CN106725838A - Have the conduit and its ablation method of balloon expandable and RF ablation function concurrently - Google Patents
Have the conduit and its ablation method of balloon expandable and RF ablation function concurrently Download PDFInfo
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- CN106725838A CN106725838A CN201710077036.3A CN201710077036A CN106725838A CN 106725838 A CN106725838 A CN 106725838A CN 201710077036 A CN201710077036 A CN 201710077036A CN 106725838 A CN106725838 A CN 106725838A
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- sacculus
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- 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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- 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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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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- A61M25/104—Balloon catheters used for angioplasty
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- A61B2018/00422—Angioplasty
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Abstract
The invention discloses a kind of conduit and its ablation method for having balloon expandable and RF ablation function concurrently.The radio frequency ablation catheter is used to melt the hyperplastic tissue on tube wall or nerve, including:Positioned at the expandable balloon of catheter proximal end, positioned at the ablation part of sacculus outer wall or inside, while sacculus is progressively expanded, ablation part melts to hyperplastic tissue or nerve.With the ablation of radio frequency ablation catheter be combined with each other the dilating effect of expandable balloon by the radio frequency ablation catheter, accomplishes to be melted in expansion.
Description
Technical field
The present invention relates to a kind of conduit for having balloon expandable and RF ablation function concurrently, also relate to disappear using the radio frequency
Melt the ablation method of conduit, belong to interventional medical device technical field.
Background technology
Interventional medical device is an important branch of the medical apparatus industry grown up over nearly 10 years, related intervention
Treatment is a brand-new technology, and it has opened the new page of medical science and technology.PCI is by using a series of intervention apparatus
The Clinics and Practices carried out with material and modernization digital diagnosis and treat equipment are operated.Compared with traditional surgery, carry out intervention and control
Treat, without operating on, only need local anaesthesia, cut the osculum of 1~2mm, with bleeding it is few, wound is small, few intercurrent disease, safety can
By, post-operative recovery is fast the advantages of, significantly reduce the pain that patient is born, the operation difficulty of operator is reduced, during operation
Between and the hospital stays significantly shorten, expense is also substantially reduced.
It is most have generation with the Minimally Interventional Therapy for treating cardiovascular and cerebrovascular disease during interventional medical device industry development
One of technology of table, related intervention apparatus industry development is swift and violent, and this is mainly due to the master that cardiovascular and cerebrovascular disease is the mankind
Disease is wanted, fatal rate and disability rate are very high.Minimally Invasive Devices mainly include following several classes:(1) cardiovascular intervention apparatus:
Coronary artery bracket for eluting medicament, PTCA sacculus dilating catheters, guiding catheter, angiography catheter, guiding wire etc.;(2) cerebrovascular intervention
Apparatus:Carotid stents, vertebral artery stent, intracranial vessel support, microtubular, micro-wire, liquid embolism materials etc.;(3) periphery
Vascular interventional devices:Main artery overlay film frame, subclavian artery support and renal artery stent etc.;(4) electro physiology intervention apparatus:Penetrate
Frequency ablation catheter, mapping catheter.
In the prior art, sacculus dilating catheter is applied to the percutaneous transluminal angio plasty (PTA) of peripheral vascular system,
And suitable for treating the occluded lesions of autologous or artificial dialysis arteriovenous fistula.Sacculus dilating catheter applies also for peripheral blood piping
The rear expansion of balloon expandable stent or Self-expanded stent in system.By long-term experiment and clinical research, applicant has following
It is further discovered that:
1. hemadostewnosis lesion
Although hemadostewnosis can effectively open vessel lumen using balloon expandable treatment, it occur frequently that ISR,
Main cause is that balloon expandable can stimulate local vessel wall proliferation of smooth muscle, and various methods are employed at present to control balloon expandable
Reangiostenosis afterwards, such as interior radiation, medicinal balloon etc., but dilating sacculus+RF ablation combined synchronization pair is not used still
Narrow positions carries out the technology of PCI.
Clinical research is proved, on the basis of conventional balloon angioplasty vasculitis, carried out in the near-end of narrow positions
Nerve ablation, can greatly improve raising curative effect, not only can alleviate the pain of suffering limb with postoperative, and can keep blood vessel
Vascular surface nerve ablation long, to improve blood vessel it is long-term unobstructed with important value, thus it is speculated that be nerve ablation alleviate or solve
Except the vascular tone (spasm) of local vascular, but existing method is the then tissue ablation again using first balloon expandable,
Need two steps, two positions, two complete equipments.
2. tube chamber neoplastic lesion
Such as cholangiocarcinoma, cancer of the esophagus, intestinal cancer etc., it is difficult to adapt to the disease of tubulose using the ablating electrode pin of conventional needle-like long
Become, simple balloon dilatation and stenting treatment can quickly occur ISR due to the hyperplasia of tumour, prior art using interior radiation+
The method of support improves the unobstructed time of tube chamber, but still can not simultaneously carry out balloon expandable and tube wall tissue's (tube wall
Nerve) ablation RF ablation equipment.
3. spastic lesion
Such as maga-esophagus, the sustained contraction of orifice of the stomach is shown as, also not using balloon expandable and nerve ablation knot
The report that the equipment of conjunction is treated.
Disclose a kind of for special treatment in the Chinese utility model patent of Patent No. ZL 201220369156.3
Intraluminal catheter, including:Radio-frequency electrode, sacculus, conduit, connection buttock line and joystick;Sacculus two ends are connected with conduit, ball
The conduit of capsule one end is connected to realize being powered by connecting buttock line with joystick, and radio-frequency electrode is combined on the wall of sacculus.
Although the intraluminal catheter that above-mentioned utility model patent is provided can carry out the orthosympathetic ablation of the arteria renalis,
Due to balloon expandable degree cannot be controlled in operating process, and because hyperplasia causes the caliber of blood vessel different parts different, can
Can prevent electrode from adherent or can not be fully adherent, it is impossible to reach expected therapeutic effect.
The content of the invention
Primary technical problem to be solved by this invention is that offer is a kind of has balloon expandable and RF ablation function concurrently
Conduit.With the ablation of radio frequency ablation catheter be combined with each other the dilating effect of expandable balloon by it, at the same accomplish expansion and
Ablation, it is also possible to while realizing the ablation of tube wall hyperplasia and tube wall nerve.
Another technical problem to be solved by this invention is to provide a kind of ablation side using above-mentioned radio frequency ablation catheter
Method.
For achieving the above object, the present invention uses following technical schemes:
A kind of radio frequency ablation catheter, for being melted to the hyperplastic tissue on tube wall or nerve, including:Led positioned at described
The expandable balloon of pipe front end, positioned at the ablation part of the sacculus outer wall or inside, while the sacculus is progressively expanded, institute
Ablation part is stated to melt the hyperplastic tissue or nerve.The radio frequency ablation catheter by the dilating effect of expandable balloon with
The ablation of radio frequency ablation catheter be combined with each other, and accomplishes to be melted in expansion.
A kind of ablation method using above-mentioned radio frequency ablation catheter, the conduit includes sacculus and is arranged on sacculus outside
Or the ablation part of inside, comprise the following steps:
The sacculus is delivered at narrow blood vessel;
To the sacculus pressurising;
When pressure reaches predetermined value, then turn on the ablation part and melted;
The predetermined value can expand the narrow blood vessel.
The present invention is melted while using balloon expandable Stenosis to each layer tissue on local tube wall, so that
It is reduced or eliminated and narrow probability occurs again, alleviate or eliminate the tension force (spasm) of local vascular or tube chamber, pipe can be kept
The long-time in chamber is unimpeded.Radio frequency ablation catheter of the invention and ablation method are bright in aspect effects such as treatment tube chamber stenotic lesions
It is aobvious, it is possible to achieve to melt the good result while expanding, reduce ISR.
Brief description of the drawings
During Fig. 1 is of the invention, the first embodiment schematic diagram of the conduit that expandable balloon is combined with ablating electrode;
During Fig. 2 is of the invention, the second embodiment schematic diagram of the conduit that expandable balloon is combined with fixed support;
During Fig. 3 is of the invention, the 3rd embodiment structural representation of the conduit that expandable balloon is combined with detachable holder;
During Fig. 4 A are of the invention, the mode of ameliorating schematic diagram of 3rd embodiment;
Fig. 4 B are the partial enlarged drawing in the range of L in Fig. 4 A;
Fig. 5 is that constant pressure of the invention melts flow chart;
Fig. 6 is progressively supercharging ablation flow chart of the invention;
During Fig. 7 is for the present invention, the fourth embodiment structural representation of the conduit of cutting ablating electrode is used;
Fig. 8 is the cross-sectional view of conduit shown in Fig. 7;
Fig. 9 is in the present invention, expandable balloon is combined the 5th example structure of the conduit of ablation nerve with endo-luminal ultrasound
Schematic diagram;
During Figure 10 is of the invention, the mode of ameliorating schematic diagram of the 5th embodiment;
Figure 11 be various embodiments of the present invention in, the structural representation of cut-off type sacculus;
Figure 12 be various embodiments of the present invention in, non-cut-off type balloon structure schematic diagram;
Figure 13 be various embodiments of the present invention in, non-cut-off type balloon structure schematic diagram.
Specific embodiment
Detailed specific description is carried out to technology contents of the invention with specific embodiment below in conjunction with the accompanying drawings.
With the ablation of radio frequency ablation catheter be combined with each other the dilating effect of expandable balloon by the present invention, accomplishes that side is expanded
The ablation of side, i.e., sacculus stricture dilation and tube wall ablation just can be simultaneously realized with a conduit, and (including VSMC disappears
Melt and/or the sympathetic nerve of adventitia melt), it is also possible to while realizing the ablation of tube wall hyperplasia and tube wall nerve.The present invention is in profit
While with balloon expandable Stenosis, each layer tissue on local tube wall is melted, occurred again so as to be reduced or eliminated
Narrow probability, alleviates or eliminates the tension force (spasm) of local vascular or tube chamber, and the long-time of tube chamber can be kept unimpeded.
Ablation mode described in the present invention refers to that emitted energy is melted, and the energy is not limited to electric flux, ultrasonic wave
Deng.
It is described in detail below in conjunction with the accompanying drawings.
< first embodiments >
As shown in figure 1, used as the first embodiment of the present invention, what expandable balloon and commonly attached wall ablating electrode were combined leads
Pipe, including catheter proximal end 1, long tube 2 and handle 4.
Handle 4 is provided with pressure regulating controller 3 (referred to as:Pressure controller), push-pull button 41 and wire drawing 5 (only show drawing
The tail end of silk 5).Wire drawing 5 passes through catheter proximal end 1, long tube 2 and handle 4.
Catheter proximal end 1 includes sacculus 10 and is attached to one or more electrodes 20 of the periphery of sacculus 10.Catheter proximal end 1 is also
Including multiple thermocouples 40.Optionally, catheter proximal end 1 can also include multiple pressure sensors 30.Pressure is set to pass
Sensor can intuitively understand the adherent power size of electrode 20.Pressure sensor 30 can be omitted, using pressure controller 3 come manually
Control source of the gas/liquid source.
According to operation needs, sacculus 10 can be constant pressure or supercharging sacculus.In the present embodiment, sacculus 10 is Isobarically Control
Sacculus.If pressure sensor 30 detects adherent power and is not reaching to predetermined value (such as 6 atmospheric pressure), with catheter controller
Automated manner or operator's manual mode, carry out pressure increase operation;If adherent power has reached predetermined value, with conduit control
Device automated manner processed or operator's manual mode, carry out steady pressure adjustment operation;Subtract if adherent power is more than predetermined value
Pressure.So, constant pressure is realized, so as to ensure adherent power stabilization within a predetermined range (such as 5 by pressure regulating controller
~7 atmospheric pressure).Range of pressure values, it is relevant with the sacculus material characteristic and design parameter, can set as the case may be.
For example, compliant balloon is thin, pressure value is smaller;Non-compliance sacculus relative thick, pressure value can be with larger.
The diameter of sacculus 10 is the maximum the choice of diameter according to target ablation region, for example, need to be no more than 4 to caliber
When the blood vessel of millimeter is melted, the sacculus of 4 millimeters of diameter is just selected.Typically, balloon diameter refers to that nominal pressure (is also referred to as named
Pressure) under expansion diameter, the expansion diameter under sacculus maximum pressure value (be less than burst pressure) is more than or equal to target caliber.And
And, usual sacculus specification is more, and 0.5 or 0.25mm is spaced between general requirements.Such as caliber is 3~6mm, then advised from maximum
The conduit of lattice diameter, the i.e. foley's tube of diameter 6mm, the foley's tube without frequently changing different size.
One or more electrodes 20 (ablation part) are distributed with the sacculus 10 of catheter proximal end 1.In the behaviour of pressure controller 3
Under work, sacculus 10 can realize expansion and contraction.Sacculus 10 expansion make electrode 20 adherent, sacculus collect then it is recyclable to sheath (not
Diagram) in.Sacculus 10 can be expanded sacculus 10 by irrigating liquid or gas procedure, the liquid of perfusion can for contrast agent,
Cool brine, liquid nitrogen etc..The gas of perfusion can be carbon dioxide etc..
Electrode 20 positioned at the outside of sacculus 10 is used to carry out RF ablation.Multiple electrodes 20 are separately positioned on the outer of sacculus 10
Side, so as to there is good adherent power between electrode 20 and blood vessel.Electrode 20 is connected respectively to the radio frequency source of conduit.
Pressure sensor 30 can be distributed in balloon surface optional position, and optimal is, close to the position of electrode 20, to be used for
The adherent power of detecting electrode 20.In automated manner, the adherent power according to pressure sensor 30 automatically turns on or stops source of the gas/liquid
Pressure regulating controller 3 at the import of source, so that automatic to sacculus pressurising (pressurization) or not pressurising (release).In manual mode
In, the adherent power size that pressure sensor 30 is detected is revealed, and the value of the adherent power for showing is checked by operator,
Pressure regulating controller 3 is adjusted manually to realize the pressurization or release of sacculus.
Guide-tube structure in the present invention can be realized:After sacculus is adherent, electrode is melted;When sacculus is in blood vessel axial direction
On original position expand again after, electrode is melted again;Can also be melted in the adherent rear electrode of sacculus, sacculus is in blood
Electrode is melted again after pipe axial movement.
In the present embodiment, pressure sensor 30 is superimposed and is arranged on the outside of sacculus 10 respectively with electrode 20.Pressure sensor
It is close to the outer wall of sacculus 10, electrode 20 is located on pressure sensor 30, i.e. pressure sensor 30 is between sacculus 10 and electrode 20.This
Under the mode of kind, electrode 20 is protruded in the outside of sacculus 10, outside the outer surface (close to the surface of blood vessel cavity wall) of electrode 20 and sacculus 10
The distance of side, more than the thickness of of electrode 20 itself.In the present embodiment, the outer surface of electrode 20 is equal to pressure to the distance in the outside of sacculus 10
The thickness of force snesor 30 is plus the thickness of of electrode 20 itself.Using such structure, electrode 20 is set with the non-protruding of routine
Electrode compare, can as breast nail more be deep into hyperplastic tissue, RF ablation effect is more preferable.Meanwhile, it is deep into increasing
Electrode 20 in raw tissue, can be embedded in hyperplastic tissue to a certain extent, play a part of anchoring balloon 10, it is to avoid in pressurising
Journey sacculus 10 is slided relative to cavity wall.Additionally, during electrode ablation, even if hyperplastic tissue's uneven surface, sacculus or
Person's electrode is all without being moved or slide, and electrode increases with the contact area of tissue, and ablation effect and efficiency are improved.
Optionally, pressure sensor 30 may be alternatively located at the outer wall of sacculus 10, arranged side by side with electrode 20 near electrode 20
Position at.Pressure sensor 30 is used for the size of the adherent power of detecting electrode.In this structure, can be thick by increasing electrode 20
The modes such as degree, make electrode 20 protrude in the outside of sacculus 10, i.e. the upper surface (close to the surface of blood vessel cavity wall) of electrode 20 and sacculus
The distance in 10 outsides, more than the thickness (about 0.05 millimeter of conventional electrodes thickness) of conventional electrodes 20 itself, reaches 0.05 millimeter~2
Between millimeter, even more preferably between 0.2~1 millimeter.Electrode top can be plane or arc surface, curved surface etc., herein
In the case of, the distance in electrode top and the outside of sacculus 10 refers to the peak of upper surface to the distance in the outside of sacculus 10.
In the present embodiment, multiple thermocouples 40 are separately positioned on the position near electrode on the outer wall of sacculus 10.As can
Scheme is selected, thermocouple 40 can also be arranged on the position of the lower section of close electrode 20 on the inwall of sacculus 10, or be arranged on sacculus
The neighbouring position of the lower section of electrode 20 on 10 inwalls.
The top of catheter proximal end 1, also top developing head 50, are fixed by head end connector 51, can axially activity.Development
The tail end of head wire drawing 5 can be connected with the push-pull button 41 on handle, for further expansion and contraction, also can outward move to handle
Outside 4, direct wire feed or wire drawing.
<Second embodiment>
It is succinct effective for what is described, in this explanation the present embodiment part different from first embodiment.
As shown in Fig. 2 in the present embodiment, fixed support 21 is provided with outside sacculus 10.The one end of support 21 and conduit top
End is fixed, and is connected on head end connector 51 (referring to Fig. 1);The other end exposes from long tube.Fixed support 21 can be collected, but
It is that can not depart from sacculus, including but not limited to basket type support.
It is basket type support in figure medium-height trestle, multiple electrodes 20 is set thereon.After support 21 is expanded, the part of electrode 20 or complete
In portion's embedment tissue, increase the adherent power of electrode and improve ablation efficiency.Electrode 20 is arranged on the scaffolding thread 211 of support 21, this
The structure of sample causes that sacculus of the invention scope applicatory is larger.Such as sacculus of 4mm diameters, can be used on diameter less than 4mm
Blood vessel in, it is also possible in the blood vessel with diameter greater than 4mm.When the blood vessel more than 4mm is used in, even if sacculus 10 has been arrived
Up to nominal pressure values, but electrode 20 is not yet adherent, then 101 (also referred to as connecting silk thread) expandable stents of available adjustment silk, so that
Electrode 20 on support 21 is adherent, is effectively melted.So, the position of ablation is needed in such as once performing the operation for many places, and pipe
Footpath differs greatly, then the method, the conduit without frequently changing big specification can be used.
It will appreciated by the skilled person that electrode 20 can also be arranged on sacculus 10, from the space of support 21
Expose in (gap between scaffolding thread 211), and do not contacted with scaffolding thread 211.Because the void ratio of basket type support is larger, electricity
Pole 20 is readily arranged as not disturbed with scaffolding thread 211, it is to avoid ball occurs during balloon expandable or stent-expansion
Electrode and the mutual collision friction of support on capsule.Now, electrode 20 also protrudes from the scaffolding thread 211 of support 21, with certain journey
Embedded proliferation of smooth muscle tissue on degree, to increase adherent power, and expands the contact area with hyperplastic tissue, so as to improve ablation effect
Really.In the present embodiment, the distance of the upper surface of electrode 20 to sacculus outer surface more than scaffolding thread 211 upper surface to sacculus appearance
Thickness of the thickness of itself of the distance in face, such as electrode 20 more than scaffolding thread 211.
Pressure sensor 30 can be arranged on sacculus 10 and in the space of support 21 of the vicinity of electrode 20, and with branch
Frame silk 211 is not contacted.Certainly, pressure sensor 30 can also be arranged on the lower section of electrode 20.In the case, electrode 20 from
Body thickness can just be less than or equal to the thickness of scaffolding thread 211, need to only make the thickness of pressure sensor 30 and electrode 20 itself
Thickness sum, more than the thickness of scaffolding thread 211.
<3rd embodiment>
It is succinct effective for what is described, in this explanation the present embodiment part different from first embodiment.
Different from first embodiment and second embodiment, with reference to Fig. 3~Fig. 4, in the present embodiment, the outside of sacculus 10 is set
There is separable support 21, including network, flap support or helical mount etc. (hereinafter referred to as:Support) etc..Separable branch
Frame 21 can depart from after opening from sacculus 10, and indwelling is in intravascular.After support 21 is separated with sacculus 10, due on sacculus 10 still
There is electrode 20 to exist, therefore after sacculus 10 is moved into the position outside support 21, the electrode 20 on sacculus 10 still can be to other blood
Pipe portion position carries out expansion ablation, is now equivalent to do not have standoff conduit (first embodiment).
Shown in Fig. 3 is mode that electrode 20 is arranged on the sacculus 10 with detachable holder 21;Fig. 4 A and Fig. 4 B show
What is shown is the outer surface that electrode 20 is arranged on sacculus 10, and the mode contacted with support 21.Different from second embodiment and Fig. 2,
Support 21 is not connected to catheter tip 51.
In Fig. 4 A and Fig. 4 B, electrode 20 is arranged on the position of the outer surface of sacculus 10, and the structure with support 21 is adapted, so that
Electrode 20 is directly or indirectly contacted (as shown in enlarged drawing 4B) with the energy point 212 on support 21.Using such structure, electrode
Ablation energy can be passed to energy point 212 on support 21 (also referred to as by 20:Energy sheet emitting), by scaffolding thread 211
Energy point 212 melted.Preferably, energy point 212 is the projecting point thickened on support so that energy point 212 is compared with support
Other positions of silk 211 are more prominent to hyperplastic tissue, so as to increase contact area, increase adherent power.Energy is set on scaffolding thread 211
Point (energy sheet emitting) is routine techniques, be will not be described here.
Another structure is that after the pressurising of sacculus 10, electrode 20 exposes (without connecing from the space of scaffolding thread 211
Touch), and electrode thickness more than scaffolding thread 211 thickness, electrode 20 just can be than support 21 closer to vascular wall.It is fixed
Electrode 20 on sacculus 10, its position distribution needs to stagger with support, can use various designs, for example, with reference to sacculus folding
Folded mode, support shape and distribution of electrodes mode, the position that electrode is fixed on sacculus are remote at a distance of trying one's best with scaffolding thread 21, with
Realize the position relationship for mutually staggering of electrode and support grid after sacculus pressurising.
Sacculus 10 and support 21 are separable, to realize that sacculus 10 is recoverable to sheath, support 21 are retained in blood vessel
It is interior.The pressure sensor 30 and electrode 20 and temperature sensor 41 set on sacculus 10, three can be in the radial direction of sacculus 10
Upper stacking (stacked on top), it is also possible to be distributed side by side.
When sacculus 10 is unexpanded, can be by pulling wire drawing so that sacculus 10 is expanded, while the sacculus 10 in process of expansion
Support 21 is gradually promoted to expand.The electrode 20 of the outer surface of sacculus 10, it is gradually adherent with the expansion of sacculus 10.
Because support 21 is designed to barrel-shaped, support axially can be axially in parallel with blood vessel, therefore support 21 is supported at first
Contact at the minimum diameter of blood vessel, i.e. the most position of proliferation of smooth muscle.At this moment, multiple pressures of the outer surface of sacculus 10 are distributed in
Force snesor 30 detects the adherent power of electrode 20, wherein one or more pressure sensors 30, most apart from proliferation of smooth muscle
The nearest position in position pressure sensor, detect larger adherent power (close to preset value), and other pressure sensors 30
The adherent power for detecting is smaller, not up to preset value.
These adherent power are reached with the electrode 20 of preset value, is melted.With ablation procedure, proliferation of smooth muscle is thinning.
At this moment, the adherent power for detecting before is the pressure sensor 30 of preset value, and the adherent power for now detecting declines, less than default
Value.Then, by way of automatic or manual, the pressure of sacculus 10 can be increased.
Pressure with sacculus 10 increases, and sacculus 10 makes the enlarged-diameter of support 21.The network structure of support 21 can be fixed
Proliferation of smooth muscle tissue, it is to avoid due to the slip that relative smooth flesh hyperplastic tissue occurs in the Plenum Process of sacculus 10.Electrode
20 do not contact with scaffolding thread 211 and are contacted with scaffolding thread 211 and energy from the situation or electrode 20 exposed between scaffolding thread 211
Point 212 protrudes from the situation of the other parts of scaffolding thread 211, plays electrode or the energy point embedded increasing to a certain extent of ablation
Raw tissue or tube wall, so as to improve adherent power and expand contact area.Meanwhile, using the knot of sacculus or support, or both
Close, expansion of blood vessels.Thus reach and melt while the effect of expansion of blood vessels tube wall.
Therefore, the present embodiment conduit goes for the blood vessel with change caliber, brings two advantages:One is same leading
Pipe go for tiny blood vessel (such as blood vessel of caliber 4mm) be equally applicable to thick blood vessel (such as caliber 12mm's
Blood vessel);Two is because blood vessel hyperplasia causes the caliber of same blood vessel to change (such as blood vessel of caliber 12mm, because hyperplasia causes
The caliber of local location is reduced to 6mm), such blood vessel can be melted using same conduit.
The working method of conduit is illustrated below.This working method is applied to all embodiments.
When catheter proximal end 1 works, catheter proximal end 1 is placed in the narrow positions (hyperplasia position) of blood vessel target area, will
Sacculus 10 carries out expansion and fills up (high pressure) with certain pressure, so as to expand narrow, sacculus 10 can use contrast agent or titanium dioxide
Carbon is expanded, and observes expansion effect.Way main at present is to carry out balloon dilatation with physiological saline.
Sacculus 10, due to the presence of hyperplasia, can produce dog bone phenomenon, the near-end of sacculus 10, distal end in name pressure expansion
Diameter is all higher than the near-end of support 21, distal diameter.Using non-compliance or semi-compliant sacculus, dog bone phenomenon can be reduced
Influence.If balloon expandable is unable to reach required effect, the expansion pressure of sacculus 10 is adjusted to low-pressure area (with higher-pressure region
Compare, the sacculus internal pressure increased caused by balloon diameter in sacculus low-pressure area increases less), while carrying out electrode ablation.Low pressure
Area's pressure value is usually 0.1atm~6atm (depending on the parameter difference such as specific material, wall thickness, diameter regarding sacculus).Sacculus 10 is adjusted
Carry out being expanded in ablation to low-pressure area, can reduce the smooth muscle cell of hyperplasia, so that ablation areas caliber (former hyperplasia
Section) it is consistent with target caliber or close.
Ablation procedure has various ways.Conventional one kind is constant pressure ablation.Constant pressure value can be preset (at this moment
The pressure of sacculus will can expand the blood vessel for becoming narrow due to hyperplasia, typically 3~30atm, after narrowed blood vessels
Caliber determines that usual pressure value is 4~6atm), then conduit is melted while automatic dilating sacculus 10.Specifically, disappear
Before melting, constant pressure value, the parameter such as ablation time and temperature are preset.Then melted according to Fig. 5 steps.
As shown in figure 5, sacculus pressurising end starts to give the pressurising (step 1) of sacculus 10.When pressure reaches predetermined value, this is kept
Pressure (step 2), at this moment turns on electrode 20 and is melted (step 3).In the case where constant pressure value is kept, because default
Constant pressure value be the pressure value that can expand narrow blood vessel, than larger, it is possible to remaining sacculus outer surface and blood
Inner surface of tube wall is in close contact.Simultaneously as thickness of electrode is larger, more can be deep into vascular wall so that the energy of electrode
Hyperplastic tissue or nerve fiber that amount is more entered on vascular wall, improve ablation effect.
Foregoing is situation about being remained up using pressurising end, and pressure sensor 30 is not needed now.If pressurising end is being filled
Pressure is reached in the case of be shut off after default constant pressure value, and the pressure of sacculus 10 can be kept by pressure sensor 30
Power.Because ablation can cause the myocyte's hyperplasia on vascular wall to reduce, caliber becomes big, and then adherent power reduces, on sacculus 10
Pressure sensor 30 senses that adherent pressure reduces, and pressure becomes less than predetermined value (step 4), in being to continue with giving the pressurising of sacculus 10
(return to step 1).
When pressure sensor 30 senses that adherent pressure reaches predetermined value (step 2), then turn on electrode 20 and melted
(step 3).When ablation is completed, then into step 5, judge whether ablation targets are reached.If reaching ablation targets, i.e. working as
All ablation is finished for myocyte's hyperplasia under preceding preset pressure value, and ablation areas diameter reaches or close to target caliber.Now,
Blood vessels caliber no longer increases, and the pressure that pressure sensor 30 is sensed maintains predetermined value, then terminate ablation;If do not reached
Into then melting again.Can be melted again after balloon electrode is rotated to an angle, or remain former when melting again
But melted again after the constant propulsion certain distance front and rear in intravascular of angle, it is also possible to just repeatedly melted in same position,
Until terminating.
The judgement whether ablation terminates can have following several ways.In general, the gross ablation time can be set before ablation,
The parameters such as interval supercharging ablation time t1 and temperature.Within the gross ablation time, carry out being expanded in ablation by above-mentioned steps;Terminate
After ablation, range estimation judges whether ablation reaches or close to target caliber, if need it is in situ/shift and melt again.
For example hyperplasia is serious, sets ablation time 1min, after ablation once (is expanded) in ablation, rotatable certain angle
Proceed ablation after degree, or mobile certain size;Until ablation areas diameter reaches or close to target caliber.
Also can carry out judging whether to terminate once to melt by parameters such as impedance, temperature, the power of detection.
After completing ablation, sacculus is shunk, contrast agent row renal arteriography is injected, to observe expansion effect and the unobstructed feelings of blood flow
Condition.As expanded and melting dissatisfied, repeat 2~3 times.
Another kind is progressively supercharging ablation.Expansion pressure value mode can be stepped up to be melted in expansion.Before ablation, need to set
Determine initial pressure value M0With maximum pressure value MmaxAnd other parameters (gross ablation time, interval supercharging ablation time t1 and temperature
Deng).Parameter preset can also include needing increased pressure value, supercharging value N every time.It is appreciated that supercharging value N is positive number, can
To be fixed value, or any value set in advance, for example from larger numerical value progressively reduce etc. difference (for example
N1=2, N2=1.5, N3=1, N4=0.5)
As shown in fig. 6, with pressure initial value M0Start to give the pressurising (step 1) of sacculus 10.When pressure sensor 30 is sensed
Pressure reaches initial value M0, then conduction electrode 20 melted (step 2).Next between judging that whether ablation time adds up to reach
Every supercharging ablation time t1 (step 3).Now, myocyte's hyperplasia has melted a part, and blood vessels caliber increases, then pressure sensor
30 pressure for sensing reduce.
If reaching interval supercharging ablation time t1, into step 4, sacculus 10 is with larger newest pressure predetermined value
Mn=Mn-1+N(Mn≤Mmax) pressurising is carried out, then judge newest pressure predetermined value MnWhether maximum M is reachedmax(step 5).
If reaching maximum Mmax, then judge whether to need adjustment ablation locations (step 66), for example rotation or movable electrode.
Return to step 2 continues to melt if maximum is not reaching to.
In step 3, if not up to interval supercharging ablation time t1, return to step 2, proceeds ablation.
In step 5, if MnNot up to maximum Mmax, then return to step 2, continue to melt.
If not needing adjustment position in step 6, for example, ablation effect is reached, then collected sacculus, terminated ablation.
It refers to that myocyte's hyperplasia all fall by ablation that ablation effect is reached, it is not necessary to further melted.
M values need to set upper limit Mmax, it is to avoid reach the burst pressure force value of sacculus, material, wall of the numerical values recited according to sacculus
The parameter settings such as thickness, diameter, generally less than 20atm, for example, 12atm or 14atm.
Balloon pressure value in the present invention gradually increases.Because ablation causes myocyte's hyperplasia to diminish, blood vessels caliber
Become big, it is necessary to bigger balloon pressure just adapts to the caliber for having become big, the adherent power of raising, improvement ablation effect.
Adjustment position melts again, can be melted again after balloon electrode is rotated to an angle, or remain former
But melted again after the constant propulsion certain distance front and rear in intravascular of angle, it is also possible to just repeatedly melted in same position.
Electrode on sacculus can be one or more, and one or more electrodes can be while or wherein 1 or wherein several transmittings
RF energy, and external electrode forms loop;Multiple electrodes on sacculus are alternatively wherein 1 as negative pole, 1 in addition/many
Individual electrode simultaneously or alternately launches radio frequency, and negative electrode forms loop.
Therefore, in the present invention, because sacculus works in different pressure areas (low-pressure area and higher-pressure region), with different
Expansion diameter, goes for the blood vessel with change caliber.Bring two advantages:One to be that same conduit goes for tiny
Blood vessel (such as blood vessel of caliber 4mm) be equally applicable to thick blood vessel (such as blood vessel of caliber 12mm);Two is due to blood
Pipe hyperplasia causes the caliber of same blood vessel to change (such as blood vessel of caliber 12mm, because hyperplasia causes the caliber of local location to subtract
Small is 6mm), such blood vessel can be melted using same conduit.
Multiple temperature measuring equipments (can be thermocouple) can also be distributed with the present embodiment, on sacculus 10, sacculus is can be located at
In the intermediate layer of 10 outer wall, inwall or multilayer sacculus, for detecting ablation points temperature in ablation procedure.And, according to thermometric
The temperature that device is detected, can start security control (temperature is too high, then be automatically stopped ablation), or pressure regulation (temperature is too low,
Then pressurising increases balloon pressure (must not exceed sacculus maximum pressure value) or by adjusting wire drawing expanded stent to increase electrode paste
Wall pressure power.
The material of support 22 can be:The materials such as metal material, macromolecular material, metal and macromolecular material combination.Support
22 can be an integrated support, or multistage composition.The outer surface of support 22 is provided with one or more energy launch point (examples
Such as electrode 20), multiple energy launch point conductions may be combined to achieve multiple spot wheel burning, same to burning.
When sacculus 10 is in initial rounding state and expansion, the energy launch point on electrode and support 22 on sacculus 10
Effectively contact is kept, and energy can be transmitted.In other words, sacculus and support are contacted when initial, and contact is still kept during expansion;Completion disappears
After melting, sacculus is shunk, and sacculus and support are separated.On radio frequency point and support 22 optionally, or on sacculus 10
Electrode carry out energy transmission, for melting.
When sacculus 10 shrinks, support 22 and sacculus 10 are separated.Sacculus 10 is expanded, the synchronous expansion of support 22.Had below
Body explanation.
Situation one:Active expanding support
Active expanding support, support is actively expanded.
If the interelectrode connection silk thread 101 on sacculus on radio frequency point and support is shorter, due to sacculus thin-walled, weight
Gently, under the drive of short connection silk thread 101 or buckle, balloon expandable is opened, and connection silk thread keeps connection radio frequency point and electrode
State.
If the connection silk thread 101 between radio frequency point on sacculus on radio frequency point and support is more long, during stent-expansion, connection
Silk thread will not stretch sacculus, so sacculus will not be opened.After can just be expanded after sacculus pressurising, support is set further to expand or carry
Adherent power high.
After ablation, when conduit withdraws/rotates, connection silk thread is disconnected, and sacculus and support are separated.Sacculus is collected, and support is still protected
Hold expansion state, indwelling Ink vessel transfusing.
Between sacculus and support connect, may be selected silk thread 101 connect, into after target location, webmaster from sheath out,
Automatic expansion, has radio frequency silk thread to connect between the electrode on radio frequency line and support on sacculus;Balloon expandable, silk thread 101 is still protected
Connection is held, electrode of the RF energy to support can be effectively transmitted;After ablation is completed, sacculus is collected, and adjustment angle, makes silk
Line receives pulling force, because support has been expanded, is close in target vessel wall, then conduit recession or rotation, and silk thread stress is increased, connecting filament
Electrode connection points position on line 101 and support is provided with weak spot (can be by modes such as diameter thickness, materials), and this position is received
Pulling force is disconnected, and support and sacculus are separated.
Can also be to snap connection mode between sacculus and support as the alternative solution of connection silk thread.Buckle ensures branch
Radio frequency point on electrode and sacculus on frame is effectively contacted;After support active/passive is expanded, buckle point is still effectively contacted;It is complete
Into after ablation, sacculus is collected, and buckle point stress is separated, then sacculus and support are separated.
Situation two:Passive expanding support
Support is passive expansion class, then be initially contact, and support is oppressed during balloon expandable, it is synchronously expanded.Completion disappears
After melting, support keeps expansion form, and indwelling is in intravascular.
Before ablation, stent-expansion, because hyperplasia is present, possibly cannot make stent-expansion to consistent with target caliber or close
Degree, but because follow-up sacculus melts in pressurising, make hyperplasia thinning, caliber becomes big, and support just can further be expanded.
Pre-set low pressure pressurising is first pressed in sacculus pressurising, follow-up to be pressurizeed in ablation.Nominal pressure value can also be directly set to
Melted.
For the energy for melting, be delivered to the electrode 20 on sacculus 10, then be delivered on support 22, then by support 22 outside
The emitted energy point that surface is set, is delivered to vascular wall, and target area is melted.
Sacculus 10 shrinks, and negative-pressure ward sacculus 10, the diameter of sacculus 10 is reduced to minimum, when sacculus 10 reduces, support 22
Depart from sacculus 10, stay in target tube chamber.
As described above, expansion can synchronously or successively.Cannot be drawn in after stent-expansion, but, make connecting line/tie point or
Connection buckle stress disconnects or separates, it is possible to collect sacculus.
If active expanding support, support actively expand, it is lightweight due to sacculus thin-walled, it is short connection silk thread or
Under the drive of buckle, sacculus is opened;As the connection silk thread between the radio frequency point on radio frequency point and support on sacculus is more long, then support expands
Zhang Shi, although the radio frequency point in support Top electrode and sacculus is still connected by connecting filament long, but sacculus will not be opened;Sacculus pressurising
Expansion, makes support further expand or improve adherent power;After ablation, sacculus is collected, and support still keeps expansion state, conduit to return
When removing/rotating, connecting filament is disconnected, and sacculus and support are separated.
If support is passive expansion class, contact is initially, support is synchronously expanded during balloon expandable, after completing ablation,
Support keeps expansion form;Before ablation, stent-expansion, due to hyperplasia exist, possibly cannot make stent-expansion arrive with target caliber
Consistent or close degree, but because follow-up sacculus melts in pressurising, make hyperplasia thinning, support is just further expanded;Ball
Pre-set low pressure pressurising is first pressed in capsule pressurising, follow-up to be pressurizeed in ablation, or being directly set to nominal pressure value is melted.
<Fourth embodiment>
Fig. 7 and Fig. 8 is fourth embodiment of the invention, and the structure of the conduit that expandable balloon is combined with cutting ablating electrode is shown
It is intended to.
In the present embodiment, the radio frequency ablation catheter 1 with expandable balloon, the front end of conduit 1 is a sacculus 10, sacculus 10
Genesis analysis have one or more cutter sweeps (cutting blade) 23.Cutting blade 23 is also simultaneously ablating electrode, can be in cutting
Melted simultaneously.Cutting blade 23 on one cutter sweep can be integrated, can be also made up of multistage cutting blade (mutually it
Between can turn on or be not turned on).During ablation, the cutting blade 23 on multiple cutter sweeps can be melted simultaneously, or separate independent
Ablation, or wherein several cutting blade combinations are melted simultaneously.
Multiple temperature measuring equipments are distributed with sacculus, in can be located at the intermediate layer of sacculus outer wall, inwall or multilayer sacculus.
In the longitudinally mounted cutting blade 23 in the outer surface of sacculus 10.When sacculus 10 is expanded, cutting blade 23 can cut lesion.
So, when sacculus 10 is expanded, preassembled cutting blade 23 on sacculus 10 can cut out one neatly in diseased region
The edge of a knife.Because cutting blade 23 is also simultaneously ablating electrode, therefore, can be melted while cutting.With ablation
Carry out, adherent power reduces, pressure sensor can feed back to controller, controller control is pressurized to sacculus, so as to realize that side is melted
Expand on side.
During balloon expandable, due to the ablation of cutting blade 23, it is allowed to which sacculus 10 is progressively expanded to improve adherent power, therefore ball
The pressure of capsule 10 slowly rises with the expansion of sacculus 10.In dilating sacculus 10, excessively pressurization is avoided, prevent sacculus 10
Cutting blade 23 is retained in chamber during rupture.
<5th embodiment>
Applicant in tissue ablation it was found that, give local vessel wall a certain degree of RF ablation dosage, can
Purposefully to cause the sympathetic fiber on externa to be denatured, it is also possible to reduce the thickness of local vessel wall tube wall, subtract
The quantity of smooth muscle myocyte on few vascular wall, while keeping the integrality of vascular wall.It is therefore proposed that by balloon expandable and tube wall
The mode that nerve ablation is combined.
Fig. 9 and Figure 10 is fifth embodiment of the invention, and the guide-tube structure that expandable balloon is combined with endo-luminal ultrasound device shows
It is intended to.Wherein, Fig. 9 is the structural representation of tube wall (focus ultrasonic to tube wall) ablation, and Figure 10 is that (focus ultrasonic is arrived nerve ablation
Theca externa) structural representation.
In the present embodiment, the sacculus 10 of the front end of conduit 1 is provided with one or more (electrodes of electrode 20 in the outer surface of sacculus 10
It is optional, it is also possible to be not provided with electrode), it is internally provided with a ultrasonic transmitter 80 (ablation part) in sacculus 10.Ultrasound hair
The releasable focusing ultrasonic wave of injection device 80 realizes endo-luminal ultrasound tube wall (proliferation of smooth muscle ablation) to tube wall;Ultrasonic transmitter 80
Also releasable focusing ultrasonic wave realizes nerve ablation (nerve fiber ablation) to theca externa.
When sacculus 10 is expanded, the transmitting ultrasonic wave of ultrasonic transmitter 80, focusing to target ablation position carries out ultraphonic pipe
Wall melts or nerve ablation.Sacculus 10 is further expanded in ablation procedure, can expand while being melted.Carry out ultraphonic pipe
When wall melts, because myocyte's hyperplasia is ablated to a part, then the adherent power of sacculus 10 reduces, and pressure sensor 30 can sense
To this change, the pressurising from triggering to sacculus 10, the adherent power of holding.
In addition, Figure 11 to Figure 13 shows the different type schematic diagram of the expandable balloon in the present invention.These types point
Can be with the various design examples for passing through of holding part blood flow when not being expansion.Can be the form lived of blood vessel blockage after expansion,
Such as cylinder, circle are bulging, spherical etc.;Or keep the form of blood vessel circulation.
For example after expandable balloon expansion, can be cylindric, circle drum or spherical, or hexagonal is quincunx, five jiaos
The forms such as star.It is first cylinder, circle drum, spherical, then for holding part blood flow, can be but be not limited to quincunx, pentalpha etc..
It is adherent that distribution of electrodes is capable of achieving electrode in sacculus peak position, after balloon expandable;And Ink vessel transfusing blood in target area after balloon expandable
Liquid is still negotiable.
When hemadostewnosis is treated, balloon angioplasty of the invention is narrow, while the ablating electrode on sacculus is to blood vessel
Wall tissue is melted, including the sympathetic nerve on smooth muscle and/or adventitia on tube wall, plays several effects:It is thinning smooth
The thickness of flesh, is reduced or prevention vasopasm, expansion of blood vessels, pre- anti-restenosis.It is appreciated that setting penetrating outside sacculus simultaneously
Frequency ablating electrode and the ultrasonic electrode for being arranged on balloon interior, can be simultaneously to the god on tube wall hyperplasia muscle cell and tube wall
Through being melted.
Supravasal sacculus of the invention, even if using compliant balloon, can also overcome dog bone to show by stent-expansion
The generation of elephant.
Ablating electrode release ablation energy on sacculus can be different according to the lesion degree of local tube wall, give different
Dosage, the mode of optimization is bipolar or multipole ablation mode.
The various dose of ablation smooth muscle tissue as needed, can be selected:It is thinning, pre- anti-restenosis, or do not melt
Smooth muscle tissue, only melts the sympathetic nerve on adventitia.
The conduit and its ablation method for having balloon expandable and RF ablation function concurrently provided by the present invention is carried out above
Detailed description, it is apparent that the form that implements of the invention is not limited thereto.For those of ordinary skill in the art
For, in the case of without departing substantially from spirit and claims of the present invention scope to it carry out it is various obvious change all
Within protection scope of the present invention.
Claims (17)
1. a kind of radio frequency ablation catheter, it is characterised in that including:
Positioned at the expandable balloon of the catheter proximal end,
Positioned at the ablation part of the sacculus outside or inside,
After the sacculus is adherent, the ablation part is melted.
2. radio frequency ablation catheter as claimed in claim 1, it is characterised in that:
The ablation part is electrode,
Distance thickness more than the electrode of the electrode top apart from institute's sacculus upper surface.
3. radio frequency ablation catheter as claimed in claim 1, it is characterised in that:
The ablation part is electrode,
The thickness of the electrode is less than or equal to 2 millimeters more than 0.05 millimeter.
4. radio frequency ablation catheter as claimed in claim 3, it is characterised in that:
The ablation part is cutting ablating electrode.
5. radio frequency ablation catheter as claimed in claim 1, it is characterised in that:
The conduit also includes being arranged on the support on the outside of the sacculus, and the support includes multiple scaffolding threads.
6. radio frequency ablation catheter as claimed in claim 5, it is characterised in that:
The ablation part is electrode,
The electrode is not contacted with the support, and is exposed from the space of the scaffolding thread.
7. the radio frequency ablation catheter as described in claim 1 or 6, it is characterised in that:
The support is detachable holder;
After the sacculus is separated with the support, the ablation part is melted again.
8. radio frequency ablation catheter as claimed in claim 6, it is characterised in that:
Thickness of the thickness of the electrode more than the scaffolding thread.
9. radio frequency ablation catheter as claimed in claim 5, it is characterised in that:
The ablation part refers to set the energy launch point for ablation on the bracket,
The conduit also includes being arranged on the electrode of the sacculus outer surface,
The energy launch point is connected with the electrode.
10. radio frequency ablation catheter as claimed in claim 1, it is characterised in that:
The conduit also includes being arranged on the ultrasonic electrode of the balloon interior.
11. radio frequency ablation catheters as claimed in claim 1, it is characterised in that:
Connected by connecting silk thread between the support and the sacculus,
When the support is active expanding support, the stent-expansion, while pulling the ball by the connection silk thread
Capsule, makes the balloon expandable;
When the support is passive expanding support, the balloon expandable oppresses the stent-expansion.
12. radio frequency ablation catheters as claimed in claim 11, it is characterised in that:
The connection silk thread is provided with breakaway poing, for being broken under stressing conditions, so that the support and the sacculus point
From.
13. radio frequency ablation catheters as claimed in claim 1, it is characterised in that:
By snapping connection between the support and the sacculus, the buckle, for that can be disconnected under stressing conditions, so that
The support is separated with the sacculus,
When the support is active expanding support, the stent-expansion, while pulling the sacculus by the buckle, makes
The balloon expandable;
When the support is passive expanding support, the balloon expandable oppresses the stent-expansion.
A kind of 14. ablation methods of use radio frequency ablation catheter, the radio frequency ablation catheter includes sacculus and is arranged on sacculus
Outside or the ablation part of inside, it is characterised in that comprise the following steps:
The sacculus is delivered at narrow blood vessel;
To the sacculus pressurising;
When pressure reaches predetermined value, then turn on the ablation part and melted;
The predetermined value can expand the narrow blood vessel.
15. RF ablation methods as claimed in claim 14, it is characterised in that further include following steps:
Judge whether ablation targets are reached;
If reaching ablation targets, terminate ablation;If do not reached, sacculus is collected, after adjustment position, return to step 1
Melt again.
16. RF ablation methods as claimed in claim 14, it is characterised in that:
Pre-set low pressure pressurising is first pressed to the sacculus pressurising, is then pressurizeed in ablation.
17. RF ablation methods as claimed in claim 16, it is characterised in that further include following steps:
If ablation time reaches interval supercharging ablation time, sacculus is pressurizeed, reach larger newest pressure predetermined value Mn=
Mn-1+N(Mn≤Mmax) pressurising is carried out, wherein N is supercharging value.
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CN201710077036.3A CN106725838B (en) | 2016-02-11 | 2017-02-13 | Catheter with balloon dilation and radio frequency ablation functions and ablation method thereof |
US15/894,920 US20180228537A1 (en) | 2017-02-13 | 2018-02-12 | Medical device comprising a balloon-stent assembly and methods of using the same |
US18/309,750 US20230285174A1 (en) | 2017-02-13 | 2023-04-28 | Medical device comprising a balloon-stent assembly and methods of using the same |
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CN2016100843995 | 2016-02-11 | ||
CN201710077036.3A CN106725838B (en) | 2016-02-11 | 2017-02-13 | Catheter with balloon dilation and radio frequency ablation functions and ablation method thereof |
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