CN106852703A - A kind of radio frequency ablation catheter for renal artery - Google Patents
A kind of radio frequency ablation catheter for renal artery Download PDFInfo
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- CN106852703A CN106852703A CN201510902263.6A CN201510902263A CN106852703A CN 106852703 A CN106852703 A CN 106852703A CN 201510902263 A CN201510902263 A CN 201510902263A CN 106852703 A CN106852703 A CN 106852703A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
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Abstract
The invention discloses a kind of radio frequency ablation catheter for renal artery, including the adjusting part for adjusting nerve, adjusting part includes electrode and the load bearing component for carrying the electrode, electrode is used to that energy transmission to nerve will to be adjusted, electrode includes the wire electrode being wrapped on load bearing component, load bearing component has first shape and the second shape, and under first shape, adjusting part is arranged to be suitable to move in the blood vessel；Under the second shape, electrode is in and is adapted to that energy transmission to the position of nerve will be adjusted.Compared with prior art, the length that electrode extends on load bearing component is longer, and this causes that radio frequency ablation catheter for renal artery of the invention has more preferable ablation effect.
Description
Technical field
The present invention relates to electrosurgery, more particularly to a kind of radio frequency ablation catheter for renal artery.
Background technology
Intractable hypertension, i.e., be still difficult to control to using 3 kinds or more medicines (all using a diuretics)
Hypertension (sBP >=160mmHg), clinically more typically, its paathogenic factor is numerous, and pathogenesis is indefinite,
Medication effect is very poor, and diagnosis and treatment technology are still not mature enough, one of great difficult problem as hypertension therapeutic.
Newest animal and clinical laboratory data prove significantly hold the regulation (for example removing sympathetic nerve) of renal nerve
Lower intractable hypertension long, the renal artery radiofrequency ablation art that such as latest developments go out.Renal artery radiofrequency ablation art is
A kind of to send into privileged site in the arteria renalis by by electrode catheter intravascular, release radio-frequency current causes the sympathetic god of the arteria renalis
Through local solidification necrosis, denervated interventional techniques are reached.Radio-frequency current damage range is small, does not result in body
Harm, therefore, renal artery radiofrequency ablation art has become a kind of effective removal orthosympathetic method of the arteria renalis.Mesh
Before, single-stage radio frequency ablation catheter for renal artery has been occurred in that to implement renal artery radiofrequency ablation operation.The single-stage arteria renalis is penetrated
The head of frequency ablation catheter has single electrode, the ablation of One-Point Location can be carried out to arteria renalis sympathetic nerve, due to one
Secondary operation can only melt to a point position, therefore operating efficiency is relatively low.
In addition, the regulation to renal nerve is proved to have certain effect to various diseases related to kidney, particularly kidney is handed over
Relevant disease caused by the neural overactivity of sense.For example, congestive heart failure (CHF) can cause exception high
Renal sympathetic nerve is activated, and so as to cause the reduction of the water and sodium that are removed from body, and increases the secretion of feritin.It is increased
Renin secretion causes Renal vascular to shrink, and causes the reduction of renal blood flow.So as to, kidney can be with for the reaction of heart failure
The spiral of heart failure condition is set to decline extension.
It is existing at present although being had been reported that in pertinent literature or patent for adjusting the orthosympathetic related equipment of the arteria renalis
Apparatus there is operation inconvenience, cost of manufacture is high or the defect such as inefficiency.
In consideration of it, the invention provides a kind of radio frequency ablation catheter for renal artery.
The content of the invention
In view of the drawbacks described above of prior art, the technical problems to be solved by the invention are to provide a kind of operation easily
Radio frequency ablation catheter for renal artery.
To achieve the above object, the invention provides a kind of radio frequency ablation catheter for renal artery, including for adjusting nerve
Adjusting part, it is characterised in that the adjusting part include electrode and the supporting part for carrying the electrode
Part, the electrode is used to adjust energy transmission to the nerve, and the electrode includes being wrapped in the load bearing component
On wire electrode, the load bearing component has first shape and the second shape, under the first shape, the regulation
Component is arranged to be suitable to move in the blood vessel；Under second shape, the electrode is in and is adapted to the regulation
Energy transmission to it is described nerve position.
Further, the electrode extends on the load bearing component, the electrode is had the 4th shape and the 5th shape
Shape, the 4th shape of the electrode and the first shape of the load bearing component are adapted, the 5th shape of the electrode with
Second shape of the load bearing component is adapted.
Further, the electrode is wound around on the load bearing component wire electrode by coil winding machine or by hand
It is made.
Further, a diameter of 0.05~0.25mm of the wire electrode.Further, using glue by the electrode
The two ends of silk are adhered on the load bearing component, so that the wire electrode is fixed on the load bearing component.
Further, the glue is UV solidification glues or epoxide-resin glue or other binding agents.
Further, by by the two ends pyrocondensation insulating barrier of the wire electrode so that the wire electrode be fixed on it is described
On load bearing component.Further, the wire electrode is made up of platinumiridio or gold.
Further, the electrode is the continuous electrode being closely wound by the wire electrode.
Further, the distance of two adjacent rings wire electrode is 0~0.5mm, and the continuous electrode is in the load bearing component
The length of upper extension is 10~45mm.
Further, the continuous electrode is mutually welded with 1~8 group of wire.
Further, the electrode is to be wound in multigroup packet electrode by the wire electrode, in every group of electrode
The wire electrode is to be closely wound.
Further, in every group of electrode, the distance of two adjacent rings wire electrode is 0~0.5mm；Two adjacent groups electricity
The distance of pole is 1~15mm, and the length that every group of electrode extends on the load bearing component is 2~5mm.
Further, every group of electrode is mutually welded with one group of wire.
Further, the electrode is mutually welded with one or more groups of wires, and the wire is for transmission regulation energy and instead
Feedback temperature, impedance.
Further, the electrode is welded together by scolding tin with the wire, and pad is coated by insulating barrier.
Further, the electrode is welded together by gold or silver with the wire, and pad is exposed or logical
Cross insulating barrier cladding.
Further, the load bearing component includes Part I and Part II, the Part II cladding described first
Part, the wire is arranged on the Part II inside and is passed and the electrode from the outermost layer of the Part II
Welding.
Further, the arteria renalis ablation catheter also includes the position for the adjusting part to be transported to the nerve
The transfer unit put, the distal end of the transfer unit is connected with the near-end of the load bearing component.
Further, the near-end is the one end away from the neural site for needing regulation, and the distal end is near the need
The one end in the neural site to be adjusted.
Further, the transfer unit includes metal tube layer, and the outer surface pyrocondensation of the metal tube layer has a floor height point
Sublayer.
Further, the metal tube layer is made up of NiTi alloys or stainless steel material, and the material of the macromolecule layer is
PET, FEP or PTFE.
Further, the radio frequency ablation catheter for renal artery also include for user grip handle, the handle with
The near-end connection of the transfer unit.
Further, the handle sets what is be integrated with the connection cable of external energy generator.
Further, the wire is inside the Part II of the load bearing component and described in the transfer unit
Macromolecule layer inside extends and in the handle.
Further, the energy that the external energy generator occurs is RF energy, heat energy, electromagnetic energy, ultrasonic wave
One or more in energy, microwave energy and luminous energy.
Further, control line is additionally provided with the Part II, the control line has preforming helical structure,
So that the load bearing component has preforming helical structure.
Further, the control line is made of metal or macromolecular material, and the metal includes NiTi or stainless
Steel material.
Further, the diameter of the control line is between 0.10~0.50mm.
Further, the outer wall of the control line has the insulating barrier formed by pyrocondensation, and the insulating barrier is PTFE
Or FEP.
Further, the material of the Part I is NiTi alloys.
Further, the surface of the Part I has cutting decorative pattern, and the cutting decorative pattern is easy to the load bearing component
Switch between the first shape and second shape.
Further, the cutting decorative pattern is to cut the straight line to be formed on the surface of the Part I according to cutting angle
Groove or multiple cylindrical grooves.
Further, the cutting angle is between 30 °~80 °.
Further, cutting angle of the straight-line groove on the load bearing component surface is identical.
Further, cutting angle of the straight-line groove on the load bearing component surface is different, and the straight-line groove exists
Cutting angle of the cutting angle of the distal end of the load bearing component more than the near-end in the load bearing component.
Further, the cutting interval between the adjacent cylindrical groove is identical.
Further, the material of the Part II is TPU or Pebax.
Further, the external diameter of the transfer unit is 0.6~1.2mm.
Further, the 0.9~1.45mm of external diameter of the load bearing component.
Further, the first shape is straight or approximate straight, and described second is shaped as spirality or approximate helical
Shape.
Further, spiral a diameter of 4~14mm.
Further, the length of the load bearing component is 40~140mm.
In a kind of better embodiment of the invention, there is provided a kind of radio frequency ablation catheter for renal artery, including with
Transfer unit in the adjusting part of regulation nerve and for the adjusting part to be transported to the position of the nerve,
Wherein, the adjusting part includes electrode and the load bearing component for carrying the electrode, and the electrode is used for will
Regulation energy transmission is to the nerve, and the electrode includes the wire electrode being wrapped on the load bearing component, described to hold
Carrying part has first shape and the second shape, and under the first shape, the adjusting part is arranged to be suitable to
Moved in blood vessel；Under second shape, the electrode is in and is adapted to the regulation energy transmission to the nerve
Position；The arteria renalis ablation catheter also includes sheath, and the sheath is coated at the transfer unit, the sheath
The load bearing component is set to switch between the first shape and second shape.
Further, the sheath can be slided under the control of controlling organization along the transfer unit, when control is described
Sheath slides into when being coated at the adjusting part along the transfer unit, and the load bearing component is cut by second shape
The first shape is changed to, when then controlling the sheath to slide into the disengaging adjusting part along the transfer unit,
The load bearing component switches to second shape by the first shape.
Further, the arteria renalis ablation catheter also include for user grip handle, the handle with it is described
The near-end connection of transfer unit, the controlling organization is arranged on the handle.
Further, the internal diameter of the sheath is 1.0~1.45mm, and external diameter is 1.25~1.60mm.
Further, the 0.9~1.45mm of external diameter of the load bearing component, the external diameter of the transfer unit is 0.7~1.2mm.
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 to contain 20-40wt%BaSO4Pebax or TPU.
Further, braiding webmaster is provided with the outer layer, the braiding webmaster includes the first braided wires section, second
Braided wires section and the 3rd braided wires section.
Further, the hardness of the first braided wires section is 25 ± 15D or 50A-90A, the second braided wires section
Hardness be 40 ± 15D, the hardness of the 3rd braided wires section is 72 ± 15D.
Further, the braided wires of the first braided wires section, the second braided wires section and the 3rd braided wires section are stainless steel
Silk or Ni-Ti.
In another better embodiment of the invention, there is provided a kind of radio frequency ablation catheter for renal artery, including it is used for
The adjusting part and the transfer unit for the adjusting part to be transported to the position of the nerve of nerve are adjusted, its
In, the adjusting part includes electrode and the load bearing component for carrying the electrode, and the electrode is used to adjust
Amount of energy saving is delivered to the nerve, and the electrode includes the wire electrode being wrapped on the load bearing component, the carrying
Part has first shape and the second shape, and under the first shape, the adjusting part is arranged to be suitable in blood
Moved in pipe；Under second shape, the electrode is in and is adapted to the regulation energy transmission to the nerve
Position；The inside of the inside of the load bearing component and the transfer unit is respectively provided with silk guide passage, in the load bearing component
Silk guide passage inside the silk guide passage in portion and the transfer unit is one, and the silk guide passage is easy to guiding wire
Movement, the movement of the guiding wire can make the load bearing component the first shape and second shape it
Between switch.
Further, the distal end of the load bearing component has hole, and the guiding wire can enter described by the hole
Silk guide passage；Opening is provided with the transfer unit, the opening connects with the silk guide passage, the opening is used
Passed from the silk guide passage in the guiding wire.
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, and the material of the soft head is silica gel, thermoplastic elastic body.
Further, the centre of the guard block has the hole.
Further, when the guiding wire inserts the load bearing component from the hole of the distal end of the load bearing component
During the silk guide passage, the load bearing component switches to the first shape by second shape；Led when described
When the opening of the silk from the transfer unit passes and detach the load bearing component, the load bearing component is by described the
One shape switches to second shape.
The radio frequency ablation catheter for renal artery that the present invention is provided has advantages below：
(1) electrode is the continuous electrode that is formed to be closely wound by wire electrode or is divided into multigroup packet electrode,
Compared with the electrode of other forms, more long, more continuous electrodes can be set on the load bearing component, and
The spiral bending of the load bearing component is not influenceed.In addition, compared with prior art, electrode length is longer, this makes
Obtaining radio frequency ablation catheter for renal artery of the invention has more preferable ablation effect.
(2) special shape control unit part is not needed, using guiding wire or the shape of sheath load bearing component,
Simple structure, low manufacture cost.
(3) load bearing component surface is cut, is easy to change the shape of load bearing component.
The technique effect of design of the invention, concrete structure and generation is described further below with reference to accompanying drawing, with
It is fully understood from the purpose of the present invention, feature and effect.
Brief description of the drawings
Fig. 1 is the structural representation of people's kidney；
Fig. 2 is the structural representation of people's arteria renalis；
Fig. 3 is the structural representation of the radio frequency ablation catheter for renal artery of sheath cast continuous electrode of the invention；
Fig. 4 is the partial enlarged drawing of Fig. 3；
Fig. 5 is one schematic diagram of straight-line groove of cutting angle identical on the surface of the Part I of load bearing component, in figure
Load bearing component is in first shape；
Fig. 6 is the different schematic diagram for straight-line groove of cutting angle on the surface of the Part I of load bearing component, in figure
Load bearing component is in first shape；
Fig. 7 is another schematic diagram of the different straight-line groove of cutting angle on the surface of the Part I of load bearing component,
Load bearing component is in first shape in figure；
Fig. 8 is the schematic diagram of multiple cylindrical grooves on the surface of the Part I of load bearing component, and load bearing component is in the in figure
One shape；
Fig. 9 is the structural representation of the radio frequency ablation catheter for renal artery of sheath cast packet electrode of the invention, is carried in figure
Part is in the second shape；
Figure 10 is the structural representation of the radio frequency ablation catheter for renal artery of quick exchange shape of the mouth as one speaks continuous electrode of the invention, figure
Middle load bearing component is in the second shape；
Figure 11 is the structural representation of the radio frequency ablation catheter for renal artery of quick exchange shape of the mouth as one speaks packet electrode of the invention, figure
Middle load bearing component is in the second shape.
Specific embodiment
In the present invention, the abbreviation used：
PTFE refers to polytetrafluoroethylene (PTFE), i.e. Polytetrafluoroethylene；
FEP refers to fluorinated ethylene propylene copolymer, i.e. Fluorinated ethylene propylene；
TPU refers to TPUE rubber, i.e. Thermoplastic polyurethanes；
PET refers to polyethylene terephthalate, i.e. Polyethylene terephthalate；
Pebax refers to polyether block amide, i.e. Polyether block amide
For convenience of description, by close the user (or handle) of device or part or away from needing to adjust in the present invention
The one end in neural site be referred to as " near-end ", by device or part away from user's (or handle) or near needing to adjust
The one end in the neural site of section is referred to as " distal end ".
Nerve in the present invention refers to the renal sympathetic nerve on people's arteria renalis；
Regulation nerve refers to the activation for being removed or being reduced the nerve by way of damage or non-damaging；
Energy refers to one or more in radio frequency, heat, cooling, electromagnetic energy, ultrasonic wave, microwave or luminous energy；
Blood vessel refers to people's arteria renalis；
It refers to the adjusting part not injured blood vessel wall when adjusting part is moved in the blood vessel to be suitable to move in the blood vessel；Adjust
Section component is not more than the internal diameter of blood vessel in the full-size radially of blood vessel；It is easy when adjusting part is moved in the blood vessel
In by vascular bending section；
By it is described regulation energy transmission to the position of renal nerve refer to when regulating member in the blood vessel when, at least one electrode
Position in contact vascular wall.
Fig. 1, Fig. 2 show people's kidney, the structure of people's arteria renalis.
As shown in figure 1, people's kidney anatomically includes kidney 1, the arteria renalis 2 is connected to heart via the sustainer of belly,
Oxygen containing blood supplies kidney 1 by the arteria renalis 2；The blood of deoxidation flows via renal vein 3 and inferior caval vein 4 from kidney 1
To heart.
As shown in Fig. 2 renal nerve 21 is along the axially extending of the arteria renalis 2, renal nerve 21 is general in the arteria renalis 2
In adventitia.
The radio frequency ablation catheter for renal artery of embodiments of the invention, for adjusting the renal nerve 21 on the arteria renalis 2,
Described regulation refers to the activation for being removed or being reduced renal nerve 21 by way of damage or non-damaging.If necessary to adjust
The nerve (for example, heart related neural) at other positions, or other regulative modes are needed (for example, it is desired to improve
Nerve activation), those skilled in the art can according to the present invention make rational expectation, creative labor need not be put to
Dynamic adjustment.
As shown in figs. 34, An embodiment provides a kind of radio frequency ablation catheter for renal artery, specifically,
It is a kind of radio frequency ablation catheter for renal artery of sheath cast continuous electrode, its structure includes adjusting part and transfer unit 61,
Adjusting part is defeated including for carrying the load bearing component 62 of electrode 5 and will adjust energy transmission to the electrode 5 of nerve
Part 61 is sent for adjusting part to be transported to the position of nerve.The distal end of transfer unit 61 is near with load bearing component 62
End is connected.Transfer unit 61 and load bearing component 62 can be one, or split.Transfer unit 61
Be shaped as elongate, bar shaped, thread or fibrous one kind, external diameter is 0.7~1.2mm.Transfer unit 61 is wrapped
Include metal tube layer, the outer surface pyrocondensation of the metal tube layer has a floor height molecular layer, wherein metal tube layer by NiTi alloys or
Stainless steel material is made, and the material of macromolecule layer is PET, FEP or PTFE.The length of load bearing component 62 is 40~140
Mm, external diameter is 0.9~1.45mm, and load bearing component includes Part I and Part II, Part II cladding described the
A part, the material of Part I is NiTi alloys, and the material of Part II is TPU or Pebax.
Load bearing component 62 has first shape and the second shape, and under first shape, adjusting part is suitable to move in the blood vessel
It is dynamic；Under the second shape, adjusting part will adjust energy transmission to the position of nerve by electrode 5.
In the present embodiment, electrode 5 is the continuous electrode being closely wound by wire electrode, specifically by coil winding machine
Or manual wire electrode is tightly wound around on load bearing component is made.Wherein a diameter of 0.05~0.25mm of wire electrode,
In the present embodiment, the diameter of wire electrode is set to 0.10mm.The material of wire electrode can using biocompatibility preferably or
More stable metal or metal alloy, such as platinum group metal, gold etc., the electrode in the present embodiment are closed using platinoiridita
Gold makes.
Electrode 5 extends on load bearing component 62 and has the 4th shape and the 5th shape, the 4th shape of electrode 5 with hold
The first shape for carrying part 62 is adapted, and the 5th shape of electrode 5 is adapted with the second shape of load bearing component 62,
I.e. the shape of load bearing component 62 will not be affected because electrode 5 is wound on load bearing component 62 for wire electrode.
In order that electrode 5 is firmly installed on load bearing component 62, and reduces the damage to vascular wall as far as possible, can be with profit
The two ends of wire electrode are adhered on load bearing component 62 so that wire electrode is fixed on load bearing component 62 with glue.Glue
Water can select UV solidification glues, epoxide-resin glue or its mixture or other binding agents, and so both having can reach medical treatment
The biocompatibility of purposes, and have certain cohesive force to metal alloy and macromolecular material.Also can be exhausted by pyrocondensation
Be bonded on load bearing component at the two ends of wire electrode by the mode of edge layer, so as to wire electrode is fixed on load bearing component 62.
The length that continuous electrode extends on load bearing component 62 is 10~45mm, and the distance of two adjacent rings wire electrode is 0~0.5
mm。
Electrode 5 in the present embodiment is mutually welded with 1~8 group of wire, and the wire is arranged on the Part II of load bearing component 62
It is internal and passed from the outermost layer of the Part II and welded with electrode 5, wire be used to transmitting regulation energy and feedback temperature,
The parameters such as impedance.Wire electrode can be welded together by scolding tin with wire, and now pad is coated by insulating barrier.
In other embodiments, wire electrode can also be welded together by gold or silver with wire, and now pad can be with naked
Dew, it is also possible to coated by insulating barrier.
The radio frequency ablation catheter for renal artery of the sheath cast continuous electrode of the present embodiment also includes the hand gripped for user
Handle, handle 8 is connected with transfer unit 61.Wire is inside the Part II of load bearing component 62 and transfer unit 61
Macromolecule layer inside extend and in handle 8.Handle 8 is set to the connection cable of external energy generator
One, thus 1~8 group of wire of the present embodiment also produces equipment such as radiofrequency generator to be connected with external energy.It is outside
The energy that power generator occurs is in RF energy, heat energy, electromagnetic energy, ultrasonic energy, microwave energy and luminous energy
One or more.
When electrode 5 is near the neural site for needing regulation, electrode 5 discharges certain energy and acts on the neural position
Point, so as to play a part of to adjust the neural site (for example, reduce or eliminate orthosympathetic activation).
Electrode 5 can realize the purpose by transferring heat to the neural site.For example, for nerve modulation
Heat transfer heating mechanism can include that heating ablation and the heat of non-ablation become or damages, for example, can be by the temperature of target nerve fibre
Degree increases to over required threshold value to realize that the heat of non-ablation becomes, or is become with realizing the heat of ablation more than temperature higher.Example
Such as, target temperature can about 37 DEG C -45 DEG C (for non-thermal ablation hot temperatures), or, the target temperature can
So that at about 45 DEG C or higher, the heat for ablation becomes.
Electrode 5 can also realize the purpose by the way that cooling is delivered into the neural site.For example, by target nerve fibre
Temperature be reduced to less than about 20 DEG C and become with realizing the heat of non-frozen, or the temperature of target nerve fibre is reduced to about 0
Become with realizing the heat of freezing below DEG C.
Electrode 5 can also be realized by the way that energy field is applied into target nerve fibre.The energy field can include：Electromagnetism
Energy, radio frequency, ultrasonic wave (including high-intensity focusing ultrasonic wave), microwave, luminous energy (including laser, infrared ray and near red
Outside line) etc..For example, the nerve modulation of thermal induction can be delivered to target nerve by by pulse or continuous heat energy field
Fiber and realize.Wherein, one kind is pulse radiation frequency electric field or other types of pulse heat energy than more preferably energy mode.
Pulse radiation frequency electric field or other types of pulse heat energy can facilitate bigger heat level, longer total duration and/
Or more preferable controlled intravascular renal nerve modulation treatment.
No matter the purpose of regulation nerve is realized by which kind of energy mode, and the arteria renalis is penetrated in user is using the present embodiment
When frequency ablation catheter is operated, electrode 5 needs and produces the energy (such as radiofrequency generator) or produce electrode 5 itself
The equipment of the raw energy is electrically connected.These equipment and electrode 5 and the connection of these equipment are people in the art
In prior art known to member (for example, it is provided for connecting the interface of these equipment in apparatus of the present invention, when using
It is capable of achieving plug and play), no longer narration in detail here.
In the present embodiment, mode of the electrode 5 near the renal nerve site for needing regulation is：Enter human body via blood vessel,
By arteria renalis inwall near nerve site.Therefore the technical issues that need to address are：Should realize that electrode 5 can be tight
Patch blood vessel acts on the nerve of relevant position, needs electrode 5 easily to move in the blood vessel again, not injured blood vessel
Wall.
In the present embodiment, control line is additionally provided with the Part II of load bearing component 62, the control line has preforming
Helical structure, so that there is load bearing component preforming helical structure control line to use metal, such as NiTi or stainless
Steel material is made, and can also be made of macromolecular material in other embodiments.The diameter of control line is 0.10~0.50
Between mm.The outer wall of control line has the insulating barrier formed by pyrocondensation, and the insulating barrier is PTFE or FEP.
The first shape of load bearing component 62 is straight or approximate straight；The second of load bearing component 62 is shaped as spirality
Or approximate spiral；When load bearing component 62 is first shape, load bearing component 62 carries electrode 5 in the blood vessel
It is mobile；When load bearing component 62 is the second shape, electrode 5 is in and is adapted to regulation energy transmission to the position of renal nerve.
In the present embodiment, the first shape of load bearing component 62 is straight or close to straight, or elongate or fiber
Shape is thread, and the cross section of the straight is preferably circular or approximate circle, and the widest part of cross section is interior straight less than blood vessel
Footpath.So, under first shape, when adjusting part is moved in the blood vessel, adjusting part will not injured blood vessel wall.
When needing to be adjusted the nerve on the arteria renalis, because the interior diameter of people's arteria renalis is generally 4~7mm, therefore,
Adjusting part is not more than 4mm in the full-size radially of the arteria renalis, it is preferably provided as 1~2mm, can both expire
Foot is moved easily in intravascular, and with enough rigidity and is easy to make, it is possible to reduce the chi of the wound of patient
It is very little.Used as the change of the specific embodiment, first shape can also allow certain bending or corrugated bending,
Its cross section can also be other shapes, as long as its surface is smooth, easily can move in intravascular without damaging blood
Tube wall.
In the present embodiment, the second shape generally spirality of load bearing component 62, in blood vessel radially, load bearing component
The widest part it is bigger than first shape, the electrode 5 of carrying is come close to or in contact with vascular wall, thus near kidney god
Through.
The spiral diameter for having certain elasticity, load bearing component 62 in view of blood vessel is set to 4~14mm.For
The less individuality of arteria renalis internal diameter, such as internal diameter are 4mm or so, can be by the spiral diameter of load bearing component 62
It is set to 5~6mm or so；For the individuality that arteria renalis internal diameter is larger, such as internal diameter is 7mm or so, can be by spiral shell
The diameter of rotation is set to 8~9mm or so.
Second shape of load bearing component 62 can also be other shapes, such as with the irregular shape of round and smooth bending,
As long as when load bearing component in the blood vessel when, electrode be in contact vascular wall position.
In the present embodiment, for the ease of changing the shape of load bearing component 62, to the table of the Part I of load bearing component 62
Cut in face.As shown in Fig. 5~Fig. 8, on the surface of the Part I of load bearing component 62, according to cutting angle from
The distal end of load bearing component 62 carries out cutting formation to the near-end of load bearing component 62.Such as, according to cutting angle from carrying
The distal end of part 62 carries out cutting straight line and forms straight-line groove to the near-end of load bearing component 62,；According to cutting angle from
The distal end of load bearing component 62 carries out cutting multiple cylindrical grooves to the near-end of load bearing component.
Horizontal positioned load bearing component 62, if straight-line groove, cutting angle is exactly the angle α of straight line and horizontal direction；If
It is multiple cylindrical grooves, cutting angle is exactly the angle α on line and horizontal direction between the central point of multiple cylindrical grooves.
As shown in figure 5, in another preferred embodiment of the invention, straight-line groove be with the cutting angle of α=53 °,
Near-end since the distal end of load bearing component 62 to load bearing component 62, continuously cut formation according to straight line.Wherein,
Between 0.2449mm~0.6566mm, the straight-line groove shown in Fig. 5 is in load bearing component 62 for the cutting width of straight-line groove
Cutting angle on Part I is consistent all the time.
As shown in fig. 6, in another embodiment of the invention, straight-line groove includes two parts：A part is with α=53 °
Cutting angle, since the distal end of load bearing component 62, according to straight line continuously cut formation；Another part is to work as to lean on
During nearly 62 near-end of load bearing component, progressively reduce cutting angle (α '), and according to the cutting angle (α ') for progressively reducing,
Until load bearing component 62 near-end, continuously cut formation according to straight line.
As shown in fig. 7, in another embodiment of the present invention, straight-line groove includes two parts：A part is with α=53 °
Cutting angle, since the distal end of load bearing component 62, according to linear interval cut what is formed；Another part is to work as to lean on
During nearly load bearing component near-end, progressively reduce cutting angle (α '), and according to the cutting angle (α ') for progressively reducing, straight
Near-end to load bearing component 62, cut what is formed according to linear interval.The cutting width of straight-line groove exists
Between 0.2449mm~0.6566mm.
As shown in figure 8, in another preferred embodiment of the invention, on load bearing component 62, multiple cylindrical grooves are
With the cutting angle of α=30 °, according to 0.7150mm cutting interval (horizontal interval of two neighboring cylindricality groove center),
Proximally cut what multiple cylindricalitys were formed from the distal end of load bearing component.Each cylindrical groove is to angle with horizontal square
120°。
In the present embodiment, electrode 5 is continuous electrode, and compared with the electrode of other forms, continuous electrode is in load bearing component
The length extended on 62 is longer.It is, in general, that, it is necessary to 3-8 position of renal nerve when carrying out renal nerve ablative surgery
Point is melted.And the electrode 5 in the present embodiment is connected with multigroup (such as 1~8 group) wire, on the one hand, welding
During multigroup wire, evenly, temperature, impedance monitoring are more accurate for its energy transmission；On the other hand because electrode 5 is company
Continuous electrode, thus electrode in electrode 5 releases energy simultaneously.So, carried out using the pipe guide in the present embodiment
During ablative surgery, it is only necessary to which carrying out the positioning of Primary regulation component can just complete ablative surgery, and with ablation well
Effect.
The element of measurement temperature, such as thermocouple are may be provided on load bearing component 62.
The distal end of load bearing component 62 is provided with the guard block 10 for vascular damaged to be reduced or avoided, guard block
10 effect is that vascular damaged is reduced or avoided, when touching vascular wall, because itself is sufficiently flexible and can
Rapid resilience, will not cause damage to blood vessel；Another effect of guard block 10 is to whole renal artery radiofrequency ablation
Conduit plays guide effect, and when the bending place of blood vessel is run into, itself can bend according to the bending degree of blood vessel, so that
Whole pipe guide is guided to pass through the bending place of blood vessel.
Guard block 10 is relatively soft part, can be the part that the relatively soft macromolecular material of material makes,
In the present embodiment, guard block 10 is soft head, as shown in Figure 4, it is to avoid the distal end injured blood vessel of load bearing component；Soft head
Made using elastomeric material, elastomeric material is rubber, silica gel or thermoplastic elastomer (TPE)；The length of soft head is 3~15mm,
Maximum gauge is less than 1.33mm.
In other embodiments, guard block 10 can also be spring, be arranged at the distal end of load bearing component, and spring is used
Ni-Ti alloys or stainless steel make, and pitch is closing twist, disclosure satisfy that aeroelastic requirements.The length of spring is 25~50
Mm, spiral external diameter is 0.25~0.6mm, a diameter of 0.045~0.12mm of spring wire.
In the present embodiment, as shown in figs. 34, the radio frequency ablation catheter for renal artery of sheath cast continuous electrode also includes sheath
7, the sheath 7 is coated at transfer unit 61, and the shape for adjusting load bearing component 62, sheath 7 is being installed on handle
Can be slided along transfer unit 61 under the control of the controlling organization 81 on 8, thus sheath 7 enables load bearing component 62
Switch between first shape and the second shape.Specifically, when control sheath 7 slides into overcoat along transfer unit 61
When adjusting part, because the hardness of the material of the distal end of sheath 7 is bigger than load bearing component 62, load bearing component 62 is by initial
Second shape (spirality or approximate spiral) of state switch to can first shape (straight or close to straight), then
When control sheath 7 slides into disengaging adjusting part along transfer unit 61, due to the elastic reaction of itself of load bearing component 62
Power, load bearing component 62 returns to the second shape by first shape.Load bearing component 62 is achieved in first shape and
Switching between two shapes.In addition, the distal end of sheath 7 or distal attachment may be provided for showing sheath under X-ray
The flag member of pipe, in case in operation, sheath 7 is stretched out outside load bearing component 62 and damages nephridial tissue too much.
The internal diameter of sheath 7 is 1.0~1.45mm, and external diameter is 1.25~1.60mm.Sheath 7 includes internal layer and outer layer,
Internal layer wall thickness is 0.015~0.5mm, and the material of internal layer is PTFE, and coefficient of friction is smaller, when sheath 7 is relative to holding
Carrying when part 62 is slided can play smooth effect.The material of outer layer is Pebax or TPU, can contain 20~40
Wt%BaSO4。
Braiding webmaster can be set in the outer layer of sheath 7, including the first braided wires section, the second braided wires section and the 3rd are compiled
Knit silk section.The hardness of the first braided wires section is 25 ± 15D or 50A-90A, the hardness of the second braided wires section for 40 ±
15D, the hardness of the 3rd braided wires section is 72 ± 15D.First braided wires section, the second braided wires section and the 3rd braided wires
The braided wires of section are stainless steel wire or Ni-Ti.First braided wires section, the second braided wires section and the 3rd braided wires section are not
With hardness can be realized by the hardness of identical form of presentation and different outer layer materials (such as Pebax),
Can be realized by the hardness of identical outer layer material (such as Pebax) and different form of presentations.
Fig. 9 is the structural representation of the radio frequency ablation catheter for renal artery of sheath cast packet electrode of the invention, with sheath cast
Unlike the radio frequency ablation catheter for renal artery of continuous electrode, electrode therein is to be wound in multigroup packet by wire electrode
Electrode.Wire electrode in wherein every group electrode 11 is to be closely wound, the two adjacent rings wire electrode in every group of electrode 11
Distance is 0~0.5mm, and the distance of two adjacent groups electrode is 1~15mm, and every group of electrode 11 prolongs on load bearing component 62
The length stretched is 2~5mm.Every group of electrode 11 in packet electrode is mutually welded with one group of wire.The packet electrode with it is existing
The electrode for having other forms is compared, it is also possible to increase the length on load bearing component 62, thus with preferably ablation effect
Really.Can be connected with each other between each group electrode, it is also possible to be not connected with each other and independent of one another.If each group electrode is mutual
Connection, then each group electrode releases energy simultaneously, if each group electrode is independent of each other, can individually control one group
Electrode individually releases energy.
The radio frequency ablation catheter for renal artery of sheath cast continuous electrode or sheath cast the packet electrode in embodiments of the invention
The course of work is as follows：
(1) sheath 7 is first slid into adjusting part along transfer unit 61, load bearing component 62 is by the second shape (spiral shell
Rotation shape or approximate spiral) it is changed into first shape (straight or approximate straight), it is easy to move in the blood vessel；
(2) at the renal sympathetic nerve on mobile radio frequency ablation catheter for renal artery to people's arteria renalis；
(3) sheath 7 is slid into disengaging load bearing component 62, load bearing component 62 is changed into the second shape from first shape,
Electrode 5 on load bearing component 62 is close to the nerve that blood vessel acts on relevant position, discharges certain energy so as to rise
To the effect for adjusting the neural site (for example, reduce or eliminate orthosympathetic activation)；
(4) sheath 7 is slid into adjusting part again, load bearing component 62 is changed into first shape from the second shape again；
(5) radio frequency ablation catheter for renal artery is removed into human body.
In addition to being controlled to the shape of load bearing component 62 above by sheath 7, can also control by another way
The shape of load bearing component processed 62.The renal artery radiofrequency ablation of the quick exchange shape of the mouth as one speaks continuous electrode for example shown in Figure 10 is led
Pipe, and the quick exchange shape of the mouth as one speaks shown in Figure 11 is grouped the radio frequency ablation catheter for renal artery of electrode.In its structure, such as
Shown in Figure 10 and Figure 11, the radio frequency ablation catheter for renal artery from sheath cast continuous electrode or sheath cast packet electrode is different
, the inside (the specifically inside of the Part I of load bearing component 62) of load bearing component 62 and transfer unit
61 inside (the specifically inside of the metal tube layer in transfer unit 61) has silk guide passage (not shown),
The silk guide passage inside silk guide passage and transfer unit 61 inside load bearing component 62 is one, and silk guide passage is easy to
The movement of guiding wire, the movement of guiding wire can be such that load bearing component 62 is cut between first shape and the second shape
Change.The centre of the guard block 10 of the distal end of load bearing component 62 has hole (not shown), and guiding wire can by the hole
Into silk guide passage.Opening 12 is provided with transfer unit 61, it is referred to herein as quick to exchange mouth, the opening and seal wire
Channel connection, passes for guiding wire from silk guide passage.Specifically, when guiding wire from load bearing component 62
Distal end hole insert load bearing component 62 silk guide passage when, load bearing component 62 switches to first shape by the second shape；
When opening 12 of the guiding wire from transfer unit 61 passes and detach load bearing component 62, load bearing component 62 is by
One shape switches to the second shape.
In the present embodiment, the material of guiding wire is NiTi alloys.
Quick exchange shape of the mouth as one speaks continuous electrode or the quick arteria renalis for exchanging shape of the mouth as one speaks packet electrode in embodiments of the invention are penetrated
The course of work of frequency ablation catheter is as follows：
(1) at the renal sympathetic nerve for first importing on human body predetermined position, i.e. people's arteria renalis guiding wire；
(2) by guiding wire afterbody, by the hole in the middle of the guard block 10 of radio frequency ablation catheter for renal artery front end,
The silk guide passage of load bearing component 62 is inserted, and 61 quick exchange mouthful 12 is passed from transfer unit；Due to leading
Silk insertion load bearing component, it is (straight that load bearing component 62 is changed into first shape from the second shape (spirality or approximate spiral)
Or it is approximate straight), be easy to move in the blood vessel；
(3) at the renal sympathetic nerve on mobile radio frequency ablation catheter for renal artery to people's arteria renalis；
(4) guiding wire is detached into load bearing component 62, load bearing component 62 is changed into the second shape, holds from first shape
The electrode 5 on part 62 is carried, is close to the nerve that blood vessel acts on relevant position, discharge certain energy so as to rise
To the effect for adjusting the neural site (for example, reduce or eliminate orthosympathetic activation)；
(5) guiding wire is pushed into load bearing component 62, load bearing component 62 is changed into first shape from the second shape again；
(6) radio frequency ablation catheter for renal artery is removed into human body.
Preferred embodiment of the invention described in detail above.It should be appreciated that one of ordinary skill in the art without
Need creative work just can make many modifications and variations with design of the invention.Therefore, it is all in the art
Technical staff under this invention's idea on the basis of existing technology can by logical analysis, reasoning, or a limited experiment
With the technical scheme for obtaining, all should be in the protection domain being defined in the patent claims.
Claims (10)
1. a kind of radio frequency ablation catheter for renal artery, including for adjusting the adjusting part of nerve, it is characterised in that
The adjusting part includes electrode and the load bearing component for carrying the electrode, and the electrode is used to that energy will to be adjusted
Amount is delivered to the nerve, and the electrode includes the wire electrode being wrapped on the load bearing component, the load bearing component
With first shape and the second shape, under the first shape, the adjusting part is arranged to be suitable in the blood vessel
It is mobile；Under second shape, the electrode is in and is adapted to the regulation energy transmission to the position of the nerve.
2. radio frequency ablation catheter for renal artery as claimed in claim 1, it is characterised in that the electrode is by institute
State the continuous electrode that wire electrode is closely wound.
3. radio frequency ablation catheter for renal artery as claimed in claim 1, it is characterised in that the electrode is by institute
State wire electrode and be wound in multigroup packet electrode, the wire electrode in every group of electrode is to be closely wound.
4. a kind of radio frequency ablation catheter for renal artery, including for adjusting the adjusting part of nerve and for by the tune
Section component be transported to it is described nerve position transfer unit, it is characterised in that the adjusting part include electrode and
Load bearing component for carrying the electrode, the electrode is used to adjust energy transmission to the nerve, the electricity
Pole includes the wire electrode being wrapped on the load bearing component, and the load bearing component has first shape and the second shape,
Under the first shape, the adjusting part is arranged to be suitable to move in the blood vessel；Under second shape, institute
State electrode and be in and be adapted to the regulation energy transmission to the position of the nerve；
The arteria renalis ablation catheter also includes sheath, and the sheath is coated at the transfer unit, and the sheath makes institute
Stating load bearing component can switch between the first shape and second shape.
5. radio frequency ablation catheter for renal artery as claimed in claim 4, it is characterised in that the sheath is in control machine
Can be slided along the transfer unit under the control of structure, be coated at when controlling the sheath to be slid into along the transfer unit
During the adjusting part, the load bearing component switches to the first shape by second shape, then controls described
When sheath slides into the disengaging adjusting part along the transfer unit, the load bearing component is switched by the first shape
It is second shape.
6. radio frequency ablation catheter for renal artery as claimed in claim 4, it is characterised in that the sheath includes internal layer
And outer layer, the material of the internal layer is PTFE, and wall thickness is 0.015~0.5mm, the outer layer be containing
20-40wt%BaSO4Pebax or TPU.
7. a kind of radio frequency ablation catheter for renal artery, including for adjusting the adjusting part of nerve and for by the tune
Section component be transported to it is described nerve position transfer unit, it is characterised in that the adjusting part include electrode and
Load bearing component for carrying the electrode, the electrode is used to adjust energy transmission to the nerve, the electricity
Pole includes the wire electrode being wrapped on the load bearing component, and the load bearing component has first shape and the second shape,
Under the first shape, the adjusting part is arranged to be suitable to move in the blood vessel；Under second shape, institute
State electrode and be in and be adapted to the regulation energy transmission to the position of the nerve；
The inside of the inside of the load bearing component and the transfer unit is respectively provided with silk guide passage, inside the load bearing component
Silk guide passage and the transfer unit inside silk guide passage be one, the silk guide passage is easy to guiding wire
Mobile, the movement of the guiding wire can make the load bearing component between the first shape and second shape
Switching.
8. radio frequency ablation catheter for renal artery as claimed in claim 7, it is characterised in that the load bearing component it is remote
End has hole, and the guiding wire can enter the silk guide passage by the hole；It is provided with the transfer unit
Opening, the opening connects with the silk guide passage, described to be open for the guiding wire from the silk guide passage
Pass.
9. radio frequency ablation catheter for renal artery as claimed in claim 8, it is characterised in that when the guiding wire from
When the silk guide passage of the load bearing component is inserted in the hole of the distal end of the load bearing component, the load bearing component by
Second shape switches to the first shape；When the opening of the guiding wire from the transfer unit is worn
When going out and detaching the load bearing component, the load bearing component switches to second shape by the first shape.
10. radio frequency ablation catheter for renal artery as claimed in claim 1, it is characterised in that the first shape is straight
Or it is approximate straight, described second is shaped as spirality or approximate spiral.
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| CN201510902263.6A CN106852703A (en) | 2015-12-08 | 2015-12-08 | A kind of radio frequency ablation catheter for renal artery |
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| CN201510902263.6A CN106852703A (en) | 2015-12-08 | 2015-12-08 | A kind of radio frequency ablation catheter for renal artery |
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| CN109223171A (en) * | 2017-07-10 | 2019-01-18 | 上海安通医疗科技有限公司 | It is a kind of for adjust nerve conduit device |
| CN111772783A (en) * | 2020-08-21 | 2020-10-16 | 白龙腾 | Ablation system with bendable electrodes |
| CN113633373A (en) * | 2021-08-02 | 2021-11-12 | 上海安通医疗科技有限公司 | Radial artery puncture ablation catheter |
| CN114711955A (en) * | 2022-05-11 | 2022-07-08 | 上海安通医疗科技有限公司 | Electric control ablation catheter for radial artery |
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