Summary of the invention
Because the above-mentioned defect of prior art, technical problem to be solved by this invention is to provide a kind of easy to operate, pipe guide for the treatment of relevant disease for regulating kidney neural that cost of manufacture is low.Kidney is neural for being positioned at the renal sympathetic nerve on people's renal artery, in the present invention adjustment kidney nerve refer to by damage or non-invasive mode remove or reduce the activation of described nerve, the invention provides a kind of for regulating the pipe guide of kidney nerve, by intravasation, release regulation energy regulates the renal sympathetic nerve on renal artery.
For achieving the above object, the invention provides a kind of for regulating the pipe guide of kidney nerve, comprising adjusting part and transfer unit;
Described adjusting part comprises electrode supporting part and multiple electrode; Described multiple electrode is set to adjusting energy to be delivered to nerve; Described electrode supporting part is set to carry described multiple electrode;
Described electrode is connected with wire;
Described transfer unit is set to described adjusting part is transported to the position near described nerve;
It is characterized in that,
Described electrode supporting part is flexible, and pretreated for having the first shape;
Described pipe guide also comprises the rigid element be arranged in described transfer unit; When described rigid element inserts described electrode supporting part, described electrode supporting part keeps second shape corresponding to described rigid element; When described rigid element detaches from described electrode supporting part, described electrode supporting part is replied as described first shape;
Under described first shape, described electrode supporting part is set to be suitable for, by described multiple electrode, adjusting energy is delivered to described nerve; Under described second shape, described electrode supporting part is set to be suitable for moving in the blood vessel.
Further, the described insertion of described rigid element and described detaching are controlled by rigid element motion control mechanism.
Further, described rigid element is tinsel.
Described tinsel is preferably NiTi alloy.
Further, described electrode supporting part adopts memorial alloy to make.
Further, described first shape of described electrode supporting part is spiral type or approximate spiral.
Further, described second shape of described electrode supporting part is straight or approximate straight.
Further, the diameter of described first shape is 4-12mm.
Further, multiple described electrode can Co ntrolled release energy separately.Whether namely whether an electrode is delivered to nerve by adjusting energy, be delivered to by adjusting energy neural irrelevant with other electrodes; Only can there is an electrodes transfer adjusting energy.
Further, multiple described electrode Co ntrolled release energy simultaneously.Namely partial electrode or all electrodes transmit adjusting energy simultaneously, and the state whether each electrode transmits adjusting energy is independent of each other.
Further, the cross section of described electrode is annular.
Further, the number of described electrode is 2-6, and when described electrode supporting part is in the first shape, the distance between adjacent electrode is 4-15mm.
Further, the number of described electrode is 4.
Further, described electrode adopts platinumiridio material.
Further, described electrode uses binding agent to be bonded in described electrode supporting part.
Described binding agent is preferably UV and solidifies glue or epoxide-resin glue.
Further, electrode described in each within it has for it provides the independent wire of energy on surface.
Further, described wire bonds is in the inner surface of described electrode.
Further, described wire is arranged on the outside of described electrode supporting part and described transfer unit, and by the coated described electrode supporting part of the first insulating barrier and described transfer unit.
Further, the outside of described electrode supporting part and described transfer unit has the second insulating barrier, and described wire is arranged on the outside of described first insulating barrier, and coated by described second insulating barrier.
Further, described first insulating barrier and/or described second insulating barrier are that pyrocondensation macromolecular material is formed.
Further, described macromolecular material is PET/FEP/PTFE/TPU.
Further, the far-end of described electrode supporting part arranges the guard block for reducing or avoid vascular damaged.
Further, described guard block is soft head.
Further, described guard block is made up of rubber, silica gel or thermoplastic elastic material.
Further, the length of described guard block is 3-50mm.
Further, described transfer unit and described electrode supporting part are one.
Further, the far-end of described transfer unit is connected with the near-end of described electrode supporting part.
Further, described transfer unit is set to tubulose.
Further, the external diameter of described transfer unit is 0.5-1.0mm, and wall thickness is 0.05-0.15mm.
Further, described transfer unit adopts Ni-Ti alloy to make.
Further, described pipe guide also comprises the handle for gripping, and described handle is connected with the near-end of described transfer unit, and described wire is connected with described handle.
Further, described rigid element motion control mechanism is installed in described handle, and described rigid element motion control mechanism controls the motion of described rigid element by gear.
Further, described rigid element motion control mechanism is positioned at outside described handle, and directly manually operation controls the motion of described rigid element.
Further, described adjusting energy is one or more in radio frequency, heat, cold, electromagnetic energy, ultrasound wave, microwave or luminous energy.
Further, the surface of described electrode supporting part is cut.
Further, described electrode supporting part surface cuts into straight-line groove according to cutting angle.
Further, described electrode supporting part surface cuts into multiple cylindrical groove according to cutting angle.
Further, described cutting angle is between 30 ° ~ 80 °.
Further, described straight-line groove is identical at the described cutting angle on described electrode supporting part surface.
Further, described straight-line groove is different at the described cutting angle on described electrode supporting part surface, and described straight-line groove is greater than the described cutting angle at described electrode supporting part near-end at the described cutting angle of described electrode supporting part far-end.
Further, the cutting interval between adjacent described cylindrical groove is identical.
Provided by the invention for regulating neural pipe guide, the shape that use is simple, cost is lower, supporting construction that is convenient operation carrys out control electrode supporting part, thus realize pipe guide at endovascular movement or transmission adjusting energy.Adopting disclosed by the invention for regulating neural pipe guide, without the need to using guiding wire, operating easier, greatly reduce the workload of medical worker, also for the valuable time has been striven in operation, greatly increase the chance of success of operation, there is very strong Clinical practicability.
Provided by the invention for regulating neural pipe guide, each electrode controls separately, and the duty of any one electrode is not by the impact of other electrodes, and medical worker according to actual needs, can select one, part or all of electrode release regulation energy.Provided by the present invention for regulating neural device operation convenient, can regulate multiple neural site simultaneously or selective control be carried out to some neural site, thus increase work efficiency, and improve the accuracy for the treatment of further, and when some electrode failure, medical worker can select working electrode flexibly, greatly have submitted the disposal ability of equipment chance failure, ensure normally carrying out of operation, there is important clinical meaning.
In the present invention, the abbreviation of using:
PTFE refers to politef, i.e. Polytetrafluoroethylene;
FEP refers to fluorinated ethylene propylene copolymer, i.e. Fluorinatedethylenepropylene;
TPU refers to Polyurethane Thermoplastic Elastomer rubber, i.e. Thermoplasticpolyurethanes;
PET refers to polyethylene terephthalate, i.e. Polyethyleneterephthalate.
For convenience of explanation, by the close user (or handle) of device or parts or away from needing the one end in the neural site regulated to be called " far-end " in the present invention, by device or parts away from user (or handle) or near needing the one end in the neural site regulated to be called " near-end ".
Be described further below with reference to the technique effect of accompanying drawing to design of the present invention, concrete structure and generation, to understand object of the present invention, characteristic sum effect fully.
Detailed description of the invention
Fig. 1, Fig. 2 show people's kidney, the arteriorenal structure of people.
As shown in Figure 1, people's kidney comprises kidney 1 anatomically, and renal artery 2 is connected to heart via the aorta of abdominal part, and oxygen containing blood supplies kidney 1 by renal artery 2; The blood of deoxidation flows to heart via renal veins 3 and postcava 4 from kidney 1.
As shown in Figure 2, kidney nerve 21 extends along the axis of renal artery 2, and kidney neural 21 is general in the adventitia of renal artery 2.
For regulating neural pipe guide in the present embodiment, for regulating the kidney nerve 21 be positioned on renal artery 2, described adjustment refers to and is removed by damage or non-invasive mode or reduced the activation of kidney nerve 21.If need to regulate the nerve at other position (such as, heart related neural), or need other regulative mode (such as, need to improve neural activation), adjustment that those skilled in the art can make rational expectation according to the present invention, that do not need to be put to creative work.
For regulating neural pipe guide in the present embodiment, comprising the adjusting part 5 for regulating described nerve, carrying the transfer unit 6 of described adjusting part 5; Adjusting part 5 comprises the electrode 51 for adjusting energy being delivered to kidney nerve and is used for carrying the electrode supporting part 52 of electrode 51, and electrode supporting part 52 has the first shape and the second shape.Fig. 3 and Fig. 4 respectively illustrates the first shape and second shape of electrode supporting part 52.Under the first shape, adjusting energy can be delivered to the position of kidney nerve by least one electrode 51 of adjusting part 5, and under the second shape, adjusting part 5 is for moving in the blood vessel; Pipe guide also comprises rigid element 9, and rigid element 9 is set to be in the second shape by support electrode supporting part 52.
In the present embodiment, electrode 51 transmits adjusting energy and to the mode in the neural site of the kidney needing to regulate is: enter human body via blood vessel, by renal artery inwall near neural site.Therefore the technical issues that need to address are: should realize electrode 51 and can be close to the nerve that blood vessel acts on relevant position, need again electrode 51 to move easily in the blood vessel, not injured blood vessel wall.
Electrode supporting part 52 adopts memory material to make, and heat treatment in advance becomes the first shape, and has cavity.
As shown in Figure 3, in the present embodiment, the first shape entirety of electrode supporting part 52 is spiral type, and in the radial direction of blood vessel, the widest part of electrode supporting part 52 is larger than the second shape, and the electrode 51 of carrying can be made like this to come close to or in contact with blood vessel wall, thus neural near kidney.
Consider that blood vessel has certain elasticity, the spiral diameter of electrode supporting part 52 is set to 4-12mm.For the individuality that renal artery internal diameter is less, such as internal diameter is about 4mm, the spiral diameter of electrode supporting part 52 can be set to about 5-6mm; For the individuality that renal artery internal diameter is larger, such as internal diameter is about 7mm, the diameter of spiral can be set to about 8-9mm.
First shape of electrode supporting part 52 can be also other shape, such as, have round and smooth bending irregular shape, as long as when described electrode supporting part in the blood vessel time, electrode is in the position contacting blood vessel wall.
As shown in Figure 4, rigid element 9 electrode insertion supporting part 52, electrode supporting part 52 is in the second shape, detaches electrode supporting part 52, and electrode supporting part 52 is in the first shape.。
The insertion of rigid element 9 and detaching is controlled by rigid element motion control mechanism 10.
In a preferred embodiment of the invention, rigid element 9 is tinsel.
Described tinsel is preferably Ni-Ti alloy.
Electrode supporting part 52 has the helical structure of cavity for being heat-treated to.
First shape of electrode supporting part 52 is spiral type or approximate spiral; Second shape of electrode supporting part 52 is straight shape or approximate straight shape.When electrode supporting part 52 is the first shape, adjusting energy can be delivered to the position of kidney nerve by least one electrode of adjusting part 5; When electrode supporting part 52 is the second shape, electrode supporting part 52 carries electrode 51 and moves in the blood vessel.
As shown in Figure 4, in the present embodiment, the second shape of electrode supporting part 52 is straight or close to straight, also can be that elongate is fibrous or thread, the cross section of this bar shaped be preferably circular or sub-circular, and the widest part of cross section is less than the interior diameter of blood vessel.Like this, under the second shape, when adjusting part 5 moves in the blood vessel, adjusting part 5 can not injured blood vessel wall.When needing to regulate the nerve on renal artery, because the arteriorenal interior diameter of people is generally 4-7mm, therefore, the full-size of adjusting part 5 in arteriorenal radial direction is not more than 4mm, preferably be set to 1-2mm, both can meet at Ink vessel transfusing convenient mobile, and there is again enough rigidity and be convenient to make, and the size of the wound of patient can be reduced.As the change of this detailed description of the invention, the second shape also can allow certain bending or corrugated bending, and its cross section also can be other shape, as long as its smooth surface, can move and not injured blood vessel wall at Ink vessel transfusing easily.
Work process for the pipe guide regulating kidney nerve in the present embodiment is as follows:
1, first by rigid element 9 electrode insertion supporting part 52, makes electrode supporting part 52 become the second shape from preformed first shape;
2 move pipe guide to the renal sympathetic nerve place on human body renal artery;
Rigid element 9 is detached electrode supporting part 52 by 3, electrode supporting part 52 becomes spiral type from straight, namely be the first shape by the second recovery of shape, now, electrode 51 on electrode supporting part 52, be close to the nerve that blood vessel acts on relevant position, discharge certain energy thus play the effect regulating this neural site (such as, reduce or eliminate orthosympathetic activation);
4 by rigid element 9 electrode insertion supporting part 52, and electrode load bearing component 52 is the second shape by the first transfer of shapes again;
Pipe guide is shifted out human body by 5.
Electrode 51 is connected with the wire of feed adjustment energy, and each electrode 51 works alone, and has independent wire respectively.Electrode whether release regulation energy, has nothing to do with other electrodes; Only can there be one or partial electrode transmission adjusting energy, also can work by all electrodes simultaneously, transmit adjusting energy; The state whether each electrode transmits adjusting energy is independent of each other.The inner surface of electrode 51 has for it provides the wire of energy.Electrode supporting part 52 has the first insulating barrier with the outside of transfer unit 6, and wire is arranged on the outside of the first insulating barrier, and at coated second insulating barrier in outside of wire and the first insulating barrier.
When electrode 51 is in time needing the neural site regulated, electrode 51 discharges certain energy and acts on this neural site, thus plays the effect regulating this neural site (such as, reduce or eliminate orthosympathetic activation).
Electrode 51 can realize this object by heat being delivered to this neural site.Such as, heat transfer heating mechanism for neuroregulation can comprise heating ablation and the non-thermal change that melts or damage, such as, the temperature of target nerve fiber can be increased to over required threshold value to realize the non-thermal change melted, or exceed higher temperature to realize the thermal change melted.Such as, target temperature can about 37 DEG C-45 DEG C (the thermal change temperature for non-thermal ablation), or described target temperature can at about 45 DEG C or higher, for the thermal change melted.
Electrode 51 also can realize this object by cooling being delivered to this neural site.Such as, the temperature of target nerve fiber is reduced to less than about 20 DEG C to realize the thermal change of non-frozen, or the temperature of target nerve fiber is reduced to less than about 0 DEG C to realize freezing thermal change.
Electrode 51 can also by being applied to target nerve fiber to realize by energy field.This energy field can comprise: electromagnetic energy, radio frequency, ultrasound wave (comprising high-intensity focusing ultrasonic wave), microwave, luminous energy (comprising laser, infrared ray and near infrared ray) etc.Such as, thermoinducible neuroregulation can by by pulse or continuous print heat energy field be delivered to target nerve fiber and realize.Wherein, a kind of ratio more preferably energy mode be the pulse heat energy of pulse radiation frequency electric field or other type.The pulse heat energy of pulse radiation frequency electric field or other type can facilitate larger heat level, longer total duration and/or better controlled intravascular renal neuroregulation to treat.
Which kind of no matter by energy mode realize regulating neural object, when user to use in the present embodiment for regulating neural pipe guide to carry out work, electrode needs and produces this energy (such as radiofrequency generator) or the equipment producing this energy of electrode 51 own is electrically connected.The prior art that the connection of these equipment and electrode and these equipment is well known to those skilled in the art (such as, interface for connecting these equipment is set in apparatus of the present invention, can plug and play be realized during use), no longer describe in detail here.
In order to better transmit adjusting energy, the cross section of electrode 51 is ring-type.When described electrode supporting part is in the first shape, namely when in renal artery, electrode supporting part 52 is spiral type, the electrode 51 on electrode supporting part 52 is in the position of contact renal artery inwall, namely neural near kidney, so just can carry out adjustment work.
In the present embodiment, the number of electrode 51 is four, and when electrode supporting part 52 is in the first shape (helical form), adjacent electrode 51 is 4-15mm in the distance axially of blood vessel.In general, when carrying out the operation of kidney nerve ablation, need to melt 3-8 site of kidney nerve.Therefore, when using the pipe guide in the present embodiment to carry out ablative surgery, the location (making electrode 51 contact blood vessel) of Primary regulation assembly 5 can complete melting of four sites, and completes the location that whole ablative surgery only needs to carry out twice adjusting part 5.The number of electrode 51 also can be set to 2-6, if but number is too much, the cost of manufacture of pipe guide can be increased; And number is less, the work efficiency of ablative surgery can be reduced.
The metal or metal alloy that the material of electrode 51 can adopt biocompatibility better or more stable, such as platinum group metal, the electrode 51 in the present embodiment adopts platinumiridio to make.
In order to make electrode 51 firmly be arranged on electrode supporting part 52, and reducing the damage to blood vessel wall as far as possible, glue can be used to be bonded on electrode supporting part 52 by electrode 51, and form seamlessly transitting between electrode 51 and electrode supporting part 52.Glue can select UV to solidify glue, epoxide-resin glue or its mixture, so both has the biocompatibility that can reach medical application, has certain cohesive force again to metal alloy and macromolecular material.
Wire is connected to energy generation apparatus, such as radiofrequency generator, is welded on the inner surface of electrode 51, and wire is arranged at the outside of electrode supporting part 52 and transfer unit 6.When multiple electrode is set, need to arrange multiple conducting wires respectively by multiple Electrode connection to energy generation apparatus.
Electrode supporting part 52 can also be arranged the element for measuring tempeature, such as thermocouple, and corresponding wire.
The far-end of electrode supporting part 52 arranges the guard block for reducing or avoid vascular damaged, an effect of guard block reduces or avoids vascular damaged, when touching blood vessel wall, because self is enough soft and can resilience rapidly, can not cause damage to blood vessel; Another effect of guard block plays guide effect to whole pipe guide, and when running into the bending place of blood vessel, self can bend according to the bending degree of blood vessel, thus guides whole pipe guide smoothly by the bending place of blood vessel.
Guard block is relatively soft-component, and can be the parts that the relatively soft macromolecular material of material makes, in the present embodiment, guard block be soft 8, as shown in Figure 3 and Figure 4, avoids the far-end injured blood vessel of electrode supporting part 52; Soft head adopts elastomeric material to make, and elastomeric material is rubber, silica gel or thermoplastic elastomer (TPE); The length of soft head is 3-15mm, and maximum gauge is less than 1.33mm.
Guard block can be also spring, is arranged at the far-end of electrode supporting part 52, and spring adopts Ni-Ti alloy or rustless steel to make, and pitch is closing twist, can meet aeroelastic requirements.The length of spring is 25-50mm, and spiral external diameter is 0.25-0.6mm, and the diameter of spring wire is 0.045-0.12mm.
Transfer unit 6 and described electrode supporting part 52 can be one.
Transfer unit 6 and described electrode supporting part 52 also can be splits, and the far-end of transfer unit 6 is connected with the near-end of electrode supporting part 52.
Transfer unit 6 is tubulose, and external diameter is 0.5mm-1.0mm, and wall thickness is 0.05-0.15mm; Ni-Ti alloy is adopted to make; Outer surface pyrocondensation one deck macromolecular material; Macromolecular material is PET/FEP/PTFE/TPU.
For the ease of the shape 52 using rigid element 9 to change electrode supporting part, the surface of electrode supporting part 52 is cut.Rigid element 9 control electrode supporting part 52, makes it have the first shape or the second shape, and when rigid element 9 electrode insertion supporting part 52, electrode supporting part 52 becomes straight shape from spiral type, namely becomes the second shape from the first shape; When rigid element 9 detaches electrode supporting part 52, electrode supporting part 52 becomes spiral type from straight shape, namely from the second recovery of shape be the first shape.
The surface of electrode supporting part 52 is according to cutting angle, from the far-end of electrode supporting part 52 to the near-end of electrode supporting part 52, be cut into straight-line groove or multiple cylindrical groove, specifically as shown in Figure 5-Figure 8.Horizontal positioned electrode supporting part 52, if be cut into straight-line groove, cutting angle is exactly the angle α of straight line and horizontal direction; If be cut into multiple cylindrical groove, cutting angle is exactly the line between the central point of multiple cylindrical groove and the angle α in horizontal direction.
In a preferred embodiment of the present invention, electrode supporting part surface cuts into straight-line groove according to cutting angle, specifically as shown in Fig. 5, Fig. 6 and Fig. 7.
On the surface of electrode supporting part, the straight-line groove shown in Fig. 5 be with the cutting angle of α=53 °, from the far-end of electrode supporting part to the near-end of electrode supporting part, carry out cutting continuously according to straight line and formed.Wherein, the cutting width of straight-line groove is between 0.2449mm ~ 0.6566mm, and the cutting angle of the straight-line groove shown in Fig. 5 on electrode supporting part is consistent.
Straight-line groove shown in Fig. 6 is divided into two parts: a part is with the cutting angle of α=53 °, from the far-end of electrode supporting part, cuts formation continuously according to straight line; Another part is when near electrode supporting part near-end, progressively reduces cutting angle (α '), and according to the cutting angle progressively reduced (α ') until the near-end of electrode supporting part, to cut formation continuously according to straight line.
Straight-line groove shown in Fig. 7 is divided into two parts: a part is with the cutting angle of α=53 °, from the far-end of electrode supporting part, is interrupted cutting is formed according to straight line; Another part is when near electrode supporting part near-end, progressively reduces cutting angle (α '), and according to the cutting angle progressively reduced (α ') until the near-end of electrode supporting part, to be interrupted according to straight line that cutting formed.Wherein, the cutting width of straight-line groove is between 0.2449mm ~ 0.6566mm.
In another preferred embodiment of the present invention, electrode supporting part surface cuts into multiple cylindrical groove according to cutting angle, as shown in Figure 8, on electrode supporting part 52, multiple cylindrical groove be with the cutting angle of 30 °, according to 0.7150mm cutting interval (horizontal intervals at adjacent two cylindrical groove centers), proximally cut formation from the far-end of electrode supporting part 52.Each flute profile decorative pattern and horizontal square are 120 ° to angle.
Pipe guide also comprises the handle 7 gripped for user.Transfer unit 6 is connected with handle 7.Wire is arranged on handle 7.Handle 7 is set to one with the connection cord of external energy generator, or is placed through two parts of conversion port connection, and wire is connected with the connection cord of external energy generator by handle 7.
Rigid element motion control mechanism 10 can be arranged in handle 7, manipulates detaching and inserting of rigid element 9 by handle 7 by gear.It is outside that rigid element motion control mechanism 10 also can be arranged on handle 7, manually directly controls detaching and inserting of rigid element 9.In the present embodiment, as shown in Figure 3 and Figure 4, rigid element motion control mechanism 10 is the outsides being arranged on handle 7, manually detaches or inserts rigid element.
More than describe preferred embodiment of the present invention in detail.Should be appreciated that the ordinary skill of this area just design according to the present invention can make many modifications and variations without the need to creative work.Therefore, all technical staff in the art, all should by the determined protection domain of claims under this invention's idea on the basis of existing technology by the available technical scheme of logical analysis, reasoning, or a limited experiment.