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, 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 scalable spiral, one end (far-end) of the folded ring 3 of described scalable 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 scalable 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 scalable spiral, described at least one electrode 4 is arranged along the circumferential and axial of the folded ring 3 of described scalable spiral, and described at least one electrode 4 all can be used in the extraction signal of telecommunication and melts; 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 scalable spiral.
Specifically, the folded number of rings of the folded ring 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 described conduit 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 folded ring 3 of scalable 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 of folded ring extension, 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 modes such as resistance welded, thermal weld, glue bonding, and forms slick and sly structure, to avoid stabbing blood vessel.The folded ring of scalable 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 folded ring 3 of scalable spiral can be drawn thinly, folded simultaneously ring diameter reduces, and realizes the flexible purpose of folded ring.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 in control stick 2 moving process.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 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 the 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 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 of conduit pipe shaft 1 is than the big 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 control hands handle; Control stick 2 by conduit 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 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 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 using interventional guide wire 7 and earlier it being in place, the cavity of this control stick 2 is enclosed within on the seal wire 7, and pushes ahead target blood along seal wire 7.
Send in the 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 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.