CN109833089A - Suitable for treating the ablation needle assemblies and ablation system of hypertrophic cardiomyopathy - Google Patents

Suitable for treating the ablation needle assemblies and ablation system of hypertrophic cardiomyopathy Download PDF

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Publication number
CN109833089A
CN109833089A CN201811079426.5A CN201811079426A CN109833089A CN 109833089 A CN109833089 A CN 109833089A CN 201811079426 A CN201811079426 A CN 201811079426A CN 109833089 A CN109833089 A CN 109833089A
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CN
China
Prior art keywords
ablation
needle
insulating sleeve
electrode needle
needle body
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201811079426.5A
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Chinese (zh)
Inventor
丘信炯
李阳
李雯雯
彭波波
张庭超
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Hangzhou Noocheng Medical Devices Co Ltd
Original Assignee
Hangzhou Noocheng Medical Devices Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Hangzhou Noocheng Medical Devices Co Ltd filed Critical Hangzhou Noocheng Medical Devices Co Ltd
Publication of CN109833089A publication Critical patent/CN109833089A/en
Priority to PCT/CN2019/090923 priority Critical patent/WO2020052302A1/en
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1487—Trocar-like, i.e. devices producing an enlarged transcutaneous opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle

Abstract

The present invention provides a kind of ablation needle assemblies and ablation system.The ablation needle assemblies include hollow insulating sleeve and ablation needle, and the electrode needle body activity of ablation needle is installed in insulating sleeve.The distal portion of electrode needle body has the first main inclined plane, the proximal end and distal end of first main inclined plane are located at the opposite sides of electrode needle body axis, and first main inclined plane proximal end and the distance between electrode needle body axis be greater than or equal to the distance between the distal end of the first main inclined plane and electrode needle body axis, angular range between first main inclined plane and electrode needle body axis is 15 °~60 °, so that the ablation areas of electrode needle body distal portion is no longer spherical or close to spherical shape, but show the irregular shape towards the opposite side deflection of the first main inclined plane, to reduce the maximum width of ablation areas, to adapt to flat cardiac septum structure, ablation is avoided to penetrate to the internal membrane of heart, radiofrequency ablation therapy especially suitable for hypertrophic cardiomyopathy.

Description

Suitable for treating the ablation needle assemblies and ablation system of hypertrophic cardiomyopathy
Technical field
The present invention relates to the field of medical instrument technology more particularly to a kind of ablation needle groups suitable for treating hypertrophic cardiomyopathy Part and ablation system.
Background technique
Hypertrophic cardiomyopathy (Hypertrophic cardiomyopathy, referred to as: HCM), is a kind of common normal dyeing Body dominant inheritance cardiovascular disease is mainly shown as that the one or more segments of left ventricle (Left Ventricle, LV) are plump, one As diagnostic criteria be thickness be more than or equal to 15mm.When there is mitral anterior lobe systolic anterior motion (Systolic Anterior Motion, SAM) recline interventricular septum, and cause left ventricular outflow tract view (Left Ventricular Outflow Tract, LVOT) narrow Even block, i.e., when LVOT pressure difference is excessive, just referred to as obstructive hypertrophic cardiomyopathy (Hypertrophic Obstructive Cardiomyopathy, HOCM), HOCM accounts for about the 70% of HCM patient.Therapeutic strategy to HCM is to expand LVOT to reduce pressure Difference simultaneously mitigates its obstruction, and method mainly has drug therapy, interventricular septum rotary-cut art, interventricular septum ethanol ablation art.Drug therapy is opposite For it is simple and easy, but some patientss medication effect is bad or does not tolerate；Interventricular septum rotary-cut art, i.e. improvement Morrow art are Chest is opened by surgical operation and cuts off hypertrophic cardiomyopathy, and excision position is mainly interventricular septum front and concentrates on left room face, cutting off rear chamber Spacer thickness can reduce by 50%, and postoperative LVOT is substantially reduced, but improve Morrow art there are certain risk, and patient Post-operative recovery is also more painful；Interventricular septum ethanol ablation art is a kind of interventional therapy means, mainly the percutaneous intracavitary hat of application Sacculus is sent into the quasi- septal branch eliminated by shape arterioplasty technology, and being slowly injected into alcohol to septal branch makes it generate chemistry Property occlusion to make plump myocardium of ventricular septum ischemic, necrosis, the decline of thinning, convergent force reduce LVOT, although such method is kept away The pain of operation is exempted from, but in clinical application, alcohol may cause myocardial infarction by branch vessel, however it remains certain wind Danger.Therefore, need that a kind of wound is small and more safe and effective therapeutic modality for hypertrophic cardiomyopathy.
Radio frequency ablation needle or microwave melt needle are a kind of Minimally Interventional Therapy instruments, are applied primarily to treatment liver at present The tumour at the positions such as dirty, kidney, soft tissue.As shown in Figures 1 and 2, the distal end P of existing radio frequency ablation needle or microwave melt needle It is usually designed to positive triangular pyramid, coniform, spherical or umbrella electrode, it is intended to increase the contact area with tumor tissues T, hold Large area, spherical shape or ablation region A close to spherical shape can be formed when row ablation.As shown in Figure 3 and Figure 4, because of heart chamber The structure for being spaced S is more flat, and spherical or close to spherical shape zone of ablation A penetrates readily through that (Fig. 4 is shown using existing to internal membrane of heart E The be positive ablation needle of triangular pyramid of some distal ends carried out RF ablation to the interventricular septum tissue of fresh Pigs Hearts, in ablation 12 minutes Afterwards, it is seen that the ablation region A whitened is close to spherical shape, and has penetrated to internal membrane of heart E), causes conductive beam damage and arrhythmia cordis, institute Treatment hypertrophic cardiomyopathy is not particularly suited for aforementioned existing radio frequency ablation needle or microwave melt needle.
Summary of the invention
The present invention provides a kind of ablation needle assemblies and ablation system suitable for treating hypertrophic cardiomyopathy.
The ablation needle assemblies include hollow insulating sleeve and ablation needle；The ablation needle includes that activity is installed on institute The electrode needle body in insulating sleeve is stated, the insulating sleeve is stretched out in the distal end of the electrode needle body；The electrode needle body Distal portion there is the first main inclined plane, the proximal end of first main inclined plane and the distal end of the first main inclined plane are located at electrode needle master The opposite sides of body axis, and the distance between the proximal end of the first main inclined plane and electrode needle body axis are greater than or equal to the first master The distance between the distal end on inclined-plane and electrode needle body axis, the angle between first main inclined plane and electrode needle body axis Range is 15 °~60 °.The setting of first main inclined plane is so that the ablation areas of electrode needle body distal portion is no longer spherical or close Spherical shape, but the irregular shape towards the opposite side deflection of the first main inclined plane is showed, so that the maximum for reducing ablation areas is wide Degree avoids ablation from penetrating to the internal membrane of heart to adapt to flat cardiac septum structure, prevents damage conductive beam, especially suitable for The radiofrequency ablation therapy of hypertrophic cardiomyopathy.
The distal portion of the electrode needle body also has the second main inclined plane in one of the embodiments, and described second is main Inclined-plane is oppositely arranged with the first main inclined plane, and the angle between second main inclined plane and electrode needle body axis is main less than first Angle between inclined-plane and electrode needle body axis.
In one of the embodiments, the angular range between second main inclined plane and electrode needle body axis be 5 °~ 30°。
The distal end of first main inclined plane and the distal portion of the electrode needle body intersect in one of the embodiments, One straight line, the distal end of second main inclined plane and the distal portion of the electrode needle body intersect at the same straight line.
The ablation needle assemblies further include several auxiliary puncture faces in one of the embodiments, and several auxiliary are worn Thorn face is located at the two sides of first main inclined plane and chamfers the distal portion of the electrode needle body, and several auxiliary puncture Face and first main inclined plane intersect at a point to form the end of the electrode needle body, and the electrode needle is deviateed in the end The axle center of main body.
The quantity in the auxiliary puncture face is two in one of the embodiments, and described two auxiliary puncture faces are closed Angle between the axisymmetrical of the electrode needle body, each auxiliary puncture face and the axis of the electrode needle body Range is 30 °~60 °.
The distal end of the insulating sleeve is straight in one of the embodiments,.
The distal end of the insulating sleeve is the tip of beveling in one of the embodiments, and when executing ablation, described The inclined direction at the tip of beveling and the inclined direction of first main inclined plane are runed counter to.
The ablation needle further includes the ablation hand connecting with the electrode needle body proximal end in one of the embodiments, Handle, detachable between the insulating sleeve proximal end and the ablation handle and rotate connection, the ablation handle is relatively described exhausted Edge sleeve rotating is to drive the electrode needle body to rotate relative to the insulating sleeve.
The ablation needle assemblies further include biopsy needle in one of the embodiments, the biopsy needle and the ablation needle It is more alternately installed in the insulating sleeve.
The ablation needle assemblies further include puncture needle core in one of the embodiments, and the puncture needle core disappears with described Melt needle or the biopsy needle is more alternately installed in the insulating sleeve and is detachably connected with the insulating sleeve, the puncture The insulating sleeve is stretched out in the distal end of needle core.
In one of the embodiments, the ablation handle include shell, the driving assembly being contained in the shell and With the connector of the driving component rotation connection, the insulating sleeve is detachably connected with the connector；The driving group Part drives and moves axially relatively between the insulating sleeve and the electrode needle body, to adjust the remote of the electrode needle body The length of the insulating sleeve is stretched out at end.
The driving component includes sliding part and the regulating part that connect with the sliding part in one of the embodiments, The connector is coaxially disposed and rotates with the sliding part and connect, and the regulating part controls the sliding part and axially moves along it It is dynamic, to drive the insulating sleeve connected with the connector mobile relative to the electrode needle body.
The axial direction on the shell along the sliding part offers control flume, the adjusting in one of the embodiments, The shell is stretched out from the control flume in one end of part；Through the movement regulating part described in the position control of the control flume Sliding part moves along its axis.
At least side of the control flume is equipped with scale marker in one of the embodiments,.
Elastic component is equipped between the regulating part and the sliding part in one of the embodiments, the elastic component Extending direction is towards the control flume；The inner wall of the shell is equipped with multiple detents corresponding with the scale marker, described Regulating part is equipped at least one protrusion；When the elastic component extends naturally, protrusion described in the elastic component pushing tow is caught in described In detent.
The distal loop of the sliding part is equipped with card slot in one of the embodiments, and the proximal end of the connector is equipped with card Circle, the retainer ring is caught in the card slot so that the sliding part and connector rotation connect.
The distal end of the insulating sleeve has the first guide portion in one of the embodiments, and first guide portion exists Develop under medical imaging devices.
The distal end of the electrode needle body has the second guide portion, second guide portion in one of the embodiments, Develop under medical imaging devices.
Cooling duct is equipped in the electrode needle body in one of the embodiments,.
The ablation system includes ablation needle assemblies and is electrically connected between the electrode needle body of the ablation needle Energy generating apparatus.
The energy generating apparatus is radio-frequency signal generator or microwave generator in one of the embodiments,.
In one of the embodiments, the ablation system further include be connected with the proximal end of the electrode needle body it is cold But device.
Ablation needle assemblies of the invention and ablation system compared with prior art, at least have the advantages that
The distal portion of electrode needle body is equipped with the first main inclined plane, and the proximal end and distal end of first main inclined plane are located at electricity The opposite sides of pole needle main body axis, and the distance between the proximal end of the first main inclined plane and electrode needle body axis are greater than or equal to The distance between the distal end of first main inclined plane and electrode needle body axis, between first main inclined plane and electrode needle body axis Angular range be 15 °~60 ° so that the ablation areas of electrode needle body distal end is no longer spherical or close to spherical shape, but be in Now it can adapt to flat towards the irregular shape of the opposite side deflection of the first main inclined plane to reduce the maximum width of ablation areas Flat cardiac septum structure avoids ablation from penetrating to the internal membrane of heart, damage conductive beam is prevented, especially suitable for hypertrophic cardiomyopathy Radiofrequency ablation therapy.
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.
Schematic diagram when Fig. 1 is existing umbrella ablation needle ablated tumor tissue；
Fig. 2 is the schematic diagram that existing ablation needle is formed by spherical ablation zone；
Fig. 3 is the schematic diagram using existing ablation needle ablation cardiac septum；
Fig. 4 is that the dissection picture after ablation experiment is carried out to Pigs Hearts interventricular septum using existing ablation needle；
Fig. 5 is the structural schematic diagram of the ablation needle assemblies of the embodiment of the present invention；
The ablation needle and the structural schematic diagram after insulating sleeve assembly that Fig. 6 is the embodiment of the present invention；
Fig. 7 is ablation needle shown in Fig. 5 and the main view after insulating sleeve assembly；
Fig. 8 is the insulating sleeve structure schematic diagram of one embodiment of the invention；
Fig. 9 is the enlarged diagram of the distal end of the electrode needle body of one embodiment of the invention；
Figure 10 is schematic cross-section of the electrode needle body shown in Fig. 9 in the position A-A；
Figure 11 is the electrode needle body structural schematic diagram of one embodiment of the invention；
Figure 12 a is the stereoscopic schematic diagram of the first embodiment of electrode needle body distal portion in the present invention；
Figure 12 b is the schematic front view of the first embodiment of electrode needle body distal portion in the present invention；
Figure 12 c is the straight insulating sleeve in the first embodiment cooperation distal end of electrode needle body distal portion in the present invention in room The schematic diagram melted in interval；
Figure 12 d is that the first embodiment cooperation distal end of electrode needle body distal portion in the present invention is the insulation sleeve of chamfered tip The schematic diagram that pipe is melted in interventricular septum；
Figure 13 a, Figure 13 b are that the second embodiment of electrode needle body distal portion in the present invention is vertical under different perspectives respectively Body schematic diagram；
Figure 13 c, Figure 13 d show with the main view that Figure 13 e is the second embodiment of electrode needle body distal portion in the present invention respectively Intention, right side view and schematic top plan view；
Figure 13 f is the straight insulating sleeve in the second embodiment cooperation distal end of electrode needle body distal portion in the present invention in room The schematic diagram melted in interval；
Figure 13 g is that the second embodiment cooperation distal end of electrode needle body distal portion in the present invention is the insulation sleeve of chamfered tip The schematic diagram that pipe is melted in interventricular septum；
Figure 14 a, Figure 14 b are that the 3rd embodiment of electrode needle body distal portion in the present invention is vertical under different perspectives respectively Body schematic diagram；
Figure 14 c, Figure 14 d are the right depending on showing of the 3rd embodiment of electrode needle body distal portion in the present invention respectively with Figure 14 e Intention, schematic front view and schematic top plan view；
Figure 14 f is the straight insulating sleeve in the 3rd embodiment cooperation distal end of electrode needle body distal portion in the present invention in room The schematic diagram melted in interval；
Figure 14 g is that the 3rd embodiment cooperation distal end of electrode needle body distal portion in the present invention is the insulation sleeve of chamfered tip The schematic diagram that pipe is melted in interventricular septum；
Figure 15 a, Figure 15 b are that the fourth embodiment of electrode needle body distal portion in the present invention is vertical under different perspectives respectively Body schematic diagram；
Figure 15 c, Figure 15 d, Figure 15 e and Figure 15 f are the fourth embodiment of electrode needle body distal portion in the present invention respectively Schematic front view, schematic rear view, right side view and schematic top plan view；
Figure 15 g is the straight insulating sleeve in the fourth embodiment cooperation distal end of electrode needle body distal portion in the present invention in room The schematic diagram melted in interval；
Figure 15 h is that the fourth embodiment cooperation distal end of electrode needle body distal portion in the present invention is the insulation sleeve of chamfered tip The schematic diagram that pipe is melted in interventricular septum；
Figure 16 is that the dissection picture after ablation experiment is carried out to Pigs Hearts interventricular septum using ablation needle of the invention；
Figure 17 is ablation needle shown in Fig. 7 and the schematic cross-section after insulating sleeve assembly；
Figure 18 is the driving assembly structural schematic diagram of the ablation needle of the embodiment of the present invention；
Figure 19 is the biopsy needle of the embodiment of the present invention and the fractionation schematic diagram of insulating sleeve；
Figure 20 is the combination diagram of biopsy needle and insulating sleeve shown in Figure 18；
Figure 21 is the puncture needle core of the embodiment of the present invention and the fractionation schematic diagram of insulating sleeve；
Figure 22 is the combination diagram of puncture needle core and insulating sleeve shown in Figure 20；
Figure 23 a to Figure 23 c is the using process diagram of the ablation needle assemblies of one embodiment of the invention；
Figure 24 a to Figure 24 e is the using process diagram of the ablation needle assemblies of another embodiment of the present invention；
Figure 25 is the structural schematic diagram of the ablation system of the 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 ablation needle assemblies and ablation system for being suitable for treating hypertrophic cardiomyopathy of the invention Structure, limit herein term " proximal end " and " distal end " as intervene medical field common terminology.Specifically, " distal end " indicates hand Far from one end of operator in art operating process, " proximal end " indicates 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. 5 to Fig. 7, the present invention provides a kind of ablation needle assemblies 100, for by inserting through apical approach Enter patient's heart, ablation operation is carried out to plump myocardium of ventricular septum, to treat hypertrophic cardiomyopathy.The ablation needle assemblies 100 include insulating sleeve 30 and ablation needle 10.The ablation needle 10 is close including electrode needle body 11 and with electrode needle body 11 Hold the ablation handle 12 of connection.The insulating sleeve 30 be movably set in the electrode needle body 11 it is outer and with the ablation handle 12 is detachable and rotate connection.Insulating sleeve 30 is stretched out in the distal end of the electrode needle body 11, since insulating sleeve 30 is all exhausted Edge, the part that electrode needle body 11 stretches out insulating sleeve 30 execute ablation operation.Specifically, the electrode needle body 11 electrically connects When connecing radio-frequency signal generator, electrode needle body 11 transmits high-frequency current and makes band in the pathological tissues of 11 distal end surrounding of electrode needle body High speed oscillating movement occurs for the negative ions of charge, and the ion of high speed oscillation makes pathological tissues because of a large amount of heat of friction generation Interior temperature increases, and finally makes the protein denaturation in sick cell, intraor extracellular loss of water, coagulability occur in pathological tissues Necrosis, to realize RF ablation；When the electrode needle body 11 is electrically connected microwave generator, 11 distal end shape of electrode needle body At microwave field, the dipole molecules such as hydrone in pathological tissues are produced under the action of microwave field because of friction of motion, sharp impacts Heat increases temperature in pathological tissues, finally makes the protein denaturation in sick cell, intraor extracellular loss of water, lesion There is coagulation necrosis in tissue, to realize microwave ablation.Also, the insulating sleeve 30 and the ablation handle 12 are detachable Connection, so that can be dismantled ablation needle 10 and insulating sleeve 30, still by insulating sleeve 30 after completing ablation operation 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 other operation enhanced conveniences are efficient.Further, the ablation handle 12 can be rotated relative to the insulating sleeve 30 To drive the electrode needle body 11 to rotate relative to the insulating sleeve 30, i.e. the electrode needle master of insulating sleeve 30 and ablation needle 10 Body 11 is not integral structure, when needing to rotate ablation needle 10, insulating sleeve 30 can be kept not turn, to reduce to tissue Damage, and the resistance rotated is smaller.
When executing ablation operation, insulation tube of the insulating sleeve 30 as ablation needle 10.In order to improve insulating sleeve 30 supportive, and convenient for being pierced into tissue, it is preferable that the insulating sleeve 30 makes tube body by metal material, then at this The outer surface coating insulating coating of tube body is made, and the metal material includes but is not limited to 304 stainless steels, 321 stainless steels or 631 Stainless steel tube, the insulating coating include but is not limited to PTFE coating, titanium nitride coating, parylene coating etc..It makes described exhausted The metal material of edge casing 30 should have enough hardness to be pierced into tissue, while the bio-compatible for needing to have excellent Property, the insulating coating need to have reliable insulating properties, excellent biocompatibility and lesser coefficient of friction, and require exhausted It combines closely between edge coating and the outer surface of tube body of insulating sleeve 30, insulating coating is not easily to fall off, such as can choose 304 not Rust steel pipe adds PTFE coating, 321 stainless steel tubes that titanium nitride coating or 631 stainless steel tubes is added to add parylene coating etc..In view of exhausted Edge reliability and technological feasibility, the thickness of various insulating coatings should all >=3 μm.It is understood that in other embodiments, The insulating sleeve 30 can also be made by insulating materials completely, for example PEEK, PI or PA etc. can satisfy hardness requirement Plastic tube, for another example ceramic tubes such as alumina porcelain, steatite ceramic or boron nitride.
The distal end of insulating sleeve 30 can be it is straight, be also possible to beveling tip.Preferably, insulating sleeve 30 is remote End is tip, and each position of insulating sleeve 30 is relatively easily inserted into tissue, and is made around the insulation sleeve The tissue of each position of pipe 30 is different from the contact area of electrode needle body 11, thus according to the anatomical structure of tissue, It determines the ablation areas needed, and realizes orientation, positioning ablation by adjusting the direction of insertion of the insulating sleeve 30.
Further, insulating sleeve 30 is equipped with scale marker 31 to indicate that insulating sleeve 30 is inserted into the depth of tissue, institute Stating scale marker 31 includes a series of scale values, and scale value is proximally gradually increased from distal end.When 30 insertion group of insulating sleeve When knitting interior, it can know that insulating sleeve 30 is inserted into the depth of tissue by the scale value on observation insulating sleeve 30, to know The insulating sleeve 30 is inserted into the approximate location in tissue.Further, as shown in figure 8,30 distal end of the insulating sleeve has The first guide portion 34 that can develop under medical imaging devices, the length need >=5mm of first guide portion 34, to guarantee position Whether the accuracy of guidance, the first guide portion 34 can help doctor to judge 30 distal end of insulating sleeve along desired puncture path row Into and whether close to scheduled ablation locations.Specifically, first guide portion 34 can be in 30 distal end of insulating sleeve Increased a part of structure, or the distal end of the insulating sleeve 30 is subjected to certain processing and is obtained.Due to ultrasonic development phase It is smaller compared with other damages of visualization mode (such as x-ray fluoroscopy) to human body, preferably by the insulating sleeve 30 close to the tube body of distal end Rough rough surface is surface-treated into form the first guide portion 34, adapts to the demand of ultrasonic development.Such as it can be to exhausted Edge casing 30 does the surface roughening treatments such as sandblasting or punching close to the part of distal end and forms the first guide portion 34.Also, this hair In bright, the surface roughness of first guide portion 34 is not answered excessively high, while realizing ultrasonic development demand, will not influence The propulsion of the insulating sleeve 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.11 surface of electrode needle body due to being provided with the insulating sleeve 30, the ablation needle 10 need not be coated with absolutely Edge material simplifies the manufacture craft of the electrode needle body 11 of ablation needle 10, and insulating sleeve 30 can be the electricity of ablation needle 10 Pole needle main body 11 provides support and protection, to allow to reduce the diameter of the electrode needle body 11, such as the electrode needle master 20G~16G may be selected in the diameter of body 11, on the one hand facilitates to further decrease tissue damage, on the other hand due to be ablated The structure of interventricular septum tissue 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.
The electrode needle body 11 of the ablation needle 10 is electrically connected energy generating apparatus, wherein the energy generating apparatus It can be microwave generator or radio-frequency signal generator.The electrode needle body 11 of ablation needle 10 exposes the part of insulating sleeve 30 to group It knits and passes out microwave energy or RF energy, to carry out ablation operation.
Also referring to Fig. 5 to Fig. 7 and Fig. 9 and Figure 10, the electrode needle body 11 of ablation needle 10 contacts the part of tissue RF energy or microwave energy, which can be transmitted, causes tissue to generate high temperature, so that tissue coagulation is downright bad and reaches therapeutic purposes, but Local temperature is excessively high to will affect the normal tissue for not needing to carry out ablation operation, therefore the electrode needle body 11 of the ablation needle 10 Interior to be equipped with cooling duct 16, the cooling duct 16 is used to convey the cooling medium (such as cooling water) of gaseous state or liquid to high-temperature portion Position cools down, to control local temperature when ablation operation.
Further, as shown in figure 11, the distal end of the electrode needle body 11 has and can show under medical imaging devices Second guide portion 17 of shadow, length >=5mm of second guide portion 17, the second guide portion 17 can be shown 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 17 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 17, 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 17 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 the electrode needle body 11 expose insulating sleeve 30 part ablation behaviour is carried out to pathological tissues Make.
It is worth noting that: since the structure of cardiac septum is more flat, answered when melting the hypertrophic cardiomyopathy in interventricular septum Large area, spherical shape or ablation areas close to spherical shape are avoided the formation of, prevents ablation from penetrating to the internal membrane of heart, therefore the present invention is to electrode The part that 11 distal top of electrode needle body is approached in distal portion, that is, electrode needle body 11 of needle main body 11, which devises, to be different from now There is the structure of technology.
It is the first embodiment of 11 distal portion of electrode needle body please refer to Figure 12 a to Figure 12 d.The electrode The distal portion of needle main body 11 has the first main inclined plane 112, and first main inclined plane 112 is outer with the distal portion of electrode needle body 11 Intersect to chamfer electrode needle body 11 on surface.Position is distinguished in the proximal end of first main inclined plane 112 and the distal end of the first main inclined plane 112 In the opposite sides of 11 axis of electrode needle body.Specifically, first main inclined plane 112 and the distal portion of electrode needle body 11 Outer surface intersection can be as shown in Figure 12 a and Figure 12 b, the outer profile whole and electrode needle body of the first main inclined plane 112 The outer peripheral surface of 11 distal portion intersects, and is also possible to the part outer profile of the first main inclined plane 112 and the distal end of electrode needle body 11 The outer peripheral surface in portion intersects, remaining outer profile then intersects with the top surface of the distal portion of electrode needle body 11, thus the first main inclined plane 112 Proximal end and the distance between 11 axis of electrode needle body be greater than or equal to distal end and the electrode needle body 11 of the first main inclined plane 112 The distance between axis.Further, the angle [alpha] 1 between first main inclined plane 112 and electrode needle body axis is smaller, then The distal end of electrode needle body 11 is more sharp, in the case where electrode needle body 11 is combined with insulating sleeve 30 and punctured, more has Helping puncture, but considers the feasibility of manufacture craft, α 1 cannot be too small, therefore, first main inclined plane 112 and electrode needle body The range of angle [alpha] 1 between 11 axis is 15 °~60 °.Preferably, as shown in figure 21, it actively installs and wears in insulating sleeve 30 Pricker core 40, that is, puncture needle core 40 and electrode needle body 11 are more alternately installed in insulating sleeve 30, to pass through puncture needle core 40 combine with insulating sleeve 30 and are punctured, and in this embodiment, 11 need of electrode needle body are installed into insulating sleeve 30 It is middle to execute ablation, without being punctured.
As shown in fig. 12 c, the distal end of the insulating sleeve 30 can be straight.In the plumpness of interventricular septum S to be ablated In cardiac muscular tissue, the distal portion of electrode needle body 11 stretches out insulating sleeve 30, and the portion of ablation is able to carry out in electrode needle body 11 Position includes the outer surface that first main inclined plane 112 and electrode needle body 11 expose insulating sleeve 30.First main inclined plane, 112 phase For 11 outer surface of electrode needle body of its opposite side, it is equivalent to the electrode needle cut off on first main inclined plane 112 11 outer surface of main body is formed by the first zone of ablation under 11 outer surface of the electrode needle body effect of 112 opposite side of the first main inclined plane The electrode needle body 11 of domain A1 from 112 opposite side of the first main inclined plane outwardly extends, institute's shape under the effect of the first main inclined plane 112 At the second ablation region A 2 extended to the outside from the first main inclined plane 112, the shape of this ablation areas at two is different, and second Ablation region A 2 more approaches the axis of electrode needle body 11 compared with the first ablation region A 1, so the first ablation region A 1 and second The whole ablation region A that ablation region A 2 is composed no longer is spherical or close to spherical shape, but is presented as shown in fig. 12 c Out towards the irregular shape of the opposite side deflection of the first main inclined plane 112, so that the maximum width of ablation region A is reduced, energy The flat structure for enough adapting to cardiac septum S, avoids ablation from penetrating to internal membrane of heart E, prevents damage conductive beam, is particularly suitable for leading to It crosses through apex of the heart interventricular septum ablation hypertrophic cardiomyopathy.
As shown in figure 12d, the distal end of insulating sleeve 30 can also be the tip of beveling, and when execution ablation, insulating sleeve The inclined direction of the inclined direction of 30 chamfered tip and first main inclined plane 112, which is runed counter to, (can melt handle 12 by rotation The rotation of electrode needle body 11 is driven to realize).Distal tip with insulating sleeve 30 shown in Figure 12 c is compared with straight situation, When 30 distal end of insulating sleeve is chamfered tip, the area of 11 outer surface of electrode needle body of 112 opposite side of the first main inclined plane is bigger, the The whole ablation region A that one ablation region A 1 and the second ablation region A 2 are composed shows main towards first more obviously The irregular shape of the opposite side deflection on inclined-plane 112 more adapts to the flat structure of cardiac septum S, and ablation is avoided to penetrate to intracardiac Film E is particularly suitable for by through apex of the heart interventricular septum ablation hypertrophic cardiomyopathy.
It is the second embodiment of 11 distal portion of electrode needle body please refer to Figure 13 a to Figure 13 g.The electrode needle The difference of the second embodiment and above-mentioned first embodiment of 11 distal portion of main body is: the distal portion of electrode needle body 11 further includes The auxiliary of the two beveling electrode needle bodies 11 punctures face 116, and it is main oblique that two auxiliary puncture face 116 is located at described first The two sides in face 112.Two auxiliary puncture face 116 is intersected with the outer surface of first main inclined plane 112 and electrode needle body 11, The outer surface in two auxiliary puncture face 116, the first main inclined plane 112 and electrode needle body 11 intersects at a point to form electrode needle master The sharp end of body 11, and the axle center of the electrode needle body 11 is deviateed in the end.When electrode needle body 11 and insulation sleeve The combination of pipe 30 is when being punctured, the sharp end enable to puncture be more easier with it is smooth.Preferably, two auxiliary Axisymmetrical of the puncture face 116 about the electrode needle body 11, each auxiliary puncture face 116 and the electrode needle body The range of angle beta between 11 axis is 30 °~60 °.It is understood that being located at described in some other embodiment The auxiliary of first main inclined plane, 112 two sides punctures face quantity can be more, mutually interconnect between adjacent auxiliary puncture face as long as meeting It connecing, all auxiliary puncture faces and first main inclined plane 112 intersect at a point to form the sharp end of electrode needle body 11, and Deviate the axle center of the electrode needle body 11 in the end；In other embodiments, auxiliary puncture face can also be The conical surface.
It please distinguish 3f refering to fig. 1 and Figure 13 g, although increasing the auxiliary puncture face 116, electrode needle body 11 The mechanism that distal portion executes ablation is identical, no longer progress repeated description herein with above-mentioned first embodiment.Likewise, whole Ablation region A be no longer spherical or close to spherical shape, but show the irregular shape towards 112 opposite side deflection of the first main inclined plane Shape can adapt to the flat structure of cardiac septum S so that the maximum width of ablation region A is reduced, and ablation is avoided to penetrate To internal membrane of heart E, damage conductive beam is prevented, is particularly suitable for by through apex of the heart interventricular septum ablation hypertrophic cardiomyopathy.
It is the 3rd embodiment of 11 distal portion of electrode needle body please refer to Figure 14 a to Figure 14 g.The electrode needle The difference of the 3rd embodiment and above-mentioned first embodiment of 11 distal portion of main body is that the distal end of electrode needle body 11 further includes Two main inclined planes 114, second main inclined plane 114 are oppositely arranged with the first main inclined plane 112, second main inclined plane 114 and electrode The outer surface intersection of needle main body 11 is to chamfer the electrode needle body 11, and second main inclined plane 114 and electrode needle body 11 Angle [alpha] 2 between axis is less than the angle [alpha] 1 between 11 axis of the first main inclined plane 112 and electrode needle body.Specifically, described Angle [alpha] 2 between 11 axis of two main inclined planes 114 and electrode needle body ranges preferably from 5 °~30 °.Further, described The distal end of one main inclined plane 112 and the distal portion of electrode needle body 11 intersect at a straight line, the distal end of the second main inclined plane 114 and electrode The distal portion of needle main body 11 intersects at the same straight line.The electrode needle body 11 of this structure is usually required in aftermentioned Figure 21 institute It after showing that puncture needle core 40 is combined with insulating sleeve 30 and punctured, then installs in insulating sleeve 30, is executed by its distal portion Ablation.
As shown in figure 14f, the distal end of insulating sleeve 30 can be straight.In the hypertrophic cardiomyopathy of interventricular septum S to be ablated In tissue, the distal portion of electrode needle body 11 stretches out insulating sleeve 30, and the position packet of ablation is able to carry out in electrode needle body 11 Include first main inclined plane 112 and the second main inclined plane 114.Second main inclined plane 114 by excision be located at second main inclined plane 114 it On 11 outer surface of electrode needle body formed, the first main inclined plane 112 by excision be located at first main inclined plane 112 on it is more 11 outer surface of electrode needle body formed, 112 opposite side of the first main inclined plane the second main inclined plane 114 effect under be formed by first Ablation region A 1 is extended to the outside from the second main inclined plane 114, is formed by the second ablation region A 2 under the effect of the first main inclined plane 112 It is extended to the outside from the first main inclined plane 112, the shape of this ablation areas at two is different, and the second ablation region A 2 disappears compared with first Tabetisol domain A1 more approaches 11 axis of electrode needle body, so what the first ablation region A 1 and the second ablation region A 2 were composed Whole ablation region A is no longer spherical or close to spherical shape, but shows not advising towards the opposite side deflection of the first main inclined plane 112 Then shape can adapt to the flat structure of cardiac septum S so that the maximum width of ablation region A is reduced, and avoid melting It penetrates to internal membrane of heart E, prevents damage conductive beam, be particularly suitable for by through apex of the heart interventricular septum ablation hypertrophic cardiac muscle Disease.
As shown in Figure 14 g, the distal end of insulating sleeve 30 can also be the tip of beveling, and when execution ablation, insulating sleeve The inclined direction of the inclined direction of 30 chamfered tip and first main inclined plane 112, which is runed counter to, (can melt handle 12 by rotation The rotation of electrode needle body 11 is driven to realize).Distal tip with insulating sleeve 30 shown in Figure 14 f is compared with straight situation, When 30 distal end of insulating sleeve is chamfered tip, not only there is the second main inclined plane 114 in the opposite side of the first main inclined plane 112, and there are also be located at the 11 outer surface of electrode needle body between two main inclined planes 114 and insulating sleeve, 112 opposite side of the first main inclined plane execute the area of ablation Bigger, the whole ablation region A that the first ablation region A 1 and the second ablation region A 2 are composed shows court more obviously To the irregular shape of the opposite side deflection of the first main inclined plane 112, the flat structure of cardiac septum S is more adapted to, ablation is avoided to wear Thoroughly to internal membrane of heart E, it is particularly suitable for by through apex of the heart interventricular septum ablation hypertrophic cardiomyopathy.
It is the fourth embodiment of 11 distal portion of electrode needle body please refer to Figure 15 a to Figure 15 h.The electrode needle The difference of the fourth embodiment and above-mentioned 3rd embodiment of 11 distal portion of main body is that the distal portion of electrode needle body 11 further includes The auxiliary of the two beveling electrode needle bodies 11 punctures face 116, and it is main oblique that two auxiliary puncture face 116 is located at described first Face 112 and the two sides of the second main inclined plane 114.Two auxiliary puncture face 116,114 phase of the first main inclined plane 112 and the second main inclined plane The sharp end for a little forming electrode needle body 11 is met at, and the axle center of the electrode needle body 11 is deviateed in the end.When Electrode needle body 11 is combined with insulating sleeve 30 when being punctured, the sharp end enable to puncture be more easier with it is suitable Freely.Preferably, axisymmetrical of two auxiliary puncture face 116 about the electrode needle body 11, each auxiliary puncture The range of angle beta between face 116 and the axis of the electrode needle body 11 is 30 °~60 °.It is understood that other In some embodiments, the quantity positioned at the auxiliary puncture face of 114 two sides of first main inclined plane 112 and the second main inclined plane can be more It is more, it is connected with each other between adjacent auxiliary puncture face as long as meeting, all auxiliary puncture faces and first main inclined plane 112 and the Two main inclined planes 114 intersect at a point to form the sharp end of electrode needle body 11, and the electrode needle master is deviateed in the end The axle center of body 11；In other embodiments, auxiliary puncture face also can be the conical surface.
It please distinguish 5g refering to fig. 1 and Figure 15 h, although increasing the auxiliary puncture face 116, electrode needle body 11 The mechanism that distal portion executes ablation is identical, no longer progress repeated description herein with above-mentioned 3rd embodiment.Likewise, whole Ablation region A be no longer spherical or close to spherical shape, but show the irregular shape towards 112 opposite side deflection of the first main inclined plane Shape can adapt to the flat structure of cardiac septum S so that the maximum width of ablation region A is reduced, and ablation is avoided to penetrate To internal membrane of heart E, damage conductive beam is prevented, is particularly suitable for treatment hypertrophic cardiomyopathy.
Please refer to Fig. 6, Fig. 7, Figure 17 and Figure 18, the ablation handle 12 include driving assembly 120 and with the drive The connector 121 of the dynamic rotation of component 120 connection, is detachably connected between 30 proximal end of insulating sleeve and the connector 121. In other words, the insulating sleeve 30 is connect by the connector 121 with driving assembly 120, is driven by driving assembly 120 Insulating sleeve 30 is moved along the extending direction of electrode needle body 11 relative to the electrode needle body 11, according to actual ablation model The length of insulating sleeve 30 is stretched out in the distal end for enclosing the electrode needle body 11 that demand adjusts ablation needle 10.In the present embodiment, insulation sleeve The proximal end of pipe 30 is equipped with external screw thread, and the distal end of connector 121 is equipped with internal screw thread compatible with the external screw thread of insulating sleeve 30, leads to Cross the external screw thread and the cooperation realization insulating sleeve 30 of the internal screw thread and being detachably connected for connector 121.Further, In some embodiments of the invention, the insulating sleeve 30 is equipped with externally threaded its distal end side that is positioned against and is equipped with grip part 33, In order to the dismounting for rotate or with the ablation needle 10 relative to the ablation needle 10.In the present embodiment, in the insulation The outer wall setting multi-turn protrusion of casing 30, to form the grip part 33.
Please refer to Figure 17, the driving component 120 include axially disposed sliding part 122 and with the sliding part 122 The regulating part 123 of connection.The connector 121 is coaxially disposed and rotates with the sliding part 122 and connect, i.e., so that connector 121 can be rotated relative to sliding part 122 using its axis as axle center, so that the insulating sleeve connecting with connector 121 30 can be rotated relative to sliding part 122, and electrode needle body 11 is attached with ablation handle 12, i.e., so that the insulation Casing 30 can comparative electrode needle main body 11 rotated.As a result, when needing to rotate adjustment ablation needle 10 or biopsy needle 20, 30 position of insulating sleeve can be kept constant, only ablation needle 10 or biopsy needle 20 of the rotary penetrating in insulating sleeve 30, no It only can reduce the friction or damage to tissue, and the resistance rotated is smaller, it is easily operated.In the present embodiment, the sliding The distal loop of part 122 is equipped with card slot 1221, and the proximal end of the connector 121 is equipped with the retainer ring being adapted to the card slot 1221 1211, the retainer ring 1211 is caught in just in the card slot 1221, so that connector 121 can be around axial-rotation, but it cannot edge Axial movement realizes that the connector 121 is connected with the sliding part 122 rotation.Also, in ablation procedure, in order to make The inclined direction of the inclined direction of the chamfered tip of the insulating sleeve 30 and first main inclined plane 112 runs counter to or prevents to lead The scale value melted on handle 12 is conveniently checked in line and cooling line overflexing, torsion winding, and operator, which needs to rotate, to disappear When melting handle 12 or/and ablation needle 10, operator can grasp connector 121 and insulating sleeve 30 is kept not turn, and rotate institute The ablation handle 12 of ablation needle 10 is stated, to drive the electrode needle body 11 to rotate by the ablation handle 12, to reduce To the frictionally damage of tissue when insulating sleeve 30 rotates, and the resistance rotated is smaller.
In the sliding part 122 be equipped with axially through through-hole, 11 proximal end of electrode needle body of the ablation needle 10 is worn The through-hole is crossed, ensure that the coaxial of insulating sleeve 30 and ablation needle 10.11 proximal end of electrode needle body of the ablation needle 10 with It is fixedly connected between ablation handle 12 by modes such as the common bonding in this field, clamping, pin joints.
The extension side of the connector 121 and the axial direction of the sliding part 122 and the electrode needle body 11 of the ablation needle To identical, the regulating part 123 controls sliding part 122 and moves along its axis, to drive the insulating sleeve connecting with connector 121 30 comparative electrode needle main bodys 11 are mobile, to adjust the length that the insulating sleeve 30 is stretched out in the distal end of electrode needle body 11, thus Can be according to the anatomical structure of diseased region and the needs of actual ablation area, the distal end of adjustment electrode needle body 11 is stretched out exhausted The length of edge casing 30.In the present embodiment, the regulating part 123 is set on sliding part 122, and extending direction and sliding part 122 Extending direction it is vertical, by push regulating part 123 be axially moveable, to drive sliding part 122 to be axially moveable.Sliding part In the proximal end of 122 distal end insertion insulating sleeve 30, so that sliding part 122 and insulating sleeve 30 are coaxial, it is axially moveable sliding When part 122, the insulating sleeve 30 is driven to be axially moveable.In the present embodiment, the distal end of the sliding part 122 is taper, absolutely The inner wall of the proximal end of edge casing 30 is set as taper corresponding with sliding part 122, so that the distal end of sliding part 122 can hold It changes places and is inserted into insulating sleeve 30 and is able to achieve axially position, additionally it is possible to facilitate the assembly of retainer ring 1211 Yu card slot 1221.
The ablation handle 12 of the ablation needle 10 includes shell 124, and the driving component 120 is contained in shell 124.This In embodiment, the shell 124 includes the first shell and second housing being oppositely arranged, and passes through buckle, bonding etc. therebetween Mode is fixed together, and the driving component 120 is assemblied in shell 124 to facilitate.Along cunning on the shell 124 The axial direction of moving part 122 offers control flume 1222.Control flume 1222 can be opened up directly on the first shell or second housing, A slot can be respectively opened on the first shell and second housing and then snaps together to form control flume 1222.The regulating part 123 stretch out shell 124 from control flume 1222 away from one end of the sliding part 122；By mobile regulating part 123 in control flume 1222 position, to control the moving along its axial direction of sliding part 122.
Further, 1222 one or both sides of control flume are provided with scale marker 1225.Actuation regulating part 123 is to control It is described exhausted can to know that the ablation needle 10 exposes for scale value corresponding to observation regulating part 123 behind a certain position of slot 1222 processed The length of edge casing 30, i.e. ablation needle 10 are able to carry out effective ablation length of ablation.When actuation regulating part 123 is at control When 1222 most proximal end of slot processed, the corresponding scale value of regulating part 123 is maximum, and the ablation needle 10 exposes the length of the insulating sleeve 30 Spend longest；When actuation regulating part 123 is at 1222 distalmost end of control flume, the corresponding scale value of regulating part 123 is minimum, described The length that ablation needle 10 exposes the insulating sleeve 30 is most short.According to the anatomical structure difference of different tissues, ablation needle 10 has The adjustable extent of effect ablation length is also different.
Referring to Figure 6 together, Fig. 7, Figure 17 and Figure 18, the inner surface of the shell 124 is equipped with axially to be set along sliding part 122 The the first guide part (not shown) set, the surface of sliding part 122 are equipped with second matched with first guide part and lead To part 1223, by the cooperation of the second guide part 1223 and the first guide part so that sliding part 122 swimmingly moves along its axis. Specifically, the first guide part can be groove, and the second guide part 1223 can be to be set on sliding part 122 to fit with the groove The fin matched；First guide part can also be arranged to fin, and the second guide part 1223 can be to be set on sliding part 122 The groove being adapted to fin.
Elastic component 125, the extension side of the elastic component 125 are additionally provided between the regulating part 123 and the sliding part 122 To towards control flume 1222.The inner wall of the shell 124 is corresponding with the scale marker 1225 of 1222 one or both sides of control flume Position be equipped with multiple detents 1226.The regulating part 123 is equipped at least one protrusion 1231.The elastic component 125 can be with But be not limited to spring, elastic slice or elastic washer etc..Under natural conditions, the protrusion of regulating part 123 described in 125 ejection of elastic component 1231 are caught in the positioning that regulating part 123 and sliding part 122 are realized in the detent 1226, and operator presses down on regulating part manually 123, the elastic component 125, which is pressurized, to be shunk, and the protrusion 1231 of regulating part 123 is separated from detent 1226 and freed, at this time edge Axial push-and-pull regulating part 123 can drive sliding part 122 and insulating sleeve 30 to be axially moveable, to adjust the dew of ablation needle 10 The length of insulating sleeve 30 out effectively melts length；When regulating part 123 reaches, a certain graduation position acquisition is desired effectively to disappear After melting length, operator unclamp regulating part 123, the elastic component 125 due to natural resiliency reset, ejection regulating part 123 it is convex It plays 1231 to be caught in corresponding detent 1226, regulating part 123 and sliding part 122 is enabled to position and remain stationary in the position.
It is understood that in other embodiments, the electrode needle body 11 can be set and melt in handle 12 Driving assembly is fixed, and insulating sleeve 30 is only detachable with the ablation handle 12 and rotates and connect, and cannot axially move.This In the case of kind, actuation driving assembly will drive electrode needle body 11 and be axially moveable when being axially moveable, to adjust electrode needle master The length that body 11 stretches out insulating sleeve 30 effectively melts length, and driving assembly is closer to 12 distal end of ablation handle, electrode needle The length that main body 11 stretches out insulating sleeve 30 is longer.
Please refer to Figure 19, Figure 20 and Figure 23 a to Figure 23 c, in the present invention, the ablation needle assemblies 100 further include biopsy needle 20, the ablation needle 10 is more alternately installed in the insulating sleeve 30 with the biopsy needle 20, further, the biopsy needle 20 can carry out detachably and rotate to connect with the insulating sleeve 30.Specifically, the biopsy needle 20 includes biopsy needle main body 21 and the biopsy handle 22 that is connect with 21 proximal end of biopsy needle main body；After ablation needle 10 is separated with insulating sleeve 30, the biopsy needle 20 biopsy needle main body 21 installs in insulating sleeve 30, and the biopsy handle 22 of insulating sleeve 30 and biopsy needle 20 is detachable simultaneously Rotation connection.In other words, ablation needle 10 can be detachably connected with insulating sleeve 30, and biopsy needle 20 can also be with insulating sleeve 30 are detachably connected, and after ablation needle 10 and insulating sleeve 30 are split, biopsy needle 20 can be connect with insulating sleeve 30. Therefore, after completing ablation operation, the connection of ablation needle 10 and insulating sleeve 30 is released, insulating sleeve 30 is stayed within the organization, Channel is provided for biopsy procedure, so that biopsy needle 20 quickly reaches desired biopsy sites, avoids repeated puncture, is reduced pair The damage of tissue；Alternatively, after formerly can completing biopsy procedure, releasing biopsy needle 20 and insulation sleeve in some surgical procedures The connection of pipe 30, insulating sleeve 30 is stayed within the organization, provides channel for ablation operation, so that ablation needle 10 quickly reaches expectation Ablation locations.Also, since insulating sleeve 30 and the biopsy needle main body 21 of biopsy needle 20 are detachable and rotate and connect, to make It obtains in biopsy procedure, if desired rotates biopsy needle 20, insulating sleeve 30 can be kept motionless, to reduce the damage to tissue Wound, and the resistance rotated is smaller.
Incorporated by reference to Figure 21, Figure 22 and Figure 24 a to Figure 24 e, further, in some embodiments of the invention, the ablation needle Component 100 further includes puncture needle core 40, and the diameter of puncture needle core 40 is greater than the diameter of the ablation needle 10 or biopsy needle 20, is punctured The diameter range of needle core 40 is preferably 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 is more alternately installed in the insulating sleeve 30 with the ablation needle 10 or biopsy needle 20 and and insulation sleeve Pipe 30 is detachably connected, and insulating sleeve 30 is stretched out in the distal end of puncture needle core 40.In the present embodiment, the distal end of puncture needle core 40 is in point Sharp needle-shaped or triangular pyramid, proximal end can fix a joint for fittings with internal threads 41, the internal screw thread of the connector 41 and insulation The external screw thread of 30 proximal end of casing is adapted.After increasing puncture needle core 40, can before ablation or before biopsy by puncture needle core 40 with The combination of insulating sleeve 30 punctures tissue, releases the connection of puncture needle core 40 and insulating sleeve 30 later, withdraws from puncture needle Core 40, then ablation needle 10 or biopsy needle 20 are penetrated into insulating sleeve 30.It is relatively large in diameter, can be compared with the puncture needle core 40 of hard Insulating sleeve 30 provides preferable supportive, therefore the combination of puncture needle core 40 and insulating sleeve 30 is more convenient for puncturing, and can When preventing from directly being punctured using ablation needle 10 or biopsy needle 20, ablation needle 10 or biopsy needle 20 are damaged.
Further, referring to Figure 6 together and Figure 25, the present invention also provides a kind of ablation systems, including the ablation needle Component 100 and energy generating apparatus 110.In some embodiments of the invention, the ablation system 200 further includes medical imaging devices 120 and/or cold source feedway 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 cold source feedway 130 passes through cooling tube Road 160 is connected to the cooling duct 16, and gaseous state or liquid cooling medium are provided in the cooling duct Xiang Suoshu 16.The medicine shadow Remote location as device 120 for insulating sleeve 30 and ablation needle 10 described in real-time display, can be selected from ultrasound, CT, nuclear-magnetism, X At least one of x ray fluoroscopy x, it is preferably ultrasonic.
The ablation needle assemblies 100 of the invention and ablation system be suitable for hypertrophic cardiomyopathy treatment, in particular to Under ultrasound guidance, by being punctured through the apex of the heart, ablation needle assemblies 100 is inserted into patient's heart, plump interventricular septum is penetrated Frequency ablation or microwave ablation.As shown in figure 16, using ablation needle assemblies 11 and ablation system of the invention to the room of fresh Pigs Hearts It is spaced tissue and carries out RF ablation, used by being tested with ablation shown in Fig. 4 after power ablation 12 minutes, ablation region A is in Reveal the irregular shape of the opposite side deflection towards the first main inclined plane 112 of electrode needle body 11, internal membrane of heart E is without damage, can See that ablation needle assemblies 100 and ablation system of the invention are suitable for the ablation of the interventricular septum tissue of flat structure, is particularly suitable for Through apex of the heart interventricular septum ablation hypertrophic cardiomyopathy.As shown in Figure 23 a to Figure 23 c, the use of the ablation needle assemblies 100 Process are as follows:
Step 1: ablation needle 10 is installed in insulating sleeve 30 first, by connector 121 by insulating sleeve 30 with disappear The ablation handle 12 for melting needle 10 connects, and obtains ablation needle assemblies as shown in FIG. 6.Actuation regulating part 123 is to drive the driving Component 120 and insulating sleeve 30 are axially moveable with respect to ablation needle 10, using insulating sleeve 30 as the insulation tube of ablation needle 10, are obtained Obtain the i.e. effective ablation length of length that desired ablation needle 10 exposes insulating sleeve 30.
Step 2: as shown in fig. 23 a, by insulating sleeve 30 and rib of the ablation needle 10 through patient under the guidance of Vltrasonic device It punctures between bone through the apex of the heart and is entered in interventricular septum wall by the external membrane of heart, open radio-frequency signal generator, insulating sleeve 30 is exposed by ablation needle 10 Part RF ablation is carried out to plump myocardium of ventricular septum, destroy the activity of corresponding site myocardium of ventricular septum, make myocardial necrosis It is atrophy, thinning, to keep left ventricular outflow tract view broadening, release obstruction.Hypertrophic cardiomyopathy is treated using the ablation needle assemblies 10, both The risk and pain of surgery rotary-cut opening operation chest and extracorporal circulatory system are avoided, also no chemical ethanol ablation is invalid or alcohol is excessive The risk of large area heart infarction is caused, simple and easy, extremely small to patient trauma, operation risk is small, and significant in efficacy.
Step 3: as shown in Figure 23 b and Figure 23 c, when needing to carry out ablation operation, and needing to implement biopsy operation, The connection for releasing insulating sleeve 30 and connector 121 after ablation has been executed, has withdrawn from ablation needle 10 and indwelling insulating sleeve 30, then Biopsy needle 20 penetrates insulating sleeve 30 and extracts tissue samples for biopsy.The insulating sleeve 30 provides logical for biopsy procedure Road can be avoided repeated puncture, reduce the damage to tissue, and biopsy needle 20 is enabled to quickly to reach desired biopsy position It sets.
It is understood that in some cases, it can also be before executing ablation first by insulating sleeve 30 and biopsy needle 20 Combination punctured, biopsy, then withdraws from biopsy needle 20 and indwelling insulating sleeve 30, then actuation regulating part 123 makes driving group Part 120 reaches and is located in desired graduation position, and ablation needle 10 is finally penetrated insulating sleeve 30, passes through rotary connector 121 set up the connection of insulating sleeve 30 Yu connector 121, and ablation needle 10 executes ablation with desired effective ablation length, together Sample can be avoided repeated puncture, reduce the damage to tissue.
As shown in Figure 24 a to Figure 24 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 insulating sleeve 30 before ablation or before biopsy and puncture, release puncture later Puncture needle core 40 is withdrawn from the connection of needle core and insulating sleeve 30, and indwelling insulating sleeve 30 is in patient's body, then to insulating sleeve 30 Ablation needle 10 or biopsy needle 20 are inside penetrated, ablation or biopsy procedure is carried out, to increase puncture strength, and prevents puncture process from damaging 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 (23)

1. a kind of ablation needle assemblies suitable for treating hypertrophic cardiomyopathy, which is characterized in that including hollow insulating sleeve and Ablation needle；The ablation needle includes that activity is installed on electrode needle body in the insulating sleeve, the electrode needle body it is remote The insulating sleeve is stretched out at end；The distal portion of the electrode needle body has the first main inclined plane, the proximal end of first main inclined plane The opposite sides of electrode needle body axis, and the proximal end of the first main inclined plane and electrode needle are located at the distal end of the first main inclined plane The distance between main body axis is greater than or equal to the distance between distal end and the electrode needle body axis of the first main inclined plane, and described the Angular range between one main inclined plane and electrode needle body axis is 15 °~60 °.
2. the ablation needle assemblies as described in claim 1 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the electrode needle The distal portion of main body also has the second main inclined plane, and second main inclined plane is oppositely arranged with the first main inclined plane, and described second is main Angle between inclined-plane and electrode needle body axis is less than the angle between the first main inclined plane and electrode needle body axis.
3. the ablation needle assemblies as claimed in claim 2 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that described second is main Angular range between inclined-plane and electrode needle body axis is 5 °~30 °.
4. the ablation needle assemblies as claimed in claim 2 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that described first is main The distal portion of the distal end on inclined-plane and the electrode needle body intersects at a straight line, distal end and the electrode of second main inclined plane The distal portion of needle main body intersects at the same straight line.
5. the ablation needle assemblies as described in claim 1 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that further include several The puncture face of auxiliary, several auxiliary puncture faces are located at the two sides of first main inclined plane and chamfer the electrode needle body Distal portion, several auxiliary puncture faces and first main inclined plane intersect at a point to form the end of the electrode needle body End, and the axle center of the electrode needle body is deviateed in the end.
6. the ablation needle assemblies as claimed in claim 5 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the auxiliary is worn The quantity in thorn face is two, and axisymmetrical of described two auxiliary puncture faces about the electrode needle body, each described auxiliary Angular range between the puncture face of helping and the axis of the electrode needle body is 30 °~60 °.
7. the ablation needle assemblies as claimed in claim 2 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the insulation sleeve The distal end of pipe is straight.
8. the ablation needle assemblies as claimed in claim 2 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the insulation sleeve The distal end of pipe is the tip of beveling, and when executing ablation, the inclined direction at the tip of the beveling and first main inclined plane Inclined direction run counter to.
9. such as the ablation needle assemblies described in any item of the claim 1 to 8 for being suitable for treating hypertrophic cardiomyopathy, feature exists In, the ablation needle further include the ablation handle being connect with the electrode needle body proximal end, the insulating sleeve proximal end with it is described It melts detachable between handle and rotates connection, the ablation handle is rotated relative to the insulating sleeve to drive the electrode needle Main body is rotated relative to the insulating sleeve.
10. the ablation needle assemblies as described in claim 1 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that further include living Needle is examined, the biopsy needle and the ablation needle are more alternately installed in the insulating sleeve.
11. the ablation needle assemblies for being suitable for treating hypertrophic cardiomyopathy as described in claim 1 or 10, which is characterized in that also wrap Include puncture needle core, the puncture needle core and the ablation needle or the biopsy needle be more alternately installed in the insulating sleeve and with The insulating sleeve is detachably connected, and the insulating sleeve is stretched out in the distal end of the puncture needle core.
12. the ablation needle assemblies as claimed in claim 9 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the ablation Handle includes shell, the driving assembly being contained in the shell and rotates the connector connected with the driving component, described Insulating sleeve is detachably connected with the connector；The driving component drive the insulating sleeve and the electrode needle body it Between move axially relatively, to adjust the length that the distal portion of the electrode needle body stretches out the insulating sleeve.
13. the ablation needle assemblies as claimed in claim 12 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the driving Component includes sliding part and the regulating part that connect with the sliding part, and the connector is coaxially disposed and rotates with the sliding part Connection, the regulating part control the sliding part and move along its axis, to drive the insulation sleeve connecting with the connector Pipe is mobile relative to the electrode needle body.
14. the ablation needle assemblies as claimed in claim 13 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the shell On along the axial direction of the sliding part offer control flume, the shell is stretched out from the control flume in one end of the regulating part；It is logical It crosses and moves regulating part sliding part described in the position control of the control flume and move along its axis.
15. the ablation needle assemblies as claimed in claim 14 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the control At least side of slot is equipped with scale marker.
16. the ablation needle assemblies as claimed in claim 15 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the adjusting It is equipped with elastic component between part and the sliding part, the extending direction of the elastic component is towards the control flume；The shell it is interior Wall is equipped with multiple detents corresponding with the scale marker, and the regulating part is equipped at least one protrusion；The elastic component When extending naturally, protrusion described in the elastic component pushing tow is caught in the detent.
17. the ablation needle assemblies as claimed in claim 13 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the sliding The distal loop of part is equipped with card slot, and the proximal end of the connector is equipped with retainer ring, and the retainer ring is caught in the card slot so that the company It connects to rotate with the sliding part and connect.
18. the ablation needle assemblies as described in claim 1 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the insulation The distal end of casing has the first guide portion, and first guide portion is developed under medical imaging devices.
19. the ablation needle assemblies for being suitable for treating hypertrophic cardiomyopathy as described in claim 1 or 18, which is characterized in that described The distal end of electrode needle body has the second guide portion, and second guide portion is developed under medical imaging devices.
20. the ablation needle assemblies as described in claim 1 for being suitable for treating hypertrophic cardiomyopathy, which is characterized in that the electrode Cooling duct is equipped in needle main body.
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. ablation system as claimed in claim 21, which is characterized in that further include being connected with the proximal end of the electrode needle body Logical cooling device.
CN201811079426.5A 2017-11-28 2018-09-15 Suitable for treating the ablation needle assemblies and ablation system of hypertrophic cardiomyopathy Pending CN109833089A (en)

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CN201821512454.7U Active CN209826963U (en) 2017-11-28 2018-09-15 Ablation needle assembly and ablation system suitable for treating hypertrophic cardiomyopathy
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