Summary of the invention
The purpose of this utility model provides a kind of renal artery radio-frequency (RF) ablation conduit, and the technical problem that solve is effectively to reduce intractable hypertension patient's blood pressure.
This utility model is by the following technical solutions: a kind of renal artery radio-frequency (RF) ablation conduit, and described renal artery radio-frequency (RF) ablation conduit is made up of the ablation catheter of the sheath pipe and the sheath pipe of packing into; Described sheath pipe near-end is connected with the sheath pipe joint, and sheath pipe far-end tube wall has aperture; Described 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 radio-frequency (RF) energy that radiofrequency generator produces sends ablating electrode to constituted; Described ablation catheter can make ablating electrode stretch out aperture along moving in the sheath pipe and rotating.
Sheath pipe of the present utility model is made 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 utility model is soft, and proximal length 950mm to 1000mm is harder.
Sheath pipe far-end tube wall of the present utility model have 3 to 6 along sheath pipe circumference be 120 ° to 60 ° uniform, along the sheath tubular axis to tactic aperture.
Aperture of the present utility model 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 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 utility model and the sheath pipe outer wall, the indicating ring is identical with little hole count.
One side of the contiguous aperture side of indicating ring of the present utility model is 6mm to 7mm with the distance at aperture center, and the indicating ring width is 1.5mm to 2.0mm, and thickness is 0.1mm to 0.5mm, is formed by hairspring filament winding system, or is made by annular metal, material platinum, tungsten or gold.
Ablation catheter tube body diameter of the present utility model 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; Described 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 utility model 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 utility model is the copper cash of diameter 0.34mm to 0.36mm, is arranged in the ablation catheter pipe shaft.
Lead of the present utility model is the copper cash of diameter 0.34mm to 0.36mm, is arranged in the ablation catheter pipe shaft.
This utility model compared with prior art, adopt the sheath pipe to get involved in the renal artery, 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 by radiography and indicating, control the ablation points position, sympathetic nerve in the renal artery is melted treat intractable hypertension.
The specific embodiment
Below in conjunction with drawings and Examples this utility model is described in further detail.
As shown in Figure 1, renal artery radio-frequency (RF) ablation conduit of the present utility model is made up of theablation catheter 2 of thesheath pipe 1 and thesheath pipe 1 of packing into.
As shown in Figure 2,sheath pipe 1 is used to enter the human body renal artery, is made of polytetrafluoroethylene PTFEinner tube 3 and sheath pipeouter wall 6 coaxial settings, andsheath pipe 1 near-end is connected with sheath pipe joint 7.The coefficient of friction of PTFE is little, andinner tube 3 adopts PTFE, can guaranteeablation catheter 2 by 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 pipeouter 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 60 °apertures 5 uniform, that arrange alongsheath pipe 1 axial order alongsheath pipe 1 circumference, makeaperture 5 onsheath pipe 1 tube wall, arrange shape in the shape of a spiral,aperture 5 is oval, ellipse short shaft is 1.2mm to 1.5mm, major axis is 8mm to 9mm, the transverse direction is alongsheath pipe 1 axis direction so thatablation catheter 2 far-ends fromaperture 5 freely by and stretch out.Be provided with annular indicatingring 4 betweensheath pipe 1inner tube 3 of near-end one side of eachaperture 5 and the sheath pipeouter wall 6, be used to identify the position ofaperture 5.
In when operation,sheath pipe 1 rigidity is strong more to be reversed and pushes easily more, 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, requiresheath 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 ofsheath pipe 1 by near-end to far-end deliquescing gradually.Sheath pipeouter wall 6 materials are polymer, the far-end material is soft, the near-end material is then harder, sheath pipeouter wall 6 material selection biocompatibility are block polyetheramides resin PEBAX preferably, as French Arkema (A Kema) company, hardness is respectively the PEBAX of 72D (PEBAX 7233SN 01), 63D (PEBAX 6333SN 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.Sheathpipe 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, makesablation catheter 2 be reversed and push within it.
As shown in Figure 3,ablation catheter 2 is made of ablation catheter pipe shaft 8, the ablatingelectrode 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.
Ablation catheter 2 enterssheath pipe 1 from the near-end ofsheath pipe 1, the doctor is by the union joint 10 of rotation,promotion ablation catheter 2 near-ends, the ablatingelectrode 9 ofcontrol ablation catheter 2 far-ends rotates and it is sent to far-end, respectively to aperture 5 places ofsheath pipe 1, ablatingelectrode 9 is stretched out inaperture 5 outside thesheath pipe 1 to sympathetic supraneural ablation points, discharge, melt one by one, fully melt sympathetic nerve in the renal artery.Therefore,ablation catheter 2 needs good operating characteristics, is reversed and pushes easily, and the rear stability that puts in place is good.Ablation catheter pipe shaft 8 internal diameters are 0.6mm to 0.7mm, and external diameter is 1.1mm to 1.3mm, can push freely in theinner tube 3 of sheath pipe 1.The operation ofwhole ablation catheter 2 can pushablation catheter 2 to melting the place by the support force ofsheath pipe 1 and the frictional force ofablation catheter 2 outer walls andsheath pipe 1 inner chamber all alongsheath pipe 1 inner chamber (beinginner tube 3).Ablation catheter pipe shaft 8 from the inside to the outside by the nylon Nylon of internal layer pipe and PEBAX manage compound, the steel wire webmaster in middle level, outer field PEBAX outer tube is formed.The stainless steel cloth that steel wire adopts Hunan EPT Medical Equipment Co., Ltd. to produce, the stainless steel silk diameter is that 0.02mm, steel wire bore are 0.7mm to 0.8mm, density is 30 to 150 orders/square inch PSI.PEBAX pipe and PEBAX outer tube can be selected the material of PEBAX 55D for use, satisfy biocompatibility and reverse requirement.
Ablatingelectrode 9 is used to transmit radio-frequency (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 ablatingelectrode 9 by union joint 10 and ablation catheter pipe shaft 8, lead sends the radio-frequency (RF) energy that radiofrequency generator produces to ablatingelectrode 9, to ablatingelectrode 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, indicatingring 4 is 3 to 6, identical withaperture 5 numbers, be arranged betweeninner tube 3 and the sheath pipeouter wall 6, indicatingring 4 is positioned ataperture 5 near-ends one side, one side of indicatingring 4 contiguous aperture sides is 6mm to 7mm with the distance ataperture 5 centers, indicatingring 4 width are 1.5mm to 2.0mm, thickness is 0.1mm to 0.5mm, formed by hairspring filament winding system, also can be made by annular metal, material is selected platinum Pt, tungsten W or golden Au, the made indicating ring development effect of these three kinds of materials is superior, and the doctor can accurately be located inoperation sheath pipe 1 process.
As shown in Figure 5, the ablatingelectrode 9 ofablation catheter 2 distal ends stretches out one by one from theaperture 5 ofsheath pipe 1, andaperture 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.
Renal artery radio-frequency (RF) ablation conduit of the present utility model adopts following preparation method to obtain, and is divided into the preparation of sheath pipe and ablation catheter, may further comprise the steps:
One, preparation sheath pipe
1, adopts 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, be extruded into hardness and be respectively the PEBAX pipe of 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 PTFE HS 2: No. 15/14 PTFE tube of 1AWG Heat ShrinkThinWall 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, manual 3 to 6 on the indicating ring that equidistantly puts, spacing between adjacent two indicating rings is 12mm to 13mm, and the indicating ring width is 1.5mm to 2.0mm, and thickness is 0.1mm to 0.5mm, the indicating ring is an annular metal, material is platinum Pt, tungsten W, golden Au, form by the filament coiling, or annular metal is made (heat shrink process of back can embed the indicating ring in inner tube and the outer tube).
4, put the PEBAX pipe that hardness is respectively 72D, 63D, 55D by hand on the PTFE tube that is with the indicating ring, 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 of U.S. ZEUS company: 1Heat Shrink perfluoroethylene-propylene copolymer FEP heat-shrinkable tube, the hot contraction ratio of FEP is 1.6: 1, internal diameter 4mm to 4.5mm, wall thickness 0.25mm, adopt 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 rod iron that will peel off the sheath pipe inside of FEP heat-shrinkable tube is extracted, and cut directly with blade at two ends.
7, use the HP-JGC50 type semiconductor side laser marking machine that Wuhan is luxuriant and the Mk system company limited is produced, 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, 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, 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 German DR.BOY Gmbh ﹠amp; The BOY22 type injection machine injection moulding of Co.KG company is also welded the sheath pipe joint, and the machine barrel temperature is 453F, injection time 50s, injection pressure 50PSI, cool time 15S, sheath control is finished fully; Sheath pipe joint ABS resin material, its shape can be conventional intervention apparatus shape, by prior art processing.
Two, preparation ablation catheter
1, work out the steel wire webmaster with the stainless steel silk of diameter 0.02mm on the K80-32-72-1K type braider of U.S. Wilhelm Steeger Inc company, 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, the Nylon bore is 0.4mm to 0.5mm, 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 the holy 35 type extruders of pacifying the plastics machinery company limited of Dongguan City, the specification that French A Kema Arkema company is produced is the PEBAX raw material of 55D, 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, outside being the PEBAX pipe of 0.6mm to 0.7mm, internal diameter puts the steel wire webmaster by hand; 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 that puts U.S. ZEUS company on the PEBAX outer tube: 1Heat Shrink FEP heat-shrinkable 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.
8, during the ablating electrode near-end that will weld lead was packed the remote stomidium of the ablation catheter pipe shaft for preparing into, lead penetrated 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 finished.
Renal artery ablation catheter of the present utility model, use 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 by 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 by sheath pipe aperture, is pushed out to ablation catheter outside the sheath pipe.
Five, observe ablating electrode near the renal artery inwall by radiography and indicating ring, expression renal artery ablation catheter has been laid and has been finished, 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 this utility model adopts can put into renal artery, and the ablation catheter external diameter is 1.0mm to 1.3mm, outside the oval aperture of extended sheath pipe, renal artery inwall sympathetic nerve is carried out pointwise melt.This utility model is by femoral artery puncture and angiography, the radio-frequency (RF) ablation conduit is imported renal artery, ablating electrode sends the sympathetic nerve of radio-frequency (RF) energy destruction domination kidney and treats hypertension, by 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 for the treatment of intractable hypertension.
Embodiment 1, 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, 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 melts, 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 default position.Can judge by the indicating ring of sheath pipe far-end whether the position is correct, recall seal wire, ablation catheter is 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 confirming that the position accurately, radiofrequency generator is electrically connected with lead, connect the radiofrequency generator power supply, voltage is 220V, and power setting is 8W, and discharge frequency is 500KHz, 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, illustrates 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 illustrates that renal artery radio-frequency (RF) ablation conduit of the present utility model has clinical therapeutic efficacy.