The multipole ablation catheter of renal arteryTechnical field
The present invention relates to medical instruments field, be specifically related to a kind of renal artery sympathetic nerve ablation catheter for hypertension interventional therapy.
Background technology
Intractable hypertension, refers to that the Drug therapy (comprising 3 kinds of depressor therapeutic alliances of diuretic) at maximum tolerated dose still cannot reach target pressure value.These patients are High risk groups of major cardiovascular events.
In April, 2009, Krum etc. have reported the new technique of percutaneous catheter kidney sympathetic nerve radiofrequency ablation intractable hypertension.The method is cut off kidney sympathetic nerve by radio-frequency (RF) ablation, and does not affect other abdominal paries, pelvis or lower limb nerve domination, has reached the object of avoiding severe complication in blood pressure lowering.In November, 2010, one relates to perspective, the randomized controlled trial that carry out 24 medical centers, and " Symplicity HTN-2 research " is published in lancet." Symplicity HTN-2 research " result shows, refractory hypertension patient is carried out, through conduit TSD, can obtaining remarkable and lasting efficacy of antihypertensive treatment.106 routine refractory hypertension patients are included in this test altogether in, and test group patient all adheres to carrying out multiple medicines associating antihypertensive therapy after carrying out RSD, and matched group patient only carries out multiple medicines therapeutic alliance.Test group patient's blood pressure in the time of 6th month 32/12mmHg that on average declined, matched group patient blood pressure is all without changing.And complication or the adverse events that operation is relevant do not found in research, and operation in patients metanephros function status is good.
As a new technology, the apparatus matching also relatively lacks, at present for clinical product, also there are problems, the more product of use is the Symplicity ablation system of Medtronic company clinically, because only having an electrode ablation, cause operation more complicated, the problems such as radio-frequency (RF) ablation time length.
CN102274074A discloses a kind of Multi-electrode open-type radio frequency ablation catheter, and one end of conduit is Open architecture, and what the problem that easy generation can not fit tightly with blood vessel when renal artery goes sympathetic nerve to melt and causing melted failure may.CN201469401U discloses a kind of helical form renal artery sympathetic nerve frequency ablation electrode catheter, and electrode is helical structure, and simplicity of design is difficult to operation, has equally can not fit tightly the problem of blood vessel and cause melting the risk of failure.
Summary of the invention
The renal artery sympathetic nerve ablation catheter that the object of this invention is to provide a kind of simple to operate, dependable performance.According to arteriorenal anatomical structure, the present invention can provide the electrode of ablation catheter to fit tightly renal artery blood vessel, and diameter is adjustable, and the conduit that a plurality of electrodes melt simultaneously can significantly reduce the consumption of X ray, has reduced operation easier simultaneously.
For achieving the above object, the invention provides the multipole ablation catheter of a kind of renal artery, the ablation catheter and the function handle that comprise adjustable bent catheter sheath, adjustable diameter, described adjustable bent catheter sheath one end is fixed on the crooked control piece of function handle, controls the free bend of the other end by crooked control piece; The skeleton that comprises at least two adjustable diameters of the ablation catheter of described adjustable diameter, on every skeleton straight section, fix at least one electrode, each electrode is connected with the ablation apparatus interface of function handle by wire, ablation catheter one end is fixed in described skeleton one end, the other end be fixed on can the skeleton connector with respect to ablation catheter activity on, skeleton control valve one end of described ablation catheter is connected with head end part through skeleton connector, the other end is fixed on the skeleton control piece of function handle, and described skeleton control piece can be controlled the diameter adjustment of described skeleton; One end of the ablation catheter of described adjustable diameter is fixed on the ablation catheter extension and contraction control part of function handle, and the skeleton that can realize described ablation catheter by ablation catheter extension and contraction control part passes in and out described adjustable bent catheter sheath.
The framing structure of described adjustable diameter is straight section in the middle of being, two ends are contracted to the Rugby structure of a bit.
The skeleton of described adjustable diameter is 2~8, more preferably 3~4.
The skeleton straight section length of described adjustable diameter is 10~30mm, according to arteriorenal length, more preferably 15~20mm.
On the straight section of the skeleton of described adjustable diameter, be fixed with 1~3 electrode, can be on each skeleton, to have 1 electrode, and in another plane, be not staggered, also can be 1~2 electrode that distributes on adjacent skeleton, and in another plane, be not staggered, each electrode connects a wire, and the other end is connected with the ablation apparatus interface of function handle, by radio-frequency (RF) ablation energy delivery to electrode.
The diameter of the skeleton of described adjustable diameter straight section from described adjustable bent catheter sheath discharges is 3~10mm, according to arteriorenal normal dia, more preferably 3~8mm.
Described adjustable bending pipe sheath is double lumen structure, a logical ablation catheter of tube chamber, a logical traction fiber of tube chamber, traction fiber one end in described adjustable bending pipe sheath is fixed on the end of adjustable bending pipe sheath, the other end is fixed on the traction fiber fixture of function handle, can realize by controlling the movement of traction fiber fixture the free bend of adjustable bending pipe sheath, preferred angle of bend is spent 0~90, thereby ablation catheter can be entered in renal artery easily.
On described function handle, be provided with ablation apparatus interface, each electrode is connected with described ablation apparatus interface by wire, and described ablation apparatus interface can be realized and being connected of radio-frequency (RF) ablation instrument by connecting line, by transmission of radio-frequency energy to each electrode.More preferably, can choose different electrodes according to arteriorenal architectural feature melts.
Described each electrode is connected with temperature sensor, is connected, and can realizes and being connected of radio-frequency (RF) ablation instrument by connecting line by wire with described ablation apparatus interface, and the temperature signal of each electrode is presented on radio-frequency (RF) ablation instrument.
Radio frequency ablation catheter provided by the invention, can disposablely melt a plurality of points, and ablation points is discontinuous, temperature is controlled, treat the hypertensive while removing renal artery sympathetic nerve, avoided excessively melting the risk with renal artery angiostenosis, simultaneously because once melting, can greatly reduce the use of operating time and X ray, improve the accuracy melting.
Accompanying drawing explanation
Fig. 1 is the structural representation of the multipole ablation catheter of renal artery.
Fig. 2 is the structural representation of the multipole ablation catheter skeleton income of renal artery adjustable bending pipe sheath.
Fig. 3 is the multipole ablation catheter of the renal artery schematic diagram that skeleton does not discharge in vivo.
Fig. 4 is the multipole ablation catheter of the renal artery schematic diagram of skeleton after discharging in vivo.
The explanation of Reference numeral
1, adjustable bent catheter sheath; 2, adjustable diameter ablation catheter; 3, the skeleton of adjustable diameter; 4, electrode; 5, skeleton connector; 6, skeleton control valve; 7, head end part; 8, function handle; 9, crooked control piece; 10, ablation catheter extension and contraction control part; 11, skeleton control piece; 12, traction fiber fixture; 13, ablation apparatus interface; 14, aorta; 15, renal artery; 16, kidney; RS: renal artery sympathetic nerve (Renal Sympathetic).
The specific embodiment
Below in conjunction with drawings and Examples, the specific embodiment of the invention is described further, following examples are only for technical scheme of the present invention is more clearly described, and can not limit the scope of the invention with this.
Figure 1 shows that the guide-tube structure schematic diagram that the present invention is melted for renal artery sympathetic nerve.Described ablation catheter comprisesablation catheter 2 and the function handle 8 of adjustablebent catheter sheath 1, adjustable diameter, and described adjustablebent catheter sheath 1 one end is fixed on the crooked control piece of function handle 89, controls the free bend of the other ends by crooked control piece 9, the skeleton that comprises at least twoadjustable diameters 3 of theablation catheter 2 of described adjustable diameter, on everyskeleton 3 straight sections, fix at least oneelectrode 4, eachelectrode 4 is connected with the ablation apparatus interface 13 of function handle 8 by wire,ablation catheter 2 one end are fixed in describedskeleton 3 one end, the other end be fixed on can theskeleton connector 5 with respect to ablation catheter activity on,skeleton control valve 6 one end of described ablation catheter are connected withhead end part 7 throughskeleton connector 5, the other end is fixed on the skeleton control piece 11 of function handle 8, described skeleton control piece 11 can be controlled the diameter adjustment of describedskeleton 3, one end of theablation catheter 2 of described adjustable diameter is fixed on the ablation catheter extension and contraction control part 10 of function handle 8, can realize the described adjustablebent catheter sheath 1 ofskeleton 3 turnover of described ablation catheter by ablation catheter extension and contraction control part 10.
Skeleton 3 structures of adjustable diameter are straight section in the middle of being, two ends are contracted to the Rugby structure of a bit, the skin ofskeleton 3 is to have elastic macromolecule tubing, in each skeleton, there is sizing Nitinol, its diameter is 0.2~0.5mm, can makeskeleton 3 discharge the shape of the rear maintenance design of adjustablebent catheter sheath 1.
Theskeleton 3 of adjustable diameter is 2~8, more preferably 3~4, its straight section length is 10~30mm, according to the length ofrenal artery 15,15~20mm more preferably, on straight section, be fixed with 1~3electrode 4, can be on eachskeleton 3, to have 1electrode 4, and in another plane, be not staggered, also can be 1~2electrode 4 that distributes onadjacent skeleton 3, and in another plane, not be staggered, eachelectrode 4 connects a wire, the other end is connected with the ablation apparatus interface 13 of function handle 8, by radio-frequency (RF) ablation energy delivery to electrode 3.Described eachelectrode 3 is connected with temperature sensor, is connected, and can realizes and being connected of radio-frequency (RF) ablation instrument by connecting line by wire with described ablation apparatus interface 13, and the temperature signal of each electrode is presented on radio-frequency (RF) ablation instrument.
Theskeleton 3 of adjustable diameter discharges from adjustablebent catheter sheath 1 by ablation catheter extension and contraction control part 10, and through skeleton control piece 11, carry out the diameter control ofskeleton 3, can between 3~10mm, regulate, according to arteriorenal normal dia, more preferably between 3~8mm, regulate.
Adjustablebending pipe sheath 1 is double lumen structure, alogical ablation catheter 2 of tube chamber, a logical traction fiber of tube chamber, traction fiber one end is fixed on the end of adjustablebending pipe sheath 1, the other end is fixed on the traction fiber fixture 12 of function handle 8, can realize by controlling the movement of traction fiber fixture 12 free bend of adjustablebending pipe sheath 1, preferred angle of bend is spent 0~90, therebyablation catheter 2 can be entered in renal artery easily.
On function handle 8, be provided with ablation apparatus interface 13, eachelectrode 4 is connected with ablation apparatus interface 13 by wire, and ablation apparatus interface 13 can be realized and being connected of radio-frequency (RF) ablation instrument by connecting line, by transmission of radio-frequency energy to each electrode 4.When reality is used, can choosedifferent electrode 4 according to the architectural feature ofrenal artery 15 and melt.
Figure 2 shows that the structural representation of the multipole ablation catheter skeleton income of renal artery of the present invention adjustable bending pipe sheath, by promoting backward the ablation catheter extension and contraction control part 10 of function handle 8, the skeleton ofablation catheter 2 can be drawn in to adjustablebent catheter sheath 1, adjust skeleton control piece 11 simultaneously and makehead end part 7 draw in adjustablebent catheter sheath 1, make its laminating closely.
Figure 3 shows that the multipole ablation catheter of the renal artery of the present invention schematic diagram that skeleton does not discharge in vivo, by the multipoleablation catheter skeleton 3 income adjustablebending pipe sheaths 1 of renal artery, pass through femoral artery puncture, under X ray guiding, enteraorta 14, ablation catheter is placed nearrenal artery 14 entrances, control the crooked control piece 9 of function handle 8, make the crooked suitable angle of adjustablebent catheter sheath 1, aim atrenal artery 15 entrances, by adjustablebent catheter sheath 1 by promoting forward the ablation catheter extension and contraction control part 10 of function handle 8, make theskeleton 3 ofablation catheter 2 release adjustablebent catheter sheath 1, enterrenal artery 15.
Figure 4 shows that the multipole ablation catheter of the renal artery of the present invention schematic diagram of skeleton after discharging in vivo.When theskeleton 3 ofablation catheter 2 enters afterrenal artery 15, promote backward skeleton control piece 11, makehead end part 7touch skeleton connector 5, makeskeleton 3 be adjacent to the blood vessel wall ofrenal artery 15, whether suitable by X ray assess location, as improper in position, can adjust by ablation catheter extension and contraction control part 10 and skeleton control piece 11, after the ideal of position, ablation apparatus interface 13 be connected to radiofrequency melting instrument, set parameter, melt.In ablation procedure, the temperature that melts of each electrode is presented on radiofrequency melting instrument in real time, as occurs excess Temperature, can end melting of this electrode, avoids excessively melting.
The above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, do not departing under the early stage of the technology of the present invention principle; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.