A kind of RF ablation device
Technical field
The present invention relates to a kind of medical apparatus and instruments, be specifically related to a kind of RF ablation device, particularly relate to and a kind ofly for renal artery, remove orthosympathetic RF ablation device, reduce the kidney sympathetic excitability, be used for the treatment of intractable hypertension.
Background technology
Hypertension is the Major Risk Factors of apoplexy, coronary heart disease, heart failure, angiopathy and chronic renal failure.Hypertension is suffered from the whole world approximately 1,000,000,000 adults, wherein only 1/3 obtains effectively to control.Underdiagnosis and to treat compliance poor be one of not good enough reason of curative effect, even but a large amount of patient accepts the optimal drug treatment still can not be effectively controlled.In fact, in clear and definite clinical trial at present, the patient of nearly 20%-30% fails to reach target blood pressure (even having accepted to surpass 3 kinds of treated with combined medications), finally develops into intractable hypertension.
So-called intractable
Hypertension2008 american heart association (AHA) it is defined as: improve through life style, take simultaneously the antihypertensive drugs (wherein a kind of for diuretic) of 3 kinds of different mechanism of action, or need at least 4 kinds of medicines systolic pressure and diastolic pressure could be controlled at target level (<140/90mmHg).
Although hypertensive pathology, physiological mechanism are complicated, neuroendocrine system is to keep the important mechanisms of blood pressure balance, and it is orthosympathetic is overexcited and is considered to the basic link of hypertension incidence.A large amount of zooperies and clinical research also confirm the impact of sympathetic nervous system on blood pressure, find that orthosympathetic excitement degree and patient's blood pressure level is proportionate.Wherein, the kidney sympathetic nervous system is kidney Sympathetic Nerve and the nervus centripetalis of the most close renal artery wall particularly, for bringing out and causing that systemic hypertension plays decisive role, thereby forms the theory that blocking-up kidney sympathetic nerve can reduce blood pressure.
Theoretical and orthosympathetic experience of early stage surgical excision based on this, " percutaneous catheter kidney sympathetic nerve radio-frequency ablation procedure " treatment intractable hypertension was explored by American-European countries since 2007, obtained satisfied curative effect, for the treatment of intractable hypertension provides new thinking and method.after the interventional technique femoral artery puncture that the method employing doctor is familiar with, renal artery is carried out wall melt to block the transmission of kidney sympathetic signal, the SymplicityTM kidney denervation system that mainly comprises Medtronic, the OneShotTM kidney Renal denervation system of Coyidien, the V2 kidney denervation system of the Enlig HNTTM kidney Renal denervation system of St.Jude and Vessix Vascular, these products have all obtained the CE authentication, and SymplicityTM kidney denervation system also obtains the TGA authentication, clinical effectiveness confirms that these products reach does not affect other abdominal paries in blood pressure lowering, pelvis or lower limb nerve domination, for the treatment of intractable hypertension provides new thinking and method.
Although a large amount of clinical effectivenesses confirm, the reduction that the blood pressure that adopts this kind internal medicine ablation catheter to treat rear patient has persistence, the method is had relatively high expectations to patient itself.As there not being the problems such as renal artery stenosis, branched renal artery; Because sympathetic nerve is positioned at the renal artery adventitia, catheter ablation just need to melt wall with tremulous pulse in addition, and this is larger to the renal artery infringement, easily causes renal artery stenosis; The ablation points position is not easy to hold, and these all cause the limitation of its application.Therefore, adopt the Surgical laparoscope technology directly outside renal artery, sympathetic nerve to be melted, can effectively be applied to exist the patient of renal artery deformity, the while is snap action renal artery outer wall sympathetic nerve directly, reduces arteriorenal infringement.
Summary of the invention
The purpose of this invention is to provide a kind of medical apparatus and instruments, adopt radio-frequency ablation technique, can be used for removing the renal artery sympathetic nerve, reduce the kidney sympathetic excitability, the treatment intractable hypertension.
The invention provides a kind of RF ablation device, be used for removing the renal artery sympathetic nerve, reduce the kidney sympathetic excitability, this device comprises: can and can carry out to renal artery the ablating electrode of radio-frequency (RF) ablation operation partly or entirely around renal artery; Control the motion of ablating electrode and realize electrode pair arteriorenal around operating-controlling mechanism.
Described ablating electrode consists of electrode member, electrode tip holder and temperature sensor.
Described electrode member is bipolar electrode pair, can act on after pairing; Wherein electrode member is device or the combinations such as wire electrode, electrode retaining collar or electrode slice.
Described electrode tip holder is that the collet of electrode member supports, and supports the electrode member on it.
Described temperature sensor is thermoelectricity resistance type or thermocouple type.
Described thermal resistance or thermocouple can provide feedback signal, are used for tissue temperature around measuring transducer, wherein feedback signal with to survey tissue temperature proportional.
Described temperature sensor can be controlled at zone of ablation renal artery temperature any temperature range in 37-200 ℃ of scope.Preferably, temperature range is controlled in 45-65 ℃.
During lower than 45 ℃, temperature sensor is with signal feedback to radio-frequency signal generator when temperature, and radio-frequency signal generator continuous firing, radio-frequency (RF) energy sustained delivery, to renal artery, avoid the renal artery temperature too low; Temperature is during higher than 65 ℃, and radio-frequency signal generator stops transferring energy, avoids the renal artery excess Temperature.
Described ablating electrode has Multiple Shape, is point-like, pliers shape, annular, ellipse, spiral type or rake shape, perhaps difform combination.
Described ablating electrode acts on outside the renal artery blood vessel, in fascia.Can block renal artery blood flow during ablating electrode work, also can keep renal artery unimpeded.
Described operating-controlling mechanism, can control ablating electrode motion, make its around or part around renal artery; And be connected with radio-frequency signal generator, with transmission of radio-frequency energy to ablating electrode.
Patient for intractable hypertension, under laparoscopically assistance, the passage of setting up by perforator, use this RF ablation device, renal artery sympathetic nerve to the patient carries out the radio-frequency (RF) ablation operation, removes the sympathetic nerve on renal artery, reduces the kidney sympathetic excitability, control/reduce patient's blood pressure, the treatment intractable hypertension.Can once melt, also can repeatedly melt, act on the renal artery middle part.
The advantage of this invention is, by peritoneoscope, directly melts the EV sympathetic nerve of renal artery, and operation quick and precisely; Melt and need not wall, the renal artery blood vessel injury is little; Need not to use developing agent and X ray, reduce to the murder by poisoning of kidney with to the radiation injury of human body; Clinical selected patient's expanded range, the patient who even has branched renal artery or renal artery stenosis also can adopt this mode.
Description of drawings
Fig. 1 is the overall schematic of an embodiment of RF ablation device of the present invention.
Fig. 2 a and Fig. 2 b are the structural representations of oval ablating electrode of the present invention.
Fig. 3 a is the structural representation of pliers shape ablating electrode of the present invention.
Fig. 3 b is the structural representation of spiral type ablating electrode of the present invention.
Fig. 3 c is the structural representation of rake shape ablating electrode of the present invention.
Fig. 4 a and Fig. 4 b are the schematic diagrams of operating-controlling mechanism of the present invention.
The specific embodiment
Structure and the working method of RF ablation device of the present invention are described in detail in detail below in conjunction with drawings and Examples.
2008 american heart association (AHA) with intractable
HypertensionBe defined as: improve through life style, take simultaneously the antihypertensive drugs (wherein a kind of be diuretic) of 3 kinds of different mechanism of action, or need at least 4 kinds of medicines systolic pressure and diastolic pressure could be controlled at target level (<140/90mmHg).
Although hypertensive pathology, physiological mechanism are complicated, neuroendocrine system is to keep the important mechanisms of blood pressure balance, orthosympathetic be overexcited be considered to the basic link of hypertension incidence.A large amount of zooperies and clinical research also confirm the impact of sympathetic nervous system on blood pressure, find that orthosympathetic excitement degree and patient's blood pressure level is proportionate.Wherein, the kidney sympathetic nervous system is kidney Sympathetic Nerve and the nervus centripetalis of the most close renal artery wall particularly, for bringing out and causing that systemic hypertension plays decisive role, thereby forms the theory that blocking-up kidney sympathetic nerve can reduce blood pressure.
RF ablation device of the present invention, be used for melting and remove renal artery sympathetic nerve on every side, reduces the kidney sympathetic excitability, thereby reach the purpose for the treatment of intractable hypertension.
Fig. 1 has shown an illustrative schematic diagram of renal artery ablating device of the present invention, and this ablating device 100 comprises: 1) can be partly or entirely around renal artery, and can carry out to renal artery the ablating electrode 101 of radio-frequency (RF) ablation operation; 2) can control the motion of ablating electrode, and realize electrode pair arteriorenal all or part of around operating-controlling mechanism 102.
Show in Fig. 2 a and Fig. 2 b that ablating electrode 101 consists of electrode member 201, electrode tip holder 202 and temperature sensor 203.Fig. 2 a and Fig. 2 b be respectively ablating electrode 101 signal front view and launch top view fully, select two wire electrodes as in the parallel intercalation electrode seat 202 of electrode member 201, form electrode pair.Temperature sensor 203 is also in the intercalation electrode seat, and whether the discharge of regulation and control electrode member 201, reaches the purpose of controlling the zone of ablation temperature.Preferably, in 45-65 ℃ of scope, during lower than 45 ℃, the radio-frequency signal generator continuous firing, provide radio-frequency (RF) energy when temperature with Temperature Setting, and the electrode pair discharge, melt the sympathetic nerve on the renal artery pipe; During higher than 65 ℃, radio-frequency signal generator quits work when temperature, and electrode pair quits work, and anti-hemostatic tube is excessively melted.
Ablating electrode can be various shapes, and is oval as shown in Figure 2 a and 2 b, pliers shape as shown in Fig. 3 a, and spiral type as shown in Fig. 3 b, harrow shape as shown in Figure 3 c.When ablating electrode is worked, use pliers shape ablating electrode shown in Fig. 3 a, renal artery is blocked; While using ablating electrode shown in Fig. 2 a and Fig. 2 b, Fig. 3 b, 3c, it is unimpeded that renal artery keeps.
Shown in Fig. 4 a and Fig. 4 b, operating-controlling mechanism is the handle type controlling organization.Wherein, the handle control mechanism of Fig. 4 a signal is class pistol shape, by handle, controls, and can make ablating electrode around outside renal artery.Fig. 4 b handle type controlling organization is round bar shape, by the control of handle button, front end is wrapped in outside renal artery with the serpentine pipe of ablating electrode.Its concrete structure and operation principle can, by multiple existing techniques in realizing, not repeat them here.
Although described a plurality of embodiment, one of ordinary skill in the art appreciates that countless variations and/or revise and can make and can not break away from the broadly described spirit and scope of the present invention.Therefore, embodiments of the invention are all just illustrative in all senses, rather than restrictive.
The present invention is not limited to the particular content described in embodiment.Ground of the present invention renal artery ablating device goes also to can be used for the neural ablation of other blood vessel/tissue the hypertensive purposes of renal artery sympathetic nerve treatment except being applied to radio-frequency (RF) ablation.