CN103750898A - Intraluminal ablation catheter - Google Patents
Intraluminal ablation catheter Download PDFInfo
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- CN103750898A CN103750898A CN201410007017.XA CN201410007017A CN103750898A CN 103750898 A CN103750898 A CN 103750898A CN 201410007017 A CN201410007017 A CN 201410007017A CN 103750898 A CN103750898 A CN 103750898A
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Abstract
The invention provides an ablation catheter for use in human lumens. The catheter a far end, a near end, a support unit, and a slender tube body; the far end and the near end are connected through the support unit and the slender tube body. The far end is connected with an energy generator. The support unit at the far end is elastic and compressible. The support unit is single arch shaped and comprises a far end bottom, a top and a near end bottom. The support unit is provided with at least two regulation elements. The support unit is further provided with a traction wire. The catheter has the advantages of operational safety and high efficiency, and the use of the traction wire further optimizes adaptability and operability of the catheter.
Description
Technical field
The present invention relates to medical apparatus and instruments, be specifically related to a kind ofly in blood vessel or in body lumen, near local organization wall of the lumen being applied to energy, realize and to melt or the apparatus of neuromodulation.
Background technology
A kind of important application of intracavity ablation catheter is that near local organization renal artery blood vessel wall is applied to energy.Kidney sympathetic innervation, in renal artery blood vessel wall, applies energy near local organization renal artery blood vessel wall, can effectively reduce the orthosympathetic activity of kidney, can make some patients' Blood pressure drop.Its typical model of action is through conduit, modulation element to be transported to the target tube intracavity of health, and by energy delivery to wall of the lumen and near tissue thereof, thereby reach melting or other energy modulation effects of destination organization.
Hypertension is common chronic disease, also be the topmost risk factor of cardiovascular and cerebrovascular disease, its apoplexy, myocardial infarction, the major complications such as exhaustion and chronic nephropathy at heart, not only disable, fatality rate is high, and seriously consume medical treatment and social resources, cause heavy burden to family and country.
In hypertensive formation mechanism, renin angiotensin aldosterone system (Renin Angiotensin Aldosterone System, RAAS) be important regulating blood pressure system, it is by maintaining the balance of body water, electrolyte and blood pressure to the adjusting of heart, blood vessel, kidney.Studies confirm that, RAAS causes hypertension by following 3 approach: (1) RAAS activates and causes sodium retention; (2) RAAS activates can increase sympathetic nervous system activity; (3) RAAS activates directly vasoconstrictive.
Meanwhile, kidney sympathetic nervous system (Sympathetic Nervous System, SNS), is most kidney Sympathetic Nerve and the nervus centripetalis that is distributed in renal artery wall especially, for bringing out with keeping system hypertension, plays decisive role.The orthosympathetic overacfivity of kidney, is maintained hypertension.
Orthosympathetic be overexcited also promoted to a certain extent the activation of RAAS, improve the heavily absorption of sodium, accelerate heart beating, and increase the often amount of fighting and peripheral vascular resistance, so it also can improve and suffers from other risk of cardiovascular diseases.It is predicted in hyperpietic, have 25%～47% to suffer from insulin resistant or impaired glucose tolerance simultaneously.The orthosympathetic overacfivity of kidney increases Angiotensin II secretion, and this will cause, and insulin-like growth factor-i (IGF-1) is movable to be reduced; Similarly, RAAS adjusting has increased oxidative stress (OS) also probably causes the insulin resistant of skeletal muscle, and latter is one of reason of type 2 diabetes mellitus morbidity.
Both domestic and external facts have proved, hypertension is the disease that can prevent and control, current, hypertensive primary treatment means are by the mode of making the life better and Drug therapy.The pharmacology's strategy that obstructs kidney output sympathetic nerve to intensify result comprises central action sympatholytic thing, beta-blocker, angiotensin converting enzyme inhibitor, receptor blocking agent and diuretic.Yet these pharmacology's strategies have obvious restriction, comprise limited effect, compliance issues, side effect etc.For example, on the basis of the mode of making the life better, applied after 3 kinds of antihypertensive drugs (comprising diuretic) of enough and reasonable associating, blood pressure is still on target level, or while at least needing 4 kinds of medicines just can make reach mark blood pressure, this class hypertension is referred to as refractory hypertension (or intractable hypertension).In China, obstinate hypertension accounts for hyperpietic's 15%～20%.Therefore, for this some patients were, in the mode of making the life better now, combine outside multi-medicament scheme, explore the new method for the treatment of intractable hypertension, be clinical in the urgent need to.
Through conduit renal artery sympathetic nerve ablation (RDN), for the orthosympathetic strategy that melts of renal artery, as the mode of sympathetic nerve modulation, the safety and efficacy of the method is being proved to be in recent years, and is used to gradually the clinical treatment of obstinate hypertension.Renal artery sympathetic nerve is through after melting, and it imports into and spreads out of autonomic activity decreased; The activity decreased of feritin-aldosterone system has been brought out in the reduction of nervus centrifugalis activity, the heavily absorption of the minimizing of peripheral vascular resistance, sodium and the increase of blood flow, and all these results are all conducive to Blood pressure drop.In fact, according to Krum, the discovery of the clinical research team of H. etc., orthosympathetic deactivation all has clinical meaning for treatment associated chronic renal disease (CKD), heart failure, diabetes and sleep apnea etc. disease.
Fig. 1 has shown the distribution of kidney sympathetic nerve 4 along renal artery blood vessel wall.From blood vessel side, kidney sympathetic nerve 4 extends to kidney 700 from aorta 1 through main renal artery 7 and renal artery branch blood vessel 70 along blood vessel.
In prior art, the ablation catheter of common a kind of kidney neuromodulation is shown in Fig. 2.This ablation catheter 5 is with elongated tube chamber, and its far-end 53 has compliant section and a modulating unit is set, and for example electrode 55, and its near-end 51 is connected with one handle 500.In ablation catheter, there is wire, by handle 500, be connected with power generator 9 with cable 91; The compliant section that simultaneously doctor can control far-ends 53 by handle 500 is out of shape, and carrys out contacting of control electrode 55 and target blood inwall.This ablation catheter can percutaneous puncture intravasation, under developing apparatus auxiliary, then is delivered to renal artery 7 through aorta 1, by applying the energy of heat energy or electric energy, to modulate the nerve fiber that contributes to renal function.
In use, doctor is first posted by renal artery 7 near the position of 70 minutes prongs of branch vessel by electrode 55, carries out the neuromodulation of first; Then, edge is away from the new target location of the set direction of kidney 700, on arteriorenal inwall, select each time a position, doctor need to merge ablation catheter the angle of rotation electrode backward, direction on arteriorenal inwall shape of spinning in target location is arranged, and repetitive operation is to increase the coverage rate of modulation nerve fiber.Usually, at one-sided renal artery, need to carry out 4 to the neuromodulation of 6 target locations, therefore, the operating time that doctor need to be longer, just can complete the operation that movement repeatedly, location and the electrode paste of this ablation catheter lean on, increased patient's risk and misery.Secondly, in multiple bearing operation, doctor often cannot determine last time or the position of primary modulation point more early, probably near same target location, does the neuromodulation of repetition, causes the excessive damage to blood vessel wall.Again, doctor adjusts the electrode position of far-end by handle, relying on developing apparatus completely observes the recession distance of electrode and the anglec of rotation and cannot look at straight with eyes, therefore be difficult to judge rapidly and accurately distance and the angle between adjacent modulation point, the design pattern of the modulating mode on the renal artery inwall that more difficult realization is envisioned, for example, actual modulation point may not be that spiral type is arranged, and does not reach the modulation effect of expection.
Another kind of the prior art for arteriorenal ablation catheter as shown in Figure 3.The far-end 53 of this ablation catheter comprises compressible spiral supporting component 54, by a sheath pipe, is delivered to after the targeted treatment site in renal artery, and this supporting component gets final product Automatic-expanding after discharging from sheath pipe.On the supporting component of this ablation catheter, there are a plurality of electrodes, can in a plurality of positions of renal artery inwall, carry out kidney neuroregulation simultaneously.But, because the supporting component of this ablation catheter is helical structure, rely on its elasticity and Automatic-expanding expansion, the bulbs of pressure of supporting component are scattered in the larger area of radial periphery, when the rigidity of supporting component hour, the pressure that electrode puts on blood vessel wall, compared with little and contact poor effect causes the heat utilization rate of its neuromodulation to reduce, needs higher rf modulations power just can reach required modulation effect.Meanwhile, more heat is taken away by blood flow, causes blood heat too high.Otherwise, when the rigidity of supporting component is larger, can cause the far-end of ablation catheter more difficultly to enter sheath, go out sheath and carry at intracavity, therefore, there is the technical contradiction that is difficult to overcome in this technical scheme.
Therefore, need to improve the ablation catheter for kidney neuromodulation of the prior art.
Summary of the invention
It is a kind of for modulating the ablation catheter of kidney nerve that the embodiment of the present invention provides, and is intended to solve ablation catheter of the prior art and is difficult to realize the technical problem of kidney neuromodulation safely and efficiently.
In order to solve the problems of the technologies described above, the embodiment of the present invention is by the following technical solutions: a kind of intracavity ablation catheter, there is a near-end and a far-end, the main body and the supporting component that also comprise the elongated tubular product linking together, described main body is connected with power generator by described near-end, described supporting component is positioned at described far-end, described supporting component has elasticity and can be compressed, at least two modulation elements are set on described supporting component, described modulation element arrives nervous tissue for the energy delivery that described power generator is produced, described supporting component is single arch shape, described supporting component has far-end bottom, top and proximal end base, described proximal end base connects described main body, described at least two modulation elements are arranged at described top, or, at described top and described far-end bottom, at least one modulation element is respectively set.
Further technical scheme also comprises, traction fiber is also set on described supporting component, the far-end of described traction fiber is fixed on described far-end bottom, the near-end of described traction fiber extends to the near-end of described ablation catheter slidably through the tube chamber of the pilot hole in described proximal end base and described main body, while launching at described supporting component automatic expansion, by operating described traction fiber, can shorten distance between described far-end bottom and described proximal end base to adjust the shape of described supporting component, so that modulation element can abut on blood vessel described in each simultaneously.
Further technical scheme also comprises, described supporting component comprises continuous supporter and is wrapped in the insulating barrier of the outside of described supporter, described supporter is tubulose substantially or is shaft-like, described supporter has single arch shape and makes described supporting component also have similar single arch shape, described supporter also comprises four turn of bilges can distinguishing free bend, wherein two turn of bilges and between distal transition connect far-end bottom and the top thereof of described supporter, another two turn of bilges and between near-end changeover portion connect top and the proximal end base thereof of described supporter.
Further technical scheme also comprises, when described supporter is tubulose substantially, described supporter is processed by tubing, and described in each, turn of bilge has respectively the breach forming by removing a part of tubing; When described supporter is while being shaft-like, described in each, the width of turn of bilge and/or thickness are less than the corresponding size of the remainder of described support bar.
Further technical scheme also comprises, when described supporter is tubulose substantially, described in each, the breach of turn of bilge is in the inner side of single arch shape of described supporter, or, the rings that described in each, turn of bilge comprises a ring or at least two coaxial series connection also leave connecting portion in the same side of this turn of bilge and form teeth groove in the contrary side of this turn of bilge, the teeth groove of two turn of bilges that are directly connected with far-end bottom or the proximal end base of described supporter is respectively all towards the outside of single arch shape of described supporter, the teeth groove of another two turn of bilges that are directly connected with the top of described supporter is all towards the inner side of single arch shape of described supporter.
Further technical scheme also comprises, when described supporter is tubulose substantially, described supporter also comprises an extension, and the proximal end base of described supporter connects described main body by described extension, and the flexible pipe that described extension is surface hollow-out also communicates with the tube chamber of described main body.
Further technical scheme also comprises, the surface of described extension has staggered decorative pattern breach.
Further technical scheme also comprises, when described supporter is while being shaft-like, described insulator is tubulose and comprises at least two inner chambers, and described supporter is arranged in an inner chamber of described insulator.
Further technical scheme also comprises, the electrode of a flexible boot segment or a cap shape is set at the far-end of described supporting component.
Further technical scheme also comprises, when described supporting component is during in naturalness, the height of described supporting component is selected in the scope of 3 millimeters to 8 millimeters, and the distance between described far-end bottom and proximal end base is selected in the scope of 15 millimeters to 40 millimeters.
With respect to prior art, the embodiment of the intracavity ablation catheter that the present invention is disclosed has obtained significant beneficial effect, not only be convenient to be transported in target blood by sheath pipe, can also make a plurality of electrodes close contact blood vessel simultaneously, it locates the modulation that can realize the nervous tissue of a plurality of novel sites each time, and location is safer, convenient, energy transfer efficiency is higher, when guaranteeing shorter operating time, also reduces the risk to patient.Further, at the own elasticity of supporting component,, under the mating reaction of the control of traction fiber and sheath pipe, ablation catheter can switch freely fast between various states, has higher safety and operability.
Accompanying drawing explanation
Fig. 1 is the schematic diagram of renal artery and relevant blood vessel and organ;
Fig. 2 is of the prior art for modulating the schematic diagram of a kind of ablation catheter of renal artery nerve;
Fig. 3 is the far-end partial schematic diagram of another kind of ablation catheter of the prior art;
Fig. 4 is the schematic diagram of a kind of embodiment of ablation catheter of the present invention;
Fig. 5 is the far-end partial schematic diagram of the ablation catheter embodiment in Fig. 4;
Fig. 6 A, Fig. 6 B and Fig. 6 C are respectively ablation catheter embodiment in Fig. 4 far-end partial schematic diagram when compressive state, naturalness and holding state;
Fig. 7 A and Fig. 7 B are to be the schematic diagram of a kind of supporter of ablation catheter employing of the present invention;
The far-end partial schematic diagram of the another kind of embodiment that Fig. 8 A and Fig. 8 B are ablation catheter of the present invention;
Fig. 9 A and Fig. 9 B are the generalized section of the adoptable a kind of supporter of embodiment in Fig. 8 A;
Fig. 9 C is the generalized section that the supporter in Fig. 9 A is connected with ablation catheter main body;
Fig. 9 D is that the supporter in Fig. 9 A increases extension axonometric chart afterwards;
Figure 10 A and Figure 10 B are the structural representation of the supporter of the third embodiment employing of the present invention;
Figure 11 A is the far-end partial schematic diagram of the 4th kind of embodiment of ablation catheter of the present invention;
Figure 11 B is the schematic diagram of a cross section of the insulation tube shown in Figure 11 A;
Figure 11 C is the vertical section schematic diagram of the electrode of the cap shape shown in Figure 11 A.
The specific embodiment
In order to make the technical problem to be solved in the present invention, technical scheme and beneficial effect more explicit, below enumerate embodiment by reference to the accompanying drawings, the present invention is further elaborated.Should be appreciated that following specific embodiment is only for setting forth General Principle of the present invention and preferred embodiment, and should not be used for limiting technical scheme of the present invention.
Fig. 1 has shown arteriorenal typical anatomical structure.The porch of main renal artery 7 connects aorta 1, and blood flow flows to kidney 700 from aorta 1 via renal artery 7 and branch vessel 70.Usually, the internal diameter of main renal artery blood vessel is between 3 to 8mm.The invention provides the various embodiments of intracavity ablation catheter, the modulation element of ablation catheter can be positioned the intracavity of main renal artery 7 or the renal artery branch blood vessel 70 suitable with main renal artery internal diameter, by arteriorenal inwall Dui Shen nervous tissue, melts.
Embodiment mono-
Fig. 4 has shown the first embodiment of disclosed intracavity ablation catheter.This ablation catheter has an elongated main body 22, near-end 21 and a far-end 23, at far-end 23, there is a supporting component 24 being connected with main body 22, this supporting component 24 has elasticity, under naturalness, be single arch shape, that is to say, this supporting component 24 comprises a top 27 and divides two bottoms 26 of the both sides that occupy top 27, wherein, far-end bottom is connected with the far-end at top 27 by a stretch section, proximal end base is connected with the near-end at top 27 by another stretch section, and proximal end base is also directly connected with main body 22.Supporting component 24 comprises the supporter (not shown) of a single arch shape, and supporting component 24 is can be compressed stretching and enter in sheath pipe together with main body 22, then by vascular access, is transported to the inside of renal artery 7.While discharging from sheath pipe, supporting component 24 can automatic expansion and is recovered its natural single arch shape.
Can on the top 27 of supporting component 24 and two bottoms 26, a modulating unit be respectively set, as electrode 25, to contact with the inwall of target blood, and to the nervous tissue's delivery of energy in blood vessel wall.Should guarantee the circuit insulating properties of electrode 25, preferably adopt insulant that electrode 25 is fixed on to (not shown) on supporter.In all embodiment of the present invention, on each supporting component of ablation catheter, be provided with at least two electrodes, the electrode that these quantity do not wait forms one group, unless otherwise noted, all uses electrode 25 to be referred to as the whole one group of electrode on supporting component.
The electrode 25 of this ablation catheter can be set up circuit with power generator 9 by one group of wire (not shown) of main body 22 inside and one group of cable 91 of handle 200 outsides and be connected, being placed in endovascular electrode 25 can be with external electrode 8 in same circuit loop, when power generator 9 sends radio-frequency (RF) energy, electrode 25 inspires one pole (monopolar) electric field.During use, doctor sets up transport path by vascular puncture point, near-end 21 control handles 200 at ablation catheter, supporting component 24 is pushed in patient's target blood by transport path, and then adjust the shape of supporting component 24 and the position of electrode 25 by handle 200 operation control members.In general, in the process of ablation catheter turnover sheath pipe, the shape of supporting component 24 will change, can in blood vessel, locate supporting component 24, also can realize a plurality of electrodes 25 simultaneously with the good contact of blood vessel, therefore, for the conventional sheath pipe of ablation catheter, also can have the effect of similar control member, be not difficult to select the suitable parameter of supporting component 24, make the safety of ablation catheter and operability all be better than prior art.
In the present embodiment, as preferred technical scheme, described control member is traction fiber 29, and common sheath pipe only helps out.The far-end of this traction fiber 29 is fixed on the far-end bottom of supporting component 24, and its near-end extends on the handle 200 of near-end 21 through the proximal end base of supporting component 24 and main body 22.Traction fiber 29 can be relatively and the proximal end base of supporting component 24 and main body 22 be free to slide, in the far-end bottom of supporting component 24 and that section of traction fiber 29 between proximal end base, be basically parallel to top 27.Tension traction fiber 29, can dwindle the distance between far-end bottom and proximal end base, increases the bending height of single arch shape of supporting component 24, electrode 25 is abutted on target blood inwall, to improve energy delivery efficiency.
Fig. 5 has shown the more details of the supporting component 24 in Fig. 4, and insulating barrier 28 is wherein cutaway view, to demonstrate bag supporter 30 within it.Supporting component 24 have axially with radially, it is axial consistent with main body 22 axially, for radially, around the direction of axial-rotation, is circumferential with axial vertical direction.Supporting component 24 comprises elastic supporter 30 and is wrapped in the insulating barrier 28 on supporter 30, supporter 30 has the single arch shape consistent with supporting component 24, on far-end bottom 261, there is electrode 251, on top 27, have electrode 252, in proximal end base 262, have electrode 253.Insulating barrier 28 may be substantially of tubulose, guarantee the circuit insulating properties of electrode 251,252,253, and each electrode has a part of outer surface to be exposed to outside insulating barrier 28 at least, to contact conducting with blood vessel wall.Far-end bottom 261 can also connect a boot segment 31, can be connected by welding, gluing or interference fit, and the far-end of supporting component 24 ends at the smooth end face place of boot segment 31, and this end face can be hemispherical, prevents supporting component 24 injured blood vessel inwalls.The far-end of traction fiber 29 is fixed on far-end bottom 261 through the otch 28a on insulating barrier 28; On near the insulating barrier 28 proximal end base 262, there is another otch 28b, the pilot hole sliding as guiding traction fiber 29, the near-end of traction fiber 29 from otch 28b through proximal end base 262, again through the cavity of main body 22 and be fixed on handle 200, traction fiber 29 can be free to slide on the track retraining in proximal end base 262 and main body 22.Pull traction fiber 29, can increase the height of supporting component 24, top 27 is to the vertical dimension of connecting line between far-end bottom 261 and proximal end base 262.The height of the supporting component 24 under naturalness, generally can be less than or equal to arteriorenal internal diameter.In certain embodiments, supporter 30 and traction fiber 29 have determined the shape of supporting component 24 jointly.If without special instruction, far-end bottom 261 and the proximal end base 262 of supporting component will be referred to as with bottom 26.
Fig. 7 A has shown a kind of embodiment of supporter 30, and available elasticity tubing cutting is shaped into elongated single arch shape again, and its structure and technique are all fairly simple.Usually, selecting the wall thickness of tubing is 0.1 millimeter to 0.3 millimeter, and typical value is 0.2 millimeter.The width of far-end bottom 301, top 302 and the proximal end base 301 of supporter 30 can be 0.3 millimeter to 2.0 millimeters, respectively the far-end of corresponding supporting component 24 bottom 261, top 27 and proximal end base 262.Supporter 30 has single arch shape, and makes described supporting component 24 also have similar single arch shape.
In certain embodiments, according to rigidity or the assembling demand of supporter 30 axial different parts, its width and thickness also can change.As shown in Figure 7A, when supporter 30 bends as single arch shape, can form several turn of bilges.Particularly, between turn of bilge 304 and turn of bilge 305, be distal transition, connected proximal end base 301 and the top 302 of supporter 30; Between turn of bilge 306 and turn of bilge 307, be near-end changeover portion, connected top 302 and the far-end bottom 303 of supporter 30.Wherein the width of each turn of bilge and/or thickness can be less than width and/or the thickness of top 302 and bottom 301,303, are also less than width and/or the thickness of distal transition and near-end changeover portion, are beneficial to the molding in advance of supporter 30.The rigidity of distal transition and near-end changeover portion is all greater than each turn of bilge, so that enough large support muscle power to be provided.For example, the width of turn of bilge 304 is narrower than the width of far-end bottom 301, and the ratio of the width of the width that turn of bilge 304 is the narrowest and far-end bottom 301, between 0.3 to 1, can be realized by machining modes such as cutting, polishing.Fig. 7 B is the partial top view of turn of bilge 304, is the part in Fig. 7 A 310 has been amplified.The thickness of each turn of bilge also can be less than the thickness of the remainder of supporter 30, the thickness of the thinnest part of each turn of bilge can be controlled between 0.05 millimeter to 0.25 millimeter, its typical value is 0.12 millimeter, can adopt the modes such as sandblast, chemical polishing to do attenuate processing to tubing.Such turn of bilge is just more soft than the remainder of supporter 30, is conducive to adjust and control the shape of supporting component 24, also guarantees the resilience force that supporting component 24 is required.For example, supporting component 24 is more easily compressed into sheath; While adjusting the shape of supporting component 24 with traction fiber 29, only need the distortion of turn of bilge, and bottom and top can both hold its shape substantially with support electrode, guarantee to be arranged in stable the abutting in blood vessel wall of electrode at bottom and top.
Embodiment bis-
The present invention also provides another embodiment of intracavity ablation catheter, and the embodiment of its supporting component 24 as shown in Figure 8 A.Have an important difference with the previous embodiment of ablation catheter, the supporting component 24 of the present embodiment has the supporter 30 of tubulose, and insulating barrier 28 can closely be enclosed within on the outer surface of tubular support 30.
In some embodiments, insulating barrier 28 is heat-shrinkable sleeve pipe, and the sleeve pipe before pyrocondensation can slide on the supporter 30 of tubulose, and the casing diameter after pyrocondensation diminishes, and has formed the insulating barrier 28 tightening at tubular support 30 outer surfaces.Heat-shrinkable sleeve pipe is polymeric material normally, for example: polyolefin, polytetrafluoroethylene (PTFE), fluorinated ethylene-propylene rare (FEP), polyethylene terephthalate (PET).In other embodiment, insulating barrier 28 can be the heat-shrinkable T bush of multilamellar, makes the radial dimension of the cross section of supporting component 24 meet more accurately designing requirement.
On supporter 30, adjacent electrode can be arranged equally spacedly, and for example, electrode 251,253 can be arranged on the both sides of electrode 252 symmetrically.In the present embodiment, each electrode can be the becket with certain length, better at supporter 30 and the fixed effect on insulating barrier 28 of tubulose.For example, electrode adopts the gold that purity is 99.95%, and its length is selected between 0.5 millimeter to 3 millimeters.In similar embodiment, can there be different number of electrodes and arrangement, the length of each electrode also can be unequal.Fig. 8 B is the amplification view of the local B of far-end of supporting component 24, has shown the set-up mode of the electrode 251 of supporting component 24 far-ends.Can adopt machinery mill pressure mode, electrode 251 be embedded to the outer wall of insulating barrier 28, the outer surface of electrode 251 is concordant with the outer surface of insulating barrier 28.
In the present embodiment, boot segment 31 comprises one section of bourdon tube 312, the coiling of available metal filament, its distal-most end can be processed into a hemispheric termination 311, an elastic yarn 313 is arranged at the inner chamber of bourdon tube 312 and has one end to be fixed on termination 311, the near-end of the near-end of bourdon tube 312 and elastic yarn 312 all along far-end bottom 261 axially and be fixed in the tube chamber of far-end bottom 261, can fix by similar fashion such as soldering, interference fit, viscose glues.The far-end of boot segment 31 can be arc, to adapt to different vascular anatomy structures.In order to guarantee the flexibility of boot segment 31, reduce the frictionally damage to blood vessel, simultaneously for ablation catheter provides better guide effect, preferably, bourdon tube 312 and elastic yarn 313 all can adopt Nitinol, and length can be set to 5 millimeters to 20 millimeters.
Fig. 8 B also shows, wire 32 is connected to remote electrode 251 in the tube chamber of supporter 30.Fig. 9 A has further illustrated the profile of supporter 30, wire generally passes through from the inside of tube chamber 300, in far-end bottom 301, top 302 and the proximal end base 303 of supporter 30, be provided with respectively the pore 321,322,323 that allows the wire (not shown) of each electrode or sensor to pass through, two turn of bilges 304,305 have connected proximal end base 301 and top 302, and another two turn of bilges 306,307 have connected top 302 and far-end bottom 303.On the supporter 30 of tubulose, also can hold sensor, as temperature sensor.Supporter 30 can adopt has hyperelastic tubing, and if external diameter is the NiTi pipe of 1.0 millimeters to 3.0 millimeters, typical outer diameter is 1.4 millimeters.By machining, cut for example, removes the excess stock of inner side of each turn of bilge of supporter 30, only near the complete local body of reservation bottom 301,303 and top 302.Then, supporter 30 is bent as single arch shape, then do heat treatment shaping.
Adjust single arch shape of supporter 30, can make supporter 30 become the holding state shown in Fig. 9 B from the naturalness shown in Fig. 9 A, top 302 increases to the vertical dimension (being the height of supporter 30) of line between far-end bottom 301 and proximal end base 303, and the distance that turn of bilge 304 and turn of bilge are 307 (being the adjustable length of supporter 30) reduces.For example, for the supporter 30 of naturalness, its height can be set to 4 millimeters, and adjustable length can be set to 16.8 millimeters; Under the effect of traction fiber 29, supporter 30 can be changed into holding state, and when the camber of single arch shape reaches capacity, the height of supporter 30 can increase to 7.4 millimeters, and adjustable length can reduce to 6 millimeters.In fact, under the control of traction fiber 29, the height of the supporter 30 in holding state can change between 4 millimeters to 7.4 millimeters, and adjustable length can change between 16.8 millimeters to 6 millimeters, to adapt to the renal artery of different inner diameters.Doctor can be by developing apparatus, and the impedance display on power generator panel, judge electrode on supporting component 24 and the contact condition between renal artery inwall, and then control the pulling force of traction fiber 29, so that electrode resetting make electrode paste lean against the better effects if on renal artery inwall on renal artery inwall.The above-mentioned size that supporter 30 is selected, can adapt to internal diameter and be the renal artery of 4.5 millimeters to 7 millimeters.In other embodiments, supporter 30 can be arranged between 6 millimeters to 35 millimeters at the adjustable length of naturalness, and the adjustable length when holding state is between 4 millimeters to 20 millimeters.It is the renal artery of 3 millimeters to 9 millimeters that such ablation catheter can adapt to internal diameter, and in length is the renal artery region of 10 millimeters to 50 millimeters, resetting and modulation kidney are neural.
As shown in Figure 9 C, near proximal end base 303, retained this complete tubing of a segment base, the length that this section of tubing extends to distal direction from the edge 310 of proximal end base 303 can be set to 0.5 millimeter to 2.5 millimeters, for connecting the main body 22 of proximal end base 303 and ablation catheter, can directly be enclosed within on the compliant section 220 of main body 22 far-ends.The near-end of traction fiber 29 just can be connected on handle 200 through the inner chamber of proximal end base 303 and compliant section 220, and this structure is very beneficial for the regulation and control of traction fiber 29 and is free to slide.If adopt metal material to make compliant section 220, available laser spot welding fixes connection proximal end base 303 and compliant section 220, and solder joint 308 can be 0.5 millimeter to 1.5 millimeters with the distance at the edge 310 of proximal end base 303.
In another embodiment of supporter 30, the extension 309 of certain length can directly be increased in proximal end base 303, as shown in Fig. 9 D.For example, while making supporter 30 with cut tubing, near proximal end base 303, length in reserve is one section of tubing of 50 millimeters to 120 millimeters, and utilize this section of tubing of cut hollow out, form flexible extension 309, the staggered decorative pattern breach on its surface allows extension 309 towards all directions free folding.Near the part of supporter 30 solder joint 308 has larger rigidity, if the far-end of the main body of ablation catheter 22 is fixedly attached on extension 309, solder joint 308 suitably increases with the distance of single arch shape of supporter 30, supporter 30 is more easily bent and smoothly by dividing prong in the right angle between renal artery 7 and aorta 1, reduce the damage to blood vessel.The extension 309 of supporter 30 is with staggered hollow out decorative pattern, also make the far-end of ablation catheter have compliance concurrently and turn round control, also be convenient to hold traction fiber 29 and be conducive to regulation and control and be free to slide traction fiber 29, therefore, being more conducive to supporting component 24 in endovascular resetting.
Embodiment tri-
The present invention also provides another embodiment of ablation catheter, and it has supporter 30 as shown in Figure 10 A.Be with one of main distinction of previous embodiment, each turn of bilge of the supporter 30 of tubulose comprises a ring or at least two rings of connecting vertically, each ring is connected with supporter 30 by connecting portion, described connecting portion is in the same side of corresponding turn of bilge, there is breach in the same way at axial two ends at each ring, described breach is all at the opposite side of corresponding turn of bilge, namely that side relative with connecting portion.When insulating barrier 28 is enclosed within on supporter 30 outer surfaces; cover near the insulating barrier 28 of turn of bilge and be subject to support and the protection of described ring; substantially can not form fold or subside in the indentation, there of hollow out, insulating barrier 28 outer surfaces keep round and smooth, avoid blood vessel to cause damage.And supporter 30 has substantially retained comparatively complete inner chamber and smooth inner wall near each turn of bilge, be easier to arrange electrode cable (not shown) and sensor conductor (not shown) in the inner chamber of supporter 30.
Figure 10 B has illustrated the general configuration of the tubing after hollow out, and this is the side view before tubing bending setting.Take turn of bilge 304 as example, connected coaxially three rings 304a, 304b, 304c, the connecting portion between adjacent ring is in the same side, and the breach between adjacent ring, jointly towards opposite side, forms teeth groove jointly.After supporter 30 bending setting, near the teeth groove of the turn of bilge 304 far-end bottom 301 is towards the outside of single arch shape, near the teeth groove of the turn of bilge 307 proximal end base 303 is also towards the outside of single arch shape, and near the teeth groove of two turn of bilges 305,306 at top 302 all towards the inner side of single arch shape, arbitrary teeth groove can not hinder the distortion of supporter 30.That is to say, teeth groove all deviates from the part that supporting component 24 contacts with blood vessel, and the part that each turn of bilge may contact with blood vessel has complete smooth tube wall, therefore, and can injured blood vessel wall with the turn of bilge of teeth groove.Ring spacing can equate or not etc., can not be set to 0.2 millimeter to 1.5 millimeters.The length of ring can equate or not etc., can not be set to 0.1 millimeter to 1 millimeter.In the present embodiment, wherein two turn of bilges 304,307 respectively comprise three rings, and another two turn of bilges 305,306 respectively comprise two rings.Should be appreciated that each turn of bilge can have the ring of other quantity, these rings also can be wedge shape to be given prominence to and forms serrated slot, and the ring of each turn of bilge and teeth groove also can have other shape, size and layout.
Because supporter 30 has than the inwall of more complete intracavity space and smoother, the near-end of traction fiber 29 also can pass the inner chamber of whole supporter 30 until leave the mouth of pipe of proximal end base 303 from far-end bottom 301, then enters the inner chamber of main body 22.
The present embodiment can only adopt two electrodes, be separately positioned on far-end bottom 301 and top 302, and the proximal end base 303 of supporter 30 does not need to carry electrode and can shorten as far as possible, and proximal end base 303 does not need to enter completely renal artery 7, therefore, such ablation catheter, more easily by the larger blood vessel of angle of bend, is also more suitable for the shorter situation of renal artery 7.
Comparable bottom 301,303, top 302 is longer, also can be than bottom 301,303 blood vessel wall that more stably reclines, thus it is more secure to make to be arranged in the ablation effect of electrode at supporter top 302, therefore, longer electrode 252 can be loaded in top 302, or loads the electrode 252 of a plurality of separation.
Embodiment tetra-
The present invention also provides the another kind of embodiment of ablation catheter, and its supporting component 24, as shown in Figure 11 A and Figure 11 B, comprises a supporter 30, electrode 251, electrode 252 and insulation tube 280.Be with a main difference part of aforementioned embodiments; in insulation tube 280, be provided with the support chamber 281 and the guidewire lumen 282 that are parallel to its axis; supporter 30 is enclosed within the inside of support chamber 281; guidewire lumen 282, for hold electrodes wire 32 and sensor conductor 34, is conducive to arrange and protect various wires like this.Figure 11 B is the cutaway view in the C-C cross section of the insulation tube 280 in Figure 11 A.
The electrode 251 that is fixed on the distal-most end of insulation tube 280 is cap shape, and Figure 11 C is the cutaway view of the internal structure of electrode 251.Electrode 251 has hemi-spherical cavities, its end is round and smooth and have smooth transition with insulation tube 280 surfaces, a temperature sensor 33 can be set at the intracavity of electrode 251, utilize thermal conductive resin to fix, make the contact point 71 between electrode 251 and renal artery 7 have better effect, also the local temperature that is beneficial to accurate monitoring blood vessel wall changes, and prevents that local vascular is overheated.
Can open a pore 281a in tube chamber 281 outer surface of approximately 0.5 millimeter to 1 millimeter of distance electrode 251, see Figure 11 C, the far-end of traction fiber 29 is fixed on the far-end of supporter 30 through pore 281a, the near-end of traction fiber 29 is got back to the inside of support chamber 281 through the pilot hole (not shown) on the near-end outer wall of insulation tube 280, then extends to the near-end of main body 22.
In the present embodiment, the supporter 30 that can adopt incising pipes as shown in Figure 7 A to form, also can make supporter 30 with the titanium-nickel wire that diameter is 0.1 millimeter to 0.5 millimeter.
Also can be directly at the outer surface of insulation tube 280, hydrophilic coating be set, to reduce the frictional force between insulation tube 280 surfaces and sheath pipe or blood vessel.
Should be appreciated that the some preferred embodiments that above are only intracavity ablation catheter of the present invention.For one of ordinary skill in the art, can carry out Selection and Constitute according to above-mentioned specific embodiment, in conjunction with described several functions advantage, directly to reach other embodiment of technical solution of the present invention.All any modifications of doing within the spirit and principles in the present invention, be equal to and replace and improvement etc., based on object of the present invention, essence and enlightenment, within all should being included in the protection domain that the present invention advocates.
Claims (10)
1. an intracavity ablation catheter, there is a near-end and a far-end, the main body and the supporting component that also comprise the elongated tubular product linking together, described main body is connected with power generator by described near-end, described supporting component is positioned at described far-end, described supporting component has elasticity and can be compressed, at least two modulation elements are set on described supporting component, described modulation element arrives nervous tissue for the energy delivery that described power generator is produced, it is characterized in that: described supporting component is single arch shape, described supporting component has far-end bottom, top and proximal end base, described proximal end base connects described main body, described at least two modulation elements are arranged at described top, or, at described top and described far-end bottom, at least one modulation element is respectively set.
2. an intracavity ablation catheter as claimed in claim 1, it is characterized in that: traction fiber is also set on described supporting component, the far-end of described traction fiber is fixed on described far-end bottom, the near-end of described traction fiber extends to the near-end of described ablation catheter slidably through the tube chamber of the pilot hole in described proximal end base and described main body, while launching at described supporting component automatic expansion, by operating described traction fiber, can shorten distance between described far-end bottom and described proximal end base to adjust the shape of described supporting component, so that modulation element can abut on blood vessel described in each simultaneously.
3. an intracavity ablation catheter as claimed in claim 1 or 2, it is characterized in that: described supporting component comprises continuous supporter and is wrapped in the insulating barrier of the outside of described supporter, described supporter is tubulose substantially or is shaft-like, described supporter has single arch shape and makes described supporting component also have similar single arch shape, described supporter also comprises four turn of bilges can distinguishing free bend, wherein two turn of bilges and between distal transition connect far-end bottom and the top thereof of described supporter, another two turn of bilges and between near-end changeover portion connect top and the proximal end base thereof of described supporter.
4. an intracavity ablation catheter as claimed in claim 3, is characterized in that: when described supporter is tubulose substantially, described supporter is processed by tubing, and described in each, turn of bilge has respectively the breach forming by removing a part of tubing; When described supporter is while being shaft-like, described in each, the width of turn of bilge and/or thickness are less than the corresponding size of the remainder of described support bar.
5. an intracavity ablation catheter as claimed in claim 4, it is characterized in that: when described supporter is tubulose substantially, described in each, the breach of turn of bilge is in the inner side of single arch shape of described supporter, or, the rings that described in each, turn of bilge comprises a ring or at least two coaxial series connection also leave connecting portion in the same side of this turn of bilge and form teeth groove in the contrary side of this turn of bilge, the teeth groove of two turn of bilges that are directly connected with far-end bottom or the proximal end base of described supporter is respectively all towards the outside of single arch shape of described supporter, the teeth groove of another two turn of bilges that are directly connected with the top of described supporter is all towards the inner side of single arch shape of described supporter.
6. an intracavity ablation catheter as claimed in claim 3, it is characterized in that: when described supporter is tubulose substantially, described supporter also comprises an extension, the proximal end base of described supporter connects described main body by described extension, and the flexible pipe that described extension is surface hollow-out also communicates with the tube chamber of described main body.
7. an intracavity ablation catheter as claimed in claim 6, is characterized in that: the surface of described extension has staggered decorative pattern breach.
8. an intracavity ablation catheter as claimed in claim 3, is characterized in that: when described supporter is while being shaft-like, described insulator is tubulose and comprises at least two inner chambers, and described supporter is arranged in an inner chamber of described insulator.
9. an intracavity ablation catheter as claimed in claim 1 or 2, is characterized in that: the electrode that a flexible boot segment or a cap shape are set at the far-end of described supporting component.
10. an intracavity ablation catheter as claimed in claim 1 or 2, it is characterized in that: when described supporting component is during in naturalness, the height of described supporting component is selected in the scope of 3 millimeters to 8 millimeters, and the distance between described far-end bottom and proximal end base is selected in the scope of 15 millimeters to 40 millimeters.
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| WO2015175948A1 (en) * | 2014-05-16 | 2015-11-19 | Medtronic Ardian Luxembourg S.A.R.L. | Systems, devices, and methods for modulating renal nerve tissue |
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