CN102688093B - Renal artery cold saline water radio frequency ablation controllable electrode catheter - Google Patents
Renal artery cold saline water radio frequency ablation controllable electrode catheter Download PDFInfo
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- CN102688093B CN102688093B CN201210204490.8A CN201210204490A CN102688093B CN 102688093 B CN102688093 B CN 102688093B CN 201210204490 A CN201210204490 A CN 201210204490A CN 102688093 B CN102688093 B CN 102688093B
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Abstract
The invention discloses a renal artery cold saline water radio frequency ablation controllable electrode catheter, aiming at solving the technical problem that when radio frequency ablation is carried out on the sympathetic nerves on the renal artery wall, the controllable electrode catheter can reduce the damage for the inner walls of blood vessels. The far end of a catheter body is connected with an electrode head which is wound into a densely-winding spiral spring with the external diameter of 0.08-2.00mm and the length of 1.5-4mm by a platinum-iridium alloy wire or platinum-tungsten wire; and the end of the far end is in a semi-circular spherical shape. Compared with the prior art, the renal artery cold saline water radio frequency ablation controllable electrode catheter is provided with the electrode head which is wound into the densely-winding spiral spring by a platinum-iridium alloy wire or platinum-tungsten wire with the diameter of 0.005-0.3mm, so that the ablation spot is narrow and the depth is high; therefore, hypertension can be treated by the electrode head which emits radio frequency energy to damage the renal sympathetic nerves, and the minimum damage is caused to the inner walls of the renal artery vessels when the sympathetic nerves on the outer wall of the renal artery vessels are broken.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments of interventional therapy, particularly a kind of frequency ablation electrode catheter that is used for the treatment of intractable hypertension.
Background technology
Intractable hypertension is more common clinically, and paathogenic factor is numerous, and pathogenesis is indefinite, and medication effect is very poor.Medical circle thinks always, and sympathetic activation and the hypertension of kidney are in close relations.When the sympathetic nerve of kidney is overexcited, renal blood vessels is shunk, and reduces the excretion of kidney, make moisture and salt retention in vivo, promote renal secretion feritin simultaneously, caused the increase of blood Angiotensin-Converting II and aldosterone, and latter two material, the just factor of hypertension.
As can be seen here, blood pressure is mainly regulated by kidney.Nowadays the thinking of hypertension therapy is to reduce angiotensin by medicine, yet the sympathetic nerve spreading all on renal artery is also to cause hypertensive arch-criminal.If these nerves are too active, secretion feritin is too much too fast, just be enough to the effect that " payment " falls medicine blood pressure lowering.Renal artery inner membrance radio-frequency ablation procedure will be eliminated this overwrought sympathetic nerve exactly.Easy and the safety of this therapy.During treatment, doctor under image-guided, carries out radio-frequency (RF) ablation by conduit to the sympathetic nerve spreading all on renal artery tube wall, cut away partial nerve, thereby reduce the function of sympathetic nerve conducts information, renin secretion is reduced, angiotensin reduces, and finally reduces blood pressure.
When the renal artery ablation catheter of one of prior art carries out radiofrequency ablation therapy, doctor's control crank makes it the far-end stretch bending of ablation catheter fit with renal artery blood vessel wall, turn-knob on turning handle is controlled the rotation of ablation catheter far-end simultaneously, mobile ablation locations, reach at different parts and melt, conventionally when the sympathetic nerve on renal artery melts, higher power must be set and high impedance just can interrupt the sympathetic nerve of renal artery blood vessel, during radio-frequency (RF) ablation, impedance is up to 300 Ω, therefore very large to blood vessel damage.Two of prior art is to adopt the ARR ablation catheter for the treatment of to melt the sympathetic nerve on renal artery, reach treatment intractable hypertension, this kind of conduit diameter is thicker, handles inconvenient in renal artery blood vessel, and it is larger to melt area, also renal artery is caused to larger damage.
Summary of the invention
The object of this invention is to provide a kind of renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit, the technical problem that solve is, when the sympathetic nerve on renal artery tube wall is carried out to radio-frequency (RF) ablation, to reduce the damage to blood vessel.
The present invention is by the following technical solutions: a kind of renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit, be provided with catheter tube, the near-end of catheter tube is connected with control handle, the far-end of described catheter tube is connected with electrode tip, the platinumiridio silk that electrode tip is 0.005mm-0.3mm by diameter or platinum-tungsten alloys silk, turn to external diameter 0.80mm-2.00mm, long 1.5mm-4mm's is close around helical spring, and distal end is that semicircle is spherical.
Catheter tube near-end of the present invention connects the far-end of Brine Pipe, and the near-end of Brine Pipe is connected with Brine Pipe joint, and catheter tube, Brine Pipe and Brine Pipe joint sealing are connected and are interconnected.
Control handle near-end of the present invention connects cool brine joint.
The body of catheter tube of the present invention is soft by firmly tapering to from near-end to far-end hardness, when body distal length is the distal portions of 50mm-100mm and the bending of body main part, body distal portions axis is parallel with body main part axis, the distance of two axial lines is 10mm-40mm, on the body main part inwall of catheter tube, embeds and has stainless steel cloth.
In the body main part of catheter tube of the present invention, far-end is provided with becket, and far-end and the becket of controlled bracing wire steel wire are welded to connect, and the near-end of controlled bracing wire steel wire connects control handle.
The handle case near-end of control handle of the present invention has the first radial hole, in it, be inserted with bracing wire fixation with steel wire post, the bottom of bracing wire fixation with steel wire post has first through hole vertical with its axis, in handle case, in position corresponding to described the first radial hole, be provided with column handle inner core, on handle inner core, have the second radial hole, handle inner core has the second through hole along axis, bracing wire fixation with steel wire post bottom enters in the second radial hole, make the first through hole and the second through hole UNICOM, described controlled bracing wire steel wire is through the second through hole, the first through hole hole, controlled bracing wire steel wire is rotated to 1 to 4 circle around controlled fixation with steel wire post, by controlled bracing wire steel wire from end-to-end nearly tension far away.
The near-end of the push rod of control handle of the present invention inserts in the axial hole of handle case from the far-end of handle case, form vertically sliding-contact with handle case, in handle case, radially have screw, the corresponding screwhole position of push rod has elongated slot vertically, push rod stop screw screws in described screw, one section of the end of stop screw puts in elongated slot, and the elongated slot two ends on push rod have along circumferential cannelure, and cannelure has been embedded in damped ring.
Control handle near-end of the present invention is connected with adapter, and radio-frequency (RF) energy transfer wire far-end is connected to the helical spring near-end platinum wire end of electrode tip, and near-end is connected to radiofrequency generator through catheter tube, control handle and adapter.
The measuring probe of critesistor or thermocouple is set in electrode tip far-end helical spring of the present invention, and the holding wire near-end near-end of critesistor or thermocouple is connected to temperature measurer through catheter tube, control handle and adapter.
In electrode tip distal end of the present invention, be connected with safety line, the near-end of safety line is fastened on catheter tube near-end; Described safety line adopts stainless steel round wire or flat filament, long 850mm-1100mm, and circle silk external diameter is 0.01mm, flat filament area of section is 0.0000785mm2, in its far-end electrode insertion head; Described safety line safety line far-end joint steel pipe; steel pipe far-end stretches out electrode tip far-end; the material of steel pipe is Nitinol, platinumiridio or rustless steel; external diameter is 0.46mm-0.71mm; internal diameter is 0.36mm-0.61mm; stretching out long is 2mm-10mm; the distal end of steel pipe is welded with little ball; external diameter is 0.50mm-0.80mm; the steel pipe that stretches out electrode tip far-end is equipped with protecting film outward; the material of protecting film is block polyetheramides or polyurethane, block polyetheramides PEBAX 2533 or PEBAX 3533, and polyurethane is PU80AE or PU70AE.
The present invention compared with prior art, the platinumiridio silk that electrode tip is 0.005mm-0.3mm by diameter or platinum-tungsten alloys silk, turning to external diameter is the close around helical spring of 0.80mm-2mm, the catheter tube of radio-frequency (RF) ablation connects Brine Pipe, the cool brine passing into during operation carries out cooling to renal artery blood vessel, make to melt speckle very narrow, the degree of depth is large, therefore, the radio-frequency (RF) energy that electrode tip sends is destroyed the sympathetic nerve of domination kidney and is treated hypertension, in the orthosympathetic while of interrupting renal artery vessel outer wall, the damage that renal artery blood vessel is caused is minimum.
Accompanying drawing explanation
Fig. 1 is the structural representation of renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit of the present invention.
Fig. 2 is the schematic diagram of renal artery cool brine radio-frequency (RF) ablation controllable electrodes distal end of catheter case of bending of the present invention.
Fig. 3 is pipe structure schematic diagram of the present invention.
Fig. 4 is the left view of Fig. 3.
Fig. 5 is the distal portions structural representation () of renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit of the present invention.
Fig. 6 is the A partial enlarged drawing in Fig. 5.
Fig. 7 is the B partial enlarged drawing in Fig. 5.
Fig. 8 is the structural representation of control crank.
Fig. 9 is the cutaway view of handle case.
Figure 10 is that Fig. 9 is left view.
Figure 11 is the cutaway view of push rod.
Figure 12 is the left view of Figure 11.
Figure 13 is the A-A profile of Figure 11.
Figure 14 is the B-B profile of Figure 11.
Figure 15 is the front view of stop screw.
Figure 16 is the left view of Figure 15.
Figure 17 is the front view of bracing wire fixation with steel wire post.
Figure 18 is the left view of Figure 17.
Figure 19 is the top view of Figure 17.
Figure 20 is the front view of handle inner core.
Figure 21 is the left view of Figure 20.
Figure 22 is the top view of Figure 20.
Figure 23 is the installation diagram of body of the present invention and control handle.
Figure 24 is the distal portions structural representation (two) of renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit of the present invention.
The specific embodiment
Below in conjunction with drawings and Examples, structure of the present invention is described in further detail.
As shown in Figure 1, renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit 10 of the present invention, from far-end to near-end, is linked in sequence by electrode tip 11, catheter tube 12, control handle 13, and control handle 13 near-ends are connected with adapter 14 and cool brine joint 19.
As shown in Figure 3 and Figure 4, the long 850mm-1100mm of catheter tube 12, external diameter 1.67mm-2.33mm, internal diameter 1.50mm-2.10mm, by the first plastic tube 121, the second plastic tube 122, the 3rd plastic tube 123 and the 4th plastic tube 124 connect and compose body from near-end to far-end, the first plastic tube 121, the second plastic tube 122, the 3rd plastic tube 123 and the 4th plastic tube 124 adopt respectively macromolecule tubing polyurethane or block polyetheramides PEBAX plastic tube, it is 72D that the detailed trade mark of material is respectively PEBAX 7233(hardness), PEBAX 6333(hardness is 63D), PEBAX 6333(hardness is 63D) and PEBAX 5533(hardness be 55D), caliber is 2.00mm-2.33mm, the body forming is soft by firmly tapering to from near-end to far-end hardness.As shown in Figures 2 and 3, the distal portions that body distal length is 50mm-150mm and body main part can bend, and during bending, body distal portions axis is parallel with body main part axis, and the distance of two axial lines is 5mm-40mm.
On body main part inwall, embed and have stainless steel cloth 127, stainless steel cloth 127 adopts the stainless steel silk that string diameter is 0.01mm-0.05mm, is woven into the stainless steel cloth of every square millimeter of node 10-100.Because body adopts from near-end to far-end hardness by firmly tapering to soft macromolecule tubing and stainless steel cloth 127, make body there is good propelling movement and moment of torsion transmits performance, and it is injured to protect distal vessels to avoid.
In body main part, be provided with polytetrafluoroethylene PTFE bracing wire steel wire sheath 126, bracing wire steel wire sheath 126 long 850mm-1100mm, external diameter 0.30mm-0.50mm, internal diameter 0.25mm-0.45mm.In bracing wire steel wire sheath 126, be provided with controlled bracing wire steel wire 125, the long 850mm-1100mm of controlled bracing wire steel wire 125, string diameter 0.25mm-0.45mm.In body main part, far-end is provided with becket 128, and becket 128 adopts platinumiridio (platinum 90%, iridium 10%), external diameter 2.00mm-2.33mm, internal diameter 1.90mm-2.13mm, thick 0.1mm-0.2mm.As shown in Figure 6, the far-end of controlled bracing wire steel wire 125 and becket 128 are welded to connect.
While making catheter tube 12, adopt polytetrafluoroethylene PTFE rod 129 as plug, PTFE rod 129 long 1000mm-1500mm, external diameter is 1.50mm-2.10mm.First controlled bracing wire steel wire 125 is passed to the hole of bracing wire steel wire sheath 126, far-end is solder-connected on becket 128 by the method for silver-colored stannum soldering, then stainless steel cloth 127 is enclosed within on bracing wire steel wire sheath 126 and PTFE tube 129, again by near-end to far-end by the first plastic tube 121, the second plastic tube 122, the 3rd plastic tube 123 and the 4th plastic tube 124 are enclosed within on stainless steel cloth 127 successively, adopt hot rheological molding (hot-fluid change) method by the first plastic tube 121, the second plastic tube 122, the 3rd plastic tube 123 and the 4th plastic tube 124 become one with stainless steel cloth 127 hot-fluids, be made into body, technological parameter is heating-up temperature 350F-450F, speed is 0.5cm/s-1.0cm/s.In body after hot-fluid becomes, there is bracing wire steel wire sheath 126 and PTFE tube 129, because the thermostability of polyurethane or block polyetheramides PEBAX and politef is different, make bracing wire steel wire sheath 126 and PTFE tube 129 and the first plastic tube 121, the second plastic tube 122, the 3rd plastic tube 123 and the 4th plastic tube 124 can adhesion.From near-end is extracted PTFE tube 129, as shown in Figure 4, on body, leave a manhole 12-1, this through hole is as the passage of radio-frequency (RF) energy transfer wire 16, critesistor or thermocouple 17, safety line 18 and Brine Pipe 191.After body completes, becket 128 is enclosed among the plastic material of body, forms one with plastic material.
As shown in Fig. 5, Fig. 6 and Fig. 7, radio-frequency (RF) energy transfer wire 16, critesistor or thermocouple 17, safety line 18 are arranged in catheter tube 12.The far-end connection electrode of catheter tube 12 11, electrode tip 11 is connected with the safe medical grade glue of pleasure of happy safe (China) company limited of catheter tube 12 use medical grade.The platinumiridio silk that electrode tip 11 is 0.005mm-0.3mm by diameter or platinum-tungsten alloys silk, turn to external diameter 0.80mm-2.00mm, long 1.5mm-4mm's is close around helical spring, the distal end of electrode tip 11 is the platinum piece that semicircle is spherical, has the blind hole (inclined hole) of inclination in the plane in semicircle is spherical.
Radio-frequency (RF) energy transfer wire 16 adopts copper enamel-covered wire, external diameter 0.005mm-0.008mm, and its far-end is connected to the helical spring near-end platinum wire end of electrode tip 11 by silver-colored stannum method for welding, and near-end stretches out from catheter tube 12 near-ends.
The measuring probe of critesistor or thermocouple 17 is arranged in electrode tip 11 far-end helical springs, during making, the probe of critesistor or thermocouple 17 is packed in the inclined hole of electrode tip 11, and fill inclined hole space with happy safe medical grade glue, probe is bonded on electrode tip 11 distal end inwalls by glue, and the holding wire near-end of critesistor or thermocouple 17 stretches out from catheter tube 12 near-ends.
Safety line 18 adopts stainless steel round wire or flat filament, long 850mm-1100mm, circle silk external diameter is 0.01mm, flat filament area of section is 0.0000785mm2, in its far-end electrode insertion head 11, by argon arc welding or Laser Welding method, be solder-connected in electrode tip 11 distal ends, the near-end of safety line 18 stretches out from catheter tube 12 near-ends, be fastened on catheter tube 12 near-ends, for preventing that electrode tip 11 from use coming off.
Make after catheter tube 12, the near-end of radio-frequency (RF) energy transfer wire 16, critesistor or thermocouple 17, safety line 18 is inserted to the through hole 12-1 of catheter tube 12 from the far-end of catheter tube 12, from the near-end of catheter tube 12, pass.The near-end of electrode tip 11 is connected by the method that hot-fluid becomes with the far-end of catheter tube 12, and the equipment of employing is the hot bulb-tubulating machine of BS-50 of Shenzhen Xin Shuanke Industrial Co., Ltd., and technological parameter is heating-up temperature 350F-450F, and be 5S-10S heat time heating time.The 4th plastic tube 124 covers the platinum helical spring of proximal length 2-3mm, and electrode tip 11 is firmly connected together with catheter tube 12.
As shown in Figure 7, the near-end of security thread 18 is wrapped in after the near-end of catheter tube 12, by the method that hot-fluid becomes, it is connected as one with catheter tube 12 securely, can prevent that electrode tip 11 from falling in human vas from catheter tube 12 far-end accidental.Technological parameter is heating-up temperature 350F-450F, and speed is 0.5cm/s-1.0cm/s.
As shown in Figure 8, the near-end of the push rod 131 of control handle 13 inserts in the axial hole of handle case 132 from the far-end of handle case 132, coaxial with handle case 132, and forms vertically sliding-contact with handle case 132.In handle case 132, radially have screw 1321, the corresponding screw of push rod 131 1321 positions have elongated slot 1311 vertically, push rod stop screw 133 screws in after described screw 1321, one section of the end of stop screw 133 puts in elongated slot 1311, the axial location in the time of can limiting push rod 131 and slide along handle case 132.Elongated slot 1311 two ends on push rod 131 have along circumferential cannelure 1312, and cannelure 1312 has been embedded in damped ring 136, and push rod 131 is fixed in handle case 132.Handle case 132 near-ends have the first radial hole 1322, for radially inserting outside to inside bracing wire fixation with steel wire post 134 from handle case 132 along handle case 132.The bottom of bracing wire fixation with steel wire post 134 has first through hole 1342 vertical with its axis.In handle case 132, be provided with handle inner core 135 in the position of described the first radial hole 1322 correspondences, handle inner core 135 is column, coaxially arrange with handle case 132, have the second radial hole 1352 on handle inner core 135, handle inner core 135 has the second through hole 1353 along axis.Handle inner core 135 from near-end pack into handle case 132 interior, bracing wire fixation with steel wire post 134 packs into from the first radial hole 1322, its underpart enters in the second radial hole 1352, makes the first through hole 1342 and the second through hole 1353 UNICOMs, both axis coaxles are in line.
As shown in Figure 9 and Figure 10, handle case 132 adopts acetal resin, for cylindric, along axis, has four coaxial, the different through holes of diameter, and the aperture in the hole of each near-end one side is greater than the aperture in the hole that its far-end is adjacent.
As shown in Figure 11, Figure 12, Figure 13 and Figure 14, push rod 131 is cylindric, adopts acetal resin, along cylindric axis, has two coaxial, the different through holes of diameter, and the aperture of proximal end is less than the aperture in the hole of far-end.It is trapezoidal annular protrusion 1313 that the outer rim of near-end one side is extended with cross section for one week, facilitates doctor to operate and promotes, in push rod 131 processes, with hands, directly to hold trapezoidal protruding 1313 parts, just can promote push rod 131 and move axially.The middle part outer rim of push rod 131 has elongated slot 1311 vertically, and the two ends of elongated slot 1311 have along circumferential cannelure 1312.
As shown in Figure 15 and Figure 16, stop screw 133 adopts rustless steel, and screw thread is M3, long 3.5mm-4.0mm, hexagonal in adopting.
As shown in Figure 17, Figure 18 and Figure 19, bracing wire fixation with steel wire post 134 adopts rustless steel, be shaped as column, bracing wire fixation with steel wire post 134 one end end accessories have first through hole 1342 vertical with its axis, bracing wire fixation with steel wire post 134 other end end faces have the one one word groove 1341, instrument easy to use when assembling.
As shown in Figure 20, Figure 21 and Figure 22, handle inner core 135 adopts acetal resin, be shaped as column, handle inner core 135 has the second through hole 1353 along its axis, handle inner core 135 one end end faces have the 21 word groove, instrument easy to use while being used for assembling, handle inner core has the second radial hole 1352 near 135 other end ends, on the post edge relative with the second radial hole 1352, along axis, has groove 1351.
As shown in figure 23, the near-end of catheter tube 12 puts in the through hole of push rod 131 far-ends of control handle 13, bonding with happy safe medical grade glue in the junction of push rod 131 distal portion and catheter tube 12 outer rims, and catheter tube 12 and push rod 131 are fixed as one.Cannelure 1321 is embedded in damped ring 136.Catheter tube 12 near-ends are connected with happy safe medical grade glue sealing with the far-end of a Brine Pipe 191, and Brine Pipe 191 adopts polyurethane or block polyether acyl PEBAX, external diameter 2.00mm-2.33mm, internal diameter 1.50mm-1.8mm, long 10mm-25mm.Handle inner core 135 is packed into handle case 132 from near-end, and bracing wire fixation with steel wire post 134 inserts the second radial hole 1352 of handle inner core 135 from the first radial hole 1322 of handle case 132.The near-end of push rod 131 is inserted in the through hole of handle case 132 far-ends, radio-frequency (RF) energy transfer wire 16, critesistor or thermocouple 17, Brine Pipe 191 pass from the hole of handle case 132 far-ends by the groove 1351 of handle inner core 135, stretch out outside control handle 13.The second through hole 1353 by controlled bracing wire steel wire 125 through handle inner core 135, and pass by the first through hole 1342 holes of controlled fixation with steel wire post 134.With screwdriver, insert in the one one word groove 1341 of controlled fixation with steel wire post 134, rotate controlled fixation with steel wire post 134 by controlled bracing wire steel wire 125 around controlled fixation with steel wire post 134 rotation 1 to 4 circles, thereby by controlled bracing wire steel wire 125 from end-to-end nearly tension far away.On the screw 1321 of handle case 132, screw in stop screw 133, put in the elongated slot 1311 of push rod 131, make push rod 131 can only in handle case 132, carry out moving axially of limited travel.
The near-end of radio-frequency (RF) energy transfer wire 16, critesistor or thermocouple 17 is connected to adapter 14, then be connected via wires to radiofrequency generator, temperature measurer by adapter 14.Near-end at Brine Pipe 191 is connected with Brine Pipe joint 19, catheter tube 12, Brine Pipe 191 and Brine Pipe joint 19 are tightly connected and are interconnected, make the cool brine entering through Brine Pipe joint 19, Brine Pipe 191, catheter tube 12 can arrive electrode tip 11, the gap between helical spring two turns of platinum of electrode tip 11, flow out.
The 10 pin Connection Blocks that adapter 14 adopts Lei Mo trade (Shanghai) Co., Ltd. to sell.Brine Pipe joint 19 adopts the female Luer 100:1 of standard.
As shown in figure 24, another frame mode of electrode tip 11, safety line far-end joint steel pipe 8, steel pipe 8 far-ends stretch out electrode tip 11 far-ends, the material of steel pipe 8 is Nitinol, platinumiridio or rustless steel, the external diameter of steel pipe 8 is 0.46mm-0.71mm, internal diameter is 0.36mm-0.61mm, stretching out long is 2mm-10mm, the distal end Laser Welding of steel pipe 8 is connected to a little ball, the external diameter of little ball is 0.50mm-0.80mm, stretch out the outer protecting film 9 that is equipped with of steel pipe 8 of electrode tip 11 far-ends, the material of protecting film 9 is polyurethane or block polyetheramides PEBAX, block polyetheramides PEBAX is that PEBAX 2533(hardness is 25D) or PEBAX 3533(hardness be 35D), polyurethane is PU80AE or PU70AE.Close winding spring far-end is bonding is connected for the near-end of protecting film 9 and electrode tip 11.
As shown in Figure 2, when doctor performs the operation, grasp handle case 132, to far-end, promote push rod 131, because the length of controlled bracing wire steel wire 125 is fixed, therefore push rod 131 carries out moving axially of limited travel in handle case 132, thereby the far-end of catheter tube 12 will be occured bending and deformation.To near-end, retract push rod 131, the far-end of catheter tube 12 is returned to original state, and the far-end of catheter tube 12 recovers to stretch.
During operation technique, the guiding catheter by renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit 10 of the present invention by prior art is inserted in renal artery blood vessel from the femoral artery of operator, and adapter 14 is connected to upper radiofrequency generator, and cool brine joint 19 connects brine pump.Hold handle case 132, to far-end, push push rod 131, the far-end of renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit 10 produces case of bending as shown in Figure 2, and platinum helical spring electrode tip 11 is close to renal artery wall.Now starting radiofrequency generator and brine pump discharges and melts renal artery blood vessel wall.After this point melts, to near-end, pull catheter tube 12 certain distances and rotate to an angle and again renal artery blood vessel wall is discharged and melted, repeat, after above process three to four times, the sympathetic nerve along renal artery blood vessel wall to be interrupted, thereby reach the object for the treatment of intractable hypertension.
Saline is the sodium chloride normal saline of health check-up concentration 0.9%, the osmotic pressure value of normal saline and normal person's blood plasma, tissue fluid are all much the same, can not reduce and increase Na ion concentration in normal human, so can pass into normal saline as fluid infusion during operation, as cooling electric cartridge 11 with by ablation points.
Experiment in vitro
(1), experiment material
Smart beef, the Sal of one one jin heavy left and right.
(2), experimental facilities
The IBI(Irvine Biomedical Inc. of U.S. Ai Er gulf Biomedicines, Inc.) T5000 type radiofrequency generator is one, one of the HH-2 type constant temperature water bath of Shanghai Mei Xiang Instrument Ltd., one of the BT100-2J type peristaltic pump of Baoding LanGe constant flow pump Co., Ltd, one, renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit of the present invention, the diameter 2.00mm of electrode tip.
(3), experimental technique
1, in constant temperature water bath, add water, add Sal in water, making saline health check-up concentration is 0.9%, simulate blood.Start constant temperature water bath power supply, water is heated to 37 ℃.
2, beef is put into constant temperature water bath, the adapter of renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit of the present invention is connected to radiofrequency generator, salt water swivel connects cool brine, starts peristaltic pump to pouring into cool brine in conductive pipe, and saline flows out from the helical spring gap of platinum of electrode tip.
3, the electrode tip of conduit 11 is close to beef surface, starts radiofrequency generator electric discharge and melt.
Set radiofrequency generator power 4W, 40 ℃ of temperature, impedance 300 Ω, 10 ablation points, every melts 120 seconds time, and 5 revs/min of peristaltic pump rotating speeds, utilize brine-cooled, practical impedance 127 Ω, depth of ablation reaches 2.558mm, and beef is melted, and experiment parameter is in Table 1.
(4), experimental result
Default 40 ℃, melt time 120s, reach preset temperature, be 15s average time, average actual power is 4W, on average melts area and is: 7.3mm * 5mm=36.5mm2, mean depth: 4.5mm.In ablation procedure, programming rate is fast, and actual power changes within the scope of 2-3W.Evidence: renal artery cool brine radio-frequency (RF) ablation controllable electrodes catheter ablation process stabilization of the present invention, can produce effective ablation lesions.Brine Pipe and peristaltic pump are connected, start peristaltic pump, take rotating speed in 10 revs/min of speed irrigating catheter bodys; Respectively peristaltic pump is arranged on to 5 revs/min of rotating speeds, 1 rev/min, by electrode tip, in being close to test beef, observing radiofrequency generator displays temperature is 36 ℃, closes peristaltic pump again, and radiofrequency generator displays temperature is 37 ℃, confirms that critesistor or thermocouple monitoring temperature are normal.Start radiofrequency generator, peristaltic pump is arranged on 5 revs/min of rotating speeds, starts to melt test, records ablation parameters.Traveling electrode head, changes radiofrequency generator parameter setting, and startup radiofrequency generator carries out second point and melts test.Repeat above process, until complete total Test.Test complete face width and the length of measuring under the microscope and record zone of ablation, then along the centrage that melts speckle, cut open, measure and record depth of ablation.Pass into the actual power of the frequency ablation electrode catheter after saline and compare and want high approximately 2.5 times with not passing into saline, depth of ablation is wanted dark approximately 2 times.In ablation procedure, programming rate is fast, and actual power changes within the scope of 1-2W.Evidence: renal artery cool brine radio-frequency (RF) ablation controllable electrodes catheter ablation process stabilization of the present invention, radio frequency is even, can produce effective ablation lesions, and the surface of beef has no obvious damage.
Apply renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit of the present invention and carry out renal artery and melt, can interrupt the sympathetic nerve being attached on renal artery vessel outer wall, reach the object for the treatment of intractable hypertension.Meanwhile, injury renal artery blood vessel being caused is less.
Table 1 beef surface radio-frequency (RF) ablation experiment parameter.
Claims (8)
1. a renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit, be provided with catheter tube (12), the near-end of catheter tube (12) is connected with control handle (13), it is characterized in that: the far-end of described catheter tube (12) is connected with electrode tip (11), the platinumiridio silk that electrode tip (11) is 0.005mm-0.3mm by diameter or platinum-tungsten alloys silk, turn to external diameter 0.80mm-2.00mm, long 1.5mm-4mm's is close around helical spring, and distal end is that semicircle is spherical, in the body main part of described catheter tube (12), far-end is provided with becket (128), the far-end of controlled bracing wire steel wire (125) and becket (128) are welded to connect, and the near-end of controlled bracing wire steel wire (125) connects control handle (13), handle case (132) near-end of described control handle (13) has the first radial hole (1322), in it, be inserted with bracing wire fixation with steel wire post (134), the bottom of bracing wire fixation with steel wire post (134) has first through hole (1342) vertical with its axis, in handle case (132), the position corresponding at described the first radial hole (1322) is provided with column handle inner core (135), on handle inner core (135), have the second radial hole (1352), handle inner core (135) has the second through hole (1353) along axis, bracing wire fixation with steel wire post (134) bottom enters in the second radial hole (1352), make the first through hole (1342) and the second through hole (1353) UNICOM, described controlled bracing wire steel wire (125) is through the second through hole (1353), the first through hole (1342) hole, controlled bracing wire steel wire (125) is rotated to 1 to 4 circle around controlled fixation with steel wire post (134), by controlled bracing wire steel wire (125) from end-to-end nearly tension far away.
2. renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit according to claim 1, it is characterized in that: described catheter tube (12) near-end connects the far-end of Brine Pipe (191), the near-end of Brine Pipe (191) is connected with Brine Pipe joint (19), and catheter tube (12), Brine Pipe (191) and Brine Pipe joint (19) are tightly connected and are interconnected.
3. renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit according to claim 2, is characterized in that: described control handle (13) near-end connects cool brine joint (19).
4. renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit according to claim 1, it is characterized in that: the body of described catheter tube (12) is soft by firmly tapering to from near-end to far-end hardness, when body distal length is the distal portions of 50mm-100mm and the bending of body main part, body distal portions axis is parallel with body main part axis, the distance of two axial lines is 10mm-40mm, on the body main part inwall of catheter tube (12), embeds and has stainless steel cloth (127).
5. renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit according to claim 1, it is characterized in that: the near-end of the push rod (131) of described control handle (13) inserts in the axial hole of handle case (132) from the far-end of handle case (132), form vertically sliding-contact with handle case (132), in handle case (132), radially have screw (1321), the corresponding screw of push rod (131) (1321) position has elongated slot (1311) vertically, push rod stop screw (133) screws in described screw (1321), one section of the end of stop screw (133) puts in elongated slot (1311), elongated slot (1311) two ends on push rod (131) have along circumferential cannelure (1312), cannelure (1312) has been embedded in damped ring (136).
6. renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit according to claim 1, it is characterized in that: described control handle (13) near-end is connected with adapter (14), radio-frequency (RF) energy transfer wire (16) far-end is connected to the helical spring near-end platinum wire end of electrode tip (11), and near-end is connected to radiofrequency generator through catheter tube (12), control handle (13) and adapter (14).
7. renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit according to claim 6, it is characterized in that: the measuring probe of critesistor or thermocouple (17) is set in described electrode tip (11) far-end helical spring, and the holding wire near-end of critesistor or thermocouple (17) is connected to temperature measurer through catheter tube (12), control handle (13) and adapter (14).
8. renal artery cool brine radio-frequency (RF) ablation controllable electrodes conduit according to claim 1, it is characterized in that: in described electrode tip (11) distal end, be connected with safety line (18), the near-end of safety line (18) is fastened on catheter tube (12) near-end, described safety line (18) adopts stainless steel round wire or flat filament, long 850mm-1100mm, and circle silk external diameter is 0.01mm, flat filament area of section is 0.0000785mm2, in its far-end electrode insertion head (11), described safety line (18) far-end joint steel pipe (8), steel pipe (8) far-end stretches out electrode tip (11) far-end, the material of steel pipe (8) is Nitinol, platinumiridio or rustless steel, external diameter is 0.46mm-0.71mm, internal diameter is 0.36mm-0.61mm, stretching out long is 2mm-10mm, the distal end of steel pipe (8) is welded with little ball, external diameter is 0.50mm-0.80mm, stretch out the outer protecting film (9) that is equipped with of steel pipe (8) of electrode tip (11) far-end, the material of protecting film (9) is block polyetheramides or polyurethane, block polyetheramides is PEBAX 2533 or PEBAX 3533, polyurethane is PU80AE or PU70AE.
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Address after: 518057 601, building B, Tongfang information port, No. 11, songpingshan Langshan Road, songpingshan community, Xili street, Nanshan District, Shenzhen City, Guangdong Province Patentee after: Shenzhen huitai Medical Equipment Co., Ltd Address before: 518057, Guangdong, Baoan District, Guanlan Road, Shenzhen, Guanlan Road, Fu Industrial Park, A7 building, 2 floor Patentee before: Shenzhen Huitai Medical Instrument Co., Ltd. |