CN102125460B - Renal artery radio frequency ablation catheter as well as manufacturing method and application method thereof - Google Patents
Renal artery radio frequency ablation catheter as well as manufacturing method and application method thereof Download PDFInfo
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- CN102125460B CN102125460B CN2011100954571A CN201110095457A CN102125460B CN 102125460 B CN102125460 B CN 102125460B CN 2011100954571 A CN2011100954571 A CN 2011100954571A CN 201110095457 A CN201110095457 A CN 201110095457A CN 102125460 B CN102125460 B CN 102125460B
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Abstract
The invention discloses a renal artery radio frequency ablation catheter as well as a manufacturing method and an application method thereof, and aims to solve the technical problem of reducing the blood pressure of a patient with refractory hypertension. The renal artery radio frequency ablation catheter comprises a sheath tube and an ablation catheter loaded in the sheath tube, wherein a small hole is formed on the wall of the distal end of the sheath tube and an ablation electrode of the ablation catheter extends out of the small hole. The manufacturing method provided by the invention involves in the independent manufacturing of the sheath tube and the ablation catheter. The application method provided by the invention comprises the following steps: the sheath tube and the ablation catheter are delivered into a renal artery through a femoral artery, and the ablation electrode is pushed to reach the position of the small hole of the sheath tube and then move out of the sheath tube to ablate the sympathetic nerves in the renal artery. Compared with the prior art, the sheath tube is loaded into the renal artery, and the ablation catheter extends out of the small hole of the sheath tube to ablate the sympathetic nerves on the inner wall of the renal artery one by one so as to destroy the sympathetic nerves dominating the kidney, so as to achieve the purpose of treating refractory hypertension by ablation of the sympathetic nerves in the renal artery.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments and preparation method thereof, particularly a kind ofly be used to get involved the arteriorenal sympathetic nerve of RF ablation and treat RF ablation conduit of intractable hypertension and preparation method thereof.
Background technology
Intractable hypertension is more common clinically; Paathogenic factor is numerous, and pathogenesis is indeterminate, and medication effect is very poor; Diagnosis and treatment technology are still not mature enough; Become one of great difficult problem of hypertension therapeutic, and this type of patient is associated with other cardiovascular diseasess usually, like coronary heart disease, diabetes, heart failure, hyperlipidemia, nephropathy, peripheral arterial disease, apoplexy, left ventricular hypertrophy etc.In hypertensive various complication, the most remarkable with the infringement of the heart, brain, kidney, according to statistics, 50% cardiovascular disease is caused by hypertension.At present because of blood pressure improves, cardiovascular and cerebrovascular disease takes place cause the annual whole world about 7,100,000 of dead number.In China crowd's more than 40 years old the cause of death, heart disease and cerebrovascular are classified first and the 3rd respectively as, and total first dead risk factor is a hypertension.
On March 30th, 2009; Occur excision kidney sympathetic nerve in the world first and treat the research report of intractable hypertension; Report also provides the current research result: on average take 4.7 kinds of antihypertensive refractory hypertension patients for 45; Accepting to go the treatment of kidney sympathetic nerve art after 1 year, reduced 27/17mmHg on the basis of its average outpatient service blood pressure average 177/101mmHg before treatment.This human trial result shows that it possibly be safe selection that new technique is treated uncontrollable hyperpietic for several criteria.It is a kind of simple type ablation catheter that the femoral artery puncture that proposes in the report inserts the treatment conduit; Far-end has a termination electrode, is connected to the NiTi steel wire, carries out RF ablation first after being advanced into the renal artery far-end; Then in returning the vertical process of merger rotary guide pipe gradually; On the renal artery wall, carry out 4～6 times and vertically reach the intermittent RF ablation that goes in ring, each persistent period is no more than 2 fens kinds, and releasing energy is no more than 8 watts.Continue to monitor the variation of catheter tip temperature and impedance in the ablation procedure, and change release by predetermined scheme adjustment RF energy according to these.Non-pharmaceutical method of this treatment intractable hypertension causes that people pay close attention to greatly, based on microcatheter technology go kidney sympathetic nerve method simple and safe, for thorough effectively treatment intractable hypertension has brought new hope.But the conduit of prior art is simple and easy, can not be effectively and treatment intractable hypertension reliably.
Summary of the invention
The purpose of this invention is to provide a kind of renal artery RF ablation conduit and preparation method thereof, the technical problem that solve is effectively to reduce intractable hypertension patient's blood pressure.
The present invention adopts following technical scheme: a kind of renal artery RF ablation conduit, and said renal artery RF ablation conduit is made up of the sheath pipe and the ablation catheter of the sheath pipe of packing into, and said sheath pipe near-end is connected with the sheath pipe joint, and sheath pipe far-end tube wall has aperture; Said ablation catheter by the ablation catheter pipe shaft, be connected ablation catheter pipe shaft distal end ablating electrode, be connected the union joint of ablation catheter pipe shaft proximal end and the lead that the RF energy that radiofrequency generator produces sends ablating electrode to constituted; Said ablation catheter can make ablating electrode stretch out aperture along moving in the sheath pipe and rotating.
Sheath pipe of the present invention is made up of inner polytetrafluoroethyllayer layer pipe and coaxial setting of block polyetheramides resin sheath pipe outer wall; The inner tube internal diameter is 1.71mm to 1.83mm; External diameter is 1.78mm to 2.43mm, and sheath pipe outer wall internal diameter is 2.00mm to 2.50mm, and external diameter is 2.50mm to 2.80mm.
Sheath pipe outer wall distal length 90mm to 150mm material of the present invention is soft, and proximal length 950mm to 1000mm is harder.
Sheath pipe far-end tube wall of the present invention have 3 to 6 along sheath pipe circumference be 120 ° to 60 ° be uniformly distributed with, along the sheath tubular axis to tactic aperture; Aperture is oval; Ellipse short shaft is 1.2mm to 1.5mm, and major axis is 8mm to 9mm, and the transverse direction is along the sheath tube axis direction.
Be provided with annular indicating ring between the sheath inner tube layer pipe of near-end one side of aperture of the present invention and the sheath pipe outer wall; The indicating ring is identical with little hole count, and one side of the contiguous aperture side of indicating ring is 6mm to 7mm with the distance at aperture center, and the indicating ring width is 1.5mm to 2.0mm; Thickness is 0.1mm to 0.5mm; Form by hairspring filament winding system, or process, material platinum, tungsten or gold by annular metal.
Ablation catheter tube body diameter of the present invention is 0.6mm to 0.7mm; External diameter is 1.1mm to 1.3mm, and the ablation catheter pipe shaft is from the inside to the outside by the nylon tube of internal layer with the block polyetheramides pitch tube is compound, the stainless steel silk webmaster in middle level, outer field block polyetheramides resin outer tube are formed; Said stainless steel silk diameter 0.02mm, stainless steel cloth bore are 0.7mm to 0.8mm, and density is 30 to 150 order/square inches.
Ablating electrode of the present invention adopts platinumiridio or platinum and stainless steel solid structure, is external diameter 1.33mm, the cylinder of length 2mm to 4mm.
Lead of the present invention is the copper cash of diameter 0.34mm to 0.36mm, is arranged in the ablation catheter pipe shaft.
A kind of method for preparing of renal artery RF ablation conduit, sheath pipe and ablation catheter prepare respectively, and one, preparation sheath pipe may further comprise the steps: 1, with 72D, 63D, 55D block polyetheramides resin; Be extruded into hardness and be respectively the pipe of 72D, 63D, 55D; Internal diameter is 2.0mm to 2.5mm, and external diameter is 2.5mm to 2.8mm, screw speed: 10n/min to 30n/min; Barrel pressure: 1500Mpa to 2000Mpa, hauling speed: 30m/s; 2, be on the rustless steel rod iron of 1.7mm to 1.8mm at external diameter, put polyfluortetraethylene pipe, internal diameter is 2.80mm to 3.01mm before shrinking, and is heated to 335 ℃ to 345 ℃, and shrinking the back internal diameter is 1.70mm to 1.83mm, naturally cools to room temperature and shrinks; 3, in the beginning of polyfluortetraethylene pipe pipe distal end 3mm to 5mm place, equidistantly put 3 to 6 on indicating ring, the spacing between adjacent two indicating rings is 12mm to 13mm; The indicating ring width is 1.5mm to 2.0mm; Thickness is 0.1mm to 0.5mm, and the indicating ring is an annular metal, and material is platinum, tungsten or gold; Form by the filament coiling, or annular metal is processed; 4, put the block polyetheramides pitch tube that hardness is respectively 72D, 63D, 55D on the polyfluortetraethylene pipe pipe of indicating ring being with, distal length 90mm to 150mm adopts 55D, and proximal length 950mm to 1000mm adopts 72D; 5, outside the block polyetheramides pitch tube, put perfluoroethylene-propylene copolymer heat-shrinkable tube, hot contraction ratio is 1.6:1, internal diameter 4mm to 4.5mm, and wall thickness 0.25mm is heated to 205 ℃ to 225 ℃ thermal contractions, divests heat-shrinkable tube behind the natural cooling; 6, rod iron is extracted; 7, press circumferential 120 ° to the 60 ° uniform distribution of sheath pipe; On the sheath pipe, get 3 to 6 apertures along the sheath tubular axis to order, the position at center, hole is in indicating ring far-end one side, and the indicating ring is 6mm to 7mm near the distance at aperture one side and aperture center; Aperture is oval; Ellipse short shaft is 1.2mm to 1.5mm, and major axis is 8mm to 9mm, and the transverse direction is along the sheath tube axis direction; 8, at the near-end of sheath pipe welding sheath pipe joint, the machine barrel temperature is 453F, injection time 50s, injection pressure 50PSI, cool time 15S, sheath control is equipped with to be accomplished; Two, the preparation ablation catheter may further comprise the steps: 1, with the stainless steel silk establishment steel wire webmaster of diameter 0.02mm, the internal diameter of steel wire webmaster is 0.7mm to 0.8mm, and length is 1.0m to 1.1m, is 30 to 150 order/square inches; 2, nylon is extruded into nylon tube, internal diameter is 0.4mm to 0.5mm, and wall thickness is 0.1mm, screw speed: 20n/min to 50n/min, barrel pressure: 1500Mpa to 2000Mpa, hauling speed: 20m/s to 50m/s; 3, with the block polyetheramides resin of 55D, be extruded into the block polyetheramides pitch tube of two kinds of sizes, internal diameter is respectively 0.6mm to 0.7mm and 0.9mm to 1.2mm; Wall thickness is 0.1mm; Screw speed: 20n/min to 50n/min, barrel pressure: 1500Mpa to 2000Mpa, hauling speed: 20m/s to 50m/s; Baking temperature: 350F to 400F, drying time: 4H; 4, be on the stainless steel bar of 0.4mm to 0.6mm at external diameter; Put nylon tube; Outside nylon tube, putting internal diameter is the block polyetheramides pitch tube of 0.6mm to 0.7mm; Outside internal diameter is the block polyetheramides pitch tube of 0.6mm to 0.7mm, put the steel wire pipe, put the block polyetheramides resin outer tube that internal diameter is 0.9mm to 1.2mm again in the steel wire outside; 5, on block polyetheramides resin outer tube, put heat-shrinkable tube, hot contraction ratio is 1.3:1, and internal diameter is 1.56mm before shrinking, and is heated to 205 ℃ to 225 ℃ thermal contractions, treats to divest heat-shrinkable tube behind the natural cooling; 6, the stainless steel bar core is extracted; 7, at external diameter 1.33mm, the cylinder ablating electrode near-end of length 2mm to the 4mm lead of burn-oning, lead adopts the copper cash of diameter 0.34mm to 0.36mm; The ablating electrode near-end that 8, will weld lead is packed in the remote stomidium of the ablation catheter pipe shaft for preparing, and lead penetrates from remote stomidium, extracts out from ablation catheter pipe shaft near-end again; 9, with wire bonds on union joint, with glue that union joint and ablation catheter pipe shaft near-end is bonding, ablation catheter preparation is accomplished.
A kind of method for using of renal artery RF ablation conduit may further comprise the steps: one, the ablation catheter far-end is delivered in the sheath tube cavity from sheath pipe near-end; Two, intervene operation carries out radiography to renal artery; Three, sheath pipe and ablation catheter are delivered in the renal artery from femoral artery, confirm that through the indicating ring of radiography and sheath pipe sheath pipe far-end has reached ablation site; Four, begin to push ablation catheter near-end union joint, the ablating electrode of ablation catheter far-end is pushed to sheath pipe aperture place, rotary guide pipe near-end union joint through sheath pipe aperture, is pushed out to ablation catheter outside the sheath pipe; Five, radiofrequency generator is electrically connected with lead, connects the radiofrequency generator power supply, sympathetic nerve in the renal artery is melted to far carrying out pointwise by near, and voltage 220V, frequency 500KHZ, power 8W, every melts time 5S; Six, ablation catheter is withdrawn into the sheath tube cavity, withdraws from sheath pipe and ablation catheter external together again.
The present invention compared with prior art adopts the sheath pipe to get involved in the renal artery, and ablation catheter stretches out outside the sheath pipe aperture; Renal artery inwall sympathetic nerve is carried out pointwise to be melted; Destroy the sympathetic nerve of domination kidney and treat hypertension,, can observe the ablation catheter position at operation process through radiography and indicating; Control the ablation points position, sympathetic nerve in the renal artery is melted treat intractable hypertension.
Description of drawings
Fig. 1 is the structural representation of renal artery RF ablation conduit embodiment of the present invention.
Fig. 2 is the structural representation of sheath pipe of the present invention.
Fig. 3 is the structural representation of ablation catheter of the present invention.
Fig. 4 is the sectional view that the indicating ring is housed in the sheath pipe of the present invention.
Fig. 5 is that ablating electrode of the present invention stretches out sketch map from sheath pipe tapping.
The specific embodiment
Below in conjunction with accompanying drawing and embodiment the present invention is done further explain.
As shown in Figure 1, renal artery RF ablation conduit of the present invention is made up of the sheath pipe 1 and the ablation catheter 2 of the sheath pipe 1 of packing into.
As shown in Figure 2, sheath pipe 1 is used to get into the human body renal artery, is made up of polytetrafluoroethylene PTFE inner tube 3 and sheath pipe outer wall 6 coaxial settings, and sheath pipe 1 near-end is connected with sheath pipe joint 7.The coefficient of friction of PTFE is little, and inner tube 3 adopts PTFE, can guarantee ablation catheter 2 through the time frictional force less.Inner tube 3 internal diameters are 1.71mm to 1.83mm, and external diameter is 1.78mm to 2.43mm.Sheath pipe outer wall 6 internal diameters are 2.00mm to 2.50mm, and external diameter is 2.5mm to 2.8mm.Sheath pipe 1 far-end tube wall has 3 to 6 and is 120 ° to the 60 ° apertures 5 that are uniformly distributed with, arrange along sheath pipe 1 axial order along sheath pipe 1 circumference; Make aperture 5 on sheath pipe 1 tube wall, arrange shape in the shape of a spiral; Aperture 5 is oval, and ellipse short shaft is 1.2mm to 1.5mm, and major axis is 8mm to 9mm; The transverse direction is along sheath pipe 1 axis direction so that ablation catheter 2 far-ends from aperture 5 freely through and stretch out.Be provided with annular indicating ring 4 between sheath pipe 1 inner tube 3 of near-end one side of each aperture 5 and the sheath pipe outer wall 6, be used to identify the position of aperture 5.
When operation, sheath pipe 1 rigidity is reversed more easily by force more and is pushed, and it is good to be delivered to the surgery location rear stability.But if rigidity is crossed then easy by force soft tissue injury, the potential danger that causes blood vessel, kidney perforation is arranged, therefore consider, require sheath pipe 1 front end soft as far as possible, do not injure soft tissue in the body from safety.For obtaining good security performance and operating characteristics, the hardness of sheath pipe 1 is by the deliquescing gradually of near-end to far-end.Sheath pipe outer wall 6 materials are polymer; The far-end material is soft; The near-end material is then harder; Sheath pipe outer wall 6 material selection biocompatibility are block polyetheramides resin PEBAX preferably, and like French Arkema (A Kema) company, hardness is respectively the PEBAX of 72D (PEBAX 7233 SN 01), 63D (PEBAX 6333 SN 01), 55D (PEBAX 5533SN 01); Distal length 90mm to 150mm adopts more softish material PEBAX 55D, and proximal length 950mm to 1000mm adopts harder material PEBAX 72D.Sheath pipe 1 external diameter is 2.5mm to 2.8mm, guarantees that it can push freely in renal artery, and internal diameter is 1.71mm to 1.83mm, makes ablation catheter 2 reversed and push within it.
As shown in Figure 3, ablation catheter 2 is made up of ablation catheter pipe shaft 8, the ablating electrode 9 that is connected ablation catheter pipe shaft 8 distal ends, union joint 10 and the lead that is connected ablation catheter pipe shaft 8 proximal end.
Ablating electrode 9 is used to transmit RF energy, has excellent biological compatibility.Platinumiridio or platinum and stainless steel solid structure be can select for use, external diameter 1.33mm (3.3F), the cylinder of length 2mm to 4mm are.The lead that is electrically connected with radiofrequency generator extends to ablating electrode 9 through union joint 10 and ablation catheter pipe shaft 8; Lead sends the RF energy that radiofrequency generator produces to ablating electrode 9; To ablating electrode 9 transmission radio-frequency discharge energy; Lead is the copper cash of diameter 0.34mm to 0.36mm, is arranged in the ablation catheter pipe shaft 8.
As shown in Figure 4, indicating ring 4 is 3 to 6, and is identical with aperture 5 numbers; Be arranged between inner tube 3 and the sheath pipe outer wall 6, indicating ring 4 is positioned at aperture 5 near-ends one side, and one side of indicating ring 4 contiguous aperture sides is 6mm to 7mm with the distance at aperture 5 centers; Indicating ring 4 width are 1.5mm to 2.0mm, and thickness is 0.1mm to 0.5mm, is formed by hairspring filament winding system; Also can process by annular metal; Material is selected platinum Pt, tungsten W or golden Au, and the made indicating ring development effect of these three kinds of materials is superior, and the doctor can accurately be located in operation sheath pipe 1 process.
As shown in Figure 5, the ablating electrode 9 of ablation catheter 2 distal ends stretches out from the aperture 5 of sheath pipe 1 one by one, and aperture 5 is 3 to 6, and therefore, ablation points also reaches 3 to 6, and the ablation points line is wire in the shape of a spiral, can realize sympathetic nerve in the renal artery is fully melted.
The method for preparing of renal artery RF ablation conduit of the present invention is divided into the preparation of sheath pipe and ablation catheter, may further comprise the steps:
One, preparation sheath pipe
1, adopt 35 type extruders of the holy peace of Dongguan City plastics machinery company limited, the specification that French A Kema Arkema company is produced is the PEBAX raw material of 72D, 63D, 55D, is extruded into the PEBAX pipe that hardness is respectively 72D, 63D, 55D; The PEBAX bore is 2.0mm to 2.5mm; External diameter is 2.5mm to 2.8mm, and pipe range 1.0m to 1.1m is provided with screw speed: 10n/min to 30n/min; Barrel pressure: 1500Mpa to 2000Mpa, hauling speed: 30m/s.
2, be on the 316L rustless steel rod iron produced of the Shanghai joint metal material limited company of 1.7mm to 1.8mm at external diameter; The model that puts U.S. ZEUS company by hand is No. 15/14 PTFE tube of PTFE HS 2:1 AWG HeatShrinkThinWall series; Internal diameter is 2.80mm to 3.01mm before shrinking; Adopt the 850+ type hot-air blower doubly think special electronic tool factory, PTFE tube is heated to 335 ℃ to 345 ℃, shrinking the back internal diameter is 1.70mm to 1.83mm; After naturally cooling to the room temperature contraction, obtain PTFE tube.
3, in the beginning of PTFE tube distal end 3mm to 5mm place, equidistantly put 3 to 6 on indicating ring by hand, the spacing between adjacent two indicating rings is 12mm to 13mm; The indicating ring width is 1.5mm to 2.0mm, and thickness is 0.1mm to 0.5mm, and the indicating ring is an annular metal; Material is platinum Pt, tungsten W, golden Au; Form by the filament coiling, or annular metal is processed (heat shrink process of back can embed the indicating ring in inner tube and the outer tube).
4, on the PTFE tube that is with the indicating ring, put the PEBAX pipe that hardness is respectively 72D, 63D, 55D by hand, distal length 90mm to 150mm adopts more softish material PEBAX 55D, and proximal length 950mm to 1000mm adopts harder material PEBAX 72D;
5, outside the PEBAX pipe, put the FEP HS 1.6:1 Heat Shrink perfluoroethylene-propylene copolymer FEP heat-shrinkable tube of U.S. ZEUS company; The hot contraction ratio of FEP is 1.6:1; Internal diameter 4mm to 4.5mm, wall thickness 0.25mm adopts the 850+ type hot-air blower doubly think special electronic tool factory; Be heated to 205 ℃ to 225 ℃ thermal contractions, carefully divest the FEP heat-shrinkable tube with blade behind the natural cooling; This step repetitive operation once.
6, the inner rod iron of sheath pipe that will peel off the FEP heat-shrinkable tube is extracted, and cut directly with blade at two ends.
7, the HP-JGC50 type semiconductor side laser marking machine that luxuriant and Mk system company limited is produced with Wuhan press circumferential 120 ° to the 60 ° uniform distribution of sheath pipe, along the sheath tubular axis on the sheath pipe, getting 3 to 6 apertures in proper order; The position at center, hole is in indicating ring far-end one side; The indicating ring is 6mm to 7mm near the distance at aperture one side and aperture center, and aperture is oval, and ellipse short shaft is 1.2mm to 1.5mm; Major axis is 8mm to 9mm; The transverse direction is along the sheath tube axis direction, aperture along the sheath tubular axis to, arrange shape in the shape of a spiral at sheath pipe outer wall.
8, at the near-end of sheath pipe with the BOY22 type injection machine injection moulding of German DR.BOY Gmbh & Co.KG company and weld the sheath pipe joint, the machine barrel temperature is 453F, injection time 50s, injection pressure 50PSI, cool time 15S, sheath control is equipped with to be accomplished; The sheath pipe joint is used the ABS resin material, and its shape can be conventional intervention apparatus shape, by prior art processing.
Two, preparation ablation catheter
1, on the K80-32-72-1K type establishment machine of U.S. Wilhelm Steeger Inc company, work out the steel wire webmaster with the stainless steel silk of diameter 0.02mm, the internal diameter of steel wire webmaster is 0.7mm to 0.8mm, and length is 1.0m to 1.1m, and density is 30 to 150PSI.
2, with the holy 35 type extruders of pacifying the plastics machinery company limited of Dongguan City; Nylon Nylon is extruded into nylon Nylon pipe, and the Nylon bore is 0.4mm to 0.5mm, and wall thickness is 0.1mm; Pipe range 1.0m to 1.1m; Screw speed: 20n/min to 50n/min is set, barrel pressure: 1500Mpa to 2000Mpa, hauling speed: 20m/s to 50m/s.
3, with 35 type extruders of the holy peace of Dongguan City plastics machinery company limited, the specification that French A Kema Arkema company is produced is the PEBAX raw material of 55D, and being extruded into hardness is the PEBAX pipe of two kinds of sizes of 55D; Internal diameter is respectively 0.6mm to 0.7mm and 0.9mm to 1.2mm; Wall thickness is 0.1mm, and pipe range is 1.0m to 1.1m, and screw speed: 20n/min to 50n/min is set; Barrel pressure: 1500Mpa to 2000Mpa, hauling speed: 20m/s to 50m/s.
4, be that the material that the Shanghai joint metal material limited company of 0.4mm to 0.6mm produces is on the stainless steel bar of 316L at external diameter; Put nylon Nylon pipe by hand; At the outer manual PEBAX pipe that internal diameter is 0.6mm to 0.7mm that puts of nylon Nylon pipe,, internal diameter puts the steel wire webmaster by hand outside being the PEBAX pipe of 0.6mm to 0.7mm; Put the PEBAX55D outer tube that internal diameter is 0.9mm to 1.2mm more by hand in the steel wire outside.
5, the manual FEP HS 1.3:1Heat Shrink FEP heat-shrinkable tube that puts U.S. ZEUS company on the PEBAX outer tube, hot contraction ratio is 1.3:1, internal diameter is 1.56mm before shrinking; Adopt the 850+ type hot-air blower doubly think special electronic tool factory that above-mentioned cover is heated to 205 ℃ to 225 ℃ thermal contractions by the PEBAX pipe of FEP pipe, treat carefully to divest the FEP pipe with blade behind the natural cooling; This step repetitive operation once.
6, the stainless steel bar core in the pipe is extracted, cut directly with blade at two ends, obtains the ablation catheter pipe shaft.
7, the external diameter 1.33mm (3.3F) that adopts platinum sharp metal material company limited in Kunming to produce; The cylinder ablating electrode of length 2mm to 4mm; Adopt the SLD-936 of Xin Lida Electron Group Co., Ltd of the Shenzhen type welding gun lead of burn-oning at the near-end of ablating electrode, lead adopts 0.35mm ± 0.01mm copper cash of 34# (RED) HPN-155 of U.S. MWS Wire Industries company.
The ablating electrode near-end that 8, will weld lead is packed in the remote stomidium of the ablation catheter pipe shaft for preparing, and lead penetrates from remote stomidium, extracts out from ablation catheter pipe shaft near-end again.
9, with soldering with wire bonds on union joint; Union joint adopts the not PAG.M0.4GL.AC52A model of (Shanghai) trade Co., Ltd of standard component thunder; LOCTITE4011 glue with happy safe Chinese adhesive company limited is bonding with union joint and ablation catheter pipe shaft near-end, and the ablation catheter preparation is accomplished.
The method for using of renal artery ablation catheter of the present invention may further comprise the steps:
One, the ablation catheter far-end is delivered in the sheath tube cavity from sheath pipe near-end.
Two, intervene operation carries out radiography to renal artery.
Three, sheath pipe and ablation catheter are delivered in the renal artery from femoral artery, confirm that through the indicating ring of radiography and sheath pipe sheath pipe far-end has reached ablation site.
Four, begin to push ablation catheter near-end union joint, the ablating electrode of ablation catheter far-end is pushed to sheath pipe aperture place, rotary guide pipe near-end union joint through sheath pipe aperture, is pushed out to ablation catheter outside the sheath pipe.
Five, observe ablating electrode near the renal artery inwall through radiography and indicating ring, expression renal artery ablation catheter has been laid and has been finished, and radiofrequency generator is electrically connected with lead; Connect the radiofrequency generator power supply; Sympathetic nerve in the renal artery is melted voltage 220V, frequency 500KHZ by near to far carrying out pointwise; Power 8W, every melts time 5S.
Six, after operation finishes, ablation catheter is withdrawn into the sheath tube cavity, withdraws from sheath pipe and ablation catheter external together again.
The sheath external diameter of pipe 2.5mm to 2.8mm that the present invention adopts can put into renal artery, and the ablation catheter external diameter is 1.0mm to 1.3mm, can stretch out outside the oval aperture of sheath pipe, renal artery inwall sympathetic nerve is carried out pointwise melt.The present invention is through femoral artery puncture and angiography; The RF ablation conduit is imported renal artery; Ablating electrode sends the sympathetic nerve of RF energy destruction domination kidney and treats hypertension, through radiography and indicating ring, can in operation process, observe the particular location that ablating electrode arrives; With accurate control ablation points, reach sympathetic nerve in the renal artery is melted the purpose of treating intractable hypertension.
Embodiment 1, and selecting the sheath external diameter of pipe for use is 2.6mm, the beginning of sheath pipe far-end 3mm place; By 4 oval apertures of circumferential 90 ° of even branches, adjacent aperture center distance is 12mm, and the elliptical aperture major axis is 8mm; Minor axis is 1.4mm, and 4 indicating rings are housed on the sheath pipe, and the indicating ring is 6mm near the distance at aperture side and aperture center; The indicating ring width is 2mm, and thickness is 0.5mm.The ablation catheter external diameter is 1.1mm, and far-end is equipped with ablating electrode, and the ablating electrode external diameter is 1.33mm, and length is 4mm.Two Canis familiaris L.s that suffer from intractable hypertension are carried out renal artery melt, body weight is respectively 30 kilograms, systolic pressure 200Kpa; Diastolic pressure 140Kpa, the renal artery internal diameter is 3.5mm, punctures through femoral artery; Under angiography, confirm the renal artery position; Under the supervision of X ray, send into seal wire, the effect of seal wire is that the guiding of sheath pipe is pushed to preset position.Can judge through the indicating ring of sheath pipe far-end whether the position is correct, recalls seal wire, ablation catheter pushed to the aperture of sheath pipe most proximal end from sheath pipe near-end; Rotation ablation catheter near-end union joint is delivered to the ablating electrode of ablation catheter far-end outside first aperture of sheath pipe most proximal end, according to the development observation place, after the affirmation position is accurate; Radiofrequency generator is electrically connected with lead, connects the radiofrequency generator power supply, and voltage is 220V; Power setting is 8W, and discharge frequency is 500KHz, and be 5S conduction time; First aperture place melt finish after, gently draw ablation catheter near-end union joint, carefully revolve again and turn 90 degrees; The ablating electrode of ablation catheter far-end is pushed into second aperture from near-end to far-end, and ablation method is the same.Melt four positions altogether.After four predeterminated positions all melt end, return to cancel and melt conduit, sheath pipe.Postoperative is dissected a Canis familiaris L., observes renal artery and melts situation, and ablation points is diameter 2mm round dot, and is high-visible, explains that sympathetic nerve fully melts in the renal artery.The blood pressure situation of another Canis familiaris L. was carried out for 1 term observe pressure value, pressure value is reduced to systolic pressure 100-64Kpa, and diastolic pressure 20-100Kpa explains that renal artery RF ablation conduit of the present invention has clinical therapeutic efficacy.
Claims (8)
1. renal artery RF ablation conduit, it is characterized in that: said renal artery RF ablation conduit is made up of the ablation catheter (2) of the sheath pipe (1) and the said sheath pipe of packing into; Said sheath pipe (1) near-end is connected with sheath pipe joint (7), and sheath pipe (1) far-end tube wall has aperture (5), and it is to be 120 ° to 60 ° along said sheath pipe (1) circumference to be uniformly distributed with, to arrange along sheath pipe (1) axial order that said aperture (5) is 3 to 6; The ablation catheter (2) of the said sheath pipe of packing into by ablation catheter pipe shaft (8), be connected ablation catheter pipe shaft (8) distal end ablating electrode (9), be connected the union joint (10) of ablation catheter pipe shaft (8) proximal end and the lead that the RF energy that radiofrequency generator produces sends ablating electrode (9) to constituted; The ablation catheter (2) of the said sheath pipe of packing into can move in sheath pipe (1) and rotate, and makes ablating electrode (9) stretch out said aperture (5); Said aperture (5) is oval, and ellipse short shaft is 1.2mm to 1.5mm, and major axis is 8mm to 9mm, and the transverse direction is along sheath pipe (1) axis direction.
2. renal artery RF ablation conduit according to claim 1; It is characterized in that: said sheath pipe (1) is by inner polytetrafluoroethyllayer layer pipe (3) and the coaxial formation that is provided with of block polyetheramides resin sheath pipe outer wall (6); Inner tube (3) internal diameter is 1.71mm to 1.83mm; External diameter is 1.78mm to 2.43mm, and sheath pipe outer wall (6) internal diameter is 2.00mm to 2.50mm, and external diameter is 2.50mm to 2.80mm.
3. renal artery RF ablation conduit according to claim 2 is characterized in that: said sheath pipe outer wall (6) distal length is 90mm to 150mm, and material is soft, and proximal length is 950mm to 1000mm, and material is harder.
4. renal artery RF ablation conduit according to claim 3; It is characterized in that: be provided with annular indicating ring (4) between sheath pipe (1) inner tube (3) of near-end one side of said aperture (5) and the sheath pipe outer wall (6); Indicating ring (4) is identical with aperture (5) number, and indicating ring (4) is 6mm to 7mm with the distance at aperture (5) center, and indicating ring (4) width is 1.5mm to 2.0mm; Thickness is 0.1mm to 0.5mm; Formed by hairspring filament winding system, or processed by annular metal, material is platinum, tungsten or gold.
5. renal artery RF ablation conduit according to claim 4; It is characterized in that: said ablation catheter pipe shaft (8) internal diameter is 0.6mm to 0.7mm; External diameter is 1.1mm to 1.3mm, and ablation catheter pipe shaft (8) is from the inside to the outside by the nylon tube of internal layer with the block polyetheramides pitch tube is compound, the stainless steel silk webmaster in middle level, outer field block polyetheramides resin outer tube are formed; The stainless steel silk diameter 0.02mm of said stainless steel silk webmaster, stainless steel cloth bore are 0.7mm to 0.8mm, and density is 30 to 150 order/square inches.
6. renal artery RF ablation conduit according to claim 5 is characterized in that: said ablating electrode (9) adopts platinumiridio solid construction or platinum and stainless steel solid structure, is external diameter 1.33mm, the cylinder of length 2mm to 4mm.
7. renal artery RF ablation conduit according to claim 6, it is characterized in that: said lead is the copper cash of diameter 0.34mm to 0.36mm, is arranged in the ablation catheter pipe shaft (8).
8. the method for preparing of a renal artery RF ablation conduit, the sheath pipe prepares respectively with the ablation catheter of the said sheath pipe of packing into, and one, preparation sheath pipe may further comprise the steps: 1, with 72D, 63D, 55D block polyetheramides resin; Be extruded into hardness and be respectively the pipe of 72D, 63D, 55D; Internal diameter is 2.0mm to 2.5mm, and external diameter is 2.5mm to 2.8mm, screw speed: 10n/min to 30n/min; Barrel pressure: 1500Mpa to 2000Mpa, hauling speed: 30m/s; 2, be on the rustless steel rod iron of 1.7mm to 1.8mm at external diameter, put polyfluortetraethylene pipe, internal diameter is 2.80mm to 3.01mm before shrinking, and is heated to 335 ℃ to 345 ℃, and shrinking the back internal diameter is 1.70mm to 1.83mm, naturally cools to room temperature and shrinks; 3, equidistantly put 3 to 6 on indicating ring in the beginning of polyfluortetraethylene pipe distal end 3mm to 5mm place; Spacing between adjacent two indicating rings is 12mm to 13mm; The indicating ring width is 1.5mm to 2.0mm, and thickness is 0.1mm to 0.5mm, and the indicating ring is formed by the filament coiling; Or process by annular metal, material is platinum, tungsten or gold; 4, on the polyfluortetraethylene pipe that is with the indicating ring, put the block polyetheramides pitch tube that hardness is respectively 72D, 63D, 55D; Distal length 90mm to 150mm adopts the block polyetheramides pitch tube of 55D, and proximal length 950mm to 1000mm adopts the block polyetheramides pitch tube of 72D; 5, outside the block polyetheramides pitch tube, put perfluoroethylene-propylene copolymer heat-shrinkable tube, hot contraction ratio is 1.6:1, internal diameter 4mm to 4.5mm, and wall thickness 0.25mm is heated to 205 ℃ to 225 ℃ thermal contractions, divests heat-shrinkable tube behind the natural cooling; 6, rod iron is extracted;
7, on the sheath pipe, get 3 to 6 apertures along the sheath tubular axis to order; Said aperture is pressed circumferential 120 ° to the 60 ° uniform distribution of sheath pipe, and the position at center, hole is in indicating ring far-end one side, and the indicating ring is 6mm to 7mm near the distance at aperture one side and aperture center; Aperture is oval; Ellipse short shaft is 1.2mm to 1.5mm, and major axis is 8mm to 9mm, and the transverse direction is along the sheath tube axis direction; 8, at the near-end of sheath pipe welding sheath pipe joint, the machine barrel temperature is 453F, injection time 50s, injection pressure 50PSI, cool time 15s, sheath control is equipped with to be accomplished; Two, the preparation ablation catheter may further comprise the steps: 1, with the stainless steel silk establishment steel wire webmaster of diameter 0.02mm, the internal diameter of steel wire webmaster is 0.7mm to 0.8mm, and length is 1.0m to 1.1m, is 30 to 150 order/square inches; 2, nylon is extruded into nylon tube, internal diameter is 0.4mm to 0.5mm, and wall thickness is 0.1mm, screw speed: 20n/min to 50n/min, barrel pressure: 1500Mpa to 2000Mpa, hauling speed: 20m/s to 50m/s; 3, with the block polyetheramides resin of 55D, be extruded into the block polyetheramides pitch tube of two kinds of sizes, internal diameter is respectively 0.6mm to 0.7mm and 0.9mm to 1.2mm; Wall thickness is 0.1mm; Screw speed: 20n/min to 50n/min, barrel pressure: 1500Mpa to 2000Mpa, hauling speed: 20m/s to 50m/s; Baking temperature: 350F to 400F, drying time: 4h; 4, be on the stainless steel bar of 0.4mm to 0.6mm at external diameter; Put nylon tube; Outside nylon tube, putting internal diameter is the block polyetheramides pitch tube of 0.6mm to 0.7mm; Outside internal diameter is the block polyetheramides pitch tube of 0.6mm to 0.7mm, put the steel wire pipe, put the block polyetheramides resin outer tube that internal diameter is 0.9mm to 1.2mm again in the steel wire outside; 5, on block polyetheramides resin outer tube, put heat-shrinkable tube, hot contraction ratio is 1.3:1, and internal diameter is 1.56mm before shrinking, and is heated to 205 ℃ to 225 ℃ thermal contractions, treats to divest heat-shrinkable tube behind the natural cooling; 6, the stainless steel bar core is extracted; 7, at external diameter 1.33mm, the cylinder ablating electrode near-end of length 2mm to the 4mm lead of burn-oning, lead adopts the copper cash of diameter 0.34mm to 0.36mm; The ablating electrode near-end that 8, will weld lead is packed in the remote stomidium of the ablation catheter pipe shaft for preparing, and lead penetrates from remote stomidium, extracts out from ablation catheter pipe shaft near-end again; 9, with wire bonds on union joint, with glue that union joint and ablation catheter pipe shaft near-end is bonding, ablation catheter preparation is accomplished.
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Address after: 518023 601, building B, Tongfang information port, No. 11, Langshan Road, songpingshan community, Xili street, Nanshan District, Shenzhen City, Guangdong Province Patentee after: Shenzhen huitai Medical Equipment Co., Ltd Address before: The comprehensive building of Tsinghua Nanshan District Keyuan Road Shenzhen city Guangdong province 518023 room 804 Patentee before: Shenzhen Huitai Medical Instrument Co., Ltd. |