CN103767787B - For neural RF ablation method and the radio frequency ablation system melting - Google Patents
For neural RF ablation method and the radio frequency ablation system melting Download PDFInfo
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Abstract
The invention provides a kind of RF ablation method and radio frequency ablation system melting for nerve. Wherein, radio frequency ablation system comprises that central authorities process and control module, the radio frequency release module being attached thereto respectively, volume impedance measurement module, temperature monitoring module and warning and autostore module. Central authorities process and control module, for generating guide parameters; For according to the monitoring result of volume impedance measurement module and temperature monitoring module, radio frequency release module is controlled simultaneously; Volume impedance measurement module, for measuring the volume impedance of target tissue, for location and the judgement of radio frequency damage degree of target tissue provide foundation; Temperature monitoring module, for Real-Time Monitoring target tissue temperature around, prevents the excessive damage of target tube chamber; Report to the police and automatic storage module, for the comprehensive signal of analyzing from monitoring modular, to exceeding situation and the alarm of default secure threshold, and for parameter that ablation procedure is used and information automatic arranging and the storage of collection.
Description
Technical field
The present invention relates to a kind of RF ablation method, relate in particular to one and there is guide parameters and prisonThe RF ablation method of survey means relates to corresponding radio frequency ablation system simultaneously, belongs to Medical treatment deviceTool technical field.
Background technology
In generation, differentiation and the evolution of numerous disease, neuro vegetatively extremely playThe key factor of important function. As, kidney sympathetic nerve, the excessive enhancing of its activity is in many diseasesIn disease, there is important effect: as intractable hypertension, chronic cardiac insufficiency, renal function notCarbohydrate metabolism disturbance, Stein-Leventhal syndrome etc. entirely. And for example vagal be overexcited disappearingImpact in change road ulcer is also for medical circle is paid close attention to for a long time and studies, and Vagotomy canTo reduce the secretion of hydrochloric acid in gastric juice. For another example, although the pathogenesis of asthma is still completely not clear and definite so far,But there is ample evidence to show that vegetative nerve obstacle is the key factor that development occurs asthma.
Just there is scholar to adopt surgical resection art treatment intractable hypertension as far back as the middle of last centuryTrial, although this resection at first due to concurrent serious complication usually and abandoned,But these clinical testings have also shown the potential therapeutic value to the blocking-up of kidney sympathetic nerve simultaneously.
In recent years, adopt opening clinically through skin kidney sympathetic nerve ablation of Wicresoft's interventional techniqueBegin to apply, and obtained good effect. Meanwhile, radio-frequency ablation technique is widely usedIn the treatment of the multiple lesion tissue such as heart, cancer and even skin. It utilizes radio frequency energyWhen amount acts on tissue, thereby near temperature field rapid decay treatment site conductor is comparatively concentratedCharacteristic, focus is carried out to minimally-invasive treatment by tiny catheter type probe.
In existing medical skill, the RF ablation operation selection to radio frequency ablation site in the preoperativeThere is no the accurate method of science, tool bears the character of much blindness; In art, lack the reality to degree of ablationTime dynamic monitoring means. These are all affecting to some extent and are restricting carrying of clinical effectivenessHigh and melt quality evaluation and control. Need badly clinically to design and develop out to overcome and be present inMore efficient, the safe new type nerve ablation techniques of above-mentioned defect of the prior art, method andApparatus.
Summary of the invention
Primary technical problem to be solved by this invention is to provide a kind of penetrating of melting for nerveFrequently ablation method.
It is a kind of for realizing above-mentioned radio frequency that another technical problem to be solved by this invention is to provideThe radio frequency ablation system of ablation method.
For realizing above-mentioned goal of the invention, the present invention adopts following technical scheme:
A kind of RF ablation method, comprises the steps:
(1) essential information of store patient;
(2) arrive after target tube chamber at radio frequency ablation catheter far-end, by measuring volume resistance,To target tissue location, and it is adherent to carry out radio-frequency ablation electrode;
(3) database root generates guide parameters according to patient's essential information; Select one group of guide parameters,Start radiofrequency ablation procedures;
(4) in radiofrequency ablation procedures, monitor target tissue impedance variations, and adjust accordingly radio frequency ginsengNumber;
(5) whether the resistance value that judges target tissue is in default impedance threshold scope, if result isEnd radio frequency and store radio frequency parameter; If the result is negative, repeating step (4), until targetThe resistance value of tissue is in default impedance threshold scope.
Wherein more preferably, in step (1), described patient's essential information comprises: name,One or more in sex, age, medical history, race, life region;
Wherein more preferably, in step (3), described guide parameters comprises: radio frequency power output,One or more in radio frequency load time, design temperature, impedance threshold.
Wherein more preferably, in step (3), database root generates one group according to patient's essential informationOr many group guide parameters, for operation, executor selects.
Wherein more preferably, in step (2), use the radio-frequency ablation electrode with puncture portion,After described radio-frequency ablation electrode is adherent, puncture portion carries out wears wall action.
Wherein more preferably, in step (4), in monitoring target tissue impedance variations, alsoComprise the step that tissue temperature monitoring changes, and judge whether temperature value exceedes setting threshold, ifResult is no, continues radio frequency; If result is yes, ends radio frequency, automatic alarm record and penetrateFrequently parameter.
Wherein more preferably, in step (4), also comprise optical sectioning imaging in real time dynamic chamberMonitoring and in real time dynamic endo-luminal ultrasound Imaging: Monitoring, for target tube chamber is carried out to imaging, and sentenceWhether the temperature of disconnected target tube chamber exceedes setting threshold, if the result is negative, continues radio frequency; If knotFruit is yes, ends radio frequency, automatic alarm and records radio frequency parameter.
Wherein more preferably, described RF ablation method also comprises step (6): in convalescence collectionPatient physiological index, and being stored in after associated with rf data in database, for to databaseIn data assess and automatic calibration.
A kind of radio frequency ablation system, comprises that central authorities process and control module, respectively with described central authoritiesRadio frequency release module, volume impedance measurement module, temperature monitoring that processing and control module connectModule, and the warning and the autostore module that are connected with the processing of described central authorities and control module;
Wherein, described central authorities process and control module, for generating guide parameters; Simultaneously forAccording to the monitoring result of volume impedance measurement module and temperature monitoring module, to radio frequency release moduleControl;
Described volume impedance measurement module, for measuring the volume impedance of target tissue, is target tissueLocation and radio frequency damage degree judgement foundation is provided;
Described temperature monitoring module, for Real-Time Monitoring target tissue temperature around, prevents targetThe excessive damage of tube chamber;
Described warning and automatic storage module, for the comprehensive signal of analyzing from monitoring modular,To exceeding situation and the alarm of default secure threshold, and ginseng for ablation procedure is usedNumber and the information automatic arranging and the storage that gather.
Wherein more preferably, described radio frequency ablation system also comprises respectively with described central authorities and processing and controlOptical sectioning imaging module and endo-luminal ultrasound image-forming module in the chamber that molding piece connects;
Optical sectioning imaging module in described chamber, for carrying out reality to target tissue vascular wall aroundTime dynamic imaging monitoring;
Described endo-luminal ultrasound image-forming module, for carrying out ultrasonic one-tenth to target tissue vascular wall aroundPicture monitoring.
Radio frequency ablation system provided by the invention can automatically generate guidance before operation startsParameter, for operation, executor selects; In surgical procedure, can carry out real-time impedance and temperature prisonSurvey, for surgical procedure being monitored and being regulated; In addition, radio frequency ablation system has also been equipped withEndo-luminal ultrasound image-forming module and optical sectioning imaging module, for the target tube to surgical procedureReal-Time Monitoring is carried out in chamber, prevents the undue damage of target tissue vascular wall around, be a kind of science,Safety and there is the RF ablation equipment of directive significance.
Radio frequency ablation system provided by the invention, by implementing volume impedance to neural ablation siteMeasurement, realize the target nerve that real-time dynamic monitoring melts, instruct the control of neural degree of ablationSystem and assurance, in improving curative effect and treatment accuracy, prevent the generation of complication.
This RF ablation method and radio frequency ablation system, not only can be used for treating intractable hypertensionGo the neural radio-frequency ablation procedure of the arteria renalis, also can be used for other denervate ablative surgeries, for example:Be used for the treatment of equally the kidney sympathetic nerve in intravenous route inserts renal vein of intractable hypertensionAblation; And kidney sympathetic nerve ablation in urinary tract approach inserts renal plevis kidney calices. And for example,Duodenal ulcer patients is through duodenum Chuan Bi vagus nerve branch radio-frequency ablation procedure, and asthma is suffered fromPerson is through tracheae/bronchus Chuan Bi vagus nerve branch radio-frequency ablation procedure, and diabetic is through leather belly chamberArtery is worn wall sympathetic nerve radio-frequency ablation procedure.
Brief description of the drawings
Fig. 1 is the data flowchart that RF ablation guide parameters is upgraded;
Fig. 2 is the data processing function block diagram of radio frequency ablation system;
Fig. 3 is the flow chart of data processing figure in radio frequency surgical procedure.
Detailed description of the invention
Below in conjunction with the drawings and specific embodiments, technology contents of the present invention is described in detail.
There is finger in order to eliminate the blindness of radio-frequency ablation procedure in prior art, to the invention providesLead the RF ablation method of parameter and monitoring means, and for realizing this RF ablation methodRadio frequency ablation system.
As shown in Figure 1, in this RF ablation method, the guide parameters of use derives from firstExisting clinical trial and animal experimental data, and can be undertaken not by follow-up clinical trialDisconnected renewal and adjustment. Before radio frequency operation, radio frequency ablation system can according to patient information (as:Sex, age, medical history, life region) from database, automatically generate one or more groups guidanceParameter, for operation executor choice for use. Wherein, every group of guide parameters all derives from databaseIn for the higher experimental data of similar patient's success rate, therefore there is higher directive significance.Guide parameters comprises radio frequency power output, radio frequency load time and design temperature, impedance threshold,Can also comprise other associated information, for example, impedance setting scope, temperature threshold modelEnclose etc. Each parameter in guide parameters, can be a definite value, can be also oneThe individual number range with reference value, operation executor can therefrom select a value to make voluntarilyWith, and adjust according to nerve damage degree in surgical procedure. After radio frequency operation finishes,System can be stored in operation technique data in database automatically, and database is upgraded, and usesIn the more accurate guide parameters of follow-up generation.
In this RF ablation method, for target tissue ablation areas is accurately determined, andNeural degree of ablation is judged, in the preoperative, in art and postoperatively respectively tissue is carried out to volumeImpedance measurement. Because nerve fiber has lower impedance operator, by special flap electrodeCan detect the situation that nerve fiber distributes, and, due to the tissue degeneratiaon of RF ablation andDehydration increases the impedance that causes target tissue, melts forward and backward impedance variations by contrasting nerve,Can also indirectly reflect the degree of ablation of nerve fiber. Therefore, radio frequency provided by the present inventionAblation method, the volume impedance of organizing by measurement in the preoperative positions target tissue, instructsThe accurate selection of ablating electrode position; In art, by the variation of monitoring volume impedance, to targetTissue and the lesion ablation degree of blood vessel judge, for determining the carrying out of melting or terminationCorrect time.
Safety in order to ensure ablative surgery is carried out, RF ablation method provided by the present invention andRadio frequency ablation system, has also increased the step of real-time monitoring and equipment used. For example, increaseAdd volume impedance measurement module and carried out Real-Time Monitoring for the volume impedance to radio frequency process,Increase temperature monitoring module for the temperature of radio frequency process is carried out to Real-Time Monitoring; And for example,Optical sectioning imaging module in chamber, endo-luminal ultrasound image-forming module are set up, for to target tissue weekThe vascular wall enclosing carries out real time imagery monitoring; When monitoring the temperature of target tissue vascular wall aroundWhile exceeding setting threshold, end radio frequency automatic alarm, can prevent target tissue Peripheral blood tube wallExcessive damage.
Above RF ablation method provided by the present invention and radio frequency ablation system are combinedState, be specifically described below in conjunction with accompanying drawing.
As shown in Figure 2, radio frequency ablation system provided by the invention comprises that central authorities process and control mouldPiece 1, the radio frequency release module 2, the volume impedance that are connected with central authorities' processing and control module 1 respectivelyMeasurement module 3, temperature monitoring module 4, and the report being connected with central authorities' processing and control module 1Police and autostore module 5; In addition, also comprise respectively and connecting with central authorities' processing and control module 1Optical sectioning imaging module 6 and endo-luminal ultrasound image-forming module 7 in the chamber connecing.
Wherein, central authorities process and control module 1 is the core of whole system, for collecting with itThe data of the each functional module connecting are also analyzed. First, central authorities process and control module 1Generate guide parameters according to patient's essential information; Then, according to volume impedance measurements to targetTissue positions; Finally, according to each monitoring modular (comprise volume impedance measurement module 3,Optical sectioning imaging module 6 and endo-luminal ultrasound image-forming module 7 in temperature monitoring module 4, chamber)Monitoring result, judges the neural degree of ablation of target tissue, and to radio frequency release module 2Radio frequency dispose procedure control.
Radio frequency release module 2 is carried out radio frequency and is released under the control of central authorities' processing and control module 1Put, nerve fiber is melted.
Volume impedance measurement module 3, for measuring the volume impedance of target tissue, for target tissueLocation and the judgement of radio frequency damage degree provide foundation; Temperature monitoring module 4, for Real-Time MonitoringTarget tissue temperature around, prevents the excessive damage of target tube chamber; Optical sectioning imaging mould in chamberPiece 6, for carrying out real-time dynamic optical image supervisory control to target tissue vascular wall around; In chamberUltrasonic imaging module 7, for carrying out ultrasonic imaging monitoring to target tissue vascular wall around. ReportPolice and automatic storage module 5, for the comprehensive signal of analyzing from each monitoring modular, to exceedingSituation and the alarm of default secure threshold, and for parameter that ablation procedure is used and adoptInformation automatic arranging and the storage of collection.
Finally, in conjunction with the flow chart of data processing figure shown in Fig. 3 to RF ablation provided by the inventionMethod describes. Specifically, the method comprises the steps:
(1) in the preoperative, the essential information of store patient, collect comprise patient name, age,The data such as sex, race, life region, blood pressure, the rhythm of the heart, to patient have or not cardiopulmonary etc. otherOrgan disease does multianalysis, for the foundation of data analysis and database provides condition.
(2) adopt conventional interventional technique radio frequency ablation catheter to be selectively inserted into patient's targetIn tube chamber; Arrive after target tube chamber at radio frequency ablation catheter far-end, to the volume resistance of target tube chamberAnti-measurement; By measuring volume resistance, target tissue is located, determine the position of RF ablationAnd direction; Then radio-frequency ablation electrode is adjusted to selected by the controller on conduit control handleZone of ablation, make radio-frequency ablation electrode adherent.
In the time using with the radio-frequency ablation electrode of puncture portion, after radio-frequency ablation electrode is adherent,Implement to wear again wall, puncture portion is inserted in vascular wall, and reach the degree of depth of clinical needs.
After radio-frequency ablation electrode adherent (and puncture), optionally gather radio frequency and load itFront electricity physiological signal (as impedance, nerve impulse activity, the smooth muscle rhythm and pace of moving things etc.), for performing the operationIn journey, analyzing data uses.
(3) database root generates one group or many according to patient's essential information of input in step (1)Group guide parameters; Guide parameters comprises radio frequency power output, radio frequency load time, design temperatureAnd impedance threshold. Can also comprise other associated information, for example, tissue temperature changesScope etc. Wherein, each parameter in guide parameters, can be a definite value, alsoIt can be a number range with reference value. Operation executor selects one group of guide parameters,Start radiofrequency ablation procedures.
(4) in radiofrequency ablation procedures, monitor target tissue impedance variations, and adjust accordingly radio frequency ginsengNumber; If effect is undesirable, can change other patterns, also can finely tune; Wherein, can adjustThe parameter of joint has: design temperature, power output, radio frequency load time, impedance threshold.
In radiofrequency ablation procedures, also comprise multiple dynamic monitoring means Real-Time Monitoring, ensure to penetrateThe validity frequently melting, simultaneously by the damage to target tissue vascular wall (target tube chamber) aroundDrop to minimum level. In the time that monitoring result demonstration has exceeded critical value, end radio frequency, automatically reportWarn and record radio frequency parameter, otherwise, radio frequency continued.
For example, dynamic temperature monitoring in real time: the temperature sensor in application of temperature monitoring modular 3With temperature monitoring system equipment, can in surgical procedure, carry out the temperature around distal end of catheterReal-time dynamic monitoring, measures tissue temperature and changes, and judge whether temperature value exceedes setting threshold,If the result is negative, continue radio frequency; If result is yes, end radio frequency, automatic alarm recordRadio frequency parameter.
In addition, also comprise that in real time dynamic chamber, optical sectioning imaging is monitored and dynamically in chamber, surpasses in real timeWhether acoustic imaging monitoring, exceed setting threshold for the temperature that judges target tube chamber, if result isNo, continue radio frequency; If result is yes, ends radio frequency, automatic alarm and record radio frequency parameter.
(5), during RF ablation, in real time or discontinuity monitoring target tissue impedance variations, sentenceWhether the resistance value of disconnected target tissue, in default impedance threshold scope, if result is yes, is ended to penetrateFrequency is also stored radio frequency parameter; If the result is negative, repeating step (4), until the impedance of target tissueValue is in default impedance threshold scope.
In step (5), when judged result is when being, end, after radio frequency, can also again surveyAmount electricity physiological signal, and after electricity physiological signal is associated with rf data, be stored in together databaseIn.
In addition, also comprise step (6): convalescence gathers patient physiological index (as blood after surgeryPress), and after associated with rf data, be stored in database, enter for the data to databaseRow assessment and automatic calibration, thus existing part guide parameters replaced. As periodic measurement patientPostoperative blood pressure, the blood pressure of following the tracks of RF ablation hand postoperative patient, can be according to these numbersAccording to the curative effect of judgement treatment intractable hypertension Renal denervation radio-frequency ablation procedure.
Above-mentioned data can be by successively setting up individual archives, and permanent storage is at radio frequency ablation systemIn holder, form database, can review.
A large amount of individual file data by checking, in staqtistical data base, can analyze the different peopleFamily, different regions, country variant, the best operation ginseng of the variant patients of background such as various yearsNumber interval, and then instruct doctor to perform the operation to the patient group of different identity background.
By the foundation of these methods, can also carry out orientation, analyze quantitatively, study high bloodPress patient group's formation reason, pathogenesis, and then determine the operation side for different patient groupsMethod.
In sum, RF ablation method provided by the invention, can be certainly before operation startsThe moving guide parameters that generates, for operation, executor selects; In surgical procedure, can hinder in real timeIn anti-monitoring, temperature monitoring, endo-luminal ultrasound Imaging: Monitoring and chamber, optical sectioning imaging monitoring, usesIn surgical procedure being monitored and being regulated, be a kind of science, safety and there is directive significanceRF ablation method.
Radio frequency ablation system provided by the invention, by implementing volume impedance to neural ablation siteMeasurement, realize the target nerve that real-time dynamic monitoring melts, instruct the control of neural degree of ablationSystem and assurance, in improving curative effect and treatment accuracy, prevent the generation of complication.RF ablation method provided by the invention and radio frequency ablation system, not only can be used for treating intractableThe hypertensive neural radio-frequency ablation procedure of the arteria renalis of going, also can be used for other denervate ablative surgeries,For example: the kidney in intravenous route inserts renal vein that is used for the treatment of equally intractable hypertension is handed overFeel neural ablation; And kidney sympathetic nerve ablation in urinary tract approach inserts renal plevis kidney calices.And for example, duodenal ulcer patients is through duodenum Chuan Bi vagus nerve branch radio-frequency ablation procedure,Asthmatic patient is through tracheae/bronchus Chuan Bi vagus nerve branch radio-frequency ablation procedure, diabetic's warpSkin arteria coeliaca is worn wall sympathetic nerve radio-frequency ablation procedure.
Above RF ablation method provided by the present invention and radio frequency ablation system are carried out in detailExplanation. To those skilled in the art, in the prerequisite that does not deviate from connotation of the present inventionUnder any apparent change that it is done, all will form infringement of patent right of the present invention,To bear corresponding legal liabilities.
Claims (7)
1. a radio frequency ablation system, is characterized in that:
Comprise that central authorities process and control module, be connected with the processing of described central authorities and control module respectivelyRadio frequency release module, volume impedance measurement module, temperature monitoring module, and with described centreWarning and autostore module that reason and control module connect;
Wherein, described central authorities process and control module, for generating and refer to according to patient's essential informationLead parameter; Simultaneously for according to the prison of described volume impedance measurement module and described temperature monitoring moduleSurvey result the neural degree of ablation of target tissue is judged, and described radio frequency release module is carried outControl;
Described volume impedance measurement module, for measuring the volume impedance of target tissue, for target tissueLocation and the judgement of radio frequency damage degree provide foundation;
Described temperature monitoring module, for Real-Time Monitoring target tissue temperature around, prevents target tubeThe excessive damage in chamber;
Described warning and automatic storage module, for comprehensively analyzing from described volume impedance measurement mouldThe signal of piece and described temperature monitoring module, to exceeding described volume impedance measurement module or described temperatureSituation and the alarm of the default secure threshold of degree monitoring modular, and for ablation procedure is usedParameter and information automatic arranging and the storage of collection.
2. radio frequency ablation system as claimed in claim 1, is characterized in that:
Also comprise optical sectioning imaging mould in the chamber being connected with the processing of described central authorities and control module respectivelyPiece and endo-luminal ultrasound image-forming module;
Optical sectioning imaging module in described chamber, for carry out target tissue vascular wall around in real timeDynamic imaging monitoring;
Described endo-luminal ultrasound image-forming module, for carrying out ultrasonic imaging to target tissue vascular wall aroundMonitoring.
3. radio frequency ablation system as claimed in claim 1, is characterized in that:
Described guide parameters comprises: in radio frequency power output, radio frequency load time, design temperatureOne or more.
4. radio frequency ablation system as claimed in claim 1, is characterized in that:
Described patient's essential information comprises: name, sex, age, medical history, race, lifeMultinomial in region.
5. radio frequency ablation system as claimed in claim 1, is characterized in that:
Described central authorities process and control module is used for generating one from database according to patient's essential informationGroup or organize guide parameters more.
6. radio frequency ablation system as claimed in claim 1, is characterized in that:
Described central authorities process and control module, for according to the monitoring of described volume impedance measurement moduleResult is adjusted radio frequency parameter; And whether the resistance value that judges target tissue in default impedance threshold scope,If result is yes, ends radio frequency and store radio frequency parameter; If the result is negative, continue radio frequency until targetThe resistance value of tissue is in default impedance threshold scope.
7. radio frequency ablation system as claimed in claim 1, is characterized in that:
Described central authorities process and control module, for according to the monitoring result of described temperature monitoring moduleJudge whether temperature value exceedes setting threshold, if the result is negative, continue radio frequency; If result is yes,End radio frequency, automatic alarm and record radio frequency parameter.
Priority Applications (8)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410035836.5A CN103767787B (en) | 2014-01-24 | 2014-01-24 | For neural RF ablation method and the radio frequency ablation system melting |
| ES14748628T ES2921176T3 (en) | 2013-02-07 | 2014-02-07 | Method, radiofrequency ablation system and radiofrequency ablation device thereof |
| CN201490000298.XU CN205215353U (en) | 2013-02-07 | 2014-02-07 | Radio frequency melts system and radio frequency melts equipment thereof |
| US14/766,637 US9993291B2 (en) | 2013-02-07 | 2014-02-07 | Radio frequency ablation method, system and radio frequency ablation device thereof |
| PCT/CN2014/000143 WO2014121664A1 (en) | 2013-02-07 | 2014-02-07 | Radio frequency ablation method, system and radio frequency ablation device thereof |
| EP14748628.6A EP2954865B1 (en) | 2013-02-07 | 2014-02-07 | Radio frequency ablation method, system and radio frequency ablation device thereof |
| JP2015556380A JP6453769B2 (en) | 2013-02-07 | 2014-02-07 | Induction cauterization method, system and induction cautery equipment |
| MYPI2015702559A MY179432A (en) | 2013-02-07 | 2014-02-07 | Radio frequency ablation method, system and radio frequency ablation device thereof |
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| CN201410035836.5A CN103767787B (en) | 2014-01-24 | 2014-01-24 | For neural RF ablation method and the radio frequency ablation system melting |
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| CN103767787A CN103767787A (en) | 2014-05-07 |
| CN103767787B true CN103767787B (en) | 2016-05-11 |
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