CN104257426A - Renal artery sympathetic nerve removal cold saline radiofrequency ablation catheter with seal valve - Google Patents
Renal artery sympathetic nerve removal cold saline radiofrequency ablation catheter with seal valve Download PDFInfo
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Abstract
The invention relates to a renal artery sympathetic nerve removal cold saline radiofrequency ablation catheter with a seal valve. The renal artery sympathetic nerve removal cold saline radiofrequency ablation catheter comprises a spiral ablation pipe and the seal valve connected to the far end of a through hole, wherein the through hole for a guide wire to penetrate through and saline to be injected is formed in the ablation pipe in the spiral direction. In the ablation pipe, cold saline injection and guide wire penetration share the same through hole, the seal valve is arranged at the far end of the through hole, the catheter is guided by the guide wire to enter a human body and is accurately positioned, cold saline can be injected through the through hole in the ablation process under the condition that the seal valve is sealed so that coking of the inner wall of a blood vessel and blood vessel hypertonicity of the sinews can be prevented, the internal structure of an inner pipe is greatly simplified, the outer diameter of the catheter is reduced, and manufacturing difficulty and cost are reduced; meanwhile, the ablation pipe is in the spiral shape in the ablation process, reliable curvature is provided, and therefore the renal artery sympathetic nerve removal cold saline radiofrequency ablation catheter is tightly attached to the inner wall of a renal artery, and the ablation effect is improved. The renal artery sympathetic nerve removal cold saline radiofrequency ablation catheter can be applied to the renal denervation.
Description
Technical field
The present invention relates to a kind of minimally invasive medical apparatus, particularly relate to a kind of renal artery with seal valve and remove sympathetic nerve cool brine radio frequency ablation catheter.
Background technology
Hypertension is a kind of disease of serious threat human health, is the important risk factor of multiple cardiovascular diseases, coronary heart disease particularly apoplexy, be also aggravation kidney damage, heart failure and death commonly encountered diseases because of.In the cause of disease of cardiovascular disease death, about 2/3 is relevant to hypertension.The hyperpietic of China in 2013 reaches 300,000,000 people, and wherein obstinate hypertension ratio is about 15%.Along with constantly carrying out of hypertensive correlational study, its treatment concept is also constantly updated.Although it is countless to treat hypertensive medicine, quite a few people is had to have Drug resistance.Also have patient due to the restriction (patient is difficult to adhere to, compound medicine restriction and bad medical event) of medication aspect, blood pressure can not be controlled in normal range.Need for above-mentioned reasons to develop more efficiently Therapeutic Method, wherein just comprise traumatic little interventional therapy method-renal sympathetic nerve safely and effectively and remove art.
Intractable hypertension refers to the hypertension that blood pressure still can not be effectively controlled when normal use three kinds of resistance to compression medicines (wherein a kind of is diuretic).Experimental data has proved that the blood pressure level of orthosympathetic excitement degree and patient is proportionate.Wherein sympathetic renal nerve system, particularly plays decisive role for bringing out with keeping system hypertension near the kidney Sympathetic Nerve of renal artery wall and nervus centripetalis.Orthosympathetic be overexcited facilitate the activation of angiotensiri system (RAAS) to a certain extent, in hypertensive Forming Mechanism, RAAS system is the circulation regulating system of human body classics, vital effect is played at blood pressure regulating, by maintaining the balance of body water, electrolyte and blood pressure to the adjustment of heart, blood vessel, kidney, it is an important regulatory mechanism of human physiological's function.Block renal sympathetic nerve and not only can make blood pressure drops, and Chronic organ's specific diseases that can cause sympathetic nerve excessive activation has an impact.Block renal sympathetic nerve and can also improve left ventricular hypertrophy and insulin resistant.
Renal sympathetic nerve removes art (Renal Sympathetic Denervation) also referred to as percutaneous catheter radio-frequency ablation procedure, radio-frequency (RF) energy is utilized to carry out impedance type heating to the sympathetic nerve of tunica adventitia on renal artery inwall, the orthosympathetic activity at renal artery position can be weakened, reduce nerve between kidney and cranial nerve mutual thus reduce blood pressure.Up-to-date animal and the Clinical Follow-up experimental data of 2 years show that the renal sympathetic nerve radio-frequency ablation procedure adopting percutaneous catheter can significantly and reduce blood pressure enduringly.This method also has the advantage such as Wicresoft, few intercurrent disease.Be regarded as breakthrough, for treatment intractable hypertension opens new path.After within 2009, ACC can pleasantly surprisedly expose, this therapy has become the focus of each medical apparatus corporation, Ltd research and development.
Patent documentation ZL2011103212304 discloses a kind of renal artery and removes sympathetic nerve cool brine radio-frequency (RF) ablation pipe, comprise joystick, main paragraph, can curved segment, last straight section and electrode, wherein bracing wire extends through catheter interior and is controlled by joystick, electrode is fixed on last straight section, the far-end of last straight section is fixed in one end of bracing wire, and bracing wire is arranged to the axis along conduit, bracing wire is at last straight section and can extend at not homonymy in curved segment.This conduit controls bracing wire by control operation handle, can make curved segment to bend.Because bracing wire is at last straight section with can extend at not homonymy in curved segment, thus make the axis runout of the last straight section being fixed with electrode can curved segment bending time axis have certain distance, pull bracing wire to make catheter body form curved shape.This conduit bracing wire and handle control the degree of crook of body.This conduit does not have cold brine perfusion while melting, and easily produces the damage to blood vessel when improving and melting temperature and time.Controlled the degree of crook of body by handle, randomness is comparatively large, can not realize good adherent effect; Conduit enters in human vas does not have seal wire to guide, and more difficultly after entering human body arrives at ablation site accurately, affects ablation effect.
Patent documentation ZL2012102044908 discloses a kind of renal artery cold saline water radio frequency ablation controllable electrode catheter, when carrying out radio-frequency (RF) ablation to the sympathetic nerve on renal artery tube wall, pour into cool brine to ablation site local cooling simultaneously, prevent coking and the vasospasm of tunica intima, while deepening to melt, greatly reduce the damage to blood vessel.The far-end of this catheter tube is connected with electrode tip, and electrode tip, by platinumiridio silk or platinum-tungsten alloys silk, turns to external diameter 0.80mm-2.00mm, and long 1.5mm-4mm's is close around helical spring, and distal end is that semicircle is spherical.In the main part of catheter tube, far-end is provided with becket, and the far-end of controlled bracing wire steel wire is connected with welding metal rings, and the near-end of controlled bracing wire steel wire connects control handle.Flexibility and the shape of far-end can be regulated by control handle.Although this conduit has cold brine perfusion, be the degree of crook being controlled body by handle equally, randomness is comparatively large, can not realize good adherent effect; And conduit enters in human vas and do not have seal wire to guide, more difficultly after entering human body arrive at ablation site accurately, affect ablation effect.
Summary of the invention
In order to overcome above-mentioned technical problem, a kind of simple renal artery of seal valve of being with of reliable flexibility, convenient location and making that provides is the object of the present invention is to provide to remove sympathetic nerve cool brine radio frequency ablation catheter.
The technical solution adopted in the present invention is:
Renal artery with seal valve removes a sympathetic nerve cool brine radio frequency ablation catheter, comprising:
Spiral helicinely melt pipe, described in melt in pipe to be provided with along the hand of spiral and to run through for seal wire and through hole that cool brine injects;
Be connected to the seal valve of through hole far-end, described seal valve comprise seal wire through time through hole is opened opening and seal wire withdraw from after by through hole close closure state.
As the further improvement of technique scheme, described in melt pipe and be bent into the helical form of diameter at 2 ~ 9mm in advance by the material with rebound performance.
As the further improvement of technique scheme, described in melt pipe outer wall compartment of terrain and be connected to some ring electrodes.
As the further improvement of technique scheme, described ring electrode two ends are tightly connected and melt pipe outer wall, middle part and melt between pipe outer wall and form annular chamber, what described annular chamber covered melts salt water hole pipe offering and is communicated with through hole, and described ring electrode outer wall is provided with and is communicated with side opening that is extraneous and annular chamber.
As the further improvement of technique scheme, described in melt in pipe the guidewire lumen being provided with and separating with through hole, from guidewire lumen introduce radio-frequency (RF) energy transfer wire connect each ring electrode.
As the further improvement of technique scheme, described ring electrode is provided with thermocouple, and the holding wire of described thermocouple is introduced from guidewire lumen.
As the further improvement of technique scheme, described seal valve comprises valve flap structure, and seal wire is in opening through seal valve during valve flap structure, and when seal wire deviates from valve flap structure, valve flap structure is closed and closes through hole, thus makes seal valve be in closure state.
As the further improvement of technique scheme, described seal valve comprises valve body, and described valve body is by thinning gradually in the middle of outer circumference, and be provided with otch at the thinnest part at middle part, described incision periphery forms described valve flap structure.
As the further improvement of technique scheme, described seal valve comprises the valve body of tubulose, and the end of described valve body is integrally connected to hemispherical pipe cap, and described pipe cap is provided with otch, and the periphery of described otch forms described valve flap structure.
As the further improvement of technique scheme, described in melt pipe near-end and be connected to main pipe, described main pipe and the inwall melted near pipe junction are embedded with annular metal net.
The invention has the beneficial effects as follows: the invention has the beneficial effects as follows: the present invention's cool brine melted in pipe injects and seal wire penetrates a shared through hole, and at through hole far-end, seal valve is set, seal valve close under also in time melting, inject cool brine by through hole, greatly simplify the internal structure melting pipe, decrease the inner chamber melting pipe, the external diameter of conduit is made to be reduced in suitable scope, and little ablation catheter external diameter can make conduit trans-radial or ulnar artery enter renal artery, the myometrial suture that minimizing enters through femoral artery and produces, operating time, hospital stays etc., the inner tube structure simplified can also reduce manufacture difficulty, reduce costs, melt pipe simultaneously and can be directed to by seal wire the accurate location that homonymy renal artery blood vessel realizes more than secondary, realize repeatedly melting, other melt compared with pipe with major part, greatly shorten and melt the time, reduce Principle of Pain and the dependence to doctor's operant level, and ablation catheter in the shape of a spiral, provides reliable flexibility when melting, thus is close to renal artery blood vessel, greatly improves ablation effect.
Accompanying drawing explanation
Below in conjunction with drawings and embodiments, the present invention is further described.
Fig. 1 is structural representation of the present invention;
Fig. 2 be melt pipe bend to helical form before structural representation;
Fig. 3 melts pipe admittance silk pre-structure schematic diagram;
Fig. 4 is structural representation when melting pipe admittance silk;
Fig. 5 is the partial enlarged drawing of the part A in Fig. 4;
Fig. 6 is the partial enlarged drawing of the part B in Fig. 4;
Fig. 7 melts pipe cross-sectional structure schematic diagram;
Fig. 8 melts the schematic diagram of pipe in renal artery blood vessel;
Fig. 9 is the sectional view of ring electrode;
Figure 10 is the front view of seal valve first embodiment;
Figure 11 is the A-A profile of Figure 10;
Figure 12 is the top view of Figure 10;
Figure 13 is the front view of seal valve second embodiment;
Figure 14 is the A-A profile of Figure 13;
Figure 15 is the top view of Figure 13;
Figure 16 is an embodiment of seal valve otch;
Figure 17 is another embodiment of seal valve otch;
Figure 18 is another embodiment of seal valve otch;
Figure 19 is another embodiment of seal valve otch.
Detailed description of the invention
The renal artery of band seal valve as shown in Figure 1 removes sympathetic nerve cool brine radio frequency ablation catheter, comprise connected successively by far-end to near-end melt pipe 2, main pipe 1 and handle 3, handle 3 be connected with electric connection 5 proximally by wire 4, and be connected to cool brine joint 6 by connection tube 7.
Melt pipe 2 for helical form, and have excellent rebound performance, it by the stretching rear formation of external force as shown in Figure 3, and can return back to original shape after external force elimination.Melting between pipe 2 and main pipe 1 adopts the connected mode such as sweat soldering or glue bonding to link together.Melt in pipe 2 and the hand of spiral is provided with one through hole 11, when seal wire 14 is through through hole 11, melts pipe 2 and can to slide along seal wire 14 outer wall and stretching, thus enter the assigned address of renal artery blood vessel, as shown in Figure 2 and Figure 4; And after seal wire 14 detaches, melting pipe 2 returns back to helical form, and be close to renal artery 100 inwall, as illustrated in figures 1 and 8.
Melt pipe 2 to be bent into helical form in advance by resilient material and to make, therefore naturally preformed shape can reverted back to by after External Force Acting, preferred resilient material is thermoplastic elastic material, does not certainly also get rid of the material that other had not only had rebound performance but also can be applicable to human body.The outside dimension melting pipe 2 and main pipe 1 far-end caliber identical or less than normal.The diameter melting pipe 2 under naturalness is identical with the diameter of renal artery 100 blood vessel is advisable, thus meets the requirement of adherent compactness.The arteriorenal average caliber of male is according to statistics: left side 0.60 ± 0.24cm, right side 0.67 ± 0.26cm; Women is: left side 0.42 ± 0.24cm, right side 0.46 ± 0.22cm; Therefore, melting pipe 2 diameter is 2 ~ 9mm.
As shown in Figure 4 and Figure 5, the far-end melting pipe 2 is a tip, and this most advanced and sophisticated place is provided with a seal valve 9, and sealing valve 9 is also in the far-end of through hole 11 simultaneously.Seal valve 9 comprises opening and closure state, can move smoothly through the seal wire 14 that diameter is 0.014inch ~ 0.038inch when it is in opening, and after seal wire 14 withdraws from, it can be closed into closure state automatically, thus close through hole 11 far-end, make through hole 11 become blind hole.After seal valve 9 is in closure state, the pressure being pointed to seal valve 9 by through hole 11 can be born.
Far-end due to through hole 11 arranges seal valve 9, therefore can inject cool brine in through hole 11, to ablation site local cooling, prevents coking and the vasospasm of tunica intima, reduces the damage to blood vessel while deepening to melt.From the above, through hole 11 is the shared chamber that seal wire 14 enters and cool brine injects, and guidewire lumen, salt water cavity in conventional art is united two into one, greatly simplify the internal structure melting pipe 2, facilitate its processing and fabricating.Seal valve 9 is as follows with the cooperating principle of through hole 11: will melt after pipe 2 sends to assigned address by the guiding of seal wire 14, withdraw from seal wire 14, seal valve 9 closes, and can carry out radio-frequency (RF) ablation from through hole 11 near-end injection cool brine.
Concrete, seal valve 9 is made up of the macromolecular material of elasticity excellence, such as silica gel, silicone rubber, rubber or latex class etc., passes through performance with the seal wire 14 realizing reliable sealing property and excellence.Most high injection speed 60mL/min when seal valve 9 needs the cool brine injection speed born to be not less than Clinical practice, guarantee plays the effect of distally flowing out when preventing cool brine from injecting after withdrawing from seal wire.
Seal valve 9 realizes opening and closing by valve flap structure.Specifically, be in opening at seal wire 14 through seal valve 9 during valve flap structure, when seal wire 14 is deviate from, valve flap structure is closed and closes through hole 11, thus makes seal valve 9 be in closure state.
As shown in figs. 10-12, seal valve 9a comprises a valve body, valve body with melt pipe 2 far-end and be connected firmly, its outer wall is close to and is melted the most advanced and sophisticated inwall of pipe 2.Valve body, by thinning gradually in the middle of outer circumference, makes the sealing effectiveness that seal valve 9a reaches good.As shown in figure 11, the centre of valve body is horizontal spacer body, and the upper/lower terminal of spacer body is opening, and opening is diminished to centre gradually by two ends, makes spacer body be the thinnest part of valve body.In spacer body, be provided with otch 18, namely the periphery of otch 18 defines above-mentioned valve flap structure.Seal wire 14 can strut otch 18 and easily pass through, and after seal wire 14 is withdrawn from, otch 18 closes automatically, distally flows out when preventing cool brine from injecting, and realizes reliable sealing property.
As illustrated in figs. 13-15, seal valve 9b comprises the valve body of tubulose, valve body with melt pipe 2 far-end and be connected firmly, its outer wall is close to and is melted the most advanced and sophisticated inwall of pipe 2.The end of valve body 9b is integrally connected to hemispherical pipe cap, and pipe cap is provided with otch 18, and the periphery of otch 18 forms valve flap structure, and the valve body 9b of this shape can also as the soft head melting pipe 2 while reaching sealing effectiveness.Seal wire 14 can strut otch 18 and easily pass through, and after seal wire 14 is withdrawn from, otch 18 closes automatically, distally flows out when preventing cool brine from injecting, and realizes reliable sealing property.
In the above two embodiments, otch can adopt following four kinds of shapes:
A, as shown in figure 16, in the middle of seal valve, cut one otch 18a, shape is in-line.
B, as shown in figure 17, in the middle of seal valve, cut twice otch 18b, shape is cross.
C, as shown in figure 18, in the middle of seal valve, cut three road otch 18c, shape is Y-shaped.
D, as shown in figure 19, in the middle of seal valve, cut six road otch 18d, shape is scroll.
In the present invention, as shown in Figure 1, melt pipe 2 outer wall and be evenly equipped with some ring electrodes 8 along the hand of spiral, material is platinumiridio, melt pipe 2 stretching after, the distribution of ring electrode 8 is as shown in Figures 2 to 4.Be close to renal artery inwall when radio-frequency (RF) ablation by ring electrode 8, provided by heating and melt orthosympathetic energy.For this reason, as shown in Figure 5-Figure 7, melt in pipe 2 guidewire lumen 10 being also provided with and separating with through hole 11, the radio-frequency (RF) energy transfer wire 13 introduced from guidewire lumen 10 connects each ring electrode 8.
Pipe is melted in conventional art, if want the function being reached through seal wire, injection cool brine, generally can consider to do three inner chambers, be used for by wire, seal wire and cool brine respectively, but the size range melting pipe due to renal artery is generally about 4F-5F, does three inner chambers and is difficult to realize.But from embodiments of the invention, melt in pipe 2 and only have guidewire lumen 10 and through hole 11, seal wire 14 shares a chamber with cool brine, reduces the manufacture difficulty melting pipe greatly like this.
As supporting, main pipe 1 also only has two passes equally, and this two passes is mutually separated and distinguished communication conductive wire chamber 10 and through hole 11, as shown in Figure 5 and Figure 6.The holding wire 12 of radio-frequency (RF) energy transfer wire 13 and thermocouple is penetrated in a passage wherein, radio-frequency (RF) energy transfer wire 13 enters guidewire lumen 10 and connects the end of each ring electrode 8, the holding wire 12 of thermocouple also enters guidewire lumen 10 and is mounted on the thermocouple on ring electrode 8, radio-frequency (RF) energy transfer wire 13 passes main pipe 1 with the other end of thermocouple signal line 12 and is connected electric connection 5, thus connects outside radio-frequency signal generator and temperature measurer.An other passage end of main pipe 1 is communicated with through hole 11, and one end connects cool brine joint 6 in addition, and this cool brine joint 6 can pass seal wire 14 simultaneously.
The thermoplastic elastic material that main pipe 1 is strengthened by rustless steel braided wires is made, but the hardness of main pipe 1 is higher than the hardness melting pipe 2.As shown in Figure 6, be embedded with the wire netting 17 of ring-type in main body tube near the link inwall melting pipe 2, add the twisting property of main body tube link and anti-folding anti-bending strength.
In the present invention, as shown in figs. 5 and 9, each ring electrode 8 two ends are tightly connected and melt pipe 2 outer wall, middle part and melt between pipe 2 outer wall and form annular chamber, what annular chamber covered melts the salt water hole 15 pipe 2 offering several connection through hole 11, ring electrode 8 outer wall offers and is communicated with side opening 16 that is extraneous and annular chamber, and each side opening 16 is evenly distributed, and makes the cool brine injected from through hole 11 evenly flow to blood vessel ring electrode 8 through salt water hole 15 and side opening 16.
Use procedure of the present invention is as follows: assigned address seal wire 14 being stretched to renal artery 100, operation main pipe 1 makes to melt pipe 2 and enters renal artery 100 along seal wire 14, now seal wire 14 is through seal valve 9 and through hole 11, and seal valve 9 is in opening, and melts pipe 2 and be in straight condition; Melt after pipe 2 arrives assigned address, extract seal wire 14 out, now seal valve 9 is closed, and melts pipe 2 and also returns back to helical form and the ring electrode 8 melting pipe 2 surface fits tightly renal artery 100 inwall; Pass into radio-frequency (RF) energy to ring electrode 8 to start to melt sympathetic nerve, simultaneously injection cool brine in through hole 11, cool brine by flowing out ring electrode 8 in side opening 16 and being cooled by ablation points, simultaneously also as human body fluid infusion.
The above is the preferred embodiment of the present invention, and it does not form limiting the scope of the invention.
Claims (10)
1. the renal artery with seal valve removes a sympathetic nerve cool brine radio frequency ablation catheter, it is characterized in that, comprising:
Spiral helicinely melt pipe, described in melt in pipe to be provided with along the hand of spiral and to run through for seal wire and through hole that cool brine injects;
Be connected to the seal valve of through hole far-end, described seal valve comprise seal wire through time through hole is opened opening and seal wire withdraw from after by through hole close closure state.
2. the renal artery of band seal valve according to claim 1 removes sympathetic nerve cool brine radio frequency ablation catheter, it is characterized in that: described in melt pipe and be bent into the helical form of diameter at 2 ~ 9mm in advance by the material with rebound performance.
3. the renal artery of band seal valve according to claim 1 removes sympathetic nerve cool brine radio frequency ablation catheter, it is characterized in that: described in melt pipe outer wall compartment of terrain be connected to some ring electrodes.
4. the renal artery of band seal valve according to claim 3 removes sympathetic nerve cool brine radio frequency ablation catheter, it is characterized in that: described ring electrode two ends are tightly connected and melt pipe outer wall, middle part and melt between pipe outer wall and form annular chamber, what described annular chamber covered melts salt water hole pipe offering and is communicated with through hole, and described ring electrode outer wall is provided with and is communicated with side opening that is extraneous and annular chamber.
5. the renal artery of band seal valve according to claim 1 removes sympathetic nerve cool brine radio frequency ablation catheter, it is characterized in that: described in melt in pipe the guidewire lumen being provided with and separating with through hole, from guidewire lumen introduce radio-frequency (RF) energy transfer wire connect each ring electrode.
6. the renal artery of band seal valve according to claim 5 removes sympathetic nerve cool brine radio frequency ablation catheter, it is characterized in that: described ring electrode is provided with thermocouple, and the holding wire of described thermocouple is introduced from guidewire lumen.
7. the renal artery of band seal valve according to any one of claim 1 to 6 removes sympathetic nerve cool brine radio frequency ablation catheter, it is characterized in that: described seal valve comprises valve flap structure, seal wire is in opening through seal valve during valve flap structure, when seal wire deviates from valve flap structure, valve flap structure is closed and closes through hole, thus makes seal valve be in closure state.
8. the renal artery cool brine of band seal valve according to claim 8 melts pipe, it is characterized in that: described seal valve comprises valve body, described valve body is by thinning gradually in the middle of outer circumference, and be provided with otch at the thinnest part at middle part, described incision periphery forms described valve flap structure.
9. the renal artery cool brine of band seal valve according to claim 8 melts pipe, it is characterized in that: described seal valve comprises the valve body of tubulose, the end of described valve body is integrally connected to hemispherical pipe cap, and described pipe cap is provided with otch, and the periphery of described otch forms described valve flap structure.
10. the renal artery cool brine of band seal valve according to any one of claim 1 to 6 melts pipe, it is characterized in that: described in melt pipe near-end and be connected to main pipe, described main pipe and the inwall melted near pipe junction are embedded with annular metal net.
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