CN109350234A

CN109350234A - Melt needle assemblies and ablation system

Info

Publication number: CN109350234A
Application number: CN201811293109.3A
Authority: CN
Inventors: 李阳; 张庭超; 彭波波; 丘信炯
Original assignee: Hangzhou Noocheng Medical Devices Co Ltd
Current assignee: Hangzhou Noocheng Medical Devices Co Ltd
Priority date: 2017-11-28
Filing date: 2018-10-31
Publication date: 2019-02-19
Also published as: CN109350233A; CN209826963U; WO2020052302A1; CN109833089A; CN210301203U; WO2020088140A1; CN109833091A; WO2020088139A1; CN210301204U

Abstract

The present invention provides a kind of ablation needle assemblies and ablation system.The ablation needle assemblies include hollow outer tube and ablation needle.Outer tube is movably set in outside the electrode needle body of ablation needle and is detachably connected with ablation handle, after completing ablation operation, ablation needle and outer tube can be dismantled, outer tube is still remained in tissue, channel is provided for other operation such as biopsies, repeated puncture is avoided, the damage to tissue is reduced；Electrode needle body is connected to the driving portion in ablation handle, in the case where keeping ablation needle assemblies to puncture into diseased region, it is mobile relative to outer tube by driving portion driving electrodes needle main body, just the length of outer tube is stretched out in the distal end that electrode needle body can be adjusted in real time in vivo, effectively ablation length is adjusted, in real time in vivo to adapt to the ablation demand at different lesions position or different patients.Ablation needle assemblies of the invention and ablation system are particularly suitable for the radiofrequency ablation therapy of HCM.

Description

Melt needle assemblies and ablation system

Technical field

The present invention relates to the field of medical instrument technology more particularly to a kind of ablation needle assemblies and ablation system.

Background technique

It in the prior art, can be by biopsy pin puncture extremely for the diagnosing tumor at the positions such as liver, kidney, soft tissue Lesion locations, and a small amount of tissue of fetching portion lesion locations, then carry out pathological analysis.For controlling for this kind of diseased region It treats, then lesion can be inserted by radio frequency ablation needle or microwave melt needle, lesion is led to by RF energy or microwave energy Local organization generate high temperature so that lesion tissue coagulation necrosis and reach therapeutic purposes.

Hypertrophic cardiomyopathy (Hypertrophic cardiomyopathy, referred to as: HCM), is a kind of common normal dyeing Body dominant inheritance cardiovascular disease, the disease incidence about 1:500 in general population, case fatality rate about 1.4%-2.2%.The master of HCM Show as the one or more segments of left ventricle (Left Ventricle, LV) are plump, and general diagnostic standard is greater than for thickness etc. In 15mm.It reclines interventricular septum when there is mitral anterior lobe systolic anterior motion, causes left ventricular outflow tract view (Left Ventricular Outflow Tract, LVOT) narrow or even obstruction, i.e., when LVOT pressure difference is excessive, just referred to as obstructive plumpness Type cardiomyopathy (Hypertrophic Obstructive Cardiomyopathy, HOCM), HOCM accounts for about the 70% of HCM patient. Currently, being to expand LVOT to reduce pressure difference and mitigate its obstruction to the therapeutic strategy of HCM, method mainly has between drug therapy, room Every rotary-cut art (Surgical septalmyectomy), interventricular septum ethanol ablation art (Alcohol Septal Ablation). Drug therapy is comparatively simple and easy, the pain that patient does not perform the operation, but some patientss medication effect it is bad or intolerant to By；Interventricular septum rotary-cut art, i.e. improvement Morrow art are that chest excision hypertrophic cardiomyopathy is opened by surgical operation, and excision position is mainly room Interval front simultaneously concentrates on left room face, and chamber interval thickness can reduce by 50% after excision, and postoperative LVOT is substantially reduced, but improves There are certain risks for Morrow art, and the post-operative recovery of patient is also more painful；Interventricular septum ethanol ablation art is a kind of Jie Enter treatment means, mainly apply percutaneous transluminal coronary angioplasty technology, sacculus is sent into the quasi- septal branch eliminated, Being slowly injected into alcohol to septal branch occludes its generation chemically, to make plump myocardium of ventricular septum ischemic, necrosis, thinning, receipts The decline of contracting power, reduces LVOT, although such method avoids the pain of operation, but in clinical application, alcohol passes through branch vessel It may cause myocardial infarction, however it remains certain risk.Therefore, for HCM need a kind of wound it is small and more safely, have The therapeutic modality of effect.In addition, being melted to know the effect of the lesion degree and HCM of hypertrophic cardiomyopathy after ablation It is extremely necessary for carrying out biopsy after preceding and or ablation.

As previously mentioned, radio frequency ablation needle or microwave melt needle are mainly answered at present as a kind of Minimally Interventional Therapy instrument For treating the tumour at the positions such as liver, kidney, soft tissue, and existing ablation needle is integral type mostly, on the one hand, if Ablation before and or ablation after also need to carry out other operations such as biopsy, then need repeatedly to be punctured, venipuncture difficulty is big, aggravation Damage to cardiac muscular tissue；On the other hand, ablation range required for different diseased regions or different patients is different , and the ablation needle of existing integral type is not adjustable effective ablation length of ablation needle.

Summary of the invention

It is smaller and can adjust the ablation needle that ablation needle effectively melts length in real time that the present invention provides a kind of pair of tissue damage Component and ablation system.

The ablation needle assemblies include hollow outer tube and ablation needle；The ablation needle include electrode needle body and with The ablation handle of the electrode needle body proximal end connection, the outer tube at least partly insulate, and the electrode needle body activity is worn Loaded in the outer tube；The ablation handle includes shell, with the fixed connector in the shell distal end and along the shell The driving portion of axial movement；The outer tube is detachably connected with the connector, the proximal end of the electrode needle body with it is described Driving portion is fixed, and the driving portion drives the electrode needle body mobile relative to the outer tube, to adjust the electrode in real time The length of the outer tube is stretched out in the distal end of needle main body.

Wherein, the driving portion includes sliding part and the regulating part that connect with the sliding part, the electrode needle body Proximal end is fixed with the sliding part, and the sliding part is contained in the shell, and the regulating part controls the sliding part in institute It states in shell and moves, to drive the relatively described outer tube axial movement of the electrode needle body.

Wherein, the regulating part includes key and limit body, and control flume, described limit body one end are offered on the shell It is connect with the sliding part, the other end stretches out the shell from the control flume and connects the key, pushes the key edge The control flume is mobile to control the sliding part along the axial movement of the shell.

Wherein, elastomer is equipped between the limit body and the sliding part, the inner wall of the shell is located at the control At least side of slot is equipped with multiple card slots, and the limit body is equipped at least one detent, when the elastomer extends naturally, institute Limit body described in elastomer pushing tow is stated so that the detent is caught in the card slot.

Wherein, the inner surface of the shell is equipped with the first guide way being axially arranged along the electrode needle body, the cunning The surface of moving part is equipped with the second guide way being adapted to first guide way, is led by second guide way with described first To the cooperation of body so that the sliding part is moved axially along the electrode needle body.

Wherein, the connector includes standard shaft and the retainer ring with standard shaft rotation connection, distal end and the institute of the standard shaft It states shell to be fixedly connected, the outer tube is detachably connected with the retainer ring.

Wherein, the proximal end of the standard shaft is equipped with the first card slot, and the distal end clamping of the shell is fixed on first card slot It is interior；It is equipped with the second card slot positioned at the distal side of first card slot on the standard shaft, the proximal end rotation of the retainer ring is fastened in institute It states in the second card slot.

Wherein, the distal end of the outer tube has the first guide portion, and first guide portion is shown under medical imaging devices Shadow.

Wherein, the distal end of the electrode needle body has the second guide portion, and second guide portion is in medical imaging devices Lower development.

Wherein, the inner cavity for proximally extending to distal end is equipped in the electrode needle body, and the lumen proximal is open, far End seal is closed, described interior intracavitary equipped with cooling duct, and has the first gap between the cooling duct and the inner wall of the inner cavity.

Wherein, the proximal end of the ablation handle is equipped with inflow entrance and outflux, the inflow entrance and the cooling duct Proximal end connection, the outflux are connected to first gap.

Wherein, the ablation handle further includes the piston piece in the shell, the piston piece and the sliding part Coaxial arrangement, the distal end of the piston piece and the proximal seal of the sliding part are fixed, and the sliding part and the piston piece Between formed water outlet storage chamber, the outflux and first gap are connected to the water outlet storage chamber.

Wherein, the proximal end of the sliding part is equipped with the first cavity, and the distal end of the piston piece is protruded into first cavity And seal and fix with the inner wall of first cavity, have between the distal end end face of the piston piece and the bottom wall of first cavity There is the second gap, second gap forms the water outlet storage chamber.

Wherein, the ablation handle further includes the sleeve member fixed in the shell and with the shell, the set Cylinder part and the piston piece are coaxially disposed, the distal end of the sleeve member be sheathed on outside the proximal end of the piston piece and with the piston Part is movable and is tightly connected, and water inlet storage chamber, the inflow entrance and described are formed between the piston piece and the sleeve member Cooling duct is connected to the water inlet storage chamber.

Wherein, the proximal end of the piston piece is equipped with the second cavity, and the distal end of the sleeve member is equipped with third cavity, the work The proximal end of plug member is inserted into the third cavity and is tightly connected with the third cavity inner wall, second cavity and described the Three cavitys are connected to form the water inlet storage chamber.

Wherein, sealing ring is arranged on the outer wall of the proximal end of the piston piece, the sealing ring seals the piston piece Gap between proximal end and the sleeve member.

Wherein, water outlet transfer tube is equipped in the water inlet storage chamber, the distal end of the water outlet transfer tube passes through the piston Part is connected to the water outlet storage chamber, and the proximal end of the water outlet transfer tube is connected to the outflux.

Wherein, the water outlet transfer tube include can be along the spiral section of the sleeve member axial stretching.

Wherein, the ablation needle assemblies further include biopsy needle, and the biopsy needle and the ablation needle are more alternately threaded onto institute It states in outer tube and is detachably connected with the outer tube.

Wherein, the ablation needle assemblies further include puncture needle core, and the puncture needle core is more alternately installed with the ablation needle It is detachably connected in the outer tube and with the outer tube, the outer tube is stretched out in the distal end of the puncture needle core.

The ablation system includes the ablation needle assemblies and electrically connects between the electrode needle body of the ablation needle The energy generating apparatus connect.

Wherein, the energy generating apparatus is radio-frequency signal generator or microwave generator.

It wherein, further include the cooling device being connected with the proximal end of the electrode needle body.

In the present invention, the ablation needle assemblies include the outer tube and ablation needle, and the outer tube is movably set in The electrode needle body of the ablation needle is outer and is detachably connected by the shell of connector and ablation handle, i.e., so that completing to disappear After melting operation, outer tube can be removed from connector, so that ablation needle is dismantled with the outer tube, still by outer tube It stays within the organization, provides channel for other operation such as biopsies, avoid repeated puncture, reduce the damage to tissue, and can So that biopsy procedure enhanced convenience is efficient.Further, in the present invention, electrode needle body is connected to the driving in ablation handle Portion drives the electrode needle master by the driving portion in the case where keeping the ablation needle assemblies to puncture into diseased region Body is mobile relative to the outer tube, and the outer tube is stretched out in the distal end that just can adjust the electrode needle body in real time in vivo Length, i.e., adjust effectively ablation length, in real time in vivo to adapt to the ablation demand at different lesions position or different patient. Ablation needle assemblies of the invention and ablation system are particularly suitable for the radiofrequency ablation therapy of HCM.

Detailed description of the invention

More clearly to illustrate construction feature and effect of the invention, come with reference to the accompanying drawing with specific embodiment to its into Row is described in detail.

The ablation needle and the structural schematic diagram after outer tube fractionation that Fig. 1 is ablation needle assemblies of the invention；

Fig. 2 is ablation needle shown in Fig. 1 and the structural schematic diagram after outer tube assembly；

Fig. 3 is ablation needle shown in Fig. 1 and the main view after outer tube assembly；

Fig. 4 is the exploded perspective schematic diagram of ablation needle assemblies shown in Fig. 1；

Fig. 5 is the outer sleeve structure schematic diagram of one embodiment of the invention；

Fig. 6 is the outer sleeve structure schematic diagram of one embodiment of the invention；

Fig. 7 is the structural schematic diagram of the electrode needle body of one embodiment of the invention；

Fig. 8 is ablation needle assemblies shown in Fig. 3 along the diagrammatic cross-section of the position B-B；

Fig. 9 is the schematic perspective view of the standard shaft of one embodiment of the invention；

Figure 10 is the diagrammatic cross-section of the connector of one embodiment of the invention；

Figure 11 is ablation needle assemblies shown in Fig. 3 along the diagrammatic cross-section of the position C-C；

Figure 12 is the ablation handle of ablation needle shown in Fig. 4 except the perspective exploded view after decapsidate；

Figure 13 is the schematic perspective view of an angle of the sliding part in Figure 12；

Figure 14 is the schematic perspective view of another angle of the sliding part in Figure 12；

Figure 15 is the schematic perspective view of another angle of the sliding part in Figure 12；

Figure 16 is the schematic perspective view of another angle of the sliding part in Figure 12；

Figure 17 is the enlarged diagram melted at the control flume of the shell of needle assemblies in the present invention；

Figure 18 a is the perspective enlarged diagram of electrode needle body in the present invention；

Figure 18 b is diagrammatic cross-section of the electrode needle body shown in Figure 18 a along the position A-A；

Figure 19 is diagrammatic cross-section of other structures of the ablation needle in addition to shell in the present invention along axial direction；

Figure 20 is the schematic perspective view that a direction of handle inner piston part is melted in the present invention；

Figure 21 is the schematic perspective view that another direction of handle inner piston part is melted in the present invention；

Figure 22 is the schematic perspective view that a direction of handle inside and outside sleeve is melted in the present invention；

Figure 23 is the structural schematic diagram that another direction of handle inside and outside sleeve is melted in the present invention；

Figure 24 and Figure 25 is to adjust electrode needle body distal end stretching outer tube after ablation needle and outer tube assembly in of the invention The process schematic of length；

Figure 26 is the biopsy needle of the embodiment of the present invention and the structural schematic diagram that outer tube combines；

Figure 27 is the puncture needle core of the embodiment of the present invention and the fractionation schematic diagram of outer tube；

Figure 28 is the combination diagram of puncture needle core and outer tube shown in Figure 27；

Figure 29 is the schematic block diagram of the ablation system of the embodiment of the present invention；

Figure 30 a to Figure 30 c is the using process diagram of the ablation needle assemblies of one embodiment of the invention；

Figure 31 a to Figure 31 e is the using process diagram of the ablation needle assemblies of another embodiment of the present invention.

Specific embodiment

Following will be combined with the drawings in the embodiments of the present invention, and technical solution in the embodiment of the present invention carries out clear, complete Site preparation description.Wherein, the drawings are for illustrative purposes only and are merely schematic diagrams, is not considered as limiting the invention.

In order to clearly describe the structure of ablation needle assemblies and ablation system, limit herein term " proximal end " and " remote End " is intervention medical field common terminology.Specifically, " distal end " indicates one far from operator in operative process End, " proximal end " indicate one end in operative process close to operator.

Unless otherwise defined, all technical and scientific terms used in the present invention are usually managed with those skilled in the art The meaning of solution is identical.Used term is intended merely to describe the purpose of specific embodiment the present invention in the description, is not purport In the limitation present invention.

Also referring to Fig. 1 to Fig. 4, the present invention provides a kind of ablation needle assemblies 100, for carrying out ablation operation.It is described Melting needle assemblies 100 includes outer tube 30 and ablation needle 10.The ablation needle 10 include electrode needle body 11 and with the electricity The ablation handle 12 of 11 proximal end of pole needle main body connection.11 activity of electrode needle body is threaded onto the outer tube 30, even if The distal end for obtaining the electrode needle body 11 can stretch out the outer tube 30 and can adjust the distal end of the electrode needle body 11 The length of the outer tube 30 can be stretched out.Specifically, the present invention in, the ablation handle 12 include shell 121, with it is described outside The connector 122 that shell 121 distally connects and the driving portion that can be moved axially along the shell 121 in the shell 121 123.The axial direction of the shell 121 is identical as the axial direction of the electrode needle body 11.The outer tube 30 and the connector 122 It is detachably connected, the proximal end of the electrode needle body 11 and the driving portion 123 are fixed on ablation needle assemblies 100 and puncture into patient After intracorporal diseased region, it is axially moveable by the opposite outer tube 30 of 123 driving electrodes needle main body 11 of driving portion, it just can be in The length of the outer tube 30 is stretched out in the distal end for adjusting electrode needle body 11 in real time in vivo, to adapt to different lesions position or difference The ablation demand of patient, without will melt needle assemblies 100 withdraw from patient adjust in vitro effectively ablation length after puncture again, pole The earth improves procedure efficiency, reduces the damage to tissue, and due to most of axial length of electrode needle body 11 Degree be housed in outer tube 30, and it is indirect coated by tissue, in vivo adjust electrode needle body 11 distal end stretch out institute The resistance being subject to when stating the length of outer tube 30 is smaller, it is easier to adjust.Wherein, the outer tube 30 and the connector 122 It is detachably connected, refers to that the outer tube 30 such as is connected through a screw thread, is connected together at detachable connection methods and the connector 122 connections, so that can easily dismantle ablation needle 10 and outer tube 30, after completing ablation operation by outer tube 30 still remain in tissue, provide channel for other operations (such as biopsy), avoid repeated puncture, reduce the damage to tissue Wound simplifies surgical procedure.Further, the outer tube 30 is rotatably connected with the connector 122, i.e., outer tube 30 connects After on connector 122, it can be rotated using the axis of connector 122 as axis, in ablation procedure, if necessary to electric rotating Pole needle main body 11, can keep outer tube 30 motionless, and rotation melts handle 12 to drive electrode needle body 11 to rotate, and avoid housing The rotation of pipe 30 causes to damage to tissue, and the resistance being subject to when rotation is smaller.

In the present invention, the outer tube 30 at least partly insulate, in other words, the outer tube 30 can all insulate or Person's SI semi-insulation.Preferably, all insulation of outer tube 30.The outer tube is stretched out in the distal end of the electrode needle body 11 30, when 30 all insulation of outer tube, the part that the electrode needle body 11 stretches out the outer tube 30 executes ablation behaviour Make, the length that the electrode needle body 11 stretches out the part of the outer tube 30 is effectively to melt length；When the outer tube When 30 SI semi-insulation, the electrode needle body 11 stretches out the part of the outer tube 30 and the portion that the outer tube 30 is nonisulated Point execute ablation operation, the electrode needle body 11 stretch out the outer tube 30 part and the outer tube 30 it is nonisulated The sum of partial length is effectively to melt length.As shown in figure 5,30 SI semi-insulation of outer tube is specially that outer tube 30 leans on First tube body 30a of nearly proximal end is insulation system, and second tube body 30b of the outer tube 30 close to distal end is uninsulated structure, thus The nonisulated part of outer tube 30 can also transmit high-frequency current or microwave, increase ablation areas.

The outer tube 30 can be at least partly made of insulating material or the outer tube 30 can be all by non-exhausted Edge material is made, and then at least partly covers insulating coating in the outer surface of the outer tube 30, when executing ablation operation, institute It states outer tube 30 and covers insulation tube of the part of insulating layer as ablation needle 10.In order to improve the supportive of outer tube 30, and just In piercing tissue, it is preferable that the outer tube 30 is made of metal material, and the outer surface of tube body coats insulating coating, institute Stating metal material includes but is not limited to 304 stainless steels, 321 stainless steels or 631 stainless steels, and the insulating coating includes but is not limited to PTFE coating, titanium nitride coating, parylene coating etc..Make the outer tube 30 metal material should have enough hardness with It is pierced into tissue, while the biocompatibility for needing to have excellent, the insulating coating there need to be reliable insulating properties, excellent Biocompatibility and lesser coefficient of friction, and require closely to tie between insulating coating and the outer surface of tube body of outer tube 30 It closes, insulating coating is not easily to fall off, such as can choose 304 stainless steel tubes and add PTFE coating, 304 stainless steel tubes that Parylene is added to apply Layer, 321 stainless steel tubes add titanium nitride coating or 631 stainless steel tubes to add parylene coating etc..In view of insulating reliability and technique Feasibility, the thickness of various insulating coatings should all >=3 μm.It is understood that in other embodiments, the outer tube 30 It can be made completely by insulating materials, for example PEEK, PI or PA etc. can satisfy the plastic tube of hardness requirement, for another example high alumina The ceramic tubes such as porcelain, steatite ceramic or boron nitride.

The distal end of outer tube 30 can be it is straight, be also possible to beveling tip.Preferably, the distal end of outer tube 30 is Tip enables each position of outer tube 30 to be relatively easily inserted into tissue, and makes each around the outer tube 30 The tissue of position is different from the contact area of electrode needle body 11, to determine and need according to the anatomical structure of tissue Ablation areas, and by adjusting the direction of insertion of the outer tube 30 realize orientation, positioning ablation.

Further, referring to Fig. 5, outer tube 30 is equipped with scale marker 31 to indicate that outer tube 30 is inserted into the depth of tissue Degree, the scale marker 31 includes a series of scale values, and scale value is proximally gradually increased from distal end.When outer tube 30 is inserted into When in tissue, it can know that outer tube 30 is inserted into the depth of tissue by the scale value on observation outer tube 30, to know institute State the approximate location that outer tube 30 is inserted into tissue.Further, as shown in fig. 6, have can be 30 distal end of the outer tube The first guide portion 34 developed under medical imaging devices, the length need >=5mm of first guide portion 34, to guarantee position guidance Accuracy, the first guide portion 34 can help doctor judge the distal end of outer tube 30 whether advance along desired puncture path and whether Close to scheduled ablation locations.Specifically, first guide portion 34 can be in increased one of 30 distal end of outer tube Separation structure, or the distal end of the outer tube 30 is subjected to certain processing and is obtained.Since ultrasonic development compares other visualization modes The damage of (such as x-ray fluoroscopy) to human body is smaller, also both economical, preferably by the outer tube 30 at the tube surfaces of distal end Rough rough surface is managed into form the first guide portion 34, adapts to the demand of ultrasonic development.Such as it can be to outer tube 30 The surface roughening treatments such as sandblasting or punching, which are done, close to the surface of the second tube body 30b of distal end forms the first guide portion 34.Also, In the present invention, the surface roughness of first guide portion 34 do not answer it is excessively high, can't while realizing ultrasonic development demand Influence the propulsion of the outer tube 30 in the tissue.

The biocompatibility that stainless steel etc. has excellent conductive capability can be selected in the electrode needle body 11 of the ablation needle 10 Metal makes.Due to being provided with the outer tube 30 at least partly to insulate, 11 surface of electrode needle body of the ablation needle 10 need not It is coated with insulating materials, simplifies the manufacture craft of the electrode needle body 11 of ablation needle 10, and outer tube 30 can be ablation needle 10 electrode needle body 11 provides support and protection, to allow to reduce the diameter of electrode needle body 11, such as the electrode needle 20G~16G may be selected in the diameter of main body 11, on the one hand facilitates to further decrease tissue damage, if on the other hand to be ablated group The structure knitted such as interventricular septum is more flat, and the diameter of electrode needle body 11 is smaller, is more suitable for melting flat tissue, and And the generation for the problems such as pneumothorax, hydropericardium can be prevented when melting the hypertrophic cardiomyopathy in interventricular septum, reduce bleeding.As a result, The ablation needle assemblies of the present embodiment are particularly suitable for the ablation art of HCM.

The electrode needle body 11 can be electrically connected the energy generating apparatus such as radio-frequency signal generator or microwave generator, with Carry out ablation operation.Specifically, when the electrode needle body 11 is electrically connected radio-frequency signal generator, electrode needle body 11 transmits high frequency Electric current makes negative ions electrically charged in the pathological tissues around 11 distal end of electrode needle body that high speed oscillating movement, high speed occur The ion of oscillation increases temperature in pathological tissues, finally makes the albumen in sick cell because friction generates a large amount of heat Qualitative change, intraor extracellular loss of water, there is coagulation necrosis in pathological tissues, to realize RF ablation；The electrode needle master When body 11 is electrically connected microwave generator, electrode needle body 11 distally forms microwave field, the dipoles such as hydrone in pathological tissues Molecule heat production due to friction of motion, sharp impacts under the action of microwave field increases temperature in pathological tissues, finally makes There is coagulation necrosis in protein denaturation in sick cell, intraor extracellular loss of water, pathological tissues, to realize that microwave disappears Melt.

Referring to Fig. 7, the distal end of the electrode needle body 11 of the ablation needle 10 can be in sharp triangular pyramid or needle-shaped Etc. shapes, conducive to ablation needle 10 electrode needle body 11 combined with outer tube 30 after implement puncture, the electrode of certain ablation needle 10 Other shapes, such as spherical, umbrella etc. also can be set into the distal end of needle main body 11.

Further, referring to Fig. 7, the distal end of the electrode needle body 11 have can develop under medical imaging devices The second guide portion 13, the length need >=5mm of second guide portion 13, the second guide portion 13 can show under medical imaging devices Shadow helps doctor to judge whether 11 distal end of electrode needle body reaches or in scheduled ablation locations.Specifically, described second draws Leading portion 13 can be in the increased a part of structure in the distal end of the electrode needle body 11, or by the electrode needle body 11 Distal end carries out certain processing and obtains.Preferably, by the surface treatment of 11 distal end of electrode needle body at rough coarse Face adapts to the demand of ultrasonic development to form the second guide portion 13, for example can do and spray to the surface of 11 distal end of electrode needle body The processing such as sand or punching.Also, in the present invention, the surface roughness of second guide portion 13 do not answer it is excessively high, realize ultrasound While development demand, the propulsion of the electrode needle body 11 in the tissue will not influence.The ablation needle of the present embodiment as a result, Component is particularly suitable for the ablation of ultrasound guidance, and operator will can melt needle assemblies under ultrasound guidance, through puncturing Distal end be sent into patient's body, by ablation needle 10 stretch out outer tube 30 part to pathological tissues carry out ablation operation.

Please refer to Fig. 4 and Fig. 8, in one embodiment of the invention, the shell 121 includes the first shell 121a being oppositely arranged With second housing 121b, can be linked together by modes pairings such as buckle, bonding, screw fixations therebetween.Described first Snap-gauge 1212 is equipped on shell 121a and the second housing 121b.

The connector 122 includes the standard shaft 122a and retainer ring 122b with standard shaft 122a rotation connection, the standard shaft The proximal end of 122a is fixedly connected with the shell 121.Axial direction setting of the standard shaft 122a along electrode needle body 11, electrode needle body 11 It is protruded into shell 121 across the axle center of standard shaft 122a.

Specifically, Fig. 8 to Figure 10 is please referred to, the proximal loop of the standard shaft 122a is equipped with the first card slot 1221, standard shaft 122a Extend proximally into the shell 121, and 1212 pairing of snap-gauge on the first shell 121a and second housing 121b be caught in it is described In first card slot 1221.In the present embodiment, the bottom wall profile of first card slot 1221 is rectangle, and being caught in for snap-gauge 1212 is described Inner surface in first card slot 1221 reclines the bottom wall of the first card slot 1221 so that standard shaft 122a and shell 121 it is fixed and Standard shaft 122a can not opposite shell 121 rotated.Also, in the present embodiment, the shell 121 passes through the first shell 121a Connect to obtain with second housing 121b pairing, convenient for snap-gauge 1212 is caught in the first card slot 1221, with realize standard shaft 122a with The fixation of shell 121.Further, the distal side of first card slot 1221 is equipped with the second card slot 1222, the retainer ring 122b Proximal end be caught in second card slot 1222.Specifically, the profile of the bottom wall of second card slot 1222 is circle, the card The proximal end of circle 122b can be around the axial-rotation of standard shaft 122a after being caught in the second card slot 1222, but cannot be axially moveable, i.e., Retainer ring 122b can rotate in situ.

Further, the outer tube 30 is detachably connected with the retainer ring 122b.In the present embodiment, the outer tube 30 Proximal end be equipped with external screw thread, be equipped with internal screw thread be adapted to the external screw thread in the retainer ring 122b, the proximal end of outer tube 30 and The retainer ring 122b is threadedly coupled.It is understood that in other embodiments of the invention, the proximal end of the outer tube 30 with The retainer ring 122b can also be connected by other removablies such as buckle.In ablation procedure, when needing to make in order ablation hand Conducting wire and cooling line outside handle 12 prevent conducting wire and cooling line overflexing, torsion from winding, and conveniently checking ablation hand Scale value on handle 12, when operator needs to rotate ablation handle 12 or/and ablation needle 10, operator can grasp described Retainer ring 122b keeps outer tube 30 not turn, and rotates the ablation handle 12 of the ablation needle 10, to pass through 12 band of ablation handle It moves the electrode needle body 11 to rotate, can be avoided the rotation of outer tube 30 and frictionally damage, and electrode needle body are caused to tissue 11 resistances that rotate in outer tube 30 are smaller.Further, in some embodiments of the invention, the outer tube 30 is equipped with outer spiral shell The position of line is equipped with grip part 33 towards its distal end side, in order to carry out rotation relative to the ablation needle 10 or disappear with described Melt the dismounting of needle 10.In the present embodiment, in the outer wall setting multi-turn protrusion of the outer tube 30, to form the grip part 33.

Further, the distal end of the standard shaft 122a is frustum structure, in order to which retainer ring 122b is packed into the second card slot 1222 It is interior.Also, the distal portions of the standard shaft 122a are arranged in the outer tube 30, to support the distal end of the outer tube 30, So that the connection between the outer tube 30 and the connector 122 is more stable.

Referring to Figure 4 together and Figure 11, Figure 12, the driving portion 123 include sliding part 1231 and with the sliding part The regulating part 1232 of 1231 connections.The proximal end of electrode needle body 11 and sliding part 1231 are fixed.Sliding part 1231 is contained in shell In 121, regulating part 1232 controls sliding part 1231 along the axial movement of shell 121, to drive electrode needle body 11 relatively described Outer tube 30 is mobile.

Please refer to Figure 13 to Figure 16, in this implementation, the sliding part 1231 include cylindric first part 1231a and With the second part 1231b of the first part 1231a square connecting.The central axis of the first part 1231a and The central axis of two part 1231b, the first part 1231a have the first cavity 12311, the second part 1231b It is equipped with the first centre bore 12312, the electrode needle body 11 passes through first centre bore 12312 and ends or partially protrude into In first cavity 12311.Also, the proximal end of the electrode needle body 11 and the inner wall of the first centre bore 12312 are fixed, with Realize that electrode needle body 11 and sliding part 1231 are fixed.In the present embodiment, by first centre bore 12312, injecting glue is simultaneously Make adhesive curing, so that electrode needle body 11 and sliding part 1231 are fixed.Further, the inner surface of shell 121 is equipped with along electrode The surface of first guide part 1213 of 11 extending direction of needle main body setting, the sliding part 1231 is equipped with and first guide part Second guide part 12313 of 1213 adaptations is protected by the cooperation of second guide part 12313 and first guide part 1213 It demonstrate,proves sliding part 1231 to move axially along electrode needle body 11, sliding part 1231 is mobile just to drive electrode needle body 11 with respect to outer tube 30 is mobile, to adjust the length that electrode needle body 11 distally stretches out outer tube 30.In the present embodiment, the first guide part 1213 is to slide Slot, the second guide part 12313 are protrusion, and the protrusion is embedded in the sliding slot and moves along the sliding slot.It is understood that In other embodiments of the invention, first guide part 1213 or protrusion, the second guide part 12313 can be cunning Slot.

Fig. 2, Figure 11 are please referred to Figure 17, in the present embodiment, the regulating part 1232 includes key 12321 and interconnecting piece 12322, control flume 1211 is provided in the axial direction on the shell 121.In the present embodiment, the first shell 121a and described Two shell 121b are respectively equipped with groove in the position that the two is interlocked, groove and the second housing on the first shell 121a Groove on 121b forms the control flume 1211 after fastening.It is understood that in other implementations of the invention, control flume 1211 can also only be formed on the first shell 121a or on the second housing 121b.One end of the interconnecting piece 12322 with The second part 1231b connection of the sliding part 1321, the other end stretch out the shell 121 from the control flume 1211 and connect The key 12321, pushing the key 12321 to move along the control flume 1211 just can control sliding part 1231 along shell 121 axial movement, to drive the electrode needle body 11 fixed with sliding part 1231 mobile relative to outer tube 30, to adjust electricity The length of the outer tube 30 is stretched out in the distal end of pole needle main body 11.The lesion of patient's body is punctured into ablation needle assemblies 100 Behind position, housing just easily can be stretched out in the distal end for adjusting electrode needle body 11 in real time in vivo by actuation institute key 12321 The length of pipe 30 adjusts effectively ablation length, to adapt to the ablation demand at different lesions position or different patients.The present embodiment In, the interconnecting piece 12322 is fixedly connected described including limit body 12322a and the one end column 12322b, the column 12322b Limit body 12322a, the other end connect the second part 1231b of the sliding part 1231, and the limit body 12322a is pressed with described Key 12321 connects.Wherein, the column 12322b is arranged along the axial direction perpendicular to sliding part 1231 and can be along its own It is axially moved.

In the present embodiment, two column 12323b are arranged in parallel, and each column 12323b is far from limit body 12322a's One end is equipped with annular groove, and detachable card holds E type snap ring 12324 in the annular groove.Second of sliding part 1231 Point 1231b is equipped with the first plane 12314 and second plane 12315 opposite with first plane 12314, and described the Two part 1231b are equipped with from first plane 12314 and penetrate to two apertures 12316 of second plane 12315, and two A column 12322b protrudes into the aperture from 12314 side of the first plane respectively away from one end of the limit body 12322a In 12316, and the E type snap ring 12324 is located at 12315 side of the second plane.Further, in this embodiment described Elastomer 1322 is equipped between limit body 12322a and the sliding part 1321.The elastomer 1322 can be, but not limited to as bullet Spring, elastic slice or elastic washer etc..In the present embodiment, the elastomer 1322 is spring, and the spring is set around the column The periphery 12323b, and between the limit body 12322a and first plane 12314.It is understood that of the invention Some embodiments can also be not provided with column 12323b, and 1322 both ends of elastomer are directly individually fixed in the limit On body 12322a and the sliding part 1231, to connect the limit body 12322a and the sliding part 1231.Shell 121 it is interior Wall is equipped with multiple spaced card slots 1214 in at least side of the control flume 1211, and the limit body 12322a is equipped with At least one detent 123221.When the elastomer 1322 extends naturally, limit body described in 1322 pushing tow of elastomer 12322a so that the detent 123221 is caught in the card slot 1214, meanwhile, the limit body 12322a drives the column 12322b is moved along the axial direction of column 12322b, until E type snap ring 12324 is against the second plane 12315.At this point, cannot The regulating part 1232 is enough moved, i.e., so that the sliding part 1231 remains stationary, avoids the electrode needle body 11 from stretching out outer The length of casing 30 changes.When need to change electrode needle body 11 stretch out outer tube 30 length when, operator manually to Lower pressing keys 12321, limit body 12322a and column 12322b are moved down, and the elastomer 1322, which is pressurized, to be shunk, limit body Detent 123221 on 12322a is separated from card slot 1214 to free, at this time can band along axial push-and-pull key 12321 Dynamic sliding part 1231 and electrode needle body 11 are axially moveable, so that the length that electrode needle body 11 stretches out outer tube 30 is adjusted, Effectively melt length；After key 12321, which reaches a certain position, obtains desired effective ablation length, operator unclamps key 12321,1322 natural resiliency of elastomer resets, and the detent 123221 on ejection limit body 12322a is caught in the card slot In 1214, so that regulating part 1232 and the positioning of sliding part 1231 remain stationary in the position.

Please again refering to Fig. 2 and Figure 17, the outer surface of the shell 121 is equipped with multiple scale markers 1215, multiple described Scale marker 1215 and multiple card slots 1214 correspond.After actuation regulating part 1232 to a certain position of control flume 1211 Scale value corresponding to observation regulating part 1232 can know that the electrode needle body 11 distally stretches out the length of outer tube 30, All in the case where insulation, length, that is, ablation needle 10 that electrode needle body 11 distally stretches out outer tube 30 is able to carry out outer tube 30 Effective ablation length of ablation.As shown in Figure 24 and Figure 25, when actuation regulating part 1232 is at 1211 distalmost end of control flume, The corresponding scale value of regulating part 1232 is maximum, and the electrode needle body 11 distally stretches out the length longest of the outer tube 30, Length is L_max；When actuation regulating part 1232 is at 1211 most proximal end of control flume, the corresponding scale value of regulating part 1232 is most Small, the length that the electrode needle body 11 distally stretches out outer tube 30 is most short, and the length is L_min.According to the dissection of different tissues The adjustable extent of architectural difference, effective ablation length of electrode needle body 11 is also different, for example, in disappearing applied to HCM When melting treatment, the adjustable extent of effective ablation length of electrode needle body 11 is 5mm~35mm.

Figure 18 a, Figure 18 b and Figure 19 are please referred to, the part that the electrode needle body 11 of ablation needle 10 contacts tissue, which can transmit, to be penetrated Frequency energy or microwave energy cause tissue to generate high temperature, so that tissue coagulation is downright bad and reaches therapeutic purposes, but local temperature It is excessively high to will affect the normal tissue for not needing to be melted, therefore the electrode needle body 11 of the ablation needle 10 is except tip portion Outside entity, other parts are hollow inner cavity 111, and are equipped in institute inner cavity 111 and the inner wall interval of inner cavity 111 and coaxial cold But channel 113, the inner cavity 111 and cooling duct 113 are used to convey gaseous state or the cooling medium (such as cooling water) of liquid carries out Cooling, to control temperature when ablation operation.In the present embodiment, using a tubule as cooling duct 113.In the present invention, It is also equipped with thermocouple 112 in the inner cavity 111, with the temperature of 11 surrounding tissue of real-time measurement electrode needle body.The present embodiment In, the thermocouple 112 is arranged in cooling duct 113 and the inner wall interval with cooling duct 113.The ablation handle 12 Proximal end is equipped with inflow entrance 114 and outflux 115, and the inflow entrance 114 is connected to the proximal end of the cooling duct 113, described cold But first gap between 111 inner wall of channel 113 and the inner cavity is connected to the outflux 115, and cooling medium is through flowing Entrance 114 is circulated in cooling duct 113, and flow to first gap from the distal end of cooling duct 113, then through outflux 115 outflows realize the cooling to electrode needle body 11 and its surrounding tissue to form the circulation of cooling water.

Specifically, Figure 12 and Figure 19 are please referred to Figure 21, the ablation handle 12 further includes being set in the shell 121 Piston piece 1233, the piston piece 1233 are coaxially disposed with the sliding part 1231.The distal end of the piston piece 1233 and sliding The proximal seal of part 1231 is fixed, and between sliding part and piston piece 1233 formed water outlet storage chamber C1, the outflux 115 and The first gap between cooling duct 113 and 111 inner wall of inner cavity is connected to water outlet storage chamber C1, and cooling medium is through cooling duct The first gap between 113 and 111 inner wall of inner cavity flow in water outlet storage chamber C1, then is flowed out by outflux 115.The present embodiment In, the substantially cylindrical structure of piston piece 1233, the diameter of distal end is less than the diameter of proximal end, and its distal end is fitted into cunning In 12311 proximal end of the first cavity of moving part 1231, by marine glue to the distal end of piston piece 1233 in the first cavity 12311 Fixation is sealed between wall.Also, the bottom wall of the distal end end face 12331 of the piston piece 1233 and the first cavity 12311 it Between there is the second gap, second gap constitutes the water outlet storage chamber C1.Further, the proximal end of the piston piece 1233 To being distally extended with the second cavity 12332.The bottom wall of second cavity 12332 is equipped with the second centre bore 12333, and described the First centre bore 12312 of two centre bores 12333 and sliding part 1231 is coaxial.The proximal end of the cooling duct 113 passes through described Second centre bore 12333 ends or ends after protruding into the second cavity 12332, and the proximal end of the cooling duct 113 and the The inner wall of two centre bores 12333 is fixed.

Further, Figure 12, Figure 19 and Figure 22, Figure 23 are please referred to, the ablation handle 12 further includes being set to the shell The fixed sleeve member 1234 in 121 and with the shell 121, the sleeve member 1234 are coaxially disposed with the piston piece 1233. The distal end of the sleeve member 1234 is sheathed on outside the proximal end of the piston piece 1233 and movable and close with the piston piece 1233 Envelope connection.Also, water inlet storage chamber C2, the inflow entrance 114 are formed between the piston piece 1233 and the sleeve member 1234 And the cooling duct 113 is connected to the water inlet storage chamber C2, cooling medium enters water inlet storage chamber C2 through inflow entrance 114 It is interior, it enters back into cooling duct 113.Specifically, the sleeve member 1234 is also substantially cylindrical, including one from distal end to proximal end The third cavity 12341 of extension.The proximal end of the piston piece 1233 is fitted into the third cavity 12341 of the sleeve member 1234 And with 12341 inner wall of third cavity sealing and movable connection.When regulating part 1232 drives sliding part 1231 to be slided along axial direction When dynamic, the sliding part 1231 drives piston piece 1233 mobile, and the proximal end of piston piece 1233 is just along axis in third cavity 12341 To movement and without departing from the third cavity 12341 out.Also, second cavity 12332 and the third cavity 12341 Connection forms the water inlet storage chamber C2.The inflow entrance 114 and outflux 115 are set to the bottom wall of the third cavity 12341 On 12342, and the center of the bottom wall 12342 is additionally provided with third centre bore 123421, and the thermocouple 112 is from the third Heart hole 123421 passes through.When driving sliding part 1231 to be axially moveable by regulating part 1232, sliding part 1231 is with piston 1233 relative sleeve part 1234 of part is mobile, so that the space of the water inlet storage chamber C2 is variable.Sliding part 1231, which drives, lives Plug member 1233 moves in sleeve member 1234, and both piston piece 1233 and sleeve member 1234 share a part of axial space always, Help to reduce the axial length for melting handle 12.

In this implementation, several sealing rings 12337, the sealing ring are arranged on the outer wall of the proximal end of the piston piece 1233 Gap between the proximal end and the sleeve member 1234 of the 12337 sealing piston pieces 1233, avoids into water storage chamber C2 Gap outflow of the cooling medium between sleeve member 1234 and the piston piece 1233.

Further, referring to Fig. 4, the ablation handle 12 further includes being removably connected to 121 proximal end of shell End cap 124, for sealing the proximal end of the shell 121.The end cap 124 be equipped with spaced inlet pipeline perforating, Outlet pipeline perforating and bundle conductor perforating.The inlet pipeline perforating can allow for connecting with inflow entrance 114 into Water lines 116 pass through, and the outlet pipeline perforating can allow for the outlet pipeline connecting with outflux 114 117 to pass through, described Bundle conductor perforating can allow for the conducting wire being electrically connected with thermocouple 112 and the conducting wire being electrically connected with electrode needle body 11 to be formed Bundle conductor 118 pass through.

Further, please refer to Figure 12 and Figure 19, the water inlet storage chamber C2 is interior to be equipped with water outlet transfer tube 1235, institute The distal end for stating water outlet transfer tube 1235 passes through the piston piece 1233 and is connected to the water outlet storage chamber C1, the water outlet transfer tube 1235 proximal end is connected to the outflux 115, and connect with the outlet pipeline 117.In the present embodiment, the water outlet switching Pipe 1235 includes the spiral section 1235a that can be stretched along 1234 axial direction of sleeve member.It is slided when actuation regulating part 1232 drives When moving part 1231 and piston piece 1233 are axially moveable, the spiral section 1235a of transfer tube 1235 is discharged in water inlet storage chamber C2 Piston piece 1233 can be followed to occur to stretch or shrink, the axial movement without influencing piston piece 1233 also can be avoided and pull out Water lines 117 frequently pass in and out shell 121, to avoid the friction and damage to outlet pipeline 117.

Arrow in Figure 19 illustrates the flow path of cooling medium.Specifically, cooling medium is passed through from inlet pipeline 116 Inflow entrance 114 enters in the water inlet storage chamber C2, then flow in cooling duct 113 from the water inlet storage chamber C2, then from The first gap between 111 inner wall of cooling duct 113 and the inner cavity of electrode needle body 11 flows out in water outlet storage chamber C1, through going out Water transfer tube 1235 flow to outflux 115, most flows out afterwards through outlet pipeline 117, realizes cooling medium in electrode needle body 11 Cooling cycle.

Figure 26 is please referred to, in some embodiments of the invention, the ablation needle assemblies 100 further include biopsy needle 20, institute It states ablation needle 10 and the biopsy needle 20 is more alternately installed in the outer tube 30.Specifically, the biopsy needle 20 includes living Inspection needle main body and the biopsy handle being connect with the biopsy needle proximal；The ablation needle 10 is separated with the outer tube 30 Afterwards, the biopsy needle main body of the biopsy needle 20 installs in the outer tube 30, and stretches to biopsy position along the outer tube 30 It sets, to implement biopsy operation.Further, the biopsy handle of the biopsy needle 20 also can detachably connect with the outer tube 30 It connects.In other words, the ablation needle 10 can be detachably connected with the outer tube 30, the biopsy needle 20 can also with it is described Outer tube 30 is detachably connected, can be by the biopsy needle 20 after the ablation needle 10 is split with the outer tube 30 It is connect with the outer tube 30.Therefore, after completing ablation operation, the connection of ablation needle 10 and the outer tube 30 is released, it will Outer tube 30 stays within the organization, provides channel for biopsy procedure, so that biopsy needle 20 quickly reaches desired biopsy sites, avoids Repeated puncture reduces the damage to tissue；Alternatively, after formerly can completing biopsy procedure, being released in some surgical procedures The connection of biopsy needle 20 and outer tube 30, outer tube 30 is stayed within the organization, provides channel for ablation operation, so that ablation needle 10 Desired ablation locations are quickly reached, equally can be avoided repeated puncture, reduce the damage to tissue.

Incorporated by reference to Figure 27 and Figure 28, further, in some embodiments of the invention, the ablation needle assemblies 100 further include Puncture needle core 40, the diameter of puncture needle core 40 are greater than the diameter of the ablation needle 10 or biopsy needle 20, the diameter of puncture needle core 40 Range preferably from 19G~16G.And puncture needle core 40 is preferably made compared with the material of hard, such as: stainless steel.The puncture needle core 40 are more alternately installed in the outer tube 30 with the ablation needle 10 or biopsy needle 20 and detachably connect with the outer tube 30 It connects, the outer tube 30 is stretched out in the distal end of the puncture needle core 40.In the present embodiment, the distal end of the puncture needle core 40 is in sharp Needle-shaped or triangular pyramid, proximal end can fix a joint for fittings with internal threads 41, the internal screw thread and outer tube of the connector 41 The external screw thread of 30 proximal ends is adapted.It, can be before ablation or before biopsy by puncture needle core 40 and housing after increasing puncture needle core 40 The combination of pipe 30 punctures tissue, releases the connection of puncture needle core 40 and outer tube 30 later, withdraws from puncture needle core 40, then to Ablation needle 10 or biopsy needle 20 are penetrated in outer tube 30.It is relatively large in diameter, can mention compared with the puncture needle core 40 of hard for outer tube 30 Combination for preferable supportive, therefore puncture needle core 40 and outer tube 30 is more convenient for puncturing, and can prevent from directly utilizing When ablation needle 10 or biopsy needle 20 are punctured, ablation needle 10 or biopsy needle 20 are damaged.

Further, Fig. 4, Figure 19 and Figure 29 are please referred to, the present invention also provides a kind of ablation system 200, including described is disappeared Melt needle assemblies 100 and energy generating apparatus 110.The energy generating apparatus 110 passes through the bundle conductor 118 and electrode needle body 11 are electrically connected, to carry out ablation operation.In some embodiments of the invention, the ablation system 200 further includes medical image Device 120 and/or cooling device 130.Wherein, the energy generating apparatus 110 is electrically connected the ablation needle 10, the energy Generating device 110 can be, but not limited to as radio-frequency signal generator or microwave generator.The cooling device 130 passes through inlet pipeline 116 and outlet pipeline 117 with ablation needle assemblies 100 connect, in the electrode needle body 11 recycle gaseous state or liquid are provided Cooling medium.The medical imaging devices 120 are used for outer tube 30 and the remote location of electrode needle body 11 described in real-time display, It can be selected from least one of ultrasound, CT, nuclear-magnetism, x-ray fluoroscopy, it is preferably ultrasonic.

The ablation needle assemblies 100 of the invention and ablation system 200 can but be not limited to apply the treatment in HCM, with And the treatment and biopsy of kidney, liver or soft tissue neoplasm.

As shown in Fig. 4 and Figure 30 a to Figure 30 c, the present embodiment illustrates the ablation needle assemblies 100 for treating HCM Use process:

Step 1: ablation needle 10 is installed in outer tube 30 first, hand by outer tube 30 and is melted by connector 122 Handle 12 connects, and obtains ablation needle assemblies 100 as shown in Figure 2.Actuation regulating part 1232 is to drive the sliding part 1231 and electricity Pole needle main body 11 is axially moveable with respect to outer tube 30, and electrode needle body 11 expected from acquisition one distally stretches out the length of outer tube 30 Degree, that is, obtain preliminary effective ablation length.

Step 2: as shown in Figure 30 a, by outer tube 30 and electrode needle body 11 by between rib cage under the guidance of Vltrasonic device It punctures through the apex of the heart and is entered in interventricular septum wall by the external membrane of heart, open radio-frequency signal generator, outer tube 30 is stretched out by electrode needle body 11 Part carries out RF ablation to plump myocardium of ventricular septum.In ablation procedure, if effectively ablation length need to be adjusted, along axial direction The mobile key 12321 is with actuation regulating part 1232 and sliding part 1231, drive electrode needle body 11 phase in real time in vivo To the movement of outer tube 30 to be adjusted to required effective ablation length.

RF ablation can destroy the activity of corresponding site myocardium of ventricular septum, make myocardial necrosis atrophy, thinning, to make a left side Ventricular outflow tract view is broadening, releases obstruction.HCM is treated using the ablation needle assemblies 100, had both avoided surgery rotary-cut opening operation chest and body The risk and pain of outer circulation, also that chemical ethanol ablation is not invalid or the excessive risk for causing large area heart infarction of alcohol, simply Easy, extremely small to patient trauma, operation risk is small, and significant in efficacy；Effectively disappear further, it is possible to adjust in real time in vivo Melt length, greatly improve procedure efficiency, reduces the damage to tissue.

Step 3: releasing the company of outer tube 30 and connector 122 after having executed ablation as shown in Figure 30 b and Figure 30 c It connects, withdraws from ablation needle 10 and indwelling outer tube 30, then biopsy needle 20 penetrates outer tube 30 and extracts tissue samples for biopsy.Institute It states outer tube 30 and provides channel for biopsy procedure, can be avoided repeated puncture, reduce the damage to tissue, and enable to Biopsy needle 20 quickly reaches desired biopsy sites.

It is understood that in some cases, it can also be before executing ablation first by outer tube 30 and 20 groups of biopsy needle Conjunction punctured, biopsy, then withdraws from biopsy needle 20 and indwelling outer tube 30, ablation needle 10 is finally penetrated outer tube 30, is led to The connection that connector 122 sets up outer tube 30 Yu ablation needle 10 is crossed, equally can be avoided repeated puncture, reduces the damage to tissue Wound.

As shown in Figure 31 a to Figure 31 e, in some embodiments of the invention, the ablation needle assemblies 100 increase puncture After needle core 40, it can combine puncture needle core 40 with outer tube 30 before ablation or before biopsy and puncture, release puncture needle later The connection of core 40 and outer tube 30, withdraws from puncture needle core 40, and indwelling outer tube 30 is penetrated in patient's body, then into outer tube 30 Ablation needle 10 or biopsy needle 20 carry out ablation or biopsy procedure, to increase puncture strength, and prevent puncture process lesion ablation needle 10 or biopsy needle 20.

The above is the preferred embodiment of the present invention, it is noted that for those skilled in the art For, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also considered as Protection scope of the present invention.

Claims

1. a kind of ablation needle assemblies, which is characterized in that including hollow outer tube and ablation needle；The ablation needle includes electrode Needle main body and the ablation handle connecting with the electrode needle body proximal end, the outer tube at least partly insulate, the electrode needle Subject activity is threaded onto the outer tube；The ablation handle include shell, the connector fixed with shell distal end and Along the driving portion of shell axial movement；The outer tube is detachably connected with the connector, the electrode needle body Proximal end is fixed with the driving portion, and the driving portion drives the electrode needle body mobile relative to the outer tube, to adjust in real time The length of the outer tube is stretched out in the distal end for saving the electrode needle body.

2. melting needle assemblies as described in claim 1, which is characterized in that the driving portion include sliding part and with the sliding The regulating part of part connection, the proximal end of the electrode needle body are fixed with the sliding part, and the sliding part is contained in the shell Interior, the regulating part controls the sliding part and moves in the shell, to drive the relatively described housing of the electrode needle body Pipe axial movement.

3. ablation needle assemblies as claimed in claim 2, which is characterized in that the regulating part includes key and limit body, described Control flume is offered on shell, described limit body one end is connect with the sliding part, and the other end is from described in control flume stretching Shell simultaneously connects the key, pushes the key to move along the control flume to control the sliding part along the axis of the shell To movement.

4. ablation needle assemblies as claimed in claim 3, which is characterized in that be equipped with bullet between the limit body and the sliding part Property body, the inner wall of the shell be located at the control flume at least side be equipped with multiple card slots, the limit body be equipped at least One detent, when the elastomer extends naturally, limit body described in the elastomer pushing tow is so that the detent is caught in the card In slot.

5. ablation needle assemblies as claimed in claim 2, which is characterized in that the inner surface of the shell is equipped with along the electrode needle The first guide way that main body is axially arranged, the surface of the sliding part are equipped with the second guiding being adapted to first guide way Body, by the cooperation of second guide way and first guide way so that the sliding part is axial along the electrode needle body It is mobile.

6. ablation needle assemblies as described in claim 1, which is characterized in that the connector includes standard shaft and revolves with the standard shaft Turn the retainer ring of connection, the distal end of the standard shaft is fixedly connected with the shell, and the outer tube is detachably connected with the retainer ring.

7. melting needle assemblies as claimed in claim 6, which is characterized in that the proximal end of the standard shaft is equipped with the first card slot, described The distal end clamping of shell is fixed in first card slot；Second is equipped with positioned at the distal side of first card slot on the standard shaft The proximal end rotation of card slot, the retainer ring is fastened in second card slot.

8. ablation needle assemblies as described in claim 1, which is characterized in that the distal end of the outer tube has the first guide portion, First guide portion is developed under medical imaging devices.

9. ablation needle assemblies as claimed in claim 1 or 8, which is characterized in that the distal end of the electrode needle body has second Guide portion, second guide portion are developed under medical imaging devices.

10. ablation needle assemblies as claimed in claim 2, which is characterized in that be equipped in the electrode needle body and proximally extend To the inner cavity of distal end, and the lumen proximal is open, and distal end is closed, it is described it is interior it is intracavitary be equipped with cooling duct, and the cooling is logical There is the first gap between road and the inner wall of the inner cavity.

11. as claimed in claim 10 ablation needle assemblies, which is characterized in that it is described ablation handle proximal end be equipped with inflow entrance and Outflux, the inflow entrance are connected to the proximal end of the cooling duct, and the outflux is connected to first gap.

12. ablation needle assemblies as claimed in claim 11, which is characterized in that the ablation handle further includes being set to the shell Interior piston piece, the piston piece and the sliding part are coaxially disposed, the proximal end of the distal end of the piston piece and the sliding part Sealing is fixed, and water outlet storage chamber, the outflux and first gap are formed between the sliding part and the piston piece It is connected to the water outlet storage chamber.

13. ablation needle assemblies as claimed in claim 12, which is characterized in that the proximal end of the sliding part is equipped with the first cavity, The distal end of the piston piece is protruded into first cavity and is sealed with the inner wall of first cavity and fixes, the piston piece There is the second gap, second gap forms the water outlet storage chamber between distal end end face and the bottom wall of first cavity.

14. ablation needle assemblies as described in claim 12 or 13, which is characterized in that the ablation handle further includes set on described The sleeve member being fixedly connected in shell and with the shell, the sleeve member and the piston piece are coaxially disposed, the sleeve member Distal end be sheathed on outside the proximal end of the piston piece and movable with the piston piece and be tightly connected, the piston piece with it is described Water inlet storage chamber is formed between sleeve member, the inflow entrance and the cooling duct are connected to the water inlet storage chamber.

15. ablation needle assemblies as claimed in claim 14, which is characterized in that the proximal end of the piston piece is equipped with the second cavity, The distal end of the sleeve member is equipped with third cavity, the proximal end of the piston piece be inserted into the third cavity and with the third chamber Internal wall is tightly connected, and second cavity is connected to form the water inlet storage chamber with the third cavity.

16. ablation needle assemblies as claimed in claim 14, which is characterized in that be arranged on the outer wall of the proximal end of the piston piece Sealing ring, the sealing ring seal the gap between the proximal end of the piston piece and the sleeve member.

17. ablation needle assemblies as claimed in claim 15, which is characterized in that be equipped with water outlet switching in the water inlet storage chamber Pipe, the distal end of the water outlet transfer tube passes through the piston piece and is connected to the water outlet storage chamber, described to be discharged the close of transfer tube End is connected to the outflux.

18. ablation needle assemblies as claimed in claim 17, which is characterized in that the water outlet transfer tube includes can be along the sleeve The spiral section of part axial stretching.

19. ablation needle assemblies as described in claim 1, which is characterized in that the ablation needle assemblies further include biopsy needle, described Biopsy needle is more alternately threaded onto the outer tube with the ablation needle and is detachably connected with the outer tube.

20. the ablation needle assemblies as described in claim 1 or 19, which is characterized in that it further include puncture needle core, the puncture needle core More alternately be threaded onto the outer tube with the ablation needle and be detachably connected with the outer tube, the puncture needle core it is remote The outer tube is stretched out at end.

21. a kind of ablation system, which is characterized in that including the described in any item ablation needle assemblies of such as claim 1 to 20 and The energy generating apparatus being electrically connected between the electrode needle body of the ablation needle.

22. ablation system as claimed in claim 21, which is characterized in that the energy generating apparatus is radio-frequency signal generator or micro- Wave producer.

23. the ablation system as described in claim 21 or 22, which is characterized in that further include the proximal end with the electrode needle body The cooling device being connected.