CN110151298A

CN110151298A - The device and method for treating lung tumors

Info

Publication number: CN110151298A
Application number: CN201811187814.5A
Authority: CN
Inventors: 珀内斯库·多林; 瑞纳·沙肖克; 盖尔芬德·马克; 粱·马克; 梵利拉·辛普利西奥
Original assignee: Zedan Medical Co Ltd
Current assignee: Zedan Medical Co Ltd
Priority date: 2018-02-15
Filing date: 2018-10-12
Publication date: 2019-08-23

Abstract

Device and method for melting lung neoplasm, and refer in particular to the method through being melted in patients with respiratory tract to lung neoplasm.

Description

The device and method for treating lung tumors

Technical field

The main public affairs of the embodiment of the present invention have stated the device and method melted to malignant pulmonary tumour, and refer in particular to from patient The method of lung tumors ablation is carried out in respiratory tract.

Background technique

In worldwide, in the cause of death relevant to cancer, lung cancer occupies first place.In fact, the lethal number of lung cancer It measures more than the summation of breast cancer, colon cancer and the lethal quantity of prostate cancer.Non-small cell lung cancer (NSCLC) is the most common lung Cancer type names the pneumonocyte occurred in canceration.About 75% to 80% patients with lung cancer has NSCLC.In NSCLC early stage, cancer Cell is not diffused into other than initial cancerous region also.It is available preferably to control if can find that and treat in lung cancer early stage Treat result.The standard treatments of lung cancer early stage include that operation removes cancer cell as much as possible, chemotherapy and/or radiotherapy at present.

Operation removes lung or the lobe of the lung, is the gold standard treatment method for treating I phase or II phase non-small cell lung cancer.Unfortunate It is that annual only 15% to 30% lung cancer patient diagnosed is the candidate of this operation.Especially many has chronic obstructive The patient of lung disease (COPD) is not appropriate for such operation.

Percutaneous lung puncture radio-frequency ablation procedure (RFA) be it is a kind of is increasingly received and is approved be used to treat primary with turn One of the method for shifting property lung neoplasm, this method are related under the guide of CT technology, and one piece of electrode needle is spiked through the wall of the chest Process.The direct success rate of this technology has lower Peri operative mortality and 8% to 12% up to 95% or more Perioperative complications rate.Pneumothorax is the complication most frequently occurred, but is less than 10% case and needs to use chest tubes Drainage system.Have in 85% to 90% target lesions and continues complete tumor response.

The method that bronchoscope auxiliary lung neoplasm ablation is considered as next-generation No operation tumour heating ablation by many doctors and patients, but It is that can melt the special installation of sufficiently large volume of tissue in targeting regions due to lacking, and develop slowly.It is this limitation also by To the challenge of some other factors, for example need to be operated by bronchoscope working channels；It is guided and is melted by endoscope The degree of difficulty of electrode arrival target tumor；Lung tissue can disperse cooling characteristic by blood flow, and diffusion, evaporation and convection current are cold But factor, a large amount of air comprising radio frequency path resistance can be increased, and can with respiratory movement the target tissue of deformation.By Air can be penetrated easily in microwave energy, the considerations of for the latter's factor, resulted on Therapy study to the inclined of microwave energy It is good.However, radiofrequency tissue heating ablation is advantageous in easy degree and efficiency, and praised highly by industry.

In conclusion the transmission method of RF energy, and suitable for the lung neoplasm ablating device under bronchoscope transmission, according to It is old to need to improve.The device of future ideality can have certain flexibility, and flexible relative, be applicable to small-bore work In channel, it may be preferable to less than 2 millimeters, to approach the tumour close to lung periphery.

Summary of the invention

The present embodiments relate to arrive the methods, devices and systems for being applied to lung neoplasm and melting across bronchus.The present invention is real Applying example includes following aspect:

Device and system can inculcate conduction liquid (such as HTS) to respiratory tract by melting casing in bronchus, to reduce Tissue impedance, and expand the range of effective RF energy conducting electrode.

Obstruction leads to the respiratory tract of target tumor；

From tumour periphery or center, tumour is wrapped up or punctured with ablating electrode；

RF ablation is carried out to tumour with the structure configuration of monopole, more monopoles, bipolar, multipole and multiphase RF ablation；

Carry out ablated tumor with radiofrequency ablation energy, radio-frequency electrode is inculcated with common or hypertonic saline, and lead to The feedback from temperature sensor is crossed, concentration, temperature, flow or the impedance of physiological saline are inculcated, to control RF ablation energy Amount；

It is not opened, is squeezed by the part for including tumour to lung, reduced volume or part is not opened, carry out ablated tumor；

So that ablation casing is included seal wire, replaces bronchoscope；

With the replaceable bronchoscope and electrode casing for including seal wire, to arrange electrode in respiratory tract；

With casing handle design that is spring or can pushing and pulling, to arrange electrode needle in tumour；

According to benign real-time biopsy results, the biopsy tool being guided is replaced with into ablation work that is non-guide or being guided Tool, and under fluoroscopy or the guidance of ultrasonic wave, it manipulates these tools and reaches position identical with biopsy is carried out；

The blood flow of targeting regions in lung is flowed to by reduction to reduce the oxygen content in the region, and is transmitted in ablation energy Prior to or just when arrival, lead to the hypoxic injury in the region；

When guide in bronchus, boot scheme is generated with CT imaging data, to assist ablation casing logical It crosses bronchoscope to push ahead, and is promoted by the branch of patients bronchial to tumour direction.Perhaps also can use electromagnetism with Track is combined with CT data, reaches tumour to assist guidance ablation casing to pass through bronchial tree.Ablation casing can be placed in Inside the respiratory tract close to tumour or in tumour or any appropriate position of some in branch-like lung cavity network.One After denier is in place, when ablation casing continues to promote to tumour or suitable position, it can be imaged with fluoroscopy technology.It can Combined with fluoroscopy or CT by other imaging techniques, such as MRI, ultrasound etc., or as the technology of replacing, to guide Bronchoscope.Alternatively, melting the biography that installation is mutually compatible with the system of manned guidance bronchoscope on casing in bronchus Sensor (such as 3D electromagnetic coil).

The content that the embodiment of the present invention is announced further comprises following aspect:

1. a kind of method for treating patients with lung cancer, the physiological respiration road including passing through patient, are transported to quilt in lung for casing It is diagnosed as the targeting regions of canceration；With the casing, into lung, solution is injected in targeting regions；Into lung region inject the solution While, ablation thermal energy is transmitted to the solution in target lung region.

2. method described in first further comprises, before injecting solution, the lung in target lung region is compressed immediately Point.

3. method described in first further comprises, before injecting solution, to one section of respiratory tract in the lung region It is closed.

4. method described in first further comprises, before injecting solution, the air in the lung region is excluded.

5. method described in first further comprises, make the lung region of the region adjacent by compressing the lung region It does not open.

6. method described in first further comprises, the compression to the lung region includes to the multiple of a certain respiratory tract Branch's force, so that these branches are more compact each other.

7. including being passed from the multi-electrode for being arranged in tumour proximal end to tumour transmission ablation energy in method described in first Defeated RF energy melts the RF energy by tumour, and to it.

8. a kind of method that can treat patient's target zone of ablation lung neoplasm includes: across bronchus to intrapulmonary target zone of ablation Deliver the service pipe of an elongation；In the target zone of ablation, which is arranged to substantially firm form；By this Service pipe delivers an ablation casing to target zone of ablation；Solution is injected to target zone of ablation；By using the ablation set Pipe, after when inject solution or and then injecting solution, to target zone of ablation application thermal energy, to treat tumour.

9. method described in the 8th article further comprises, with medical imaging technology, one is generated in lung and leads to target The path of zone of ablation, and it includes edge that wherein the service pipe by an elongation, which is deliverrf into the step in lung across bronchus, The path deliver the service pipe.

10. method described in the 8th article further comprises, solution is conveyed to the respiratory tract around ablation bushing electrode, from And avoid the overheat of electrode or respiratory tract wall.

11. method described in the 8th article further comprises, biopsy work is delivered to targeting regions by the service pipe of elongation Tool, and biopsy is carried out to tumour.

12. method described in the 8th article, wherein described after carrying out biopsy to tumour, which can be from elongation Service pipe in remove, which keeps in situ, and can make to melt casing and be delivered to target along the service pipe and disappear Tabetisol.

13. method described in the 8th article, wherein the service pipe by elongation is arranged to substantially securely in target location The operation of form includes one fixed mechanism of deployment, to ensure the stability of the service pipe.

14. method described in the 8th article, wherein the service pipe of the elongation includes a bronchoscope.

15. method described in the 8th article, wherein the service pipe of the elongation includes a casing.

16. method described in the 15th article, wherein the casing can be delivered by the lumen of bronchoscope.

17. method described in the 8th article, wherein described be deliverrf into the service pipe that one extends in lung across bronchus Target zone of ablation is included in one orientable guide equipment of arrangement in the service pipe.

18. method described in the 8th article further comprises delivering a biopsy tool to target zone of ablation；It is melted from target Biopsy sample is acquired at the suspected tumor in area；And wherein it is described with ablation casing treatment lung neoplasm be to be made a definite diagnosis in biopsy sample It is carried out under the premise of pernicious.

19. method described in the 8th article, wherein the ablation casing includes multiple ablation casings, each includes extremely A few radio-frequency electrode, and such electrode can be arranged in respiratory tract branch different around target zone of ablation.

20. method described in the 8th article, wherein the ablation casing can be used to the cloth in certain orientation of respiratory tract wall Set at least one radio-frequency electrode.

21. method described in the 20th article, wherein the ablation casing includes the pipeline section that can be disposed, the pipeline section portion Affixing one's name to the form to come can be spiral shape or arc.

22. the method for the treatment of patient's lung neoplasm includes: the part injection conduction liquid into lung, and when injecting conduction liquid, It in the ablation casing extended from physiological respiration road access, releases energy to the lung point, to heat the lung point.

23. method described in the 22nd article further comprises that the distal end of the ablation casing is arranged in physiological respiration road 3 or the 4th grades of crotches.

24. method described in the 22nd article, wherein the application of the energy, is by discharging from the electrode on ablation casing Electric current is come what is realized, wherein the width of the electrode is within the scope of 0.5 millimeter to 2 millimeters, length is in 4 millimeters to 20 millimeters models In enclosing.

25. a kind of method described in the 24th article, wherein the electrode includes conductive hydrophilic material.

26. method described in the 22nd article further comprises, heating operation is carried out with a RF ablation console, it should It is 100 watts that console can keep Maximum Power Output within the period at most up to 10 minutes.

27. method described in the 22nd article, wherein when casing is melted in the delivering, including the multiple ablation casings of delivering, often One casing includes at least one radio-frequency electrode, and wherein described arrangement radio-frequency electrode includes in the multiple of tumour proximal end It melts on casing, arranges radio-frequency electrode.

28. method described in the 27th article, wherein the radiofrequency ablation energy includes a kind of state of leggy.

29. method described in the 22nd article further comprises by injection chemicals, foam, glue or steam etc. at least one Kind of method does not open the lung of lung or a part；Obstruction leads to some portion of respiratory tract in lung or lung；Or pass through mechanical respirator control System divides side pulmonary ventilation.

30. method described in the 29th article, wherein the partial region that do not open in lung includes one device of delivering, the dress Set the locking device including at least one by patients with respiratory tract；It is a certain lead in the respiratory tract to lung region fill the closing Device；The air in the lung region or at least one section of respiratory tract is absorbed from the lumen of device.

31. method described in the 29th and 30 article, wherein partial region or at least one section of respiratory tract that do not open in lung It can make to generate stable contact between the tissue of patients with respiratory tract and at least one radio-frequency electrode, this at least one radio frequency electrical Pole includes temperature sensor, can measure the temperature of the radio-frequency electrode, and this stable contact condition allow from tissue to Continual heat transfer is carried out between radio-frequency electrode, so that the temperature sensor can provide accurate tissue temperature.

32. method described in the 31st article, wherein the RF energy can be from computer console to radio-frequency electrode Transmission, can use the feedback information of temperature sensor to control radio-frequency power and period, and the wherein described this stabilization Contact condition can make the process that will organize to be heated to target temperature safer and more effective.

33. method described in the 22nd article, wherein the solution is hypertonic saline, it can be from least one implantation Mouth is transported in respiratory tract, and touches at least one radio-frequency electrode.

34. method described in the 33rd article, wherein the implantation mouth is located in this radio-frequency electrode.

Detailed description of the invention

Fig. 1 is the schematic diagram of human segmental's respiratory system.

Fig. 2 is enlarged diagram a part of in Fig. 1.

Fig. 3 is a kind of schematic diagram of ablating device distal portions, is equipped with a closing sacculus in electrode proximal end.

Fig. 4 is the schematic diagram after the device in Fig. 3 is in place.

Fig. 5 A is a kind of schematic diagram of ablating device distal portions, proximally and distally each in electrode on Yu Tongyi casing It is equipped with a closing sacculus.

Fig. 5 B is a kind of schematic diagram of ablating device distal portions, and there are two close sacculus, one of sacculus position for assembly It in electrode proximal end and is assemblied in first sleeve, another sacculus is located at electrode distal end and is assemblied in be stretched from first sleeve On the second casing out.

Fig. 6 A is the schematic diagram after the device in Fig. 5 A is in place.

Fig. 6 B is the schematic diagram after the device in Fig. 5 B is in place

Fig. 7 is a kind of schematic diagram of ablating device containing needle electrode.

Fig. 8 is the schematic diagram after the device in Fig. 7 is in place.

Fig. 9 is to dispose energy at the different location of relatively different tumours by placing multiple casings in patients with respiratory tract Measure the schematic diagram of transmission electrode.

Figure 10 A is the cross-sectional view of content shown in Fig. 9

Figure 10 B is the diagram of polyphase waveform.

Figure 10 C is the schematic diagram of multiphase radio frequency system.

Figure 10 D is divided into the digital timer schematic diagram for generating the configuration of multiphase RF ablation.

Figure 11 is the schematic diagram for manipulating the system of lung neoplasm ablating device in bronchus.

Figure 12 be in lung part do not open before, later, and injection hypertonic saline after, the curve graph of impedance and phase.

Figure 13 is electrode temperature, energy intensity, phase during the transmission of RF ablation and hypertonic saline are inculcated The curve graph of position and impedance.

Specific embodiment

The embodiment of the invention discloses the device and method for melting malignant lung tumors, and refer in particular to out of patients with respiratory tract Melt the method for lung neoplasm.This method treated out of patients with respiratory tract is also understood that as across in bronchus or bronchus Treatment method, and including from connection nose or mouth convey medical device into the respiratory tract of alveolar.So-called respiratory tract, which refers to, exhales Any anatomy inner cavity for air circulation in desorption system, including trachea-bronchial epithelial cell and bronchiole.

Fig. 1 is the schematic diagram of patient breathing system a part, including tracheae 50, trachea carina 51, left principal bronchus 52, the right side Main bronchus 53, bronchiole 54, alveolar (do not indicate, bunchy concentrates on bronchiole end) in figure, left lung 55, right lung 56. It is divided into three second level bronchuses 62 (also known as lobar bronchi) under right principal bronchus, oxygen can be transported to three right lungs Leaf, in right upper lobe 57, right middle lobe 58 and right lower lobe 59.It is divided into two second level bronchuses or lobar bronchi under left principal bronchus 66, to deliver air to two lobes of the lung of left lung, in upper left leaf 60 and lower-left leaf 61.Second level bronchus is further divided into Tertiary bronchus 69 (and being properly termed as segmental bronchi), wherein each air delivery for being responsible for homologous bronchi lung section.Branch Tracheae lung section is a branch of intrapulmonary, is distinguished it with intrapulmonary portion other parts by connective tissue diaphragm (not shown) It opens.As shown in Fig. 2, third level bronchus 69 is divided into the tiny bronchus 70 of many primary, and further it is divided into terminal ramuscule Tracheae 71, bronchioli terminales can be divided into some expiration bronchioles 72 again, and can further be divided into two to ten One breathing 73.Each breathing is made of five to six alveolar sacs 75.Each alveolar sacs is by some alveolars 74 It constitutes.Alveolar 74 is the basic anatomical elements of gas exchanges in lung.Fig. 2 also shows outer in bronchiole exterior space Enclose tumour 80.Target tumor 80 can be located at lymph node, the periphery of intrapulmonary respiratory tract wall or vertical diaphragm, space center or interior Portion.

There are mainly two types of lung cancer, are non-small cell lung cancer (NSCLC) and Small Cell Lung Cancer (SCLC) respectively.85% lung cancer It is non-small cell lung cancer, and including gland cancer, the most common lung cancer type, is formed in epithelial tissue in American men and woman Gland structure, and usually shaped in lung peripheral region；Squamous cell carcinoma, 25% lung cancer belong to such, are more typically located at Heart district domain；Large cell carcinoma accounts for about 10% in NSCLC.The embodiment of the present invention is for for that may betide outside bronchiole Enclose, in bronchiolar region center or lymph node NSCLC treatment.

One side in the embodiment of the present invention provides a kind of method for treating lung neoplasm for patient.It can be generated one to lead to The path of target point into Patients with Lung.In most of patients for having solitary nodule, one can be found by the help of CT and is led to To target, and it is suitable for the respiratory tract of fixed ablation energy transfer element, such as within 1 centimetre of target.It is pre-setting CT guidance figure with the help of, bronchoscope operator can be such that a flexible apparatus passes through with known or existing tool Respiratory tract.In one embodiment, the service pipe of an elongation enters intrapulmonary portion from respiratory tract, sets along the arrival of this paths Determine place.The service pipe of this elongation is positioned in setting place with a substantially stationary orientation.It can be with a kind of solid Mechanism is determined to ensure the stability of service pipe.In the service pipe of this elongation, a casing can pass through to lung The targeting regions in portion.Service pipe can be, such as a kind of lumen, can pass through delivery pipe or bronchoscope, and delivery pipe Or bronchoscope can be manipulated, or have one can be for lumen that seal wire passes through.It include the one of targeting regions in lung Part can be blocked, and can at least not opened partially, for example, obstruction leads to the respiratory tract of this part (for example, on casing Occlusion balloon), and given plus negative pressure in the lung, or divide the lung with other methods and do not open.It can transport The impedance and phase of tissue are measured, with the electrode on casing to confirm not the opening to a certain extent of the part in lung.The target Although not opening completely for lung point can bring ideal effect, not necessarily.Germicidal efficacy shows target lung point one When determining not opening in degree, such as respective bipolar impedance being made to reduce by 20%, it is just sufficient to effective transmission of auxiliary ablation energy. When with the targeting regions of ablation casing treatment lung tissue, hypertonic saline does not open region by casing injection lung, And RF energy is discharged from one or more electrodes on casing to region is not opened.Alternatively, can be conveyed to targeting regions more A ablation casing, and the loop of rf is formed between the electrode on several casings.In the embodiment that the present invention announces, radio frequency electrical It can extremely be used to convey ablation energy.

The service pipe of elongation can be placed on patient's body by a part of bronchoscope or bronchoscope It is interior.One orientable guide equipment can be placed in the service pipe of this elongation, the service pipe guidance that will be extended To setting regions.Biopsy tool can also be delivered to setting regions.It is this to determine before delivering biopsy tool in service pipe The guide equipment of position can be removed out of elongation service pipe.In addition, the service pipe for the elongation that can be guided can be led with 3D Boat system combines, such as the Related product of Veran Medical or SuperDimensionTM (Medtronic).Accordingly Lung tissue can carry out biopsy.If biopsy results are the positive, the lung tissue can be melted by concluding.The biopsy work Tool can be retracted, and replace with tool or ablation instruments comprising at least one energy transmission.This method can be auxiliary It helps and the energy transmission melted on casing or tool is located in region identical with the biopsy.Before treating lung tissue, Need to confirm ablation casing in the region of setting, for example, with bronchoscope views and confirming setting regions and respiratory tract group Knit the relative position of structure.In setting regions, lung tissue or tumour can be punctured.It needs to confirm and lung tissue is controlled The validity for the treatment of.

The discrimination degree of CT scan at present can show or observe that even more small rank is exhaled to missing the 7th grade or the 8th grade Inhale road.Have every reason to believe, the discrimination degree of image can also improve rapidly in future.If tracheae is starting point, and pulmonary parenchyma Brief summary is target endpoint, then the data of three-dimensional image can be generated with suitable software, and nigh respiratory tract It is middle that one or more path for leading to targeting regions is provided.Bronchoscope operator can be in real-time or guidance bronchoscope behaviour It is carried out in work along the path, and by using seal wire, bronchoscope, thin-walled high polymer pipe or pipeline or induction/guidance branch Tracheae mirror device finds correct respiratory tract channel.

After intervention path setting is good, multiple probes can be arranged, for carrying out biopsy, or the tumour identified is carried out Ablation.Biological Study on Pollinators of fruit trees-Osima jacoti, Osima excavata can be used in similar operation.The Guidance instrumentation of bronchoscope is used in combination, with described Method can melt most peripheral lesion lung neoplasm.

Current existing branchofiberoscope (FOBs) includes a light perforating fiber beam and imaging fiber or an imaging lens Head.In addition to the Biological Study on Pollinators of fruit trees-Osima jacoti, Osima excavata of only a few, some Biological Study on Pollinators of fruit trees-Osima jacoti, Osima excavata, which also include one, can be used for absorbing secretion and blood The channel of liquid, the channel pass through for local application and cleaning solution, and make a variety of to diagnose tissue and treatment procedure for recycle Equipment passes through.The outer diameter of typical diagnosis bronchoscope is 5 to 5.5 millimeters, and service pipe is 2 to 2.2 millimeters.This mouth The pipeline of diameter can with sleeve outer be 1.8 to 2 millimeters most cells brush, bronchial biopsy pincers and across bronchoscopic biopsies Needle matches.For more tiny bronchoscope, outer diameter is 3 to 4 millimeters, and has relatively thinner service pipe, is usually marked It is denoted as " P " (for paediatrics), but can be used in adult respiratory tract.Visualization branchofiberoscope more of new generation Service pipe is 2 millimeters, and outer diameter is 4 millimeters.This bronchoscope contains less fiber optics beam, so that be can for its disadvantage Imaging region is smaller.The outer diameter of Biological Study on Pollinators of fruit trees-Osima jacoti, Osima excavata is usually less than 3 millimeters.For example, Olympus BF-XP40 and BF-XP160F Outer diameter be 2.8 millimeters, service pipe be 1.2 millimeters.There is special installation (such as the reusable cytobrush of suitable bore And tweezers) can be used for acquiring tissue samples.The active length of present age visualization bronchoscope is all 60 centimetres.These bronchuses Mirror is suitable for leading in respiratory tract distal end to arrange seal wire, and the seal wire is for replacing conveyance conduit or energy transmission pipeline.

Navigation bronchoscope (NB) includes two stages: making a plan and navigates.In the stage of making a plan, it is obtained ahead of time CT scan can be used to mark and plan the path for leading to intrapulmonary target.In navigation stage, these targets preplaned and Path can be shown, and can be used to be navigated and led to deeper position in intrapulmonary.After arriving at target, NB can be A variety of applications are realized in same operating process.The CT scan of chest is loaded into suitable software, so that the software can To rebuild a variety of 3D renderings of patients with respiratory tract.Doctor can use these images to mark target position, and plan logical To the path of these target positions.Using in the good path of periodic plan and the real-time navigation of making a plan, doctor can will be had The probe of sensor and the service pipe of elongation are guided to specified one or more target positions.After reaching designated position, doctor Teacher can lock the position of the service pipe of the elongation, and can remove pickup probe.The service pipe of the elongation can be branch Airway wall tool or casing provide the approach for leading to target tumor.

Open a part of target lung tissue not

As shown in Figure 1, lung is divided into five lobes of the lung, including right upper lobe, right middle lobe, right lower lobe, upper left leaf and lower-left leaf.These The lobe of the lung is successively divided into down multiple lung sections.Each lobe of the lung and lung section are substantially independent, and have exclusive bronchus and lung dynamic Arteries and veins branch.If the respiratory tract obst ruction of leading to the lobe of the lung or lung section for one simultaneously will be in it with a kind of check valve or filling device Air extraction, the lobe of the lung or lung section will not open or reduce volume, thus in lung other regions under the pressure of its application, Compress the regional organization.From to unlike the other tissues of the sensitive human body of tumour, lung tissue itself has highly compatible, can press Contracting and the characteristic that can not finally open.Atelectasis refers to the lung in all or part of region or not opening for the lobe of the lung.When a respiratory tract quilt When obstruction, without or lesser amount of negative pressure can be transported to the target moiety of intrapulmonary.Therefore, neighbouring part or lung section will It can be squeezed, and exclude the gas being trapped in it.Another method, or other, it also can use vacuum suck device, it will It passes through the cavity for clogs airways device (such as sacculus).This vacuum suck device can further exclude target lung area Gas in domain, to not open target lung region more efficiently." a part for not opening lung " mentioned in the embodiment of the present invention, Refer to compression, reduction or reduce a part of region in lung, and does not need to realize and not open completely.Without extra gas Body, these alveolar sacs will reduce.Although collateral ventilation effect can be such that the lung section that do not open inflates again, tired out by heat Tissue contracts caused by product and lasting gas resorption, can overcome, or at least partly offset filling again to targeting regions Gas effect.When targeting regions have been inflated, the inlet of target respiratory tract can be sealed with sacculus.It can use and work as from sacculus In the cavity that passes through, carry out further gas absorption.

Lung compliance is a key property of lung, and is influenced by different pathology.It is especially relevant to cancer ablation Be: pulmonary fibrosis is related with lung compliance reduction；Pulmonary emphysema/COPD is related with lung compliance raising, the reason is that alveolar and elasticity The missing of tissue；Pulmonary surfactant can improve lung compliance by reducing water surface tension.The inner surface of alveolar covers It is covered with one layer of thin liquid.Moisture in the liquid has very high surface tension, and can provide a kind of power, to make alveolar not ?.The presence of surface reactive material in the liquid, can break this water surface tension, so that alveolar is less susceptible to inwardly not open. If alveolar is not opened, need enough power that can just open alveolar, it means that lung compliance will drastically reduce.Lung It does not open, is clinically defined as the visible lung region in x-ray imaging and does not open, generally be intended to avoid.But local atelectasis Benefit can be brought for the target lung cancer ablation of the treatment of pulmonary emphysema and this author proposition.During tumour ablation, target lung Region is not opened, or the reduction in bulk bring benefit comprising target tumor region includes: to put in the respiratory tract of package tumour The electrode set so as to preferably concentrate ablation energy, or can improve the effect of tumour ablation closer to tumour；It does not open Gas in region or the region by respiratory tract framework of diminution can be removed, so that the transmission of ablation energy and thermal energy be made to pass The effect broadcast is more effective；Not opening for lung section can lead to anoxic, so as to cause lacking for ischaemia vessel retraction and the lung section Blood, and metabolism bring cooling effect can be reduced, while improving the utilization rate of thermal energy；Spray irrigating solution, such as hypertonic physiology Salt water may be limited in targeting regions, so that most electrode ablation is exported in targeting regions.Safety can be improved in this way Property, and the function and effect of energy transmission are improved, reduction is sprayed onto adjacent tissue by irrigating solution evaporation (due to overheat) or unintentionally Caused by energy transmission non-effective effect；Contact of the electrode with tissue persistently just, or will have bigger contact surface.Separately Outside, ablation energy, such as radio-frequency electrical energy can be transmitted by computer-controlled ablation console.Opening a part of lung not can By promoting the stability and pressure that contact between tissue and electrode, the effect of Lai Gaijin temperature-controlled ablation.For example, ablation console It can control the energy transmissions parameters such as radio-frequency power, radio-frequency power change rate or duration, in the respiratory tract do not opened or shunk, In electrode or the temperature sensor on surface can provide more accurate temperature feedback to computer-controlled ablation console, meanwhile, The promotion of contact stabilization and pressure can be improved the stability of heat transfer and electrical conduction, temperature sensor provided More accurate surrounding them tissue temperature.Therefore, can the ablation energy of opposite target lung tissue and tumour transmission optimize, And the temperature of target tissue safely more effectively can be increased to set temperature point.

Other regions are not opened in the lobe of the lung, lung section or the lung defined by respiratory tract form, and provide air by respiratory tract Effect, can be bypassed ventilation effect hindered.This collateral ventilation effect usually occurs having incomplete interlobar fissure and lung Divide in the patient of damage or damage.The method of other lung section or segmental atelectasis may include heating lung tissue, or to target lung Section or lobe of the lung injection chemical substance, foam or hot steam.For example, steam is injected into volume space as the lobe of the lung or lung section, It can lead to not opening for the space.The characteristic of lung is, when a segmental atelectasis, the lung section that is nearby squeezed can be compressed it, and The space for not opening the release of lung section is filled.With bronchoscope and bronchoscope means of transport, come to there is collateral ventilation road Lung or lung the technology do not opened of a part, stated in patent US7412977B2.Part atelectasis, especially Not opening for upper leaf, is proposed before, to reach similar with pulmonary emphysema advanced stage lung volume reduction surgery as a result, not building also still View is implemented in tumour heating ablation (such as RF ablation).The technology of proposition includes: obstruction object and valve, steam (such as thermal effect Answer), foam and the injecting glue into respiratory tract.Also it refers to and mechanical compression is carried out to a part of lung with spring or coil.In this structure In thinking, all these methods can be by modifying and applying in any lobe of the lung or lung section, to can identify and be diagnosed as by CT The treatment of cancer of malignant tumour.

Finally, the technology that can use a kind of One-lung ventilation, entire lung is not opened temporarily.In two main bronchus, Respectively with the endotracheal tube for having filling device, lung is intubated and is ventilated.Health is enough so as to bearing this mode Patient, in side lung be blocked and carry out treatment operation while, can also be by using the other side with mechanical respirator Lung is breathed.It, can be good by electrode arrangement before lung is vented and is not opened.In this case, side ventilation is for behaviour Author carries out atelectasis and does not have much affect.

So that a part of target lung is not opened the range that there are also tools to act on by increasing RF ablation, carrys out adjuvant therapy ablation Other benefits.The air being present in respiratory tract is a kind of bad heat conductor and electric conductor.By making respiratory tract not open (example Such as, by clogs airways or other in the method being mentioned above) these air are excluded, radio frequency can be enhanced and inflated before Penetration power in tissue.We herein propose, and not opening a part of target lung is that one kind assists enhancing to pass by electrode The method of delivery of energy amount, this electrode can also combine utilization in intrabronchial conduit with another equipment, such as one kind.Ball Capsule (such as internal-filling liquid body or gas), another space-closed device, the valve that one can dispose, the steam of injection, ventilation fan, glue note Or bracket, clogs airways can be used to, and open that a part of region that target tumor is wrapped up in lung not.This sacculus can To be used to block a part of respiratory tract, and when these respiratory tracts are obstructed, the gas in its region in alveolar is can be absorbed in blood flow. Alternatively, vacuum pressure can be used, stranded air is discharged by the cavity in the sacculus.This getter action can continue It carries out 30 seconds to 10 minutes, depending on thinking contraction to be achieved or not Zhang Chengdu.If lacking air in respiratory tract, alveolar will It shrinks.In some cases, the one of the space or space inflated before blood, other liquid and secretion may be packed into Part, so that this space better effect when conducting RF energy and heat.

In addition, not opening for lung section can lead to anoxic, to further result in lung ischaemia vessel retraction.Flow to target The decrease for marking region blood flow leads to velocity of blood flow and is metabolized the reduction of cooling effect, and makes the utilization efficiency of thermal energy higher.

A kind of method melting lung neoplasm includes, with it is a kind of can be with clogs airways and the casing of ablation tissue, to one The progress of part target lung is not opened.This method comprises the following steps: (such as curing with CT etc. the position of identification intrapulmonary target tumor Learn imaging technique)；Integrative medicine image and airmanship generate 3D navigation picture；Bronchoscope is conveyed by the respiratory tract of patient, Its distal end is placed near target lung region, the property of can choose is navigated using 3D in the process or electromagnetic navigation is assisted； The position of tumour is determined by biopsy；It lubricates bronchoscope, close inside simultaneous ablation functionality casing and endotracheal tube lumen；It is logical It crosses bronchoscope service pipe and places the casing for closing simultaneous ablation functionality；The distal portions for manipulating the casing arrive at targeting regions； Guidance (such as with standard, electronics or navigation bronchoscope) ablating electrode makes itself and tumour as close possible to or including leading to Seal wire is crossed to convey the casing；The property of can choose, by measuring electrode impedance, imaging technique or electromagnetic navigation, to confirm electricity The orientation or contact situation of pole；Optionally sealing sacculus is positioned proximal in the respiratory tract of ablation areas；In bronchus While lens head is imaged, sacculus is inflated；When absorbing air, open the target moiety in lung not, Or carry out other atelectasis steps (such as absorbing the air in target lung point) disclosed herein；Optionally to group The electrical impedance knitted is monitored (such as between radio-frequency electrode and earthing pole or between Double RF electrode), wherein the stabilization, The impedance of duration indicates that lung is not opened so that tissue and electrode come into full contact with (for example, in one of author research, impedance Decline degree in atelectasis reaches 24% to 38%)；Lavation electrode, or conduction liquid injection target lung is divided；From electrode Automatically controlled ablation energy is transmitted to target tissue；Or the liquid remained in the lung point can be removed with casing；From closing sacculus Middle exhaust, and the casing is removed from patient's body；The respiratory tract being related in therapeutic process is imaged, come find bleeding or The sign blistered, and perform corresponding processing as needed.Alternatively, ablating electrode can be moved to the next position, some Different location carries out subsequent ablation.Before mobile ablation probe, if being difficult to relocate in the part of atelectasis, perhaps It needs to be inflated the lung that do not open before point.In some cases, the air deflating state of the lung point perhaps can be kept, and When relocating electrode, conduction liquid is optionally injected.Alternatively, position mark can be placed in or around tumour, Come help later utilize CT determine tumour whether successful ablation.

To target, lung is dispensed into conduction liquid

In some progress or without opening targeting regions in (for example, reduction or compression) lung not, and pass through injection conduction In embodiment of the liquid to enhance RF ablation effect, the injection of conduction liquid can be the form for injecting a certain amount of hypertonic saline (for example, hypertonic saline that concentration is 5% to 20%) it is (such as straight can to create deeper wider array of ablation range in this way Diameter is greater than or equal to 1.5 centimetres of ablation range), to enhance the effect of entobronchus mirror lung neoplasm ablation.It can also use The conduction liquid of other types.Alternatively, a kind of conduction liquid of high viscosity can be injected into targeting regions, or with a kind of sticky The variable conduction liquid of degree is injected into targeting regions in the state of its low sticky degree, and promotes its viscosity after this.Example The ion salt of such as sodium chloride can convert high polymer with umklapp transformation and water mixes, and be increased to body from the temperature lower than body temperature After temperature, high viscosity state is converted to.Suitable high polymer can be a kind of block copolymer, be made of polyethylene glycol PLGA-PEG-PLGA is that a kind of polylactic-co-glycolic acid of FDA certification is covalently esterified at main chain both ends.Another is high The example of polymers can be based on polyethylene glycol, silk, wool, chitosan, alginates, pectin, DNA, cellulose, polysialia acid, Dendron shape polylysine, poly- (lactic acid-ethanol) are sour (PLGA), gellan gum, polysaccharide, poly-aspartate etc. and these substances Combination.The substance of these mixing can be designed to keep hypertonic saline when the polymer of high viscosity property is added High conductivity.It may insure preferably to control electrical conduction in the conduction liquid that Mass is opened in this way.These high polymers can be can It is biochemical degradation, biocompatible or bio-absorbable.Ion component may include, such as M.sup.+X.sup.- Perhaps wherein M belongs to alkaline element substance or alkaline-earth metal to the compound of the forms such as M.sup.2+Y.sup.2-, such as lithium, Sodium, potassium, rubidium, caesium, X, which represents halogen, acetic acid and other elements that can balance M.sup.+, Y, can be the shape of X.sub.2 Formula or halogen, acetic acid, carbonate, sulfate, phosphate and other elements that can balance M.sup.2+ mixture, It can be formic acid, glycosyl acid, lactic acid, propionic acid, caproic acid, oxalic acid, malic acid, citric acid, benzoic acid, uric acid and its corresponding conjugation Alkali.The ingredient of conduction liquid may further include such as assisted tissue, and auxiliary needle further treats cancer cell or impermeable The pharmaceutical preparation of ray comparison.Enough conduction liquids can be injected, so that the space other than target respiratory tract, alveolar and lung tissue Inside it is also injected into conduction liquid.The method can compare electrode contact surface by the way that ablation energy (such as radio frequency or microwave) to be transferred to It is realized in more tissues, the effective dimensions (such as creating dummy electrodes) of electrode can be increased in this way, realize electrode and group Knit more stable and lasting contact effect.Conduction liquid, such as hypertonic saline can help to realize less energy leakage, And make more energy conductions to tissue, so that ablation energy more effectively conducts.Compared with generic physiological solution, energy It is lost less in hypertonic saline, is because hypertonic saline has higher conduction effect, and comes therefrom lower Contact impedance.It is more difficult to reach its boiling point due to there is less energy loss in hypertonic saline.Therefore, exist In the ablation that atelectasis part is discharged by hypertonic saline, it is not likely to generate and burns deformation and expand showing for damage As.Conduction liquid can be injected with previously described method and apparatus, and optionally in the target lung for the part for making surrounding them In the case where not opening, conduction liquid recycling is carried out.Fig. 4 illustrates an example of equipment 220, which can block target in lung Part, and open the part not, while can be melted with a kind of irrigation electrode, and include irrigating mouth region domain 235 At least one electrode 234.

Alternatively, the author of patent in some zooperies, inculcates into the respiratory tract obstructed by similar closing sacculus Hypertonic saline, and stumbled on to its transporting heat energy from the CT scan in two weeks later by radio frequency, such combination Method can effectively kill tissue.Before some inhibit adhesion molecule and layer studies have shown that hypertonic saline can pass through The expression of hop protein, to be obviously reduced tumour cell to the adhesiving effect of endothelial tissue.(Shields CJ1,Winter DC, Wang JH,Andrews E,Laug WE,Redmond HP.Department of Academic Surgery,Cork University Hospital and National University of Ireland,Wilton.Hypertonic saline impedes tumor cell-endothelial cell interaction by reducing adhesion molecule and laminin expression.Surgery.2004Jul；136 (1): 76-83.) it is possible to hinder in this way Only tumour cell shifts in the course of surgery.It is recorded according to some other document, some researchers also once carried out utilizing physiology The similar research that salt water triggering cellular self-destruction goes out.These researchers kill cancer cell using salt chemical substance in an experiment. They have invented a kind of technology, cancer cell can be caused self to decompose by injecting salt chemical substance into cancer cell. (Busschaert,N.,Park,S.,Baek,K.,Choi,Y.,Park,J.,Howe,E.,Hiscock,J., Karagiannidis,L.,Marques,I.,Felix,V.,et al(2017).A synthetic ion transporter that disrupts autophagy and induces apoptosis by perturbing cellular chloride Concentrations.Nature Chemistry, 9 (7), 667-675. and Ko, S., Kim, S., Share, A., Lynch, V.,Park,J.,Namkung,W.,Van Rossom,W.,Busschaert,N.,Gale,P.,et al(2014) .Synthetic ion transporters can induce apoptosis by facilitating chloride anion transport into cells.Nature Chemistry,6(10),885-892.)

High temperature hypertonic saline plays the role of preferable in infiltration and diffusion process, and cell can be promoted de- Water effect.The increase of extracellular physiological saline can lead to the loss of moisture in peripheral cell.Therewith, in transmission RF energy When, this high temperature hypertonic saline can assist that cell is dried.In comparison, at one at present existing one In the research of kind standard ablation casing (ThermoCool), rating of set is 50 watts, and uses room temperature physiological saline high-speed (30 Milliliter is per minute) it is inculcated, the quantity of dead cell obviously tails off as the result is shown.Concentration can be higher than 5%, such as dense Degree injects in target space for 10% hypertonic saline, and certain temperature is heated to it by the electrode at boot proximal end Degree, such as it is heated to 75 to 105 degrees Celsius.Alternatively, can by the implantation mouth on casing directly into lung segregate region Inculcate high temperature hypertonic saline.The segregate region can be soaked in high temperature and hypertonic physiological solution and be set at least 2 minutes Time, or leaching sets 1 to 30 minutes as needed, hereafter can inculcate room temperature physiological saline by closed electrode, or with normal Warm saline replaces high warm saline, or from implantation mouth directly by the methods of physiological saline exclusion to hypertonic saline Cool down with regional area.This operation can be repeated, until reaching ideal ablation effect.In short, being promoted hypertonic Its diffusion effect still can be improved in the temperature of physiological saline, and hypertonic saline can be improved therewith and be transferred into cell Ability, also, the hypertonic saline or other physiological saline of heating are inculcated, have in terms of killing tumour cell certain excellent Place, this will be very promising developing direction.

Alternatively, can be modulated to conduction liquid, so as to adjust its conductibility and viscosity electrically and thermally.For example, a kind of Conduction liquid source may include the combination in multiple sources, thus the characteristic of the conduction liquid of adjustable injection targeting regions.A kind of software behaviour The controller of control can be prior to or just when injecting mixed solution, by the material mixing in each source at presetting or set automatically Ratio.For example, can star different pumps, these pumps are maintained in certain rate and duration, so as to selectivity Ground acquires the substance of a certain amount of each provenance.It, can be by these before conveying mixed solution to targeting regions by this device Various solution are pumped into a mixing chamber, or can be delivered directly to targeting regions by these solution simultaneously or sequentially.Pass through The information that sensor collection arrives, controller can be calculated according to automatic setting value, such as at device distal portions, required The ratio of various solution.Alternatively, the controller can according to the different characteristics of conduction liquid, such as conductibility, viscosity, temperature or Pressure, to adjust the parameter of ablation energy transmission (for example, the flow of conduction liquid, ablation energy power, set temperature, gain are oblique Rate, cycle duration).For example, adjust conduction liquid flow or in conductibility at least one of, may include adjust wherein at least one Keep the probe value of temperature sensor be in set temperature range, or wherein described in set temperature range can be 70 DEG C between 110 DEG C, being perhaps higher than a certain temperature threshold or the wherein described temperature threshold can be 80 DEG C.At another In example, a kind of system can use to adjust the conductibility of conduction liquid, when reference solution temperature is 25 DEG C, by conductibility control System is in 10mS/cm to 450mS/cm range.

For example, injecting hypertonic saline in the preclinical ablation experimental stage with 5 milliliters of speed per minute.It is holding In continuous two minutes radio frequency transmission stages, 10 milliliters of hypertonic saline can be injected.It, can be in phase in the next ablation stage Ablation in two minutes is carried out with place.So always meeting the hypertonic saline of 20 milliliters of injection together.The length in heating ablation whole space Wide about 3.5 centimetres, 3.1 centimetres and 3 centimetres high, total volume is about 17 cubic centimetres.In addition, hypertonic saline is considered as It is virose to cancer cell, chemical ablation can also be carried out to tumour cell.Physiological saline in lung tissue can replace lung Air in bubble, and in the alveolar for the surrounding that permeated by the hole Kohn and Lambert conduit.Nonionic iodinated contrast agent can be used Hypertonic saline dyeing to pouring into, is imaged it at CT.Other conduction irrigating solutions can also be used to be imaged, such as sulfuric acid Aluminium.In ablation procedure, implantation can be persistently supplemented with inhalator in the conduction liquid of ablation areas, conduction liquid stream is formed, to disappear The heat generated in solution is dissipated, so as to further assist melting.Different solution can be blended in one under computer It rises, becomes that conduction ion concentration is controllable, adjustable and predictable solution.Alternatively, the filling of non-current conduction liquid is covered in target Tissue is marked, to assist generating certain damage interface, it is sufficient to melt target tumor.In one embodiment, amount of ablation is decided by, Such as the distance between tumor size, target tumor and radio-frequency electrode, or the degree of closeness with fragile sensitive non-target structure, it can With according to the amount of ablation of setting, to determine using flowing or noncurrent conduction liquid, wherein the non-current infusion can be with In the ablation of small quantity, flowing infusion can be used in the somewhat larger operation of amount of ablation, and the implantation of greater flow Liquid or cooling injectant can be used in the huger operation of amount of ablation.Conduction liquid can be injected before starting to melt, and be right Lung tissue carries out ablation and prepares, and conduction liquid is flowed into the tissue.Convey the biography such as hypertonic saline Drain can make ablation energy console work in wider array of power bracket, it is sufficient to achieve the purpose that treatment.Figure 11 is described Temperature 304, power 305, impedance 306 and the phase 307 of electrode proximal end temperature 303, electrode distal end under lavation state, with height Physiological saline is seeped with the example under 1 milliliter per minute of speed injection state.Temperature therein can control at 70 DEG C to 100 DEG C Between, although temperature may limitedly fluctuate outside the range.

Alternatively, a kind of needle tubing being placed in respiratory tract inner tissue or tumour can be used, to inject conduction liquid, so as to Conduction liquid more effectively or is selectively delivered to targeting regions.The needle tubing may further include, a kind of and temperature and resistance The radio-frequency electrode that anti-sensor combines, RF energy is transmitted directly in the tissue of tumor vicinity or in tumour.

Alternatively, adjustment conduction liquid, such as hypertonic saline can be titrated, to match the size of amount of ablation.It can pass through Concentration, the injection rate of physiological saline are adjusted, or the position of adjustment choke structure is come to close to different size of lung point It is titrated.The physiological saline of higher concentration has better conductive effect, and can produce bigger ablation lesions effect.It can To spray a greater amount of irrigating solutions to larger range of lung tissue, to realize large-scale ablation lesions.The bigger portion being blocked The lung divided, which may require that, injects a greater amount of hypertonic salines, to realize larger range of ablation lesions.Radio frequency transmission parameter can The adjustment of the case where to be titrated according to hypertonic saline.For example, irrigation solution amount can be according to the non-ideal fluctuation of impedance threshold To increase.

Embodiment 1 (cylindrical ablating electrode)

Fig. 3 illustrates an example of device 220, can deliver out of service pipe, for blocking target lung point simultaneously It opens the part not, dispenses to target lung into conduction liquid, monitor tissue characteristics state, and melt to tumour.Fig. 4 is indicated Situation of the device in practice in Fig. 3.

The device 220 possesses the casing 229 of an elongation, and the proximal end of this casing should can retain outside the patient's body, And its distal portions 215 can should be delivered to close to target from service pipe and swell the target lung region of lung neoplasm.This is remote End part 215 can pass through service pipe (such as the service pipe 225 of bronchoscope 221, or can be from bronchoscope service pipe The casing 213 of transmission) it delivers.In delivery process, the maximum outside diameter of device should be less than the interior of its service pipe passed through Diameter (for example, being less than or equal to 2 millimeters, is less than or equal to 1.5 millimeters).Alternatively, the device 220 can contain a guidewire lumen 236 (for example, a kind of internal diameter is about 0.38 millimeter, can pass through the polyimide tube of 229 lumen of casing) allows the device along leading Silk 227 delivers.Casing 229 can be made of the material with such as Pebax720, and outer diameter is about 1.4 millimeters of form.The set Pipe can be a kind of flexible sleeve, can there is corner of the radius less than 2.5 millimeters, and the outer diameter of the wherein described flexible sleeve No more than 2 millimeters, length is at least 60 centimetres.

The device 220 can be used at least part that interim one section of obstruction leads to target tumor region respiratory tract, such as Fig. 3 With shown in Fig. 4, which possesses a kind of closure elements, such as a kind of inflatable balloon or filling device 231.This elongation Casing 229 include that lumen 222 (for example, a kind of internal diameter is about 0.38 millimeter, can pass through the polyamides of 229 lumen of casing Imines pipe), there is on lumen 222 one to be located in filling device 231, for filling and draining the opening 232 of filling device.This is filled out It fills and sets 231 and can be respiratory tract (such as the diameter range of a kind of certain respiratory tracts of suitable obstruction or diameter in a certain range At 3 millimeters to 10 millimeters) sacculus (such as a kind of compliant balloon).It can be injected by lumen 222 to the filling device 231 Liquid (for example, gas can be air, liquid can be water, physiological saline or contrast solution), to be carried out to the filling device Filling.Alternatively, liquid can be manually injected into the syringe that is connected with 220 proximal part of device, and hydraulic can lead to The locking that reaches a standard is kept to valve.The filling device can be absorbed filling liquid with syringe, by opening lock to valve to be arranged It lets out, and then removes it.It is used to inject or be discharged liquid alternatively, a kind of system for operating the device may include one Pump, to fill or drain sacculus.

Alternatively, the occlusion balloon 231 can have a kind of different choke structure form, such as a kind of valve that can be disposed, or One kind having blocking material, such as PTFE, the bracket disposed.

Fig. 4 describes the ablating device 220 in Fig. 3 and has intervened in selected respiratory tract 151, which includes an elongation Casing 229；One is placed in the boot distal portion, for blocking the filling device 231 of this section of respiratory tract；One exhaust outlet 235, Make to carry out stream with the liquid that device proximal part is connected in lumen (not shown) to change；One suction apparatus (such as vacuum pump) is used By the air transfer in 151 distal end of respiratory tract into the filling device 231, to make the target moiety, lung section or the lobe of the lung It does not open.Can by use negative pressure (such as with suction apparatus), by the air transfer in target lung region to exhaust outlet 235 In connected lumen, air can be discharged to device proximal part, Jin Erpai from the lung point by the lumen by this exhaust outlet Patient is external out.As shown, the exhaust outlet 235 can be used for transmission conduction liquid (such as hypertonic saline) simultaneously.Alternatively, Air will be extracted by another different lumen from target lung point, such as filled out by guidewire lumen 236 or one Fill the lumen (not shown) for another for having outlet on the casing 229 for set 231 distal ends.Other can make at least partly target The method that mark lung region is not opened also is stated herein.

Device 220 shown in Fig. 3 and Fig. 4 further includes the distal end being placed at 220 distal portions 215 of device Electrode 234, and be connected with the conductor 238 (such as 32AWG copper wire) for passing through device proximal end from the casing 229 of device, it fills The proximal end set is connected with energy transmission console.The remote electrode 234 can be cylinder, and radius is in 1 millimeter to 2 millimeters range Interior (such as 1.5 millimeters), length within the scope of 4 millimeters to 7 millimeters (such as 5 millimeters).Optionally arranged on casing 229 One proximal electrode 237, the casing filling device 231 distal end (such as within the scope of 5 millimeters to 40 millimeters, about 20 millimeters Distance 239), in the proximal end of remote electrode 234 (such as within the scope of 5 millimeters to 20 millimeters, about 10 millimeters of distance 240). The proximal electrode 237 is connected with conductor 241 (such as 32AWG copper conductor), which passes through from casing 229, arrival and energy Transmit the proximal end of the connected pipeline of console.As shown in figure 9, remote electrode 102 and proximal electrode 103 can be with collective effect, shapes At electrical circuit, for measuring or monitoring the electrical impedance and phase in the tissue of two motor proximal ends.The impedance or phase can For reflecting the case where lung point does not open, or to disappear the step of opening lung point not or during ablation energy transmits Melt tissue and the hand-to-hand degree of electricity.For example, in experiment test, in remote electrode (such as 234 in Fig. 3) and proximal electrode The bipolar impedance measured between (such as 237 in Fig. 3) has dropped about 5% to 20% (such as from 400 Europe to 350 Europe).Therewith It is that phase can never open -20 ° to -60 ° before state accordingly, changes to -10 ° after not opening Dao -30 °.Figure 12 is illustrated Under 480kHz state, different tissues connect the numerical value in lower situation for impedance 300 and phase 301, including generally contact, target lung Being contacted containing solution after dividing the forced contact after not opening and injecting hypertonic saline to target respiratory tract.In addition, with hypertonic Physiological saline filling is not when opening the space of respiratory tract, and electrical impedance can be stablized and lasting in the first part of RF ablation It reduces.This stabilization of electrical impedance and lasting behavior phenomenon can indicate that target respiratory tract not opened to operator, and realize More fully tissue contact.

Hypertonic saline (HTS) refers to that any sodium chloride-containing (NaCl) concentration is higher than concentration of physiological saline (0.9%) Solution.Usually used concentration includes the NaCl containing 2%, 3%, 5%, 7% and 23%, and usually can by medical department, It is provided by sterile bag or aseptic bottle.In medical practice, the Penetration Signature of these solution can be used, rather than transport properties (such as mitigating oedema).

By the lavation mouth 235 on electrode 234, by conduction liquid (such as concentration is 5% to 20% hypertonic saline) It is transported to target lung point, or additionally or alternatively, by the injection that closing sacculus 231 is distally stretched out and led to from device 220 Conduction liquid is transported to target lung point by lumen, this lumen can from or stretch out not from electrode opening.The injection lumen From lavation mouth (such as 235), casing 229 is passed through, reaches the proximal part with conduction liquid source and the attachable device of hydraulic pump.Or Person can inject conduction liquid with guidewire lumen 236.

In addition, or in conjunction with Bu Zhang target lung split-phase, can be filled with electricity consumption conduction liquid, such as hypertonic saline The space inflated before.According to the function and effect of virtual electrode, RF ablation transmission is can be enhanced in the use of hypertonic saline Effect.

After filling device 231 is by target lung partial blockage, or do not opening, and inject conduction liquid and think under state, radio frequency Ablation energy can be transported to the electrode 234 of distal end from an energy transmission console.Can on remote electrode 234 or it One temperature sensor 242 (such as T-T type thermocouple) of interior arrangement, and being connected with thermocouple wire 243, the thermocouple wire is from casing 229 extend to the proximal part of device 220, which can be connected with energy transmission console.The temperature sensor 242 It can be used to monitor in energy transport, the temperature of electrode 234, and use the temperature as the parameter of control energy transmission (for example, temperature control power transmission will match with the set temperature point within the scope of 45 DEG C to 95 DEG C, it may be preferable at 50 DEG C to 80 Between DEG C, or steady controllable power transmission is realized within the scope of 45 DEG C to 95 DEG C, it may be preferable between 50 DEG C to 80 DEG C, take It certainly in the concrete condition in locating region, avoids overheating).

As shown in figure 4, the degree of ablation 244 is heavily dependent on, the conduction liquid measure injected in target lung point.

The refurn electrode for being used to form electrical circuit can be a kind of dispersive electrode, can be placed on the skin of patient, so that RF energy can be conducted between remote electrode 234 and dispersive electrode by tissue.Alternatively, proximal electrode 237 can also be used To transmit ablation energy.

As shown in figure 4, a kind of bronchoscope 221 contains a camera lens 224, light source 223 is located in patients with respiratory tract, one It can be used to the device casing 220 of clogs airways, tumour ablation art can be implemented by the service pipe 225 of bronchoscope Target moiety 226 (such as a part, the lobe of the lung or lung section of lung) in lung.Seal wire 227 may include a navigation sensor 228, It or include navigation sensor 246 (such as Fig. 3) (such as electric bronchoscope, calutron, 3D at ablation boot proximal end Calutron, Vltrasonic device), targeting regions are placed it in 3D navigation system, and device casing 220 can be in wire leading pipe In chamber 236, delivered along seal wire.Alternatively, the device casing 220 can stretch, adjustable filling device 231 and remote electrode it Between distance, and include first sleeve 229, have a closing sacculus 231 in the distal portions of this casing 229, liquid (such as Air, pure water, physiological saline) it can be by the lumen of first sleeve 229, by being located at the ball in sacculus for solution circulation Capsule charging port 232 is injected and makes balloon inflation.The first sleeve 229 includes a lumen 233, and one the is included in lumen 233 Two casings 230, second casing 230 can stretch advance, wherein including at least one ablating electrode 234.Alternatively, such as Fig. 3 institute Show, ablating electrode can be placed in first sleeve, distally in the position of closing sacculus, and sacculus and interelectrode distance can To be fixed or adjustable.Distance is scalable between this sacculus and electrode or adjustable design bring benefit is, can Electrode is placed in tumour adjacent domain, and closing sacculus is placed in ideal position, these can depend on respiratory tract The size of geometry, the size of target lung point or tumour.Alternatively, second casing 230 can according to first sleeve 229, Carry out steering or turn-knob.The ablating electrode 234 may include at least one lavation mouth 235, carry out lavation electrode.

Or an optics fibre can be extraly arranged in the casing 229 apart from the first elongation of enclosed construction distal end Mirror is tieed up, for the image of the respiratory tract apart from enclosed construction distant place is presented.It can help in this way, such as the receipts of confirmation respiratory tract To inspection of respiratory tract injury etc. when contracting, electrode positioning or deployment enclosed construction.

Alternatively, can be applied in guidewire lumen 236 if injecting liquid by inlet 235 to carry out lavation to electrode Add attraction, causes liquid reflux access, carry out withdrawal liquid.

Alternatively, as shown in fig. 5 a and fig. 6, which can gather around that there are two closure elements, such as a kind of inflatable balloon Capsule or filling device 431,481.One of closure elements are located at ablating electrode proximal end, another is located at electrode distal end.It is this The casing 429 of elongation includes that lumen 422,483 (for example, a kind of internal diameter is about 0.38 millimeter, can pass through 429 lumen of casing Polyimide tube), there is on lumen 422,483 one to be located in filling device 431,481, for filling and draining filling device Opening 432,482.The filling device 431 or 481 can be one kind and be suitble to the certain respiratory tracts of obstruction or diameter in a certain range Respiratory tract (such as diameter range is at 3 millimeters to 10 millimeters) sacculus (such as a kind of compliant balloon).For example, between sacculus Distance can be within the scope of 20 to 40 millimeters of lungs.Liquid can be injected to the filling device 431,481 by lumen 422,483 (for example, gas can be air, liquid can be water, physiological saline or contrast solution), to be filled to the filling device. Alternatively, liquid can be manually injected into the syringe that is connected with 420 proximal part of device, and hydraulic it can pass through pass It is latched to valve and keeps.The filling device can be locked by opening to valve, be absorbed filling liquid with syringe, to be drained, And then it removes it.Alternatively, a kind of system for operating the device may include the pump for being used to inject or be discharged liquid, Simultaneously or separately sacculus is filled or is drained.

Alternatively, the occlusion balloon 431 or 481 there can be a kind of different choke structure form, such as a kind of can dispose Valve or one kind have blocking material, such as PTFE, the bracket disposed.

Fig. 6 A describes the ablating device 420 in Fig. 5 A and has intervened in selected respiratory tract 151, which includes an elongation Casing 429；It is placed in the boot distal portion, is located at electrode both ends, for blocking 431 He of filling device of this section of respiratory tract 481；One exhaust outlet 435, makes to carry out stream with the liquid that device proximal part is connected in lumen (not shown) to change；One sucking dress (such as vacuum pump) is set, for excluding the air between the 151 distal end locking device 431,481 of respiratory tract, to make the target Partially, lung section or segmental atelectasis.The air in target lung region can be turned by using negative pressure (such as with suction apparatus) It moves on in the lumen being connected with exhaust outlet 435, air can be discharged to device from the lung point by the lumen by this exhaust outlet Proximal part, and then it is external that patient is discharged.As shown, can be used for transmission conduction liquid simultaneously (such as hypertonic for the exhaust outlet 435 Physiological saline).Alternatively, air will be extracted by another different lumen from target lung point, such as pass through wire leading pipe There is another lumen (not shown) of outlet on chamber 436 or a casing 429 between filling device 431,481.Separately It is some that the method that at least partly target lung region is not opened can be made also to be stated herein.

By the lavation mouth 435 on electrode 434, by conduction liquid (such as concentration is 5% to 20% hypertonic saline) It is transported to target lung point, or additionally or alternatively, by the injection that closing sacculus 431 is distally stretched out and led to from device 420 Conduction liquid is transported to target lung point by lumen (not shown), this lumen can from or stretch out not from electrode opening.It should Lumen is injected from lavation mouth (such as 435), passes through casing 429, is reached close with conduction liquid source and the attachable device of hydraulic pump End part.

As shown in Figure 6A, a kind of bronchoscope 221 contains a camera lens 224, and light source 223 is located in patients with respiratory tract, and one A device casing 420 that can be used to clogs airways, tumour ablation art can be implemented by the service pipe 225 of bronchoscope Target moiety 226 (such as a part, the lobe of the lung or lung section of lung) into lung.Seal wire 227 may include a navigation sensor 228, or include at ablation boot proximal end navigation sensor 446 (as shown in Figure 5 A) (such as electric bronchoscope, Calutron, 3D calutron, Vltrasonic device), targeting regions, and device casing 420 are placed it in 3D navigation system It can be delivered in guidewire lumen 436 along seal wire.

Alternatively, as shown in Figure 5 B, which can stretch, adjustable filling device 531 and remote electrode it Between distance (for example, from the distance within the scope of one 20_ to 40 millimeters be adjusted within the scope of another 30 to 70 millimeters away from From), and include first sleeve 529, has a closing sacculus 531 in the distal portions of this casing 529, liquid (such as air, Pure water, physiological saline) it can be by the lumen 522 of first sleeve 529, by being located at the sacculus in sacculus for solution circulation Charging port 532 is injected and makes balloon inflation.The first sleeve 529 includes a lumen 533, includes one second in lumen 533 Casing 230, second casing 230 can stretch advance, wherein including at least one ablating electrode 534.

This second casing 230 includes that a lumen 583 (for example, a kind of internal diameter is about 0.38 millimeter, can pass through casing The polyimide tube of 230 lumens), there is on lumen 583 one to be located in filling device 581, for filling and draining filling device Opening 582.The filling device 581 can be the respiratory tract of a kind of certain respiratory tracts of suitable obstruction or diameter in a certain range The sacculus (such as a kind of compliant balloon) of (such as diameter range is at 3 millimeters to 10 millimeters).

Fig. 6 B describes the ablating device 520 in Fig. 5 B and has intervened in selected respiratory tract 151, which includes an elongation First sleeve 529 and second casing 230；It is placed in the boot distal portion, is located at electrode both ends, is exhaled for blocking the section Inhale the filling device 531 and 581 in road；One exhaust outlet 535, makes the liquid being connected in lumen (not shown) with device proximal part Stream is carried out to change；One suction apparatus (such as vacuum pump), for excluding between the 151 distal end locking device 531,581 of respiratory tract Air, to make the target moiety, lung section or segmental atelectasis.It can be by using negative pressure (such as with suction apparatus), it will For air transfer in target lung region into the lumen being connected with exhaust outlet 535, this exhaust outlet can be by the lumen, will be empty Gas is discharged to device proximal part from the lung point, and then it is external that patient is discharged.As shown, the exhaust outlet 535 can be used simultaneously In transmission conduction liquid (such as hypertonic saline).Alternatively, air will be taken out by another different lumen from target lung point It takes out, such as has outlet on the second casing 230 between filling device 531,581 by guidewire lumen 536 or one Another lumen (not shown).Other methods that at least partly target lung region can be made not open also table herein It states.

By the lavation mouth 535 on electrode 534, by conduction liquid (such as concentration is 5% to 20% hypertonic saline) It is transported to target lung point, or additionally or alternatively, by the injection that closing sacculus 531 is distally stretched out and led to from device 520 Conduction liquid is transported to target lung point by lumen (not shown), this lumen can from or stretch out not from electrode opening.It should Lumen is injected from lavation mouth (such as 535), is passed through the second casing 230, is reached and conduction liquid source and the attachable device of hydraulic pump Proximal part.

Distance is scalable between distance or proximal end and distal balloon catheter or adjustable design band between this sacculus and electrode The benefit come is electrode can be placed in tumour adjacent domain, and closing sacculus is placed in ideal position, these can take Certainly in the size of the geometry of respiratory tract, the size of target lung point or tumour.Especially this proximal end and distal balloon catheter it Between adjustable distance can isolate one section of specific region in respiratory tract, so as to significantly reduce or minimize, such as arrange Unexpected influence bring risk in air, infusion liquid or ablation procedure out.Alternatively, second casing 230 can be according to Sleeve 529 carries out steering or turn-knob.The ablating electrode 534 may include at least one lavation mouth 535, carry out lavation electrode.

This double-enclosure apparatus structure may further include following advantage:

● reduce the influence of collateral ventilation.Collateral ventilation is a kind of common lung physiology function.It is empty in collateral ventilation effect Gas can be circulated between the lobe of the lung, bronchus or alveolar by the access between bronchiole.Compared with normal breathing, although The air-flow of collateral ventilation is fainter, but still can exclusion to local air or liquid infusion have an impact.It is this double Locking device structure can provide more perfect baffle space in target respiratory tract.In this isolated respiratory tract section, come It can be minimized from the influence of collateral ventilation.

● in the treatment locally more concentrated.In this section of isolated respiratory tract, it can be carried out for this specific region empty Gas excludes and the implantation of conduction liquid, and ablation energy can be made to focus more on this region.The locking device can also play To the sealing function of substance or energy, extending influence for air, liquid or energy can be reduced in this way, while saving energy.

● reduce the risk that accidental injury is generated to lung tissue.This double-enclosure apparatus structure can provide additional fixed point, To further increase the stability of ablation casing.Especially ablation casing distal portions, due to it includes ablating electrode, Ablation probe or wire tips can Free Transform or bending in the original strength range of casing, it is any to come from boot distal portion Unexpected activity, for example, being excluded or liquid infusion during is nonequilibrium leads to casing 429,529 by dynamic deformation from motion in air Flexible and distal portions movements may all cause damage (such as puncturing, friction, tissue deformation), to influence to lung tissue Ablation effect, and result in the need for additional treatment remedial measure.It furthermore, can be to avoid by hypertonic saline or heat The lung parenchyma for being transferred to pleura or being located next to pleura.The closing sacculus of distal end can be by the hypertonic physiology salt that will inculcate Water is maintained in the safe range that pleura has certain distance, come reduce by thermal energy or the dehydration from hypertonic saline make With the risk for generating damage to pleura.For example, a kind of length of distal balloon catheter can be at least 10 millimeters, and it can consider this Sample is the safe distance of opposite pleura.If the distal end of device to be inserted into the far-end of respiratory tract straight, it is possible to meeting in this way Make device distal end apart from pleura or lung parenchyma less than 10 millimeters, closing sacculus is filled at this time, then can will be inculcated Hypertonic saline and transmitting heat keep in safe range.

Or casing can be extended positioned at the distal end of proximal end enclosed construction, or second in the first elongation casing 529 In 230, positioned at the distal end of distal end enclosed construction, an optical fiber mirror is extraly arranged, it is remote apart from enclosed construction for presenting The image of the respiratory tract at place.When can help in this way, such as confirm the contraction of respiratory tract, electrode positioning or deployment enclosed construction Inspection etc. to respiratory tract injury.

Alternatively, can by pleural cavity (such as pleural space) place one piece of probe, come generate one it is limited and can The pneumothorax of control, so that the target moiety in lung be made not open.Thoracocentesis (also known as thoracentesis) is known to one kind, for from The operation that liquid or gas are excluded in lung, during operation, enters pleural cavity by chest wall with a kind of Fine needle biopsy.By this Method can change the pressure difference of pleural cavity and intrapulmonary part, so that intrapulmonary part is not opened more easily.Alternatively, can be by a kind of dispersion Formula refurn electrode is inserted into and is deployed in lung by thoracocentesis, and radio-frequency current is guided to refurn electrode.Alternatively, can It is special to protect some regions not to be ablated to convey cold soln, such as physiological saline or pure water with thoracocentesis It is not when tumour is located at lung periphery, and to pleura visceralis or other organs (such as heart, esophagus, neural, diaphragm or other Important non-target tissue) have ablation risk in the case where.

Embodiment 2 (needle electrode)

Alternatively, as shown in Figure 7 and Figure 8, the embodiment of similar Fig. 3 or the radio-frequency electrode 234 being represented in Fig. 4, wherein at least One kind can be needle electrode 250, for puncturing respiratory tract wall, radio-frequency electrode is arranged in target tumor 80 or neighbouring In lung tissue.This needle electrode 250 can contain lavation mouth 251, for filling with passing through casing 229 and extend to entire casing The lavation chamber progress liquid for setting proximal end is through-flow.The length of the needle electrode 250 can be (such as 6 within the scope of 5 millimeters to 10 millimeters Millimeter is to 8 millimeters, 7 millimeters), diameter is in the range of 0.1 millimeter to 1.7 millimeters (such as 1.5 millimeters).Alternatively, the needle-shaped electricity Pole may include a guidewire lumen 252 (such as internal diameter can be within the scope of 0.38 millimeter to 0.76 millimeter), can make the dress It sets and is delivered along seal wire.The end 253 of the needle electrode 250 can be it is sharp, so as to spike through respiratory tract wall, example Such as, which can be mitered into the shape of shape or other similar such as pencil points as shown in the figure.In practice, When the needle electrode 250 as shown in Figure 8, when being placed in lung tissue, can be injected from lavation mouth 251 into lung tissue Conduction liquid (such as concentration is 20% hypertonic saline).

Alternatively, the device 255 can be delivered along seal wire, seal wire can be placed on lung tissue or tumour after biopsy procedure In, so that the needle electrode 250 can more easily be arranged in region same as the biopsy.

Alternatively, the distal portions 256 of this device 255 for having needle electrode 250 have a spring mechanism, including a bullet Needle electrode 250, can be locked in spring-compressed position, and when close with device 255 by spring 257 and a fastening lock 258 The switch of end part, when fastening lock 258 is opened, which can will be equipped with the electrode tube 259 of needle electrode 250 It releases, length (such as 5 millimeter to 10 millimeter) of the needle electrode from spring-compressed state when is allow to be stretched over the shape disposed out State length (such as extending 5 millimeters to 10 millimeters again).Release spring pushes momentum when needle electrode 250 that puncture can be assisted to exhale Inhale road wall.The mechanism of fastening lock 258 can be, for example, a rotary shaft, with the fixing element on far-end electrode tube 259 It is mutually chimeric.The rotary shaft can be connected in a bracing wire, and this device casing 229 that is drawstring through is until the close end of device Point, it can be connected with a switch in proximal part, which can be used to exert a force to the bracing wire, to release the locking mechanism 258。

In another embodiment of lung cancer ablation, in the end for the casing for being used to puncture respiratory tract, it may include one and penetrate Frequency penetrating electrodes (such as diameter is 0.5 millimeter, and length is 1 millimeter), the outer diameter of this casing can be from radio frequency penetrating electrodes Diameter excessively arrives the diameter (such as 1.5 millimeters) of distal ablation electrode.Radio frequency penetrating electrodes can with have radio frequency tapping mode function The energy transmission console of energy is connected.Radio frequency penetrating electrodes and energy transmission have in the openheart surgeries such as such as diaphragm puncture It is used.

Alternatively, there are the distal portions of the device of needle electrode can turn to, can assist guiding sharp tips to respiratory tract Wall to be punctured, and needle electrode 250 is placed in lung neoplasm or in neighbouring lung tissue.

Alternatively, the proximal electrode 237 can be additional or cooperate with remote electrode 250, to transmit ablation RF energy.It should Proximal electrode 237 can also contain lavation mouth 263, for by casing 229 and extending to entire 255 proximal end of casing bit Lavation chamber progress liquid is through-flow, which is connected with conduction liquid console or pump.In proximal electrode 237 and remote electrode 250 On lavation mouth 263 and 251, can be connected with identical or different lavation lumen, to transmit conduction liquid.It is shown in Fig. 8 this, There is lavation mouth 263 on proximal electrode 237 and have in the embodiment of lavation mouth 251 on remote electrode 250, conduction liquid can be from Lavation mouth 251 or 263, or from two, be transferred in lung tissue or in tumour from this, and/or can be remote for transmission to filling device 231 In respiratory tract at end.RF energy can also be more likely to be transported to both electrodes by binary channels single-stage rf-mode On 237 and 250.For example, each channel can have a complete electrical circuit, and dispersive electrode can be arranged in patient's skin In skin or in vivo, and any channel can be adjusted according to another.Alternatively, an ablation energy console can pass through Ablation energy is transferred on the two electrodes 250 and 237 by double pole mode.

Embodiment 3 (mostly ablation casing)

Fig. 9 illustrates the example on two casings 100 and 101 comprising energy transmitting electrode 102 and 103, can use one Flexible bronchoscope 221 is disposed respectively, and electrode is placed in the respiratory tract at 80 both ends of target tumor.The device can be with , can be by the service pipe 225 of bronchoscope 221 comprising a closed casing 270, or by delivery cannula 213, passed It send.The closed casing 270 may include a filling device 271, such as one can be placed in complying on closed casing 270 Property sacculus.One filling lumen out of closed casing by passing through and leaving from the port 272 in filling device, to dispose or fill out Fill the filling device 271.The closed casing 270 can contain two or more ablation lumens 273 and 274, and make to export position In distal end in the position of filling device 271.Other conception forms of closure elements also have mentioned in embodiments of the present invention.Set Pipe 100 and 101 can be delivered in the respiratory tract of filling device distal end by lumen 273 and 274.In lumen 273 and 274, often One can include a valve, will seal around the casing 100 and 101 delivered, the targeting regions in lung are kept Low pressure accommodates conduction liquid.The casing can be delivered along seal wire 104 by guidewire lumen 106 and 107.The electrode can with it is logical The electrical conduction substance for crossing casing arrival boot proximal portion is connected, such as certain electric bridge, can send out for example, by conducting wire and radio frequency Raw device electrical connection.Each casing can containing multiple, can simultaneously or separately fill can electrode.Alternatively, each casing can wrap Monitoring electrode 275 and 276 containing impedance and phase, to monitor between remote electrode 103 and impedance electrodes 276 or remote electrode The impedance and phase organized between 102 and impedance electrodes 275, thus obtain respiratory tract do not open, conduction liquid injection, tissue characteristics or The case where ablation of tissue degree.It has been filled in lung in the part of the obstruction of device 271, it can be by electrode 102 and 103 Conduction liquid 216 is injected into target lung point by lavation mouth 277 or 278.

It, can be by the electrode on casing by along 104 delivery cannula 100 and 101 of seal wire with such as Biological Study on Pollinators of fruit trees-Osima jacoti, Osima excavata It is arranged in the region set in respiratory tract.Casing 100 and 101 may include a guidewire lumen 106 and 107, and can lead to The operation (OTW) based on seal wire is crossed to be adjusted and replace.Can with current mature device in patients with respiratory tract into Row navigation.For example, bronchoscope electromagnetic navigation, it is a kind of using electromagnetic technique, in pulmonary branches air pipe passway, to endoscope work The medical procedure that tool or casing are positioned and navigated.Virtual electronic bronchoscope (VB) is a kind of stereoscopic electric brain imaging technique, Intrabronchial image can be provided by spiral CT scans.With thorax computer tomoscan (CT) and disposable sleeve Tool set, virtual, the three-dimensional bronchgraphy figure of generation, doctor can find the setting regions in lung, Lai Jinhang lesion Position biopsy, lymph node sampling, the casing for for guided radiation treatment being marked or guiding brachytherapy.It is existing in this way Some technologies can be used to diagnosing tumor be carried out by biopsy, or place seal wire, to dispose one for treatment process formulation plan Or multiple treatment casings.Near target ablation areas (such as apart from target ablation areas or in 0 to 10 milli of target ablation areas Rice range in) respiratory tract in place seal wire 104 after, Biological Study on Pollinators of fruit trees-Osima jacoti, Osima excavata can be taken out, and seal wire is left in place and is set, In this way electrode casing can be replaced along seal wire.Alternatively, electromagnetic navigation bronchoscope can also carry out similar utilization.Alternatively, this More casing bits may include a kind of similar to double-enclosure apparatus structure shown in Fig. 5 A and 5B.

By the way that bronchoscope is replaced with casing on seal wire, can by more casings comprising electrode or sacculus element according to It is placed.It is surrounded in tumour by energy transmission, and after bronchoscope and seal wire are removed, the proximal end of casing can It is connected with the radio-frequency signal generator external with patient.The technology being related in the embodiment of the present invention can or be shown in biopsy results It is used to melt lymph node in the case where showing lymphatic metastasis.

It can use the not radio transparent label on seal wire or casing, electrode be placed on the exact position of setting. For example, radio-frequency electrode can be it is nonradiable.Any ablation casing announced in embodiments of the present invention, can be in casing Distal portions include a kind of delay or mechanism of ammonium fixation, to ensure that respective energy transmission may be at setting position, and It avoids unexpectedly being displaced and occur, especially when patient respiratory or cough.For example, a kind of delay or mechanism of ammonium fixation can wrap Include a kind of designed non-linear section (not shown) on casing in advance, a kind of fillable sacculus, spring control or bracing wire control Standard shaft, bracket or the barb that can be disposed in boot distal portion of system.The size and shape design of electrode casing can be useful in In the service pipe of conventional bronchoscope or Biological Study on Pollinators of fruit trees-Osima jacoti, Osima excavata.The embodiment of the present invention is transmitted to energy transmission and signal is related to The multinomial electrical connection of (temperature and impedance) is conceived.The ablation casing may include a mass transfer lumen, Ke Yiyong To convey substance, such as the substance of medicament, the contrast material for anatomy imaging and display atelectasis in respiratory tract.Alternatively, After removing seal wire, guidewire lumen may be used as mass transfer lumen, thus need to minimize the radius of the casing.It is this Ablation casing may include a kind of lavation transmission lumen, for injecting irrigating solution in the respiratory tract to surrounding them, to avoid Calcination, impedance rise and cause larger range of damage.This lavation transmission lumen can be with the mass transfer pipe of the foregoing description Chamber or guidewire lumen are same lumen.

As shown in Figure 10 A, different at three, be marked as placed in the respiratory tract of B1, B2 and B3 three labels for The radio-frequency electrode of E1, E2 and E3.For example, can be real by these three electrodes of different cannulated deliveries, such as shown in Fig. 9 Apply example.It can use multiphase RF ablation waveform, to set a kind of rotation ablation electric field, to the more specific tumour of position form Convey ablation energy.Figure 10 B describes a kind of multiphase radio frequency waveform, can be used to melt the target surrounded by multiple radio-frequency electrodes Tumour, RF1 therein are transmitted to the radiofrequency signal of electrode E1, and RF2 is transmitted to the radiofrequency signal of electrode E2, and RF3 is transmission To the radiofrequency signal of electrode E3.In this embodiment, the waveform of RF1, RF2 and RF3 mutually form 120 ° of phase offset, to enhance The level of coverage of tumor space, and be possible to realize the ablation lesions of same degree.From principle, in addition to flowing to or deriving from Multielectrode electric current is a kind of galvanic series that phase difference indicates, phased RF ablation has similar work former with bipolar ablation Reason.Each electrode is controlled by the radio frequency source of an out of phase.It is this each electrode to (for example, E1-E2, E2-E3 and E3-E1 the radio-frequency voltage formed between) can make radio-frequency current form more unified fuel factor in tumor space.Power is at 1 watt To between 100, the period is between 30 seconds to 600 seconds.Temperature sensor be can use to control in current location set by user Temperature value.These target temperature can be more likely within the scope of 50 DEG C to 80 DEG C within the scope of 45 DEG C to 95 DEG C.It can transmit not The radio-frequency signal generator of same-phase ablation energy can have additional output stage.Figure 10 C illustrates multiphase RF energy supply 175 A kind of example, wherein each phase of output stage 177 containing independent control.The phase of radiofrequency signal in each output stage Source 176 can be provided by different radio frequencies to control, or by software or hardware, such as divide high-frequency electronic calculator, use One central microcontroller wheel flow control, as shown in Figure 10 D.As shown in Figure 10 D, a kind of electronic timer may include a base Quasi- frequency 180, the period (such as from t0 to t1) of the frequency can be 1/6th of frequency 181,182 and 183, these frequencies (181,182 and 183) can be for transmission in ablating electrode, and can offset in a reference period.Alternatively, each electrode E1, E2 and E3 (and corresponding RF output voltage VRF1, VRF2 and VRF3) can constitute one completely with dispersion ground level Electrical circuit, ground level is connected at a channel 178 of source of radio frequency energy 175 with ground voltage VGND.Another embodiment can be with Comprising being more or less than 3 electrodes and waveform (such as two electrodes and waveform)

In the example that one melts about bipolar or multi-pole rf, relevant parameter is transferred to multiple electricity by radio frequency control platform The combination of pole, multiple sacculus or sacculus and electrode energy element, these parameters include power and 10 within the scope of 1 watt to 100 watts Second to the period within the scope of 600 seconds.The valuation of tissue impedance is detecting high impedance within the scope of 30 Europe to 1000 Europe When, system can terminate transmission energy or reduce energy work rate, to avoid tissue from being burnt, or avoid due to overheat and electrode and Uncontrollable ablation caused by respiratory tract wall poor contact.After more dry tissue natural moistening or by lavation, energy transmission can To be automatically resumed.Impedance monitoring can also be applied in energy transport simultaneously, to judge whether tissue temperature rises To sufficiently high, reaching can be with the requirement of ablated tumor, and judges whether energy transmission is completed.These parameters can be used for multiphase and penetrate In frequency ablation waveform or monophasic waveform.

Alternatively, ablation energy can be transported to multiple radio frequencies and be disappeared by ablation energy console by multichannel single mode Melt in electrode (such as being transported to a single ablating device or different ablating devices), and independent waveform (example can be used VRF1, VRF2 etc. as shown in figure 10 c).

System

As shown in figure 11, entobronchus mirror lung neoplasm ablating device, such as the device (example announced in embodiments of the present invention Such as, device 220,255 or 270), can be a part of system 290, further comprises computer ablation energy (such as radio frequency) Console 291, including the programmable controller containing software 292, conduction liquid source 293 and injection pump 294, vacuum pump 295, closing Conducting wire device tucker 296 (such as the tucker or syringe for having valve 297) and be attached thereto, leads to device proximal part And the pipeline being connected with console, injection pump or vacuum pump.

Alternatively, system 290 may include multiple ablating devices, such as shown in Fig. 9 multiple it can pass through closed casing 270 The ablating device 100 and 101 of delivering, or such as 220 or 255 multiple ablating devices.The system 290 also may include seal wire 227, delivery cannula 213 disperses ground level or bronchoscope 221.Ablation console 291 may further include and ablating device The monitoring loop and software 298 of impedance and phase that electrode on (220,255,270) is connected, to measure impedance and phase, and These numerical value are supplied to operator.Alternatively, the monitoring loop of impedance and phase and software 298 can be placed in another component In, which can be connected with ablation console, come the impedance or phase of input measurement, to control ablation console software 292 algorithm.

The software 292 may include the algorithm for being used to control vacuum pump 295, to control vacuum pump for target lung point Air excludes.The vacuum pump may include a pressure sensor, to indicate draught head of the target lung point between atmospheric pressure. The peak suction that the vacuum pump can apply is in 1 to 5 barometric pressure ranges, and the algorithm can be poor with input air pressure, and Draught head closes vacuum pump when being greater than peak suction difference, and vacuum pump will receive signal at this time, to close the gas of corresponding lung point Stream.In the embodiment of the present invention, lung can be discharged by a lumen in air, and conduction liquid can be infused by the same lumen Enter, which may include an automatic control switching valve, keeps liquid through-flow and turns between vacuum pump and injection pump functional status Change, for example, the algorithm can by baroceptor signal detection to enough lungs that do not open point, or by tissue impedance and Phase, and the signal of coupling apparatus (such as 220,255 or 270) proximally and distally electrode, detect enough lungs that do not open Point, valve conversion operation can be carried out at this time.For example, the software 292 can control ablation console 291, to proximally and distally Electrode transmits electrical waveform, tissue impedance and phase is monitored in operated vacuum pumps 295, and dropped to expression lung point in impedance When not opening, vacuum pump is closed.The software 292 can control injection pump 294, and conduction liquid is transported to dress from conduction liquid source 293 In setting, and it is injected into target lung point, or electrical waveform can be transmitted, while monitoring impedance or phase, carrys out aid conductive liquid Injection.Alternatively, can continue to inject conduction liquid when transmitting ablation energy from console 291.The software 292 can be further The data for controlling ablation energy transmission, including the Safety monitoring data to temperature and impedance.

Alternatively, the flow that the software 292 when transmitting ablation energy, can control injection conduction liquid (such as passes through control The rate of injection pump), according to the electrode temperature information from temperature sensor (such as 242 and 262) feedback, to obtain setting temperature Degree.For example, can keep the transmission state of a kind of firm power and constant injection flow can adjust when close to set temperature Power and flow are saved, or the two is adjusted simultaneously, to reach the set point of temperature.It is set if the actual temperature of electrode is lower than When fixed point, injection flow and/or hoisting power can reduce.If the actual temperature of electrode is higher than set point, it can increase Flow is injected, and/or reduces power.

Such as the conduction liquid of hypertonic saline etc., boiling point may be above 100 DEG C, be can permit in this way to the conduction Stronger ablation energy is inputted in liquid, and higher solution temperature can assist ablation target tissue.By cartilaginous When respiratory tract wall delivers thermal energy and electric energy to tumour, such situation is perhaps highly advantageous with being worth, because of the thermal conductivity of respiratory tract wall Performance and conductivity are relatively low, and the ablation of tumour then needs powerful ablation effect.For example, the height for being 20% with concentration Physiological saline is seeped as conduction liquid, and boiling point can be within the scope of 105 DEG C to 110 DEG C.

In closed target lung region, by the way that the temperature of conduction liquid in the region is lifted approximately its boiling point, to produce Raw steam, is perhaps helpful.It generates steam and is limited in intrapulmonary targeting regions using locking device (such as sacculus), The vapour pressure of conduction liquid can be improved, to further increase its boiling point, stronger ablation energy can be conveyed in this way.By cartilage The respiratory tract wall of matter is constantly exposed to somewhat longer a period of time in 100 DEG C or so of temperature, such as 2 minutes to 10 minutes, this Sample can make its continuity more preferably, and conduction liquid can be made preferably to pass through respiratory tract, and be transported to target lung tissue.And And after heating pulmonary parenchyma, pulmonary parenchyma can be shunk, and the multiple respiratory tracts being connected with pulmonary parenchyma can be furthered more compact. The steam generated in target lung region can prior to or just when conveying ablation energy, by and to shrink coupled lung real The effect of tumour ablation can be enhanced in matter in this way.A kind of energy transmission console may include a kind of energy transmission control algolithm Mechanism, the algorithm mechanism can make the conduction liquid in targeting regions in the state of certain hydraulic, be maintained at and close on boiling point In temperature range.Alternatively, a kind of algorithm mechanism may include a steam generation stage, so that the transmission of energy is being suitable for generating It is carried out under the conditions of the temperature spot of steam (for example, steam is sent out if using the hypertonic saline that concentration is 20% as conduction liquid The temperature set-point in raw stage can be more biased towards within the scope of 100 DEG C to 110 DEG C at 105 DEG C or so).To target lung tissue Ablation procedure can be carried out in temperature environment raised in this way, and continue carry out 1 to 10 minutes.Alternatively, the steam generation Stage may include a default stage (such as time within two minutes), or can be controlled by the impedance between monitoring electrode System, the sharp peaks of high impedance can indicate the generation of steam.Alternatively, the steam generation stage could alternatively be cryogenic ablation rank Section.For example, the energy transmission in first two minutes can carry out under 105 DEG C of set temperature, it can in two minutes later To carry out under the conditions of 85 DEG C, energy transmission is carried out under conditions of 105 DEG C in two minutes after this, and successively replace It carries out, until ablation stage (such as total duration was at 8 to 15 minutes or 10 minutes or so) end, or until having reached treatment effect Fruit (such as average impedance is increased to target value).Alternatively, pressure can be inputted to console with the pressure transducer of device distal end Signal can indicate the generation of a certain amount of steam by raised pressure.Alternatively, passing through ablation in the steam generation stage Effect of the element to conduction liquid transmission ablation energy, carrys out heat transfer liquid, to generate steam, or to can use locking device remote End, the thermal resistance coil being placed on device carrys out transporting heat energy, to generate steam.Thermal resistance coil can be a kind of resistance gold Belong to, be wrapped with insulated coil (such as polyimides, Parylene) in device pipe axis, so as to only by heat transfer come Heat transfer liquid.The steam generation stage can also be before the tumour ablation stage, if the set temperature of the tumour ablation is low The temperature needed for the steam generation stage.

When injecting conduction liquid to targeting regions, target set temperature can be controlled at 95 DEG C with a kind of algorithm mechanism It within the scope of 110 DEG C, is more biased towards in 105 DEG C, and then by the control of conduction liquid temperature below its boiling point.Alternatively, perfect condition is Steam is generated in closed targeting regions, set temperature in this case within the scope of 105 DEG C to 115 DEG C so that There is certain Security Assurance Mechanism in system, for example, when impedance, temperature sharply increase, or electric phase (example in suddenly change Such as the phase between ablation current and ablation voltage), it can quickly trigger the RF energy effect of shutting down.

Described above or statement system, casing and device can share at least one controller.The controller can wrap Include the digital processing unit (CPU) for having memory, an analog circuit, or one or more digital processor units and one The combination of item or a plurality of analog circuit.In current statement and statement, which is for executing certain operating procedures.This It can be realized by that can construct or editable controller by certain methods.For example, including one or more for one kind The controller of CPU can store one or more programs wherein.These programs include some instructions, when controller executes behaviour When making, allow controller execute the foregoing description or statement the step of.Alternatively, if controller is simulation, the control The circuit design of device should can be used to handle the electric signal in use process, such as execute the control step of the foregoing description or statement Signal in rapid.

Although disclosed herein is at least one exemplary embodiments of the invention, it will be appreciated that any repair wherein content Change, replace and substitute, it will be apparent to those skilled in art that and can be not past under the scope of the invention It carries out.Described in schema and perhaps each embodiment of explanation has used duplicate component symbol to show, it should be appreciated that Each embodiment can be regarded as independent of each other.The disclosed invention is intended to cover any modification or variation of exemplary embodiment Embodiment.In addition, in the present invention, term " including (comprise/comprising) " not do not include other elements or Step, term " one (a/one) " does not include not a plurality of numbers, and term "or" means either or both all. In addition, except in addition non-present invention or context illustrate that the feature or step that the present invention has described can also be with other feature or steps Rapid combination, and in any order using appearance.This specification is declared the patent of benefit of priority or the entire disclosure of application Content is incorporated herein by reference.

Claims

1. the present invention claims right be:

The system that a kind of pair of target lung tissue carries out ablation, the system include:

One ablation energy source；

The casing that one or more can deliver in a respiratory tract, the one or more casing contain an active section, should Active section includes the ablation that at least one connect with the ablation energy source；

One proximal end closure elements for being located at the ablation nearside and a distal end for being located at the ablation distal side are sealed Close element；

One is not opened device, this is not opened device and is configured to that the casing active section can be cooperated to be located at institute to reduce a part State the spatial content of the lung tissue between proximal end closure elements and distal end closure elements；

One can supply the implantation device of conduction liquid to the casing active section；

One controller can be used to control the ablation energy source and come to ablation wherein the controller is configured to Element transmission ablation energy, and can be used to control the implantation device and supply conduction liquid to the casing active section.

2. system described in claim 1, further comprises:

One proximal end suction chamber, the proximal end suction chamber extend through one in one or more of casings, and including one A port in the proximal end closure elements, and

One distal end suction chamber, the distal end suction chamber extend through one in one or more of casings, and including one A port in the distal end closure elements,

Wherein the proximally and distally suction chamber be connected to it is described do not open device, and being configured to can be described from being located at Lung point between proximal end closure elements and distal end closure elements removes air or fluid.

3. system described in claims 1 or 2, wherein the proximal end closure elements and distal end closure elements include one or Multiple distensible sacculus, one or more sealers, one or more extensible valves and/or one or more have The extensible bracket of closed material.

4. system according to any one of the preceding claims, wherein the proximal end closure elements and distal end closure elements The distance between be adjustable.

5. system according to any one of the preceding claims is located at wherein one or more casings include one The first sleeve of the ablation nearside and second casing positioned at the ablation distal side, the proximal end closing Element is carried by the first sleeve, and the distal end closure elements are carried by second casing.

6. system according to any one of the preceding claims further comprises at least one sensor, the sensor quilt It is configured to detect at least one control parameter, wherein the control parameter represents one in described sleeve pipe active section surrounding space A physical characteristic.

7. system according to claim 6, wherein at least one described sensor is placed in the casing active section, Wherein the physical characteristic is in temperature, pressure, electrical impedance or the electric conductivity of the substance of the casing active section surrounding space One.

8. according to right want 6 or 7 described in system, wherein the controller can be used to:

The numerical value of at least one control parameter is received,

According to one or more numerical value of at least one received control parameter, to control the implantation device to described Casing active section supplies conduction liquid.

9. the system according to any one of claim 6 to 8, wherein the controller can be used to:

The numerical value of at least one control parameter is received,

The processing numerical value, and

The numerical value according to one or more generates at least one output signal, which includes following one or more:

Mono- identifiable output of user of o, optionally, the identifiable output of the user includes voice signal, visual signal or vibration Dynamic signal operates for prompting user and described does not open device to reduce lung tissue corresponding with described sleeve pipe active section portion The spatial content divided,

The state output of the o mono- not Zhang Chengdu of withering for indicating the lung point,

Mono- instruction output of o, does not open device for automatically controlling this to reduce lung tissue corresponding with described sleeve pipe active section Partial spatial content.

10. system according to any one of the preceding claims, wherein the controller can be used to:

When the implantation device supplies conduction liquid, the ablation source is controlled to the ablation and transmits ablation energy；Or

After the implantation device has supplied a certain number of conduction liquids, controls the ablation source and transmitted to the ablation Ablation energy.

11. system according to any one of the preceding claims, wherein the implantation device includes:

One for by the device of one or more casing connections to conduction liquid source, the device to include at least one Conduction liquid source can be connected to positioned at the casing active section proximal end or on one or more outlet conduits；With

At least one pump, the pump is to be pumped into the pipeline from conduction liquid source for conduction liquid and be gone out by the one or more Mouth outflow at least can control the implantation device by pumping described in control and supply wherein the controller is configured to To conduction liquid.

12. according to system described in the above claim, wherein the pipeline is that a tubular sheath can either connect for one The bronchoscope of the casing of receipts, or the wherein described pipeline is a kind of luminal structure, and

Wherein one or more outlets are located relative to not open the distal end of device, and it is corresponding or close on it is described at least One ablation.

13. according to any one of the preceding claims and system described in claim 8 is combined, wherein the control fills The step of defeated device supply conduction liquid includes being transported to the pipeline according to the numerical value of one or more control parameters to adjust In conduction flow quantity, one in electric conductivity or ingredient.

14. according to any one of the preceding claims and combine system described in claim 6, wherein it is described at least one Sensor is a kind of temperature sensor, and the control parameter represents the temperature of substance in described sleeve pipe active section surrounding space, When especially in casing insertion respiratory tract, which represents the temperature of lung tissue in described sleeve pipe active section surrounding space Degree.

15. system according to any one of the preceding claims, wherein described is used to reduce not opening for lung tissue part Device is connect with a vacuum pumping source, which is configured for drawing in the lung space around the casing active section Liquid or gas, and described proximally and distally at least one of the suction chamber and the vacuum pump fluid communication.

16. the system described according to any one of the preceding claims and in conjunction with claim 15, wherein the controller It can be used to execute with the next item down:

The deployment of at least one in the proximally and distally closure elements is monitored according to the numerical value of the control parameter,

The vacuum pumping source is controlled according to the numerical value of the control parameter to adjust the sucking to air,

According to the numerical value of the control parameter, to monitor the deployment of at least one in the proximally and distally closure elements, and control The system vacuum pumping source is to adjust the sucking to air.

17. according to any one of the preceding claims and system as claimed in claim 6 is combined, wherein the controller can To be used to execute the reduction for confirming the lung tissue segment space capacity, which includes:

The numerical value of the control parameter is received,

By the way that the numerical value of the control parameter compared with reference standard, being judged to, the spatial content of the lung tissue part is No abundant reduction.

18. system according to claim 17, wherein the controller can be further configured to, if weighing After benefit requires process described in 17, when the spatial content of lung tissue part sufficiently reduces, control the proximal end and At least one in the closure elements of distal end is to terminate or slow down its deployment process.

19. system described in 7 or 18 according to claim 1, wherein described control very according to the numerical value of the control parameter If empty pumping source includes: the sky of lung tissue part after the process described in claim 17 to adjust the sucking to air Between capacity sufficiently reduce when, control the vacuum pumping source to terminate or reduce sucking.

20. a kind of ablation casing includes:

The flexible sleeve that one or more can deliver in lung airways；

At least one ablation, which is located at the distal portions of the one or more flexible sleeve, and disappears with one Melting energy source can be electrically connected；

One liquid outlet being connected with conduction liquid source；

The delivery outlet of at least one conduction liquid, the delivery outlet are located at the distal portions of the casing, and can be with the liquid discharge Mouth carries out fluid interaction, and

One is located at the proximal end closure elements of at least one ablation nearside, and one is located at least one described The distal end closure elements in ablation distal side.

21. casing described in claim 20, wherein the proximally and distally closure elements may include that one or more can Dilating sacculus, one or more sealers, one or more extensible valves, and/or it is one or more with closed material Extensible bracket.

22. casing described in claim 20 or 21, further comprise a tubular structure or one can be used to recycle it is described One or more flexible sleeves bronchoscope, wherein the distal portions of one or more of flexible sleeves can be from the pipe It is come out in shape structure or bronchoscope, wherein the proximally and distally closure elements can be by the tubular structure or bronchoscope It is entrained.

23. casing described in any one of claim 20 to 22, wherein one or more of flexible sleeves include:

The first sleeve of one nearside positioned at least one ablation and at least one ablation described in Second casing in the distal side of element,

Wherein the proximal end closure elements are carried by the first sleeve, and the distal end closure elements are covered by described second Pipe carrying.

24. casing described in any one of claim 20 to 23, further comprises:

One proximal end suction chamber, which extends through one in one or more of flexible sleeves, and wraps Include the port being located in the proximal end closure elements

One distal end suction chamber, which extends through one in one or more of flexible sleeves, and wraps Include the port being located in the distal end closure elements.

25. casing described in any one of claim 20 to 24, wherein the delivery outlet of at least one conduction liquid is located at institute It states between proximal end closure elements and the distal end closure elements.

26. it is remote to represent this for detecting for casing described in any one of claim 20 to 25, including at least one sensor At least one control parameter value of physical characteristic around end part, and the wherein described physical characteristic is the boot distal portion One of temperature, pressure, electrical impedance or electrical conductance of ambient substance.