Ablation energy converter supporter also partly defines anechoic room 712.In the distal end of ablation energy converter supporter 710, even Radiopaque, circular distal lid 714 is connect.

As shown in Figure 45 B, pipe 715 can be set and extend through the center cavity 708 of sheath, by imaging array Center cavity, and extend to the proximal end of ablation energy converter supporter 710.Pipe 715, which may include to carry, is connected to energy converter simultaneously It is transmitted to the chamber of the electric wire (being not shown for clarity) of the proximal end of conduit, for the electric wire of temperature sensor (not shown) To measure ablation transducer temperature and define the wire leading pipe 716 of guidewire lumen.Wire leading pipe 716 can be with interior diameter (for example, About 0.020 ") flexible polymer property management such as polyimides, seal wire (for example, with about 0.0181 " diameter) can be by this Wire leading pipe is inserted into.As shown, wire leading pipe 716 passes through pipe 715 and by melting the subsequent channel of energy converter 717 (relative to disappearing Melt the sighted direction of energy converter) in ablation energy converter supporter 710, then reach end cap 714 center cavity 718.Wherein This construction of central shaft (it is referred to as the longitudinal axis herein) out-of-alignment of guidewire lumen and conduit allows to melt energy converter quilt Be positioned close to or positioned at conduit central axis.By positioning ablation energy converter close to or at central axis, rather than Close to conduit periphery, conduit diameter can be made and melt the ratio smaller of transducer width.For example, ablation transducer width can be with It is 2mm and conduit can be 8.5Fr.In some embodiments, the ratio of conduit diameter and ablation transducer width is no more than 2.5.In this embodiment, guidewire lumen optionally ablation energy converter position proximally and distally generally not with guidewire lumen Alignment.

The embodiment of exemplary ablation catheter shown in Figure 45 A and 45B is configured to use brine as energy converter Coolant.As shown in streamline 719, brine can flow through the chamber of pipe 715 and enter anechoic room 712, then pass through end cap 714 Center cavity 718 leave conduit and enter blood flow, carry extra heat and left from ablation energy converter.Optionally, brine-cooled agent Anechoic room can be left by the hole (not shown) in film 711, which can on the surface of anechoic room 712 or indoors Remote area in be evenly spaced apart.The coolant left by film can provide the Thermal protection of vascular wall.Optionally, brine Coolant can by the distal end of anechoic room in conduit but do not shared with wire leading pipe 716 the port (not shown) of chamber 718 from It opens.Melting energy converter can be for example electrically insulated with Parylene (not shown), to prevent brine short-circuit.Disclosed herein is insulation , the energy converter that brine is compatible construction example.

In this embodiment, film 711 is melting transducing in the proximally and distally end of ablation energy converter supporter Extend on the outer surface of device supporter, but in some embodiments, it can only extend on an end of supporter Or do not extend on the outer surface of ablation energy converter supporter optionally.In this embodiment, film is arranged such that nothing Outer surface of the echo studio substantially conforming to the conduit proximally and distally of anechoic room.In this embodiment, film 711 has Such construction：Usually follow at least part of construction of the outer surface of the conduit proximally and distally of room.In this implementation In scheme, film 711 is unsuitable for extending to the outside when fluid conveying is to room, but may be adapted to this mode in other embodiments. By being unsuitable for radial outward expansion, film 711 can be generally considered as having fixed construction.In some embodiments, film 711 With the thickness between 0.0002 " and 0.009 ".

Imaging array 702 can be configured to display image artifacts, and the relative boresight direction of beam is melted in identification, such as such as this Shown in literary described and Figure 34 C.Image artifacts can be by the disabling part in space, the array in imaging array (for example, if one Kind or more imaging transducer can individually fail and activate), fiducial marker creates, or is incorporated into from array generation image Software.Imaging array can be configured to that the image artifacts opposite with the ablation sighted direction of beam are presented.

Embodiment shown in Figure 45 A may include radiopaque marker, for promoting conduit relative to target portion The placement of position and orientation.As shown in Figure 45 C, imaging transducer arrays 702 can be wrapped in 721 relevant level of imaging plane Include radiopaque marker 720.For example, the center of imaging plane 721 and radiopaque marker 720 can be away from ablation energy converter 703 726 preset distance 724 (for example, distance within the scope of 6mm, 7mm, 8mm, 9mm, 10mm or 1 to 15mm) of center.Conduit 700 can be placed in the deflectable conveying sheath 722 with radiopaque marker 723 so that imaging array marker 720 away from From sheath marker 723 be with a distance from 725, wherein distance 724 and 725 it is roughly the same (for example, 8mm or within the scope of 1 to 15mm away from From).In some embodiments, roughly the same one meaned in distance 724 and 725 is in another 10%, or In another 5%.

The remote area 700 of ablation catheter may include the sheath alignment line 701 for positioning the conduit in sheath 722, to confirm The 723 range Imaging planar tags 720 of marker of sheath are desired distances 725.Alignment line 701 can print in conduit sheath Or etching, either as shrink belt application or can be applied on conduit using method known to conduit manufacturing field Visually differentiable line.The thickness of alignment line 701 can be in the range of such as 0.1mm to 1mm.Conduit is located in sheath In method may include following：It is inserted the catheter into sheath before the vascular system for inserting the catheter into patient；Visually will The distal tip of conveying sheath 722 is aligned with sheath alignment line 701；Such as spring clip of moveable depth gauge 739 is positioned in catheter sheath Pipe proximal end, against the proximal port 741 of conveying sheath, as shown in Figure 45 E；Ablation catheter is removed from conveying sheath 722, Depth gauge 739 is set to be located in conduit sheath.It may then pass through and sheath is conveyed into vascular system first, then by ablation catheter It is inserted in a sheath, until depth gauge 739 is against the proximal port 741 of sheath, the conduit of the depth gauge 739 with positioning is inserted into patient Vascular system in, as shown in Figure 45 E.It can be with relative to the method for the destination organization positioning conduit and sheath and identification depth of ablation Including by being aligned imaging tags 720 and anatomic marker L such as carotid bifuracations and imaging being indicated L and ultrasonic imaging battle array Conduit 700 and sheath 722 are advanced to first position by the imaging of row 702, as shown in Figure 45 C.Indicate L when observing on the ultrasound image When, the center for melting energy converter 722 is aligned by distance 724 with the center of destination organization T (for example, arteria carotis diaphragm).It can clap Radioscopic image is taken the photograph to capture the first position and highlight radiopaque marker 720 and 723.Then as shown in Figure 45 D, Conduit 700 and sheath 722 can be advanced to the second position, and the marker 723 of mesotheca is moved to the first of imaging tags 720 Position is simultaneously aligned with label L.The second position of marker can see on fluoroscopy figure and with the capture of first position The mirage phantom of image compares.In the second position, imaging plane 721 is now in position 1 (where ablation energy converter center 726) Place, and the ultrasonoscopy at the center including destination organization T and the target area of surrounding tissue can be shot.It can from this image To measure the distance between conduit and target T 727 and for adjusting dosimeter and control depth of ablation.It then can be by conduit 700 Position 1 is returned to the reset of sheath 722, wherein imaging plane 721 is aligned with mark L.By rotary guide pipe to be aimed at relative to mark The sighted direction for melting energy converter is directed toward target T by image artifacts.In this positioning, ablation beam will be targeted to target T. Depth of ablation can be entered ablation console to set energy transportation parameters (for example, power and time), and can convey and disappear Melt energy.

As shown in Figure 45 E, with embodiment shown in Figure 45 A and with integrated imaging transducer or transducer array And the component of system that other embodiments for being configured to open loop brine-cooled are used together may include following：It is deflectable Conveying sheath 722 (for example, 8.5FR compatibility), with integrated imaging ablation catheter 700 (show include handle 730 conduit Proximal end), brine-cooled agent supply 731, coolant pump 732, coolant hose 733, can be connected to coolant supply 731 With the coolant input port 734 on handle 730, computerization supersonic melting console 735 passes through connector cable 737 It is electrically connected to the electric connector 736 of handle 730 and is communicated with pump 732, ultrasonic imaging console 738, it is logical with ablation console Letter and seal wire 740.Computerization melt console 735 optionally include algorithm for image enhancement, such as by Figure 27,28, 29,30 and 31 illustrate.

It is configured to the conduit used without conveying sheath

It can be intravascular ablation catheter to convey sheath, be especially configured to melt leading for carotid body from jugular vein Pipe, provides several useful functions.For example, multiple devices that conveying sheath can include ablation catheter for bull ladle provide channel；It Ablation catheter can be protected during insertion from physical damage；It can be provided about deflection or torque in its remote area, Come relative to target ablation position (for example, arteria carotis diaphragm, carotid body, carotid bifuracation, neck are dynamic in order to manipulate jugular vein Arteries and veins) positioning is imaged or ablation catheter；It can allow imaging or ablation catheter relative to sheath deflection area extend or retract or Rotation, to allow the shape for being suitable for manipulating carrier vein (for example, jugular vein) or alignment or realize its imaging or ablation energy converter A series of or constructions of the element relative to the desired position at target ablation position.For example, during carotid body ablation procedure at As the best orientation of energy converter can be distally or close in arteria carotis diaphragm or carotid bifuracation or anatomic marker such as arteria carotis In the about 5mm at end (in for example, about 3mm, in about 2mm, in about 1mm).Imaging transducer is most during carotid body ablation procedure Good positioning can be alternately or additionally aligned in the certain distance of anatomic marker and with them so that ablation energy converter phase Can be with run-home ablation site for the sighted direction of the ultrasonoscopy obtained, while avoiding passing through non-target tissues such as Arteria carotis may interfere with other blood vessels or tissue that ablation energy is transported to target site.For example, the aiming side of ablation energy converter To the wall that can be directed through the vein (for example, jugular vein) containing conduit, by limited amount interstitial tissue (for example, small In about 5mm, it is less than about 4mm, is less than about 3mm, is less than about 2mm, is less than about 1mm), and enter target tissue volume product (for example, neck is dynamic Arteries and veins diaphragm).

In some embodiments, it can be configured to provide the work(of conveying sheath for the conduit through vein imaging and ablation Can, and therefore can be used without conveying sheath.For example, conduit can be configured to convey by seal wire.Conduit can include The guidewire lumen of a part of length along its overall length or in remote area.Seal wire can be in order to defeated by the meanders of vascular system Conduit is sent, and can be used for conveying other devices if necessary.

In some embodiments, conduit can in its remote area, such as be imaged or melt energy converter or The proximal end of element has deflectionable part, and carrier therein is positioned in provide distortion or manipulate at least part of conduit The position of blood vessel (for example, jugular vein) or the function of shape.Conduit can be in more than one direction (for example, 2,3 or 4 sides To) deflectable.Conduit can have more than one deflectionable part, can deflect on a different plane.For example, such as Figure 38 It is shown, the first deflectionable part 600 can with deflection in the plane being aligned of sighted direction 601 of ablation energy converter with Vein is manipulated in the plane, and conduit can further include the second deflectionable part 602, the second deflectionable part 602 can be One or more planes (for example, 2 planes) other than the plane of one deflectionable part are (for example, in the first deflectionable part Plane on the right side of 45 to 90 degree and left side 45 to 90 spend plane) it is deflectable.Second deflectionable part 602 can be deflectable first The distal end of part 600.As shown in figure 39, both deflectionable parts 600 and 602 that real diagram represents leading in non deflected state Pipe.Scribing line represents the conduit that the first deflectionable part 600 is in the deflection state deflected in the first plane.First deflectionable part 600 can be with about 2 to 4cm long length and in its complete deflection state with about 2 to 4cm radius of curvature.Draw chain-dotted line Represent the second deflectionable part deflected in the second plane.Dot dot dash is drawn to represent in the second deflectable portion that third plane deflects Point.The schematic diagram of Figure 39 shows the conduit for the non deflected and deflection state not limited by blood vessel.Second deflectionable part can carry For the function of the other adjustment or fine tuning to catheter position.Being connected to the individual bracing wire of individual actuator can be used for solely The first and second deflector of Site control or the deflection in different directions.Conduit may also include deflectionable part 600 and 602 with Passive flexible portion 603 between imaging and ablation part 604.

As shown in figure 40, conduit can be configured to provide deflection at the different distance away from imaging and ablation part.For example, Conduit may include from imaging and ablation part with different length or apart from a plurality of bracing wire of setting.This can with compensating duct relative to Convey the ability that sheath is promoted or retracted.Conduit deflection characteristic such as size and curvature can with herein to deflectable sheath description class Seemingly.The schematic diagram of Figure 40 shows the conduit for the non deflected and deflection state not limited by blood vessel.Figure 40 show to be configured to The conduit of the sighted direction 610 roughly the same direction deflection of ablation, and deflection is configured to away from being imaged and ablation part 612 First distance 611 or second distance 613 start.Real diagram represents the conduit of non deflected state.Scribing line is represented away from being imaged and disappear Melt the conduit deflected at the first distance 611 of part 612.It draws chain-dotted line and represents the conduit deflected in second distance 613.Individually Bracing wire may be connected to individual actuator to independently control different deflectors.

In some embodiments, the ablation of conduit and imaging moiety can be fixed relative to deflectionable part, Huo Zheke Selection of land can have adjustable relative position.As shown in Figure 41 A to 41C, conduit 620 may include passive flexible portion 621, the quilt Imaging and ablation part 622 on the dynamic sufficiently flexible remote area to allow conduit of flexible portion 621 are pressed into blood vessel at it It is tilted when in the inner surface of wall 623, it is still sufficiently rigid will be imaged and ablation portion when deflectionable part 624 is deflected It gives the pressure being added on vascular wall and is converted into and be enough to manipulate vascular wall or vascular wall.It can be desirable to tilting imaging and ablation portion Point so that the longitudinal axis 627 of its axis 625 and the arteria carotis communis 3 in the imaging region in imaging transducer is substantially parallel.When neck is total When the ultrasonoscopy of artery is shown as ellipse, can be imaging and ablation part axis it is not parallel with the axis of arteria carotis communis Instruction.Equally, when the image of arteria carotis communis is shown round, it may indicate that axis is parallel.Including away from deflectionable part Conduit apart from adjustable ablation and imaging moiety can be configured to the passive flexible portion with adjustable in length.Figure 41A shows the conduit 620 with the passive deflectionable part 621 of relatively short (for example, about 10mm).Shorter is passive deflectable Part is more rigid than longer passive deflectionable part, this allows more power to be applied to vascular wall 623, can cause to be imaged With ablation 622 relatively small inclination of part or permissible vascular wall 623 by the distance 626 of mobile bigger.Figure 41 B are shown The conduit 620 of passive deflectionable part 621 with opposite moderate-length (for example, about 25mm).Increase passive deflectionable part Length can increase flexibility compared with short length, but long passive deflectionable part is more rigid.With it is shorter passive Deflectionable part is compared, this arrangement allows less power to be applied to vascular wall 623, can cause to be imaged and melt part 622 Relatively large inclination or permissible vascular wall 623 are by the smaller distance of movement 626.Figure 41 C show to have relatively long The conduit 620 of the passive deflectionable part 621 of (for example, about 50mm).The length for increasing passive deflectionable part can be further Increase the flexibility compared with short length.Compared with shorter passive deflectionable part, this arrangement allows less power to apply It is added to vascular wall 623, imaging and ablation 622 relatively large inclination of part or permissible vascular wall 623 can be caused to be moved Smaller distance 626.

For example, the ablation of conduit and imaging moiety can telescopically be adjusted relative to deflectionable part.For example, imaging and Ablation part and the distance between deflectionable part can between about 0mm to 50mm (for example, between 5mm and 30mm, Between 5mm and 20mm, between 5mm and 15mm, between 5mm and 10mm) it is adjustable.The imaging of conduit and ablation part can be with It is adjusted by rotation relative to deflectionable part.Being adjusted by rotation property can be prolonged by the proximal end region (for example, in handle) from conduit The torque line for reaching imaging and ablation part to make imaging and the rotation of ablation part provide in proximal end rotational torque line. Optionally, being adjusted by rotation property can be provided by torque coil, which can have the chamber along its axis, the chamber that can be For conducting wire or the pipeline of coolant.Optionally, as shown in Figure 42, conduit may include the integrated sheath for having axial cavity 631 630, and be imaged and melt part 632 and may be coupled to the elongated tubular for being located in intracavitary and being connect with a part for handle 634 633.Inner tube can be moveable to allow for longitudinal translation 635 in integrated sheath, this allows the position for being imaged and melting part It is adjustable relative to integrated sheath.Relative to the adjustable imaging of deflectionable part and leading for part is melted with position Pipe can further include locking mechanism 636 or coupler to maintain the relative position, and the locking mechanism 636 or coupler may be adapted to be solved Lock is to adjust relative position.

It is configured to without in the optional embodiment individually used to conveying sheath in conduit, conduit may include to lead A part for pipe and it is not intended to the integrated sheath for individually being removed or being used, as shown in figure 42.In this construction, integrated sheath exists Remote area includes deflectionable part 637.Deflector can for example by being connected to the actuator 639 on handle 640 bracing wire 638 activate.Integrated sheath may include the chamber 631 along its length, and elongated tubular 633 can pass through the chamber.Elongated tubular can be Connection imaging and ablation part 632 on its remote area 641, and can further include all or part operated needed for energy converter Conducting wire and coolant cavity are (for example, for the power pipeline of imaging transducer, the power pipeline for melting energy converter, all Such as the pickup wire of temperature sensor line, coolant conveyor chamber, coolant return cavity, guidewire lumen), it is not shown.Elongated tubular can be with Be in integrated sheath 630 it is rotatable 641, therefore ablation energy can be adjusted relative to the deflection direction 643 of integrated sheath Sighted direction 642.Optionally, elongated tubular 633 can integrate intrathecal move to translate 635 along its axis, such as up to In the range of about 20mm, to allow the deflectionable part for adjusting integrated sheath and melt the fore-and-aft distance 644 between energy converter.At this In one construction, imaging and ablation part 632 can be with the overall diameters of the diameter bigger of the chamber 631 than integrated sheath, because of transducing Device part transit chamber need not promote or retract during use.In Figure 42, scribing line represents the conduit in deflection state, and Imaging and ablation part 632 are pressed on the inner wall of blood vessel 645 (for example, jugular vein).It is outstanding from the distal tip of integrated sheath 637 A part for elongated tubular 633 may be used as passive flexible portion 646 and can have the length within the scope of about 1 to 5cm, or Optionally there is adjustable length, as shown in figure 42.When deflectionable part 637 is deflected and is imaged and melts part 632 When being pressed towards vascular wall 645, passive flexible portion 646 can have enough flexibilities and be inclined with allowing to be imaged and melting part 632 It is oblique but sufficiently rigid to apply force to manipulate its position to vascular wall 645.

The conduit for being configured to use without conveying sheath may be structured to protect the imaging of conduit during conveying and disappear Melt part.In some embodiments, conduit may include film, define anechoic room or during conveying it is frangible and easily by The other assemblies of damage.As shown in Figure 43 A and 43B, the protection of fragile components can be, for example, with the shape of retractible lantern ring 650 Formula or lid, this covers to cover during conveying and is such as imaged and melts the fragile components of part 651 and can work Place (for example, close to carotid bifuracation or target ablation position) is opened after being positioned about or movement.Protection cap can be also constructed At the vascular system for protecting patient during conveying.For example, lid can be smooth and not sharp edge and have Allow in vascular system through the length of bending 652 (for example, less than about 20mm long, being less than about 15mm long).Protection cap can be with It is deployable structure, is configured to that there is the undeployed configuration during conduit conveying and the expansion shape for conveying ablation energy State.Such as shown in Figure 43 C and 43D, protection cap may include two splines (splines) 655 and echoless membrane material 656. Spline can be positioned at covering fragile components and such as melt on the side of conduit of transducer assemblies 657.In undeployed configuration, figure 43C, spline 655 and film 656 can be snugly held in the side of conduit.In unfolding state figure 43D, spline can be bent, with Just they are removed from the transport path of ablation energy 658, and membrane material may remain between spline and by stretching or It is unfolded to extend.Spline can by user can and actuator (for example, on handle of conduit) undeployed state transition To unfolded state.For example, actuator can apply tension to bracing wire, so that the end of spline is moved towards each other, them is made to be bent.

It is adapted and configured to the ablation energy converter cooled down with saline solution

Ablation catheter may include ablation energy converter, especially be configured for the ablation transducing cooled down with sterile saline solution Device.Can be in conveying sterile saline solution (for example, physiological saline) to blood flow it is safe because NaCl in blood gram point Sub- osmolality is similar, and different from delivering water into blood flow, this may have undesired effect.It is described herein several Embodiment is constructed with closed loop coolant flow, and wherein coolant is not expected enters blood flow.However, if coolant unintentionally It leaks into the blood flow of patient, then device or program can mitigate any risk for causing undue detriment.For example, conduit or system can It is configured to monitoring coolant flow speed or pressure, and coolant flow is given a warning or stop if detecting leakage.It is another The method for mitigating the risk that coolant enters blood flow is to use sterile and biocompatibility coolant.It is transported to a small amount of of blood flow Water can be safe in certain patients.However, can even be further decreased using sterile saline solution as coolant Risk effect.Some embodiments as described herein, conduit shown in such as Figure 36, are purposely allowed coolant to enter blood flow.It is right Use saline solution may be especially important as coolant in such embodiment.

Saline solution contains ion and is conductive.Ablation energy converter may include the circuit for the opposite face for being connected to piezoelectric board Antipode.The ablation energy converter for being configured to be cooled down with saline solution may include solve brine cause it is short between two electrodes The measure of the influence on road.

It is configured to the ablation energy converter of brine-cooled may include preventing brine from causing short circuit between two electrodes Electrical insulator.Electrical insulator can be applied to all conductive surfaces of energy converter.Optionally, as shown in Figure 44 A, electrical insulator The conductive surface being electrically connected with one of electrode 671 and 672 that can be applied only to energy converter.For example, electrical insulation 665 can be with It is applied to side 667 and the back side 668 of ablation energy converter 666, and melts disappearing towards destination organization transmission ultrasound for energy converter The face 669 for melting energy 670 can not have insulating part.Optionally, if the back side of ablation energy converter is installed on back lining materials Without being connected to coolant, then the side of energy converter and back lining materials can be electrically insulated with brine-cooled agent.It wherein will electrical isolation It is applied at least part of ablation energy converter, the electrical connection of ablation energy converter is conveyed electrical current to or is electrically connected with being electrically connected Conductive component to prevent brine from conducting electric current between electrical connection, cause short circuit or interfere ablation energy converter function other Construction can be possible.

The example of electrically insulating material may include that Parylene, polyurethane, silicones, nylon, PEEK, polyamide, polyamides are sub- Amine or the other materials with suitable electrical insulation property in thin layer.Can select electrical insulation prevent electric current by and Allow heat transfer, therefore heat can be removed from energy converter by coolant, and allows transducer vibrations without apparent Decaying.Method using insulating materials may include a part (for example, transmission surface) for masking ablation energy converter, using insulation material Expect (for example, vapor deposition, thermosetting, adhesive or other coating processes), and removal shelter is with the exposure part.

Ablation energy converter can be mounted or embedded in crooked circuit or circuit board, this can promote manufacturability and carry For being electrically insulated to prevent brine-cooled agent from keeping ablation energy converter short-circuit.

Ablation catheter can be configured to directly flow through ablation energy converter in guiding brine-cooled agent, thus it only with two A contact in electrode.For example, brine-cooled agent can only be contacted with the transmission surface of energy dissipating energy converter, not with the side of energy converter Or rear-face contact.By energy converter being located in the ablation energy converter support part for preventing fluid contact side or the back side (for example, using sealing or adhesive) can prevent side and the rear-face contact of coolant and ablation energy converter.

The individual coolant flow 680 physically and electrically detached each other as shown in Figure 44 B and 681 can be by melting transducing Device face 682 and backing 683, this can provide high cooling effect, while prevent short circuit.For example, ablation energy converter can use bonding Agent 685 is maintained in ablation energy converter supporter 684, which also makes the side insulation of energy converter and prevent coolant in the past Portion 682, energy converter transmission equipment side pass through, arrive energy converter back side or back lining materials 686.One coolant flow 680 can be defeated It is sent to the front of energy converter, and the second coolant flow 681 can be transported on the back of energy converter, or is transported to and changes On the mounted back lining materials of energy device.Each coolant flow can be by having individual source, individual conveyor chamber and individually Discharge chamber is separated from each other.

As shown in Figure 44 C, the embodiment of the ablation catheter with open loop energy converter cooling system can be configured to not have There are the film or air bag that room is created around ablation energy converter.The stream of coolant 690 can pass through the transmission surface 691 of ablation energy converter simultaneously Into blood flow.With containing coolant and compared with making it through the conduit of return cavity, this construction allows much bigger coolant Flow velocity, because flow resistance reduces.In addition, when such construct is not by by including the pressure limit created in the conduit of the film of room When processed (this may lead to the failure mode that film seals), the flow velocity of bigger can be allowed wherein.Ablation is not surrounded to change Can device sealing chamber an embodiment may include electrical insulation to prevent from covering side and the back side as shown in Figure 44 C and It is not the short circuit of transmission surface.Optionally, electrical insulation can surround entire ablation energy converter.For example, compatible with brine-cooled agent Energy converter can coat Parylene-C on each conductive surface with saline contacts, and Parylene-C can have 10 to 30 microns Thickness (for example, 10 to 25 microns, 20 to 25 microns, 22 microns).

Transmitting from ablation energy converter is imaged

Substitute or in addition to integrate fiducial marker with based on ultrasound video on generate aim at artifact other than, it is intravascular at Picture and ablation system can be configured as the image for generating since the signal generation ultrasonic echo of ablation energy converter conveying, to carry For the accurate instruction of the sighted direction to melting energy converter.Ablation energy converter can generate the ultrasound letter synchronous with imaging transducer Number, and imaging transducer can detect signal.These ultrasonic signals not necessarily play the role of ablation tissue, but mainly rise The effect communicated with imaging transducer.However, ultrasonic signal will be sent out from catheter ablation energy converter, and with supersonic melting signal The identical direction in direction propagated during ablation travels in tissue.For example, since ablation energy converter can have about 20MHz Resonant frequency, and imaging transducer can with about 9MHz resonant frequency.Imaging pulse (for example, be with frequency The electric current of 9MHz) imaging transducer can be transmitted to from console, imaging transducer vibration sends ultrasonic waves into surrounding tissue In.As shown in Figure 37 A, the echo of the imaging wave from the tissue that rebounds out returns to imaging transducer, to be detected by imaging system With the video based on ultrasound for being converted into displaying surrounding tissue.Ablation energy converter can sense and beam back synchronous imaging pulse, or It is directly activated by amplifying identical imaging pulse.For example, system control position can be to imaging transducer and ablation energy converter two Person sends synchronous signal to be imaged to the sighted direction 503 for melting energy converter, and desired mesh is aimed to help to melt energy converter Mark 504.Although melting energy converter has higher resonant frequency, it has proved that have when the imaging pulse of 9MHz is sent to When the transducer assemblies of 20MHz resonant frequencies, energy converter has enough bandwidth and sensitivity, this causes in the range of 9MHz Ablation energy converter transmitting is enough can be detected by imaging transducer and can lead to the ultrasound of image enhancement.These aim at transmitting with The identical direction in transported direction is transported to tissue with ablation ultrasound emission.It is exposed to the region production for the tissue for aiming at transmitting Raw additional echo, the additional echo are detected by imaging transducer and are regarded in as illustrated in figure 37b based on ultrasound It is illustrated as the enhancing echo area of highlighted sector or wedge 505 on frequency.It is alternatively possible to introduce or change supply at The arbitrary phase delay between the imaging signal of transducer energy is treated as the imaging signal of transducer energy and supply, causes to come Helpful destructive interference between ultrasonic imaging signal and the reflective echo for the treatment of signal.For example, the phase delay of 180 degree Destructive interference can be generated between being imaged and melting energy converter echo and lead to the echo of reduction on the video based on ultrasound The region of reflection is similar to shown in Figure 37 C, and wherein sighted direction will be more darker than the image of surrounding.User can be disappeared by manipulating Melt conduit or delivery sheath to adjust the sighted direction of ablation energy converter, until the video based on ultrasound shows satisfactorily court Emit to the aiming of destination organization (for example, arteria carotis diaphragm).

Use limiter：

Medical apparatus or system such as conduit and system disclosed herein including console can be configured to limitation dress The use set, the use are intended that disposably.Medical apparatus can be designed as being conveyed in limited parameter such as energy Duration in safety and effective and functional or only used in a patient.In one embodiment, it is disclosed herein Such as any conduit of disposable medical apparatus can be intended for only one patient, and for primary in the patient or more Repeatedly ablation.In addition, before attempting another ablation in same patient, allow user that device and console are disconnected or closed The power supply of console.Used for anti-locking apparatus uses parameter, disposable medical apparatus to can be configured to provide beyond its expection Information allows console to determine whether disposable apparatus alreadys exceed it and be expected using license to console.For example, being supplied to control Whether the information of platform processed may include the instruction that whether had used before disposable apparatus (for example, ablation energy warp-wise It is conveyed) and whether pass by since the last time of disposable apparatus uses or first use the finger of predetermined lasting time Show.The use of disposable apparatus is limited into the predetermined lasting time after secondary use on it or first use, can be caused another Position patient can not be realized using the device, but still provide time enough so that the device is used for multiple times in same patient.It is predetermined Duration can be such as 1,2,3,4,5 or 6 hour, or be usually required less than (such as sterilizing medical apparatus) between patient Time quantum.

In an embodiment as shown in Figure 46 A, disposable medical apparatus 800 is (for example, handle or a sex medicine Device) include the nonvolatile memory storage 802 of such as EEPROM and the timer 804 of such as timing circuit.Console 803 software 801 can read mnemonic 802 and it is written.Mnemonic 802 is gone back other than restriction information Can include other information, for example, confirming that device is true identifier or device characterization information.The software of console can be read Mnemonic 802 is taken to be new with determining device 800 or have been used before.If from being not used before device 800, Then the software of console can be in (such as when first time activating ablation energy) setting timer after timer start event 804。

Include two universal input/output (I/O) signals in mnemonic 802.First I/O 806 is configured to export And it is connected to direct current (DC) voltage regulator 810.When timer start event is (for example, ablation energy is activated or disposably Medical apparatus is activated) when, voltage regulator 810 will start its output so that fixed voltage is transported to resistor/capacitor (RC) timing circuit 804.D/C voltage is that the charging of time capacitor 814 reaches complete in a few seconds by charging resistor 812 Voltage.In this embodiment, it is full (for example, will timer only could to be set to using new disposable medical apparatus Time capacitor, which is charged to, to be completely filled with).Time capacitor provides high capacitance, this allows long duration timing options, and provides It is rapidly filled with the time (for example, several seconds).

If connecting or reconnecting to console 803 or another console by previously used disposable medical apparatus, Then the output of memory device is not opened, and DC adjusters 810 will not supply any voltage to RC timing circuits 804, therefore Charge present on time capacitor 814 will not be changed.When the power-off of console 803 or disposable medical apparatus 800 are from console When 803 disconnection, all DC power supplies are removed from disposable medical apparatus 800.The voltage across time capacitor 814 is allowed to pass through now Discharging resistor 816 discharges.The value of discharging resistor 816 determines can reuse disposable medical apparatus 800 in it Duration (for example, the number of minutes, hourage or number of days).In order to control any undesirable electric discharge of time capacitor 814, Ultralow leakage diode 818 and high resistance isolation resistor 820 are used in the signal path of time capacitor 814.This two The circuit 804 is allowed accurately to work when no electric power is applied to circuit.

When disposable medical apparatus is connected or reconnects to console or when console is re-energised, console is logical It crosses serial communication and sends order to memory device 802 to check the 2nd I/O signals 808 (it is arranged to input).The signal It is connected to voltage comparator 822, voltage comparator 822 will be across the voltage of time capacitor 814 and accurate internal reference electricity Voltage levels are compared.If timing capacitor voltage is higher than this reference voltage, the output of comparator will be arranged to 1, Indicate that the time for allowing to use is remaining.If voltage is less than this reference voltage, comparator output will be arranged to 0, indicate Allow the time used no longer remaining.Memory device 802 is by the feedback of status of voltage comparator to console software 801.

As shown in the flow chart of Figure 46 B and the schematic circuit diagram of Figure 46 A, when disposable medical apparatus is detected as connecting When 830, console software 801 will be communicated with memory device 802 with by reading the first word stored in memory device 802 Save whether to have been used 832 before checking disposable medical apparatus 800.If disposable medical apparatus is set using byte It is set to unused (for example, the first byte is 0), then console software 801 starts the use of disposable medical apparatus 800 and passes through Such as it charges to RC timing circuits 804 via 806 opening memory device output signal of output and timer is set as 100% 834.Then disposable medical apparatus 800 is used for its expected program 836.However, if disposable medical apparatus uses word Section is arranged to use (for example, the first byte is 1), then generator (such as is not deposited to the charging of RC timing circuits by closing Reservoir device output signal 806) and timer state 838 is read, timer state 838 is defeated for example, by reading memory device Enter whether the instruction permission usage time of signal 808 is remaining or how much residue allows usage time.If disposable medical apparatus Pot life is remaining (for example, RC timing circuit states are height), then console software 801 starts using disposable medical apparatus 100% is reset to (for example, being filled to RC timing circuits by opening memory device output signal 806 using and by timer Electricity) 834.If the pot life of disposable medical apparatus is no longer remaining (for example, RC timing circuit states are low), console Software 801 disables disposable medical apparatus 840 or display error message.When system completes medical procedures, can be set using Byte (for example, if not being arranged in the past) 835.This allow device be connected but from be not used, if device 800 be connected to it is to be measured The console 801 of examination or during manufacturing process be connected this can be useful.After medical procedures, as long as device 800 It is not disconnected from console or console does not power off 842, device 800 can be used for another medical procedures infinitely.Such as Fruit device 800 is disconnected from console or console powers off and conduit is automatically reconnected or is connected to another console 844, Then console software 801 will operation by validation check with check allow any usage time whether residue 838.

In the another embodiment shown in the flow chart such as Figure 46 C, algorithm is similar, however after medical procedures, or Person is when the new disposable medical apparatus 800 of connection, or when connecting used disposable medical apparatus, console is soft Part 801 carries out validation check 853 and 858.When used device 800 is connected to console software 801, check whether surplus The remaining any time 858, and starter 866 but timer are not reset is 100%854 if time residue, such as Figure 46 B Shown in embodiment.In this embodiment, timer is only arranged in device First Contact Connections primary, and is consumed in timer Forbidden device 860 after time to the greatest extent.When system completes medical procedures, byte can be set using (for example, if not setting in the past Set) 855.For this embodiment, when timer durations are arranged system can be considered uses in medical procedures 856 Time span (for example, typical length, average value, range, maximum value) or expected program quantity (for example, typical long Degree, average value, range, maximum value) or device 800 be connected to power control platform 803 and inactive time span.Example Such as, timer 804 can be configured so that the time span of the 100% at least program of duration is multiplied by program quantity and adds Upper device is connected but inactive time span.In addition, timer durations are contemplated that when conduit and console disconnect The license event that may occur.For example, can be acceptable below：If doctor disconnects device 800 from console, simultaneously Re-positioning device is in the new position repetitive routine of same patient；Or the effect of assessment prior treatment；Or it solves patient and asks Topic such as anesthesia, safety or comfortable；Or the equipment for replacing components of system as directed.The reasonable time amount of acceptable event can be taken into account in In timer durations.

Optionally, console software 801 can be arranged second after allowing usage time to expire in memory device 802 Byte.Second byte can be secured against rewriting, to prevent someone from connecting circuit and charge to timing circuit to reset one The timer of secondary sex medicine device.

Optionally, when in 856 medical procedures in 836 or Figure 46 C of Figure 46 B use console 803 and a sex medicine When device 800 (i.e. system), console software 801 can communicate with memory device 802 and disposable medical apparatus is arranged and use Byte is to use and (the first byte is set as 1).First byte can repeatedly read construction with write-once to protect.This It is meant that once byte is changed for the first time, it cannot be reset as 0.Or in other words when the application guard method, one The disposable medical apparatus of denier is arranged to use, it cannot be reset as being not used.It can reuse and be set using byte Being set to the unique temporal of used disposable medical apparatus is, if timer 804 is without electric discharge completely as described above.

Optionally, system may be structured to that there is a limited number of license to use, for example, in use (for example, conveying ablation Energy) after, console software 801 can increase the value being stored in EEPROM, which can be under the primary protection of write-in.

Any medical apparatus suitable for receiving signal from console may include using limiter, such as suitable for defeated with energy Any medical apparatus for sending console to couple.

Therapy：

The ablation energy source of such as high-frequency current generator for therapeutic ultrasound can be located at the outside of patient.Occur Device may include computer control unit either automatically or manually to adjust the frequency and intensity for the energy for being applied in conduit, apply The opportunity and period of energy, and apply the safety limit of energy.It should be appreciated that energy delivery electrodes described herein Embodiment can be electrically connected to generator, even if generator is not clearly shown or described by each embodiment.

It is configured to aiming at ultrasonic energy into the ultrasound ablation conduit of arteria carotis diaphragm to may include ultrasonic visualization Ability.Ultrasonic visualization may include Doppler with to blood flow imaging.Doppler's rotary guide pipe in external carotid artery can be used, To determine when that conduit passes through arteria carotis diaphragm to aim at internal carotid.Supersonic melting can towards internal carotid laying for direction simultaneously It is deposited in target arteria carotis diaphragm.

It can be by applying the ablation energy from the neighbouring ablation in the distal end of carotid body ablating device in neck At artery body or neighbouring carotid body generates the tissue damage of ablation.The tissue damage of ablation can make carotid body disability or can To inhibit the activity of carotid body or interrupt conduction of the afferent nerve signals from carotid body to stomodaeal nervous system.Carotid body Disability or inhibit to reduce the response for the change that blood vessel glomus cell form blood gas and efficiently reduce incoming neck to move The activity of arteries and veins somatic nerves or the chemoreceptor reflex of patient obtain.

Include being based at least partially on to confirm that patient is situated between with sympathetic nerve according to the method for a specific embodiment The disease led melts at least one carotid body of patient, the disease such as heart that the sympathetic nerve mediates, metabolism Or the disease of lung, such as hypertension, insulin resistance, diabetes, pulmonary hypertension, drug resistance hypertension (such as intractable height Blood pressure), congestive heart failure (CHF) or for heart failure or the expiratory dyspnea of the disease reason of lung.

Program may include diagnosing, the selection based on diagnosis, further screen (such as the baseline of chemosensitivity is commented Estimate), it is based at least partially on diagnosis or further screens via chemocepter (such as carotid body) ablation procedure for example One in disclosed embodiment treats patient.In addition, after the ablation, the method for the treatment of may include being melted It is assessed afterwards with (such as the adjustment of medicinal treatment, in new position of making decision compared with baseline estimate and based on the assessment Or different parameter re-treatments is used, or if only having melted a chemocepter before, melt the second chemoreception Device).

Carotid body ablation procedure may include following step or combinations thereof：Patient is calm, positions target peripheral chemical Receptor, visualization target peripheral chemoreceptor (such as carotid body) confirm that target ablation position is peripheral chemical impression Device is in close proximity to peripheral chemoreceptor, confirms target ablation position safely away from preferably protected important structure (such as hypoglossal nerve, sympathetic nerve and vagus nerve), before, during or after ablation steps stimulation (such as electricity, machine It is tool, chemical) it is provided to target site or target peripheral chemoreceptor, the physiological responses to the stimulation are monitored, are being disappeared The forward direction target site for melting step provides temporary nerve block, monitors the physiological responses to the temporary nerve block, fiber crops Liquor-saturated target site protects brain not dynamic by potential embolism, Thermal protection artery or wall of vein (such as arteria carotis, jugular vein) or neck The interior direction of arteries and veins spacer film or important neuromechanism, ablation targets position or peripheral chemoreceptor monitor ablation parameter (such as blood flow in temperature, pressure, duration, arteria carotis) monitors physiological responses also, if dangerous during ablation Or undesired physiological responses occur before collateral neurotrosis becomes permanent, stop melting, during ablation steps Or the reduction of chemocepter movable (such as chemosensitivity, HR, blood pressure, ventilation, sympathetic nerve activity) is confirmed later, it removes Ablating device is assessed after being melted, and chemocepter ablation procedure is repeated to another peripheral chemoreceptor in patient Any step.

Assessment may include physiology test or the acquisition of information after patient screening and ablation, for example, chemocepter is anti- Penetrate sensitivity, central sympathetic activity, heart rate, heart rate variability, blood pressure, ventilation, the generation of hormone, peripheral vascular resistance, Blood pH, blood PCO₂, the degree of hyperventilation, peak value VO₂、VE/VCO₂Slope.Be measured directly maximal oxygen uptake ( It is more correctly pVO in heart failure patient₂) and the effciency of respiratory index VE/VCO₂Slope has been shown as being heart failure It the reproducible mark of middle exercise tolerance and provides objectively and other about the clinical state of patient and the information of prognosis.

Therapy may include carrying out electro photoluminescence to target area to confirm close to carotid body using stimulating electrode.Example Such as, having under about 20 to the microseconds of 40Hz and 50 to 500 (μ s) pulse duration for positive carotid body stimulating effect is generated There is the stimulus signal of 1-10 milliamperes of (mA) trains of pulse that can indicate, stimulating electrode is sufficiently closing to carotid body or carotid body Effectively to be melted to it in the range of nerve.Positive carotid body stimulating effect can be the increase of application simultaneously with stimulation Blood pressure, heart rate or ventilation.These variables, which can be monitored, record or show, to be confirmed with helping to assess close to carotid body.Example Such as, technology catheter-based can have the stimulating electrode for being in close proximity to the ablation for ablation.Selectively, ablation It itself can be used also as stimulating electrode.Selectively, the energy delivery element of the ablation energy of conveying non-electrical form, for example, it is low Temperature ablation applicator, can be configured as and also convey electrical stimulation signal described above.Another selectable embodiment party again Case includes the stimulating electrode different from ablation.For example, can make stimulation probe sudden and violent with by performing the operation during surgery The doubtful carotid body contact of dew.Positive carotid body stimulating effect can be confirmed structure under a cloud be carotid body and Ablation can start.Physiological monitor (such as heart rate monitor, blood pressure monitor, blood flow monitor, MSNA monitors) can be with It is communicated with the stimulus generator (it can be also ablation generator) of computerization to provide the feedback information in response to stimulation.Such as Fruit physiological responses are related to the stimulation of offer, then the generator of computerization can provide the instruction of positive confirmation.

Alternatively or additionally, the drug of the chemosensitive cell of known excitation carotid body can be injected directly Enter in arteria carotis or whole body is administered in patient's vein or artery to cause hemodynamic or breathing response.It can excite The example of the drug of chemocepter includes nicotine, atropine, doxapram, almitrine, hyperkalemia, theophylline, adenosine, sulphur Compound, lobeline, acetylcholine, ammonium chloride, methylamine, potassium chloride, anabasine, coniine, cytimidine, acetaldehyde, l- MeChs Acetyl base ester and ethylether (acetyl ester and the ethyl ether of 1-methylcholine), amber Phatidylcholine, piperidines, same-iso- muscarine and the single phenol ester of acetylsalicyclic amide, the alkaloid of Veratrum, sodium citrate, three phosphorus Adenosine monophosphate, dinitrophenol, caffeine, theobromine, ethyl alcohol, ether (ether), chloroform, phenyldiguanide (phenyldiguanide), sparteine, Coraminum (nikethamidum), cardiazol (pentylenetetrazole), dimethylamino methylene two The Methyl iodide (iodomethylate of dimethylaminomethylenedioxypropane) of oxygroup propane, second Base trimethyl ammonium propane (ethyltrimethylammoniumpropane), trimethyl ammonium, hydroxytryptamine, papaverine, it is new this It is bright, acid.

The method of description may include the drug delivery to the Ultrasound-activated of arteria carotis complex.Drug can be impregnated in energy In the particle of enough Ultrasound-activateds.Including the microvesicle of such pharmaceutical composition, nano particle, liposome and encapsulating are in the polymer The intravenous or direct intra-tumoral injection of bioactivator undergoes physical change when being subjected to ultrasonic beam.Composition includes micro emulsion Liquid can generate microvesicle as cavitation nucleus in injection process, and enhance the conveying of the Intracellular drug in arteria carotis complex. Supersonic beam is administered to and can be discharged by applications of ultrasound shadow with stimulation therapy agent with the arteria carotis complex of the drug infusion of encapsulating Loud selected volume.Other than the release of therapeutic agent, the microvesicle generated in situ during ultrasonic irradiation program can be to ultrasound Imaging generates in addition guidance.

Therapy can also include after the ablation electricity or chemical stimulation be applied to target area or capapie Apply, to confirm successfully ablation.Can monitor heart rate, blood pressure or the change of ventilation or by heart rate, blood pressure or ventilation and disappearing The reaction of stimulation is compared so that whether the carotid body for assessing targeting is ablated to before melting.After ablation stimulation can use for into The same equipment stimulated before row ablation carries out.Physiological monitor (such as heart rate monitor, blood pressure monitor, blood flow monitor, MSNA monitors) it can be communicated with the stimulus generator (it can be also ablation generator) of computerization to provide in response to thorn Sharp feedback information.If compared with the physiological responses before ablation, relevant physiological responses are stimulated with given after the ablation It reduces, then the generator of computerization can provide instruction ablation effect or possible program suggestion, such as repeats ablation, adjusts Whole ablation parameter changes position, melts another carotid body or chemical sensor or terminator program.

Device described herein can also be used by electric nerve retardance come temporarily stun or block nerves conduction.Temporarily When nerve block can be used for before ablation confirm ablation position.For example, temporary nerve block can blockade with The associated nerve of carotid body, this can cause to confirm that the position may be for melting effective physiological effect.In addition, temporarily When nerve block can blockade preferably be avoided cause physiological effect (such as physiological effect can by observe patient eye Eyeball, tongue, throat or facial muscles or heart rate and breathing by by monitoring patient are noted) important nerve, such as Vagus nerve, hypoglossal nerve or sympathetic nerve.This can alert the user position not in safe location.Similarly, it does not deposit In the temporary nerve block of the physiological effect for indicating the temporary nerve block of these important nerves and instruction carotid body nerve The combination of physiological effect may indicate that the position is in carotid body melted in safety and effective position.

Important nerve may be positioned close to target site and can be damaged not inadvertently and unintentionally.Nerve thorn Swash or retardance may assist in before irreversible ablation occurs and determine these nerves in ablation areas.These nerves can wrap It includes following：

Vagus nerve beam-vagus nerve is the beam for the nerve for carrying different function, such as a) gill motor neuron is (special Internal organ spread out of (efferent special visceral)), it is responsible for swallowing and sounding and is distributed to rami pharyngei, god on larynx Through and nervus laryngeus inferior；B) Visceromotor neuron (common internal organ outflow), be responsible for unconscious muscle and body of gland control and by It is distributed to heart, lung, oesophagus, stomach, solar plexus and muscle and gastral body of gland；C) internal organ sensing god Through first (common somatic afferent volley), be responsible for visceral sensitivity (visceral sensibility) and be distributed to uterine neck, Chest, abdomen fiber and carotid body and aortic body；D) internal organ sensing neurones (special somatic afferent volley) is born It blames the sense of taste and is distributed to epiglottis and taste bud；E) common sensing neurones (common visceral afferent volley), are responsible for cutaneous sensibility (cutaneous sensibility) and the auricular branch for being distributed to external ear, duct and eardrum.Vagal dysfunction can To be detected by following：A) sound caused by neurotrosis changes (tongue when vagal damage can lead to speech The hoarse of failure or voice is moved, if guiding the branch to larynx to be destroyed)；B) it is swallowed caused by neurotrosis Difficult (vagus nerve controls many muscle in maxilla and tongue, and the difficulty swallowed can be caused if being broken ring)；c) (pharyngeal reflex, which is controlled and damaged by vagus nerve, can be such that this reflection loses, this can increase by saliva for the change of pharyngeal reflex Or the risk choked of food)；D) (hearing loss can be because of the external ear to innervation ear for the hearing loss caused by neurotrosis The damage of vagal branch cause)：E) (vagal damage can be with for the cardiovascular problem caused by neurotrosis Lead to cardiovascular side effect, including irregular heartbeat and arrhythmia cordis)；Or f) digestive problems caused by neurotrosis (are confused The problem of contraction of stomach and intestines can be led to by walking the damage of nerve, this can lead to constipation).

Superior laryngeal nerve-superior laryngeal nerve is the branch of vagus nerve beam.Functionally, superior laryngeal nerve function can be divided For sensitivities and motility component part.It senses sexual function and a variety of input signals from supraglottic larynx head is provided.Motility work( It can relate to the power supply to ipsilateral cricothyreoideus.The contraction of cricothyreoideus makes lamina of cricoid cartilage retreat at articulatio cricothyreoidea Tiltedly, the extension, tension and interior receipts (adduction) for leading to vocal fold cause the pitch generated to increase.The dysfunction of superior laryngeal nerve Pitch can be changed and lead to that explosion sound can not be sent out.The paralysis of bilateral is shown as tired and hoarse voice.

Cervical sympathetic nerve-cervical sympathetic nerve provides outflow to internal carotid nerve, external carotid nerves and superior cervical cardiac nerve Fiber.It provides the sympathetic nerve of head, neck and heart and dominates.By sympathetic nerve dominate organ include eyes, lachrymal gland and Salivary gland.The dysfunction of cervical sympathetic nerve includes bernard's syndrome, be can fully identify and may include following Reaction：A) part ptosis (upper eyelid it is sagging, due to superior tarsalis, also referred to as Muller's muscle (M ü ller's Muscle the loss that sympathetic nerve) dominates)；B) (upside down ptosis, palpebra inferior slightly rise for inverted ptosis It is high)；C) anhidrosis (perspire and reduce on the side that face is affected)；D) myosis (small pupil, such as relative to will be by pupil The receipts of the asymmetric side of small or pupil contraction to less than two millimeters of diameter or pupil expected from the light quantity that hole receives Contracting)；E) endophthalmos (marking that eyes sink)；F) ciliospinal reflex (ciliospinal reflex or pupillary-skin reflex, by ipsilateral Pupil in response to be applied to neck, face and upper trunk pain expansion form) loss.If the right side of neck is subjected to Pain stimulation, then right pupil expands about 1-2mm from baseline.It is this to be reflected in bernard's syndrome and be related to cervical sympathetic nerve fibre It is not present in the breakage of dimension.)

Summary：

The chemoreceptor reflex in the disease and enhancing mediated with sympathetic nerve is had already envisaged for (such as from carotid body To the high afferent nerve signals conduction of central nervous system, such as indicated in some cases by high peripheral chemical sensibility ) patient in by oriented energy ablation targets ablation site (such as peripheral chemoreceptor, carotid body), it is outer to reduce The input signal conduction of all chemosensitivities and reduction from peripheral chemoreceptor to central nervous system.In addition, having set Want the chemoreceptor reflex in the disease and enhancing mediated with sympathetic nerve (such as from carotid body to central nervous system High afferent nerve signals send, as in some cases by high peripheral chemical sensibility instruction) patient in pass through Approach ablation targets ablation site (such as peripheral chemoreceptor, carotid body) in vein blood vessel, to reduce peripheral chemical The input signal conduction of sensibility and reduction from peripheral chemoreceptor to central nervous system.Chemoreceptor reflex activity Such as blood flow, blood CO are stimulated with to hypoxemia and others₂, concentration of glucose or blood pH the expected of sensibility subtract The input signal from chemocepter can be directly reduced less and generates at least one beneficial effect, such as maincenter is handed over Feel the reduction of psychoactive, the reduction of feeling of (expiratory dyspnea) of being short of breath, vasodilation, the increase of exercising ability, blood pressure Reduction, the reduction of sodium and water retention, blood volume is to the reallocation of skeletal muscle, the reduction of insulin resistance, hyperventilation The reduction of the reduction, hypocapnia reduce, be short of breath, the increase of the baroreflex of pressoreceptor and pressure sensibility, fan Nervous increase is walked, or improves the symptom for the disease that sympathetic nerve mediates, and can finally slow down progression of disease and extension Service life.It should be understood that it may include raised sympathetic tight that can use the disease that the sympathetic nerve of carotid body ablation mediates , raised sympathetic nerve/parasympathetic activity ratio, be mainly ascribable to central sympathetic anxiety singularly or undesirably High autonomic imbalance is attributable to traceable super to peripheral chemoreceptor (such as carotid body) at least partly The sympathetic tone of sensitive or hyperactive incoming excitation increased.Certain that there is baseline hypocapnia wherein or be short of breath In a little important clinical cases, the reduction of hyperventilation and respiratory rate can be expected.It should be understood that in the context of this article Hyperventilation mean beyond individual metabolism need breathing, typically result in slightly but significant hypocapnia (hypocapnea) (blood CO₂Normal value of the partial pressure below about 40mmHg, such as in the range of 33 to 38mmHg).

Patient with the CHF or hypertension concurrent with raised peripheral chemoreceptor activities and sensibility is frequent The reaction as their system is hypercarbia (although being not).The reaction usually for hyperventilation, from System removes CO₂Inadaptable trial, to overcompensation and the system that generates hypocapnia and alkalosis.Certain researchers This supersensitivity/hyperactivity hyperkinesia of carotid body is attributed to the direct effect of catecholamines, catecholamines are in CHF The hormone excessively recycled in the blood flow of patient.The program may be useful for treating these patients, and the patient is because coming from The high anxiety of carotid body exports and generates hypocapnia and possible alkalosis.These patients are particularly prone to periodicity The low with central apnea ventilation type event of breathing, these events cause awakening, sleep to be interfered, cause intermittence low-oxygen and It is that itself is harmful and difficult to treat.

It should be understood that Amur (Cheyne Stokes) type Cheyne-Stokes are used as to CO₂Maincenter hypersensitivity, to O₂With CO₂Peripheral chemical sensibility and extended circulation delay combination betide sleep, take exercise and even rest during patient. All these parameters frequently exist in the CHF patient in high mortality risk.Therefore, hypocapnia, CHF, height are suffered from Chemosensitivity and extended circulation delay patient, and when being particularly presented on rest (rest) or during exercise or By the patient of the Cheyne-Stokes of hypoxia inducible, it may be possible to the beneficiary of proposed treatment.

Hyperventilation is defined as the breathing needed in the metabolism of given time and activity level beyond people.Hyperventilation is more Specifically it is defined as beyond CO₂It is removed from blood with blood CO₂It is maintained in normal range (NR) (for example, about 40mmHg partial pressures) The ventilation volume per minute of required ventilation volume per minute.For example, with arterial blood PCO in the range of 32-37mmHg₂'s Patient be considered hypocapnia and in the hyperventilation.

For the purpose of present disclosure, hyperventilation is equivalent to the different of carbon dioxide in the blood caused by hyperventilation Often low level (such as hypocapnia (hypocapnia), hypocapnia (hypocapnea) or hypocapnia (hypocarbia)).Hyperventilation is with hypoventilation (such as hypoventilation) on the contrary, hypoventilation is often with lungs disease Occur in the patient of disease and leads to the level of the carbon dioxide in blood high (such as hypercarbia (hypercapnia) or height Carbohemis (hypercarbia)).

Low carbon dioxide partial pressure in blood leads to alkalosis, because of CO₂It is acid and reduction CO in the solution₂ Keep blood pH more alkaline, leads to the blood plasma calcium ion reduced and nerves and muscles excitability.The situation is in heart patient It is undesirable, because it can increase the probability of cardiac arrhythmia.

Alkalemia (Alkalemia) can be defined as blood basicity is abnormal or increased pH.Respiratory alkalosis be by The state caused by body excessive loss carbon dioxide, the typically result of hyperventilation.The alkalosis of compensation is wherein to compensate The form that mechanism has normally been restored pH directions.It is realized for example, compensation can increase excretion bicarbonate by kidney.

Other results changed of the alkalosis compensated during the break during exercise or as metabolic balance are likely to become It is uncompensated.Therefore, the method invented is applicable to the treatment of both uncompensated and compensation respiratory alkalosis.

It is short of breath and means quickly to breathe.For the purpose of present disclosure, exhale for about 6 to 16 times per minute during the break The respiratory rate of suction is considered normal, but the respiratory rate reduced in heart patient has known benefit.Breathing is anxious The reduction of rush can be expected reduction respiration dead space, increase the effciency of respiratory, and increase parasympathetic anxiety.

Treat embodiment：The effect of chemoreceptor reflex and central sympathetic activity in CHF

The chronic raising of sympathetic nerve activity (SNA) is related to the development of certain form of hypertension and progress and promotees At the progress of congestive heart failure (CHF).It is also known that the excitatoty heart of sympathetic nerve, body and maincenter/ Peripheral chemoreceptor be reflected in CHF and hypertension by singularly enhance (Ponikowski, 2011 and Giannoni, 2008 With 2009).

Arterial chemoreceptor plays important regulating and controlling effect in the control of aloveolar ventilation.They also apply cardiovascular function Add potent influence.

Oxygen (O in human body₂) conveying and carbon dioxide (CO₂) removing by two control systems, behaviour control and generation Thank to control and regulation.Metabolism ventilation control system drives our breathing and ensures point about pH, carbon dioxide during the break Press (PCO₂) and oxygen partial pressure (PO₂) optimum cell homeostasis.Metabolism control fine-tunes two groups of changes of function using providing Learn receptor：Central chemoreceptor and peripheral chemoreceptor such as aorta chemistry in the ventral medulla of brain Receptor and chemical receptor of carotid body.Carotid body is one small oval (to be frequently described as the grain of rice (grain Of rice)) and very vascular organ, be located at carotid bifuracation in or its near, neck always moves at carotid bifuracation Arteries and veins branches into internal carotid (IC) and external carotid artery (EC).Central chemoreceptor is to hypercarbia (high PCO₂) sensitive, and And peripheral chemoreceptor is to hypercarbia and hypoxemia (low blood PO₂) sensitive.Under normal circumstances, sensor is by it The activation of respective stimulation lead to be intended to restore the rapid ventilation of cell homeostasis and respond.

Early in 1868, Pfl ü ger recognized hypoxemia stimulation ventilation, this excites the receptor for oxygen sensitivity in big intracerebral And the research of the positioning at each position in peripheral circulation.When Corneille Heymans and his colleague observe, When flowing is reduced by the oxygen content of the blood of the bifurcated of arteria carotis communis, ventilation increases (won Nobel for him in 1938 Prize) when, being responsible for the searching of the oxygen chemical sensor of the ventilation response to hypoxemia is largely considered having completed.

The hypoxemia in the case where carotid chemoreceptor (such as carotid body) is there is no (after surgical operation removing) The persistence of stimulating effect causes other researchers (including Julius Comroe among them) anoxic chemical-sensitive Property is attributed to other positions, including periphery position (such as aortic body) and central brain position (such as hypothalamus, pons and Both rostral ventrolateral medulla).Aortic chemoreceptor in aortic body may be also the important chemistry of the mankind Receptor has great influence to vascular tone and cardiac function.

Chemical receptor of carotid body reflects：

Carotid body is a tuftlet chemocepter (also referred to as blood vessel glomus cell) and the bifurcated (fork) positioned at arteria carotis Medial surface near and the medial surface of bifurcated (fork) that be in most cases located directly in arteria carotis support cell, The bifurcated (fork) of arteria carotis extends along throat both sides.

These organs are used as different chemical stimulations of the detection from arterial blood and are triggered this in afferent fibre Information is communicated to the sensor of the action potential of central nervous system (CNS).As response, CNS activation control hearts rate (HR), kidney The reflection of function and peripheral blood circulation, to keep blood gas O₂And CO₂With the desired homeostasis of blood pH.It is this to relate to And the closed loop control function of blood gas chemocepter is referred to as chemical receptor of carotid body reflection (CBC).Carotid body Chemoreceptor reflex is integrated in CNS together with the carotid sinus pressure reflection (CSB) of arterial pressure is kept.In the life of health In object, both reflections are maintained at blood pressure and blood gas in narrow physiological range.Chemical sensor in the arch of aorta For closed loop chemoreceptor reflex and baroreflex contributing redundant (redundancy) and work(is fine-tuned with pressure sensor handle Energy.Other than sensing blood gas, carotid body is understood to be now for blood flow and speed, blood pH and grape Sugared concentration sensitive.It will be understood, therefore, that in the disease of such as hypertension, CHF, insulin resistance, diabetes and other disturbed metabolisms In disease, the input signal conduction of carotid body nerve can be raised.Carotid body hyperactive, which is possibly even present in, not to be deposited In detectable hypersensitivity to hypoxemia and hypercarbia, hypoxemia and hypercarbia are traditionally used to indicate that carotid body Function.Therefore the purpose of proposed treatment is to remove or reduce the afferent nerve signals from carotid body and reduce neck to move Contribution of the arteries and veins body to central sympathetic tone.

Carotid sinus pressure is reflected through the pressure sensor (such as pressoreceptor) for being incorporated with sensing arterial pressure Degeneration factor is realized.Pressoreceptor exists in other positions, such as aorta and coronary artery.Important angiosthenia Ergoreceptor is located in carotid sinus, and carotid sinus is slightly expansion of the internal carotid 201 at its origin from arteria carotis communis Open structure.Carotid sinus baroreceptor is detached close to carotid body but in anatomical structure with carotid body.Feeling of stress Receiver in response to arterial wall stretching, extension and blood pressure information is communicated to CNS.Pressoreceptor is distributed in the artery of carotid sinus In wall, and chemocepter (blood vessel glomus cell) gathering is in carotid body.This makes selectivity reduce described in the application Chemoreceptor reflex be possibly realized, while substantially absolving baroreflex.

Carotid body shows the big sensibility (Low threshold and high harvest) to hypoxemia.In chronic congestive heart failure (CHF) in, it is therefore an objective to which heart can finally be aggravated by weakening the stomodaeal nervous system activation of whole body Low perfusion in the starting stage of CHF The progress of dysfunction, the progress of cardiac dysfunctions then increases additional heart abnormality, the positive feedback of progressive deterioration follows Ring, the vicious circle with negative consequence.Think, the increased major part of sympathetic nerve activity (SNA) is to be based on CNS in CHF The increase of horizontal sympathetic nerve flowing and the inhibition based on arterial pressure reflection function.In the past few years, it has been shown that outer The enhancing that the increase (raised chemoreceptor reflex function) of the activity and sensibility of all chemocepters also occurs in CHF SNA in play an important role.

Effect of the chemoreceptor reflex being changed in CHF：

As frequently occurred in chronic disease states, it is exclusively used in keeping homeostasis and correction under normal circumstances The chemoreceptor reflex of hypoxemia contributes to the sympathetic tone increased in CHF patient, or even under the conditions of normoxic. Through obtained from multinomial zooscopy to the sensibility enhanced extremely of periphery chemical sensor especially carotid body how tribute It offers in the understanding of the tonicity raising (tonic elevation) of SNA in CHF patient.According to a theory, local vascular is tight Plain receptor system is opened to play at all the chemical receptor of carotid body sensibility being enhanced in CHF.In addition, in CHF patient It has clearly been established with the evidence in animal model the two of CHF, chemical receptor of carotid body is reflected in CHF patient and passes through It is often hypersensitization and contributes to the tonicity raising of sympathetic nerve function.This entanglement derive from the incoming of reflex arc and The function being changed in the level of both central pathways.Cause the raised incoming active mechanism from carotid body in CHF Not yet it is fully understood.

Regardless of the exact mechanism of carotid body hypersensitization behind, from carotid body and other autonomous path drives Chronic sympathetic activation leads to the further deterioration of positive feedback loop cardiac function.When CHF then occurs, increase heart The seriousness of dysfunction cause chemical receptor of carotid body reflection function these change gradual gradually rise and into one Step increases sympathetic activity and heart deteriorates.It is happened at the triggering for causing the cascade event to start in the development of CHF or the cause of disease The time-histories that factor and the cascade event occur is still unclear.However, causative factor is finally bundled in heart pump The cardiac output of functional failure and reduction.According to a theory, in carotid body, the gradual and chronic reduction of blood flow may It is the key that cause chemical receptor of carotid body reflection function in CHF unconformable variation occurs.

There is ample evidence showing that having increased periphery and central chemoreceptor reflection sensitive in heart failure Property, it may be related to the seriousness of disease.Also some evidences show that central chemoreceptor reflection is experienced by peripheral chemical Device Reflective regulation.According to current theory, carotid body is the significant contributor of the peripheral chemoreceptor reflection in the mankind；It is main Artery body has small contribution.

Although it is still unclear to cause the mechanism of the central chemoreceptor reflex sensitivity changed, enhance Peripheral chemoreceptor reflex sensitivity may in carotid body influence be passed to sensibility nitric oxide generate be suppressed with And the raising of the integrated maincenter Angiotensin II of maincenter of influence chemocepter input is relevant.The chemocepter of enhancing Reflection can partly cause the breathing and the ventilation response of exercise, expiratory dyspnea, Amur in chronic heart failure of enhancing The sympathetic activation observed in patient.The ventilation when chemoreceptor reflex of enhancing can also cause rest and take exercise Spend and be short of breath (such as quickly breathing), the periodic breathing during exercise, rest and sleep, hypocapnia, blood Pipe is shunk, the peripheral organ of reduction is perfused and hypertension.

Expiratory dyspnea：

It is short of breath or expiratory dyspnea be and the physical activity level of patient it is out-of-proportion expiratory dyspnea or laborious sense Feel.It is the symptom of a variety of different diseases or disorder and can be acute or chronic.Expiratory dyspnea is to suffer from cardiopulmonary The most common complaint of patient of disease.

Expiratory dyspnea be considered due to Neurotransmission, breathing mechanics and central nervous system relevant response it Between complicated interaction.The specific region for the perception that may influence expiratory dyspnea property is recognized in midbrain.

Dyspneic experience depends on its seriousness and potential reason.The feeling itself is due to from lung, thoracic cavity, chest Nerve endings relaying (relay) in flesh or diaphragm is incorporated in the perception and explanation of the feeling with patient to the pulse of brain Combination together.In certain cases, the feeling of patient being short of breath is by the anxiety reinforcing about its reason.Patient is breathing Be described as to difficult diversity, make one it is uncomfortable it is short of breath, when making chest muscle move increased effort or fatigue impression, The panic sense to suffocate or the feeling of the tightening in the wall of the chest or spasm.

Dyspneic four are to be based on its reason by generally accepted classification：Heart, lung, mixing heart or Lung and non-cardiac or non-lung.The most common dyspneic heart disease and tuberculosis of generating is asthma, pneumonia, COPD Ischaemic with cardiac muscle or heart attack (myocardial infarction).Foreign-body aspiration, it is toxic to the damage of air flue, pulmonary embolism, fill Courageous and upright heart failure (CHF), the anxiety (panic disorder) with hyperventilation, anaemia and because sitting life style body Deadaptation or obesity can generate expiratory dyspnea.In most of cases, has difficulty in breathing and add with potential disease Occur again.Expiratory dyspnea can also derive from the resistance of the weakness of the wall of the chest or chest muscle or the lungs elasticity, air flue of damage, reduction Hinder, increased oxygen demand or lead to increased pressure and fluid in lungs, such as poor heart pump action in CHF.

The acute dyspnea to break out is the common cause of emergency treatment.Most of cases of acute dyspnea are related to lung (lungs and breathing) disorderly, angiocardiopathy or thoracic trauma.Dyspneic (acute dyspnea) the most allusion quotation that breaks out Type it is associated：Air flue narrow or air-flow hinder (bronchial spasm), lungs an artery in blockade (lung bolt Plug), acute heart failure or myocardial infarction, pneumonia or panic disorder.

Chronic respiratory difficulty is different.Long-standing expiratory dyspnea (chronic respiratory difficult) be most often lungs or Chronic or progressive disease the performance of heart, such as COPD comprising chronic bronchitis and pulmonary emphysema.Chronic respiratory is tired Difficult treatment depends on potential disorderly.Asthma can often use and reduce the drug therapy of airway spasm and be removed from patient environmental The combination of disallergization original is managed.COPD needs drug therapy, lifestyle change and long term body rehabilitation.Anxiety disorder is usual It is treated using drug therapy and therapeutive combination.

Although the exact mechanism having difficulty in breathing in different morbid states is disputable, query is not that CBC exists It plays a role in the most of performance of this symptom.Expiratory dyspnea seems most to generally occur in from peripheric receptor When incoming input is enhanced or when the cortex Oversensing of respiratory work.

The surgical operation of glomus removes and the excision of carotid body nerve：

For the surgical operation therapy of asthma, the removing (glomectomy) of carotid body or glomus is cured by Japanese surgery Raw Komei Nakayama are described in the 1940s.According to Nakayama, the patient's that he suffers from asthma to 4,000 In research, about 80% is cured or improves after the procedure and 58% claims and keeps good knot after 5 years for six months Fruit.Komei Nakayama have carried out his most of operations in Chiba universities during World War II.In 20 generation It records the later stage fifties, 160 U.S. patients of American surgeon doctor Overholt couple have carried out Nakayama operations.He feels It is required that two carotid bodies are removed only in three cases.He reports that certain patients are in the wink being removed when carotid body Between or even earlier, when injection prevention activity of the carotid body by procaine (procaine hydrochloride), experience mitigation.

Overholt he described in the paper Glomectomy for Asthma that Chest is delivered in 1961 with Under mode surgical operation glomectomy：" in the broken line in neck, the one third distance between angle of mandible and clavicle Place carries out two inch cuts.Platysma is divided and nutator is laterally retracted.Dissection carried out downwards to Arteria carotis sheath, exposure bifurcated.Superior thyroid artery is ligated and nearby divides to help neck at its edge (take-off) The rotation of bulbus arteriosus and the inside of exposure bifurcated.Carotid body is about the size of the grain of rice and to be hidden in outside the artery of blood vessel In film and color having the same.It removes and is extremely less than outside the Perivascular artery of one centimeters of bifurcated for one centimetre higher than bifurcated Film.Connection of this cut-out around the neuropile of carotid body.Adventitial dissection is required to position and identify arteria carotis Body.It is usually precisely located at bifurcated at its interior side point.It rarely, can in the center of crotch (crotch) or on the outside It is found on wall.The parteriole of clamping, segmentation and ligation into carotid body.Then it is clamped, divides and ligatures on carotid body The upper handle of the tissue of side.”

In January nineteen sixty-five, New England Journal of Medicine have delivered the report of 15 cases, wherein In order to treat bronchial asthma unilateral removing Cervical Vessels ball (carotid body), but there is no target advantageous effect.This is effectively Ground stopped is used to treat the practice of the glomectomy of asthma in the U.S..

Winter develops the technology of separation nerve, which helps carotid sinus nerve being divided into two beams, arteria carotis Sinus (baroreflex) and carotid body (chemoreceptor reflex), and selectively cut off the latter.Winter technologies are to be based on His this discovery, the mainly lateral surface at carotid bifuracation and the carotid body (change of carotid sinus (baroreflex) nerve Learn receptor reflection) it is neural mainly in medial surface.

The nerve modulation of chemical receptor of carotid body reflection：

Hlavaka describes implantation electricity in the U.S. Patent Application Publication 2010/0070004 that August in 2009 is submitted on the 7th To apply electric signal, the electric signal blocks or inhibits with the chemocepter signal in dyspneic patient stimulator. Hlavaka is instructed, and " certain patients can benefit from reactivation or adjust the ability of chemoreceptor function." Hlavaka concentrations In to chemoreceptor reflex carrying out neural tune by selectively blocking the conduction the nerve that carotid body is connected to CNS Section.Hlavaka is described using the implantable electric pulse generator for not changing or changing carotid body tissue or chemocepter Nerve modulation conventional method.

Central chemoreceptor is located in brain and is difficult to approach.Peripheral chemoreceptor reflection is mainly easier to Close carotid body is adjusted.The 1940s and in the 1960s, before go carotid body to treat about operation The clinical practice of asthma has very limited clinical success.

Kidney denervation：

System disclosed herein or the embodiment of device can be used for through following ablation in body cavity (for example, artery, quiet Arteries and veins, blood vessel, respiratory cavity, esophagus, bronchiole, gastrovascular cavity) neighbouring destination organization：It will be with integrated image-forming component or by structure It causes the ablation catheter being used together with individual imaging catheter (such as ultrasonic imaging) to be placed in chamber, is carried using image-forming component For tissue (for example, anatomic marker or destination organization) image in order to guide ablation energy towards destination organization, and to mesh Mark tissue conveying ablation energy (for example, supersonic melting energy, chemical agent, radio-frequency current).Destination organization can be away from cavity wall 0mm In the range of to 2cm (for example, 0 to 1cm, 0 to 1.5cm, 0 to .5cm).Kidney denervation can be can be using disclosed The optional program to carotid body ablation of device or system.The kidney denervation program for adopting disclosed device and system can Including ablation catheter is transported to renal vein and ablation energy is directed to renal nerve from conduit.Target renal nerves can be in the arteria renalis In outer membrane or near it, in the tissue between renal artery bifurcation, around the kidney adjacent with the renal artery ostium from aorta In the tissue of artery.Other kidney denervation programs are usually directed to is sent to the arteria renalis for ray by radiopaque contrast agent transport Imaging.However, the kidney of some patients is not resistant to contrast agent.The program of proposal can be executed without conveying contrast agent or device To the arteria renalis.Imaging can be used to identify renal artery bifurcation, and ablation energy can be transported to the tissue between bifurcated artery.The body Long-pending tissue can be referred to as renal artery bifurcation diaphragm, and the renal nerve containing high concentration.Additionally or alternatively, imaging can be with For the position of thin vessels in identification object region, in target area thin vessels may by be used as radiator remove thermal energy come Hinder effectively ablation.Ablation energy can be transported to the region for not including thin vessels radiator in target area.

Embodiment

1. a kind of supersonic melting conduit is configured to interact with ultrasound imaging catheter, the supersonic melting conduit Including：

Remote area and proximal end region；

Imaging catheter chamber, by its receiving, proximally region extends to the imaging of remote area and leads the imaging catheter chamber Pipe；

In the anechoic room of remote area；And

The indoor supersonic melting energy converter of echoless,

Wherein imaging catheter chamber is configured to that imaging catheter is located in the aiming of supersonic melting energy converter in unfolded state Sighted direction is left in direction and in retracted mode.

2. the conduit of embodiment 1 further includes the cooling fluid chamber for cooling down anechoic room.

3. the conduit of embodiment 1, the wherein sighted direction of supersonic melting conduit are in unfolded state and are led by imaging The radial direction of conduit is left in the imaging plane that pipe generates.

4. the conduit of embodiment 1 further includes the mating feature part for being coupled with imaging catheter in proximal end region, Middle mating feature part with by imaging catheter, the actuator of transition is associated between unfolded state and retracted mode.

5. the conduit of embodiment 1, wherein the conduit is configured to the controllable deflection of remote area, wherein deflecting Plane and supersonic melting energy converter are coplanar.

6. the conduit of embodiment 1 further includes the chamber for being configured to accommodate seal wire.

7. a kind of supersonic melting conduit is configured to and the ultrasound imaging catheter phase interaction with ultrasonic imaging energy converter With the supersonic melting conduit includes：

Remote area and proximal end region；

Imaging catheter chamber, the imaging catheter chamber be configured to by its receiving proximally region extend to remote area Imaging catheter；

In the anechoic room of remote area；And

The indoor supersonic melting energy converter of echoless,

Wherein imaging catheter chamber is configured to the ultrasonic imaging energy converter by ultrasound imaging catheter far from supersonic melting transducing Device position so that when ultrasonic imaging energy converter transmission and received wave to provide ablation when image when, supersonic melting energy converter can Convey ablation energy.

8. the supersonic melting conduit of embodiment 1 or 7, including acoustic insulation body to be to shield passing through for supersonic melting energy, Wherein acoustic insulation body includes the air microballoon in embedded epoxy resin.

9. the supersonic melting conduit of embodiment 8, wherein acoustic insulation body have about 200 to 300 microns of thickness, and Include the microballoon with about 15 to 25 microns of diameter and the microballoon with the diameter in about 180 to 210 microns of range.

10. the supersonic melting conduit of embodiment 1 or 7, including fiducial marker, the fiducial marker have relative at As the positioning of energy converter and the sighted direction of ablation energy converter.

11. the supersonic melting conduit of embodiment 10, wherein fiducial marker are the hollow tubes filled with air.

12. a kind of supersonic melting conduit, including：

Distal component, the distal component include supersonic melting energy converter, echoless shell and ablation directional reference label Device, echoless shell define distal end room at least partly, and supersonic melting energy converter is located remotely interior, and distal component is suitable for Ultrasonic imaging energy converter is accommodated wherein,

Ablation directional reference marker is positioned and adapted to relative to supersonic melting energy converter, when ultrasonic imaging energy converter is remote It when positioning and activate in the component of end, is created on the image created by ultrasonic imaging energy converter and aims at artifact, aimed at artifact and be suitable for It is used to indicate ablation direction；And

The elongated sheath proximally extended from distal component.

13. the conduit of embodiment 12 disappears wherein when ultrasonic imaging energy converter is in activated positon in distal component Melt directional reference marker to axially align with ultrasound imaging catheter.

14. the conduit of embodiment 12 makes wherein ablation directional reference marker is arranged relative to supersonic melting energy converter The direction of the ablation energy emitted from supersonic melting energy converter can be determined based on the position indicated on image by obtaining.

15. the conduit of embodiment 14, wherein ablation directional reference marker is fixed in echoless shell.

16. the conduit of embodiment 15, wherein echoless shell include the first film and the second film, ablation directional reference label Device is fixed between the first film and the second film.

17. the conduit of embodiment 16, wherein ablation directional reference marker has the construction of bending.

18. the conduit of embodiment 12, wherein ablation directional reference marker has the construction of bending.

19. the conduit of embodiment 12, wherein the construction of the ablation promising part tubular component of directional reference marking instrument.

20. the conduit of embodiment 12 is set wherein ablation directional reference marker is neighbouring ablation directional reference marker The extension for the support member set.

21. the conduit of embodiment 12, wherein ablation directional reference marker is impermeable echogenic material.

22. the conduit of embodiment 21, wherein ablation directional reference marker includes stainless steel.

23. the conduit of embodiment 12, wherein supersonic melting conduit be configured to be inserted through the jugular vein of patient and its Middle supersonic melting energy converter is configured to be placed on the target ablation near sites including carotid body.

24. the conduit of embodiment 12, wherein distal component further include be configured to wherein by its receiving ultrasound at As the chamber of conduit.

25. the conduit of embodiment 12, wherein supersonic melting energy converter are flat energy converters, it is in directly with being parallel to The axis of the longitudinal axis of the elongated sheath of construction.

26. the conduit of embodiment 25, wherein flat energy converter is located remotely in the outer radius portion in region.

27. the conduit of embodiment 12, wherein echoless shell have at the first axial position of ablation ultrasonic transducer There is first thickness, and there is the second thickness more than first thickness at the second axial position of ablation ultrasonic transducer distal end Degree.

28. the conduit of embodiment 12, wherein echoless shell include at least the first and second film sections, and described first and the Two film sections are fixed together in the second axial position.

29. the conduit of embodiment 12 further includes fluid cavity, fluid cavity is in fluid communication with supersonic melting energy converter, fluid Chamber further includes the electric connector being electrically connected with ablation ultrasonic transducer.

Further include being fixed at least part of elongated sheath and from elongated sheath 30. the conduit of embodiment 12 The ablation energy converter supporter that at least part extends to distal end, ablation ultrasonic transducer are installed in ablation energy converter supporter On.

31. the conduit of embodiment 30, further include be fixed on ablation ultrasonic transducer and ablation energy converter supporter it Between tablet.

32. the conduit of embodiment 30, wherein ablation energy converter supporter further includes being suitable for accommodating ultrasonic imaging wherein The chamber of conduit.

33. the conduit of embodiment 30, wherein ablation energy converter supporter include with catheter proximal end regional connectivity at least Chamber is discharged in one fluid.

34. the conduit of embodiment 30, wherein ablation energy converter supporter include defined by lateral edges and backer board it is recessed It falls into, recess is suitable for accommodating supersonic melting energy converter wherein, wherein ablation energy converter is fixed in recess so that lateral edges phase It extends radially outwardly for ablation energy converter, to allow cooling fluid to be flowed freely on ablation energy converter.

35. the conduit of embodiment 34, wherein ablation energy converter supporter be configured to cause on ablation energy converter it is cold But the turbulent flow of fluid.

36. a kind of method in computer system, including：

It receives the image based on ultrasound and is used as input, the letter received since ultrasonic imaging energy converter based on the image of ultrasound Number；

Determine the position of artifact in the image based on ultrasound, the artifact is by the fiducial marker on supersonic melting energy converter It is created in response to the ultrasonic wave generated by ultrasonic imaging energy converter；

Based on artifact position, the sighted direction of the ablation energy from supersonic melting energy converter is determined；And

Create enhancing based on ultrasound image as output to show over the display, the enhancing based on ultrasound Image includes the sighted direction of the image based on ultrasound and the ablation energy from supersonic melting energy converter.

37. the method for embodiment 36, wherein determining that the position of the artifact in the image based on ultrasound includes that identification is based on A part for the image of ultrasound, a part for the image based on ultrasound is when the orientation of the image based on ultrasound is in response to ultrasound The movement of imaging transducer and when changing, not substantially change shape.

38. a method of computer implementation, the method includes：

Receive the target ablation position for carotid body ablation created by the ultrasonic signal transmitted from ultrasonic transceiver Video or based on ultrasound image, the video or based on ultrasound image supersonic melting energy converter be located at be used for carotid body It is captured when the target ablation near sites of ablation；

Enhance video by one or more of visions auxiliary, animation or message or based on ultrasonic image, one of which Or more vision auxiliary, animation or message include about the ablation for carotid body ablation from supersonic melting energy converter The information of the sighted direction of energy；With

The video of enhancing or the image based on ultrasound are shown on a user interface.

39. a method of computer implementation, the method includes：

Receive the target ablation position for carotid body ablation created by the ultrasonic signal transmitted from ultrasonic transceiver Video or based on ultrasound image, the video or based on ultrasound image supersonic melting energy converter be located at be used for carotid body It is captured when the target ablation near sites of ablation；

Enhance video by one or more visions auxiliary, animation or message or the image based on ultrasound, wherein one A or more vision auxiliary, animation or message include about positioned at the target ablation near sites melted for carotid body The information of the estimated location of the ablation areas of supersonic melting energy converter；And

The video of enhancing or the image based on ultrasound are shown on a user interface.

40. the computer implemented method of embodiment 38, one of which or more vision auxiliary, animation or message package Include the information of the estimated location of the ablation areas about supersonic melting energy converter.

41. the computer implemented method of embodiment 39 or 40, wherein the information of the estimated location about ablation areas Including supersonic melting energy converter towards direction and/or supersonic melting energy converter will convey the direction of ablation energy.

42. the computer implemented method of embodiment 39,40 or 41, wherein the letter of the estimated location about ablation areas Breath includes the estimating depth and/or width of the ablation areas of supersonic melting energy converter.

43. the computer implemented method of any one of embodiment 39 or embodiment 40 to 42, wherein about ablation The information of the estimated location in region includes the estimation profile of ablation areas.

44. the computer implemented method of any one of embodiment 39 or embodiment 40 to 43, wherein about ultrasound The information for melting the estimated location of the ablation areas of energy converter passes through the user-defined and/or automatic setting of consideration ablation procedure Parameter determine.

45. the computer implemented method of any one of embodiment 39 or embodiment 40 to 44, wherein supersonic melting The ablation energy that the estimated location of the ablation areas of energy converter is based at least partially on selection is composed to determine.

46. the computer implemented method of any one of embodiment 39 or embodiment 40 to 45, wherein supersonic melting One or more of anatomy of the estimated location of the ablation areas of energy converter by consideration for the candidate of ablation process are joined It counts to determine.

47. the computer implemented method of any one of embodiment 39 or embodiment 41 to 47, wherein supersonic melting The estimated location of the ablation areas of energy converter is by considering disappearing for the conduit about the concrete type for carrying supersonic melting energy converter Melt the information of characteristic to determine.

48. the computer implemented method of embodiment 47, wherein about the type for carrying supersonic melting energy converter Conduit Ablation characteristic information include the lesion depths that will be estimated and/or width and the conduit of the concrete type ablation energy Amount and duration associated information.

49. the computer implemented method of any one of embodiment 39 or embodiment 41 to 47, one of which or more A variety of vision auxiliary, animation or message further include about the ablation energy for carotid body ablation from supersonic melting energy converter The information of the sighted direction of amount.

50. the computer implemented method of embodiment 38 or 49, wherein being used for about from supersonic melting energy converter The information of the sighted direction of the ablation energy of carotid body ablation is by using the position of fiducial marker or video or based on super Aiming artifact in the image of sound determines.

51. the computer implemented method of embodiment 50, wherein fiducial marker are disposed in ultrasonic relative to carrying Melt the scheduled position of sighted direction of the ablation catheter of energy converter.

52. the computer implemented method of embodiment 51, wherein fiducial marker include working as close to target ablation position There is when placement compared with surrounding structure and/or surrounding tissue the band or pipe of apparent high echo or low echogenic material or structure.

53. the computer implemented method of embodiment 50 or 51, wherein fiducial marker include piezoelectric element.

54. the computer implemented method of embodiment 50 carries supersonic melting transducing wherein will aim at artifact and be located in On the ablation catheter of device, with the opposite direction of the instruction conveying ablation energy on the image based on ultrasound.

55. the computer implemented method of embodiment 50, wherein about dynamic for neck from supersonic melting energy converter The information of the sighted direction of the ablation energy of arteries and veins body ablation is by using the position of multiple fiducial markers or video or based on super Aiming artifact in the image of sound determines.

56. the computer implemented method of any one of embodiment 39 and 40 to 55, wherein video or the figure based on ultrasound As being created with ultrasound imaging catheter.

57. the computer implemented method of embodiment 56, wherein ultrasound imaging catheter are placed on for carotid body In the jugular vein close to carotid bifuracation of the candidate of ablation.

58. the computer implemented method of any one of embodiment 39 and 40 to 57, further includes：

Based on conduit or in video or based on the image of ultrasound, the visible known dimensions for aiming at artifact determine video Or the scale of the image based on ultrasound.

59. the computer implemented method of any one of embodiment 39 and 40 to 58, one of which or more vision Auxiliary, animation or message include the information of one or more distances between the anatomical features at target ablation position.

60. the computer implemented method of embodiment 59, one of them or more distance include it is below a kind of or It is more kinds of：Jugular vein, arteria carotis diaphragm, internal carotid, external carotid artery or arteria carotis diaphragm boundary to the opposite position of reference point Set, the variation of artery diameter, artery diameter, anatomical features relative position variation, estimation ablation or establishment ablation Size and relative position.

61. the computer implemented method of any one of embodiment 59 and 62 further includes based on target ablation position One or more distances between anatomical features provide ablation therapy guidance to the user or suggest.

62. a kind of computer system for monitoring arteria carotis ablation procedure is configured to execute embodiment 38,39 and The operation of 40 to 61 any one.

63. the computer system of embodiment 62, including it is configured to the video of display enhancing or the image based on ultrasound Display and be configured to receive the input interface of video from supersonic imaging apparatus or the image based on ultrasound.

64. a kind of computer-readable medium is included in when being executed by computer system and computer system is allowed to execute embodiment party The instruction of the operation of any one of case 38,39 and 40 to 61.

65. the system for being imaged and melting carotid body with image enhancement, including：

Conduit, the conduit have ultrasonic imaging energy converter and ablation；

Melt console；

Ultrasonic imaging console, the ultrasonic imaging console be configured to signal be transported to imaging transducer and from Imaging transducer receives signal；

The algorithm that computer executes creates the video based on ultrasound from imaging transducer received signal；

Image enhancing unit utilizes video of the computerized algorithm processing based on ultrasound for the image for creating enhancing；And

Show the display of the image of enhancing.

66. the system of embodiment 65 wherein the image enhanced is covered on the image based on ultrasound, and indicates to melt Conveying direction, arteria carotis, the ablation profile of estimation, the depth of ablation of estimation and the ablation locations of the establishment of estimation of energy.

67. the system of embodiment 65, wherein computerized algorithm use the opposite position of the ablation locations and arteria carotis of estimation The calculating set controls ablation console.

68. the computer implemented method of the parameter for determining carotid body ablation procedure, this method include：

Receive the information of the size of the expectation ablated volume of the ultrasonic carotid body ablation procedure of characterization；With

Information based on reception automatically determines one or more of supersonic melting transportation parameters；And

It is supplied to supersonic melting transport system using transportation parameters as output.

69. the computer implemented method of embodiment 68, one of which or more supersonic melting transportation parameters include The ablation energy used by ablation transport system is composed.

70. the computer implemented method of embodiment 69, wherein ablation energy spectrum indicate that conveying disappears during processing routine Melt the overview of the acoustical power of energy and the amount of duration.

71. the computer implemented method of embodiment 68 or 70, one of which or more supersonic melting transportation parameters It is determined by considering one or more of anatomical parameters for the candidate of ablation process.

72. the computer implemented method of the embodiment of any one of embodiment 68 to 71, one of which or more Kind supersonic melting transportation parameters are by considering the ablation transducer characteristics about the specific conduit for carrying supersonic melting energy converter Information determines.

73. the computer implemented method of embodiment 72, wherein disappearing about the conduit for carrying supersonic melting energy converter The information for melting transducer characteristics includes the electrical power of the lesion depths that will be estimated and/or width and the specific ablation catheter and continues The information of association in time.

74. the computer implemented method of any one of embodiment 68 to 73, wherein ultrasonic carotid body ablation procedure Desired ablated volume based on the ultrasound by being transmitted from the ultrasonic transducer at the target ablation position melted for carotid body The video of signal creation is automatically determined based on ultrasonic image.

75. the computer implemented method of embodiment 74, wherein automatically determining including one in assessment target ablation position The position of kind or more anatomical features or size.

76. the computer implemented method of embodiment 75, one of which or more anatomical features include arteria carotis Diaphragm, carotid body, internal carotid and external carotid artery and jugular vein.

77. the computer implemented method of any one of embodiment 68 and 69 to 76, wherein automatically determining a kind of or more A variety of supersonic melting transportation parameters include the digital mould using the information and/or assessment simulation program retrieved from previous ablation procedure Type.

78. the computer implemented method of any one of embodiment 68 and 69 to 76, further includes：

The body of automatic monitoring patient or the movement on head；

Identification meets the movement for being predefined with criterion standard of instruction patient risk；And

It generates instruction movement and has reached the signal for being predefined with criterion standard.

79. a kind of computer system for monitoring arteria carotis ablation procedure is configured to execute embodiment 82,68 and The operation of 69 to 78 any one.

80. a kind of computer-readable medium is included in when being executed by computer system and computer system is allowed to execute embodiment party The instruction of the operation of any one of case 82,68 and 69 to 78.

81. the computer implemented method of embodiment 68, one of which or more supersonic melting transportation parameters include The duration of energy conveying and acoustical power, wherein acoustic power range is between 2 watts and 25 watts, and duration ranges were at 3 seconds And between 25 seconds.

82. a kind of method in computer system, including：

The distance of the line from jugular wall to the part of connection internal carotid and external carotid artery is received as input, the distance From the image measurement based on ultrasound, should image based on ultrasound by from the ultrasonic transducer received signal being positioned in jugular vein It obtains；

Supersonic melting transportation parameters are determined based on transmission range；

It is supplied to supersonic melting transport system using transportation parameters as output.

83. a kind of ultrasound catheter being suitable for use in imaging and ablation tissue, including：

In the deflectionable part for being imaged and melting segment proximal.

84. the conduit of embodiment 83 further includes multiple deflectionable parts, any one is optionally in different planes Upper deflection.

85. the conduit of embodiment 83, the wherein conduit include supersonic melting energy converter, and deflectionable part be suitable for Melt the plane deflection of the sighted direction alignment of energy converter.

86. the conduit of embodiment 83, wherein conduit include being imaged and melting part, and conduit is adapted so that can be changed into The position of picture and ablation part relative to deflectable position.

87. the conduit of embodiment 86, wherein the position of imaging and ablation part can be scalable relative to deflectionable part It changes and/or is rotatably changed relative to deflectionable part in ground.

88. the conduit of embodiment 86, wherein conduit further include locking mechanism with maintain to be imaged and melt part with can be inclined The relative position of transfer part point.

89. a kind of ultrasound catheter is configured in the multiple distance deflections of imaging and ablation part away from conduit.

90. a kind of ultrasound catheter being suitable for use in imaging and ablation tissue, including：

Slender member optionally includes elongated tubular, which is included in its distal tip or close to its distal end end The imaging at end and ablation areas；With

The integrated sheath integrated with slender member, the integrated sheath extend around a part for slender member.

91. the conduit of embodiment 90, wherein slender member are suitable for being rotated relative to integrated sheath and axially movable At least one of.

92. the conduit of embodiment 90, wherein integrated sheath includes at least part of chamber along its length, slender member exists Wherein extend.

93. the conduit of embodiment 92, the wherein remote area (optionally including imaging and ablation part) of slender member Width (such as diameter) be more than chamber diameter.

94. a kind of ultrasound catheter being suitable for use in imaging and ablation tissue, including：

The imaging of distal tip in conduit or the distal tip close to conduit and supersonic melting part；With with imaging and super Sound melts the relevant moveable protection mechanism in part.

95. the conduit of embodiment 94, wherein moveable protection mechanism is adapted to imaging and supersonic melting part Mobile and structural change at least one.

96. the conduit of embodiment 94, wherein moveable protection mechanism has undeployed configuration or the structure for conveying Make the construction with unfolded state or for ablation.

97. the conduit of embodiment 94, wherein moveable protection mechanism is adapted to imaging and supersonic melting part Axial movement.

98. the conduit of embodiment 94, wherein moveable protection mechanism is suitable for being moved out of the ablation energy for ablation Path.

99. the conduit of embodiment 94, wherein moveable protection mechanism is suitable for changing construction to melt.

100. the conduit of embodiment 98, wherein moveable protection mechanism includes at least one spline, this is at least one At least part of spline is suitable for becoming more curved than delivery configuration in ablation constructs.

101. the conduit of embodiment 100, wherein moveable protection mechanism includes at least two coupled with membrane material Spline, the membrane material define imaging and the ablation room of conduit at least partly.

102. the conduit of embodiment 101, wherein film are suitable for being unfolded when spline is moved to ablation construction from delivery configuration Or at least one of stretching, extension.

103. the conduit of embodiment 94, wherein moveable protection mechanism is suitable for being moved by actuator, actuator is optional Ground is a part for handle.

104. the conduit of embodiment 103, wherein moveable protection mechanism be suitable for by using with actuator and removable The bracing wire that dynamic protection mechanism is operatively connected is activated and is moved.

105. a kind of ultrasound catheter being suitable for use in imaging and ablation tissue, suitable for be purposely allowed coolant leave conduit into Enter ambient enviroment.

106. the distal end workspace that the conduit of embodiment 105, wherein conduit are suitable for that coolant is purposely allowed to leave conduit Domain enters ambient enviroment.

107. a kind of method using ultrasound catheter in patients, including brine-cooled agent conveying by conduit and is left Conduit enters patient.

108. a kind of ultrasound catheter being suitable for use in imaging and ablation tissue, including：

Supersonic melting energy converter, at least part are electrically insulated with coolant such as brine-cooled agent.

109. at least part of the conduit of embodiment 108, wherein supersonic melting energy converter is coated with electrical insulator, appoint The side and/or the back side of selection of land supersonic melting energy converter.

110. the conduit of embodiment 108, wherein at least part of supersonic melting energy converter is by being installed in backing It is not electrically insulated above and with cooling fluid with coolant connection.

110. the conduit of embodiment 108, wherein with supersonic melting energy converter be at least one component being electrically connected and Coolant is electrically insulated.

111. a kind of method of manufacture supersonic melting energy converter, includes a part for masking supersonic melting energy converter；Xiang Chao Sound melts transducer application insulating materials；With removal shelter.

112. a kind of supersonic melting conduit, wherein supersonic melting energy converter are installed in or are embedded in flexible circuit or circuit Plate.

113. a kind of supersonic melting conduit, including supersonic melting energy converter and coolant flow path, wherein conduit, which is constructed, makes The only a part for obtaining supersonic melting energy converter is exposed to coolant.

114. the conduit of embodiment 113, wherein supersonic melting energy converter are arranged on ablation energy converter supporter recess It is interior, described at least one of the side and the back side for being configured to that coolant is prevented to be exposed to supersonic melting energy converter that be recessed.

115. a kind of supersonic melting conduit, including supersonic melting energy converter, the first coolant flow path and the second coolant flow Diameter, the first and second coolants flow path are physically separated from one another.

116. it is cold to be wherein exposed to first on front side of supersonic melting energy converter for the supersonic melting conduit of embodiment 115 But agent flow path (but being not exposed to the second coolant flow path), and the back side of energy converter or disappearing of being attached thereon of ablation energy converter The back of the body for melting energy converter supporter is exposed to second flow path (but being not exposed to the first coolant flow path).

117. the supersonic melting conduit of embodiment 115, wherein supersonic melting energy converter are mounted to ablation energy converter branch Gripping member.

118. the supersonic melting conduit of embodiment 115, further include be in fluid communication with the first coolant flow diameter it is first cold But agent source and the second coolant source being in fluid communication with the second coolant flow diameter, two kinds of fluid sources are not in fluid communication.

119. the ultrasound catheter of embodiment 115, wherein the first and second coolant flow paths are including supersonic melting transducing In the remote area of the conduit of device.

120. the ultrasound catheter of embodiment 115, wherein the first and second coolant flow paths include supersonic melting approaching In the region in the distal end of catheter region of energy converter.

121. the ultrasound catheter of embodiment 115 further includes the first and second fluid outlets not being in fluid communication.

122. a kind of supersonic melting conduit including supersonic melting energy converter, which does not include surrounding supersonic melting transducing The outdoor cover of device, the anti-Hemostatic Oral Liquid of outdoor cover are contacted with ablation energy converter.

123. a kind of supersonic melting conduit including supersonic melting energy converter, conduit be configured at least when coolant not by Ablation energy converter is exposed to ambient enviroment such as blood towards when ablation energy converter conveying.

124. a kind of supersonic melting conduit including supersonic melting energy converter, which does not include defining around ablation transducing The film or air bag of the room of device.

Claims (52)

1. a kind of supersonic melting conduit, including：

Supersonic melting energy converter and ultrasonic imaging energy converter, the supersonic melting energy converter and the ultrasonic imaging transducer axes to It is spaced apart and there is fixed position relative to the ultrasonic imaging energy converter.

2. conduit as described in claim 1 further includes the insulating component at least one surface of the engagement ablation energy converter, At least one pole of the ablation energy converter is electrically isolated by the insulating component with the conductor fluid in anechoic room.

3. conduit as claimed in claim 2, wherein the first side and second of the insulating component and the ablation energy converter Side contacts.

4. conduit as claimed in claim 3, wherein the insulating component is not set on the face of the ablation energy converter.

5. such as any one of them conduit of claim 2 to 4, wherein the anechoic room includes the ablation energy converter proximal end Cooling fluid inlet port and the ablation energy converter distal end cooling fluid outlet port.

6. conduit as claimed in claim 5, wherein the cooling fluid outlet port is oriented that cooling fluid is allowed to flow to Position other than the conduit.

7. as claim 2 to 6 any one of them conduit, wherein the insulating component have 10 to 30 microns, 10 to 25 The thickness of micron, 20 to 25 microns or 22 microns.

8. conduit as described in any one of the preceding claims, wherein the anechoic room includes film.

9. conduit as claimed in claim 8, wherein the anechoic room further includes ablation energy converter supporter.

10. conduit as claimed in claim 9, wherein the ablation energy converter supporter is included therein the chamber to be formed.

11. such as claim 9 or conduit according to any one of claims 10, wherein the film is in the outer of the ablation energy converter supporter Surface extend, it is described ablation energy converter supporter proximal end and distal tip it is at least one.

12. such as any one of them conduit of claim 9 to 11, wherein the supersonic melting energy converter is by directly or indirectly It is fixed on the flat surface of the ablation energy converter supporter.

13. the conduit as described in any one of claim 8 to 12, wherein the film is arranged such that the anechoic room base Meet the outer surface of the conduit proximally and distally of the anechoic room in sheet.

14. such as any one of them conduit of claim 8-13, wherein the anechoic room is not extended past the echoless The cross section of the conduit of room proximally and distally extends.

15. the conduit as described in any one of claim 8-14, wherein the film has configuration which：It usually follows described At least part of construction of the outer surface of the conduit proximally and distally of anechoic room.

16. such as any one of them conduit of claim 8-15, wherein described in when the anechoic room is filled with fluid Film is unsuitable for extending radially outward.

17. such as any one of them conduit of claim 8-16, wherein the film has generally fixed construction.

18. the conduit as described in any one of claim 8-17, wherein the thickness of the film 0.0002 " and 0.009 " it Between.

19. conduit as described in any one of the preceding claims, wherein the ultrasonic imaging energy converter includes at least partly The more than one ultrasonic imaging energy converter being arranged around the circumference of the conduit.

20. conduit as claimed in claim 19, wherein the more than one ultrasonic imaging energy converter includes three or more A ultrasonic imaging energy converter.

21. the conduit as described in claim 19 or claim 20, wherein the more than one ultrasonic imaging energy converter quilt It is configured to generate the image for being more than 75% or the part more than 85% in the cross section for representing the tissue around the conduit.

22. the conduit as described in any one of claim 19 to 21, wherein the more than one ultrasonic imaging energy converter is not Always the circumference for surrounding the conduit extends, and the sighted direction phase wherein on the circumference with the supersonic melting energy converter The distance between anti-the first imaging transducer of position and the second imaging transducer be more than first imaging transducer and with institute State adjacent the distance between the third imaging transducer of the first imaging transducer.

23. the conduit as described in any one of claim 19 to 21, wherein the more than one ultrasonic imaging energy converter begins Extend eventually around the circumference of the conduit, and there is gap between each adjacent imaging transducer.

24. the conduit as described in any one of claim 19-23, wherein the more than one ultrasonic imaging energy converter is extremely Few one is suitable for being activated individually and being failed.

25. conduit as claimed in claim 23, wherein gap width having the same.

26. the conduit as described in any one of claim 19 to 25, wherein the more than one ultrasonic imaging energy converter quilt It is arranged so that the center of each of described more than one ultrasonic imaging energy converter is set in one plane, the plane is horizontal Pass through the longitudinal axis of the conduit.

27. conduit as described in any one of the preceding claims is led wherein the anechoic room is included in the supersonic melting Sunk area in the cross section of pipe.

28. conduit as claimed in claim 27, wherein the supersonic melting energy converter is disposed in the sunk area.

29. the conduit as described in claim 27 or claim 28, wherein the ultrasonic imaging energy converter is not disposed in institute It states in sunk area.

30. conduit as described in any one of the preceding claims, wherein the ultrasonic imaging energy converter is by conduit sheath appearance Face carries.

31. conduit as described in any one of the preceding claims, wherein the supersonic melting energy converter be set close to it is described The central shaft of conduit is Chong Die with the central shaft of the conduit, optionally in the radial direction of the conduit away from the conduit In mandrel 1mm.

32. conduit as described in any one of the preceding claims, wherein the ultrasonic imaging energy converter or described more than one Ultrasonic imaging energy converter be located relative to the proximal end of the supersonic melting conduit.

Further include being arranged behind the ablation energy converter and institute 33. conduit as described in any one of the preceding claims State the opposite guidewire lumen of the sighted direction of ablation energy converter.

34. conduit as claimed in claim 33, wherein the guidewire lumen not led with length along the ablation energy converter Pipe longitudinal axis.

35. the conduit as described in claim 33 or claim 34, wherein the guidewire lumen, wherein it is changed along the ablation Energy device simultaneously extends at the ablation energy converter rear, is not melted described in the position of energy converter proximally and distally with described substantially Guidewire lumen is aligned.

36. such as any one of them conduit of claim 33 to claim 35, wherein the guidewire lumen is in the conduit Extend along the center of the conduit in the region of end cap.

37. conduit as described in any one of the preceding claims, wherein the ablation energy converter has width, and the conduit With conduit diameter, wherein the ratio of the conduit diameter and the width is no more than 2.5.

38. conduit as described in any one of the preceding claims further includes covering the imaging transducer in side view Radiopaque marker.

39. conduit as claimed in claim 38, wherein the radiopaque marker is arranged on the imaging transducer The level of imaging plane.

40. the conduit as described in claim 38 or claim 39 further includes that the conduit is arranged on sheath therein, described Sheath includes the sheath radiopaque marker on remote area.

41. conduit as claimed in claim 40, wherein the sheath radiopaque marker is away from the radiopaque marker One axial distance, and the radiopaque marker away from it is described ablation energy converter the second axial distance of center, described first away from From substantially the same with the second distance, one of optionally wherein described distance is in the 10% of another distance.

42. such as in claim 38 to 41 any one of them conduit, wherein from the center of the radiopaque marker to The axial distance of the axial centre of the ablation energy converter is between 4mm and 12mm.

43. such as in claim 38 to 42 any one of them conduit, further include on the remote area of the conduit not Radioparent lid.

44. conduit as described in any one of the preceding claims, wherein the imaging transducer or described more than one changing Energy device is configured to generate the image of tissue plane, and the center of transmission surface of the tissue plane apart from the ablation energy converter is about 1 to 15mm, optionally about 3 to 12mm.

45. as claims 1 to 39 any one of them conduit, wherein the conduit be transformed into so that its can by conveying and Without using conveying sheath, the conduit further includes the deflectable of the ultrasonic imaging energy converter and supersonic melting energy converter proximal end Part.

46. conduit as claimed in claim 45, wherein the deflectionable part is deflectable at least two direction.

47. the conduit as described in claim 45 or claim 46, wherein the conduit have it is by axially spaced-apart, be suitable for quilt The more than one deflectionable part being individually controlled.

Further include the deflectionable part and including two ultrasounds 48. such as any one of them conduit of claim 45 to 47 Passive deflectionable part between the part of energy converter.

49. conduit as described in any one of the preceding claims further includes being configured to collect about the conduit or its group The data of one of part used simultaneously provide interface to inquire the circuit of collected data for external device (ED).

50. conduit as claimed in claim 49, wherein collected data include one or more of data below：Instruction Whether the use of one of used data, the instruction conduit or its component is held before this for one of the conduit or its component The data of continuous time and since whether the last time of one of the conduit or its component uses or had already been through since use for the first time The instruction of predetermined lasting time.

51. the conduit as described in claim 49 or claim 50, wherein being configured to collect about the conduit or its group The circuit for the data of one of part used includes timing circuit.

52. as claim 49 to 51 any one of them conduit, wherein the conduit be disposable or including one or More disposable assemblies.