The content of the invention
In view of the drawbacks described above of prior art, the technical problems to be solved by the invention be to provide a kind of operation it is convenient,Low manufacture cost, efficiency high be used for adjust renal nerve and treat the pipe guide of relevant disease.
To achieve the above object, the invention provides a kind of multi-electrode arteria renalis ablation catheter,
Including for adjusting the adjusting part of nerve and for the adjusting part to be transported into the defeated of the neural positionSend part；
The adjusting part includes being used for regulation energy transmission to the neural multiple electrodes and for carrying multiple institutesState the load bearing component of electrode；
The load bearing component has first shape and the second shape, under the first shape, the adjusting partSuitable for moving in the blood vessel；Under second shape, at least one described electrode, which is in, to be adapted to the regulation energyIt is delivered to the neural position；
Characterized in that, the multi-electrode arteria renalis ablation catheter also includes sheath；The sheath is coated at the conveyingPart, the sheath can be slided along the transfer unit and be coated at or depart from the adjusting part；
The multi-electrode arteria renalis ablation catheter is internally provided with silk guide passage, and the silk guide passage is through whole describedMulti-electrode arteria renalis ablation catheter, the silk guide passage is used for guiding wire in the multi-electrode arteria renalis ablation catheterThe internal axial movement along the multi-electrode arteria renalis ablation catheter；
The multi-electrode arteria renalis ablation catheter is configured as：Pass through the sheath or the independent role of the guiding wireOr the load bearing component can be made in the first shape and institute by the sheath and the collective effect of the guiding wireState switching between the second shape.
Further, the independent role of the sheath refers to when the sheath is slided along the transfer unit and is coated at instituteWhen stating adjusting part, the load bearing component switches to the first shape by second shape；When the sheath is along instituteWhen stating transfer unit and sliding and depart from the adjusting part, the load bearing component switches to described by the first shapeTwo shapes.
Further, the silk guide passage is proximally and distally respectively provided with opening.
Further, the independent role of the guiding wire refers to when described in the guiding wire from the silk guide passageThe opening insertion silk guide passage of distal end and when entering the inside of the load bearing component, the load bearing component is by described theTwo shapes switch to the first shape；When the opening of the guiding wire from the near-end of the silk guide passage is passedAnd when detaching the inside of the load bearing component, the load bearing component switches to second shape by the first shape.
Further, the sheath and the collective effect of the guiding wire refer to work as the sheath along the transfer unitSlide and be coated at the adjusting part, while the guiding wire is inserted from the opening of the distal end of the silk guide passageWhen entering the silk guide passage and entering the inside of the load bearing component, the load bearing component is switched to by second shapeThe first shape；When the opening of the guiding wire from the near-end of the silk guide passage is passed and detaches described holdCarry part, while when the sheath is slided along the transfer unit and departs from the adjusting part, the load bearing component byThe first shape switches to second shape.
Further, the load bearing component and the transfer unit are tubulose, and along the tubulose radial direction by introversionIt is outer to be followed successively by macromolecule layer, NiTi pipes, inner insulating layer and external insulation layer.
Further, the diameter of the macromolecule layer of the macromolecule layer of the load bearing component and the transfer unit is0.40~0.55mm, thickness is 0.025~0.1mm.
Further, the macromolecule layer of the macromolecule layer of the load bearing component and the transfer unit is integrated, by heightMolecular material is formed.
Further, the high polymer material is PET, FEP, Pebax, PE or PTFE.
Further, the surface of the NiTi pipes of the load bearing component has cutting decorative pattern, and the cutting decorative pattern is by swashingLight cuts the helix groove formed on the surface of the NiTi pipes of the load bearing component.
Further, when the load bearing component is in the first shape, projection of the helix groove in horizontal planeIncluding multiple straight-line grooves and multiple near linear grooves.
Further, the multiple straight-line groove is located at the distal end of the load bearing component, and the multiple straight-line groove includes multipleFirst straight line groove and multiple second straight line grooves.
Further, the spacing per the two neighboring first straight line groove is identical, between multiple first straight line grooves mutuallyIt is parallel.
Further, per the two neighboring second straight line groove spacing it is identical, multiple second straight line grooves each other itBetween it is parallel to each other.
Further, the axial angle of the first straight line groove and the load bearing component is 75 °~85 °, described secondThe axial angle of straight-line groove and the load bearing component is 65 °~75 °, the near linear groove and the load bearing componentThe angle of axial direction is 50 °~65 °, and the axial direction refers to when the load bearing component is in the first shape, from describedThe near-end of load bearing component points to the direction of the distal end of the load bearing component.
Further, the multiple near linear groove is located at the near-end of the load bearing component, from the remote of the load bearing componentEnd is to near-end, and the spacing between the two neighboring near linear groove gradually increases, multiple near linear groovesIt is not parallel to each other each other.
Further, the inner insulating layer of the inner insulating layer of the load bearing component and the transfer unit is PET heat-shrink tubes,Thickness after pyrocondensation is 0.012~0.05mm.
Further, the external insulation layer of the load bearing component is that TPU is managed or Pebax pipes, a diameter of 0.9~1.2mm,Thickness is 0.05~0.15mm.
Further, the external insulation layer of the transfer unit is PET or FEP heat-shrink tubes, the thickness after pyrocondensation0.012~0.1mm.
Further, the electrode sleeve and is added together in the outside of the outer insulation of the load bearing component by binding agentIt is strong fixed.
Further, the binding agent is UV solidification glues or epoxide-resin glue.
Further, the independent control release energy of multiple electrodes.
Further, multiple electrodes are while control release energy.
Further, the inner surface of each electrode is connected with wire, and the wire is used to provide institute for the electrodeTemperature and impedance when stating regulation energy and monitoring ablation.
Further, the wire is arranged between the external insulation layer of the load bearing component and inner insulating layer, and describedExtend between the external insulation layer and inner insulating layer of transfer unit.
Further, the wire passes through soldering through the external insulation layer of the load bearing component and the inner surface of the electrodeOr be laser welded.
Further, the first shape of the load bearing component is straight or approximate straight.
Further, described the second of the load bearing component is shaped as spiral shape or approximate spiral.
Further, a diameter of 4~12mm of the spiral shape or the approximate spiral, pitch are 3~10mm.
Further, the load bearing component is immunity, and is pretreated as with the first shape.
Further, the cross section of the electrode is annular.
Further, the number of the electrode is 2~6, when the load bearing component is in second shape, phaseThe distance between adjacent described electrode is 4~12mm.
Further, the electrode uses platinumiridio material or gold material.
Further, the multi-electrode arteria renalis ablation catheter also include for grip handle, the handle with it is describedThe near-end connection of transfer unit, the distal end of the handle is connected with the near-end of the transfer unit.
Further, controlling organization is provided with the handle, the controlling organization is used for the movement for controlling the sheath.
Further, the controlling organization includes termination, tooth block and gear, and the termination is located at the distal end of the handleAnd be connected with the sheath, the tooth block is connected with the termination, the gear and the tooth Block- matching；Rotate describedGear can make termination described in the tooth block push-and-pull, so that sheath described in the termination push-and-pull is moved along the transfer unit.
Further, the load bearing component and the transfer unit are integral.
Further, the near-end of the load bearing component is connected with the distal end of the transfer unit.
Further, the internal diameter of the sheath is 1.2~1.45mm, and external diameter is 1.3~1.55mm.
Further, the sheath includes internal layer and outer layer.
Further, the material of the internal layer is PTFE, and wall thickness is 0.015~0.5mm.
Further, the outer layer is Pebax or TPU, in the Pebax or TPU containing 20wt%~40wt%BaSO4Or 10wt%~30wt% BiOCl.
Further, except as noted layer outside 1~5mm of distalmost end of sheath part, the outer layer itsRemaining part point has braiding webmaster.
Further, the braiding webmaster includes the first braided wires section, the second braided wires section and the 3rd braided wires section.
Further, the establishment silk of the first braided wires section, second braided wires section and the 3rd braided wires sectionFor stainless steel wire or NiTi.
Further, the braided wires of the first braided wires section, second braided wires section and the 3rd braided wires sectionForm of presentation it is different, hardness of the sheath close to 10~20cm of distal end of handle part is more than the sheathThe hardness of the other parts of pipe.
Further, the hardness of the distal end of the sheath has transition from small to large, is easy to the multi-electrode arteria renalisAblation catheter enters arteria renalis precalculated position.
Further, the distal end of the load bearing component is provided with the guard block for vascular damaged to be reduced or avoided.
Further, the guard block is soft head.
Further, the soft head, which has, is used for the opening that the guiding wire inserts the load bearing component, the soft headOpening for the silk guide passage distal end opening.
Further, the guard block is made up of rubber, silica gel or thermoplastic elastic material.
Further, described nerve is the renal sympathetic nerve on people's arteria renalis, and described is " close described neuralPosition " refers to being located in the arteria renalis.
Further, the regulation refers to remove or reduce the neural activation by way of damage or non-damaging.
Further, described energy is one in radio frequency, heat, cooling, electromagnetic energy, ultrasonic wave, microwave or luminous energyPlant or several.
Further, the described blood vessel behaviour arteria renalis.
Further, described " being adapted to move in the blood vessel " is referred to when the adjusting part is moved in the blood vessel,The adjusting part not injured blood vessel wall.
Further, described " being adapted to move in the blood vessel " refers to radial direction of the adjusting part in the blood vesselOn full-size be not more than the internal diameter of the blood vessel.
Further, described " being adapted to move in the blood vessel " refers to radial direction of the adjusting part in the blood vesselOn full-size be not more than 3mm.
Further, described " being adapted to move in the blood vessel " refers to be easy to by vascular bending section.
Further, described " being adapted to the regulation energy transmission to the position of the renal nerve " refers to working as instituteWhen stating regulating member in the blood vessel, at least one electrode is in the position of contact vascular wall.
Further, described " being adapted to the regulation energy transmission to the position of the renal nerve " refers to describedAdjusting part is 4-12mm in the full-size radially of the blood vessel, and at least one electrode is at full-size.
Compared with existing pipe guide, multi-electrode radio frequency ablation catheter for renal artery of the invention has advantages below：
(1) present invention is provided with silk guide passage, and the distal end of load bearing component is that catheter proximal end has opening, is led when usingGuide wire can enter silk guide passage by the opening, and operation facility meets the use habit of doctor.
(2) by designing unique cutting decorative pattern, and coated insulation layer, load bearing component is made to be in the second shape (spiralShape or approximate spiral) when sufficiently large radial support power can be provided, so as to preferably press close to vascular wall.
(3) during use, guiding wire and sheath can collective effect, that is, set after sheath, can accurately controlGuiding wire processed is moved in silk guide passage, so as to straighten the spiral with sufficiently large radial support power.
(4) inwall of load bearing component and transmission assembly is provided with macromolecule layer, so as to avoid having cutting decorative patternNiTi pipes the problem of can wipe guiding wire face coat off.
(5) each electrode is individually controlled, and the working condition of any one electrode is not influenceed by other electrodes, medical mattersPersonnel can select one, part or all of electrode release regulation energy according to actual needs.It is provided by the present inventionDevice for adjusting nerve operates facility, multiple neural sites can be adjusted or to some neural positions simultaneouslyPoint carries out selective control, so as to improve operating efficiency, and further improves the degree of accuracy for the treatment of, and in some electricityIn the case of the failure of pole, medical worker can flexibly select working electrode, and the place of equipment chance failure is have submitted significantlyReason ability, ensures being normally carried out for operation, with important clinical meaning.
In the present invention, the abbreviation used：
PTFE refers to polytetrafluoroethylene (PTFE), i.e. Polytetrafluoroethylene；
PE refers to polyethylene, i.e. Polyethylene；
FEP refers to fluorinated ethylene propylene copolymer, i.e. Fluorinated ethylene propylene；
TPU refers to TPUE, i.e. Thermoplastic polyurethanes；
PET refers to polyethylene terephthalate, i.e. Polyethylene terephthalate；
The performance of Atochem (FR) Cedex 22, 94091 Paris La Defense, France of Pebax fingering state (ATO Chimie) development is between synthetic rubber and thermoplastic polyPolyether block phthalein amine elastomer between ammonia vinegar, its trade mark is referred to as Pebax.
For convenience of description, by close the user (or handle) of device or part or away from needing to adjust in the present inventionThe one end in neural site be referred to as " distal end ", by the remote user (or handle) of device or part or close to needing to adjustThe one end in the neural site of section is referred to as " near-end ".
The technique effect of the design of the present invention, concrete structure and generation is described further below with reference to accompanying drawing, withIt is fully understood from the purpose of the present invention, feature and effect.
Embodiment
Fig. 1~Fig. 4 shows one kind of multi-electrode radio frequency ablation catheter for renal artery provided by the present invention and its application methodPreferred embodiment, exemplified by the embodiment is for regulation people's renal nerve.
Fig. 1~Fig. 2 shows linked groups and the structure of people's kidney.As shown in figure 1, Ren Shen linked groups are anatomicallyIncluding kidney K, kidney K is supplied to oxygen containing blood by arteria renalis RA.Arteria renalis RA via belly aortic artery AAIt is connected to heart.The blood of deoxidation flows to heart via renal vein RV and inferior caval vein IVC from kidney.Fig. 2 is more detailedGround illustrates the anatomical part of kidney.More specifically, kidney anatomy also includes indulging along arteria renalis RA axial LTo the renal nerve RN of extension.Renal nerve RN is general in the outer membrane of the artery.In this specific embodiment, instituteThe device of offer is used to adjust the renal nerve RN being located on arteria renalis RA, and described regulation refers to by damage or non-damageThe mode of wound removes or reduced renal nerve RN activation.As the change of the embodiment, if necessary to adjustThe nerve (for example, heart related neural) at other positions, or other regulative modes are needed (for example, it is desired to more enterOne step improve nerve activation), those skilled in the art can according to the present invention make can rational expectation, need not payThe adjustment of all creative works.
Fig. 3 and Fig. 4 show the part of the multi-electrode radio frequency ablation catheter for renal artery in the embodiment.As shown in Fig. 3~Fig. 4, the conduit includes the adjusting part 100 for adjusting nerve and conveys adjusting part 100To the transfer unit 201 of the position of nerve.Adjusting part 100 includes the electrode 101 that will adjust energy transmission to renal nerveAnd for carrying the load bearing component 102 of electrode 101.Load bearing component 102 has first shape (referring to Fig. 3) and theTwo shapes (referring to Fig. 4), under first shape, adjusting part 100 is used to move in the blood vessel；Under the second shape,At least one electrode 101 is in regulation energy transmission to the position of renal nerve.In the present embodiment, load bearing component 102It is integral with transfer unit 201, the near-end of load bearing component 102 is connected with the distal end of transfer unit 201.
In the present embodiment, the transmission regulation energy of electrode 101 is to the mode in the renal nerve site for needing to adjust：Via bloodPipe enters human body, by arteria renalis inwall close to neural site.Therefore the technical issues that need to address are：It should realizeElectrode 101 can be close to the nerve that blood vessel acts on relevant position, and electrode 101 is needed again in the blood vessel easilyMove, not injured blood vessel wall.
The multi-electrode arteria renalis ablation catheter of the present embodiment also includes sheath 301 and silk guide passage 500 (referring to Fig. 5).Sheath 301 is coated at transfer unit 201, and the internal diameter of sheath 301 is 1.2~1.45mm, and external diameter is 1.3~1.55mm,Sheath 301 can be slided along transfer unit 201 and be coated at or depart from the adjusting part 100.Silk guide passage 500The inside of the multi-electrode arteria renalis ablation catheter of the present embodiment is arranged on, and through whole multi-electrode arteria renalis ablation catheter,There is a part for silk guide passage 500 in the inside of the inside of load bearing component 102 and transfer unit 201.Seal wire leads toRoad 500 is used for axial direction of the guiding wire in the inside of multi-electrode arteria renalis ablation catheter along multi-electrode arteria renalis ablation catheterIt is mobile.Silk guide passage 500 is proximally and distally respectively provided with opening (referring to Fig. 1).The distal end of silk guide passage 500 is openedMouth 106 is used for the inside that guiding wire penetrates multi-electrode arteria renalis ablation catheter, is exactly to penetrate load bearing component 102Inside, the opening of the near-end of silk guide passage 500 passes for guiding wire from multi-electrode arteria renalis ablation catheter.
The distal end of load bearing component 102 is provided with the guard block 105 for vascular damaged to be reduced or avoided.Protection portionOne effect of part 105 is that vascular damaged is reduced or avoided, when touching vascular wall because itself it is sufficiently flexible andCan resilience rapidly, blood vessel will not be caused damage；Another effect of guard block 105 is to whole pipe guideGuide effect is played, when running into the bending place of blood vessel, itself can bend according to the bending degree of blood vessel, so as to guideWhole conduit passes through the bending place of blood vessel.In the present embodiment, guard block 105 is soft head, by rubber, silica gelOr thermoplastic elastic material is made.The soft head, which has, is used for the opening that guiding wire inserts load bearing component, and the opening isFor the opening 106 of the distal end of silk guide passage 500.
Load bearing component 102 and transfer unit 201 are tubulose, and are followed successively by high score from inside to outside along the radial direction of the tubuloseSublayer, NiTi pipes, inner insulating layer and external insulation layer.Fig. 5 shows the profile of load bearing component 102, the profileTo be splitted at electrode 101, as seen from Figure 5, macromolecule is followed successively by from inside to outside along the radial direction of load bearing component 102Layer 504, NiTi pipes 503, inner insulating layer 501 and external insulation layer 502.The He of macromolecule layer 504 of load bearing component 102The macromolecule layer (not shown) of transfer unit 201 is integral, and diameter is 0.40~0.55mm, and thickness is0.025~0.1mm, is formed by high polymer material, high polymer material can for PET, FEP, Pebax, PE orPTFE。
Load bearing component 102 is pretreated as with the second shape for immunity, in order that load bearing component 102 is inThere is sufficiently large radial support power, the surface of the NiTi pipes 503 of load bearing component 102 is cut by laser during the second shapeIt is helix groove to cut the cutting decorative pattern in cutting decorative pattern, the present embodiment is formed, and Fig. 6 shows the cutting decorative pattern in waterWhen being in first shape in the perspective view of plane, figure for load bearing component 102.Projection bag of the helix groove in horizontal planeMultiple straight-line grooves or multiple near linear grooves 603 are included, multiple straight-line grooves are located at the distal end of load bearing component 102, Duo GezhiWire casing includes multiple first straight line grooves 601 and multiple second straight line grooves 602.Per two neighboring first straight line groove 601Spacing is identical, parallel to each other between multiple first straight line grooves 601；Spacing phase per two neighboring second straight line groove 602Together, multiple second straight line grooves 602 are parallel to each other each other.Multiple near linear grooves 603 are located at load bearing component 102Near-end, from the distal end of load bearing component 102 to near-end, the spacing between two neighboring near linear groove 603 is graduallyIncrease, multiple near linear grooves 603 are not parallel to each other each other.First straight line groove 601 and load bearing component 102The angle of axial direction is 75 °~85 °, and the axial angle of second straight line groove 602 and load bearing component 102 is 65 °~75 °, closelyIt it is 50 °~65 ° like the axial angle of straight-line groove 603 and load bearing component 102, axial direction herein refers to work as load bearing component102 when being in first shape, and the direction of the distal end of load bearing component 102 is pointed to from the near-end of load bearing component 102.
In the present embodiment, the inner insulating layer 501 of load bearing component 102 and the inner insulating layer (not shown) of transfer unit 201It is PET heat-shrink tubes, the thickness after pyrocondensation is 0.012~0.05mm.The external insulation layer 502 of load bearing component 102 isTPU is managed or Pebax pipes, and a diameter of 0.9~1.2mm, thickness is 0.05~0.15mm., transfer unit 201 it is outerInsulating barrier (not shown) is PET or FEP heat-shrink tubes, 0.012~0.1mm of thickness after pyrocondensation.
In the present embodiment, electrode 101 is ring-type, and is linked in the outer surface of the external insulation layer 502 of load bearing component 102.So, when load bearing component 102 is in the second shape (in the arteria renalis), the electrode 101 on load bearing component 102Position (close to renal nerve) in contact arteria renalis inwall, just can so be adjusted work.In order that electrode101 are fixedly mounted in the outer surface of the external insulation layer 502 of load bearing component 102, and reduce the damage to vascular wall as far as possibleWound, can use glue that electrode 101 is bonded on the external insulation layer 502 of load bearing component 102.This kind of glue is optionalWith UV solidification glues, epoxide-resin glue or its mixture, both with the biocompatibility of medical application can be reached, and it is rightMetal alloy and high polymer material have certain cohesive force.In addition, in the He of external insulation layer 502 of load bearing component 102The temperature being provided between inner insulating layer 501 during for providing regulation energy and monitoring ablation for electrode 101 and impedanceWire 505, wire 505 extends in the external insulation layer and inner insulating layer of transfer unit 201, in load bearing component 102Wire 505 and transfer unit 201 in wire 505 be integral.Wire 505 passes through the outer of load bearing component 102Insulating barrier 502 and electrode 101 inner surface is by soldering or is laser welded.The external insulation of load bearing component 102Layer 502 has opening (not shown) in the position that electrode 101 adheres to, and is connected to energy generation apparatus (such as radio frequencyInstrument) wire 505 weld together through the opening and the inner surface of electrode 101.By the way that wire 505 is arranged onIt can be avoided to insulate and wire must be arranged on to the outer surface of transfer unit and cause conveying in external insulation layer 502The rough technology drawback in outer surface of part, causes so as to avoid because the outer surface of transfer unit is unevenProblems., it is necessary to set many multiple electrodes 101 are connected into energy respectively when with multiple electrodes 101Produce the wire 505 of equipment.Each electrode 101 works independently, respectively with single wire 505.One electrodeWhether release adjusts energy, unrelated with other electrodes；Can only have one or partial electrode transmission regulation energy, also may be usedWorked simultaneously with all electrodes, transmission regulation energy；The state whether each electrode transmits regulation energy is independent of one another's.The element (for example, thermocouple) of measurement temperature is may be provided on load bearing component 102 and is led accordinglyThe conventional arrangement for being arranged as this area of line, wire and thermocouple, I will not elaborate.
In the present embodiment, the first shape of load bearing component 102 is straight or approximate straight or elongate or fibreShape or thread is tieed up, the cross section of the bar shaped is preferably circular or approximate circle, the widest part of cross section is less than the interior of blood vesselDiameter.So, under first shape, when adjusting part 100 is moved in the blood vessel, adjusting part 100 will not be damagedBlood trouble tube wall.When needing that the nerve on the arteria renalis is adjusted, because the interior diameter of people's arteria renalis is generally 4-7Mm, therefore, adjusting part 100 are not more than 4mm in the full-size radially of the arteria renalis, it is preferably provided as 1-2Mm, can both meet and be moved easily in the blood vessels, have enough rigidity again and be easy to make, it is possible to reduce and suffer fromThe size of the wound of person.As the change of the embodiment, first shape can also allow certain bending orCorrugated bending, its cross section can also be other shapes, can easily in the blood vessels as long as its surface is smoothMovement is without injured blood vessel wall.
In the present embodiment, the second shape generally spiral shape or approximate spiral of load bearing component 102, in the footpath of blood vesselUpwards, the widest part of load bearing component 102 is bigger than first shape, and the electrode 101 of carrying can so come close to or in contact withVascular wall, so that close to renal nerve.
There is certain elasticity in view of blood vessel, the spiral shape of load bearing component 102 or the diameter of approximate spiral are set to4~12mm, pitch are 3~10mm.For the less individual of arteria renalis internal diameter, such as internal diameter is 4mm or so, canSo that the diameter of the spiral shape of load bearing component 102 or approximate spiral is set into 5~6mm or so；For in the arteria renalisThe larger individual in footpath, such as internal diameter are 7mm or so, can be set to the diameter of spiral shape or approximate spiral8~9mm or so.
Second shape of load bearing component 102 can also be other shapes, such as irregular shape with round and smooth bending,As long as when the load bearing component 102 in the blood vessel when, electrode 101 be in contact vascular wall position.
The multi-electrode radio frequency ablation catheter for renal artery of the present embodiment makes to hold by the collective effect of sheath 301 and guiding wireCarry part 102 between first shape and the second shape to switch, i.e., when sheath 301 is slided along transfer unit 201 and outerAdjusting part 100 is placed on, while guiding wire inserts silk guide passage 500 from the opening 106 of the distal end of silk guide passage 500And when entering the inside of load bearing component 102, load bearing component 102 switches to first shape by the second shape；When guiding is ledSilk passes from the opening 107 of the near-end of silk guide passage 500 and detaches the inside of load bearing component 102, while sheath 301When being slided along transfer unit 201 and departing from the adjusting part 100, load bearing component 102 switches to by first shapeTwo shapes.
In other embodiments, for the less situation of radial support power of load bearing component 102, sheath 301 can be passed throughOr the independent role of guiding wire realizes switching of the load bearing component 102 between first shape and the second shape.Sheath 301Independent role refer to when sheath 301 is slided along transfer unit 201 and is coated at adjusting part 100, load bearing component102 switch to first shape by the second shape；When sheath 301 is slided along transfer unit 201 and departs from adjusting part 100When, load bearing component 102 switches to second shape by first shape.The independent role of guiding wire refers to when guidingSeal wire inserts silk guide passage 500 from the opening 106 of the distal end from silk guide passage 500 and enters load bearing component 102When internal, load bearing component 102 switches to first shape by the second shape；When guiding wire is from the near of silk guide passage 500When the opening 107 at end passes and detaches the inside of load bearing component 102, load bearing component 102 switches to by first shapeTwo shapes.
The course of work of multi-electrode radio frequency ablation catheter for renal artery is as follows in the present embodiment：
(1) first guiding wire is imported at the renal sympathetic nerve on human body predetermined position, i.e. people's arteria renalis；
(2) sheath 301 is coated at adjusting part 100, guiding wire is then inserted into load bearing component 102 from the first holeAnd passed from the second hole so that load bearing component 102 becomes first shape by preformed second shape, is easy in blood vesselMiddle movement；
(3) at the renal sympathetic nerve on mobile multi-electrode radio frequency ablation catheter for renal artery to the human body arteria renalis；
(4) guiding wire is detached into load bearing component 102, and sheath 301 is departed from into adjusting part 100, load bearing component102 become the second shape by first shape, now, and the electrode 101 on load bearing component 102 is close to blood vessel effectNerve in relevant position, releasing energy certain energy and acts on the neural site, so as to play the regulation nerveThe effect in site (for example, reduction or activation of elimination sympathetic nerve)；
(5) sheath 301 is coated at adjusting part 100, guiding wire is then pushed into load bearing component 102, carryingPart 102 is changed into first shape from the second shape again；
(6) multi-electrode radio frequency ablation catheter for renal artery is removed into human body.
Electrode 101 can realize the purpose by transferring heat to the neural site.For example, for nerve modulationHeat transfer heating mechanism can include the thermal change or damage of heating ablation and non-ablation, for example, can be by target nerve fibreThreshold value needed for temperature is increased to over is to realize the thermal change of non-ablation, or more than higher temperature to realize the thermal change of ablation.For example, target temperature can about 37 DEG C -45 DEG C the thermal change temperature of non-thermal ablation (are used for), or, the target temperatureCan be at about 45 DEG C or higher, for the thermal change of ablation.
Electrode 101 can also realize the purpose by the way that cooling is delivered into the neural site.For example, target nerve is fineThe temperature of dimension is reduced to less than the about 20 DEG C thermal changes to realize non-frozen, or the temperature of target nerve fibre is reduced to aboutLess than the 0 DEG C thermal change to realize freezing.
Electrode 101 can also be realized by the way that energy field is applied into target nerve fibre.The energy field can include：ElectricityMagnetic energy, radio frequency, ultrasonic wave (including high-intensity focusing ultrasonic wave), microwave, luminous energy (including laser, infrared ray and nearInfrared ray) etc..For example, the nerve modulation of thermal induction can be by being delivered to target god by pulse or continuous heat energy fieldRealized through fiber.Wherein, one kind is pulse radiation frequency electric field or other types of pulse heat than more preferably energy modeEnergy.Pulse radiation frequency electric field or other types of pulse heat energy can facilitate bigger heat level, longer total when continuingBetween and/or preferably controlled intravascular renal nerve modulation treatment.
No matter the purpose of nerve is adjusted by the way which kind of energy mode is realized, when user uses conduit provided by the present inventionWhen being operated, electrode 101 is needed with producing the energy (such as radiofrequency generator) or electrode 101 is produced this in itselfThe equipment of amount is electrically connected.These equipment and electrode and the connection of these equipment are well known to those skilled in the artPrior art (for example, be provided in apparatus of the present invention connect these equipment interface, can be realized i.e. when usingPlug-and-play), no longer narration in detail here.
In the present embodiment, the number of electrode 101 is 4.When load bearing component 102 is in the second shape (helical form)When, adjacent electrode 101 is convenient for 4~12mm ratios apart from D in the axial direction of blood vessel.It is, in general, that carrying outDuring renal nerve ablative surgery, 3-8 site of renal nerve is melted.Therefore, using in the embodimentDevice when being operated, the positioning (making electrode 101 contact blood vessel) of Primary regulation component 100 can complete 4The ablation in individual site, and complete the positioning that whole ablative surgery only needs to carry out adjusting part 100 twice.AsThe change of the embodiment, the number of electrode 101 are it can also be provided that 2~6, but if number is more, meetingIncrease the cost of manufacture of whole device；If number is less, it is possible to decrease the operating efficiency of ablative surgery.Electrode 101Material can be using the preferable or more stable metal or metal alloy of biocompatibility, such as platinum group metal (such as platinoiridita conjunctionGold).
The guiding wire of the present embodiment is wire, is made up of NiTi alloys.
The multi-electrode radio frequency ablation catheter for renal artery of the present embodiment also includes the handle 401 for gripping, the handle 401Distal end be connected with the near-end of transfer unit 201 (referring to Fig. 3).Wire 505 is in load bearing component 102 and transfer unitIt is connected after extending in 201 with handle 401.The connection cable of handle 401 and external energy generator set be integrated orThe independent two parts connected by conversion port.The movement of the sheath 301 of the present embodiment is by being arranged in handle 401Controlling organization 7 control, referring to Fig. 3 and Fig. 7, controlling organization 7 includes termination 701, tooth block 702 and gear 703,Termination 701 is located at the distal end of handle 401 and is connected with sheath 301, and tooth block 702 is connected with termination 701, gear 703Matched with tooth block 702；Rotate gear 703 can make the push-and-pull termination 701 of tooth block 702, so that the push-and-pull sheath of termination 701Pipe 301 is moved along transfer unit 201.
The material of sheath 301 is high polymer material, and such as Pebax or TPU, the material than load bearing component 102 are slightly hard, hardnessFor 50A-50D.Sheath 301 includes internal layer 302 and outer layer 303, as shown in figure 8, the material of internal layer 302 is PTFE,Wall thickness is 0.015-0.5mm, and coefficient of friction is smaller, is mainly risen when sheath 301 is relative relative to load bearing component 102 to be slidedTo smooth effect.The material of outer layer 303 is Pebax or TPU, can contain 20wt%~40wt%BaSO4Or 10wt%~30wt% BiOCl.
In addition to outer layer is apart from 1~5mm of distalmost end of sheath 301 part, the remainder of outer layer has braiding webmaster,As shown in figure 9, braiding webmaster includes the first braided wires the 313, second braided wires of section section 323 and the 3rd braided wires section 333；The braided wires of first braided wires the 313, second braided wires of section section 323 and the 3rd braided wires section 333 are stainless steel wire or Ni-TiSilk.First braided wires the 313, second braided wires of section section 323 and the 3rd braided wires 333 different hardness of section can be by identicalWeaving manner and each where the outer layer in Pebax different hardness realize, can also pass through identicalPebax hardness and different weaving manners are realized.In the present embodiment, the first braided wires section the 313, second braided wires section323 is different with the form of presentation of the braided wires of the 3rd braided wires section 333, make sheath 301 close to the distal end 10~20 of 401 handlesThe hardness of cm part is more than the hardness of the other parts of sheath 301.The hardness of the distal end of sheath 301 has from small to largeTransition, be easy to the present embodiment multi-electrode arteria renalis ablation catheter enter arteria renalis precalculated position.
Preferred embodiment of the invention described in detail above.It should be appreciated that one of ordinary skill in the art withoutNeed creative work just can make many modifications and variations according to the design of the present invention.Therefore, it is all in the artTechnical staff under this invention's idea on the basis of existing technology can by logical analysis, reasoning, or a limited experiment, all should be in the protection domain being defined in the patent claims with obtained technical scheme.