CN107049467A - A kind of adjustable freezing ablation catheter - Google Patents
A kind of adjustable freezing ablation catheter Download PDFInfo
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- CN107049467A CN107049467A CN201710411146.9A CN201710411146A CN107049467A CN 107049467 A CN107049467 A CN 107049467A CN 201710411146 A CN201710411146 A CN 201710411146A CN 107049467 A CN107049467 A CN 107049467A
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- distal end
- freezing
- unit
- core bar
- ablation catheter
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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
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
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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
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
- A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
- A61B2018/00285—Balloons
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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
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
- A61B2018/0212—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
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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
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
- A61B2018/0231—Characteristics of handpieces or probes
Abstract
The present invention relates to a kind of adjustable freezing ablation catheter, including low-temperature receiver pipeline, freezing unit, outer sheath and core bar, the low-temperature receiver pipeline and core bar are arranged in the tube chamber of the outer sheath, the distal end of the core bar is stretched out outside the outer sheath, the near-end of the freezing unit is connected with the distal end of the low-temperature receiver pipeline, the distal end of the freezing unit is flexibly connected by distal end buffer unit with the core bar, the freezing unit includes the shape memory mechanism of default form, the expansion form of the freezing unit is realized by the shape memory mechanism, when the adjustable freezing ablation catheter does not reach diseased region, the freezing unit is located in the tube chamber of the outer sheath, when relative displacement occurs for the low-temperature receiver pipeline and the outer sheath, the freezing unit realizes expansion and contraction.Go out sheath The present invention reduces freezing unit distal end and enter the resistance of sheath, prevent the deformation of outer sheath distal end, reduce pressure and hold diameter, add the security of sacculus.
Description
Technical field
The present invention relates to a kind of medicine equipment, definitely it is related to a kind of adjustable freezing ablation catheter.
Background technology
Cryoablation is, by human lesion tissue ablation, to reach the purpose for the treatment of using refrigerated source release freezing energy.It is cold
Freeze ablation techniques have been used to clinic have oncotherapy, atrial fibrillation therapy etc..
Low-temperature tumor cold therapy principle be mainly cooling after it is intracellular and it is extracellular quickly form ice crystal, cause tumour thin
Born of the same parents' dehydration, rupture.Freezing shrinks capilary simultaneously, and blood flow slows down, microvascular corrosion cast, blocking blood flow, causes tumor tissues to lack
Blood necrosis.After tumour cell multigelation, cell rupture, cellular membrane lysis promote antigens intracellular and in shielding status
Release, stimulates body to produce antibody, improves immunocompetence.Cryosurgical system is made up of three parts, i.e., cold-hot is changed
System, temperature monitoring system and cryoprobe.The indication of cryosurgical system treatment tumour is wider, is mainly used in complete
The various entity tumors of body, including the innocent and malignant tumour of liver cancer, lung cancer, prostate cancer, kidney, cancer of pancreas, bone, adrenal,
Meningioma, glioma, fibroid, uterine cancer, oophoroma, breast cancer, mammary gland fibroma, and for pain relieving of cancers etc., mesh
Preceding most commonly liver cancer and lung cancer.
Atrial fibrillation therapy is that the orifices of pulmonary veins for triggering auricular fibrillation is electrically isolated.It is exactly specifically to convey refrigerant to arrive
Refrigerated source in conduit is with orifices of pulmonary veins electrocardio triggering cell of freezing to death, so as to eliminate these electrocardios triggering stove.At present on the market
Foley's tube conveying low-temperature receiver medium is freezed in the sacculus of conduit head end, using joule thomson effect, generation cryogen is entered
Row cold therapy.The distal structure of generally freezing foley's tube is balloon structure, and refrigerant is directly sprayed onto balloon interior and forms cold
Pulmonary venous vestibule is melted in jelly source.Balloon structure causes cryoablation region unreasonable, and especially non-targeted ablation areas is larger,
Such as balloon proximal portion and balloon distal portion, balloon proximal and distal portions are non-targeted ablation areas, in freezing, when
The loss of energy when proximal part of freezing sacculus does not recline with corresponding tissue, proximal part and corresponding people when freezing sacculus
When body tissue reclines, the damage of non-treatment tissue is will result in, and then is possible to that some complication can be caused.Such as atrial fibrillation therapy
In, nervus phrenicus is close with RSPV, when melting the RSPV is possible to that diaphragmatic paralysis can be caused；And for example oesophagus
Behind left room, left room is also close apart from oesophagus, and balloon proximal is likely to cause oesophagus close to the freezing of left room cardiac muscle and damaged
Wound.In addition, freezing sacculus enters, pulmonary vein is too deep or ablation of balloon distal center may can also cause pulmonary venous stenosis.
Patent CN103200891 discloses a kind of cryogenic ablation device with deployable ascending pipe, the fluid of the device
Ascending pipe can be transitioned into the second geometrical construction from the first geometrical construction, and the first geometrical construction can be substantial linear, the second geometry
Construction can be substantially spiral shape.Although the device is easy to fit with target ablation region, but the distal end quilt of its fluid injection conduit
Be fixed on wire leading pipe, when fluid injection conduit be in the second geometrical construction when, fluid injection conduit some in cryoablation catheter
Intrathecal, a part is outside the sheath of cryoablation catheter.When fluid injection conduit is in the first geometrical construction, the fluid outside sheath
The power that ascending pipe is suppressed is very big, causes the head end size of fluid injection conduit larger, and therefore, delivery sheath integral diameter more significantly, is led
Cause the wound of atrial septum just bigger；In addition, the power for making fluid injection conduit be in the first geometrical construction is acted on wire leading pipe, lead
Fiber tube may be bent, and cause pumpback difficult.
The content of the invention
In order to overcome defect of the prior art, it is an object of the invention to provide a kind of adjustable freezing ablation catheter.
The purpose of the present invention is achieved through the following technical solutions：
A kind of adjustable freezing ablation catheter, including low-temperature receiver pipeline, freezing unit, outer sheath and core bar, the low-temperature receiver pipeline
In the tube chamber that the outer sheath is arranged on the core bar, the distal end of the core bar is stretched out outside the outer sheath, described cold
The near-end for freezing unit is connected with the distal end of the low-temperature receiver pipeline, the distal end of the freezing unit by distal end buffer unit with it is described
Core bar is flexibly connected, and the freezing unit includes the shape memory mechanism of default form, the expansion form of the freezing unit by
The shape memory mechanism realizes that, when the adjustable freezing ablation catheter does not reach diseased region, the freezing unit is located at
In the tube chamber of the outer sheath, when the low-temperature receiver pipeline and outer sheath generation relative displacement, the freezing unit is realized
Expansion and contraction.
The purpose of the present invention can also be come further to realize by the following technical programs：
In one embodiment, distal end stopping means, the distal end are provided with the adjustable freezing ablation catheter
Stopping means includes distal end stopping means I and distal end stopping means II, and the distal end stopping means I is fixedly connected at described remote
The distal end of buffer unit is held, and is flexibly connected with the core bar；The distal end stopping means II is fixedly connected on the core bar
Distal end, the distal end stopping means II limits the distal end stopping means I to core distal end direction axial displacement.
In one embodiment, the near-end of the freezing unit is provided with near-end buffer unit, the freezing unit
It is fixedly connected by the near-end buffer unit with the distal end of the low-temperature receiver pipeline.In one preferred embodiment, it is described
One end of shape memory mechanism is located at the inside of the near-end buffer unit, when the freezing unit is reclining pathological tissues,
The near-end buffer unit provides the buffering of power so that freezing unit reclines than milder.
In one embodiment, the distal end buffer unit and/or the near-end buffer unit are spring structure.
In one embodiment, the distal end buffer unit and/or the near-end buffer unit by cuts in metallic pipe and
Into to realize flexible connection.
In one embodiment, the distal end buffer unit and/or the near-end buffer unit are gradually small by a diameter
Or the nitinol alloy wire of spiral winding is made, to realize flexible connection.
In one embodiment, the distal end buffer unit and/or the near-end buffer unit are by flexible macromolecule material
Material is made.
In one embodiment, sacculus is provided with the distal end of the outer sheath, the distal end of the sacculus is fixedly connected
In the distal end of the core bar, the distal end stopping means is arranged on the inside of the sacculus.
In one embodiment, the freezing unit includes low-temperature receiver injecting cavity, low-temperature receiver accommodating chamber and shape memory mechanism.
In one embodiment, the cross section of the low-temperature receiver accommodating chamber is ellipse or rectangle or circle.
In one embodiment, the shape memory mechanism is arranged on inside the freezing unit or is arranged on
In the outer wall of the freezing unit.
In one embodiment, the shape memory mechanism is helical structure.
In one embodiment, the shape memory mechanism is cage structure.It is preferred that, the cage structure is multiple
Helical structure is arranged or is wound, and the arrangement of the multiple helical structure is many spiral knots centered on conduit axis
Structure array configuration；Or the cage structure is formed by the arrangement of strip freezing unit.
In one embodiment, near-end stopping means, the near-end limit are additionally provided with the near-end of the freezing unit
Position device is arranged on the distal end of the outer sheath, and it has two passages, and one is used to accommodate the freezing unit, another
For accommodating the core bar.
In one embodiment, it is provided with heater strip on the freezing unit.
In one embodiment, the distal end of the core bar is provided with hardness regulating device.
Compared with the existing technology, the advantage of the invention is that：
1st, the present invention it is described it is adjustable freezing ablation catheter distal end set distal end buffer unit, the freezing unit it is remote
End is flexibly connected by distal end buffer unit with the core bar, and the buffer unit can reduce freezing unit expansion or shrink
The active force acted in journey on core bar, so as to reduce the risk for causing core bar to deform during freezing unit turnover outer sheath.Such as
Shown in Fig. 5, the distal end of freezing unit of the prior art is typically directly fixed on core bar, and epitheca is withdrawn into freezing unit
During pipe, pulling force is sent on core bar from distal end stopping means, when pulling force is excessive, will be made core bar deformation or even be rolled over
It is disconnected.The present invention has been obtained point in the distal end buffer unit power that makes to be applied on core bar that adjustable freezing ablation catheter distal end is set
Solution, so as to reduce the deformation of core bar.Go out sheath in addition, the setting of distal end buffer unit reduces freezing unit distal end and enter the resistance of sheath
Power, prevents the deformation of outer sheath distal end.If as shown in fig. 6, the distal end of freezing unit is not provided with buffer unit, in freezing unit
During being moved into outer sheath and being moved out outer sheath, because the junction of its distal end and core bar is really up to the mark, make freezing list
The head end of shape memory mechanism in member is thick to be difficult to remove into outer sheath, causes sheath and to enter sheath resistance excessive, even if or
Enter in outer sheath, be also easily caused outer sheath deformation.
2nd, the present invention is provided with distal end stopping means, the distal end stopping means bag on the adjustable freezing ablation catheter
Distal end stopping means I and distal end stopping means II are included, distal end stopping means I is fixedly connected at the distal end of distal end buffer unit,
And be flexibly connected with core bar, therefore, distal end stopping means I can be moved on core bar.Distal end stopping means II is fixedly connected on
The distal end of core bar, distal end stopping means II limits distal end stopping means I to core distal end axial displacement.It is cold when needing freezing
Freeze unit to be pushed out coming from outer sheath, the distal end stopping means I positioned at freezing unit distal end is moved to distally along core bar
Stopping means II, freezing unit is withdrawn in outer sheath after freezing terminates, and distal end stopping means I is also moved proximally to therewith.
By distal end it is spacing, it is possible to achieve freezing unit stretch out every time outer sheath distance and position it is controllable.
3rd, before the adjustable freezing ablation catheter of the present invention does not reach diseased region nearby, the freezing unit is located at the epitheca
In the tube chamber of pipe, so as to reduce cryoablation distal end of catheter diameter, freezing unit is directly fixedly connected in the prior art
The mode of distal end causes distal diameter big；Secondly, one of the preferred embodiments of the present invention, the distal end of the outer sheath is provided with ball
During capsule, freezing unit is in cryoablation catheter course of conveying and is not directly contacted with sacculus, does not produce direct friction with sacculus, reduces
Sacculus risk of rupture.The distal end of freezing unit is fixed on core bar in the prior art, in order to ensure freezing unit upon discharge also
The shape memory mechanism (including the connecting portion ited with core bar) on the shape and size of pre-setting, freezing unit is kept to have one
Fixed rigidity, this rigidity make it that the total radial dimension ratio in the distal end and core bar junction of shape memory mechanism is larger, so leads
Causing the pressure for being arranged on the sacculus outside it to hold, diameter is big, and conduit is big by external diameter.Secondly as shape memory mechanism is metal material
Sacculus outside material, freezing unit is very thin high polymer material, and the mutual extruding of the two is easy during sacculus pressure is held
Sacculus is caused to rupture.And in the present invention, before pressure is held, freezing unit and shape memory mechanism therein are completely removed epitheca
In pipe, held positioned at sacculus pressure outside region, it is natural during sacculus pressure is held to be damaged to sacculus, add the peace of sacculus
Quan Xing, and because freezing unit is moved in outer sheath, sacculus pressure is held diameter and is diminished, conduit is become by diameter
It is small.
4. the preferred embodiments of the present invention not only act as resistance in freezing unit peripheral hardware Place capsule under different application environments
The effect of clinopodium polycephalum, also improves reclining and positioning performance for freezing unit and destination organization.
5. the preferred embodiments of the present invention are provided with near-end buffer unit in the near-end of the freezing unit, when the freezing
Unit is when reclining pathological tissues, and the near-end buffer unit provides the buffering of a power so that the ratio that reclines of freezing unit
It is milder, and the setting of near-end buffer unit makes the connection of freezing unit and low-temperature receiver pipeline not only be to be tightly connected but also be that elasticity connects
Connect, and the diameter of junction is become smaller, be more easy to convey into human body.
6. the cross section of low-temperature receiver accommodating chamber is ellipse or rectangle described in the preferred embodiments of the present invention, in same isometric(al)
Under the conditions of, when the freezing unit is being contracted to the outer sheath, reduce the internal diameter of outer sheath.
Brief description of the drawings
Fig. 1 is the overall structure diagram of adjustable freezing ablation catheter of the present invention.
Fig. 2 a and Fig. 2 b are the cross-sectional views along the line A-A interception shown in Fig. 1；Fig. 2 c are along shown in Fig. 1
The cross-sectional view of E-E lines interception.
Fig. 3 is the structural representation of the distal portions of adjustable freezing ablation catheter of the present invention.
Fig. 4 is the release process schematic that distal end stopping means I is not provided with the cryoablation conduit of prior art.
Fig. 5 is that the distal end of freezing unit of the prior art is fixed on the schematic diagram for causing core bar to deform on core bar.
Fig. 6 be freezing unit of the prior art distal end be not provided with distal end buffer unit cause outer sheath deform show
It is intended to.
Fig. 7 is the overall structure diagram of another embodiment of adjustable freezing ablation catheter of the present invention.
Fig. 8 a are the Longitudinal cross section schematics at the adjustable freezing ablation catheter B shown in Fig. 3, and Fig. 8 b are near-end buffer units
Structural representation.
Fig. 9 a are that the freezing unit of adjustable freezing ablation catheter of the present invention is the schematic diagram of helical structure；Fig. 9 b are
Enlarged drawing when distal end buffer unit shown in Fig. 9 a D is tapered titanium-nickel wire；Fig. 9 c are the distal end bufferings shown in Fig. 9 a D
Enlarged drawing when device is Metal Cutting pipe；Fig. 9 d are that the distal end buffer unit shown in Fig. 9 a D closes for the NiTi of spiral winding
Enlarged drawing during spun gold.
Figure 10 a are a kind of sectional views of embodiment along the line C-C interception shown in Fig. 9 a；Figure 10 b are along along Fig. 9 a
The sectional view of the another embodiment of shown line C-C interception.
Figure 11 is that the freezing unit of adjustable freezing ablation catheter of the present invention normally discharges process schematic.
Figure 12 is that the freezing unit of adjustable freezing ablation catheter of the present invention is the cage type knot that many helical structures are arranged
The schematic diagram of structure.
Figure 13 is the signal that the freezing unit of adjustable freezing ablation catheter of the present invention is the cage structure of stripe-arrangement
Figure.
Embodiment
For the objects, technical solutions and advantages of the present invention are more clearly understood, develop simultaneously embodiment referring to the drawings, right
The present invention is further described.
Distal end of the present invention refers to one end away from operator, one end of described near-end refers to Proximity operation person.
Embodiment one
As shown in figure 1, a kind of adjustable freezing ablation catheter 100, including low-temperature receiver pipeline, freezing unit 110, outer sheath 180,
Core bar 160, the low-temperature receiver pipeline and the core bar 160 are arranged in the tube chamber of the outer sheath 180, the core bar 160
Distal end stretch out outside the outer sheath 180, the near-end of the freezing unit 110 is connected with the distal end of the low-temperature receiver pipeline, described
The distal end of freezing unit 110 is flexibly connected by distal end buffer unit 140 with the core bar 160, and the freezing unit 110 includes
The shape memory mechanism of default form, the expansion form of the freezing unit 110 is realized by the shape memory mechanism, described cold
The compression diameter for freezing unit 110 is less than the internal diameter of the outer sheath 180, when the adjustable freezing ablation catheter 100 does not reach disease
When becoming position, the freezing unit 110 is located in the tube chamber of the outer sheath 180, when the low-temperature receiver pipeline and the outer sheath
During 180 generation relative displacement, the freezing unit 110 realizes expansion and contraction.
The material of the shape memory mechanism be Nitinol or thermoplastic, at relatively high temperatures by thermal finalization into
Predetermined shape.The shape memory mechanism can drive freezing unit 110 to be changed into expansion state from contraction state.Work as freezing unit
110 from the distal end of outer sheath 180 when being pushed out, and in the presence of shape memory mechanism, freezing unit 110 is with shape memory machine
The shape of structure and change, this shape is easy to freezing unit 110 to be fitted with cryoablation region.As shown in figures 10 a and 10b,
Shape memory mechanism 113 can be arranged in the internal cavities of freezing unit 110.Shape memory mechanism can also be arranged on
(not shown) in the outer wall of the freezing unit 110.The setting of shape memory mechanism causes freezing unit 110 in course of conveying
Pathological tissues can be smoothly sent in the less outer sheath 180 of caliber, so as to significantly reduce operative approach process
Damage to human body.The shape fitted with destination organization can be deformed into again after freezing unit 110 discharges from outer sheath 180
To complete freezing, freezing scope during treatment is increased, success rate of operation is improved.As shown in figure 1, the shape memory mechanism
113 be helical structure.The helical structure is made up of a titanium-nickel wire or a thermoplastic pipes or thermoplastic rod.
It is in compressive state when the helical structure is in outer sheath 180, it is linear to approach；Become helical structure after being released,
The security of conduit is improved, makes the pressure-resistant aspect of conduit safer, leakage and explosion is difficult.
As depicted in figs. 1 and 2, low-temperature receiver pipeline include air inlet pipe 1911 and muffler 1921, the near-end of air inlet pipe 1911 and
Inlet suction port 230 is connected, and the near-end of muffler 1921 is connected with return-air joint 240.The air inlet pipe 1911 and muffler 1921
The inlet channel 191 and return gas channel 192 of low-temperature receiver are formed respectively.Adiabatic apparatus is provided with outside the low-temperature receiver pipeline, it is described exhausted
Thermal runs through the non-frozen part of whole cryoablation conduit.The adiabatic apparatus is made up of vacuum chamber 200, can also be by exhausted
Hot material is made.In the present embodiment, air inlet pipe 1911 and the outside of muffler 1921 are provided with vacuum tube 201, the vacuum
The distal end of pipe 201 is connected with the distal seal of air inlet pipe 1911 and muffler 1921, the near-end and vacuum adapter of vacuum tube 201
250 are tightly connected, to realize the purpose of vacuum insulation.
The near-end of the low-temperature receiver pipeline is connected with pushing handle 220, by adjusting the delivery device pushed on handle 220
221 can be such that the freezing unit 110 for being connected to low-temperature receiver pipeline distal end is moved in outer sheath 180, to complete out sheath release and enter sheath
Withdraw.
As shown in figure 1, the distal end of freezing unit 110 is connected by the distal end buffer unit 140 with core bar 160, make freezing
Unit 110 and core bar 160 is are flexibly connected, and distal end buffer unit 140 is spring.The setting of distal end buffer unit 140 makes freezing
The cushioning effect that is connected with a power of the unit 110 in cryoablation with core bar 160, is pasted in refrigerating process with tissue
By when prevent freezing unit 110 from bending and cause tissue damage, so as to improve the validity of recline stability and operation.This
Outside, the distal end of the freezing unit 110 is flexibly connected by distal end buffer unit 140 with the core bar 160, the buffer unit
140 can reduce freezing unit 110 expand or contraction process in act on the active force on core bar 160, so as to reduce freezing
Unit 110 causes the risk that core bar 160 is deformed when passing in and out epitheca.As shown in figure 5, freezing unit 110 of the prior art is remote
End is typically directly fixed on core bar 160, during freezing unit 110 is withdrawn into outer sheath 180, and pulling force is limited from distal end
Position device is sent on core bar 160, when pulling force is excessive, will be made the deformation of core bar 160 or even be fractureed.The present invention is in adjustable freezing
The distal end buffer unit that ablation catheter distal end is set is decomposed the power being applied on core bar 160, so as to reduce core bar
160 deformation.Go out sheath in addition, the setting of distal end buffer unit reduces the distal end of freezing unit 110 and enter the resistance of sheath, prevent epitheca
Pipe 180 is distally deformed.If as shown in fig. 6, the distal end of freezing unit 110 is not provided with buffer unit, in the quilt of freezing unit 110
During movement enters outer sheath 180 and is moved out outer sheath 180, because the junction of its distal end and core bar 160 is really up to the mark, make
The head end of shape memory mechanism on freezing unit 110 is thick to be difficult to remove into outer sheath 180, is caused sheath and is entered sheath resistance mistake
Greatly, even if or enter in outer sheath 180, be also easily caused outer sheath 180 and deform.
As shown in figure 3, being provided with distal end stopping means on the adjustable freezing ablation catheter, freezing unit 110 is entered
Row is spacing.The distal end stopping means includes distal end stopping means I 120 and distal end stopping means II 130, distal end stopping means
I 120 is fixedly connected at the distal end of the distal end buffer unit 140, and is flexibly connected with the core bar 160.The distal end limit
Position device II 130 is fixedly connected on the distal end of the core bar 160, and the distal end stopping means II 130 limits the distal end
Stopping means I 120 does not limit the axial rotation of the freezing unit 110 to the axially displacement of core bar 160.Distally
Stopping means II 130 limits the highest distance position that freezing unit 110 is moved axially along core bar 160.Distal end stopping means I 120
It is fixedly connected at the distal end of distal end buffer unit 140, and is flexibly connected with core bar 160, therefore, distal end stopping means I 120
It can be moved on core bar 160.When needing freezing, freezing unit 110 is pushed out from outer sheath 180, single positioned at freezing
The distal end stopping means I 120 of first 110 distal ends is moved to the distal end stopping means II 130 along core bar 160, when freezing knot
Freezing unit 110 is withdrawn in outer sheath 180 after beam, and distal end stopping means I 120 is also moved proximally to therewith.Limited by distal end
Position, it is possible to achieve the distance of stretching outer sheath 180 and position are controllable every time for freezing unit 110.In this process, freezing list is made
The active force of the movement of member 110 is not acted directly on core bar 160, so as to reduce the deformation of core bar 160.Moreover, defeated
Send freezing unit 110 close to freezing tissue discharged and recalled freezing unit 110 enter outer sheath 180 during, distal end
Stopping means I 120 makes freezing unit 110 move axially and rotate on core bar 160, but does not depart from core bar.
In one embodiment, distal end stopping means I 120 is a spring, is enclosed on core bar 160, its near-end is connected to
The distal end of distal end buffer unit 140.Distal end stopping means II 130 is a clip, is fixedly connected on the distal end of core bar 160.Fig. 4
The release process schematic of distal end stopping means is not provided with the cryoablation conduit for showing prior art.Conveying and returning
The head end of freezing unit departs from core bar during removing, the irregular release in limited cavity near pathological tissues, leads
Causing can not effective cryoablation destination organization.And the present invention distal end stopping means setting make freezing unit 110 conveying and
Its distal end is abutted on core bar 160 all the time during withdrawing, and prevents the head end of freezing unit 110 from departing from core bar 160 so that freezing
Form after unit 110 discharges is consistent with default shape, it is ensured that cryoablation effect.
As shown in figure 3, near-end stopping means 150 is additionally provided with the adjustable freezing ablation catheter, it is cold for limiting
Freeze the diameter of near-end when unit 110 expands.The near-end stopping means 150 can prevent freezing unit 150 discharge during
The distal end rotation of outer sheath 180.Near-end stopping means 150 is arranged on the distal end of outer sheath 180, and it has two passages, an appearance
Receive freezing unit 110, another accommodates core bar 160.The setting of near-end stopping means 150 limits freezing unit 110 in epitheca
The motion in pipe exit, makes freezing unit not rotated against in the position around outer sheath, reduces diameter herein and avoids
It is in irregular shape after the irregular release of freezing unit and release.
The core bar 160 is a hollow stem, is mainly used to conveying operation related equipment or medium, and such as seal wire, mapping is led
Pipe or contrast solution etc..The near-end of core bar 160 is fixedly attached on fixed handle 210, and core bar is provided with fixed handle 210
Attachment means 213, for core bar 160 is fixed, are additionally provided with core bar liquid injection port 212, the core bar on fixed handle 210
160 inner chamber is in fluid communication with the core bar liquid injection port 212, and for injecting, contrast agent carries out radiography or injecting normal saline is rinsed
Core bar.In one embodiment, core bar 160 is ultra-thin multi-layer braided pipe, and internal layer is PEFE, and outer layer is PEBAX or nylon, in
Between be braiding layer, the PTFE of internal layer has very low coefficient of friction so that seal wire or mapping catheter can smoothly pass through, middle
Braiding layer higher support hardness can be provided, prevent conduit from bending, the Pebax or nylon of outer layer have relatively low friction system
Number so that power of the cryoablation conduit during push is smaller.
In another embodiment, the core bar 160 is high polymer material pipe, and the distal end of core bar 160 is provided with hardness
Adjusting means.The hardness regulating device is the wire of a Diameter Gradual Change, and the wire is arranged on the pipe of core bar 160
In wall, the soft durometer of the distal end of core bar 160 is adjusted by adjusting wire into the length of the distal end of core bar 160.Hardness regulation dress
Putting gradually changes the distal end hardness of core bar 160, and hardness is proximally gradually reduced to distal end, can so improve distal end of catheter
Pushability and pass through performance.
Outer sheath 180 is externally provided with low-temperature receiver pipeline 190 and core bar 160, the near-end of outer sheath 180 is fixedly connected on fixed hand
Handle 210.The distal end of outer sheath 180 is an adjustable bending structure, by adjusting the realization pair of the tune bender structure 211 on fixed handle 210
The curved function of tune of the distal end of outer sheath 180.
Embodiment two
The present embodiment and the difference of embodiment one are：As shown in fig. 7, being set in the distal end of the outer sheath 180
There is sacculus 170, the distal end of the sacculus 170 is fixedly connected on the distal end of the core bar 160, the outer layer of core bar 160
Pebax or nylon material, are easy to be tightly connected with the sacculus 170.The near-end of the sacculus 170 and the distal end of outer sheath 180
It is fixedly connected.The distal end stopping means is arranged on the inside of the sacculus 170.Distal end stopping means II 130 limits cold
Freeze the highest distance position that unit 110 is moved axially along core bar 160, prevent distal end stopping means I 120 from entering the shoulder of sacculus 170,
The junction of sacculus 170 and outer sheath 180 is arrived to, causes sacculus 170 to reveal.The present invention in freezing unit peripheral hardware Place capsule,
The effect of blocking blood flow is not only acted as under different application environments, reclining and positioning for freezing unit and destination organization is also improved
Performance.
As shown in Figure 2 a, in outer sheath 180, the space between core bar 160 and outer sheath 180 defines fluid injection cavity
181, the fluid injection cavity 181 and sacculus 170 and the sacculus liquid injection port 214 being arranged on fixed handle 210 are in fluid communication, and lead to
Cross to fluid injection chamber 181 and inject liquid and Filled Balloon 170.In one embodiment, the fixed handle connected with fluid injection chamber 181
Miniature relief valve is installed, the burst pressure and the work of sacculus 170 of the vent pressure of the miniature relief valve between sacculus 170 on 210
Make between pressure.In one embodiment, as shown in Figure 2 c, the outer sheath 180 is multi-lumen tube.
As shown in figure 11, when the distal end of the adjustable freezing ablation catheter 100 of the present invention is attached into cryoablation target area
After near, sacculus 170 is filled by liquid, and then freezing unit 110 is pushed from outer sheath 180 is discharged into sacculus 170,
Distal end stopping means I 120 positioned at the distal end of freezing unit 110 along core bar 160 is moved to the distal end stopping means II
130.Push and adjustment pushes handle 220 and the freezing unit 110 in sacculus 170 is adjacent to pathological tissues, then carry out freezing and disappear
Melt, freezing unit 110 will freeze energy and be delivered to pathological tissues by sacculus 170 and be melted in refrigerating process, ablation completion
Freezing unit 110 is recalled in outer sheath 180 afterwards, distal end stopping means I 120 is also moved proximally to therewith, then inhales flat sacculus
170, remove whole adjustable freezing ablation catheter 100.
The setting of sacculus 170 makes conduit block the blood flow Jing Guo lesion locations in refrigerating process, effectively prevents
Freezing energy is pulled away, and improves freezing efficiency, while sacculus 170 also plays the effect of a positioning, is increased and disease
Become the contact area of position, especially in the treatment of atrial fibrillation, the oral area of pulmonary vein can be navigated to.Prevent linear freezing list
Member 110 disengages from freezing region and causes freezing position to deviate.
Before adjustable freezing ablation catheter of the invention does not reach diseased region nearby, the freezing unit 110 is located at described outer
In the tube chamber of sheath 180, so that cryoablation distal end of catheter diameter is reduced, it is in the prior art that freezing unit 110 is directly solid
Surely being connected to the mode of distal end causes distal diameter big.In addition, when the distal end of the outer sheath is provided with sacculus, freezing unit
In cryoablation catheter course of conveying and sacculus is not directly contacted with, does not produce direct friction with sacculus, reduce sacculus risk of rupture.
The distal end of freezing unit is fixed on core bar in the prior art, in order to ensure that freezing unit also keeps the shape of pre-setting upon discharge
Shape memory mechanism (including the connecting portion ited with core bar) on shape and size, freezing unit has certain rigidity, this
Rigidity make it that the total radial dimension ratio in distal end and core bar junction of shape memory mechanism is larger, so causes to be arranged on its outside
The pressure of sacculus hold that diameter is big, conduit is big by external diameter.Secondly as shape memory mechanism is metal material, outside freezing unit
The sacculus in face is very thin high polymer material, and the mutual extruding of the two is easily caused sacculus rupture during sacculus pressure is held.
And in the present invention, before pressure is held, freezing unit and shape memory mechanism therein are completely removed in outer sheath, positioned at sacculus
Pressure is held outside region, natural during sacculus pressure is held to be damaged to sacculus, adds the security of sacculus, and due to
Freezing unit is moved in outer sheath, also causes sacculus pressure to hold diameter and diminish, conduit is diminished by diameter.
As figures 8 a and 8 b show, adjustable freezing ablation catheter of the invention is also set in the near-end of the freezing unit 110
It is equipped with near-end buffer unit 114, the freezing unit 110 is remote by the near-end buffer unit 114 and the low-temperature receiver pipeline
End is fixedly connected.When the freezing unit 110 is reclining pathological tissues, the near-end buffer unit 114 provides a power
Buffering so that freezing unit 110 reclines than milder, and the setting of near-end buffer unit 114 makes the He of freezing unit 110
The connection of low-temperature receiver pipeline not only to be tightly connected but also is elastic connection, and the diameter of junction is become into smaller, be more easy to convey into
Human body.Described be tightly connected ensures that the refrigerant of junction can not be revealed, and the elastic connection make it that its junction is not stiff,
It is more easy to operate to convey into human body.In one embodiment, one end of the shape memory mechanism 113 is buffered positioned at the near-end
The inside of device 114, when the freezing unit 110 is reclining pathological tissues, the near-end buffer unit 114 provides one
The buffering of power so that freezing unit 110 reclines than milder.
In one embodiment, the near-end buffer unit 114 is surface-treated, and is improved and the outer sheath
180 and the bonding strength and sealing property of the freezing unit 110, the surface treatment includes laser ablation, laser marking, spray
Sand, mechanical grinding, chemical etching etc..
In one embodiment, the distal end buffer unit 140 and/or the near-end buffer unit 114 are spring knot
Structure.In another embodiment, the distal end buffer unit 140 and/or the near-end buffer unit 114 are by cuts in metallic pipe
Form, to realize the distal end of the freezing unit 110 and/or the flexible connection of near-end and the core bar 160, the metal tube is excellent
Elect stainless steel tube or tin-tube as.In further embodiment, distal end buffer unit 140 and/or the near-end buffering dress
Put 114 nitinol alloy wires by one with the different amorphous configurations of multistage to be made, to realize the distal end of the freezing unit 110
And/or near-end is flexibly connected with the core bar 160.The different amorphous configurations of the multistage by the nitinol alloy wire with bending section and
The turn being coiled into by the nitinol alloy wire is constituted.In further embodiment, the distal end buffer unit 140 and/or
By a diameter, gradually small or spiral winding nitinol alloy wire is made the near-end buffer unit 114, to realize that the freezing is single
The distal end of member 110 and/or near-end are flexibly connected with the core bar 160.In further embodiment, the distal end buffer unit
And/or the near-end buffer unit is made up of flexible high molecular material.It is preferred that, the distal end buffer unit 140 and/or near-end
Buffer unit 114 selects metal material, can prevent shape memory mechanism 113 from poking outer sheath 180 due to bending, so as to avoid
The injury that conduit is damaged or caused to human body.Fig. 9 b to Fig. 9 d show the different structure signal of the distal end buffer unit 140
Figure.
As shown in figures 10 a and 10b, the freezing unit 110 is remembered by distal end air inlet pipe 111, distal end muffler 112 and shape
Recall mechanism 113 to constitute.The formation low-temperature receiver of distal end air inlet pipe 111 injecting cavity 115, the formation low-temperature receiver of distal end muffler 112 accommodating chamber 116.
The inlet channel 191 and return gas channel 192 of low-temperature receiver pipeline 190 hold with the low-temperature receiver injecting cavity 115 and low-temperature receiver of freezing unit 110 respectively
Chamber 116 of receiving is in fluid communication.The shape memory mechanism 113 is arranged in low-temperature receiver accommodating chamber 116 (as shown in Figure 10 a), or
The shape memory mechanism 113 is arranged in low-temperature receiver injecting cavity 115 (as shown in fig. lob).The horizontal stroke of the low-temperature receiver accommodating chamber 116
Section is ellipse or rectangle, under the conditions of same isometric(al), when the freezing unit 110 is being contracted to the outer sheath 180
When, reduce the internal diameter of outer sheath.
Vacuum tube 201, vacuum tube 201 and low-temperature receiver pipeline one entirety of formation are provided with outside low-temperature receiver pipeline, outside
Moved in sheath 180.Because low-temperature receiver pipeline and vacuum tube 201 have certain flexibility, easily bent during push, so, in this reality
Apply in example, as shown in Figure 2 c, a reinforced pipe 222 is provided with the outside of the proximal part of the vacuum tube 201, it is described to strengthen
Pipe 222 is fixedly connected with vacuum tube 201, thrust is sent into reinforced pipe 222 by the delivery device 221 on handle, then band
Dynamic vacuum tube 201 releases low-temperature receiver pipeline from outer sheath 180.
Embodiment three
The present embodiment is with the difference of embodiment one：The shape memory mechanism 113 is cage structure.Such as Figure 12 institutes
Show, the cage structure is that multiple helical structures are arranged or are wound, and the arrangement of the multiple helical structure can be
Many helical structure array configurations centered on conduit axis.As shown in figure 13, the cage structure can be that strip freezing is single
The arrangement of member 110 is formed.
In addition, being additionally provided with heater strip on the freezing unit 110, the heater strip can be managed in freezing unit 110
Circumferentially detoured on wall, also can be along the axial array distribution of freezing unit 110.The heater strip is arranged on the pipe of freezing unit 110
In wall, heater strip extends to the tube wall of vacuum tube 201 out of freezing unit 110 tube wall, then by handle joint extraction catheter.It is logical
Cross the heating to heater strip so that the process of rewarming shortens after freezing, and then shorten whole operating time.
Finally it should be noted that the foregoing is only the preferred embodiment of the present invention, not to limit this
Invention, any modifications, equivalent substitutions and improvements made within the spirit and principles of the invention etc., it should be included in this hair
Within bright protection domain.
Claims (15)
1. a kind of adjustable freezing ablation catheter (100), it is characterised in that including low-temperature receiver pipeline, freezing unit (110), outer sheath
(180) and core bar (160), the low-temperature receiver pipeline and the core bar (160) are arranged on the tube chamber of the outer sheath (180)
Interior, the outer sheath (180) is stretched out outside in the distal end of the core bar (160), near-end and the low-temperature receiver of the freezing unit (110)
The distal end connection of pipeline, the distal end of the freezing unit (110) is living by distal end buffer unit (140) and the core bar (160)
Dynamic connection, the freezing unit (110) includes the shape memory mechanism (113) of default form, the expansion of the freezing unit (110)
Open form to be realized by the shape memory mechanism (113), when the adjustable freezing ablation catheter (100) does not reach diseased region
When, the freezing unit (110) is located in the tube chamber of the outer sheath (180), when the low-temperature receiver pipeline and the outer sheath
(180) when occurring relative displacement, the freezing unit (110) realizes expansion and contraction.
2. adjustable freezing ablation catheter according to claim 1, it is characterised in that in the adjustable freezing ablation catheter
(100) distal end stopping means is provided with, the distal end stopping means includes the spacing dress of distal end stopping means I (120) and distal end
Put II (130), the distal end stopping means I (120) is fixedly connected at the distal end of the distal end buffer unit (140), and with
The core bar (160) is flexibly connected；The distal end stopping means II (130) is fixedly connected on the distal end of the core bar (160),
The distal end stopping means II (130) limits the distal end stopping means I (120) to the core bar (160) axially
Displacement.
3. adjustable freezing ablation catheter according to claim 1 or 2, it is characterised in that in the freezing unit (110)
Near-end is provided with near-end buffer unit (114), the freezing unit (110) by the near-end buffer unit (114) with it is described
The distal end of low-temperature receiver pipeline is fixedly connected.
4. adjustable freezing ablation catheter according to claim 3, it is characterised in that the distal end buffer unit (140) and/
Or the near-end buffer unit (114) is spring structure.
5. adjustable freezing ablation catheter according to claim 3, it is characterised in that the distal end buffer unit (140) and/
Or the near-end buffer unit (114) is formed by cuts in metallic pipe, to realize flexible connection.
6. adjustable freezing ablation catheter according to claim 3, it is characterised in that the distal end buffer unit (140) and/
Or by a diameter, gradually small or spiral winding nitinol alloy wire is made the near-end buffer unit (114), to realize flexible connect
Connect.
7. adjustable freezing ablation catheter according to claim 3, it is characterised in that the distal end buffer unit (140) and/
Or the near-end buffer unit (114) is made up of flexible high molecular material.
8. adjustable freezing ablation catheter according to claim 2, it is characterised in that the distal end in the outer sheath (180)
Sacculus (170) is provided with, the distal end of the sacculus (170) is fixedly connected on the distal end of the core bar (160), and the distal end is spacing
Device is arranged on the inside of the sacculus (170).
9. adjustable freezing ablation catheter according to claim 1, it is characterised in that the freezing unit (110) includes cold
Source injecting cavity (115), low-temperature receiver accommodating chamber (116) and the shape memory mechanism (113).
10. adjustable freezing ablation catheter according to claim 9, it is characterised in that the horizontal stroke of the low-temperature receiver accommodating chamber (116)
Section is ellipse or rectangle.
11. adjustable freezing ablation catheter according to claim 1, it is characterised in that shape memory mechanism (113) quilt
It is arranged on the freezing unit (110) inside or is arranged in the outer wall of the freezing unit (110).
12. adjustable freezing ablation catheter according to claim 1, it is characterised in that the shape memory mechanism (113) is
Helical structure.
13. adjustable freezing ablation catheter according to claim 12, it is characterised in that the shape memory mechanism (113)
For cage structure.
14. adjustable freezing ablation catheter according to claim 1, it is characterised in that in the near of the freezing unit (113)
End is additionally provided with near-end stopping means (150), and the near-end stopping means (150) is arranged on the remote of the outer sheath (180)
End, with two passages, one is used to accommodate the freezing unit (110), and another is used to accommodate the core bar (160).
15. adjustable freezing ablation catheter according to claim 1, it is characterised in that set on the freezing unit (110)
It is equipped with heater strip.
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| CN108056815A (en) * | 2017-12-28 | 2018-05-22 | 山东省立医院 | A kind of tumor microwave ablation needle with temperature controlling function |
| CN109480998A (en) * | 2018-11-09 | 2019-03-19 | 宁波胜杰康生物科技有限公司 | A kind of expansible cryoablation conduit |
| CN110974398A (en) * | 2019-12-04 | 2020-04-10 | 宁波胜杰康生物科技有限公司 | Cryoablation system with magnetic navigation |
| CN113100911A (en) * | 2021-05-13 | 2021-07-13 | 上海玮启医疗器械有限公司 | Cryoablation system and air source replacement method |
| CN113598926A (en) * | 2021-08-06 | 2021-11-05 | 上海市胸科医院 | Cryoablation catheter and system |
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| US20150066007A1 (en) * | 2013-08-30 | 2015-03-05 | Medtronic Ardian Luxembourg S.A.R.L. | Neuromodulation catheters with nerve monitoring features for transmitting digital neural signals and associated systems and methods |
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| US20150066007A1 (en) * | 2013-08-30 | 2015-03-05 | Medtronic Ardian Luxembourg S.A.R.L. | Neuromodulation catheters with nerve monitoring features for transmitting digital neural signals and associated systems and methods |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108056815A (en) * | 2017-12-28 | 2018-05-22 | 山东省立医院 | A kind of tumor microwave ablation needle with temperature controlling function |
| CN109480998A (en) * | 2018-11-09 | 2019-03-19 | 宁波胜杰康生物科技有限公司 | A kind of expansible cryoablation conduit |
| CN109480998B (en) * | 2018-11-09 | 2024-01-26 | 宁波胜杰康生物科技有限公司 | Expandable cryoablation catheter |
| CN110974398A (en) * | 2019-12-04 | 2020-04-10 | 宁波胜杰康生物科技有限公司 | Cryoablation system with magnetic navigation |
| CN113100911A (en) * | 2021-05-13 | 2021-07-13 | 上海玮启医疗器械有限公司 | Cryoablation system and air source replacement method |
| CN113598926A (en) * | 2021-08-06 | 2021-11-05 | 上海市胸科医院 | Cryoablation catheter and system |
| CN113598926B (en) * | 2021-08-06 | 2023-09-12 | 上海市胸科医院 | Cryoablation catheter and system |
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| CN107049467B (en) | 2020-01-14 |
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Address after: No.15, Lane 3399, Kangxin highway, Pudong New Area, Shanghai, 201321 Patentee after: Kangfeng Biotechnology (Shanghai) Co.,Ltd. Address before: No.15, Lane 3399, Kangxin highway, Pudong New Area, Shanghai, 201321 Patentee before: CRYOFOCUS MEDTECH (SHANGHAI) Co.,Ltd. |