CN102198015A - Retractable spiral laminar ring type electrode catheter - Google Patents

Abstract

Translated fromChinese

可伸缩螺旋叠环式电极导管，用于肾动脉内去交感神经，包括：控制手把；导管管身；控制杆，穿过导管管身，控制杆的一端固定到控制手把；可伸缩螺旋叠环，包括至少一个叠环，可伸缩螺旋叠环的一端固定到控制杆的另一端，可伸缩螺旋叠环的另一端固定到导管管身的一端，导管管身的该一端位于控制手把的相反侧；固定在可伸缩螺旋叠环上的至少一个电极，每个电极均能用于提取电信号和消融，每个电极下均连接有导线，导线在可伸缩螺旋叠环内沿可伸缩螺旋叠环延伸，并经过导管管身延伸到控制手把，从而与控制手把电连接；控制杆能相对于导管管身移动，从而调整可伸缩螺旋叠环的周向尺寸。本发明能实现对电极与血管壁贴合的电极贴壁紧密程度的调节。

A telescoping helical stacked loop electrode catheter for sympathetic denervation in the renal artery, including: a control handle; a catheter body; a control rod passing through the catheter body, and one end of the control rod is fixed to the control handle; The stacking ring includes at least one stacking ring, one end of the telescopic helical stacking ring is fixed to the other end of the control rod, the other end of the telescoping helical stacking ring is fixed to one end of the catheter tube body, and the end of the catheter tube body is located on the control handle On the opposite side; at least one electrode fixed on the stretchable helical stacked ring, each electrode can be used to extract electrical signals and ablate, each electrode is connected with a wire, and the wire is stretchable along the stretchable helical stacked ring The helical stacking ring extends and extends to the control handle through the catheter tube body so as to be electrically connected with the control handle; the control rod can move relative to the catheter tube body so as to adjust the circumferential dimension of the retractable helical stacking ring. The invention can realize the adjustment of the tightness of the electrode and the wall of the blood vessel.

Description

Scalable spiral stacked ring type electrode catheter

Technical field

The present invention relates to a kind of electrode catheter, more specifically relate to a kind of orthosympathetic electrode catheter 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.Radio-frequency (RF) ablation blocking-up abnormal electrical conduction comparative maturity aspect the treatment arrhythmia, but use in the orthosympathetic blocking-up of kidney also fewer because order also lacks use simple, safe and reliable special-purpose operating theater instruments, particularly Zhuan Yong radio-frequency (RF) ablation conduit.

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.Mention a kind of screw type ring renal artery sympathetic nerve radio-frequency ablation electrode conduit among the CN201469401U, it can melt along the Continuous Contact that renal artery forms non-annularity sealing.But the adherent tightness degree of electrode that electrode and blood vessel wall are fitted 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.

Summary of the invention

The purpose of this invention is to provide the adherent tightness degree of electrode that a kind of easy realization counter electrode and blood vessel wall fit adjusting be used for remove orthosympathetic electrode catheter in the renal artery.

According to the present invention, a kind of scalable spiral stacked ring type electrode catheter is provided, described scalable spiral stacked ring type electrode catheter is used for going in the renal artery sympathetic nerve, and described scalable spiral stacked ring type electrode catheter comprises: control hands handle; The conduit pipe shaft; Control stick, described control stick pass described conduit pipe shaft, and an end of described control stick is fixed to described control hands handle; The folded ring of scalable spiral, the folded ring of described scalable spiral comprises at least one folded ring, one end of the folded ring of described scalable spiral is fixed to the other end of described control stick, the other end of the folded ring of described scalable spiral is fixed to an end of described conduit pipe shaft, and a described end of described conduit pipe shaft is positioned at the opposition side of described control handgrip; With at least one electrode that is fixed on the folded ring of described scalable spiral, described at least one electrode all can be used in and extracts the signal of telecommunication and melt, all be connected with lead under each electrode, described lead extends along the folded ring of described scalable spiral in the folded ring of described scalable spiral, and extend to described control handgrip through described conduit pipe shaft, thereby be electrically connected with described control handgrip; Wherein said control stick can move with respect to described conduit pipe shaft, thereby adjusts the circumferential size of the folded ring of described scalable spiral.

According to scalable spiral stacked ring type electrode catheter of the present invention, when described control stick moves with respect to described conduit pipe shaft, can adjust the circumferential size of the folded ring of described scalable spiral, thereby realize the adjusting of the adherent tightness degree of electrode that counter electrode and blood vessel wall are fitted.Described at least one electrode all can be used in and extracts the signal of telecommunication and melt, and can avoid repeatedly adjustment devices and once melt safety and efficient height.

Preferably, the Design of length of described control stick is for making: stretching after kidney moves at described control stick, described scalable spiral is folded to be encircled, and makes the folded ring of described scalable spiral by central trunk, and enters in the renal artery.

Preferably, the described other end of described control stick comprises one section flexible pipe, circular soft ball or the soft head of taper, to avoid the damage to blood vessel.

Preferably, a described end of described control stick is fixed on the adjusting knob on the described control handgrip, thereby move described control stick by described adjusting knob and fold the circumferential size of ring, and then adjust the adherent tightness degree of electrode of its top electrode and blood vessel wall applying to adjust described scalable spiral.

Preferably, described control stick comprises the fluorine type coating, thereby effectively improves the smooth property in the control stick moving process.

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

Preferably, described at least one electrode is arranged along the circumferential and axial of the folded ring of described scalable spiral.Therefore, electrode is all arranged at the blood vessel circumferential and axial, 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, the two ends of the folded ring of described scalable spiral are equipped with round center that extends to folded ring and the support bar that extends to the both sides of folded ring, the described support bar of a described end of the folded ring of described scalable spiral is connected to the described other end of described control stick, and the described support bar of the described other end of the folded ring of described scalable spiral is connected to a described end of described conduit pipe shaft.Further preferably, in the junction of the described other end of described support bar and described control stick and the junction of a described end of described support bar and described conduit pipe shaft form slick and sly structure, to avoid stabbing blood vessel.

Preferably, described control stick is a hollow tubular.Hollow tubular structure can the double as guidewire lumen or purposes such as logical contrast agent.Further preferably, the cavity of described control stick is enclosed within on the seal wire, and is advanced to target blood along described seal wire.

Preferably, the axis projection of the folded ring of described scalable spiral becomes circular.Further preferably, described at least one folded ring comprises a plurality of folded rings, and along with described a plurality of folded rings leave described conduit pipe shaft from the near to the remote, the ring of described a plurality of folded rings footpath reduces successively, more to adapt to the characteristics that the distal vessels diameter reduces.The ring of described annulus is 3-20mm directly, and the ring that is more suitable for directly is 3-15mm.

Preferably, described at least one electrode is extracted the stronger position of the signal of telecommunication as melting target spot, the signal strength weakening degree is judged ablation effect before and after melting by contrast, melts accuracy and effectiveness thereby improve.Further preferably: choose a plurality of target ablation target spot counter electrodes or electrode pair and melt simultaneously, with effective saving operating time; Perhaps select to close on staggered electrode and melt, can obtain the discontinuous kitchen range that melts, to avoid angiostenosis.

The folded number of rings of the folded ring of described scalable spiral is preferably 1-5, more preferably 2.

Preferably, by resistance welded, thermal weld or glue bonding described support bar is connected to the described other end of described control stick and a described end of described conduit pipe shaft.

Preferably, the folded ring of described scalable spiral is made of center framework and outer layer sleeve.Described lead can enter by the perforate of described electrode below in the described outer layer sleeve on the described center framework.Described center framework can use all kinds of shape memory alloy materials, as Nitinol, rustless steel, titanium alloy etc.Described outer layer sleeve can be the macromolecular material that polyesters, polyurethane, polyamide etc. have good biocompatibility, and outer layer sleeve is more suitable for the assembling processing in product when selecting the rubber-like macromolecular material for use.

Preferably, described control stick can adopt Nitinol, stainless steel and other metal materials or hard macromolecular materials such as polyimides, nylon to make.

Preferably, the diameter of described control stick is 0.3-1.5mm.

Preferably, the quantity of the described electrode of arranging on the folded ring of described scalable spiral is 1-30, and quantity preferably is 3-15.

Preferably, the internal diameter of described conduit pipe shaft is than the big 0.1-0.5mm of external diameter of described control stick, so that control stick can move around therein.

Description of drawings

Fig. 1 is the sketch map according to scalable spiral stacked ring type electrode catheter of the present invention.

Fig. 2 is the sketch map that adopts this scalable spiral stacked ring type electrode catheter of hollow control stick structure.

The explanation of Reference numeral

1 conduit pipe shaft

2 control sticks

The folded ring of 3 scalable spirals

4 electrodes

5 support bars

6 kidneys

7 seal wires

The RP sympathetic nerve

The specific embodiment

Describe embodiments of the invention in detail below with reference to 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.

Referring to Fig. 1, be used for going in the renal artery the scalable spiral stacked ring type electrode catheter of sympathetic nerve RP to comprise: control handgrip (not shown);Conduit pipe shaft 1;Control stick 2, describedcontrol stick 2 passes describedconduit pipe shaft 1, and an end (near-end) of describedcontrol stick 2 is fixed to described control hands handle; The foldedring 3 of scalable spiral, one end (far-end) of the foldedring 3 of described scalable spiral is fixed to the other end (far-end) of describedcontrol stick 2, the other end (near-end) of the foldedring 3 of described scalable spiral is fixed to an end (far-end) of describedconduit pipe shaft 1, and a described end of describedconduit pipe shaft 1 is positioned at the opposition side of described control handgrip; With at least oneelectrode 4 that is fixed on the foldedring 3 of described scalable spiral, described at least oneelectrode 4 is arranged along the circumferential and axial of the foldedring 3 of described scalable spiral, and described at least oneelectrode 4 all can be used in the extraction signal of telecommunication and melts; Wherein saidcontrol stick 2 can move with respect to describedconduit pipe shaft 1, thereby adjusts the circumferential size of the foldedring 3 of described scalable spiral.

Specifically, the folded number of rings of the foldedring 3 of described scalable spiral is 1-5, and the folded number of rings that is more suitable for is 2; Each spiral connects and composes the folded ring of a bodily form.The axis projection of folded ring is preferred but be not limited to into circularly, and the ring footpath be 3-20mm, and the ring that is more suitable for directly is 3-15mm.Can be this product in practice and formulate the series specification of a particular data in this scope.Can adopt the identical design of each ring diameter, the design that also can adopt ring footpath (to leave describedconduit pipe shaft 1 from the near to the remote) from the near to the remote to reduce successively is more to adapt to the characteristics that the distal vessels diameter reduces.In the operation, should select with the target ablation blood vessel diameter quite or bigger specification.

The near-end of the foldedring 3 of scalable spiral and far-end are equipped with the round center that extends to folded ring and to thesupport bar 5 of the both sides of folded ring extension, are connected respectively on the described other end (far-end) of the described end (far-end) ofconduit pipe shaft 1 and control stick 2.Connected mode can be modes such as resistance welded, thermal weld, glue bonding, and forms slick and sly structure, to avoid stabbing blood vessel.The folded ring ofscalable spiral 3 is made of center framework and outer macromolecule sleeve pipe.Center framework can use all kinds of shape memory alloy materials, as Nitinol, rustless steel, titanium alloy etc.Use mould, raw material can be processed into the spiral-shaped of required size by modes such as heat treatment, stretchings.Outer layer sleeve can be the macromolecular material that polyesters, polyurethane, polyamide etc. have good biocompatibility, and outer layer sleeve is more suitable for the assembling processing in product when selecting the rubber-like macromolecular material for use.

Control stick 2 can move around with respect to conduit pipe shaft 1.Forward during (promptly towards kidney 6)mobile control stick 2, the folded ring spacing of the foldedring 3 of scalable spiral can be drawn thinly, folded simultaneously ring diameter reduces, and realizes the flexible purpose of foldedring.Control stick 2 can adopt Nitinol, stainless steel and other metal materials or hard macromolecular materials such as polyimides, nylon to make.Outside control stick 2, make the fluorine type coating and can effectively improve smooth property incontrol stick 2 movingprocess.Control stick 2 both can be bar-shaped, also can be tubulose; Hollow tubular structure can the double as guidewire lumen or purposes such as logical contrastagent.Control stick 2 diameters are 0.3-1.5mm, and length needs long enough, and the stretching expansion ring of energy after moving forward with assurance makes the folded shape circle of spiral by central trunk, and enters in the renal artery.For fear of the damage to blood vessel, it is soft first-class that the described other end (far-end) ofcontrol stick 2 can increase by one section flexible pipe or circular soft ball or taper.

The number of electrodes of arranging on the folded ring of scalable spiral is that number of electrodes is 1-30, and quantity preferably is 3-15.All be connected with lead under each electrode, can realize by modes such as soldering, electric resistance welding, mechanical crimping.The perforate of lead by electrode below enters in the outer layer sleeve on the center framework of the folded ring of scalable spiral, and extends to the conduit pipe shaft, at last to the electrical connector socket of control handgrip end.

Conduit pipe shaft 1 is a hollow structure, and the internal diameter ofconduit pipe shaft 1 is than the big 0.1-0.5mm of external diameter ofcontrol stick 2, so thatcontrol stick 2 can move around therein.Catheter proximal end is equipped with control hands handle;Control stick 2 byconduit pipe shaft 1 also is fixed on the adjusting knob (not shown) of controlling on the handgrip.By adjusting knob, can regulate the circumferential size (diameter) of folded ring bymobile control stick 2, thereby adjust the adherent tightness degree of electrode of itstop electrode 4 and blood vessel wall applying.Conduit pipe shaft 1 can be selected for use all kinds ofly to have the good biocompatibility macromolecular material and makes.

Can use the long sheath of intervention commonly used to place conduit in the operation.Referring to Fig. 2, after usinginterventional guide wire 7 and earlier it being in place, the cavity of thiscontrol stick 2 is enclosed within on theseal wire 7, and pushes ahead target blood alongseal wire 7.

Send in the predetermined blood vessel and adjustcontrol stick 2 and makeelectrode 4 adherent when good when folding ring, allelectrodes 4 all can be used for extracting electroneurographic signal and melt purpose.The position that the extraction signal is stronger is a neurological region as melting target spot, and signal strength weakening degree before and after melting by contrast can be judged ablation effect, melts accuracy and effectiveness thereby improve; Equal heeling-in has the temperature sensor (not shown) under each electrode, can realize that the temperature in the ablation procedure is accurately monitored.

In the operation, both can cooperate dispersing electrode to carry out one pole and melt, and also can choose and close on electrode and carry out bipolar ablation; According to the mapping result, can choose a plurality of target ablation target spot counter electrodes or electrode pair and melt simultaneously, can effectively save operating time.Selection closes on staggered electrode and melts and can obtain the discontinuous kitchen range that melts, to avoid angiostenosis.

The present invention is not limited to the particular content described in the specific embodiment.Scalable spiral stacked ring type electrode catheter provided by the present invention melts in renal artery the sympathetic nerve treatment hypertension purposes, also is suitable for other endovascular ablative surgeries.

Claims (10)

Translated fromChinese

1.一种可伸缩螺旋叠环式电极导管，所述可伸缩螺旋叠环式电极导管用于肾动脉内去交感神经，所述可伸缩螺旋叠环式电极导管包括：1. A retractable spiral-folded ring-type electrode catheter, which is used for sympathetic nerve removal in the renal artery, and the retractable spiral-folded-loop electrode catheter comprises:控制手把；control handle;导管管身；Catheter body;控制杆，所述控制杆穿过所述导管管身，所述控制杆的一端固定到所述控制手把；a control rod, the control rod passes through the catheter body, and one end of the control rod is fixed to the control handle;可伸缩螺旋叠环，所述可伸缩螺旋叠环包括至少一个叠环，所述可伸缩螺旋叠环的一端固定到所述控制杆的另一端，所述可伸缩螺旋叠环的另一端固定到所述导管管身的一端，所述导管管身的所述一端位于所述控制手把的相反侧；和A telescopic stacked spiral ring, the telescopic spiral stacked ring includes at least one stacked ring, one end of the telescopic spiral stacked ring is fixed to the other end of the control rod, and the other end of the telescopic spiral stacked ring is fixed to one end of the catheter shaft, the one end of the catheter shaft being on the opposite side of the control handle; and固定在所述可伸缩螺旋叠环上的至少一个电极，每个电极均能够用于提取电信号和消融，每个电极下均连接有导线，所述导线在所述可伸缩螺旋叠环内沿着所述可伸缩螺旋叠环延伸，并经过所述导管管身延伸到所述控制手把，从而与所述控制手把电连接；At least one electrode fixed on the expandable helical stacked ring, each electrode can be used to extract electrical signals and ablate, and each electrode is connected with a wire, and the wire runs along the stretchable helical stacked ring extending along the retractable helical folded ring, and extending through the catheter body to the control handle, thereby being electrically connected to the control handle;其中所述控制杆能够相对于所述导管管身移动，从而调整所述可伸缩螺旋叠环的周向尺寸。Wherein the control rod can move relative to the catheter tube body, so as to adjust the circumferential dimension of the expandable helical folded ring.2.根据权利要求1所述的可伸缩螺旋叠环式电极导管，其特征在于所述控制杆的长度设计为使得：在所述控制杆朝向肾移动后能拉伸所述可伸缩螺旋叠环，使所述可伸缩螺旋叠环通过中央大血管，并进入到肾动脉内。2. The retractable helical-folded-ring electrode catheter according to claim 1, characterized in that the length of the control rod is designed such that the stretchable helical-folded ring can be stretched after the control rod moves toward the kidney , making the stretchable helical stacked ring pass through the central large blood vessel and into the renal artery.3.根据权利要求1所述的可伸缩螺旋叠环式电极导管，其特征在于：所述控制杆的所述一端固定到所述控制手把上的调节旋钮上，从而通过所述调节旋钮移动所述控制杆以调整所述可伸缩螺旋叠环的周向尺寸。3. The retractable spiral stacked-ring electrode catheter according to claim 1, characterized in that: the one end of the control rod is fixed to the adjustment knob on the control handle, so as to move through the adjustment knob The control rod is used to adjust the circumferential dimension of the expandable helical lamination ring.4.根据权利要求1所述的可伸缩螺旋叠环式电极导管，其特征在于：所述至少一个电极沿着所述可伸缩螺旋叠环的周向和轴向排布，所述电极的数量为1-30个。4. The retractable helical stacked-ring electrode catheter according to claim 1, characterized in that: the at least one electrode is arranged along the circumferential direction and the axial direction of the telescopic helical stacked ring, and the number of the electrodes is 1-30 pieces.5.根据权利要求1至4中任一项所述的可伸缩螺旋叠环式电极导管，其特征在于：所述可伸缩螺旋叠环的两端均设有延伸到叠环的圆中心并向叠环的两侧延伸的支撑杆，所述可伸缩螺旋叠环的所述一端的所述支撑杆连接到所述控制杆的所述另一端，所述可伸缩螺旋叠环的所述另一端的所述支撑杆连接到所述导管管身的所述一端。5. The retractable helical stacked ring electrode catheter according to any one of claims 1 to 4, characterized in that: both ends of the telescopic helical stacked ring are provided with a circle extending to the center of the stacked ring and facing Support rods extending on both sides of the stack ring, the support rod at the one end of the telescopic spiral stack ring is connected to the other end of the control rod, and the other end of the telescopic spiral stack ring The support rod is connected to the one end of the catheter body.6.根据权利要求1至4中任一项所述的可伸缩螺旋叠环式电极导管，其特征在于：所述可伸缩螺旋叠环的轴向投影成圆环状。6 . The telescopic helical stacked-ring electrode catheter according to any one of claims 1 to 4 , characterized in that: the axial projection of the telescoping helical stacked ring is circular. 7 .7.根据权利要求6所述的可伸缩螺旋叠环式电极导管，其特征在于：所述圆环的环径为3-20mm。7. The retractable spiral stacked-ring electrode catheter according to claim 6, characterized in that: the ring diameter of the ring is 3-20 mm.8.根据权利要求6所述的可伸缩螺旋叠环式电极导管，其特征在于：所述至少一个叠环包括多个叠环，随着所述多个叠环离开所述导管管身由近到远，所述多个叠环的环径依次减小。8. The retractable helical stacked ring electrode catheter according to claim 6, wherein the at least one stacked ring comprises a plurality of stacked rings, and as the multiple stacked rings leave the catheter tube body by nearly The ring diameters of the plurality of stacked rings decrease successively.9.根据权利要求1至4中任一项所述的可伸缩螺旋叠环式电极导管，其特征在于：所述可伸缩螺旋叠环由中心骨架和外层套管构成。9. The retractable helical stacked-ring electrode catheter according to any one of claims 1 to 4, characterized in that: the telescoping helical stacked ring is composed of a central skeleton and an outer casing.10.根据权利要求9所述的可伸缩螺旋叠环式电极导管，其特征在于：所述中心骨架由形状记忆合金材料制成。10. The retractable spiral stacked-ring electrode catheter according to claim 9, characterized in that: the central frame is made of shape memory alloy material.

Images