A kind of arteria renalis with sealing valve removes sympathetic nerve cool brine radio frequency ablation catheterTechnical field
The present invention relates to a kind of minimally invasive medical apparatus, more particularly to a kind of arteria renalis with sealing valve goes sympathetic nerve coldSalt solution radio frequency ablation catheter.
Background technology
Hypertension is a kind of disease of serious threat human health, is a variety of cardiovascular diseases, coronary heart disease particularly cerebral apoplexyImportant risk factor, be also aggravate kidney damage, heart failure and death common disease factor.The dead cause of disease of angiocardiopathyIn, about 2/3 is related to hypertension.Chinese hyperpietic in 2013 is up to 300,000,000 people, wherein obstinate hypertension ratioExample is 15% or so.With the continuous development of the correlative study of hypertension, its treatment concept is also constantly updated.Although treating high bloodThe medicine of pressure is countless, still has quite a few people to have the resistance to the action of a drug.Also patient is due to the limitation in terms of medication（PatientIt is difficult to adhere to, compound medicine limitation and bad medical event）, prevent blood pressure from controlling in normal range (NR).For these reasonsNeed to develop more efficiently treatment method, wherein just including safely and effectively traumatic small interventional therapy method-renal sympatheticNerve removes art.
Intractable hypertension refers to normal using three kinds of resistance to compression medicines（One of which is diuretics）In the case of blood pressure according toThe hypertension that can not be so effectively controlled.Experimental data is proved the excitement degree of sympathetic nerve and the blood pressure level of patient is inPositive correlation.Wherein sympathetic renal nerve system, particularly the renal sympathetic outgoing and incoming near arteria renalis wall are neural for luringHair and holding systemic hypertension play decisive role.It is tight that being overexcited of sympathetic nerve promotes blood vessel to a certain extentZhang Su-RAAS（RAAS）Activation, in the Forming Mechanism of hypertension, RAAS systems are the classical circulation regulations of human bodySystem, vital effect is played in blood pressure control, and body water, electrolyte are maintained by the regulation to heart, blood vessel, kidneyAnd the balance of blood pressure, it is an important regulation mechanism of human physiological's function.Renal sympathetic nerve is blocked to be not only able to make under blood pressureDrop, and the Chronic organ's specific diseases that can also be caused on sympathetic nerve excessive activation produce influence.Block renal sympathetic godThrough left ventricular hypertrophy and insulin resistance can also be improved.
Renal sympathetic nerve removes art（Renal Sympathetic Denervation）Also referred to as percutaneous catheter RF ablationArt, carries out impedance type heating to the sympathetic nerve of externa on arteria renalis inwall using RF energy, can weaken arteria renalis portionThe activity of the sympathetic nerve of position, reduces the nerve interaction between kidney and cranial nerve to reduce blood pressure.Newest animal andThe Clinical Follow-up experimental data of 2 years shows can be significantly and lasting using the renal sympathetic nerve radio-frequency ablation procedure of percutaneous catheterGround reduces blood pressure.This method also has the advantages that minimally invasive, few intercurrent disease.It is considered as breakthrough, it is high for treatment intractableBlood pressure opens new path.After ACC pleasantly surprised can expose within 2009, the therapy has turned into Jiao that each medical apparatus corporation, Ltd researches and developsPoint.
Patent document ZL2011103212304 discloses a kind of arteria renalis and removes sympathetic nerve cool brine RF ablation pipe, bagInclude joystick, main paragraph, can curved segment, last straight section and electrode, wherein bracing wire extends through catheter interior and by joystick controlSystem, electrode is fixed on last straight section, and the distal end of last straight section is fixed in one end of bracing wire, and bracing wire is arranged to the axis along conduit,Bracing wire is in last straight section and can extend in curved segment in not homonymy.The conduit controls bracing wire by control operation handle, can make bendableSection bending.Because bracing wire is in last straight section and can extend in curved segment in not homonymy, thus make the axis of last straight section for being fixed with electrodeDeviate can axis of curved segment when not bending have certain distance, pull bracing wire to cause conduit that curved shape is integrally formed.The conduit is usedBracing wire and handle control the degree of crook of body.The conduit does not have cold brine perfusion while ablation, easily disappears in raisingThe damage to blood vessel is produced when melting temperature and time.The degree of crook of body is controlled by handle, it is random larger, it is impossible toRealize good adherent effect；Conduit enter human vas in there is no seal wire guiding, into human body after more difficult arrive at accurately disappearMelt position, influence ablation effect.
Patent document ZL2012102044908 discloses a kind of renal artery cold saline water radio frequency ablation controllable electrode catheter,When carrying out RF ablation to the sympathetic nerve on arteria renalis tube wall, while irrigating cool brine to ablation site local cooling, preventThe coking and vasopasm of endangium, greatly reduce the damage to blood vessel while ablation is deepened.The catheter tubeDistal end be connected with electrode tip, electrode tip turns to external diameter 0.80mm-2.00mm by platinumiridio silk or platinum-tungsten alloys silk, long1.5mm-4mm's is close around helical spring, and distal end is that semicircle is spherical.Distal end is provided with metal in the main part of catheter tubeRing, the distal end of controllable bracing wire steel wire is connected with welding metal rings, the near-end connection control handle of controllable bracing wire steel wire.Pass through manipulationHandle can adjust the flexibility and shape of distal end.Although the conduit has cold brine perfusion, but is controlled again by handleThe degree of crook of body, it is random larger, it is impossible to realize good adherent effect；And conduit enter human vas in there is no seal wireGuiding, into human body after it is more difficult arrive at accurate ablation site, influence ablation effect.
The content of the invention
In order to overcome above-mentioned technical problem, reliable flexibility, convenient positioning are provided it is an object of the invention to provide one kindAnd the simple arteria renalis with sealing valve of making removes sympathetic nerve cool brine radio frequency ablation catheter.
The technical solution adopted in the present invention is：
A kind of arteria renalis with sealing valve removes sympathetic nerve cool brine radio frequency ablation catheter, including：
Be provided with spiral helicine ablation pipe, the ablation pipe along the hand of spiral be used for seal wire run through and cool brine injection it is logicalHole；
Be connected to the sealing valve of through hole distal end, the sealing valve make when being passed through including seal wire the opening that through hole opens andThe closure state that seal wire closes through hole after withdrawing from.
As the further improvement of above-mentioned technical proposal, the ablation pipe is bent into advance by the material with rebound performanceHelical form of the diameter in 2~9mm.
As the further improvement of above-mentioned technical proposal, the ablation pipe outer wall compartment of terrain is connected to some ring electrodes.
As the further improvement of above-mentioned technical proposal, the ring electrode two ends are tightly connected ablation pipe outer wall, middle part withThe salt water hole that connection through hole is offered on annular chamber, the ablation pipe of the annular chamber covering is formed between ablation pipe outer wall, it is describedRing electrode outer wall is communicated with the extraneous side opening with annular chamber.
The guidewire lumen separated with through hole is provided with as the further improvement of above-mentioned technical proposal, in the ablation pipe, from leadingThe RF energy transfer wire that line chamber is introduced connects each ring electrode.
As the further improvement of above-mentioned technical proposal, the ring electrode is provided with thermocouple, the signal of the thermocoupleLine is introduced from guidewire lumen.
As the further improvement of above-mentioned technical proposal, the sealing valve includes valve flap structure, and seal wire passes through valve flap structureWhen sealing valve be in opening, seal wire abjection valve flap structure when valve flap structure close and close through hole so that at sealing valveIn closure state.
As the further improvement of above-mentioned technical proposal, the sealing valve includes valve body, and the valve body is by outer circumferentially intermediateGradually thinning, the thinnest part at middle part is provided with otch, and the incision periphery forms the valve flap structure.
As the further improvement of above-mentioned technical proposal, the sealing valve includes the valve body of tubulose, the end of the valve bodyHemispherical pipe cap is integrally connected to, the pipe cap is provided with otch, and the periphery of the otch forms the valve flap structure.
As the further improvement of above-mentioned technical proposal, the ablation pipe near-end is connected to main pipe, and the main pipe is with disappearingMelt the inwall near pipe junction and be embedded with annular metal net.
The beneficial effects of the invention are as follows：The beneficial effects of the invention are as follows：Cool brine in present invention ablation pipe is injected and ledSilk penetrates a shared through hole, and sets sealing valve in through hole distal end, can also be by through hole in disappearing under the closing of sealing valveCool brine is injected when melting, the internal structure of ablation pipe is greatly simplify, an inner chamber of ablation pipe is reduced, makes the external diameter of conduitIt is reduced in suitable scope, and small ablation catheter external diameter can make conduit trans-radial or ulnar artery enter the arteria renalis, subtractFew to enter and myometrial suture, operating time, hospital stays of generation etc. through femoral artery, simplified inner tube structure can also reduce systemMake difficulty, reduce cost；Ablation pipe can be directed to homonymy arteria renalis blood vessel by seal wire and realize the accurate of the secondary above simultaneouslyPositioning, realizes repeatedly ablation, compared with other most of ablation pipes, greatly shortens ablation time, reduces Principle of Pain and to doctorThe dependence of raw operation level；And ablation catheter, in the shape of a spiral there is provided reliable flexibility, is moved in ablation so as to be close to kidneyArteries and veins blood vessel, greatly improves ablation effect.
Brief description of the drawings
The present invention is further described with embodiment below in conjunction with the accompanying drawings.
Fig. 1 is the structural representation of the present invention；
Fig. 2 is to melt the structural representation before pipe bending curl；
Fig. 3 is ablation pipe admittance silk pre-structure schematic diagram；
Structural representation when Fig. 4 is ablation pipe admittance silk；
Fig. 5 is the partial enlarged drawing of the part A in Fig. 4；
Fig. 6 is the partial enlarged drawing of the part B in Fig. 4；
Fig. 7 is ablation pipe cross-sectional structure schematic diagram；
Fig. 8 is the schematic diagram for melting pipe in arteria renalis blood vessel；
Fig. 9 is the sectional view of ring electrode；
Figure 10 is the front view of sealing valve first embodiment；
Figure 11 is Figure 10 A-A profiles；
Figure 12 is Figure 10 top view；
Figure 13 is the front view of sealing valve second embodiment；
Figure 14 is Figure 13 A-A profiles；
Figure 15 is Figure 13 top view；
Figure 16 is one embodiment of sealing valve otch；
Figure 17 is another embodiment of sealing valve otch；
Figure 18 is another embodiment of sealing valve otch；
Figure 19 is another embodiment of sealing valve otch.
Embodiment
The arteria renalis with sealing valve as shown in Figure 1 removes sympathetic nerve cool brine radio frequency ablation catheter, including by distal end extremelyAblation pipe 2, main pipe 1 and handle 3 that near-end is sequentially connected, handle 3 are connected with electric connection 5, Yi Jitong proximally by wire 4Cross connecting tube 7 and be connected to cool brine joint 6.
Ablation pipe 2 is helical form, and has excellent rebound performance, and it is formed as shown in figure 3, and external force after being stretched by external forceOriginal shape can be returned back to after elimination.Melt between pipe 2 and main pipe 1 using the connection of the connected modes such as sweat soldering or glue bondingTogether.The hand of spiral is provided with one of through hole 11 in ablation pipe 2, when seal wire 14 passes through through hole 11, ablation pipe 2 can be along leading14 outer walls of silk are slided and stretched, hence into the specified location of arteria renalis blood vessel, as shown in Figure 2 and Figure 4；And in seal wire 14After detaching, ablation pipe 2 returns back to helical form, and is close to the inwall of the arteria renalis 100, as illustrated in figures 1 and 8.
Ablation pipe 2 bends curl by resilient material and is made in advance, therefore can be reverted back to naturally after being acted on by external forcePreformed shape, resilient material preferably is thermoplastic elastic material, and other are also not excluded for certainly not only has rebound performance but also energySuitable for the material of human body.The outside dimension for melting pipe 2 is identical or less than normal with the caliber of the distal end of main pipe 1.Under natureThe diameter of ablation pipe 2 is identical with the diameter of the blood vessel of the arteria renalis 100 to be advisable, so as to meet the requirement of adherent compactness.It is male according to statisticsThe average caliber of the property arteria renalis is：0.60 ± 0.24cm of left side, 0.67 ± 0.26cm of right side；Women is：Left side 0.42 ±0.24cm, 0.46 ± 0.22cm of right side；Therefore, a diameter of 2~9mm of ablation pipe 2.
As shown in Figure 4 and Figure 5, the distal end of ablation pipe 2 is a tip, and the sophisticated place is provided with a sealing valve 9, while this is closeEnvelope valve 9 is also at the distal end of through hole 11.Sealing valve 9 includes opening and closure state, at which can be with when openingA diameter of 0.014inch ~ 0.038inch seal wire 14 is moved smoothly through, and after seal wire 14 is withdrawn from, it can automatically be closed into and closeConjunction state, so as to close the distal end of through hole 11, makes through hole 11 be changed into blind hole.After sealing valve 9 is in closure state, it can bear by leading toPoint to the pressure of sealing valve 9 in hole 11.
Because the distal end of through hole 11 sets sealing valve 9, therefore cool brine can be injected in through hole 11, to ablation site officePortion cools, and prevents the coking and vasopasm of endangium, reduces the damage to blood vessel while ablation is deepened.By upperState and understand, through hole 11 is the shared chamber that seal wire 14 enters and cool brine injects, guidewire lumen, salt water cavity in conventional art are closed into two isOne, the internal structure of ablation pipe 2 is greatly simplify, facilitates its processing and fabricating.Sealing valve 9 and the cooperating principle of through hole 11It is as follows：It is sent to by the guiding of seal wire 14 by pipe 2 is melted after specified location, seal wire 14 is withdrawn from, sealing valve 9 is closed, from through hole 11Near-end injection cool brine can carry out RF ablation.
Specifically, sealing valve 9 is made up of the excellent high polymer material of elasticity, such as silica gel, silicon rubber, rubber or latexClass etc., to realize reliable sealing property and excellent seal wire 14 is by performance.Sealing valve 9 needs the cool brine injection speed bornDegree is not less than highest injection speed 60mL/min during Clinical practice, and just can guarantee that to withdraw to play after seal wire prevents cool brine from injectingWhen from distal end outflow effect.
Sealing valve 9 is to realize to open and close by valve flap structure.Specifically, the sealing valve when seal wire 14 passes through valve flap structure9 are in opening, and valve flap structure is closed and closes through hole 11 when seal wire 14 is deviate from, so that sealing valve 9 is in closure state.
As shown in figs. 10-12, sealing valve 9a includes a valve body, and valve body is connected firmly with ablation pipe 2 distal end, and its outer wall is close toMelt the sophisticated inwall of pipe 2.Valve body makes sealing valve 9a reach good sealing effectiveness by outer circumferentially intermediate gradually thinning.Such as Figure 11Shown, the centre of valve body is horizontal spacer body, and the upper/lower terminal of spacer body is opening, and opening is gradually become from two ends to centreIt is small so that spacer body is the thinnest part of valve body.Be provided with otch 18 in spacer body, the periphery of otch 18 be form it is above-mentionedValve flap structure.Seal wire 14 can strut otch 18 and easily pass through, after seal wire 14 is withdrawn from, and otch 18 is closed automatically, prevents cool brineFlowed out during injection from distal end, realize reliable sealing property.
As illustrated in figs. 13-15, sealing valve 9b includes the valve body of tubulose, and valve body is connected firmly with ablation pipe 2 distal end, its outer wallIt is close to the sophisticated inwall of ablation pipe 2.Valve body 9b end is integrally connected to hemispherical pipe cap, and pipe cap is provided with otch 18, otch 18Periphery forms valve flap structure, and the valve body 9b of this shape is also used as melting the soft head of pipe 2 while sealing effectiveness is reached.Seal wire 14 can strut otch 18 and easily pass through, after seal wire 14 is withdrawn from, and otch 18 is closed automatically, is prevented when cool brine from injecting from remoteEnd outflow, realizes reliable sealing property.
In the above two embodiments, otch can use following four kinds of shapes：
A, as shown in figure 16, in the middle of sealing valve, cuts one of otch 18a, is shaped as in-line.
B, as shown in figure 17, in the middle of sealing valve, cuts twice otch 18b, is shaped as cross.
C, as shown in figure 18, in the middle of sealing valve, cuts three road otch 18c, is shaped as Y-shaped.
D, as shown in figure 19, in the middle of sealing valve, cuts six road otch 18d, is shaped as scroll.
In the present invention, as shown in figure 1, the ablation outer wall of pipe 2 is evenly equipped with some ring electrodes 8 along the hand of spiral, material is platinumIridium alloy, after ablation pipe 2 is stretched, the distribution of ring electrode 8 is as shown in Figures 2 to 4.It is close in RF ablation by ring electrode 8Arteria renalis inwall, the energy of ablation sympathetic nerve is provided by generating heat.Therefore, as shown in Figure 5-Figure 7, also being set in ablation pipe 2The guidewire lumen 10 separated with through hole 11 is equipped with, the RF energy transfer wire 13 introduced from guidewire lumen 10 connects each ring electrode 8.
Ablation pipe in conventional art, if it is desired to reaching the function by seal wire, injection cool brine, can typically consider to do threeIndividual inner chamber, is respectively intended to by wire, seal wire and cool brine, and the size range for melting pipe yet with the arteria renalis is generally 4F-5F or so, does three inner chambers and is difficult to.But only have guidewire lumen 10 in embodiments of the invention, ablation pipe 2 and logicalHole 11, seal wire 14 shares a chamber with cool brine, so greatly reduces the manufacture difficulty of ablation pipe.
As supporting, main pipe 1 equally also only has two passes, and this two passes, which mutually separates and is respectively communicated with, leadsLine chamber 10 and through hole 11, as shown in Figure 5 and Figure 6.RF energy transfer wire 13 and thermocouple are penetrated in a passage thereinSignal wire 12, RF energy transfer wire 13 enters guidewire lumen 10 and connects the end of each ring electrode 8, the signal wire of thermocouple12 also enter guidewire lumen 10 and connect the thermocouple being arranged on ring electrode 8, RF energy transfer wire 13 and thermocouple signalThe other end of line 12 passes main pipe 1 and connects electric connection 5, so as to connect the radio-frequency signal generator and temperature measurer of outside.Main pipe 1Other passage end connection through hole 11, other end connection cool brine joint 6, the cool brine joint 6 can be passed through simultaneouslySeal wire 14.
The thermoplastic elastic material that main pipe 1 is strengthened by stainless steel braided wires is made, but main pipe 1 hardness higher than disappearingMelt the hardness of pipe 2.As shown in fig. 6, the connection end inwall in main body tube close to ablation pipe 2 is embedded with the wire netting 17 of ring-type, increaseThe twisting property of main body tube connection end and anti-folding anti-bending strength.
In the present invention, as shown in figs. 5 and 9, each two ends of ring electrode 8 are tightly connected the ablation outer wall of pipe 2, and middle part is with disappearingMelt and annular chamber formed between the outer wall of pipe 2, several salt water holes 15 for connecting through holes 11 are offered on the ablation pipe 2 of annular chamber covering,The outer wall of ring electrode 8 offers the extraneous side opening 16 with annular chamber of connection, and each side opening 16 is evenly distributed so that injected from through hole 11Cool brine is through salt water hole 15 and the uniform blood vessel flowing to outside ring electrode 8 of side opening 16.
The use process of the present invention is as follows：Seal wire 14 is stretched to the specified location of the arteria renalis 100, operation main pipe 1 makesMelt pipe 2 and enter the arteria renalis 100 along seal wire 14, now seal wire 14 passes through sealing valve 9 and through hole 11, sealing valve 9, which is in, opensState, and melt pipe 2 and be in straight condition；Melt pipe 2 to reach after specified location, extract seal wire 14 out, now sealing valve 9 is closed,Ablation pipe 2 also returns back to helical form and the ring electrode 8 on ablation pipe 2 surface is brought into close contact the inwall of the arteria renalis 100；It is logical to ring electrode 8Enter RF energy to start to melt sympathetic nerve, while injection cool brine in through hole 11, cool brine is flowed out in side opening 16 to ring electricityPole 8 and cooling is ablated to, while also as human body fluid infusion.
The simply preferred embodiment of the present invention described above, it does not constitute limiting the scope of the invention.