CN107028651A - A kind of multi-electrode radio frequency ablation catheter for renal artery - Google Patents
A kind of multi-electrode radio frequency ablation catheter for renal artery Download PDFInfo
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- CN107028651A CN107028651A CN201610290782.6A CN201610290782A CN107028651A CN 107028651 A CN107028651 A CN 107028651A CN 201610290782 A CN201610290782 A CN 201610290782A CN 107028651 A CN107028651 A CN 107028651A
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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
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
-
- 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
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00404—Blood vessels other than those in or around the heart
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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
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00505—Urinary tract
- A61B2018/00511—Kidney
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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
- A61B18/1206—Generators therefor
- A61B2018/1246—Generators therefor characterised by the output polarity
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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
-
- 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
- A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
Abstract
The invention discloses a kind of multi-electrode arteria renalis ablation catheter, including for adjusting the adjusting part of nerve, the transfer unit for adjusting part to be transported to neural position, sheath.Adjusting part includes being used for energy transmission is adjusted to the multiple electrodes of nerve and the load bearing component for carrying multiple electrodes；Load bearing component has first shape and the second shape, under first shape, and adjusting part is suitable to move in the blood vessel；Under the second shape, at least one electrode, which is in, is adapted to adjust energy transmission to the position of nerve.Sheath is coated at transfer unit, can be slided along transfer unit and be coated at or depart from adjusting part.The multi-electrode arteria renalis ablation catheter of the present invention is internally provided with silk guide passage, and the silk guide passage runs through whole multi-electrode arteria renalis ablation catheter.By the independent role of sheath or guiding wire or by sheath and the collective effect of guiding wire load bearing component can be made to switch between first shape and the second shape.
Description
Technical field
The present invention relates to electrosurgery, more particularly to a kind of multi-electrode 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 pathogenic 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 that the regulation (for example removing sympathetic nerve) to renal nerve can significantly be held
Lower intractable hypertension, the renal artery radiofrequency ablation art that such as latest developments go out long.Renal artery radiofrequency ablation art is
One kind is by sending electrode catheter intravascular into privileged site in the arteria renalis, and 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 method for removing arteria renalis sympathetic nerve.
In addition, the regulation to renal nerve is proved to have certain effect to a variety of 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, so as to cause the reduction of water and sodium 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 which, 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 having been reported that the related equipment for adjusting arteria renalis sympathetic nerve in pertinent literature or patent
Apparatus have operation inconvenience, cost of manufacture high or the defect such as inefficiency, such as electrode load bearing component can not provide foot
Enough big support forces, electrode load bearing component cutting part frictional force are larger etc..
Therefore, the present invention provides a kind of new multi-electrode 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 be to provide a kind of operation it is convenient,
Low manufacture cost, efficiency high be used for adjust renal nerve and treat the pipe guide of relevant disease.
To achieve the above object, the invention provides a kind of multi-electrode arteria renalis ablation catheter,
Including for adjusting the adjusting part of nerve and for the adjusting part to be transported into the defeated of the neural position
Send part；
The adjusting part includes being used for regulation energy transmission to the neural multiple electrodes and for carrying multiple institutes
State the load bearing component of electrode；
The load bearing component has first shape and the second shape, under the first shape, the adjusting part
Suitable for moving in the blood vessel；Under second shape, at least one described electrode, which is in, to be adapted to the regulation energy
It is delivered to the neural position；
Characterized in that, the multi-electrode arteria renalis ablation catheter also includes sheath；The sheath is coated at the conveying
Part, the sheath can be slided along the transfer unit and be coated at or depart from the adjusting part；
The multi-electrode arteria renalis ablation catheter is internally provided with silk guide passage, and the silk guide passage is through whole described
Multi-electrode arteria renalis ablation catheter, the silk guide passage is used for guiding wire in the multi-electrode arteria renalis ablation catheter
The internal axial movement along the multi-electrode arteria renalis ablation catheter；
The multi-electrode arteria renalis ablation catheter is configured as：Pass through the sheath or the independent role of the guiding wire
Or the load bearing component can be made in the first shape and institute by the sheath and the collective effect of the guiding wire
State switching between the second shape.
Further, the independent role of the sheath refers to when the sheath is slided along the transfer unit and is coated at institute
When stating adjusting part, the load bearing component switches to the first shape by second shape；When the sheath is along institute
When stating transfer unit and sliding and depart from the adjusting part, the load bearing component switches to described by the first shape
Two shapes.
Further, the silk guide passage is proximally and distally respectively provided with opening.
Further, the independent role of the guiding wire refers to when described in the guiding wire from the silk guide passage
The opening insertion silk guide passage of distal end and when entering the inside of the load bearing component, the load bearing component is by described the
Two shapes switch to the first shape；When the opening of the guiding wire from the near-end of the silk guide passage is passed
And when detaching the inside of the load bearing component, the load bearing component switches to second shape by the first shape.
Further, the sheath and the collective effect of the guiding wire refer to work as the sheath along the transfer unit
Slide and be coated at the adjusting part, while the guiding wire is inserted from the opening of the distal end of the silk guide passage
When entering the silk guide passage and entering the inside of the load bearing component, the load bearing component is switched to by second shape
The first shape；When the opening of the guiding wire from the near-end of the silk guide passage is passed and detaches described hold
Carry part, while when the sheath is slided along the transfer unit and departs from the adjusting part, the load bearing component by
The first shape switches to second shape.
Further, the load bearing component and the transfer unit are tubulose, and along the tubulose radial direction by introversion
It is outer to be followed successively by macromolecule layer, NiTi pipes, inner insulating layer and external insulation layer.
Further, the diameter of the macromolecule layer of the macromolecule layer of the load bearing component and the transfer unit is
0.40~0.55mm, thickness is 0.025~0.1mm.
Further, the macromolecule layer of the macromolecule layer of the load bearing component and the transfer unit is integrated, by height
Molecular material is formed.
Further, the high polymer material is PET, FEP, Pebax, PE or PTFE.
Further, the surface of the NiTi pipes of the load bearing component has cutting decorative pattern, and the cutting decorative pattern is by swashing
Light cuts the helix groove formed on the surface of the NiTi pipes of the load bearing component.
Further, when the load bearing component is in the first shape, projection of the helix groove in horizontal plane
Including multiple straight-line grooves and multiple near linear grooves.
Further, the multiple straight-line groove is located at the distal end of the load bearing component, and the multiple straight-line groove includes multiple
First straight line groove and multiple second straight line grooves.
Further, the spacing per the two neighboring first straight line groove is identical, between multiple first straight line grooves mutually
It is parallel.
Further, per the two neighboring second straight line groove spacing it is identical, multiple second straight line grooves each other it
Between it is parallel to each other.
Further, the axial angle of the first straight line groove and the load bearing component is 75 °~85 °, described second
The axial angle of straight-line groove and the load bearing component is 65 °~75 °, the near linear groove and the load bearing component
The angle of axial direction is 50 °~65 °, and the axial direction refers to when the load bearing component is in the first shape, from described
The near-end of load bearing component points to the direction of the distal end of the load bearing component.
Further, the multiple near linear groove is located at the near-end of the load bearing component, from the remote of the load bearing component
End is to near-end, and the spacing between the two neighboring near linear groove gradually increases, multiple near linear grooves
It is not parallel to each other each other.
Further, the inner insulating layer of the inner insulating layer of the load bearing component and the transfer unit is PET heat-shrink tubes,
Thickness after pyrocondensation is 0.012~0.05mm.
Further, the external insulation layer of the load bearing component is that TPU is managed or Pebax pipes, a diameter of 0.9~1.2mm,
Thickness is 0.05~0.15mm.
Further, the external insulation layer of the transfer unit is PET or FEP heat-shrink tubes, the thickness after pyrocondensation
0.012~0.1mm.
Further, the electrode sleeve and is added together in the outside of the outer insulation of the load bearing component by binding agent
It is strong fixed.
Further, the binding agent is UV solidification glues or epoxide-resin glue.
Further, the independent control release energy of multiple electrodes.
Further, multiple electrodes are while control release energy.
Further, the inner surface of each electrode is connected with wire, and the wire is used to provide institute for the electrode
Temperature and impedance when stating regulation energy and monitoring ablation.
Further, the wire is arranged between the external insulation layer of the load bearing component and inner insulating layer, and described
Extend between the external insulation layer and inner insulating layer of transfer unit.
Further, the wire passes through soldering through the external insulation layer of the load bearing component and the inner surface of the electrode
Or be laser welded.
Further, the first shape of the load bearing component is straight or approximate straight.
Further, described the second of the load bearing component is shaped as spiral shape or approximate spiral.
Further, a diameter of 4~12mm of the spiral shape or the approximate spiral, pitch are 3~10mm.
Further, the load bearing component is immunity, and is pretreated as with the first shape.
Further, the cross section of the electrode is annular.
Further, the number of the electrode is 2~6, when the load bearing component is in second shape, phase
The distance between adjacent described electrode is 4~12mm.
Further, the electrode uses platinumiridio material or gold material.
Further, the multi-electrode arteria renalis ablation catheter also include for grip handle, the handle with it is described
The near-end connection of transfer unit, the distal end of the handle is connected with the near-end of the transfer unit.
Further, controlling organization is provided with the handle, the controlling organization is used for the movement for controlling the sheath.
Further, the controlling organization includes termination, tooth block and gear, and the termination is located at the distal end of the handle
And be connected with the sheath, the tooth block is connected with the termination, the gear and the tooth Block- matching；Rotate described
Gear can make termination described in the tooth block push-and-pull, so that sheath described in the termination push-and-pull is moved along the transfer unit.
Further, the load bearing component and the transfer unit are integral.
Further, the near-end of the load bearing component is connected with the distal end of the transfer unit.
Further, the internal diameter of the sheath is 1.2~1.45mm, and external diameter is 1.3~1.55mm.
Further, the sheath includes internal layer and outer layer.
Further, the material of the internal layer is PTFE, and wall thickness is 0.015~0.5mm.
Further, the outer layer is Pebax or TPU, in the Pebax or TPU containing 20wt%~
40wt%BaSO4Or 10wt%~30wt% BiOCl.
Further, except as noted layer outside 1~5mm of distalmost end of sheath part, the outer layer its
Remaining part point has braiding webmaster.
Further, the braiding webmaster includes the first braided wires section, the second braided wires section and the 3rd braided wires section.
Further, the establishment silk of the first braided wires section, second braided wires section and the 3rd braided wires section
For stainless steel wire or NiTi.
Further, the braided wires of the first braided wires section, second braided wires section and the 3rd braided wires section
Form of presentation it is different, hardness of the sheath close to 10~20cm of distal end of handle part is more than the sheath
The hardness of the other parts of pipe.
Further, the hardness of the distal end of the sheath has transition from small to large, is easy to the multi-electrode arteria renalis
Ablation catheter enters arteria renalis precalculated position.
Further, the distal end of the load bearing component is provided with the guard block for vascular damaged to be reduced or avoided.
Further, the guard block is soft head.
Further, the soft head, which has, is used for the opening that the guiding wire inserts the load bearing component, the soft head
Opening for the silk guide passage distal end opening.
Further, the guard block is made up of rubber, silica gel or thermoplastic elastic material.
Further, described nerve is the renal sympathetic nerve on people's arteria renalis, and described is " close described neural
Position " refers to being located in the arteria renalis.
Further, the regulation refers to remove or reduce the neural activation by way of damage or non-damaging.
Further, described energy is one in radio frequency, heat, cooling, electromagnetic energy, ultrasonic wave, microwave or luminous energy
Plant or several.
Further, the described blood vessel behaviour arteria renalis.
Further, described " being adapted to move in the blood vessel " is referred to when the adjusting part is moved in the blood vessel,
The adjusting part not injured blood vessel wall.
Further, described " being adapted to move in the blood vessel " refers to radial direction of the adjusting part in the blood vessel
On full-size be not more than the internal diameter of the blood vessel.
Further, described " being adapted to move in the blood vessel " refers to radial direction of the adjusting part in the blood vessel
On full-size be not more than 3mm.
Further, described " being adapted to move in the blood vessel " refers to be easy to by vascular bending section.
Further, described " being adapted to the regulation energy transmission to the position of the renal nerve " refers to working as institute
When stating regulating member in the blood vessel, at least one electrode is in the position of contact vascular wall.
Further, described " being adapted to the regulation energy transmission to the position of the renal nerve " refers to described
Adjusting part is 4-12mm in the full-size radially of the blood vessel, and at least one electrode is at full-size.
Compared with existing pipe guide, multi-electrode radio frequency ablation catheter for renal artery of the invention has advantages below：
(1) present invention is provided with silk guide passage, and the distal end of load bearing component is that catheter proximal end has opening, is led when using
Guide wire can enter silk guide passage by the opening, and operation facility meets the use habit of doctor.
(2) by designing unique cutting decorative pattern, and coated insulation layer, load bearing component is made to be in the second shape (spiral
Shape or approximate spiral) when sufficiently large radial support power can be provided, so as to preferably press close to vascular wall.
(3) during use, guiding wire and sheath can collective effect, that is, set after sheath, can accurately control
Guiding wire processed is moved in silk guide passage, so as to straighten the spiral with sufficiently large radial support power.
(4) inwall of load bearing component and transmission assembly is provided with macromolecule layer, so as to avoid having cutting decorative pattern
NiTi pipes the problem of can wipe guiding wire face coat off.
(5) each electrode is individually controlled, and the working condition of any one electrode is not influenceed by other electrodes, medical matters
Personnel can select one, part or all of electrode release regulation energy according to actual needs.It is provided by the present invention
Device for adjusting nerve operates facility, multiple neural sites can be adjusted or to some neural positions simultaneously
Point carries out selective control, so as to improve operating efficiency, and further improves the degree of accuracy for the treatment of, and in some electricity
In the case of the failure of pole, medical worker can flexibly select working electrode, and the place of equipment chance failure is have submitted significantly
Reason ability, ensures being normally carried out for operation, with important clinical meaning.
In the present invention, the abbreviation used：
PTFE refers to polytetrafluoroethylene (PTFE), i.e. Polytetrafluoroethylene；
PE refers to polyethylene, i.e. Polyethylene；
FEP refers to fluorinated ethylene propylene copolymer, i.e. Fluorinated ethylene propylene；
TPU refers to TPUE, i.e. Thermoplastic polyurethanes；
PET refers to polyethylene terephthalate, i.e. Polyethylene terephthalate；
The performance of Atochem (FR) Cedex 22, 94091 Paris La Defense, France of Pebax fingering state (ATO Chimie) development is between synthetic rubber and thermoplastic poly
Polyether block phthalein amine elastomer between ammonia vinegar, its trade mark is referred to as Pebax.
For convenience of description, by close the user (or handle) of device or part or away from needing to adjust in the present invention
The one end in neural site be referred to as " distal end ", by the remote user (or handle) of device or part or close to needing to adjust
The one end in the neural site of section is referred to as " near-end ".
The technique effect of the design of the present invention, concrete structure and generation is described further below with reference to accompanying drawing, with
It is fully understood from the purpose of the present invention, feature and effect.
Brief description of the drawings
Fig. 1 is people's kidney and the structural representation of linked groups；
Fig. 2 is the structural representation of people's arteria renalis；
Fig. 3 is a kind of part of the embodiment for the multi-electrode radio frequency ablation catheter for renal artery that the present invention is provided
Schematic diagram, the figure shows the first shape of load bearing component；
Fig. 4 is the schematic diagram of another state of the multi-electrode radio frequency ablation catheter for renal artery shown in Fig. 3, and this is illustrated
Second shape of load bearing component；
Fig. 5 cuts for a kind of load bearing component of embodiment of the multi-electrode radio frequency ablation catheter for renal artery of the present invention
Face figure (is splitted) at electrode；
Fig. 6 is a kind of cutting for the load bearing component of embodiment of the multi-electrode radio frequency ablation catheter for renal artery of the present invention
Cut perspective view of the decorative pattern in horizontal plane；
Fig. 7 is a kind of decomposition of the handle of embodiment of the multi-electrode radio frequency ablation catheter for renal artery of the present invention
Figure；
Fig. 8 is a kind of partial cutaway of the sheath of embodiment of the multi-electrode radio frequency ablation catheter for renal artery of the present invention
Face figure；
Fig. 9 is the part of the sheath of another embodiment of the multi-electrode radio frequency ablation catheter for renal artery of the present invention
Profile.
Embodiment
Fig. 1~Fig. 4 shows one kind of multi-electrode radio frequency ablation catheter for renal artery provided by the present invention and its application method
Preferred embodiment, exemplified by the embodiment is for regulation people's renal nerve.
Fig. 1~Fig. 2 shows linked groups and the structure of people's kidney.As shown in figure 1, Ren Shen linked groups are anatomically
Including kidney K, kidney K is supplied to oxygen containing blood by arteria renalis RA.Arteria renalis RA via belly aortic artery AA
It is connected to heart.The blood of deoxidation flows to heart via renal vein RV and inferior caval vein IVC from kidney.Fig. 2 is more detailed
Ground illustrates the anatomical part of kidney.More specifically, kidney anatomy also includes indulging along arteria renalis RA axial L
To the renal nerve RN of extension.Renal nerve RN is general in the outer membrane of the artery.In this specific embodiment, institute
The device of offer is used to adjust the renal nerve RN being located on arteria renalis RA, and described regulation refers to by damage or non-damage
The mode of wound removes or reduced renal nerve RN activation.As the change of the embodiment, 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 more enter
One step improve nerve activation), those skilled in the art can according to the present invention make can rational expectation, need not pay
The adjustment of all creative works.
Fig. 3 and Fig. 4 show the part of the multi-electrode radio frequency ablation catheter for renal artery in the embodiment.
As shown in Fig. 3~Fig. 4, the conduit includes the adjusting part 100 for adjusting nerve and conveys adjusting part 100
To the transfer unit 201 of the position of nerve.Adjusting part 100 includes the electrode 101 that will adjust energy transmission to renal nerve
And for carrying the load bearing component 102 of electrode 101.Load bearing component 102 has first shape (referring to Fig. 3) and the
Two shapes (referring to Fig. 4), under first shape, adjusting part 100 is used to move in the blood vessel；Under the second shape,
At least one electrode 101 is in regulation energy transmission to the position of renal nerve.In the present embodiment, load bearing component 102
It is integral with transfer unit 201, the near-end of load bearing component 102 is connected with the distal end of transfer unit 201.
In the present embodiment, the transmission regulation energy of electrode 101 is to the mode in the renal nerve site for needing to adjust：Via blood
Pipe enters human body, by arteria renalis inwall close to neural site.Therefore the technical issues that need to address are：It should realize
Electrode 101 can be close to the nerve that blood vessel acts on relevant position, and electrode 101 is needed again in the blood vessel easily
Move, not injured blood vessel wall.
The multi-electrode arteria renalis ablation catheter of the present embodiment also includes sheath 301 and silk guide passage 500 (referring to Fig. 5).
Sheath 301 is coated at transfer unit 201, and the internal diameter of sheath 301 is 1.2~1.45mm, and external diameter is 1.3~1.55mm,
Sheath 301 can be slided along transfer unit 201 and be coated at or depart from the adjusting part 100.Silk guide passage 500
The inside of the multi-electrode arteria renalis ablation catheter of the present embodiment is arranged on, and through whole multi-electrode arteria renalis ablation catheter,
There is a part for silk guide passage 500 in the inside of the inside of load bearing component 102 and transfer unit 201.Seal wire leads to
Road 500 is used for axial direction of the guiding wire in the inside of multi-electrode arteria renalis ablation catheter along multi-electrode arteria renalis ablation catheter
It is mobile.Silk guide passage 500 is proximally and distally respectively provided with opening (referring to Fig. 1).The distal end of silk guide passage 500 is opened
Mouth 106 is used for the inside that guiding wire penetrates multi-electrode arteria renalis ablation catheter, is exactly to penetrate load bearing component 102
Inside, the opening of the near-end of silk guide passage 500 passes for guiding wire from multi-electrode arteria renalis ablation catheter.
The distal end of load bearing component 102 is provided with the guard block 105 for vascular damaged to be reduced or avoided.Protection portion
One effect of part 105 is that vascular damaged is reduced or avoided, when touching vascular wall because itself it is sufficiently flexible and
Can resilience rapidly, blood vessel will not be caused damage；Another effect of guard block 105 is to whole pipe guide
Guide effect is played, when running into the bending place of blood vessel, itself can bend according to the bending degree of blood vessel, so as to guide
Whole conduit passes through the bending place of blood vessel.In the present embodiment, guard block 105 is soft head, by rubber, silica gel
Or thermoplastic elastic material is made.The soft head, which has, is used for the opening that guiding wire inserts load bearing component, and the opening is
For the opening 106 of the distal end of silk guide passage 500.
Load bearing component 102 and transfer unit 201 are tubulose, and are followed successively by high score from inside to outside along the radial direction of the tubulose
Sublayer, NiTi pipes, inner insulating layer and external insulation layer.Fig. 5 shows the profile of load bearing component 102, the profile
To be splitted at electrode 101, as seen from Figure 5, macromolecule is followed successively by from inside to outside along the radial direction of load bearing component 102
Layer 504, NiTi pipes 503, inner insulating layer 501 and external insulation layer 502.The He of macromolecule layer 504 of load bearing component 102
The macromolecule layer (not shown) of transfer unit 201 is integral, and diameter is 0.40~0.55mm, and thickness is
0.025~0.1mm, is formed by high polymer material, high polymer material can for PET, FEP, Pebax, PE or
PTFE。
Load bearing component 102 is pretreated as with the second shape for immunity, in order that load bearing component 102 is in
There is sufficiently large radial support power, the surface of the NiTi pipes 503 of load bearing component 102 is cut by laser during the second shape
It is helix groove to cut the cutting decorative pattern in cutting decorative pattern, the present embodiment is formed, and Fig. 6 shows the cutting decorative pattern in water
When being in first shape in the perspective view of plane, figure for load bearing component 102.Projection bag of the helix groove in horizontal plane
Multiple straight-line grooves or multiple near linear grooves 603 are included, multiple straight-line grooves are located at the distal end of load bearing component 102, Duo Gezhi
Wire casing includes multiple first straight line grooves 601 and multiple second straight line grooves 602.Per two neighboring first straight line groove 601
Spacing is identical, parallel to each other between multiple first straight line grooves 601；Spacing phase per two neighboring second straight line groove 602
Together, multiple second straight line grooves 602 are parallel to each other each other.Multiple near linear grooves 603 are located at load bearing component 102
Near-end, from the distal end of load bearing component 102 to near-end, the spacing between two neighboring near linear groove 603 is gradually
Increase, multiple near linear grooves 603 are not parallel to each other each other.First straight line groove 601 and load bearing component 102
The angle of axial direction is 75 °~85 °, and the axial angle of second straight line groove 602 and load bearing component 102 is 65 °~75 °, closely
It it is 50 °~65 ° like the axial angle of straight-line groove 603 and load bearing component 102, axial direction herein refers to work as load bearing component
102 when being in first shape, and the direction of the distal end of load bearing component 102 is pointed to from the near-end of load bearing component 102.
In the present embodiment, the inner insulating layer 501 of load bearing component 102 and the inner insulating layer (not shown) of transfer unit 201
It is PET heat-shrink tubes, the thickness after pyrocondensation is 0.012~0.05mm.The external insulation layer 502 of load bearing component 102 is
TPU is managed or Pebax pipes, and a diameter of 0.9~1.2mm, thickness is 0.05~0.15mm., transfer unit 201 it is outer
Insulating barrier (not shown) is PET or FEP heat-shrink tubes, 0.012~0.1mm of thickness after pyrocondensation.
In the present embodiment, electrode 101 is ring-type, and is linked in the outer surface of the external insulation layer 502 of load bearing component 102.
So, when load bearing component 102 is in the second shape (in the arteria renalis), the electrode 101 on load bearing component 102
Position (close to renal nerve) in contact arteria renalis inwall, just can so be adjusted work.In order that electrode
101 are fixedly mounted in the outer surface of the external insulation layer 502 of load bearing component 102, and reduce the damage to vascular wall as far as possible
Wound, can use glue that electrode 101 is bonded on the external insulation layer 502 of load bearing component 102.This kind of glue is optional
With UV solidification glues, epoxide-resin glue or its mixture, both with the biocompatibility of medical application can be reached, and it is right
Metal alloy and high polymer material have certain cohesive force.In addition, in the He of external insulation layer 502 of load bearing component 102
The temperature being provided between inner insulating layer 501 during for providing regulation energy and monitoring ablation for electrode 101 and impedance
Wire 505, wire 505 extends in the external insulation layer and inner insulating layer of transfer unit 201, in load bearing component 102
Wire 505 and transfer unit 201 in wire 505 be integral.Wire 505 passes through the outer of load bearing component 102
Insulating barrier 502 and electrode 101 inner surface is by soldering or is laser welded.The external insulation of load bearing component 102
Layer 502 has opening (not shown) in the position that electrode 101 adheres to, and is connected to energy generation apparatus (such as radio frequency
Instrument) wire 505 weld together through the opening and the inner surface of electrode 101.By the way that wire 505 is arranged on
It can be avoided to insulate and wire must be arranged on to the outer surface of transfer unit and cause conveying in external insulation layer 502
The rough technology drawback in outer surface of part, causes so as to avoid because the outer surface of transfer unit is uneven
Problems., it is necessary to set many multiple electrodes 101 are connected into energy respectively when with multiple electrodes 101
Produce the wire 505 of equipment.Each electrode 101 works independently, respectively with single wire 505.One electrode
Whether release adjusts energy, unrelated with other electrodes；Can only have one or partial electrode transmission regulation energy, also may be used
Worked simultaneously with all electrodes, transmission regulation energy；The state whether each electrode transmits regulation energy is independent of one another
's.The element (for example, thermocouple) of measurement temperature is may be provided on load bearing component 102 and is led accordingly
The conventional arrangement for being arranged as this area of line, wire and thermocouple, I will not elaborate.
In the present embodiment, the first shape of load bearing component 102 is straight or approximate straight or elongate or fibre
Shape or thread is tieed up, the cross section of the bar shaped is preferably circular or approximate circle, the widest part of cross section is less than the interior of blood vessel
Diameter.So, under first shape, when adjusting part 100 is moved in the blood vessel, adjusting part 100 will not be damaged
Blood trouble tube wall.When needing that the nerve on the arteria renalis is adjusted, because the interior diameter of people's arteria renalis is generally 4-7
Mm, therefore, adjusting part 100 are not more than 4mm in the full-size radially of the arteria renalis, it is preferably provided as 1-2
Mm, can both meet and be moved easily in the blood vessels, have enough rigidity again and be easy to make, it is possible to reduce and suffer from
The size of the wound of person.As the change of the embodiment, first shape can also allow certain bending or
Corrugated bending, its cross section can also be other shapes, can easily in the blood vessels as long as its surface is smooth
Movement is without injured blood vessel wall.
In the present embodiment, the second shape generally spiral shape or approximate spiral of load bearing component 102, in the footpath of blood vessel
Upwards, the widest part of load bearing component 102 is bigger than first shape, and the electrode 101 of carrying can so come close to or in contact with
Vascular wall, so that close to renal nerve.
There is certain elasticity in view of blood vessel, the spiral shape of load bearing component 102 or the diameter of approximate spiral are set to
4~12mm, pitch are 3~10mm.For the less individual of arteria renalis internal diameter, such as internal diameter is 4mm or so, can
So that the diameter of the spiral shape of load bearing component 102 or approximate spiral is set into 5~6mm or so；For in the arteria renalis
The larger individual in footpath, such as internal diameter are 7mm or so, can be set to the diameter of spiral shape or approximate spiral
8~9mm or so.
Second shape of load bearing component 102 can also be other shapes, such as irregular shape with round and smooth bending,
As long as when the load bearing component 102 in the blood vessel when, electrode 101 be in contact vascular wall position.
The multi-electrode radio frequency ablation catheter for renal artery of the present embodiment makes to hold by the collective effect of sheath 301 and guiding wire
Carry part 102 between first shape and the second shape to switch, i.e., when sheath 301 is slided along transfer unit 201 and outer
Adjusting part 100 is placed on, while guiding wire inserts silk guide passage 500 from the opening 106 of the distal end of silk guide passage 500
And when entering the inside of load bearing component 102, load bearing component 102 switches to first shape by the second shape；When guiding is led
Silk passes from the opening 107 of the near-end of silk guide passage 500 and detaches the inside of load bearing component 102, while sheath 301
When being slided along transfer unit 201 and departing from the adjusting part 100, load bearing component 102 switches to by first shape
Two shapes.
In other embodiments, for the less situation of radial support power of load bearing component 102, sheath 301 can be passed through
Or the independent role of guiding wire realizes switching of the load bearing component 102 between first shape and the second shape.Sheath 301
Independent role refer to when sheath 301 is slided along transfer unit 201 and is coated at adjusting part 100, load bearing component
102 switch to first shape by the second shape；When sheath 301 is slided along transfer unit 201 and departs from adjusting part 100
When, load bearing component 102 switches to second shape by first shape.The independent role of guiding wire refers to when guiding
Seal wire inserts silk guide passage 500 from the opening 106 of the distal end from silk guide passage 500 and enters load bearing component 102
When internal, load bearing component 102 switches to first shape by the second shape；When guiding wire is from the near of silk guide passage 500
When the opening 107 at end passes and detaches the inside of load bearing component 102, load bearing component 102 switches to by first shape
Two shapes.
The course of work of multi-electrode radio frequency ablation catheter for renal artery is as follows in the present embodiment：
(1) first guiding wire is imported at the renal sympathetic nerve on human body predetermined position, i.e. people's arteria renalis；
(2) sheath 301 is coated at adjusting part 100, guiding wire is then inserted into load bearing component 102 from the first hole
And passed from the second hole so that load bearing component 102 becomes first shape by preformed second shape, is easy in blood vessel
Middle movement；
(3) at the renal sympathetic nerve on mobile multi-electrode radio frequency ablation catheter for renal artery to the human body arteria renalis；
(4) guiding wire is detached into load bearing component 102, and sheath 301 is departed from into adjusting part 100, load bearing component
102 become the second shape by first shape, now, and the electrode 101 on load bearing component 102 is close to blood vessel effect
Nerve in relevant position, releasing energy certain energy and acts on the neural site, so as to play the regulation nerve
The effect in site (for example, reduction or activation of elimination sympathetic nerve)；
(5) sheath 301 is coated at adjusting part 100, guiding wire is then pushed into load bearing component 102, carrying
Part 102 is changed into first shape from the second shape again；
(6) multi-electrode radio frequency ablation catheter for renal artery is removed into human body.
Electrode 101 can realize the purpose by transferring heat to the neural site.For example, for nerve modulation
Heat transfer heating mechanism can include the thermal change or damage of heating ablation and non-ablation, for example, can be by target nerve fibre
Threshold value needed for temperature is increased to over is to realize the thermal change of non-ablation, or more than higher temperature to realize the thermal change of ablation.
For example, target temperature can about 37 DEG C -45 DEG C the thermal change temperature of non-thermal ablation (are used for), or, the target temperature
Can be at about 45 DEG C or higher, for the thermal change of ablation.
Electrode 101 can also realize the purpose by the way that cooling is delivered into the neural site.For example, target nerve is fine
The temperature of dimension is reduced to less than the about 20 DEG C thermal changes to realize non-frozen, or the temperature of target nerve fibre is reduced to about
Less than the 0 DEG C thermal change to realize freezing.
Electrode 101 can also be realized by the way that energy field is applied into target nerve fibre.The energy field can include：Electricity
Magnetic energy, radio frequency, ultrasonic wave (including high-intensity focusing ultrasonic wave), microwave, luminous energy (including laser, infrared ray and near
Infrared ray) etc..For example, the nerve modulation of thermal induction can be by being delivered to target god by pulse or continuous heat energy field
Realized through fiber.Wherein, one kind is pulse radiation frequency electric field or other types of pulse heat than more preferably energy mode
Energy.Pulse radiation frequency electric field or other types of pulse heat energy can facilitate bigger heat level, longer total when continuing
Between and/or preferably controlled intravascular renal nerve modulation treatment.
No matter the purpose of nerve is adjusted by the way which kind of energy mode is realized, when user uses conduit provided by the present invention
When being operated, electrode 101 is needed with producing the energy (such as radiofrequency generator) or electrode 101 is produced this in itself
The equipment of amount is electrically connected.These equipment and electrode and the connection of these equipment are well known to those skilled in the art
Prior art (for example, be provided in apparatus of the present invention connect these equipment interface, can be realized i.e. when using
Plug-and-play), no longer narration in detail here.
In the present embodiment, the number of electrode 101 is 4.When load bearing component 102 is in the second shape (helical form)
When, adjacent electrode 101 is convenient for 4~12mm ratios apart from D in the axial direction of blood vessel.It is, in general, that carrying out
During renal nerve ablative surgery, 3-8 site of renal nerve is melted.Therefore, using in the embodiment
Device when being operated, the positioning (making electrode 101 contact blood vessel) of Primary regulation component 100 can complete 4
The ablation in individual site, and complete the positioning that whole ablative surgery only needs to carry out adjusting part 100 twice.As
The change of the embodiment, the number of electrode 101 are it can also be provided that 2~6, but if number is more, meeting
Increase the cost of manufacture of whole device；If number is less, it is possible to decrease the operating efficiency of ablative surgery.Electrode 101
Material can be using the preferable or more stable metal or metal alloy of biocompatibility, such as platinum group metal (such as platinoiridita conjunction
Gold).
The guiding wire of the present embodiment is wire, is made up of NiTi alloys.
The multi-electrode radio frequency ablation catheter for renal artery of the present embodiment also includes the handle 401 for gripping, the handle 401
Distal end be connected with the near-end of transfer unit 201 (referring to Fig. 3).Wire 505 is in load bearing component 102 and transfer unit
It is connected after extending in 201 with handle 401.The connection cable of handle 401 and external energy generator set be integrated or
The independent two parts connected by conversion port.The movement of the sheath 301 of the present embodiment is by being arranged in handle 401
Controlling organization 7 control, referring to Fig. 3 and Fig. 7, controlling organization 7 includes termination 701, tooth block 702 and gear 703,
Termination 701 is located at the distal end of handle 401 and is connected with sheath 301, and tooth block 702 is connected with termination 701, gear 703
Matched with tooth block 702；Rotate gear 703 can make the push-and-pull termination 701 of tooth block 702, so that the push-and-pull sheath of termination 701
Pipe 301 is moved along transfer unit 201.
The material of sheath 301 is high polymer material, and such as Pebax or TPU, the material than load bearing component 102 are slightly hard, hardness
For 50A-50D.Sheath 301 includes internal layer 302 and outer layer 303, as shown in figure 8, the material of internal layer 302 is PTFE,
Wall thickness is 0.015-0.5mm, and coefficient of friction is smaller, is mainly risen when sheath 301 is relative relative to load bearing component 102 to be slided
To smooth effect.The material of outer layer 303 is Pebax or TPU, can contain 20wt%~40wt%BaSO4Or 10wt%
~30wt% BiOCl.
In addition to outer layer is apart from 1~5mm of distalmost end of sheath 301 part, the remainder of outer layer has braiding webmaster,
As shown in figure 9, braiding webmaster includes the first braided wires the 313, second braided wires of section section 323 and the 3rd braided wires section 333；
The braided wires of first braided wires the 313, second braided wires of section section 323 and the 3rd braided wires section 333 are stainless steel wire or Ni-Ti
Silk.First braided wires the 313, second braided wires of section section 323 and the 3rd braided wires 333 different hardness of section can be by identical
Weaving manner and each where the outer layer in Pebax different hardness realize, can also pass through identical
Pebax hardness and different weaving manners are realized.In the present embodiment, the first braided wires section the 313, second braided wires section
323 is different with the form of presentation of the braided wires of the 3rd braided wires section 333, make sheath 301 close to the distal end 10~20 of 401 handles
The hardness of cm part is more than the hardness of the other parts of sheath 301.The hardness of the distal end of sheath 301 has from small to large
Transition, be easy to the present embodiment multi-electrode arteria renalis ablation catheter enter arteria renalis precalculated position.
Preferred embodiment of the invention described in detail above.It should be appreciated that one of ordinary skill in the art without
Need creative work just can make many modifications and variations according to the design of the present 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
, all should be in the protection domain being defined in the patent claims with obtained technical scheme.
Claims (10)
1. a kind of multi-electrode arteria renalis ablation catheter, including for adjusting the adjusting part of nerve and for by the regulation
Component is transported to the transfer unit of the neural position；
The adjusting part includes being used for regulation energy transmission to the neural multiple electrodes and for carrying multiple institutes
State the load bearing component of electrode；
The load bearing component has first shape and the second shape, under the first shape, the adjusting part
Suitable for moving in the blood vessel；Under second shape, at least one described electrode, which is in, to be adapted to the regulation energy
It is delivered to the neural position；
Characterized in that, the multi-electrode arteria renalis ablation catheter also includes sheath；The sheath is coated at the conveying
Part, the sheath can be slided along the transfer unit and be coated at or depart from the adjusting part；
The multi-electrode arteria renalis ablation catheter is internally provided with silk guide passage, and the silk guide passage is through whole described
Multi-electrode arteria renalis ablation catheter, the silk guide passage is used for guiding wire in the multi-electrode arteria renalis ablation catheter
The internal axial movement along the multi-electrode arteria renalis ablation catheter；
The multi-electrode arteria renalis ablation catheter is configured as：Pass through the sheath or the independent role of the guiding wire
Or the load bearing component can be made in the first shape and institute by the sheath and the collective effect of the guiding wire
State switching between the second shape.
2. multi-electrode arteria renalis ablation catheter as claimed in claim 1, it is characterised in that the independent work of the sheath
With referring to that the load bearing component is by institute when the sheath is slided along the transfer unit and is coated at the adjusting part
State the second shape and switch to the first shape；When the sheath is slided along the transfer unit and departs from the regulation group
During part, the load bearing component switches to second shape by the first shape.
3. multi-electrode arteria renalis ablation catheter as claimed in claim 1, it is characterised in that the silk guide passage it is near
End and distal end are respectively provided with opening.
4. multi-electrode arteria renalis ablation catheter as claimed in claim 3, it is characterised in that the list of the guiding wire
Solely effect refers to when the guiding wire inserts the silk guide passage from the opening of the distal end of the silk guide passage and enters
When entering the inside of the load bearing component, the load bearing component switches to the first shape by second shape；Work as institute
When stating guiding wire and being passed from the opening of the near-end of the silk guide passage and detach the inside of the load bearing component, institute
State load bearing component and second shape is switched to by the first shape.
5. multi-electrode arteria renalis ablation catheter as claimed in claim 3, it is characterised in that the sheath and described lead
The collective effect of guide wire refers to when the sheath is slided along the transfer unit and is coated at the adjusting part, simultaneously
The guiding wire inserts the silk guide passage from the opening of the distal end of the silk guide passage and enters the supporting part
During the inside of part, the load bearing component switches to the first shape by second shape；When the guiding wire from
The opening of the near-end of the silk guide passage passes and detaches the load bearing component, while the sheath is along the conveying
When part slides and departs from the adjusting part, the load bearing component switches to second shape by the first shape.
6. multi-electrode arteria renalis ablation catheter as claimed in claim 1, it is characterised in that the load bearing component and institute
It is tubulose to state transfer unit, and along the tubulose radial direction be followed successively by from inside to outside macromolecule layer, NiTi pipe, it is interior absolutely
Edge layer and external insulation layer.
7. multi-electrode arteria renalis ablation catheter as claimed in claim 6, it is characterised in that the height of the load bearing component
The diameter of the macromolecule layer of molecular layer and the transfer unit is 0.40~0.55mm, and thickness is 0.025~0.1mm.
8. multi-electrode arteria renalis ablation catheter as claimed in claim 6, it is characterised in that the height of the load bearing component
What the macromolecule layer of molecular layer and the transfer unit was integrated, formed by high polymer material.
9. multi-electrode arteria renalis ablation catheter as claimed in claim 8, it is characterised in that the high polymer material is
PET, FEP, Pebax, PE or PTFE.
10. multi-electrode arteria renalis ablation catheter as claimed in claim 6, it is characterised in that the load bearing component
The surface of NiTi pipes has cutting decorative pattern, and the cutting decorative pattern is by being cut by laser the NiTi in the load bearing component
The helix groove that the surface of pipe is formed.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNPCT/CN2016/073478 | 2016-02-04 | ||
| PCT/CN2016/073478 WO2017132935A1 (en) | 2016-02-04 | 2016-02-04 | Multi-electrode renal artery ablation catheter |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107028651A true CN107028651A (en) | 2017-08-11 |
Family
ID=58147894
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|---|---|---|---|
| CN201620395595.XU Active CN205814415U (en) | 2016-02-04 | 2016-05-04 | A kind of multi-electrode radio frequency ablation catheter for renal artery |
| CN201610290782.6A Pending CN107028651A (en) | 2016-02-04 | 2016-05-04 | A kind of multi-electrode radio frequency ablation catheter for renal artery |
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| CN201620395595.XU Active CN205814415U (en) | 2016-02-04 | 2016-05-04 | A kind of multi-electrode radio frequency ablation catheter for renal artery |
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| CN (2) | CN205814415U (en) |
| WO (1) | WO2017132935A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022143988A1 (en) * | 2020-12-31 | 2022-07-07 | 杭州德诺电生理医疗科技有限公司 | Ablation device and ablation system |
| CN115721401A (en) * | 2022-11-16 | 2023-03-03 | 上海玮启医疗器械有限公司 | Pulse ablation catheter capable of taking straight annular ring |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017132935A1 (en) * | 2016-02-04 | 2017-08-10 | 上海安通医疗科技有限公司 | Multi-electrode renal artery ablation catheter |
| GB2565113B (en) * | 2017-08-02 | 2022-06-15 | Gyrus Medical Ltd | Electrosurgical instrument |
| CN111317561A (en) * | 2018-12-14 | 2020-06-23 | 杭州普惠医疗器械有限公司 | Multi-sensing deep thermosetting electrode |
| CN113693717B (en) * | 2021-08-30 | 2023-12-05 | 上海安通医疗科技有限公司 | Radio frequency ablation catheter capable of being used for radial artery access |
| CN113729923B (en) * | 2021-09-30 | 2022-07-12 | 上海睿刀医疗科技有限公司 | Surface ablation electrode catheter and ablation equipment |
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| WO2017132935A1 (en) | 2017-08-10 |
| CN205814415U (en) | 2016-12-21 |
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