It is a kind of for adjust nerve conduit deviceTechnical field
The present invention relates to electrosurgery more particularly to it is a kind of for adjust nerve conduit device.
Background technique
Resistant hypertension is still difficult to control using 3 kinds or more drugs (all having used a diuretics)Hypertension (sBP >=160mmHg), clinically more typically, pathogenic factor is numerous, and pathogenesis is indefinite, drug therapy effectFruit is very poor, and diagnosing and treating technology is still not mature enough, becomes one of great difficult problem of hypertension therapeutic.
Newest animal and clinical laboratory data proof can significantly hold the adjusting (such as removing sympathetic nerve) of renal nerveLower resistant hypertension, such as the renal artery radiofrequency ablation art that latest developments go out long.Renal artery radiofrequency ablation art is a kind ofBy the way that electrode catheter intravascular is sent into privileged site in the arteria renalis, release radio-frequency current causes arteria renalis sympathetic nerve locally solidifyingSolidity necrosis, reaches denervated interventional techniques.Radio-frequency current damage range is small, not will cause body harm, therefore kidney is dynamicA kind of method that arteries and veins radio-frequency ablation procedure has become effective removal arteria renalis sympathetic nerve.
In addition, being proved to have certain effect to a variety of diseases relevant to kidney to the adjusting of renal nerve, especially kidney is handed overFeel related disease caused by neural overactivity.For example, congestive heart failure (CHF) can lead to abnormal high renal sympathetic mindIt is activated, so as to cause the reduction of the water and sodium removed from body, and increase the secretion of feritin.Increased renin secretion leads to kidneyVessel retraction causes the reduction of renal blood flow.To which kidney can make the reaction of heart failure the spiral of heart failure conditionDecline extends.
In conventional radio frequency ablation catheter product, one kind is to enter predetermined position by guiding wire guiding catheter.In this kind of product, it is set side by side with a plurality of cavities in conduit, one of chamber portion or is all formed by metal material, is usedMake the channel of guiding wire.The setting of a plurality of cavities is unfavorable for production assembly.
Fast exchange mouth is also provided on such conduit, for drawing guiding wire and operating to guiding wire.But due to the channel of guiding wire relative to the center of conduit be biasing, guiding wire push resistance it is larger.ThisOutside, in guiding wire moving process, metal material can wipe the hydrophilic coating on guiding wire off, and the hydrophilic coating wiped off can take offIt falls in blood vessel, causes damages to patient health.When rotary guide pipe is adjusted, guiding wire can be also wound on conduit,Cause guiding wire that can not be moved forward and backward, influence using.It is excessive once guiding wire recession occur, when being more than fast exchange mouth,It is just difficult to penetrate again, can not thus adjust the spiral-shaped of catheter proximal end electrode portion, cause the damage to patient's blood vessel.
Another kind of radio frequency ablation catheter product enters predetermined position without using guiding wire guiding catheter.However, presentClinician has generally received guiding wire as the routine of intervention operation and has used attachment, therefore, leads to not usingThe catheter product acceptance of silk is lower.In addition, good guiding and protection can be played the role of using guiding wire, if not applicableGuiding wire, conduit will be difficult to enter the blood vessel of complicated bend, especially bigger to the operation difficulty of vessel branch.
Therefore, those skilled in the art is dedicated to developing a kind of radio frequency ablation catheter, can retain guiding wire andThe setting of silk guide passage, while can reduce guiding wire again and push resistance avoids seal wire winding, coating the problems such as falling, in addition,It can also simplify and assemble and reduce cost.
Summary of the invention
In view of the above drawbacks of the prior art, technical problem to be solved by the invention is to provide one kind for adjusting mindThe conduit device of warp can reach predetermined position by guiding wire guiding catheter, while reduce because silk guide passage biasing causesGuiding wire push resistance, avoid seal wire winding, coating the problems such as falling, moreover it is possible to which simplifying to assemble simultaneously reduces cost.
To achieve the above object, provided in better embodiment of the present invention it is a kind of for adjust nerve conduit device,Adjusting component including handle, for adjusting nerve and the delivery section that is transported to the position of the nerve for component will to be adjustedPart；
Adjusting component includes for will adjust energy transmission to the multiple electrodes of nerve and be used to carry holding for multiple electrodesCarry component；
Load bearing component has first shape and the second shape, under first shape, adjusts component and is suitable for moving in the blood vessel；Under the second shape, at least one electrode, which is in, is suitble to adjust energy transmission to the position of nerve；
Handle is connected with load bearing component；
Conduit device is internally provided with silk guide passage, and silk guide passage runs through entire conduit device, and in silk guide passageThe central axis of mandrel and silk guide passage substantially overlaps；
Silk guide passage consists of three layers:
Internal layer, the cavity that internal layer is formed can accommodate guiding wire, and internal layer is arranged to reduce and rubs with guiding wireIt wipes；
Middle layer, middle layer is located at the outside of internal layer, and fits closely with internal layer, and middle layer is arranged to bond the interior of silk guide passageLayer and outer layer；
Outer layer, outer layer is located at the outside in middle layer, and fits closely with middle layer, and outer layer is positioned to provide the soft of silk guide passageToughness, adhesiveness and workability.
Further, conduit device further includes support tube, inner insulating layer, external insulation layer and conducting wire:
Support tube is located at the outside of silk guide passage；
The outside of support tube is arranged in inner insulating layer；
The outside of inner insulating layer is arranged in external insulation layer；
Conducting wire is arranged between inner insulating layer and external insulation layer, when adjusting energy and monitoring ablation for providing for electrodeTemperature and impedance
Further, the internal diameter of cavity is slightly larger than the diameter of guiding wire.
Preferably, the internal diameter of cavity is 0.37~0.60mm.
Further, internal layer is formed by high molecular material.
Preferably, the high molecular material of internal layer is HDPE, PTFE, FEP or PET.
Preferably, internal layer with a thickness of 0.015~0.15mm.
Further, middle layer is formed by polymeric adhesion material.
Preferably, the polymeric adhesion material in middle layer is LLDPE, EVA or PE.
Further, outer layer is formed by high molecular material.
Preferably, the high molecular material of outer layer is Pebax, TPU, Nylon or TPE.
Further, external insulation layer is made of the external insulation layer of transfer unit and the external insulation layer of load bearing component, supporting partThe external insulation layer of part is that TPU is managed or Pebax is managed；The external insulation layer of transfer unit is PET or FEP heat-shrink tube.
Further, inner insulating layer is formed by high molecular material, the high molecular material be PET, FEP, Pebax, PE orPTFE。
Further, support tube is NiTi pipe or stainless steel tube.
Further, handle includes the injection port that handle proximate end is arranged in, and injection port is connected to silk guide passage.
Further, the outside of injection port has helicitic texture.Preferably, which is 6% Rule cone joint.
Further, handle further includes cable port, is provided with gum sleeve at cable port.
Further, the distal end of handle is provided with gum sleeve, and transfer unit is pierced by from the gum sleeve of handle front end.
The conduit device for being used to adjust nerve in a specific embodiment of the invention, due in silk guide passage and conduitMandrel is overlapped or substantially overlaps and the three-layer set of silk guide passage, therefore has a variety of advantages relative to existing conduit:
1) retain silk guide passage, conduit is made to remain to be oriented to by guiding wire.
Guiding wire is the routine of intervention operation using attachment, can play the role of guiding and protection, clinician is non-Often get used to using guiding wire when intervening operation.If not meeting the use habit of clinician without silk guide passage.SeparatelyOutside, conduit is difficult to enter the blood vessel of complicated bend；During clinical operation, doctor is also required to grasp vessel branch sometimesMake, the conduit of no silk guide passage also hardly enters vessel branch.
The radio frequency ablation catheter of a specific embodiment of the invention remains silk guide passage, can be used cooperatively and leadSilk, meets the operating habit of doctor.In addition, there is the guiding role of guiding wire, conduit easily enter complicated bend blood vessel andVessel branch；
2) the push resistance of guiding wire is reduced；
3) it is made due to silk guide passage internal layer of high molecular material, forms smooth surface；Silk guide passage and injection port simultaneouslyConnection, under the collective effect of smooth surface and injecting fluid, guiding wire can be moved more swimmingly, be more advantageous to protection guidingSeal wire, in case the hydrophilic coating of guiding wire is scraped；The outer layer of silk guide passage is also made of high molecular material, the macromolecule materialMaterial has certain toughness, can effectively prevent fractureing for silk guide passage；
4) conduit, which can according to need rotation any angle, is bonded electrode with vascular wall, guiding wire will not be caused to windIn supravasal situation；
5) since there is no fast exchange mouth, therefore there is no guiding wire recession to be excessively difficult to the problem of penetrating again,Prevent load bearing component that can not form the state for being suitable for mobile transport and damage blood vessel；
6) setting of the angle setting and gum sleeve of the cable port of handle, is conducive to protect that draws from handle to leadLine.
It is described further below with reference to technical effect of the attached drawing to design of the invention, specific structure and generation, withIt is fully understood from the purpose of the present invention, feature and effect.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of people's kidney and linked groups；
Fig. 2 is the structural schematic diagram of people's arteria renalis；
Fig. 3 is the schematic diagram of the conduit device of a preferred embodiment of the invention.
Fig. 4 is the magnified partial view of the conduit device in Fig. 3
Fig. 5 is the cross-sectional view of the handle in Fig. 3.
Fig. 6 is transfer unit in Fig. 3 along sectional view along A-A.
Fig. 7 is the cross-sectional view of silk guide passage in Fig. 3.
Specific embodiment
In the present invention, the abbreviation used:
HDPE refers to high density polyethylene (HDPE), i.e. High Density Polyethylene；
TPE refers to thermoplastic elastomer (TPE), i.e. Thermoplastic Elastomer；
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 thermoplastic polyurethane elastomer, i.e. Thermoplastic polyurethanes；
PET refers to polyethylene terephthalate, i.e. Polyethylene terephthalate；
LLDPE refers to linear low density polyethylene, i.e. Linear low density polyethylene；
EVA refers to ethylene-vinyl acetate copolymer, i.e. Ethylene Vinyl Acetate Copolymer；
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 poly ammoniaPolyether block phthalein amine elastomer between vinegar, the trade mark are known as Pebax.
For ease of description, by the close user or the separate neural site for needing to adjust of device or component in the present inventionOne end be known as " proximal end ", be known as by separate the user of device or component or close to the one end in the neural site that needs are adjusted" distal end ".
FIG. 1 to FIG. 2 shows linked groups and the structure of people's kidney.As shown in Figure 1, Ren Shen linked groups anatomically wrapKidney K is included, kidney K is supplied to oxygen containing blood by arteria renalis RA.Arteria renalis RA is connected to heart via the aortic artery AA of abdomen.It is de-The blood of oxygen flows to heart from kidney via renal vein RV and inferior caval vein IVC.Fig. 2 illustrates anatomical one, kidney in more detailPoint.More specifically, kidney anatomy also includes the renal nerve RN longitudinally extended along the axial L of arteria renalis RA.Renal nerve RN mono-As in the outer membrane of the artery.In this specific embodiment, provided device is located on arteria renalis RA for adjustingRenal nerve RN, the adjusting refer to the activation for removing or reducing renal nerve RN by damage or non-damaging mode.As thisThe variation of specific embodiment adjusts the nerve (for example, heart related neural) at other positions if necessary, or needs otherThe regulative mode activation of nerve (for example, it is desired to further improve), those skilled in the art can make according to the present inventionCan rational expectation, do not need the adjustment for being put to creative work.
As shown in figure 3, the conduit device for adjusting nerve of one embodiment of the present of invention includes for adjusting nerveAdjusting component 100 and be transported to the transfer unit 201 in predetermined position for component 100 is adjusted.As shown in figure 4, adjusting component100 include that will adjust energy transmission to the electrode 101 in predetermined position and the load bearing component 102 for being used to carry electrode 101.CarryingComponent 102 has first shape and the second shape, under first shape, adjusts component 100 and is suitable for moving in the blood vessel；SecondUnder shape, at least one electrode 101, which is in, will adjust energy transmission to predetermined position.Load bearing component 102 and transfer unit 201 areOne, the proximal end of load bearing component 102 is connected with the distal end of transfer unit 201.Fig. 3 and 4 shows the second of load bearing component 102State.
The load bearing component 102 and transfer unit 201 of conduit device are tubulose, and internal structure is similar, all include seal wireChannel.By taking transfer unit 201 as an example, as shown in fig. 6, silk guide passage 300 is located at the center of inside of transfer unit 201, seal wire is logicalThe axis in road 300 and the axis of transfer unit 201 are overlapped or substantially overlap.The silk guide passage 300 is made of three-decker, is such as schemedShown in 7, the radial direction along 201 tubulose of transfer unit is followed successively by internal layer 301, middle layer 302 and outer layer 303 from inside to outside.Internal layer 301 mentionsFor smooth surface, the friction with guiding wire is reduced, to protect the guiding moved in the cavity 304 that internal layer is constituted to leadSilk.Middle layer 302 is located at the outside of internal layer, and middle layer is for being bonded internal layer and outer layer.The flexibility of the offer silk guide passage of outer layer 303,Adhesiveness and workability, the flexility protection silk guide passage provided are not broken in use, and workability isIt is easy to the operation such as other materials bonding, pyrocondensation, fusion.The cavity 304 that internal layer 301 is formed can accommodate guiding wire, and allow to leadGuide wire is wherein along the axial movement of transfer unit.
In the present embodiment, internal layer 301 is formed by the first high molecular material, and middle layer 302 is formed by polymeric adhesion material,Outer layer 303 is formed by the second high molecular material.First high molecular material is HDPE, PTFE, FEP or PET；The polymeric adhesionMaterial is LLDPE, EVA or PE, plays the role of binder, internal layer 301 and outer layer 303 are bonded；The second macromolecule materialMaterial is Pebax, TPU, Nylon or TPE.
The internal diameter of cavity 304 is slightly larger than the diameter of guiding wire.In one embodiment, the internal diameter of cavity 304 is0.37~0.60mm.The thickness (i.e. the distance between the lateral surface of the medial surface of internal layer 301 to outer layer 303) of silk guide passage is0.07~0.25mm.The thickness of internal layer 301 accounts for 201 thickness of transfer unit (the i.e. medial surface of internal layer 301 to transfer unit 201The distance of lateral surface) 10~30%, the thickness in middle layer 302 accounts for the 3~10% of 201 thickness of transfer unit, the thickness of outer layer 303Account for the 50~87% of 201 thickness of transfer unit.In a preferred embodiment, internal layer 301 with a thickness of 0.015~0.15mm。
The silk guide passage of load bearing component 102 and the three-decker for constituting silk guide passage are identical as in transfer unit 201,And the silk guide passage of load bearing component 102 is connected to the silk guide passage of transfer unit.
In another embodiment, the silk guide passage in the silk guide passage and transfer unit in load bearing component 102 is one, i.e., internal layer, middle layer and outer layer in load bearing component 102 and internal layer, middle layer and outer layer in transfer unit 201 are integrated,Also therefore, formation is also integrated for accommodating the cavity of guiding wire.Internal layer, middle layer and outer layer in load bearing component 102Material, size it is also identical as the corresponding portion in transfer unit 201.
Support tube 401, inner insulating layer 402, external insulation layer are additionally provided on the outside of the silk guide passage inside transfer unit 201403, the outside of silk guide passage 300 is arranged in support tube 401, and the outside of support tube 401, external insulation is arranged in inner insulating layer 402The outside of inner insulating layer 402 is arranged in layer 403.
Support tube 401 is NiTi pipe or stainless steel tube.The external insulation layer 403 of transfer unit 201 is formed by high molecular material.In one embodiment, the external insulation layer 403 of transfer unit 201 is PET or FEP heat-shrink tube, the thickness 0.012 after pyrocondensation~0.15mm, 0.5~1.2mm of internal diameter.It is also equipped with external insulation layer on the outside of the silk guide passage inside load bearing component 102, by high scoreSub- material is formed.In one embodiment, the external insulation layer of load bearing component 102 be TPU manage or Pebax pipe, internal diameter be 0.7~1.6mm, with a thickness of 0.05~0.15mm.
It is provided between the external insulation layer 403 and inner insulating layer 402 of transfer unit 201 for providing tune for electrode 101The conducting wire 404 of temperature and impedance when amount of energy saving and monitoring ablation.Conducting wire 404 is along the axially extending of radio frequency ablation catheter, conducting wire404 from the external insulation layer for extending to load bearing component 102 between the external insulation layer 403 and inner insulating layer 402 of 201 proximal end of transfer unitIt is connected between inner insulating layer, and with electrode 101.The quantity of conducting wire can be consistent with the quantity of electrode, can also be led by oneLine connects multiple electrodes.
The distal end of conduit device is provided with the first opening 103, the first opening is flushed with the distal end of radio frequency ablation catheter, theThe cavity of silk guide passage in load bearing component 102 is in communication with the outside by one opening 103.
The conduit device of the present embodiment further includes handle 500, and as shown in Figure 3 and Figure 5, the proximal end of handle 500 includes injectionMouth 501 and cable port 502.The injection port 501 is connected to the cavity 304 in silk guide passage 300, the injection entered from injection portLiquid enters in the cavity 304 of silk guide passage.The center line of injection port 501 and the center overlapping of axles of silk guide passage 300 or substantiallyIt is overlapped.Injecting fluid, guiding wire share the cavity 304 in silk guide passage, reduce the complexity of conduit device, are conducive toProduction assembly, and injecting fluid also contributes to the movement of guiding wire in the cavities, is further reduced cavity to guiding wireScrape damage.
The axis of the cable port 502 of handle 500 has a certain degree with the axis shape of silk guide passage 300, while cable port 402 is setBe equipped with gum sleeve, prevent conducting wire conduit device torsion when overflexing and be broken.The distal end of handle 500 is also equipped with rubberThe coefficient of friction that the external insulation layer of casing 503 and conduit device generates is bigger, but remains some torsions again for catheter channelTurn space, prevents fractureing for catheter channel.
The radio frequency ablation catheter cooperation guiding wire of the present embodiment uses, and specific work process is as follows:
(1) air in the cavity of silk guide passage is discharged via 501 saline injection of injection port using syringe；
(2) guiding wire is imported to the predetermined position in blood vessel；
(3) by guiding wire from the 103 insertion load bearing component 102 of the first opening for being located at 102 distal end of load bearing component, and fromIt is pierced by injection port 501.The insertion of guiding wire so that load bearing component 102 becomes first shape by preformed second shape,Convenient for moving in the blood vessel；
(4) radio frequency ablation catheter is moved to the predetermined position in blood vessel along guiding wire；
(5) load bearing component 102 is detached from injection port 501 by guiding wire, load bearing component 102 becomes second by first shapeShape adjusts energy by release and is treated at this point, the electrode 101 on load bearing component 102 is close to blood vessel；
(6) guiding wire is pushed into load bearing component 102, load bearing component 102 becomes first shape from the second shape again；
(7) radio frequency ablation catheter is removed into human body.
The guiding wire of the present embodiment is wire, is made of NiTi alloy.
Radio frequency ablation catheter in the present embodiment, in cooperation guiding wire in use, guiding wire is opened from the first of distal endMouth insertion, draws from the injection port being located on handle.Due to the central axis of silk guide passage and the center of entire radio frequency ablation catheterOverlapping of axles substantially overlap, relative to common silk guide passage and catheter center's axis out-of-alignment conduit, the push of guiding wireResistance reduces.In addition, the internal layer due to silk guide passage is formed by high molecular material, inner cavity surface is smooth, while seal wire is logicalRoad is connected to injection port, and in the case where injecting fluid further acts on, guiding wire can be moved more swimmingly, plays protective effect,The hydrophilic coating that guiding wire surface will not be wiped off because of friction, prevents potential health hazard.
After the adjusting component of conduit is directed to setting position using guiding wire, if electrode and vascular wall fitting are bad,It can be then adjusted by rotary guide pipe.Common radio frequency ablation catheter, due to silk guide passage be biasing, central shaft withThere are distances for the central axis of conduit, once so conduit rotation is more than 180 ° or more, guiding wire can be wrapped on conduit.And thisRadio frequency ablation catheter in embodiment, due to coaxial silk guide passage, it can according to need and be rotated at random, it will notCause guiding wire in supravasal winding.
On common catheter product, in order to deform load bearing component so that electrode and vascular wall fitting, need to guideSeal wire is changing to for treatment when load bearing component is not supported by guiding wire from fast exchange mouth a part of dropping backTwo shapes.However, common radio frequency ablation catheter, it is excessive to be easy recession when guiding wire is dropped back.Once guiding wire recession is superFast exchange mouth is crossed, then can not penetrate guiding wire again, this leads to not the shape for adjusting load bearing component by guiding wire, holdsMobile conduit when component the second shape of maintenance is carried, patient's blood vessel can be caused to damage.Catheter product in the present embodiment, due to notThere are fast exchange mouths, therefore, the shortcomings that seal wire may be detached to fast exchange mouth are also just not present.
The setting of the angle setting and gum sleeve of the cable port of handle, is conducive to protect conducting wire.The rubber of distal handleCasing is conducive to protect catheter channel.
The preferred embodiment of the present invention has been described in detail above.It should be appreciated that the ordinary skill of this field is without woundThe property made labour, which according to the present invention can conceive, makes many modifications and variations.Therefore, all technician in the artPass through the available technology of logical analysis, reasoning, or a limited experiment on the basis of existing technology under this invention's ideaScheme, all should be within the scope of protection determined by the claims.