CN102274074A - Multi-electrode open-type radio frequency ablation catheter - Google Patents

Abstract

The invention relates to a multi-electrode open-type radio frequency ablation catheter which is used for denervation of sympathetic nerves in the renal artery. The multi-electrode open-type radio frequency ablation catheter comprises a control handle, a catheter body, an open-type skeleton and an intake sheath, wherein one end of the catheter body is fixed to the control handle; the open-type skeleton comprises at least one rib with elastic deformation, wherein one end of each rib is fixed to the other end of the catheter body, the ribs radially extend outsides from the other end of the catheter body, electrodes are arranged on the ribs, each electrode is respectively used for extracting electroneurographic signals and ablation, a lead wire is connected to the lower side of each electrode and extends along the skeleton to the control handle after passing through the catheter body, and therefore the lead wire is electrically connected with the control handle; the catheter body passes through the intake sheath, and the one end of the intake sheath is connected to the control handle; and the intake sheath can move relative to the catheter body, so that the other end of the intake sheath can move on the open-type skeleton, and therefore the open-type skeleton can contract elastically and can be taken into the intake sheath and released from the intake sheath. The radio frequency ablation catheter has the advantages of simpleness in operation, short surgery time, ablation accuracy and controllability, and the like.

Description

Multipole opening type radio frequency ablation catheter

Technical field

The present invention relates to a kind of electrode catheter, be specifically related to a kind of orthosympathetic radio-frequency (RF) ablation conduit that is used for going in the renal artery.

Background technology

Intractable hypertension claims refractory hypertension again, is meant improvement of employing life style and the hypertension that antihypertensive drugs (comprising a kind of diuretic) treatment still can not effectively be controlled more than 3 kinds or 3 kinds.Experimental data proof hypertension is higher relevant with patient's kidney sympathetic excitability, and blocking-up kidney sympathetic nerve not only can make blood pressure drops, and the chronic organ specificity disease of sympathetic nerve excessive activation is exerted an influence; Blocking-up kidney sympathetic nerve can also improve left ventricular hypertrophy and insulin resistant.

Up-to-date animal and clinical experiment digital proof adopt percutaneous catheter kidney sympathetic nerve radio-frequency ablation technique can reduce intractable hypertension significantly enduringly, follow up a case by regular visits to the blood pressure 22/12mmHg that on average descends in 6 months.And adopting this method to have conduit intervention means utilizes radio-frequency (RF) energy can carry out the impedance type heating to the sympathetic nerve at renal artery position, can weaken its active even lost function of leading of wound, this method not only can effectively be treated intractable hypertension, and has advantages such as Wicresoft, complication are few.Industry is considered as breakthrough to this method, and thinks that it is that the treatment intractable hypertension has been opened up new main road.But this emerging technology also lacks the operating theater instruments of specialty, and particularly Zhuan Yong radio-frequency (RF) ablation conduit ensures.

Have report to be used for renal artery sympathetic nerve radio frequency heated type apparatus in the pertinent literature or in the patent, but with reach final instructions for use and also have tangible distance.The screw type ring renal artery sympathetic nerve radio-frequency ablation electrode conduit of mentioning among the CN201469401U can melt along the Continuous Contact that renal artery forms non-annularity sealing.But the adherent tightness degree of electrode can't be regulated, and can not implement monitoring and melt temperature design, is difficult to guarantee degree of ablation, has degree of ablation to cross not reach curative effect when shallow or degree of ablation causes the perforation equivalent risk; WO2010129661 and WO2008061152 have also adopted multistage to melt, and same adherent degree is difficult to guarantee.The single-point of WO2007121309 and WO2010078175 melts and is difficult to accurately select ablation site and timely definite curative effect, and needs to regulate the conductor housing electrode position to realize effectively reclining operation requirement height.

Summary of the invention

The purpose of this invention is to provide the adherent tightness degree of a kind of easy realization counter electrode adjusting be used for remove orthosympathetic multipole opening type radio frequency ablation catheter in the renal artery.

According to the present invention, a kind of multipole opening type radio frequency ablation catheter is provided, described multipole opening type radio frequency ablation catheter is used for going in the renal artery sympathetic nerve, and described multipole opening type radio frequency ablation catheter comprises: control hands handle; Conduit pipe shaft, an end of described conduit pipe shaft are fixed to described control hands handle; Open skeleton, described open skeleton comprises at least one muscle of elastically deformable, one end of every muscle all is fixed to the other end of described conduit pipe shaft, described at least one muscle outwards becomes divergent shape to extend from the described other end of described conduit pipe shaft, wherein on every muscle, be equipped with electrode, each electrode all can be used in and extracts electroneurographic signal and melt, all be connected with lead under each electrode, described lead extends along described open skeleton, and extend to described control handgrip through described conduit pipe shaft, thereby be electrically connected with described control handgrip; With take in sheath, described catheter tube was worn the described sheath of taking in, a described end of taking in sheath is connected to described control hands handle; The wherein said sheath of taking in can move with respect to described conduit pipe shaft, thereby the described other end of taking in sheath is moved on described open skeleton, make that described open skeleton can elastic shrinkage and be received to described taking in the sheath and from the described sheath of taking in and discharge.

According to multipole opening type radio frequency ablation catheter of the present invention, by the described sheath of taking in is moved with respect to described conduit pipe shaft, thereby the described described other end of taking in sheath is moved on described open skeleton, make described open skeleton elastic shrinkage and be received to and describedly take in the sheath and discharge, can adjust the adherent tightness degree of electrode of electrode and blood vessel wall applying on the described open skeleton thus from the described sheath of taking in.Each electrode all can be used in and extracts electroneurographic signal and melt, and can avoid repeatedly adjustment devices and once melt safety and efficient height.

The quantity of described at least one muscle is preferably the 1-8 bar, more preferably the 2-5 bar.

Preferably, described open skeleton comprise from the extended inverted cone section of the described other end of described conduit pipe shaft and on the direction of the axially parallel of the described other end of the described conduit pipe shaft of described inverted cone Duan Zaiyu extended straight section, described electrode is fixed on the described straight section.Straight section can guarantee that the fixed serial electrode of institute is effectively adherent.The length of described straight section is preferably 2-20mm, more preferably 2-10mm.The preferred described inverted cone section of heat treatment typing formation that adopts.Preferably: on described straight section, the number of electrodes of arranging on every muscle is 1-5, and the electrode on the adjacent muscle is staggered.Like this, at the blood vessel circumference with axially all be placed with a plurality of electrodes, can extract each position signal of telecommunication easily simultaneously and confirm ablation locations, and need not move the position of adjusting electrode, convenient and safe saving time.Preferably: described at least one muscle comprises many muscle, when described open skeleton from described when taking in sheath and discharging fully, described many muscle are being arranged on the cross-wise direction on the circumference, and the circle diameter at described straight section place is 3-15mm, and the diameter that is more suitable for is 5-12mm.

Described at least one muscle is preferably made by metal material.Described metal material is preferably marmem, and described marmem is preferably: materials such as Nitinol, the many muscle of cobalt chromium, rustless steel, titanium.

Preferably: the electrode at the other end place that is positioned at every muscle comprises the slick and sly end that is formed by metal or plastic material; Perhaps make the described other end the extending radially inwardly of every muscle along described conduit pipe shaft, and bearing of trend is the 3-30 degree with respect to the axioversion angle of the described other end of described conduit pipe shaft, thereby the electrode of avoiding being positioned at the described other end place of every muscle is stabbed blood vessel.

Preferably: the described original state of sheath of taking in is for to be received into described taking in the sheath fully with described open skeleton, described take in sheath and arrive at renal artery after, recall the described sheath of taking in discharging described open skeleton, thereby make described positioning of electrode at blood vessel.By controlling the described degree of recalling of taking in sheath, make the described described other end of taking in sheath be in the different parts of described open skeleton, thereby adjust the described electrode on the described open skeleton and the applying degree (promptly adjusting the effective diameter of described open skeleton) of described blood vessel.

Preferably, describedly take in the pipe that sheath is external diameter 1.5～4.0mm, supporting with pipe shaft, adopt medical macromolecular materials to make, for example: materials such as fluorine class, polyesters, polyurethane, polyamide, polyimides.

Measure the patient's blood vessel diameter by means such as radiographies during use, select skeleton diameter specifications product than the big 0-3mm of blood vessel diameter; After skeleton delivered to the blood vessel target location, slowly sheath was taken in recession, by X-ray machine down monitoring discharge electrode diameter and blood vessel diameter is compared, can simply accurately judge and the adherent degree of control electrode and blood vessel whether suitable.If adherent tension, can push away forward and take in sheath and reclaim skeleton to a certain extent, reduce electrode and discharge diameter, thereby reduce adherent tightness degree.

Preferably: the described other end of described conduit pipe shaft comprises the bendable section, and a described end of every muscle all is fixed to described bendable section.Further preferably, the backguy of described conduit pipe shaft embedded set, an end of described backguy is fixed on the described control handgrip, by operating described control handgrip, can control the bending of described bendable section.For example, a described end of described backguy can be fixed on the adjusting knob on the described control handgrip,, can control the bending of described bendable section by operating a described adjusting knob.A described described end of taking in sheath can be fixed on another adjusting knob on the described control handgrip.Can allow hand control handgrip of operator like this, adjust easily described bendable section bending, move and take in sheath and discharge open skeleton, realize sequence of operations such as the conveying of electrode and the control that puts in place.

Preferably: the position that signal that described electrode extracts is stronger is melted front and back signal strength weakening degree by contrast and is judged ablation effect, thereby improve the timely judgement that melts accuracy and effect as melting target spot.

When the fixed serial electrode of conduit latter end is used to melt purpose, both can have cooperated dispersing electrode to carry out one pole by external control appliance and melt, and also can choose and close on electrode and carry out bipolar ablation.A plurality of positions that the signal of telecommunication that interpretation of result goes out according to mapping is stronger, a plurality of electrodes or the electrode pair that can choose correspondence position melt simultaneously, realize melting fast purpose.There are a plurality of adherent good electrodes can avoid adjusting conduit and electrode position in the art, operation technique simplified, reduce complication and can be saved operating time for melting purpose.

Preferably, equal heeling-in has temperature sensor under each electrode, and described temperature sensor is used for the temperature of ablation procedure is accurately monitored.

Preferably, select to close on the skeleton staggered electrode/, can obtain the discontinuous kitchen range that melts, avoid angiostenosis melting.

Instrumentation provided by the invention is simple.Adopt seldinger technique to place the puncture sheath, select the multipole opening type radio frequency ablation catheter of the present invention skeleton diameter specifications according to patient vessel's diameter.The affirmation skeleton will be delivered to the renal artery porch along ventral aorta by the puncture sheath after placing fully and taking in sheath, make the conduit latter end to the renal artery ostium bending by the described adjusting knob control on the control handgrip is curved, send conduit to cover the renal artery position up to electrode section forward, described another adjusting knob recession on the turn control handgrip is taken in sheath and is discharged electrode to suitable diameter.The join dependency external equipment can extract signal of telecommunication analysis and melts; Confirm to melt to finish, push away forward and take in sheath, can withdraw from conduit after electrode skeleton is regained fully, finish operation.All conduit operations all need operation under the X-ray monitoring.

Multipole opening type radio frequency ablation catheter provided by the invention, boniness frame and take in the sheath relevant design and can be adjusted at easily in the different blood vessel diameter and to realize the optimal adherence tightness degree; Staggered a plurality of electrodes can be realized signal of telecommunication analysis and preferably carry out the purpose that a plurality of electrodes melt simultaneously that the target accuracy that effective raising is melted, the timely judgement of ablation effect are also saved operating time.

Description of drawings

Fig. 1 is the overall structure sketch map of multipole opening type radio frequency ablation catheter.

Fig. 2 illustrates and is in the not multipole opening type radio frequency ablation catheter of release conditions of skeleton.

Fig. 3 illustrates and is in the multipole opening type radio frequency ablation catheter that skeleton discharges intermediateness.

Fig. 4 illustrates the multipole opening type radio frequency ablation catheter that is in the complete release conditions of skeleton.

Fig. 5 illustrates reducing of when taking in sheath and be in half release conditions electrode circle diameter.

Fig. 6 is the schematic cross-section that skeleton is discharged the circumference of back formation fully.

Fig. 7 A is the sketch map that adopts slick and sly tip designs at the situation lower end electrode that the skeleton top electrode is arranged more; Fig. 7 B is the partial enlarged drawing of A portion among Fig. 7 A.

Fig. 8 A is terminal increasing along the sketch map of the radially intilted extension muscle of described conduit pipe shaft; Fig. 8 B is the partial enlarged drawing of B portion among Fig. 8 A.

The explanation of Reference numeral

1 conduit pipe shaft

2 take in sheath

3 electrodes

4 open skeletons

4.1 straight section

4.2 conical section

6 control handgrips

6.1 bendable section adjusting knob

6.2 take in the sheath adjusting knob

7 is slick and sly terminal

8 intilted extension muscle

The RP sympathetic nerve

9 kidneys

The specific embodiment

Specific embodiments of the present invention is described in detail below in conjunction with accompanying drawing.For ease of explanation, below will be the operator or be called " near-end " near the control handgrip away from an end of kidney, will be that an end of operator or close kidney is called " far-end " away from the control handgrip.

Figure 1 shows that the overall structure sketch map that is used for going in the renal artery orthosympathetic multipole opening type radio frequency ablation catheter of the present invention.Described multipole opening type radio frequency ablation catheter comprises: control handgrip 6;Conduit pipe shaft 1, an end (near-end) of described conduit pipe shaft is fixed to described control handgrip 6;Open skeleton 4, describedopen skeleton 4 comprises at least one muscle of the elastically deformable of being made by metal material, one end (near-end) of every muscle all is fixed to the other end (far-end) of describedconduit pipe shaft 1, described at least one muscle outwards becomes divergent shape to extend from the described other end (far-end) of describedconduit pipe shaft 1, wherein on every muscle, be equipped withelectrode 3, the number of electrodes of arranging on every muscle is preferably 1-5, electrode on the adjacent muscle is staggered, eachelectrode 3 all can be used in and extracts electroneurographic signal and melt, each electrode all is connected with the lead (not shown) 3 times, described lead extends along describedopen skeleton 4, and extend to described control handgrip 6 through describedconduit pipe shaft 1, thereby be electrically connected with described control handgrip 6; With take insheath 2, describedconduit pipe shaft 1 passes the describedsheath 2 of taking in, a described end (near-end) of taking insheath 2 is connected to described control handgrip 6; The wherein saidsheath 2 of taking in can move with respect to describedconduit pipe shaft 1, thereby the described other end (far-end) of taking insheath 2 is moved on describedopen skeleton 4, make that describedopen skeleton 4 can elastic shrinkage and be received to described taking in thesheath 2 and from the describedsheath 2 of taking in and discharge.

The length ofconduit pipe shaft 1 is generally 30-150cm.The near-end of taking insheath 2 is fixed on taking on the sheath adjusting knob 6.2 of control handgrip 6, the Design of length of taking insheath 2 is for making the far-end of taking insheath 2 can coveropen skeleton 4 fully, take in sheath adjusting knob 6.2 by regulating on the control handgrip 6, take insheath 2 and can move with respect to described conduit pipe shaft 1.Electrode 3 adopts medical metal materials such as rustless steel, gold, platinumiridio to make.The muscle of open skeleton 4 (is preferably marmem by the medical metal material with favorable elasticity, more preferably Nitinol, cochrome, rustless steel or titanium) make, the quantity of muscle is preferably the 1-8 bar, 2-5 bar more preferably, be illustrated as 4, fixed serial electrode is staggered on each electrode, in the shape of a spiral shape; The far-end ofconduit pipe shaft 1 comprises bendable section 5, and the length of bendable section 5 is 2-10cm, and its intracavity and bendable section 5 are placed with backguy prejudicially, can regulate the bending of bendable section 5 by the bendable section adjusting knob on the control handgrip 6.1; Be integrated with described bendable section adjusting knob 6.1, described sheath adjusting knob 6.2 and the electrical apparatus interface that is used to be connected external equipment taken on the control handgrip 6.

Figure 2 shows that the conduit open skeleton in the back release conditions sketch map not as yet that puts in place.In the course of conveying,open skeleton 4 is compressed to remain on and takes in the sheath, and theelectrode 3 onopen skeleton 4 reaches the renal artery place.

Fig. 3 takes in sheath for skeleton discharges the intermediateness sketch map by recession, andskeleton 4 is opened, andelectrode 3 is released.Describedopen skeleton 4 comprise from the extended inverted cone section 4.2 of the described other end (far-end) of describedconduit pipe shaft 1 and from described inverted cone section 4.2 with the direction of the axially parallel of the described other end (far-end) of described conduit pipe shaft 1 (bendable section 2) on extended straight section 4.1, can adopt for example described inverted cone section 4.2 of heat treatment typing formation, describedelectrode 3 is fixed on the described straight section 4.1.Straight section 4.1 can guarantee that the fixed serial electrode of institute is effectively adherent.

As shown in Figure 4, drop back fully when taking insheath 2, inverted cone section 4.2 is exposed fully and is realized that promptly skeleton discharges fully.Discharging many muscle of back skeleton fully is being arranged on the circumference on the cross-wise direction.When not having restraining forces, discharging the back skeleton circle diameter is its actual diameter external, and final products are the series specification of 3-15mm scope.Need select skeleton diameter specifications during use than the big 0-3mm of patient's blood vessel actual diameter.

By the recession degree thatsheath 2 is taken in control, make the far-end of taking insheath 2 be in the diverse location of inverted cone section 4.2, can realize adjusting to the actual deployment diameter of skeleton, the tightness degree of blood vessel wall thereby adjustmentelectrode 3 reclines, as shown in Figure 5.

Fig. 6 opens the circumferential section sketch map of back formation forskeleton 4 and electrode 3.Circle diameter D is a set point value in the 3-15mm scope.

In order to improve the safety of apparatus, avoid the accident of blood vessel is scratched risk.End that can theelectrode 3 that the other end (far-end) of every muscle is located on skeleton comprise by metal or plastic material form slick and sly terminal, as shown in Figure 7; The described other end (far-end) that perhaps makes every muscle extends radially inwardly along describedconduit pipe shaft 1, and bearing of trend is the 3-30 degree with respect to the axioversion angle a of the far-end of describedconduit pipe shaft 1, as shown in Figure 8.

The present invention is not limited to the particular content described in the embodiment.Multipole opening type radio frequency ablation catheter provided by the present invention also is suitable for other people and the operation of endovascular radio-frequency (RF) ablation except renal artery ablation hypertension purposes.

Claims (13)

1. multipole opening type radio frequency ablation catheter, described multipole opening type radio frequency ablation catheter is used for going in the renal artery sympathetic nerve, and described multipole opening type radio frequency ablation catheter comprises:

Control hands handle;

Conduit pipe shaft, an end of described conduit pipe shaft are fixed to described control hands handle;

Open skeleton, described open skeleton comprises at least one muscle of elastically deformable, one end of every muscle all is fixed to the other end of described conduit pipe shaft, described at least one muscle outwards becomes divergent shape to extend from the described other end of described conduit pipe shaft, wherein on every muscle, be equipped with electrode, each electrode all can be used in and extracts electroneurographic signal and melt, all be connected with lead under each electrode, described lead extends along described open skeleton, and extend to described control handgrip through described conduit pipe shaft, thereby be electrically connected with described control handgrip; With

Take in sheath, described catheter tube was worn the described sheath of taking in, and a described end of taking in sheath is connected to described control hands handle;

The wherein said sheath of taking in can move with respect to described conduit pipe shaft, thereby the described other end of taking in sheath is moved on described open skeleton, make that described open skeleton can elastic shrinkage and be received to described taking in the sheath and from the described sheath of taking in and discharge.

2. multipole opening type radio frequency ablation catheter according to claim 1, the quantity that it is characterized in that described at least one muscle is the 1-8 bar.

3. multipole opening type radio frequency ablation catheter according to claim 1 and 2, it is characterized in that: described open skeleton comprise from the extended inverted cone section of the described other end of described conduit pipe shaft and on the direction of the axially parallel of the described other end of the described conduit pipe shaft of described inverted cone Duan Zaiyu extended straight section, described electrode is fixed on the described straight section.

4. multipole opening type radio frequency ablation catheter according to claim 3, it is characterized in that: described at least one muscle comprises many muscle, when described open skeleton from described when taking in sheath and discharging fully, described many muscle are being arranged on the cross-wise direction on the circumference, and the circle diameter at described straight section place is 3-15mm.

5. multipole opening type radio frequency ablation catheter according to claim 3 is characterized in that: on described straight section, the number of electrodes of arranging on every muscle is 1-5, and the electrode on the adjacent muscle is staggered.

6. multipole opening type radio frequency ablation catheter according to claim 1 and 2 is characterized in that: the electrode at the other end place that is positioned at every muscle comprises the slick and sly end that is formed by metal or plastic material; The described other end that perhaps makes every muscle extends radially inwardly along described conduit pipe shaft, and bearing of trend is the 3-30 degree with respect to the axioversion angle of the described other end of described conduit pipe shaft.

7. multipole opening type radio frequency ablation catheter according to claim 1 and 2, it is characterized in that: the described original state of sheath of taking in is for to be received into described taking in the sheath fully with described open skeleton, described take in sheath and arrive at renal artery after, recall the described sheath of taking in discharging described open skeleton, thereby make described positioning of electrode at blood vessel.

8. multipole opening type radio frequency ablation catheter according to claim 7, it is characterized in that: by controlling the described degree of recalling of taking in sheath, make the described described other end of taking in sheath be in the different parts of described open skeleton, thereby adjust the described electrode on the described open skeleton and the applying degree of described blood vessel.

9. multipole opening type radio frequency ablation catheter according to claim 1 and 2 is characterized in that: cooperate dispersing electrode to carry out one pole and melt; Perhaps choose and close on electrode and carry out bipolar ablation.

10. multipole opening type radio frequency ablation catheter according to claim 1 and 2, it is characterized in that: described electrode comprises a plurality of electrodes, according to the mapping result from described a plurality of electrodes, chooses a plurality of electrodes or electrode pair and melts simultaneously.

11. multipole opening type radio frequency ablation catheter according to claim 1 and 2 is characterized in that: select to close on staggered electrode and melt.

12. multipole opening type radio frequency ablation catheter according to claim 3, the length that it is characterized in that described straight section is 2-20mm.

13. multipole opening type radio frequency ablation catheter according to claim 1 and 2, it is characterized in that: a described described end of taking in sheath is fixed on the adjusting knob on the described control handgrip, by operating a described adjusting knob, the described sheath of taking in is moved with respect to described conduit pipe shaft.

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