CN102198015B - Retractable spiral laminar ring type electrode catheter - Google Patents

Retractable spiral laminar ring type electrode catheter Download PDF

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Publication number
CN102198015B
CN102198015B CN201110117817.3A CN201110117817A CN102198015B CN 102198015 B CN102198015 B CN 102198015B CN 201110117817 A CN201110117817 A CN 201110117817A CN 102198015 B CN102198015 B CN 102198015B
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retractable spiral
ring
folded
folded ring
retractable
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CN102198015A (en
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郭俊敏
孙毅勇
霍慧君
严钱钱
杨谦谦
廖申扬
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Shanghai Hongdian Medical Technology Co ltd
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Shanghai Microport EP MedTech Co Ltd
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Abstract

The invention relates to a retractable spiral laminar ring type electrode catheter used for sympathetic denervation in a renal artery, which comprises a control handle, a catheter body, a control rod, a retractable spiral laminar ring and at least one electrode, wherein the control rod is penetrated through the catheter body with one end of the control rod fixed onto the control handle; the retractable spiral laminar ring comprises at least one laminar ring, one end of the retractable spiral laminar ring is fixed onto the other end of the control rod, the other end of the retractable spiral laminar ring is fixed onto one end of the catheter body, and the end of the catheter body is positioned at the opposite side of the control handle; the at least one electrode is fixed on the retractable spiral laminar ring, each electrode can be used for electric signal extraction and ablation, a lead wire is connected to the lower part of each electrode, and the lead wire extends along the retractable spiral laminar ring inside the retractable spiral laminar ring and extends to the control handle through the catheter body, thereby realizing the electrical connection with the control handle; and the control rod can move relative to the catheter body, thereby adjusting the circumferential dimension of the retractable spiral laminar ring. By using the retractable spiral laminar ring type electrode catheter, the tightness of joint between the electrode and a vascular wall can be adjusted.

Description

Retractable spiral laminar ring type electrode catheter
Technical field
The present invention relates to a kind of electrode catheter, more specifically relate to a kind of for removing orthosympathetic electrode catheter in renal artery.
Background technology
Intractable hypertension claims again refractory hypertension, refer to adopt the life style improvement and more than 3 kinds or 3 kinds antihypertensive drugs (comprising a kind of diuretic) treat the hypertension that still can not effectively control.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 significantly enduringly intractable hypertension, follow up a case by regular visits to the blood pressure 22/12mmHg that on average descends in 6 months.And adopting the method to have conduit intervention means utilizes radio-frequency (RF) energy to carry out the impedance type heating to the sympathetic nerve at renal artery position, can weaken its activity and even lose conduction function, the method not only can effectively be treated intractable hypertension, and has the advantages such as Wicresoft, few intercurrent disease.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 also fewer in the orthosympathetic blocking-up of kidney, use simple, safe and reliable Special surgical instrument because also lack at present, particularly special-purpose radio frequency ablation catheter.
Have report to be used for renal artery sympathetic nerve radio frequency heating formula apparatus in pertinent literature or in patent, but with reach final instructions for use and also have obvious distance.Mention a kind of screw type ring renal artery sympathetic nerve frequency ablation electrode catheter in 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 melt temperature design by implementing monitoring, 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 fits to electrode and blood vessel wall adjusting be used for remove orthosympathetic electrode catheter in renal artery.
According to the present invention, a kind of retractable spiral laminar ring type electrode catheter is provided, described retractable spiral laminar ring type electrode catheter is used for removing sympathetic nerve in renal artery, and described retractable spiral laminar ring type electrode catheter comprises: control the 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 retractable spiral, the folded ring of described retractable spiral comprises at least one folded ring, one end of the folded ring of described retractable spiral is fixed to the other end of described control stick, the other end of the folded ring of described retractable 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 retractable spiral, each electrode all can be used in and extracts the signal of telecommunication and melt, all be connected with wire under each electrode, described wire extends along the folded ring of described retractable spiral in the folded ring of described retractable spiral, and extend to described control handgrip through described conduit pipe shaft, thereby be electrically connected to 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 retractable spiral; And the axis projection of the folded ring of wherein said retractable spiral becomes circular, the two ends of the folded ring of described retractable spiral are equipped with the 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 retractable 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 retractable spiral is connected to a described end of described conduit pipe shaft.
According to retractable spiral laminar 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 retractable spiral, thereby realize the adjusting to the adherent tightness degree of electrode of electrode and blood vessel wall applying.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, and safety and efficient are high.
Preferably, the Design of length of described control stick is for making: the folded ring of the described retractable spiral that can stretch after kidney moves at described control stick makes the folded ring of described retractable spiral by central trunk, and enters in 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 adjusting knob on described control handgrip, thereby move described control stick by described adjusting knob and fold the circumferential size of ring to adjust described retractable spiral, and then adjust the adherent tightness degree of electrode of its top electrode and blood vessel wall applying.
Preferably, described control stick comprises the fluorine type coating, thereby effectively improves the slipping in the control stick moving process.
Preferably, under each electrode all heeling-in temperature sensor is arranged, be used for the temperature of monitoring ablation procedure, thereby realize that the temperature in ablation procedure accurately monitors.
Preferably, described at least one electrode is arranged along the circumferential and axial of the folded ring of described retractable spiral.Therefore, electrode is all arranged at the blood vessel circumferential and axial, can extract simultaneously easily each position signal of telecommunication and confirm ablation locations, and need not move the position of adjusting electrode, convenient and safe saving time.
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 round and smooth structure, to avoid stabbing blood vessel.
Preferably, described control stick is hollow tubular.Hollow tubular structure can double as the purposes such as guidewire lumen or logical contrast agent.Further preferably, the cavity of described control stick is enclosed within on seal wire, and is advanced to target blood along described seal wire.
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 footpath of described a plurality of folded rings reduces successively, the characteristics that reduce more to adapt to the distal vessels diameter.The ring footpath of described annulus is 3-20mm, and the ring footpath that is more suitable for is 3-15mm.
Preferably, the position that described at least one electrode extraction signal of telecommunication is stronger is as melting target spot, and before and after melting by contrast, the signal strength weakening degree judges ablation effect, 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 retractable 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 retractable spiral is made of center framework and outer layer sleeve.Described wire can enter by the perforate of described electrode below in described outer layer sleeve on 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 selected the assembling processing that is more suitable for when having elastic macromolecular material in product.
Preferably, described control stick can adopt Nitinol, stainless steel and other metal materials or the 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 retractable spiral is 1-30, and quantity preferably is 3-15.
Preferably, the internal diameter of described conduit pipe shaft is than the large 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 schematic diagram according to retractable spiral laminar ring type electrode catheter of the present invention.
Fig. 2 is the schematic diagram that adopts this retractable spiral laminar 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 retractable 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 near to control handgrip be the operator or be called " near-end " away from an end of kidney, will be that an end of operator or close kidney be called " far-end " away from controlling handgrip.
Referring to Fig. 1, be used for going the retractable spiral laminar ring type electrode catheter of sympathetic nerve RP to comprise in renal artery: control the handgrip (not shown); Conduit pipe shaft 1; Control stick 2, described control stick 2 passes described conduit pipe shaft 1, and an end (near-end) of described control stick 2 is fixed to described control hands handle; The folded ring 3 of retractable spiral, one end (far-end) of the folded ring 3 of described retractable spiral is fixed to the other end (far-end) of described control stick 2, the other end (near-end) of the folded ring 3 of described retractable spiral is fixed to an end (far-end) of described conduit pipe shaft 1, and a described end of described conduit pipe shaft 1 is positioned at the opposition side of described control handgrip; With at least one electrode 4 that is fixed on the folded ring 3 of described retractable spiral, described at least one electrode 4 is arranged along the circumferential and axial of the folded ring 3 of described retractable spiral, and described at least one electrode 4 all can be used in and extracts the signal of telecommunication and melt; Wherein said control stick 2 can move with respect to described conduit pipe shaft 1, thereby adjusts the circumferential size of the folded ring 3 of described retractable spiral.
Specifically, the folded number of rings of the folded ring 3 of described retractable 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 is 3-20mm, and the ring footpath that is more suitable for is 3-15mm.Can be in practice this product 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 the ring footpath (to leave described conduit pipe shaft 1 from the near to the remote) from the near to the remote and reduce successively, the characteristics that reduce more to adapt to the distal vessels diameter.In operation, should select with the target ablation blood vessel diameter quite or bigger specification.
The near-end of the folded ring 3 of retractable spiral and far-end are equipped with the round center that extends to folded ring and to the support bar 5 of the both sides extension of folded ring, are connected respectively on the described other end (far-end) of the described end (far-end) of conduit pipe shaft 1 and control stick 2.Connected mode can be the modes such as resistance welded, thermal weld, glue bonding, and forms round and smooth structure, to avoid stabbing blood vessel.The folded ring 3 of retractable spiral 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 selected the assembling processing that is more suitable for when having elastic macromolecular material in product.
Control stick 2 can move around with respect to conduit pipe shaft 1.Forward during (namely towards kidney 6) mobile control stick 2, the folded ring spacing of the folded ring 3 of retractable spiral can be drawn thinly, folded ring diameter reduces simultaneously, realizes the flexible purpose of folded ring.Control stick 2 can adopt Nitinol, stainless steel and other metal materials or the hard macromolecular materials such as polyimides, nylon to make.In the outer slipping of fluorine type coating in can effectively improving control stick 2 moving process of doing of control stick 2.Control stick 2 can be both bar-shaped, can be also tubulose; The tubular structure of hollow can double as the purposes such as guidewire lumen or logical contrast agent.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 renal artery.For fear of the damage to blood vessel, it is soft first-class that the described other end (far-end) of control 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 retractable spiral is 1-30, and quantity preferably is 3-15.All be connected with wire under each electrode, can realize by modes such as soldering, electric resistance welding, mechanical crimping.The perforate of wire by electrode below enters in outer layer sleeve on the center framework of the folded ring of retractable spiral, and extends to the conduit pipe shaft, at last to the electrical connector socket of controlling the handgrip end.
Conduit pipe shaft 1 is hollow structure, and the internal diameter of conduit pipe shaft 1 is than the large 0.1-0.5mm of external diameter of control stick 2, so that control stick 2 can move around therein.Catheter proximal end is equipped with controls the hands handle; Control stick 2 by conduit pipe shaft 1 also is fixed on the adjusting knob (not shown) of controlling on handgrip.By adjusting knob, can regulate the circumferential size (diameter) of folded ring by mobile control stick 2, thereby adjust the adherent tightness degree of electrode of its top electrode 4 and blood vessel wall applying.Conduit pipe shaft 1 can select all kinds of macromolecular materials with good biocompatibility to make.
Can use the long sheath of intervention commonly used to place conduit in operation.Referring to Fig. 2, after using interventional guide wire 7 and first it being in place, the cavity of this control stick 2 is enclosed within on seal wire 7, and pushes ahead target blood along seal wire 7.
Send in predetermined blood vessel and adjust control stick 2 and make electrode 4 adherent when good when folding ring, all electrodes 4 all can be used for extracting electroneurographic signal and melt purpose.The position that the extraction signal is stronger is neurological region as melting target spot, and signal strength weakening degree before and after melting by contrast can judge ablation effect, melts accuracy and effectiveness thereby improve; Under each electrode, equal heeling-in has the temperature sensor (not shown), can realize that the temperature in ablation procedure is accurately monitored.
In operation, both can coordinate 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.Retractable spiral laminar ring type electrode catheter provided by the present invention melts in renal artery sympathetic nerve treatment hypertension purposes, also is suitable for other endovascular ablative surgeries.

Claims (7)

1. retractable spiral laminar ring type electrode catheter, described retractable spiral laminar ring type electrode catheter are used for removing sympathetic nerve in renal artery, and described retractable spiral laminar ring type electrode catheter comprises:
Control the 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 retractable spiral, the folded ring of described retractable spiral comprises at least one folded ring, one end of the folded ring of described retractable spiral is fixed to the other end of described control stick, the other end of the folded ring of described retractable 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
Be fixed at least one electrode on the folded ring of described retractable spiral, each electrode all can be used in and extracts the signal of telecommunication and melt, all be connected with wire under each electrode, described wire extends along the folded ring of described retractable spiral in the folded ring of described retractable spiral, and extend to described control handgrip through described conduit pipe shaft, thereby be electrically connected to 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 retractable spiral;
The axis projection of the folded ring of wherein said retractable spiral becomes circular, the two ends of the folded ring of described retractable spiral are equipped with the 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 retractable 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 retractable spiral is connected to a described end of described conduit pipe shaft; And
Wherein said 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 footpath of described a plurality of folded rings reduces successively.
2. retractable spiral laminar ring type electrode catheter according to claim 1, it is characterized in that the Design of length of described control stick is for making: the folded ring of the described retractable spiral that can stretch at described control stick after kidney moves, make the folded ring of described retractable spiral by central trunk, and enter in renal artery.
3. retractable spiral laminar ring type electrode catheter according to claim 1, it is characterized in that: a described end of described control stick is fixed on adjusting knob on described control handgrip, thereby moves described control stick to adjust the circumferential size of the folded ring of described retractable spiral by described adjusting knob.
4. retractable spiral laminar ring type electrode catheter according to claim 1 is characterized in that: described at least one electrode is arranged along the circumferential and axial of the folded ring of described retractable spiral, and the quantity of described electrode is 1-30.
5. retractable spiral laminar ring type electrode catheter according to claim 1 is characterized in that: the ring footpath of described annulus is 3-20mm.
6. the described retractable spiral laminar ring type electrode catheter of any one according to claim 1 to 4 is characterized in that: the folded ring of described retractable spiral is made of center framework and outer layer sleeve.
7. retractable spiral laminar ring type electrode catheter according to claim 6, it is characterized in that: described center framework is made by shape memory alloy material.
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