CN207075928U - A kind of coronary artery radio-frequency ablation device - Google Patents

Abstract

The utility model discloses a kind of coronary artery radio-frequency ablation device, including the radio frequency output loop electrode, RF ablation device, radio frequency output connecting cable, attachment means and radio-frequency power carrier, the radio frequency output loop electrode that are sequentially connected in series are tabular.Radio frequency damage device of the present utility model can carry out effective closure occlusion, to ensure that the normal blood flow of heart coronaries circulation irrigates, real-time, convenient punishment hemorrhage complication to coronary artery blood vessel/blood flow traffic of exception.

Description

A kind of coronary artery radio-frequency ablation device

Technical field

This patent is related to medicine and hygiene fieldses intervention heart disease Clinics category, is penetrated more particularly to a kind of coronary artery Frequency damages device, for clinical practice minimally invasive heart interventional technique.

Background technology

Normal myocardium and pathology cardiac muscle are required to enough blood supplies and maintain it to be metabolized and function, and clinical reconstruction/recovery The coronary artery blood supply of ischemic myocardium is using the technologies such as PTCA, PCI, CABG, the hat related to selective occlusion " focus cardiac muscle " Shape arterial bifurcation vessel, i.e. " target vessel damage " technology, it is two important converse reasons in treatment coronary heart disease The category of thought.The former, as PCI (percutaneous coronary intervention) be also known as coronary artery (it is narrow, close The reconstruction of blood vessel is filled in, such as：Coronary artery bracket is inserted) intervention operation, refer to：Percutaneous puncture, it is sent into guiding catheter to coronary artery and opens At mouthful, with special transmission system, support is sent to coronary lesions position, then release is placed into, and recovers vessel lumen And blood flow passes through, to realize that Transcatheter technology dredges narrow or even inaccessible coronary artery tube chamber, so as to recover or change The treatment method of the blood perfusion of mercy flesh.The operation has the advantages that short treating period, wound are small, evident in efficacy.Develop in recent years Rapidly and reach its maturity, as the main application technology of clinical coronary heart disease interventional cardiac procedures.And the latter, it is above-mentioned It is selective, with controlling is inaccessible, damages pathologic coronary arterial tree blood vessel on the basis of transport path technology, block Its blood supply or related the focus blood vessel and myocardial blood flow of abnormal vascular canal, do not reach with the former (reconstruction vascular flow) completely not Together, or even antipodal heart intervention treating purpose.

In recent years, it is fast through internal membrane of heart catheter ablation although in the case where advanced CARTO and INSAI three-dimensional electrolysis cuts open mapping guidance Fast arrhythmia cordis (such as room is flutterred, atrial fibrillation, room speed) achieves preferable clinical efficacy, but still has some patientss deep because of locular wall focus Hide/or the chambers of the heart in moving complex anatomy (such as：Papillary muscle, chordae tendineae, valve, cedductor, trabecular muscles, lacuna, flesh ridge etc.), Ablation catheter be often difficult to accurately in place with stably recline, cause clinical practice and curative effect by a definite limitation.It is and coronal through conduit Intra-arterial targeting mapping positioning and physics, chemical ablation, controllability damage the external membrane of heart and middle layer segment locular wall focus cardiac muscle group Knit (such as：Hypertrophic cardiomyopathy, hold left room room speed of speed etc.), wherein, chemical ablation agent-ethanol, because of the non-boundary between its tissue Infiltration, cause the technology to be difficult to accurate control and metering and be discharged into lesion tissue scope, not guilty myocardial damage may be caused, caused Serious adverse consequences, it is more difficult to reach expected therapeutic purposes.In addition, some abnormal coronary artery blood vessel/blood flow traffic are (such as：It is coronal dynamic Arteries and veins fistula, small-sized PDA, PCI microvascular bleeding complication etc.), the effective closure occlusion of progress of still needing, to ensure that heart coronaries circulate Normal blood flow perfusion, real-time, convenient punishment hemorrhage complication.

Utility model content

The purpose of this utility model is, there is provided a kind of coronary artery radio-frequency ablation device, can be to the coronary blood of exception Pipe/blood flow traffic carries out effective closure occlusion, to ensure that the normal blood flow of heart coronaries circulation irrigates, real-time, convenient punishment Hemorrhage complication.

In order to solve the above technical problems, the utility model adopts the following technical scheme that：

For the realistic situation of intervention cardiac procedures technology at present, selectivity occlusion disease is needed in being applied with reference to clinical practice The actual knotty problem of the related coronary arterial tree of stove-i.e. processing " target vessel ", innovative it can use modern Cardiac interventional Coronary artery, cardiac electrophysiology mapping and each autocorrelation technique principle of RF ablation in field, proposition coronary artery-cardiac electrophysiology- " hybridization " complex treatment of RF ablation " integration is theoretical, designed, designed exploitation, improvement serial equipment, establishes a kind of to heart Section focus blood vessel/cardiac muscular tissue, carry out Local physical/chemically brand-new mapping location technology in target lesion position, and passing through Train of radio frequency energy carrier gatherer, fuel factor Therapeutic mode is melted with AC sine wave power radio-frequency, to heart focal zone Implement optional, controllability targeting to damage, safely and effectively realize that lesion cardiac muscle/blood vessel is implemented to position and damage, achieve Preferable clinical intervention treatment effect.

The equipment of the RF ablation fuel factor Therapeutic mode needs：A kind of coronary artery radio-frequency ablation device, including Radio frequency output loop electrode, RF ablation device, radio frequency output connecting cable, attachment means and the radio-frequency power being sequentially connected in series carry Body, the radio frequency output loop electrode are tabular.

In a kind of foregoing coronary artery radio-frequency ablation device, the attachment means include be sequentially connected in series connector, lead Line and adjuster, connector are ODU-10 core sockets.

In a kind of foregoing coronary artery radio-frequency ablation device, the radio-frequency power carrier includes radio-frequency ablation seal wire, led Silk sheath and seal wire cap end, radio-frequency ablation seal wire are located in guide wire sheaths, the softness tip of radio-frequency ablation seal wire and seal wire cap end It is connected, guide wire sheaths are metal spring sheath.The advantages of guide wire sheaths of such a structure, is that being readily available good tip touches Feel feedback, the X ray reaction visuality of seal wire is well.Importantly, RF energy is mainly by soft tip, core bar Between section and near-end push section core steel wire, by compact wound thereon rheme put outside bare metal turn sheath send out Put.Therefore metal elastic spring coil turns into this technology granting most direct news media's material of heat radiofrequency.The great advantage of this design is： The ecg signal acquiring quality that this seal wire is arrived with monopole cardiac diagnosis lead linkage record can be not only substantially improved, and can obviously reduce The resistance transmitted between radio-frequency main and transmitting media.

In a kind of foregoing coronary artery radio-frequency ablation device, the radio-frequency ablation seal wire includes soft tip, core bar Interlude and near-end push section, core bar interlude one end are connected with soft tip, and the other end is connected with near-end push section；Near-end The diameter for pushing section is more than the diameter of core bar interlude, and the diameter of core bar interlude is more than the diameter at soft tip.It is soft Tip is relatively more soft, can produce larger deformation, and it is the coronary artery that seal wire cap end is imported to patient that it, which is acted on, when soft When soft tip produces deformation, the body that will not be exchanged brings injury.Core bar interlude flexible relative tip have compared with Strong support force, its main function exactly push at soft tip at sufferer；The main function of the near-end push section is to push away Core bar interlude is sent, near-end push section is external always situated in patient when in use.Among the soft tip, core bar The making material of section and near-end push section is siliceous steel wire, and the siliceous steel wire refers to that one layer of steel wire outer surface cladding is siliceous Film, it is the artery that prevents metal from directly contacting patient that it, which is acted on, will not be occurred after the arterial contact of siliceous film and patient It is quick to wait adverse reaction；Meanwhile siliceous film also acts as the effect of insulation, the heating part of seal wire is set to be limited in soft tip, from And improve the accuracy of radio frequency damage.The phosphorus content of the siliceous steel wire is less than or equal to 0.23%, and is more than or equal to 0.18%.The phosphorus content of siliceous steel wire determines the hardness of steel wire, the siliceous steel wire in this patent need to extend into change it is dynamic In arteries and veins, so its hardness is relatively low, detected through many experiments, phosphorus content is that 0.18%-0.23% siliceous steel wire can Suitable for the patient in all ages and classes stage, phosphorus content is too high, can cause siliceous steel wire excessive high hardness, easily pierces through and changes artery, Bring serious consequence；Phosphorus content is too low, causes siliceous steel wire easily to deform upon, and is not easy to recover deformation, is unfavorable for equipment Reuse.

In a kind of foregoing coronary artery radio-frequency ablation device, the soft tip, near-end push section and seal wire cap end are equal With insulating coating, the outer layer of insulating coating has hydrophilic coating.Core bar interlude, guide wire sheaths are in naked state, purport " target spot " good contact is damaged with the ablation determined with low-resistance state of value realizing, realizes that only " target spot " position receives RF energy Heat cure effect.

In a kind of foregoing coronary artery radio-frequency ablation device, core bar interlude includes changeover portion, and changeover portion is located at core Core bar interlude is connected close to the one end at soft tip, changeover portion with soft tip, and changeover portion is streamlined.It is specifically, soft Tip, core bar interlude and near-end push section are streamlined as an entirety.It is described as one of which embodiment The radius span at soft tip is 3 millimeters to 4 millimeters.The radius at soft tip directly affects radio frequency in surgical procedure and damaged Accuracy, verified through a large amount of clinical trials, span is that 3 millimeters to 4 millimeters of soft tip can be applied to not the same year The patient of age grade section, and can get a desired effect.

Specific clinical practice is exemplified below.

First, it is coronal dynamic with heat radiofrequency occlusion deformity by " coronary artery-cardiac electrophysiology-RF ablation " hybridization technique Arteries and veins fistula blood vessel, eliminate fistula blood vessel steal blood, steal press, can thorough improvement affected area the normal blood supply of coronary artery.

Secondly, with " hybridization technique " and equipment, with heat radiofrequency amount occlusion septal hypertrophy cardiomyopathy septal branch Vasa vasorum, cause ischemic necrosis, the fibrosis of left ventricular outflow tract view interventricular septum region hypertrophic cardiomyopathy, left room stream is mitigated or eliminated Engage in this profession obstruction.

Again, transexocardial approach is marked to electricity-chemistry (locally stoping jumping perfusion) in coronary artery branch vessels at different levels Position is determined, the associated feeder blood vessel of the Ventricular Tachycardia ectopic rhythm focus in ventricle wall can be specified, and with heat radiofrequency Amount, occlusion damage the related supply blood vessel of tachycardia focus, realize and terminate ventricular tachycardia attack.

Finally, with the more extensive uses of the retrograde seal wire technologies of difficult CTO-PCI, caused micro- blood during micro-wire is advanced Manage damaging hemorrhage complication to be difficult to avoid that, generally stopped blooding with turn occlusion.This technology can do not need to increase special equipment with During technology, radio-frequency ablation electrode seal wire is sent into along the former microtubular at bleeding, with the broken of heat radiofrequency amount inaccessible capilary rapidly Bleeding is split, avoids pericardial tamponade.

Therefore, using cardiac electrophysiology Mapping of the present utility model, by radio-frequency energy vector introduction device, with radio frequency Correlation theory-technology-equipment for power heat energy is melted, choosing can in real time, safely, effectively be implemented to the segmental changes of heart Selecting property, controlling, limitation are damaged；With reference to other correlation technique equipment and theoretical further exploratory development, will further open up Wide and perfect intervention diagnosis and therapy theory, technology and the treatment level for being related to coronary artery correlation heart disease.

Compared with prior art, radio frequency damage device of the present utility model can be to coronary artery blood vessel/blood flow traffic of exception Effective closure occlusion is carried out, to ensure that the normal blood flow of heart coronaries circulation irrigates, real-time, convenient punishment hemorrhage complication. The radio frequency damage seal wire that the present apparatus is used includes soft tip, core bar interlude and near-end push section, its making material and adopted With siliceous steel wire, carbon content rate is relatively low, so the material dc resistivity is relatively low, and the material is compared with common stainless steel Material, there is more preferable maneuverability and tracing property.The soft point diameter of seal wire is minimum, and overall streamlined, adds The flexibility of seal wire, it is especially suitable for distorting, in order to which seal wire can smoothly reach target vessel, then carries out radio-frequency ablation.

Brief description of the drawings

Fig. 1 is a kind of structural representation of embodiment of seal wire of the present utility model；

Fig. 2 is a kind of structural representation of embodiment of radio-frequency power carrier；

Fig. 3 is the operation principle schematic diagram of radio-frequency ablation device；

Fig. 4 is a kind of structural representation of embodiment of attachment means.

Reference：1- near-ends push section, and 2- core bar interludes, 3- changeover portions, 4- is soft sophisticated, 5- guide wire sheaths, 6- seal wire caps end, 7- radio frequency output loop electrodes, 8- RF ablation devices, 9- radio frequencies output connecting cable, 10- attachment means, 11- Radio-frequency power carrier, 12- connectors, 13- wires, 14- adjusters, 15- radio-frequency ablation seal wires.

The utility model is further described with reference to the accompanying drawings and detailed description.

Embodiment

Embodiment 1 of the present utility model：As shown in Figure 3 and Figure 4, a kind of coronary artery radio-frequency ablation device, including successively Radio frequency output loop electrode 7, RF ablation device 8, radio frequency output connecting cable 9, attachment means 10 and the radio-frequency power of series connection carry Body 11, the radio frequency output loop electrode 7 are tabular.The attachment means 10 include connector 12, the wire 13 being sequentially connected in series With adjuster 14, connector 12 is ODU-10 core sockets.

Embodiment 2：As shown in Figure 2, Figure 3 and Figure 4, a kind of coronary artery radio-frequency ablation device, including what is be sequentially connected in series are penetrated Frequency output loop electrode 7, RF ablation device 8, radio frequency output connecting cable 9, attachment means 10 and radio-frequency power carrier 11, it is described Radio frequency output loop electrode 7 is tabular.The attachment means 10 include connector 12, wire 13 and the adjuster being sequentially connected in series 14, connector 12 is ODU-10 core sockets.

The radio-frequency power carrier 11 includes radio-frequency ablation seal wire 15, guide wire sheaths 5 and seal wire cap end 6, and radio-frequency ablation is led Silk 15 is in guide wire sheaths 5, and the softness tip 4 of radio-frequency ablation seal wire 15 is connected with seal wire cap end 6, and guide wire sheaths 5 are metal Spring protecting sleeve.

Embodiment 3：As shown in Figure 3 and Figure 4, a kind of coronary artery radio-frequency ablation device, including the radio frequency being sequentially connected in series are defeated Go out loop electrode 7, RF ablation device 8, radio frequency output connecting cable 9, attachment means 10 and radio-frequency power carrier 11, the radio frequency Output loop electrode 7 is tabular.The attachment means 10 include connector 12, wire 13 and the adjuster 14 being sequentially connected in series, even It is ODU-10 core sockets to connect device 12.

As shown in Fig. 2 the radio-frequency power carrier 11 includes radio-frequency ablation seal wire 15, guide wire sheaths 5 and seal wire cap end 6, Radio-frequency ablation seal wire 15 is located in guide wire sheaths 5, and the softness tip 4 of radio-frequency ablation seal wire 15 is connected with seal wire cap end 6, seal wire shield Set 5 is metal spring sheath.

As shown in figure 1, the radio-frequency ablation seal wire 15 includes soft tip 4, core bar interlude 2 and near-end push section 1, The one end of core bar interlude 2 is connected with soft tip 4, and the other end is connected with near-end push section 1；The diameter of near-end push section 1 is big In the diameter of core bar interlude 2, the diameter of core bar interlude 2 is more than the diameter at soft tip 4.Core bar interlude 2 wraps Changeover portion 3 is included, changeover portion 3 is located at core bar interlude 2 and is connected close to the one end at soft tip 4, changeover portion 3 with soft tip 4, Changeover portion 3 is streamlined.Soft tip 4, core bar interlude 2 and near-end push section 1 are streamlined as an entirety.It is described The radius span at soft tip 4 is 3 millimeters to 4 millimeters.The soft tip 4, near-end push section 1 and seal wire cap end 6 are equal With insulating coating, the outer layer of insulating coating has hydrophilic coating.

As shown in figure 1, radio-frequency ablation seal wire in a kind of coronary artery, including soft tip 4, core bar interlude 2 and near End push section 1, the one end of core bar interlude 2 are connected with soft tip 4, and the other end is connected with near-end push section 1；Near-end pushes section 1 diameter is more than the diameter of core bar interlude 2, and the diameter of core bar interlude 2 is more than the diameter at soft tip 4；It is described soft Soft sophisticated 4, core bar interlude 2 and the making material of near-end push section 1 are siliceous steel wires, the phosphorus content of the siliceous steel wire Equal to 0.21%.Core bar interlude 2 includes changeover portion 3, and changeover portion 3 is located at core bar interlude 2 close to the one of soft tip 4 End, changeover portion 3 are connected with soft tip 4, and changeover portion 3 is streamlined.Soft tip 4, core bar interlude 2 and near-end push section 1 is streamlined as an entirety.The radius value at the soft tip 4 is 3.5 millimeters.

As shown in Fig. 2 radio frequency in radio-frequency power carrier in a kind of coronary artery, including a kind of above-described coronary artery Seal wire is damaged, in addition to guide wire sheaths 5 and seal wire cap end 6, radio-frequency ablation seal wire are located in guide wire sheaths 5, radio-frequency ablation seal wire Softness tip 4 be connected with seal wire cap end 6, guide wire sheaths 5 are metal spring sheath.The soft tip 4, near-end push section 1 Insulating coating is respectively provided with seal wire cap end 6, the outer layer of insulating coating has hydrophilic coating.

As shown in figure 3, a kind of coronary artery radio-frequency ablation device, including be sequentially connected in series radio frequency output loop electrode 7, penetrate Radio-frequency power carrier 11 described in frequency ablation device 8, radio frequency output connecting cable 9, attachment means 10 and claim 5 or 6, it is described Radio frequency output loop electrode 7 is tabular.As shown in figure 4, the attachment means 10 include connector 12, the wire 13 being sequentially connected in series With adjuster 14, connector 12 is ODU-10 core sockets.

For damage occlusion radio frequency produced by radiofrequency melting instrument, radio frequency refer to frequency 300kHz~1000kHz it Between non-modulation sine wave.Radio-frequency current to the heat effect of tissue is realized by electric field.The utility model implements electric field Line metal elastic spring coil of charge carrier electrode seal wire head end out of coronary artery is sent, and the charged ion acted in tissue, is allowed to Move and with tissue mediators frictional heat.The temperature of local organization, determined by disperse heat production with heat loss through convection, heat loss through convection is main Caused by blood circulation.Once local temperature reaches 50 DEG C and last for several seconds, you can causes the irreversible damage of tissue.Therefore generally Damage range will be considered as in 50 DEG C of thermoisopleths, the thermoisopleth is above 50 DEG C with the temperature of inner tissue in theory.But it is worth strong Adjust, radio-frequency current energy of the present utility model exports carrier guidewire electrode, due to seal wire diameter and electrode head end only 0.07mm, it is technically difficult to realize in its guidewire electrode side or header terminal design temperature sensor.Therefore, in standing state Under, the utility model technology is only with the non-temperature control of radio frequency, i.e. power radio-frequency mode of operation.

In addition, the connection of the radiofrequency melting instrument and human body of the utility model technology uses unipolar lead connected mode, that is, adopt Use unipolar discharge.Radiofrequency melting instrument output is connected with two wires with human body, wherein one is exported by radio-frequency current energy and carried Body electrode seal wire enters the position internal, the clinical needs of arrival melt, and is referred to as " procedures electrode " (active electrode)；Separately One is connected with plate electrode (15cm*8cm), and its plate body closely pastes to touch with skin to be connected, and is referred to as " neutral electrode " (dispersive electrode).Two wires form radio frequency current circuit by tissue.Due to guidewire electrode surface Product very little, surrounding electric field intensity is big, can organize fuel factor effect to local；And skin tabular electrode area is big, to part Tissue does not produce heat effect.Human body is a part for radio frequency current circuit, and procedures electrode and neutral electrode are the biographies of electric current Approach is led, but because procedures electrode area is smaller, its surrounding electric field intensity is stronger, thus obvious heat can be produced to local organization Effect, make histocyte coagulation necrosis.Neutral electrode does not produce heat effect because area is larger, to local organization.

In addition to electrode or tissue temperature, monitoring impedance also has important to evaluation radio-frequency current to the damaging action of tissue Value.Impedance is relevant with the contact interface of electrode seal wire head end and tissue.As tissue is heated, impedance declines.When temperature liter It is high to a certain extent when, impedance can increase again, and due to albumen quick solidification, conductivity reduction, impedance can rise to high level. In order to avoid the carbonized effect caused by radio frequency as far as possible, in the radiofrequency ablation procedures for implementing this technology, monitoring resistance closely The scope of anti-value, to instructing and controlling RF ablation to have great importance.Fig. 1 is that the radio frequency of the utility model Technology design disappears Melt instrument guidance panel explanation.

The radiofrequency melting instrument basic technology index of the utility model Technology design is as follows.

Main carrier frequency rate：460kHz±20kHz

Working method：Power Control, temperature control (including temperature-sensitive, thermocouple)

Control mode：Manual control mode, floor push control mode

Power output scope：0W~75W, stepping 1W

Design temperature scope：45 DEG C~90 DEG C, stepping is 1 DEG C

Detection temperature scope：35 DEG C~90 DEG C, error ± 5 DEG C

Temperature entry condition：32 DEG C~42 DEG C

Impedance display scope：The Ω of 0 Ω~500

Radio frequency provides timing range：0-200sec

Low-resistance protection setting scope：40Ω-80Ω

High resistant protection setting scope：100Ω-500Ω

Safety standard meets 1 class CF types, has the protection of anti-defibrillation

In the present embodiment, 1. radiofrequency melting instrument：The part that the equipment needs to connect is mainly penetrating for radiofrequency melting instrument panel Frequency output interface, including：Adopt international standards general heart radiofrequency melting instrument connector, i.e., the German core socket of Ou Du (ODU) 10. Next to that the back electrode interface of radiofrequency melting instrument panel, universal card of also adopting international standards, i.e. ODU-3 cores socket.

2. radio frequency exports connecting cable：Plug-in unit selects ODU-10 core plugs, connects with radiofrequency melting instrument power output interface. Its tail end is ODU-10 core plugs, no colour circle, is connected with the handle socket of radio frequency output carrier seal wire connecting device.Its connecting line Design of length is 200cm.

3. attachment means：The near-end of the attachment means uses radio frequency handle shape connector, and its connector is also ODU-10 cores Socket；Remote interface inserts secured adjusted device using the guiding seal wire of coronary artery technology.It proximally and distally passes through the soft gold of multiply Belong to lead anchor weldering linking, the gangway for transhipment of structure radio frequency output carrier seal wire.Its length is arranged to 32cm.

4. radio-frequency power carrier：Its tail end is connected with the adjuster of radio-frequency current output carrier seal wire attachment means.True Determine RF ablation target spot Path Setup, and be implanted into the state of microtubular, place the target position that the electrode seal wire extremely melts, RF energy is provided, is finally reached the purpose of damage/closure coronary artery blood vessel.

Clinical operation step：

S001, by heart coronary artery intervention diagnosis and therapy and the routine operation of radio-frequency ablation procedure, body surface cardiac diagnosis lead is connected, is had Pressure detecting, RF ablation back electrode are created, oxygen uptake, infusion channel is established, routine disinfection, is plated in.

S002, row femoral artery or radial artery puncturing blood vessel, Access artery sheath, and inject the anti-Hemostatic Oral Liquid of appropriate heparin and coagulate Gu.

S003, it is optimal to coronary opening, multi-angle position row coronarography, selection to be sent into angiography catheter through arterial sheath X-ray projection angle (external), the related coronary artery of abundant lesions showed, select and determine to need the target vessel punished.

S004, suitable each model guiding catheter is changed, circumferentially guiding catheter is delivered to coronary ostium by artery, then It is sent into and is easily entered at guiding wire to the target lesion blood vessel of lesion relevant blood vessel through the guiding catheter.

S005, it is sent into through guiding wire at preselected microtubular or OTW foley's tubes to target lesion blood vessel, plans to implement ablation The optimal site of damage.After completing microtubular or OTW foley's tubes being placed on defined location, the guiding wire is taken out, And by having placed appropriate microtubular or OTW sacculus, it is sent into ecg signal acquiring in coronary artery/radio-frequency current output and carries Body seal wire, and it is slight push this radio-frequency electrode seal wire forward, send out microtubular head end about 5~8mm, seal wire front end is preferably in " J or U " type loops are curved, to increase the contact area of metal elastic spring coil exposed outside seal wire and lesion vesselses wall, and reduce penetrate as far as possible The contact impedance of frequency electrode seal wire and endangium (Ω of ＜ 450), to improve " damaging occlusion " curative effect.

S006, branch vessel proximal balloon is filled with low pressure and implements pre- closure, blocks the forward direction blood of target lesion blood vessel completely Flow (about 20~30min), during real-time continuous close observation bloodstream blocking, conditions of patients is (such as：Pectoralgia, uncomfortable in chest, invasive blood pressure pressure Power, cardiac monitoring, including the rhythm and pace of moving things, heart rate, ST sections and T ripples, arrhythmia cordis etc.) etc. change, if patient is without discomfort, electrocardiology, blood Hydromechanics normal table, then illustrate that the branch vessel belongs to the insignificant physiology supply vesselses of heart/cardiac muscle, you can further essence Really head end form and the position of radio-frequency ablation seal wire are implemented in adjustment, determine to implement the standard of radio-frequency ablation lesion vesselses as needed It is standby.

S007, the radio-frequency electrode seal wire end at target lesion blood vessel, the output of insertion radio-frequency energy and granting will be inserted In the seal wire adjuster of RF carrier seal wire connecting device.Meanwhile the output end of radiofrequency generator is determined again, if be adapted to radio frequency Coupling arrangement has been reliably connected.

S008, confirm that the impedance window on radiofrequency melting instrument panel has carrier-free impedance numerical monitor, and impedance numeral should In the range of radiofrequency melting instrument allows granting energy (100-500 Ω), further micro-adjustment radio-frequency electrode seal wire is otherwise needed In the position of " target spot ".After finally lesion vesselses ablation " target spot " is confirmed, you can technology and equipment of the present utility model is used, Prepare to implement super-selective, controlling, limitation RF ablation damage " target " lesion.

S009, when radio frequency seal wire and endangium contact impedance are in 450 below Ω, implement RF ablation and damage electric discharge, Radio frequency delivered power is 10~30 joules, and continuous discharging time is within 30 seconds.According to lesion damage condition can multiple discharge, until Lesion vesselses damage occlusion completely.

S010, after RF ablation damage operation terminates, continue close observation patient symptom and every Testing index 10~30 Minute, if without exception, 100~200ug of intracoronary injection nitroglycerins, it is coronal dynamic to repeat each related position at once then Arteries and veins radiography, lesion target vessel occlusion condition is checked again.

Case one：Inaccessible relevant blood vessel perforation bleeding in PCI arts

With the progress of CTO interventional therapeutic techniques, obtained extensively by PCI forward direction/or retrograde revascularization techniques Clinical practice, hence it is evident that improve the success rate for opening CTO lesion vesselses.Before seal wire, microtubular in art or microballoon capsule warp to/or Inversely (side shoot capilary) is CTO-PCI focus technology link by Occlusion.However, perforation, blood vessel during PCI The complication such as Rupture haemorrhag, happen occasionally.The methods of clinical conventional processing method is mostly using turn, plugging device at present. Its shortcoming is, material price costliness long with respect to operating time, especially in the fine branch vessel bleeding of processing coronary artery, to use bullet Spring coil, plugging device technology are even more to be difficult to success.We are expert in PCI operations, stage casing near to the collateral blood vessels caused by seal wire occurs In the case of distal section vascular puncture, Rupture haemorrhag enter cavum pericardiale in even, set using " radio-frequency ablation technology in coronary artery " and its correlation It is standby, quick blocking bleeding vessel, realize that preferable target vessel controlling damages occlusion at once, i.e.,：Effectively hemostasis.Hereafter, then pass through Other blood vessel smoothly completes follow-up infraction revascularization and support is inserted.Patient safety, smoothly complete whole operations.

Case two：Damage continuation expansion incarceration support sacculus in coronary artery

In the recent period, my Heart center is to a Patients With Myocardial Infarction row LAD-CSTO lesion PCI stent endoprosthesis, trans-radial 6F-XB guiding catheters are sent into, PILOT-50 seal wires pass through LAD lesions to distal end, Boston Scientifc-1.2* 15mm/2.5*15mm balloon pre-dilation lesion vesselses, smoothly it is sent into and positions Excel-2.5*36mm DES (made in China) support is in lesion blood vessel, and 8atm normal expansion supports, expanding stent form is good, the sacculus of negative pressure pumpback at once.Can It is because of the deformation of support sacculus outer tube distal section, the fully closed plug in central (sacculus) hole time, after causing the expansion of support sacculus malleation to discharge, negative pressure Suction balloon deflation is invalid (in that can not enter " flap valve shape "), and dilatation balloon (2.5*36mm) continues incarceration in LAD supports, passes through Exit sacculus using a variety of urgent Treating technologies (puncture, damage, aspirating), retraction not yet in effect repeatedly, i.e., can not through sacculus Effectively take out flat (retraction attenuates), can not by it is damaged exit it is external, to making sacculus in the full state of continuation expansion, Incarceration is up to 3 hours before Endovascular, complete blocking to perfusion blood flow.In this case, through fully being informed with patient, family members After next step Treatment Scheme is exchanged, patient refuses surgery open chest surgery intervention, agree to using technology of the present utility model and its Relevant device, implement sacculus radio-frequency ablation technology in percutaneous (non-to open chest) coronary artery, succeed in several minutes, safely, conveniently lead to Radio frequency output electrode seal wire of the present utility model is crossed, damages the incarceration sacculus in expansion state, it is at once that foley's tube is complete Smoothly exit in vitro, and smoothly complete follow-up PCI operations.

Attached clinical data：Male patient, 61 years old, old MI.ECG：V1-3 pathologic blocks Q ripples, and troponin is normal. CAG：The tortuous Calcified CSTO in the nearly stage casings of LAD (chronic subtotal occlusion) lesion, PCI routinely control by intervention at once Treat.Above-mentioned equipment complication occurs in art, therebetween, by the conventional urgent Treatment Methods of intervention of PCI sacculus incarcerations complication：Pressure Pump depth negative pressure reverse redoubling is persistently aspirated and (taken out flat), TERUMO-FINECROSS (1.8Fr) microtubular guiding Conquest pro- Superhard straight/elbow (30-600) the seal wire sacculus of 16/Proprss 120 punctures technology etc. and not proved effective retraction sacculus, and sacculus is still held Continuous full incarceration.

Use RF ablation skill materials and methods in percutaneous coronary of the present utility model：Deep slotting 6F-XB3.5 (Cordis) guiding catheter surpasses selection and is sent into Runthrough NS seal wires to LADm mount proximal end balls to LAD openings (protection LM) Nang Chu, protectiveness (insulation) microtubular TERUMO-FINECROSS (1.8Fr) is sent into support balloon proximal along seal wire, exchanges this Radio frequency output electrode seal wire-REW Zcy of utility model technology, deliver to balloon proximal and damage point, its seal wire head end surmounts micro- lead Pipe end mouth and the 3-4mm that lifts one's head, it is accurately positioned in micro- tortuous shape and is posted by proximal balloon " damage target spot ".REW Zcy are last in vitro End connects radio frequency output connecting cable and radio frequency output carrier seal wire connecting device of the present utility model, and defeated with radiofrequency melting instrument Outgoing interface connects；Back electrode plate is placed in patient back.Impedance 228 (＜ 500) Ω is detected, sets RF power output 20W, the heart Electricity/pressure monitoring is normal, discharges RF electric currents, discharge time 5s through PTRFD systems at once, and balloon proximal ruptures rapidly, that is, sees and fill The incarceration sacculus (contrast agent) that the is full of progressive disappearance of voluntarily shrinking back in distal end certainly, which is safety then, smoothly withdraws support foley's tube goes out in vitro； And follow-up PCI operation is continued to complete, avoid the surgery open chest surgery intervention caused by PCI mediation complication and CABG.It is postoperative right Incarceration support foley's tube inspection:The deformation of support sacculus outer tube distal section is in flat, and distal balloon catheter entirely shuts with central stomidium. Foley's tube RF seal wires, which are damaged, to recline a little in balloon proximal centrum shoulder, and it is in black deeply worried shape about 2.5mm to deform, remaining run without Abnormal damage, middle distal section sacculus are normal.

Conclusion：The case is right using sacculus radio-frequency ablation technology in super-selective percutaneous coronary of the present utility model Proximal end " target spot " sacculus of expansion incarceration sacculus is implemented voluntarily sunken and take out technology after controlling radio-frequency ablation, is a kind of peace Entirely, effectively, easily can be selected method.

Case three：Super-selective damages inaccessible " congenital coronary artery fistula " blood vessel

The utility model technology and its relevant device premenstruum (premenstrua) zoopery, confirming radio frequency seal wire occluding coronary arteries side On the basis of method security and validity, first Application is in clinical occluding coronary arteries fistula (CAF) blood vessel.Concrete condition is：Through Coronarography (CAG) is diagnosed as the patient of two CAF blood vessels, and percutaneous catheter is made in coronary artery fistula openings in blood vessels near-end Temporary transient balloon occluder, RF energy occlusion near-end fistula blood vessel is provided with radio frequency output electrode seal wire.As a result, two fistula openings in blood vessels The successful occlusion of near-end, clinical myocardinal ischemia disappear, no complication, and follow-up without leading to again after two weeks.

Attached clinical case：Patient women, 66 years old, labor angina 2 years, January is aggravated, doubt and examine " coronary heart disease " and accept for medical treatment.Body Inspection finds that L3-4 news II/VI levels diastole flow murmur, resting electrocardiogram are normal, under exercise electrocardiogram STV4-6 mild cerebral ischemics Move.The left front side wall segmental diastole bulge of left ventriculography, LVEF 0.65.Selective coronary arteriography (CAG) is shown in Left main artery Shorter, descending anterior branch opening and near-end distinguish visible two hooks blood vessels, a diameter of 2.0,2.3 millimeters, are moved to front upper right OK, sinuous tortuous, random branch, mutually coiling such as ring-type, whole last open section are irregularly expanded, and terminal blood flow gushes in smoke-like Enter main pulmonary artery and disperse to left and right pulmonary artery.In descending anterior branch, distal section vascular distribution and tube wall it is normal, tube chamber is relatively fine, blood flow Full delay.Each chamber of right cardiac catheterization, big vascular pressure are normal, and main pulmonary artery blood oxygen slightly increases (Po241.5), with blood Oxygen determination method calculates systemic blood flow (Qs：2.87L/min) and pulmonary circulation blood flow amount (Qp：3.41L/min), its from left to right point Flow is 0.54L/min.Surgical material and method：Calcification score equipment used is U.S. Johnson Company.Row damage is closed " congenital coronary artery fistula " vascular technique is filled in, it is defeated using radio frequency output electrode seal wire (REW-Zcy) of the present utility model, radio frequency Go out connecting cable, radio frequency output carrier seal wire connecting device and radiofrequency melting instrument.Operation is first with over-expense support (Extra Support) guiding catheter XB 3.5, arteria coroaria sinistra opening is inserted, is successively sent into Tip supersoft and through conduit Extra backup wire seal wires, to two fistula blood vessel loops distal end.It is sent into the pre- bolts of Microballoon sacculus row PTCA to block up, radiography Confirm fistula blood vessel distal end no blood, continuous observation electrocardiogram, blood pressure and symptom 10 minutes, confirm the blood vessel without related myocardium and rise After conducting system blood supply function of fighting, through seal wire exchange send microtubular/foley's tube (over-the-wire) enter fistula openings in blood vessels with At remote 10mm, radio frequency output electrode seal wire of the present utility model is slowly sent into by external microtubular port, and go out microtubular stomidium Up to the intravascular 10-20mm of fistula, it is connected by being adapted to attachment means with radiofrequency generator, blocking blood flow state is filled in micro- balloon expandable Under, to implementing radio frequency discharge at the fistula blood vessel of radio frequency output electrode seal wire placement.An internal discharge power is 20-30W, is put Electric 5-20s of time, after discharging 2-4 times repeatedly, the slight push-and-pull seal wire, seemingly there is " adhesion " sense, this performance as fistula blood vessel is " icarceration " seal wire is levied, and take out confirms that fistula openings in blood vessels with remote nonvisualization, repeats to make after 10 minutes after flat sacculus through Guiding radiographies Shadow, each position radiography are shown after PTRFC is treated, and at two 2-3mm of fistula blood vessel loop opening, lumen of vessels occlusion is in " undesirable root shape ", Pass through without residual blood stream.In, distal section fistula blood vessel loop nonvisualization, Left main artery, descending anterior branch, Circumflex branch development are normal, no Left main artery and Descending anterior branch opening inner film injury shows.Leave hospital within postoperative 3 days.Coronarography check has no fistula revascularization after 2 weeks.

Conclusion:This case is using sacculus radio-frequency ablation technology in super-selective percutaneous coronary, occluding coronary arteries fistula The means of blood vessel, it is a kind of interventional therapy method for safely, effectively closing abnormal coronary artery blood vessel, there is further investigation and face Bed application value.

The utility model clinical so far will be carried out extensively first, but relatively independent Cardiac interventional technology and its correlation are set It is standby, including coronary artery PTCA, PCI, CABG technology and equipment；Cardiac electrophysiology detection technique and equipment；Heart radio frequency ablation Technology and equipment is organically integrated, and is established theoretical with coronary artery-cardiac electrophysiology-RF ablation-" hybridization technique " Based on, serial equipment necessary to radio-frequency ablation technique in utility model percutaneous coronary, while establish percutaneous hat The more complete clinical method of shape intra-arterial radio-frequency ablation technique.The core of the utility model technical equipment is coronary artery Interior ecg signal acquiring/radio frequency output electrode seal wire (Radiofrenquency Electrode Wire, REW-Zcy), and Around it, a whole set of the transitional attachment means being connected with radiofrequency melting instrument.The utility model is set in development and utility model On the basis of meter, the practical problem in the work of clinical intervention of combining closely cardiology, the innovative exploration " coronary artery-heart " hybridization " technology of dirty electro physiology-RF ablation " framework, by basis and animal experiment study, realizes coronal dynamic with theoretical Electrophysiological mapping in arteries and veins branch section, and controlling and limitation implement RF ablation damage to focus blood vessel, obtain clinical Research and the good result of application.

Claims (8)

1. A kind of 1. coronary artery radio-frequency ablation device, it is characterised in that including be sequentially connected in series radio frequency output loop electrode (7), RF ablation device (8), radio frequency output connecting cable (9), attachment means (10) and radio-frequency power carrier (11), the radio frequency output Loop electrode (7) is tabular.
2. A kind of 2. coronary artery radio-frequency ablation device according to claim 1, it is characterised in that the attachment means (10) Including the connector (12), wire (13) and adjuster (14) being sequentially connected in series, connector (12) is ODU-10 core sockets.
3. A kind of 3. coronary artery radio-frequency ablation device according to claim 1 or 2, it is characterised in that the radio-frequency power Carrier (11) includes radio-frequency ablation seal wire (15), guide wire sheaths (5) and seal wire cap end (6), and radio-frequency ablation seal wire (15), which is located at, leads In silk sheath (5), the softness sophisticated (4) of radio-frequency ablation seal wire (15) is connected with seal wire cap end (6), and guide wire sheaths (5) are metal Spring protecting sleeve.
4. A kind of 4. coronary artery radio-frequency ablation device according to claim 3, it is characterised in that the radio-frequency ablation seal wire (15) soft sophisticated (4), core bar interlude (2) and near-end push section (1), core bar interlude (2) one end and softness are included Sophisticated (4) are connected, and the other end is connected with near-end push section (1)；The diameter of near-end push section (1) is more than core bar interlude (2) Diameter, the diameter of core bar interlude (2) is more than the diameter of soft sophisticated (4).
5. A kind of 5. coronary artery radio-frequency ablation device according to claim 4, it is characterised in that soft sophisticated (4), Near-end push section (1) and seal wire cap end (6) are respectively provided with insulating coating, and the outer layer of insulating coating has hydrophilic coating.
6. A kind of 6. coronary artery radio-frequency ablation device according to claim 5, it is characterised in that core bar interlude (2) Including changeover portion (3), changeover portion (3) is located at core bar interlude (2) close to the one end of soft sophisticated (4), changeover portion (3) and soft Soft tip (4) is connected, and changeover portion (3) is streamlined.
7. 7. a kind of coronary artery radio-frequency ablation device according to claim 6, it is characterised in that soft tip (4), core Bar interlude (2) and near-end push section (1) are streamlined as an entirety.
8. 8. a kind of coronary artery radio-frequency ablation device according to claim 7, it is characterised in that soft sophisticated (4) Radius span be 3 millimeters to 4 millimeters.