CN105615990A - Electrophysiology catheter - Google Patents

Electrophysiology catheter Download PDF

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Publication number
CN105615990A
CN105615990A CN201410593614.5A CN201410593614A CN105615990A CN 105615990 A CN105615990 A CN 105615990A CN 201410593614 A CN201410593614 A CN 201410593614A CN 105615990 A CN105615990 A CN 105615990A
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China
Prior art keywords
catheter
curved
silk
conduit
annular
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CN201410593614.5A
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CN105615990B (en
Inventor
程增兵
凌智瑜
殷跃辉
陈伟杰
奚云珠
孙毅勇
谭家宏
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Shanghai Hongdian Medical Technology Co ltd
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Shanghai Microport EP MedTech Co Ltd
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Abstract

The invention discloses an electrophysiology catheter. The electrophysiology catheter comprises a catheter bendable section, a catheter main body section and a catheter handle which are connected in sequence, wherein the far end of the catheter bendable section is provided with an annular ring, a plurality of annular electrodes are distributed on the annular ring, the catheter handle is provided with a ring adjusting push button, the catheter is internally provided with a first cavity, the first cavity is provided with ring adjusting wires in a penetrating manner, and the ring adjusting wires are respectively connected with the ring adjusting push button and the far end of the annular ring. According to the electrophysiology catheter provided by the invention, the far end of the catheter bendable section is provided with the annular ring, and the push button of the catheter handle and the ring adjusting wires arranged in the catheter are used for controlling the bending shape of the far end of the catheter and the diameter of the annular ring, so that the plurality of electrodes arranged on the far end of the catheter effectively attach to the mouth part or the inner wall of the renal artery, the purpose of treating the refractory hypertension and other cardiovascular diseases, such as atrial fibrillation and catecholaminergic polymorphic ventricular tachycardia related to sympathetic nerve excessive activation is achieved, and the operation is safe and reliable.

Description

A kind of electrophysiologicalcatheter catheter
Technical field
The invention belongs to medical instruments field, particularly relate to a kind of electrophysiologicalcatheter catheter.
Background technology
Intractable hypertension is common clinically, paathogenic factor is more, pathogenesis is indefinite, the weak effect of Drug therapy, diagnose and treat means not mature enough, one of main bugbear becoming hypertension therapeutic, and the patient of this disease is often accompanied by the risk factor of other cardiovascular disease, such as coronary heart disease, diabetes, heart failure, nephropathy, peripheral arterial disease, apoplexy, left ventricular hypertrophy etc. In all kinds of complication of hypertension, with the heart, brain, kidney infringement the most notable, for instance World Health Organization (WHO) add up, the cardiovascular disease of 50% is caused by hypertension. At present because pressure value raises, cardiocerebrovasculaevents events is occurred to cause that the death toll whole world every year there are about 7,100,000. And in the death factors of more than 40 years old crowd of China, heart disease and cerebrovascular are classified as first and the 3rd respectively, total the first dead risk factor is hypertension.
Medical circle is thought always, and the sympathetic activation of kidney and blood pressure raise substantial connection. The sympathetic nerve transition excitation time of kidney, renal blood vessels is shunk, and reduces the excretion of kidney, make moisture and salt retention in vivo, simultaneously facilitate renal secretion feritin, result in the increase of blood circulation angiotensin I and aldosterone, and latter two material, the factor that blood pressure raises just; Additionally, clinical research also confirms that simultaneously, the excitement of sympathetic renal nerve and heart class disease, as close in disease relationships such as atrial fibrillation, catecholamine sensitivity ventricular tachycardias, there is clinical data to show, by going renal sympathetic nerve ablation to coordinate pulmonary veins isolation etc. can be effectively improved atrial fibrillation cure rate, melted by renal artery denervation simultaneously, for tachycardic patient, can effectively reduce its heart rate.
The theoretical basis of this denervation treatment is: the sympathetic nerve of kidney is transferred into and out fiber and is distributed in the shallow surface portion (renal artery oral area is renal sympathetic nerve trunk) below renal artery wall, its activity and the generation of hypertension and remain closely related, carry out radio-frequency (RF) ablation in renal artery local and can damage sympathetic renal nerve and not involve the nervous tissue of other abdominal paries, pelvic part or lower limb. Thus the method security of this denervation treatment hypertension is good. And in curative effect, observe it can be seen that when after treatment 1 month, the blood pressure of patient substantially reduces through the researchs of 12 months, when 3 months its blood pressure reduce further, 1 year time blood pressure lowering effect still clearly, simultaneously also do not find obvious neuranagenesis.
At present, this technical field has similar devices, helical form ring renal artery sympathetic nerve frequency ablation electrode catheter as disclosed in China Patent No. 200920172984.6, principle that what it was basic melt is substantially and on the longitudinal spiral direction of renal artery inwall, the renal artery within the scope of oral area certain length is being melted, and there is a kind of new sound in academic circles at present, namely sympathetic nerve is comparatively concentrated in the distribution of renal artery oral area, if there being a kind of operating theater instruments effectively renal artery oral area to be melted, then it is in treatment intractable hypertension and heart class disease, as arrhythmia and atrial fibrillation etc. have good curative effect.
Summary of the invention
The technical problem to be solved is to provide a kind of electrophysiologicalcatheter catheter, it is possible to controlling bending and the annular ring footpath of distal end of catheter easily, so that multiple electrodes of distal end of catheter can effectively recline, renal artery oral area or inwall melt.
The present invention solves that above-mentioned technical problem employed technical scheme comprise that a kind of electrophysiologicalcatheter catheter of offer, can curved segment, catheter main body section and modular catheter including the conduit being sequentially connected, wherein, described conduit can the far-end of curved segment be annular ring, in annular ring, distribution has multiple annular electrode, described modular catheter is provided with tune circle push button, there is in described conduit the first chamber, described first intracavity is provided through adjusting circle silk, and described tune circle silk is connected with the described far-end adjusting circle push button and annular ring respectively.
Above-mentioned electrophysiologicalcatheter catheter, wherein, the described material adjusting circle silk is rustless steel or Nitinol.
Above-mentioned electrophysiologicalcatheter catheter, wherein, described first intracavity is additionally provided with titanium-nickel wire, encloses silk be welded together to form stannum ball with tune, form glueballs at annular ring far-end after the tin ball external sheath glue layer after described titanium-nickel wire runs through described first chamber.
Above-mentioned electrophysiologicalcatheter catheter, wherein, described modular catheter is additionally provided with the curved knob of control, there is in described conduit the second chamber, described second intracavity is provided through controlling curved silk, and the near-end of the curved silk of described control is connected with the curved knob of described control, and the far-end of the curved silk of described control is connected to the near-end of annular ring.
Above-mentioned electrophysiologicalcatheter catheter, wherein, the curved knob of described control is arranged on the far-end of modular catheter.
Above-mentioned electrophysiologicalcatheter catheter, wherein, the far-end of the curved silk of described control is in T shape, is fixed on conduit by glue.
Above-mentioned electrophysiologicalcatheter catheter, wherein, described conduit can be provided with surely curved silk by the second intracavity outside curved segment division ring shape circle.
Above-mentioned electrophysiologicalcatheter catheter, wherein, the two ends of described fixed curved silk connect the tubing matched with conduit cavity size respectively, and are adhesively fixed by glue and pipe inner wall.
Above-mentioned electrophysiologicalcatheter catheter, wherein, the length of described fixed curved silk is 0��80mm.
Above-mentioned electrophysiologicalcatheter catheter, wherein, the material of described fixed curved silk is rustless steel or Nitinol.
Above-mentioned electrophysiologicalcatheter catheter, wherein, described catheter main body segment length is 500��1500mm, and the conduit bendable segment length including annular ring is 20��100mm, and the circle footpath range of accommodation of annular ring is 3��10mm.
Above-mentioned electrophysiologicalcatheter catheter, wherein, described conduit at least also includes the 3rd chamber and the 4th chamber, and described 3rd intracavity is provided with Brine Pipe, is used for irrigating saline; Described 4th chamber is guidewire lumen, is provided with RF radio frequency line or/and thermocouple wire.
Above-mentioned electrophysiologicalcatheter catheter, wherein, in annular ring, distribution has 2��10 annular electrodes.
Above-mentioned electrophysiologicalcatheter catheter, wherein, the material of described annular electrode is platinumiridio or gold, and the diameter of described annular electrode is 3F��7F, and length is 1.5��5mm.
Above-mentioned electrophysiologicalcatheter catheter, wherein, the number of described annular electrode is 4, and each annular electrode individually melts with electric discharge between back pole plate or relative between each two annular electrode carry out electric discharge and melt.
Above-mentioned electrophysiologicalcatheter catheter, wherein, connects stimulation instrument and leads instrument more between two described annular electrodes that relative discharge melts.
Above-mentioned electrophysiologicalcatheter catheter, wherein, the electricity irritation frequency that described stimulation instrument is launched is 0-30 hertz.
Above-mentioned electrophysiologicalcatheter catheter, wherein, described annular electrode is uniformly placed with 4��16 salt water holes, and described saline pore diameter size is 0.08��0.16mm.
The present invention contrasts prior art following beneficial effect: electrophysiologicalcatheter catheter provided by the invention, the far-end of curved segment will can be set to annular ring, by bending and annular ring footpath, renal artery oral area or the inwall so that multiple electrodes of distal end of catheter can effectively recline of adjusting circle silk to control distal end of catheter that modular catheter push button and conduit are built-in; Multiple electrodes of distal end of catheter arrangement can stimulate mapping renal sympathetic nerve, and carry out denervation and melt, particularly the nerve stimulation of renal artery oral area, mapping and denervation melt, and then reach treatment intractable hypertension and the relevant cardiovascular disease of other sympathetic nerve excessive activations, such as atrial fibrillation, the purpose of catecholamine sensitivity room speed etc., and safe and reliable.
Accompanying drawing explanation
Fig. 1 is the electrophysiologicalcatheter catheter structural representation of the embodiment of the present invention;
The electrophysiologicalcatheter catheter that Fig. 2 is the embodiment of the present invention can curved segment amplify and case of bending change schematic diagram;
Fig. 3 a be the fixed curved silk of electrophysiologicalcatheter catheter band of the embodiment of the present invention can curved segment partial cutaway schematic; Fig. 3 b is fixed curved silk section place enlarged diagram in Fig. 3 a;
Fig. 4 be the embodiment of the present invention electrophysiologicalcatheter catheter without surely curved silk can curved segment control curved after schematic shapes;
Fig. 5 a is the structural representation before the circle footpath adjustment of the annular ring of the electrophysiologicalcatheter catheter in the embodiment of the present invention; Fig. 5 b be annular ring circle footpath reduce after structural representation;
Fig. 6 is the structural representation that the control curved line cephalic par T-shaped structure of the embodiment of the present invention is fixed in conduit;
Fig. 7 is the cross-sectional view of line A-A along Fig. 6;
Fig. 8 is the schematic diagram that the annular ring of the electrophysiologicalcatheter catheter of the embodiment of the present invention carries out at renal artery oral area melting.
In figure:
1 catheter main body section 2 conduit can curved segment 3 annular ring
4 control curved silk 5 adjusts circle push button 6 to control curved knob
7 modular catheter 8 female Luer 9 adjust circle silk
10 fixed curved silk 11 annular electrode 12 salt water holes
13 first chamber 15, chamber 14 second Brine Pipes
16 the 3rd chamber 18, chamber 17 the 4th multi-lumen tube
19 renal artery ostium 20 titanium-nickel wires
Detailed description of the invention
Below in conjunction with drawings and Examples, the invention will be further described.
Fig. 1 is the electrophysiologicalcatheter catheter structural representation of the embodiment of the present invention.
Refer to Fig. 1, the electrophysiologicalcatheter catheter that the present embodiment provides includes the conduit that is sequentially connected can curved segment 2, catheter main body section 1 and modular catheter 7, conduit can the far-end of curved segment 2 be annular ring 3, on annular ring 3, distribution has multiple annular electrode 11, modular catheter 7 is provided with tune circle push button 5 and controls curved knob 6, adjusting circle push button 5 for regulating the circle footpath of annular ring 3, controlling curved knob 6 can curved segment curved for the conduit controlling except annular ring 3. Being also associated with female Luer 8 on modular catheter 7, not shown modular catheter 7 end is welded with conduit buttock line socket. Wherein catheter main body section 1 material is generally polyurethane material, it is also possible to for Pebax, caliber is without particular/special requirement, and the renal artery blood vessel according to using is typically between 4F��8F, is advisable with 6F. The material of annular ring 3 is generally Pebax, it is also possible to for the macromolecular material that other are suitable, caliber, between 3F��7F, is advisable with 5F; As in figure 2 it is shown, by connecting the curved silk 4 of control in modular catheter 7 and conduit, it is achieved distal end of catheter is curved controlled at 0��180 ��.
Due to ventral aorta and inconsistent relatively larger because individual variation exists of renal artery meeting out of shape, far-end is curved can be passed through conduit can interpolation be various in the multi-lumen tube 18 of curved segment 2 determines bending tool, after realization control is curved, conduit can curved segment 2 curved from craspedodrome shape become as shown in Figure 3 and Figure 4 multiple curved, wherein curved shown in Fig. 3 (a), conduit curved segment 2 certain limit can be lined with a higher fixed curved silk of hardness 10 (shown in figure fixed curved filament length degree range L), as Fig. 3 (b) show the surely curved silk 10 partial enlarged drawing in multi-lumen tube 18, fixed curved silk 10 can be stainless steel silk or the Niti silk etc. (control curved after this section be craspedodrome shape substantially) that possess certain degree of hardness, the length of fixed curved silk 10 is preferably between 0��80mm, and the two ends of fixed curved silk 10 are by docking the tubing matched with multi-lumen tube 18 inner chamber size, and be adhesively fixed by glue and multi-lumen tube 18 are internal, so that conduit modular catheter 7 control curved after, conduit can curved segment 2 present certain curved, RDC or LIMA such as renal artery sheath is curved etc., and then annular ring 3 can effectively be reclined renal artery oral area, Fig. 4 is the conduit in multi-lumen tube 18 without fixed curved silk, after control is curved, due to conduit can the difference of curved segment 2 tubing hardness, the curved size presented also can change within the specific limits.
Fig. 5 is the structural representation of annular ring, as required, on annular ring 3, distribution has 2��10 annular electrodes 11, it is preferred to 4 annular electrodes 11, and annular electrode 11 is the good metal of biocompatibility, such as platinumiridio, gold etc., the diameter of annular electrode 11, between 3F��7F, is advisable with 5F, the length of electrode is again between 1.5��5mm, being advisable with 3mm, and be uniformly placed with 4��16 salt water holes on the whole circle of annular electrode 11, saline pore diameter size is 0.08��0.16mm; Each annular electrode 11 can melt individually and between back pole plate in electric discharge, or between each two annular electrode 11, relative discharge melts; Preferably, relative discharge melts can connect stimulation instrument between two annular electrodes 11, before and after melting, ablation points is stimulated, and accepts stimulus signal by leading instrument etc. more, so that whether judgement melts effective; Annular electrode is embedded with thermocouple 11 times, and the material of thermocouple is for being generally enamel wire, such as the combination of copper and constantan, thus realizing the monitor in real time of temperature in ablation procedure, being additionally welded with RF line on annular electrode 11, being used for conducting radio-frequency (RF) energy. This radio-frequency (RF) energy is typically between 6��15W, preferred power is 10W, cool brine is sent to conduit by the charge pump that while melting electric discharge, female Luer 8 connects, finally spray from the salt water hole 12 annular electrode 11, reach the purpose of perfusion ablating electrode, thus better guaranteeing to melt renal artery tissue, the flow of perfusion of saline is typically in 10��20ml/min, it is preferred that for 17ml/min. In addition this RF line can also conduct the stimulus signal launched from stimulation instrument simultaneously, reaches the purpose of stimulation of renal nerve, thus detecting electric discharge to melt whether rear renal nerve is effectively damaged.
The annular ring 3 of conduit can push away torsion 5 by the tune circle on modular catheter 7 so that the diameter of conduit annular ring 3 switches over without gradient between 3��10mm, thus meeting the demand of the different renal artery patient of the diameter that effectively reclines.
The material of the annular ring 3 of conduit is generally Pebax or other macromolecules, and this kind of material has certain style-ability after the heat treatment, therefore the sizing of annular ring 3 can rely on NITI fixed wire or this macromolecule material itself to shape; The conduit that the present embodiment provides be typically in 4 chambeies and more than, wherein the 3rd chamber 16 is for logical perfusion saline; 4th chamber 17 connects, for leading to, the wire melted needed for annular electrode 11, including RF and thermocouple wire; The near-end in the second chamber 14 is for the curved required curved silk 4 of control of logical control, and as indicated with 6, the curved silk 4 of this control is fixed on the near-end of annular ring 3, and its head end end is in T shape, is fixed in multi-lumen tube 18 by glue, and the far-end in the second chamber 14 is used for loading surely curved silk 10; First chamber 13 is for the Niti silk 20 placing sizing and the tune circle silk 9 adjusting circle required, and the material adjusting circle silk 9 can be stainless steel silk or Niti silk; Adjusting circle silk 9 and the through whole multi-lumen tube 18 of Niti silk 20, pass from tubing far-end end, and the two welded together by solder stick, welding head end forms stannum ball, and outer layer is covered by glue, finally forms glueballs at distal end of catheter end.
By Renal denervation ablation intractable hypertension, modus operandi more at present is renal artery inwall to be carried out spiral whole piece melt, owing to the renal sympathetic nerve of renal artery oral area is distributed comparatively intensive, if there being a kind of apparatus can effectively recline renal artery oral area, stimulate, mapping and electric discharge are melted, then it can effectively block the renal sympathetic nerve at this position, disease hence for treatment intractable hypertension and heart class, as the arrhythmia such as atrial fibrillation have preferably effect, electrophysiologicalcatheter catheter provided by the present invention, as shown in Figure 8, modular catheter 7 can be passed through and realize that distal annular rim circle footpath is adjustable and end is curved controlled, realize the annular electrode 11 on distal end of catheter annular ring 3 effectively to recline renal artery oral area 19, thus meeting doctor's stimulation for renal artery oral area renal sympathetic nerve, mapping and the purpose melted. and owing to annular electrode 3 being evenly distributed with the thermocouple that the cooperation of multiple fill orifice is buried, temperature in melting is controlled within the specific limits, between 30 DEG C��60 DEG C, allow to carry out the process that the whole circle of renal artery melts and be unlikely to occur so that renal artery the phenomenons such as spasm, thus finally guaranteeing the safety and effectively of conduit.
Although the present invention discloses as above with preferred embodiment; so it is not limited to the present invention, any those skilled in the art, without departing from the spirit and scope of the present invention; when doing a little amendment and perfect, therefore protection scope of the present invention is when with being as the criterion that claims define.

Claims (18)

1. an electrophysiologicalcatheter catheter, can curved segment, catheter main body section and modular catheter including the conduit being sequentially connected, it is characterized in that, described conduit can the far-end of curved segment be annular ring, in annular ring, distribution has multiple annular electrode, described modular catheter is provided with tune circle push button, has the first chamber in described conduit, described first intracavity is provided through adjusting circle silk, and described tune circle silk is connected with the described far-end adjusting circle push button and annular ring respectively.
2. electrophysiologicalcatheter catheter as claimed in claim 1, it is characterised in that the material of described tune circle silk is rustless steel or Nitinol.
3. electrophysiologicalcatheter catheter as claimed in claim 1, it is characterized in that, described first intracavity is additionally provided with titanium-nickel wire, encloses silk be welded together to form stannum ball with tune, form glueballs at annular ring far-end after the tin ball external sheath glue layer after described titanium-nickel wire runs through described first chamber.
4. electrophysiologicalcatheter catheter as claimed in claim 1, it is characterized in that, described modular catheter is additionally provided with the curved knob of control, there is in described conduit the second chamber, described second intracavity is provided through controlling curved silk, the near-end of the curved silk of described control is connected with the curved knob of described control, and the far-end of the curved silk of described control is connected to the near-end of annular ring.
5. electrophysiologicalcatheter catheter as claimed in claim 4, it is characterised in that the curved knob of described control is arranged on the far-end of modular catheter.
6. electrophysiologicalcatheter catheter as claimed in claim 4, it is characterised in that the far-end of the curved silk of described control is in T shape, is fixed on conduit by glue.
7. electrophysiologicalcatheter catheter as claimed in claim 4, it is characterised in that described conduit can be provided with surely curved silk by the second intracavity outside curved segment division ring shape circle.
8. electrophysiologicalcatheter catheter as claimed in claim 7, it is characterised in that the two ends of described fixed curved silk connect the tubing matched with conduit cavity size respectively, and are adhesively fixed by glue and pipe inner wall.
9. electrophysiologicalcatheter catheter as claimed in claim 7, it is characterised in that the length of described fixed curved silk is 0��80mm.
10. electrophysiologicalcatheter catheter as claimed in claim 11, it is characterised in that the material of described fixed curved silk is rustless steel or Nitinol.
11. electrophysiologicalcatheter catheter as claimed in claim 1, it is characterised in that described catheter main body segment length is 500��1500mm, and the conduit bendable segment length including annular ring is 20��100mm, and the circle footpath range of accommodation of annular ring is 3��10mm.
12. electrophysiologicalcatheter catheter as claimed in claim 1, it is characterised in that described conduit at least also includes the 3rd chamber and the 4th chamber, and described 3rd intracavity is provided with Brine Pipe, is used for irrigating saline; Described 4th chamber is guidewire lumen, is provided with RF radio frequency line or/and thermocouple wire.
13. electrophysiologicalcatheter catheter as claimed in claim 1, it is characterised in that in annular ring, distribution has 2��10 annular electrodes.
14. electrophysiologicalcatheter catheter as claimed in claim 13, it is characterised in that the material of described annular electrode is platinumiridio or gold, and the diameter of described annular electrode is 3F��7F, and length is 1.5��5mm.
15. electrophysiologicalcatheter catheter as claimed in claim 14, it is characterised in that the number of described annular electrode is 4, each annular electrode individually melts with electric discharge between back pole plate or relative between each two annular electrode carry out electric discharge and melt.
16. electrophysiologicalcatheter catheter as claimed in claim 15, it is characterised in that connect stimulation instrument between two described annular electrodes that relative discharge melts and lead instrument more.
17. electrophysiologicalcatheter catheter as claimed in claim 16, it is characterised in that the electricity irritation frequency that described stimulation instrument is launched is 0-30 hertz.
18. electrophysiologicalcatheter catheter as claimed in claim 13, it is characterised in that being uniformly placed with 4��16 salt water holes on described annular electrode, described saline pore diameter size is 0.08��0.16mm.
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CN106264719A (en) * 2016-07-29 2017-01-04 上海微创电生理医疗科技股份有限公司 Electrophysiologicalcatheter catheter
CN108236500A (en) * 2016-12-23 2018-07-03 上海微创电生理医疗科技股份有限公司 Electrophysiologicalcatheter catheter
CN113384319A (en) * 2021-06-02 2021-09-14 上海腾复医疗科技有限公司 A catheter
CN117481789A (en) * 2024-01-03 2024-02-02 梅奥心磁(杭州)医疗科技有限公司 Double-energy multifunctional electrophysiology catheter

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CN203815580U (en) * 2014-04-22 2014-09-10 上海微创电生理医疗科技有限公司 Renal artery radio-frequency ablation electrode catheter
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106264719A (en) * 2016-07-29 2017-01-04 上海微创电生理医疗科技股份有限公司 Electrophysiologicalcatheter catheter
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CN108236500A (en) * 2016-12-23 2018-07-03 上海微创电生理医疗科技股份有限公司 Electrophysiologicalcatheter catheter
CN113384319A (en) * 2021-06-02 2021-09-14 上海腾复医疗科技有限公司 A catheter
CN117481789A (en) * 2024-01-03 2024-02-02 梅奥心磁(杭州)医疗科技有限公司 Double-energy multifunctional electrophysiology catheter
CN117481789B (en) * 2024-01-03 2024-04-02 梅奥心磁(杭州)医疗科技有限公司 Double-energy multifunctional electrophysiology catheter

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