The arteria renalis stimulates ablating electrode conduitTechnical field
The present invention relates to a kind of medicine equipment of PCI, particularly a kind of stimulation for treating intractable hypertensionWith the electrode catheter of RF ablation renal sympathetic nerve.
Background technology
Clinically more typically, paathogenic factor is numerous, and pathogenesis is indefinite, and medication effect is very for intractable hypertensionDifference, diagnosis and treatment technology are still not mature enough, one of great difficult problem as hypertension therapeutic, and such patient is generally associated withOther cardiovascular diseases, such as coronary heart disease, diabetes, heart failure, high fat of blood, ephrosis, peripheral arterial disease, apoplexy, left ventricle fertilizerThickness etc..It is the most notable with the infringement of the heart, brain, kidney in the various complication of hypertension, for example counted according to the World Health Organization,50% angiocardiopathy is caused by hypertension.At present because pressure value increases, cardiocerebrovasculaevents events occur causes deathThe annual whole world about 7,100,000 of number.And in more than the 40 years old cause of death of crowd of China, heart disease and cerebrovascular disease are classified as respectivelyOne and the 3rd, total the first dead hazards are hypertension.
Renal sympathetic nerve is played an important role in the generation and development of hypertension, and renin release is received by activating β 1Body, sodium salt reabsorption is receptor-mediated by the α 1 of proximal tubule.The contraction that the acceptors of α 1 also take part in Renal vascular causes kidney bloodThe reduction of stream.Angiotensin-Converting causes that angiotensinⅠ (abbreviation Ang I) is converted to angiotensinⅡ (abbreviation AngII), Ang II causes vessel retraction, and proximal tubular sodium salt reabsorption, aldosterone produces the activation with stomodaeal nervous system.AngThe sympathetic nerve terminal of II pair of proximal tubular has facilitation so that norepinephrine release increases and increases with sodium salt reabsorptionBy force.Sympathetectomy can prevent hypertension caused by Ang II, and this evidence supports the sympathetic nerve intervention inductions of Ang IIThe viewpoint of hypertension.Ang II can cause swashing for renal sympathetic nerve by acting on rostral ventrolateral medulla nucleus neuron simultaneouslyIt is living.Ang II can further strengthen the propagation of vascular smooth muscle, cause the myocardial hypertrophy aldosterone to cause sodium water weight in distal tubuleAbsorb.All these factor result in generation and the hair of hypertension eventually through cardiac output is increased with increase peripheral resistanceExhibition.
As can be seen here, blood pressure is mainly adjusted by kidney.Nowadays the thinking of hypertension therapy is by medicine reductionAngiotensins, however, the sympathetic nerve spread all on the arteria renalis is also to cause the arch-criminal of hypertension.If these nerves are excessively livedJump, secretion feritin is excessively too fast, is just enough to the effect that " counteracting " falls medicine step-down.
Arteria renalis inner membrance radio-frequency ablation procedure is that thoroughly effectively treatment intractable hypertension brings new hope, but at present alsoThere is no a kind of medicine equipment to be really used for clinical treatment intractable hypertension, finding report is also only limitted to the experimental stage.AndThe conduit of prior art is simple, it is impossible to effectively and reliably treat intractable hypertension.
The content of the invention
The technical problem to be solved in the present invention is to provide a kind of same conduit of utilization rapidly and accurately on arteria renalis wallThe electrode catheter that sympathetic nerve is stimulated and melted.
In order to solve the above-mentioned technical problem, the technical solution adopted by the present invention is：
The arteria renalis of the invention stimulates ablating electrode conduit, is connected with turn from distal end to near-end and the electrode catheter may be guidedInsertion the arteria renalis and avoid electrode catheter termination damage arteria renalis inwall conductive filament head, can by change spatial form with adapt toArteria renalis inwall fully and be in close contact and renal sympathetic nerve therein is stimulated and ablative surgery basket, to basket riseThe pipe shaft of support effect, the control handle of control basket spatial form change and by the ring electrode on basket and external stimulation instrumentAnd radiofrequency generator is electrically connected and is fixed on the connector of the control handle afterbody, wherein, the length of the pipe shaft is in 70cm-150cm。
The basket is made up of many strip arms and sizing core, and being fixed in proximally by near-end sizing core for strip arm is describedThe distal end of pipe shaft, the distal end of strip arm is fixed in the near-end of the conductive filament head by distal end sizing core, what the strip arm was constitutedSpatial form can be changed into ellipsoid in the presence of along the axial force of the pipe shaft from the water chestnut cone post of original state, then become againIt is the fairing encirclement structure like space electronic track.
The strip arm is tubulose, and it is made by polyurethane, block polyamide or nylon, along it in the inner chamber of strip armNiTi flat filament axially is connected with, the NiTi flat filament can make correspondence strip brachiocylloosis under external force, after the external force is discharged,Can restore correspondence strip arm.
The ring electrode is made by platinumiridio or gold, and at least 1 is distributed with the every outer surface of the strip armIndividual ring electrode.
The ring electrode is arranged on the position of equal decile on strip arm.
The conductive filament head is linear helical spring, and its front end is the bead of semi-round ball；The helical spring is by straightFootpath is close around forming around the center pivot made by other steel wires for the stainless steel wire of 0.05mm to 0.2mm, helical spring it is outerIn 0.4mm to 1.2mm, length is in 10mm to 35mm in footpath.
Be provided with temperature transducer on the inside of the ring electrode, temperature transducer by being placed through the pipe shaft, manipulation handThe holding wire of handle is connected on the connector, and is connected with the temperature measurer in described radiofrequency generator by external cable.
The sizing core is for two and made by plastics or metal, and its section configuration is cellular, at the center of the sectionCentral circular hole is provided with, several rectangular openings are provided with around the central circular hole；Central circular hole and rectangular opening on distal end sizing core canThink through hole or blind hole, the central circular hole and rectangular opening on near-end sizing core are through hole；Institute is stretched out at the two ends of the NiTi flat filamentStrip pipe be respectively and fixedly connected on the rectangular opening of correspondence position.
In the distal end, core of shaping can make the bracing wire steel wire of strip brachiocylloosis deformation to being provided between control handle, shouldThe distal end of bracing wire steel wire is fixed on the central circular hole on distal end sizing core, and the near-end of bracing wire steel wire is shaped on core through near-endCentral circular hole and inner cavity of tube body are connected on the handle inner core on control handle.
The maximum outside diameter of the spatial form that the basket is formed is in 2mm-18mm.
Electrode catheter of the invention can carry out electro photoluminescence to arteria renalis inner membrance, and mapping causes blood pressure significantly raised to because of stimulationPoint position, find sympathetic nerve close quarters, carry out positioning target spot ablation, it is significantly more efficient ablation arteria renalis wall on sympathetic godThrough.Basket is provided with the distal end of conduit, basket is made up of multiple space strip arms, proximally and distally connecting respectively for strip arm is ledPipe pipe shaft and conductive filament head, the size of the spatial volume of basket are controlled by the control handle of catheter proximal end, so that strip arm overheadBetween the electrode and the arteria renalis inwall that are distributed fully, be in close contact, and one-time positioning Multi-contact just can complete to stimulate, melt,The multiple surgical procedures for stimulating blood pressure to verify again, more accurate and effective removal renal sympathetic nerve.The present invention is capable of achieving dynamic for kidneyThe stimulation mapping of arteries and veins, ablation, temperature control be on same ring electrode in completing, it is to avoid various process is changed caused by various apparatusesSite error, more accurately, fast.
It can eliminate it is orthosympathetic be overexcited, easy during operation and safety, doctor under image-guided, by this hairBright electrode catheter carries out RF ablation to the sympathetic nerve spread all on arteria renalis tube wall, cuts away partial nerve, reduces sympathetic godThrough the function of conducts information, reduce renin secretion, so that angiotensins is reduced causes blood pressure reduction.
Brief description of the drawings
Schematic diagram when Fig. 1 is 8 original state of electrode catheter of the invention.
Schematic diagram when Fig. 2 is the spatial form of the basket 2 transformation ellipsoid 28 in Fig. 1.
Fig. 3 is A portions enlarged diagram (i.e. the enlarged drawing of basket 2) in Fig. 1.
Fig. 4 be Fig. 1 in the spatial form of basket 2 be transformed into similar spaces electron orbit fairing surround structure 29 amplificationSchematic diagram.
Fig. 5 is B-B section views enlarged diagram (i.e. the sectional view of pipe shaft 5) in Fig. 1.
Fig. 6 is the enlarged diagram of control handle 6 in Fig. 1.
Fig. 7 is the C-C section views enlarged diagram (sectional view of core of shaping) in Fig. 3.
Reference is as follows：
Conductive filament head 1, basket 2, distal end sizing core 21, near-end sizing core 22, strip arm 23, ring electrode 24, central circular hole 25,Rectangular opening 26, water chestnut cone post 27, ellipsoid 28, fairing surround structure 29, bracing wire steel wire 3, electrified wire 4, pipe shaft 5, manipulation handHandle 6, connector 7, electrode catheter 8.
Specific embodiment
As shown in Figure 1, 2, the arteria renalis of the invention stimulates ablating electrode conduit to be applied to by the thorn to arteria renalis inwallSwash and melt to treat hypertension, it is made up of conductive filament head 1, basket 2, pipe shaft 5, control handle 6 and connector 7.
1st, the conductive filament head 1 is arranged on the distalmost end of the electrode catheter 8 (with Fig. 1 papers direction as reference, left-hand is remoteEnd, dextrad is near-end), its effect is guiding catheter into the arteria renalis and avoids catheter end head from damaging arteria renalis inwall, its profileIt is linear helical Bourdon tube, the distal end of the helical Bourdon tube is the bead in semi-round ball being welded into using scolding tin.Spiral bulletSpring be by the stainless steel wire of a diameter of 0.05mm to 0.2mm around the center pivot made by other steel wires close around forming, spiral, in 0.4mm to 1.2mm, total length is in 10mm to 35mm for the external diameter of bourdon tube.
2nd, as shown in Figure 3,4, the basket 2 by many strip arms 23, shape core and be arranged on strip arm 23 ring electricityPole 24 is constituted, and the radical of the present invention preferably strip arm 23 is 4-8 roots.
1) every strip arm 23 is tubulose, and its external diameter is 0.4mm to 1.2mm, and internal diameter is 0.3mm to 1mm, and a length of 10mm is extremely40mm, it is made by polyurethane, block polyamide or nylon, and approximate one of the original shape that all strip arms 23 are encircled into is by twoThe water chestnut cone shape of post 27 that individual identical water chestnut cone is constituted in the way of bottom surface connects, every strip arm 23 is the one of water chestnut cone post 27Bar incline.
Along its affixed resilient NiTi flat filament in axial direction in the inner chamber of strip arm 23, its thickness is 0.05mm to 0.2mm,Width is 0.2mm to 0.8mm, preferred nickel/titanium alloy silk.
The NiTi flat filament can bend to the profile of different curvature under external force, and the bending can order about corresponding stripArm 23 bends, and after the external force is discharged, correspondence strip arm 23 can again restored.
2) the sizing core is made by plastics or metal material, and sizing core is two, is respectively distal end sizing core 21 and nearEnd locating core.Proximal end face center on distal end sizing core 21 is provided with central circular hole 25 and is put around the central circular hole 25Multiple rectangular openings 26, central circular hole 25 and rectangular opening 26 can be through hole, or blind hole；On near-end sizing core 22The size being provided with distal end sizing core 21 and central circular hole 25 and rectangular opening 26 as set location, but near-end sizing coreCentral circular hole 25 and rectangular opening 26 on 22 are through hole (referring to Fig. 7).
The mouth of pipe that the strip arm 23 is stretched out in the distal end of the NiTi flat filament in every strip arm 23 is fixed in distal end sizingOn core 21 in the rectangular opening 26 of correspondence position, the mouth of pipe that the near-end of each NiTi flat filament stretches out the strip arm 23 is fixed in near-end and determinesOn core 22 in the rectangular opening 26 of correspondence position.
Distal end sizing core 21 is fixed on the near-end of the conductive filament head 1, and near-end sizing core 22 is fixed on the remote of the pipe shaft 5End.
In the distal end, core 21 of shaping can make the bracing wire steel of the strip arm 23 flexural deformation to being provided between control handle 6Silk 3, the distal end of the bracing wire steel wire 3 is fixed on the central circular hole 25 on distal end sizing core 21, and the near-end of bracing wire steel wire 3 is through closelyCentral circular hole 25 and the inner chamber of pipe shaft 5 on end sizing core 22 are connected on the handle inner core on control handle 6.
As shown in Figure 2,3, 4, when the bracing wire steel wire 3 is pulled to the direction of connector 7 along the axis of pipe shaft 5, the distal endSizing core 21 is pulled the spatial form for forcing the strip arm 23 to constitute to bore the shape of post 27 by the water chestnut of original state by the bracing wire steel wire 3Shape gradually becomes ellipsoid 28, the i.e. spatial form of basket 2 and is changed into ellipsoid 28 from the water chestnut cone shape of post 27；Continue to draw and be somebody's turn to doBracing wire steel wire 3 then makes the basket 2 be changed into being surrounded like the fairing of space electronic track the shape of structure 29.When release is to bracing wire steelDuring the external force of silk 3, under each strip arm 23 elastic restoring force effect of NiTi flat filament wherein on basket 2, it is set to surround compositionThe spatial form of basket 2 be returned to original state water chestnut cone the shape of post 27.
3) at least one ring electrode 24 as shown in Figure 2,3, 4, is arranged with the outer surface of the every strip arm 23, the ringElectrode 24 is made by platinumiridio or gold, and the external diameter of the ring electrode 24 being socketed on strip arm 23 is 0.4mm to 1.2mm, longSpend for 0.5mm to 2mm.When the ring electrode 24 is for multiple, all ring electrodes 24 are uniformly arranged along the strip arm 23.
The distal end of each ring electrode 24 respectively electrified wire 4 of 0.1mm to 0.2mm a diameter of with is affixed, correspondenceElectrified wire 4 near-end through the central circular hole 25 on near-end sizing core 22 or the rectangular opening 26 of correspondence position, pipe shaft 5, behaviourControl handle 6 connects with described connector 7, and is connected with stimulation instrument and radiofrequency generator by external wire.
Be provided with temperature transducer in the inner side of each ring electrode 24, temperature transducer by being placed through the pipe shaft 5, behaviourThe holding wire for controlling handle 6 is connected on the connector 7, and is connected with the temperature measurer in described radiofrequency generator by external cableConnect.The temperature transducer is Medical temperature measuring sensor, or conventional thermistor or thermocouple.
The change of the spatial form of basket 2 can make it into the arteria renalis after with the fully and tight patch with arteria renalis inwallTouch.The maximum outside diameter of the spatial form that the basket 2 is formed is in 2mm-18mm.
When basket 2 is into the arteria renalis and after being closely affixed with arteria renalis inwall, connecting ring electrode 24 and stimulation instrument or penetrateThe electrical connection of frequency instrument, you can electro photoluminescence or RF ablation are carried out to the sympathetic nerve on arteria renalis tube wall.
3rd, the pipe shaft 5 is made by polyurethane, block polyamide or nylon material, its length in 70cm-150cm, in itChamber is hollow channel, for placing described bracing wire steel wire 3, electrified wire 4 and holding wire (referring to Fig. 5).
Stainless steel cloth is equipped with the inwall of pipe shaft 5, its effect is the intensity and pliability for strengthening the pipe shaft 5.
4th, as shown in fig. 6, being provided with handle inner core in the control handle 6, the handle inner core and the inner chamber of control handle 6 itBetween using threaded connection, control handle is provided with outside control crank, by turn control handle adjustable handle inner core along graspThe axis direction for controlling handle 6 is moved back and forth.
The near-end of described bracing wire steel wire 3 is fixed in the distal end of the handle inner core, when forward or backwards rotating described controlDuring knob processed, you can make the traction or release of 3 pairs of baskets 2 of bracing wire steel wire.
5th, the connector 7 is arranged at the afterbody of control handle 6, and it passes through external cable with described stimulation instrument and radio frequencyInstrument is connected.