CN105377167B - The cooling duct of electrothermal module with coolant fluid cooling - Google Patents

The cooling duct of electrothermal module with coolant fluid cooling Download PDF

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Publication number
CN105377167B
CN105377167B CN201380076100.6A CN201380076100A CN105377167B CN 105377167 B CN105377167 B CN 105377167B CN 201380076100 A CN201380076100 A CN 201380076100A CN 105377167 B CN105377167 B CN 105377167B
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electrothermal module
heat
module
catheter
heat exchange
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CN105377167A (en
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亚伯拉罕·伯格
阿夫里尔·哈赞
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BERGER THERMAL RESEARCH Ltd
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BERGER THERMAL RESEARCH Ltd
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Priority claimed from PCT/IL2013/050363 external-priority patent/WO2013164820A1/en
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Abstract

Cryoablation catheter includes:Elongated flexible parts of vessels, with short rigid conduit tip, for being introduced into therapentic part;Electrothermal module;And heat exchange arrangement, for the cryogenic temperature catheter tip is chilled to from about -15 DEG C to about -30 DEG C, to freeze tissue in treatment site.

Description

The cooling duct of electrothermal module with coolant fluid cooling
Technical field
The present invention generally relates to conduits, and relate in particular to for carrying out the cold of cold therapy in therapentic part Freeze conduit (cryocatheter).
Background technology
The present invention relates to the conduits with elongated flexible parts of vessels and short rigid conduit tip (catheter tip).Root It is anticipated that depending on clinical application, parts of vessels generally about 0.5m to 1.5m is long.Rigid conduit tip generally about 0.8cm is arrived 1.5cm long.Parts of vessels and catheter tip have the outer diameter of 2.3mm to 3.3mm, correspond to French apertometer 7-10.Catheter tip End receiving end in guiding catheter dome, guiding catheter dome is usually by the biocompatible materials of such as platinum, iridium and the like It is formed.For certain surgical procedures, in single clinical procedure, catheter tip is intended to via the access interface that can be accessed from outside (manipulation will be executed along human intracavity) is introduced into human intracavity, reaches therapentic part to execute treatment here, then edge Human intracavity retracts catheter tip, and human intracavity is left at access interface.More specifically, the present invention is directed to for freezing At a temperature of the cryoablation catheter of cold therapy is executed in therapentic part, in the present case, cryogenic temperature is -10 DEG C and colder Subzero tip temperature.
Implement cryoablation catheter currently with Joule-Thomson effect, that is, so that liquid, gas or vapor refrigerant are logical The pressure line for crossing 70 bars to 150 bars, to generate the pressure loss, is generated therewith with being left by the attaching means at catheter tip It heat loss and is quickly cooled down, catheter tip is chilled to cryogenic temperature.Exemplary prior art patent disclosure case is especially wrapped United States Patent (USP) No.5 containing entitled " cryoablation conduit (the Cryo-Ablation Catheter) " for authorizing Wijkamp, 807,391, entitled " to there is conduit (the Catheter with Cryogenic and of freezing and electrothermal ablation Electrical Heating Ablation) " Patent Application Publication No.2011/0196359, it is entitled " especially It is suitable for cryosurgery tool (the Cryosurgical Instrument particularly through bronchoscopic biopsies Suitable for transbronchial biopsy) " PCT International Publication case No.WO2010/121739 etc..
Cryoablation catheter can be purchased with several brand names from Medtronic CryoCath, Inc.www.cryocath.com It buys, wherein especially includingMAX myocardial refractoriness ablation catheter andMyocardial refractoriness ablation catheter. Cryoablation catheter utilizes nitrous oxide or argon refrigerant, and can transmit tens watts from tissue heat in 4 to 5 minutes Thermal energy, for by catheter tip be chilled to -150 DEG C it is so low, to form up to the so-called ice hockey of the size of 20mm diameters, with For height freezing energy purpose, such as cryoablation etc..Cryoablation catheter also operates under partial freeze ability, for low cold Freeze energy and medium freezing energy purpose, such as the freezing mapping journey under usually -10 DEG C to -20 DEG C of narrow temperature range Sequence etc..Cryoablation catheter is considered being more difficult to manipulate than non-frozen conduit, because its construction is able to take high pressure, may cause in this way It is more difficult to manipulation conduit and is sent to desired therapentic part.In addition, cryoablation catheter is very expensive.
Invention content
The present invention is directed to the cryoablation catheter system comprising cryoablation catheter, and the cryoablation catheter has elongated flexible parts of vessels With short rigid conduit tip, it is used to execute cold therapy in treatment site.In single clinical procedure, catheter tip is usual Via can be introduced into human intracavity from the access interface of outside access, to shift therapentic part onto along human intracavity, at this In execute cold therapy, then retracted along human intracavity, it made to leave human intracavity in access interface.The cryoablation catheter of the present invention Including at least one electrothermal module, for by the outer surface directly freezed of catheter tip to close to 37 DEG C of human body temperature therapentic parts The cryogenic temperature from -10 DEG C to -30 DEG C, to freeze tissue temporarily to execute freezing procedure, then to catheter tip It thaws, to permit removing cryoablation catheter from human intracavity.The cryoablation catheter of the present invention additionally comprises heat exchange arrangement, with External coolant fluid source stream is connected to, for providing downstream coolant fluid stream, to make coolant fluid stream pass through, with The electrothermal module hot side of cooling at least one electrothermal module, so as to the outer surface at cryoablation catheter tip.
Non-frozen conduit is cooled down for a long time using electrothermal module always and/or heating duct tip is so as in therapy section Position executes treatment.Exemplary prior art patent disclosure case especially includes US 7,238 184, WO 94/19833, entitled " tool There are thermoelectric device (the Thermo electric Devices with Recuperative Heat of recuperative heat exchanger Exchangers) ", 02/080766 WO, entitled " lipid pool handles (Treatment of Lipid Pool) " etc..This The non-frozen conduit of class will be cold with the electrothermal module for cooling down its catheter tip of electrothermal module using a series of heat sink technologies The electrothermal module hot side of the opposed electrothermal module in side is cooled to human body temperature hereinafter, being still significantly larger than the cryoablation catheter of the present invention The cryogenic temperature that can be realized.Heat sink technology includes especially heat conduction solid core radiator, uses the blood pool etc. close to therapentic part.
The 11st rows of page 6 of WO 02/080766 disclose a kind of guide tube assembly part 70, have " cold " bottom surface 200, are used for Solidification or " freezing " are located at the inflammation in artery 100 and unstable lipid pool 110.02/080766 guide tube assembly parts 70 of WO can To use electrothermal module, for example, can be from the TEC Microsystems GmbH in Berlin, Germany-Erik Adlerz Hough area (www.tecmicrosystems.com) it buys.Suitable electrothermal module especially includes 1MD03-008-4,1MD03-036-4 And the like, with 25% to 30% thermal effect under the temperature difference of 30 DEG C to 40 DEG C of its electrothermal module hot and cold sides both ends Rate.The larger temperature difference at electrothermal module both ends can be such that its thermal efficiency seriously reduces, and be considered as not conforming to reality.WO 02/080766 Guide tube assembly part 70 is cooled down by blood flow, therefore can be shown, the aforementioned thermoelectricity operated under such as 15% to 20% thermal efficiency Bottom surface 200 can be cooled to such as about 10 DEG C by module, this is enough to cure inflammation or unstable lipid pool, but cannot be by bottom surface 200 are cooled to zubzero temperature.
The present invention be based on the realisation that:Can design heat exchange arrangement, so as in 3 to 4 minutes duration from Electrothermal module hot side carries out adequately heat and transmits, with the region close to 37 DEG C of human body temperature therapentic parts will catheter tip it is outer Surface freezing is to the cryogenic temperature from -10 DEG C to -30 DEG C, to generate different shape and various sizes of freezing in therapentic part Tissue.Such refrigerating capacity can freeze tissue to form the ice hockey of 6.0mm to 8.0mm diameters, be suitable for low Bioactivity in medium freezing energy cold therapy program, such as blocking tissue, provides 50 grams of anchorage force etc.. The cryoablation catheter of the present invention cannot supply high freezing energy identical with above-described Joule-Thomson cryoablation catheter, still It is contemplated that the cryoablation catheter of the present invention will be cheaply more many than Joule-Thomson cryoablation catheter, it is low and medium freezing energy therefore Measure the preferred option of cold therapy program.In addition, the present invention's is imitated based on the cryoablation catheter of electrothermal module than Joule-Thomson Cryoablation catheter is answered to be easier to control.
Can show, needed the heat of from about 1.5 watts to about 2.0 watt thermal energy to transmit within 3 to 4 minutes duration with Partial body's tissue is chilled to from about -10 DEG C to about -25 DEG C in 37 DEG C of human body temperature treatment sites.Therefore, it is based on Aforementioned actual 30% thermal efficiency needs the heat exchange arrangement of the present invention from the electrothermal module hot side heat of at least one electrothermal module Transmit the thermal energy from about 6.5 watts to 7.5 watts.This thermal energy is in view of needing from the thermal energy for having tissue to be frozen to absorb With through applying to operate the electric energy of at least one electrothermal module.In order to allow the electrothermal module cold side of electrothermal module to have about -10 DEG C to the cryogenic temperature between -30 DEG C, electrothermal module hot side must be about 10 DEG C of temperature, such as pass through aforementioned thermoelectricity mould Specified by 30 DEG C to the 40 DEG C temperature difference of the block hot side with electrothermal module cold side both ends.Downstream coolant fluid stream can be cooled to not low It, may be before being delivered to catheter tip with regard to freezing to prevent it in the cryogenic temperature close to such as about 3 DEG C.Therefore, under Swim coolant fluid stream has such as average about 5 DEG C of downstream temperature after it is delivered to catheter tip, in downstream cold But about 5 DEG C of temperature difference are left between agent fluid stream and electrothermal module hot side.According to the longitudinal direction of the electrothermal module in catheter tip or Laterally deployment, electrothermal module hot side have 20+10mm2Area occupied.The vertical and horizontal deployment of electrothermal module is correspondingly The longitudinal axis with parts of vessels is altogether to or transverse to the longitudinal axis of parts of vessels.The generally longitudinally hot side area occupied ratio of electrothermal module Lateral electrothermal module is big.Therefore, heat exchange of the invention arrangement must be designed to from 20+10mm2Electrothermal module hot side is inhaled 7.5W thermal energy is received, what this was represented is from about 250Kw/m2To 750Kw/m2Quite big heat density heat dissipation.
The present invention includes that two kinds of heat exchange is arranged to realize hot transmission degree high so as follows:First, it is so-called Heat spreader module.And second, so-called jet impulse module.
The former includes the radiator being connect with the electrothermal module hot side thermal energy of at least one electrothermal module.Radiator is led by height Thermal conductive material is made, and this kind of material usually has at least 170w/m DEG C of thermal coefficient.Suitable material especially includes metal, carbon Base heat conducting material and the like.Fansink designs at the total heat exchange surface area at least more four times greater than hot side area occupied, To absorb about 7.5 watts of thermal energy.It is contemplated by the invention that several different embodiments of following cooling fin:Fin type radiates Device.Coiled radiator.The radiator of traverse net disk stacks.Porous radiator.
The latter uses coolant fluid supply pipe, provides one or more coolant fluid jet streams, coolant fluid supply Pipe is preferably directly against electrothermal module hot side, to transmit 7.5 watts of thermal energy from electrothermal module hot side heat.About using jet stream The principle for carrying out thermal energy heat dissipation, please refers to two jet impulse papers, this two papers are incorporated herein by reference.It penetrates Stream impact paper is as follows:" localized heat to impact liquid jet of initial laminar flow, transition and turbulent scheme transmits (Local Heat Transfer to Impinging Liquid Jet in the Initially Laminar,Transitional And Turbulent Regimes) ", author is B.Elison and B.W.Webb,《Heat and mass transfer periodical (Journal of Heat and Mass Transfer)》, the 8th phase in 1994, volume 37." by the convective heat transfer for impacting round liquid jet stream (Convective Heat Transfer by Impingement of Circular Liquid Jets) ", Zuo Zhewei X.Liu and J.H.Lienhard and J.S.Lombara,《Heat transmits periodical (Journal of Heat Transfer)》, 1991 Year August, volume 113/571.Alternatively, electrothermal module hot side can be covered by shock plate, the shock plate and its electrothermal module that underlies Directly thermally contact.
The cryoablation catheter system of the present invention may be embodied as open irrigating catheter system or circulation conduit system.At the former In, coolant fluid opens the inside of human body being flushed to around therapentic part, and therefore coolant fluid must be biofacies Compatible liquid, for example, 0.9%NaCl physiological saline and the like.In the latter, cryoablation catheter is returned comprising coolant fluid Flow tube, it is coextensive with coolant fluid supply pipe, for coolant fluid to be transferred to external coolant from catheter tip Fluid target.Coolant fluid target is preferably connected to coolant fluid source in order to recycle.Coolant fluid is not necessarily Biocompatible liquid, and it can be gas, such as nitrous oxide, argon and the like.
The cryoablation catheter of the present invention can dispose one or more electrothermal modules longitudinally and/or laterally in catheter tip. The electrothermal module of cryoablation catheter according to the present invention may include single Paar label apparatus or two or more Paar label apparatus It stacks, the electrothermal module hot side of a Paar label apparatus faces the electrothermal module cold side of another Paar label apparatus.
Description of the drawings
In order to understand the present invention and understand actually how can to execute the present invention, referring now to attached drawing only only by Preferred embodiment is described in non-limiting examples, wherein with the part for indicating similar is identically numbered, and wherein:
Fig. 1 is the open block diagram for rinsing cryoablation catheter system, rinses cryoablation catheter it includes open, the opening is rinsed cold It includes lateral electrothermal module and heat exchange arrangement to freeze conduit, for forming ice hockey in therapentic part;
Fig. 2 is the open cross section for rinsing cryoablation catheter of Fig. 1 of the line A-A in Fig. 1;
Fig. 3 is the block diagram of circulating frozen conduit system, and the circulating frozen conduit system includes circulating frozen conduit, is used for Ice hockey is formed in therapentic part;
Fig. 4 is the cross section of line B-B of the circulating frozen conduit of Fig. 3 in Fig. 3;
Fig. 5 is the longitudinal section of the catheter tip of Fig. 1, and the catheter tip includes longitudinal electrothermal module and heat spreader module;
Fig. 6 is the longitudinal section of the catheter tip of Fig. 1, and the catheter tip includes lateral electrothermal module and coiled radiator;
Fig. 7 is the top orthogonal view of the coiled radiator of Fig. 6;
Fig. 8 is the longitudinal section of the catheter tip of Fig. 1, and the catheter tip includes longitudinal electrothermal module and porous radiator;
Fig. 9 is the longitudinal section of the catheter tip of Fig. 1, and the catheter tip includes longitudinal electrothermal module and fin type heat dissipation Device;
Figure 10 is the cross section of line C-C of the finned radiator of Fig. 9 in Fig. 9;
Figure 11 is the longitudinal section of the catheter tip of Fig. 3, and the catheter tip includes that lateral electrothermal module and replacement coil pipe dissipate Hot device;
Figure 12 is the top orthogonal view of the coiled radiator of Fig. 1;
Figure 13 is the longitudinal section of the catheter tip of Fig. 3, and the catheter tip includes lateral electrothermal module and conducting wire Dropbox Radiator stacks;
Figure 14 is the top orthogonal view for the conducting wire Dropbox that the radiator of Figure 13 stacks;
Figure 15 is the perspective cross-sectional view of the catheter tip of Fig. 1, and the catheter tip includes lateral electrothermal module and has single The jet impulse module of a nozzle;
Figure 16 A are the anterior elevational views of the jet impulse module of Figure 15;
Figure 16 B are the top orthogonal views of the impact zone of the nozzle of the jet impulse module of Figure 15 in electrothermal module hot side;
Figure 17 is the longitudinal section of the catheter tip of Fig. 1, and the catheter tip includes spray there are three longitudinal electrothermal module and tools The jet impulse module of mouth;
Figure 18 is the cross section of the E-E lines in Figure 17 of the catheter tip of Figure 17;
Figure 19 is the perspective cross-sectional view of the catheter tip of Fig. 3, and the catheter tip includes lateral electrothermal module and has single The jet impulse module of a nozzle;
Figure 20 is the longitudinal section of the catheter tip of Fig. 3, and the catheter tip is used for the portion of hangover area at cryoablation catheter tip;
Figure 21 is the longitudinal section of the catheter tip of Fig. 1, and the catheter tip includes longitudinal electrothermal module and lateral thermoelectricity mould Block and heat spreader module;
Figure 22 is the open block diagram for rinsing cryoablation catheter system, and the open cryoablation catheter system of rinsing includes cryoablation catheter Device is melted with the RF for executing RF ablations in therapentic part;
Figure 23 is the cross section of the F-F lines in Figure 22 of the parts of vessels of Figure 22;
Figure 24 is the open block diagram for rinsing cryoablation catheter system, and the open cryoablation catheter system of rinsing includes to have conduit The cryoablation catheter at tip, the catheter tip have sensor;
Figure 25 is the cross section of the G-G lines in Figure 24 of the parts of vessels of Figure 24;
Figure 26 is the open longitudinal section for rinsing cryoablation catheter, and the open cryoablation catheter that rinses includes a pair of of blank pipe chamber, is used In in therapentic part introducing operation tool;And
Figure 27 is the cross section of the H-H lines in Figure 26 of the parts of vessels of Figure 26.
Specific implementation mode
Fig. 1 illustrates open flushing cryoablation catheter system 100A, is used together, opens with the open cryoablation catheter 130A that rinses It includes to open to rinse elongated flexible parts of vessels 131A and open to rinse short rigid conduit tip to put flushing cryoablation catheter 130A 132A, for forming ice hockey IB in therapentic part.Cryoablation catheter system 100A must utilize biocompatible liquid for cold But purpose, in order to be flushed to inside of human body tissue therapentic part is open.The biocompatible liquid is preferably 0.9% NaCl physiological saline and the like.
Parts of vessels 131A has the length of about 0.5m to 1.5m, is denoted as E, and it is pre- that this length depends on parts of vessels The cold therapy application of phase.Catheter tip 132A has the length of about 0.8cm to 1.5cm.Parts of vessels 131A and catheter tip Hold 132A that there is the outer diameter of about 2.3mm to 3.3mm.Catheter tip 132A is in 133 receiving end of guiding catheter dome.Conduit dome 133 can have smooth spherical form.Alternatively, conduit dome 133 can be formed as different facing and shape, be similar to Commercially available RF ablation catheters and diagnostic catheter.For example, MedtronicCryoablation conduit and St.Jude Medical'sDiagnostic catheter has conduit dome 133 of different shapes.
Catheter tip 132A includes lateral electrothermal module 134, transverse to the longitudinal axis of parts of vessels 131A.Suitable thermoelectricity Module 134 includes the dash number 1MD03-008-4 of such as TEC Microsystems GmbH, can be from Berlin, Germany-A De The TEC Microsystems GmbH (www.tecmicrosystems.com) in Le Si Houghs area are bought.Electrothermal module 134 There is electrothermal module hot side 136 and electrothermal module cold side 137 during the operation of its cryoablation catheter tip 132A.Catheter tip 132A includes that heat exchange arranges 138, for carrying out hot transmission from electrothermal module hot side 136.Catheter tip 132A includes temperature-sensitive electricity Resistance 139, the temperature for monitoring electrothermal module hot side 136 or electrothermal module cold side 137.Catheter tip 132A includes one or more Flushing hole 141, for enabling the coolant fluid from catheter tip 132A to flow to the inside of human body around therapentic part. The heat exchange arrangement 138 of catheter tip 132A may be embodied as heat spreader module or jet impulse module, as described below.
Conduit dome 133 is contacted with 137 high heat conductor of electrothermal module cold side, to freeze tissue to form ice hockey IB.Conduit dome 133 is formed by the high heat conductor material of biocompatibility, and the thermal coefficient of the material is at least>50w/m DEG C, and And preferred higher.Suitable conduit dome material includes metal, such as platinum, iridium, gold etc. and high-termal conductivity plastics.Gold is especially suitable for In some applications, because the thermal coefficient of gold is high, k>250w/m℃.High-termal conductivity filling is preferably used in conduit dome 133 Material is glued in electrothermal module cold side 137, to reduce from electrothermal module cold side 137 to the temperature drop of conduit dome 133.Suitably Commercially available high-level gap fill material has about 10w/m DEG C of high thermal conductivity coefficient k.
Fig. 2 illustrates parts of vessels 131A and is constructed with extrusion molding, and it includes following longitudinal direction tube chambers:First, central tube Chamber 142 is used to downstream coolant fluid-flow being delivered to catheter tip 132A for housing coolant fluid supply pipe 143. Second, a pair of opposed tube chamber 144, for accommodating manipulation conducting wire 146, to help catheter tip 132A to pass through to therapentic part.The Three, tube chamber 147 is connected to electrothermal module 134 for housing power transmission line pair 148.And the 4th, tube chamber 149, for housing Thermal resistor wire pair 151 is connected to thermistor 139.Tube chamber 149 can be also used for accommodating other pilot.
Cryoablation catheter system 100A includes:External coolant fluid source 101, for passing biocompatibility coolant fluid Cryoablation catheter 130A is delivered to so as to cryoablation catheter tip 132A;Electrothermal module power supply 102 is connected to power transmission line pair 148;And Controller 103, the operation for controlling external coolant fluid source 101 and electrothermal module power supply 102.Controller 103 include open/ Parallel operation 104 deeply concerned, the solution for the icing control 106 of cryoablation catheter tip 132A and for thawing to catheter tip 132A Freeze control 107 and temperature levels control 108, and is connected to thermal resistor wire pair 151.Defrosting control 107 makes power transmission line Polarity reversion to 148, to cool down electrothermal module hot side 136 and heating electrothermal module cold side 137.
External coolant fluid source 101 includes under coolant fluid reservoir 109, such as 17 DEG C to 24 DEG C environment temperatures 0.9%NaCl physiological saline infusion bags.External coolant fluid source 101 includes cooling device 111, is made for cooling down physiological saline It is preferably close to cryogenic temperature, and for example, 3 DEG C to 4 DEG C to ensure that physiological saline will not freeze.Cryoablation catheter system 100A can To be operated under higher coolant fluid temperature, for example 10 DEG C, but its refrigerating capacity straight line can in this way declined.It is external Coolant fluid source 101 also includes peristaltic pump 112, for the acceptable peak flow rate (PFR) of about 35cc/min (in view of pair The open of inside of human body environment is rinsed) downstream coolant fluid-flow is delivered to cryoablation catheter 130A.
Coolant fluid supply pipe 143 has the typical internal diameter in 0.4mm to 0.7mm ranges.Coolant fluid supply pipe The flow velocity of downstream coolant fluid stream in 143 is about 1.5-4.5m/s so that its about 700- with laminar flow domain 1200 Reynolds number.This flow velocity would generally cause the up to pressure drop of 40-70psi, this is near the mark medical grade conduit group most Big permissible value.
Parts of vessels 131A has proximal end 152, opposed with catheter tip 132A, and proximal end 152 is arranged comprising end 153.End arrangement 153, which may include being connected to, manipulates the handle 154 of conducting wire 146, for being connected to external coolant fluid source 101 Rule connection 156 and electric connection 157 for being connected to controller 103.
Fig. 3 shows circulating frozen conduit system 100B, and it includes circulating frozen conduit 130B, circulating frozen conduit 130B tools There are circulation conduit component 131B and circulation conduit tip 132B, for forming ice hockey IB in therapentic part.Cryoablation catheter system The construction of 100B and operation are similar with cryoablation catheter system 100A and therefore with same reference numeral similar portions.Circulating frozen Conduit system 100B can utilize the coolant fluid of gas, steam or liquid form, this point to be different from open rinse and freeze Conduit system 100A.This cryoablation catheter system 100B is described with reference to liquid coolant.Utilization can be easily modified out by this system The cryoablation catheter system 100B of gaseous coolant.Cryoablation catheter system 100B based on gas includes gas pump rather than wriggles Pump.Cryoablation catheter system 100B based on gas is operated under high pressure, but does not have Joule-Thomson effect cryoablation catheter system It is so high.
Circulating frozen conduit system 100B with it is open rinse cryoablation catheter system 100A the difference is that, circulating frozen Conduit system 100B includes coolant fluid target 113.Cryoablation catheter 130B and cryoablation catheter 130A the difference is that, it is cold The parts of vessels 131B for freezing conduit 130B includes another tube chamber 158, for housing coolant fluid return duct 159 (referring to Fig. 4) And its catheter tip 132B does not have flushing hole.Coolant fluid return duct 159 is connected to coolant fluid target 113, cold But agent fluid target 113 is preferably connected to coolant fluid reservoir 109 again.It is supplied with the coolant fluid of cryoablation catheter 130A It is compared to pipe 143, due to the reason of external refrigerating system conduit diameter constraint, coolant fluid supply pipe 143 and coolant fluid return Flow tube 159 has smaller cross-sectional area usually in cryoablation catheter 130B.The heat exchange arrangement 138 of catheter tip 132B can To be embodied as heat spreader module or jet impulse module, to cool down electrothermal module hot side 136, as described below.
The usage of cryoablation catheter system 100A is as follows:
Catheter tip is introduced into human intracavity by surgeon via the access interface that can be accessed from outside.Surgeon Catheter tip is set to pass through to therapentic part.Controller is switched to icing pattern by surgeon, continues 3 to 5 minutes, to treat Cryoablation catheter tip at position.Catheter tip freezes tissue at catheter tip, and to form ice hockey, ice hockey is by tissue It is attached to catheter tip.Freezing process itself, which can be desired cold therapy or surgeon, can execute other doctor Course for the treatment of sequence.At the end of medical procedure, controller is switched to defrosting pattern by surgeon, continues about 30-60 seconds, to lead Defrosting tissue at tip end, to prevent pulling off catheter tip from tissue when catheter tip still freezes in tissue Torn tissue occurs for tissue in the case of end, especially in vascular program.
The thermodynamic analysis of heat exchange arrangement
Heat exchange arrangement 138 has the coolant fluid stream of incoming downstream coolant fluid stream and outflow, this fluid Stream is to flow to inside of human body environment in open rinse in cryoablation catheter system 100A, or in circulating frozen conduit system 100B It is to flow to coolant fluid target 113.
Heat exchange arrangement 138 has following specification:
h:Heat transfer coefficient
Ah:Heat exchange area
Use following symbol:
Q is total heat necessary to carrying out the heat transmission of the coolant fluid stream in being arranged from electrothermal module hot side to heat exchange Can, also that is, about 7.5 watts.Total heat energy Q=Q1+Q2, wherein Q1 are must be from the Studies of Human Body Heat for having tissue to be frozen to absorb Can, and Q2 is electric energy necessary at least one electrothermal module of operation.
Tin is temperature when incoming downstream coolant fluid stream reaches heat exchange arrangement 138.Based on Tin be introduced into it is cold For example 2 DEG C to 3 DEG C and in its subsequent heating in parts of vessels traveling process are initially cooled to before freezing in conduit, Tin estimates at 4 DEG C to 5 DEG C.
Tout is the temperature spread out of when coolant fluid stream leaves heat exchange arrangement 138.Tout is by electrothermal module hot side 136 directly or indirectly heat estimation later at 6 DEG C to 9 DEG C.
Thot is the temperature of the electrothermal module hot side 136 of at least one electrothermal module at cryoablation catheter tip, wherein
(1) Thot=Tin+ Δs t1+ Δs t2+ ...+Δ tn
Wherein Δ t1, Δ t2 ... Δs tn are the temperature difference, depend on the construction of catheter tip and its heat exchange arrangement
Tcold is the temperature of electrothermal module cold side 137, wherein for practical purposes
(2) Tcold=Thot-35 DEG C
Δ t1 is the convection current temperature difference across the coolant fluid stream of heat exchange arrangement 138 and heat exchange area Ah, meter Calculation mode is as follows:
Heat exchange arrangement 138 must can generate from about 4 DEG C to about 10 DEG C in the range of convection current temperature difference t1, make Obtaining heat exchange arrangement 138 can control from the electrothermal module hot side 136 of the outer surface for cryoablation catheter tip 133 to for freezing The cryogenic temperature treated between about -15 DEG C to about -30 DEG C of the tissue at position carries out hot transmission.
The radiator embodiment of the heat exchange arrangement of the present invention has relatively low heat transfer coefficient h, and therefore sets It counts into compared with electrothermal module hot side area occupied Af, there is larger heat exchange area Ah.The heat exchange arrangement of the present invention Jet impulse embodiment has relatively high heat transfer coefficient h, and therefore can be designed to utilize the available of electrothermal module Hot side area occupied Af as heat exchange area Ah, rather than needing other heat exchange like that according to radiator embodiment Area.
The radiator embodiment of heat exchange arrangement
Fig. 5 illustrates open irrigating catheter tip 132A, and it includes the vertical of the longitudinal axis same direction with parts of vessels 131A Thermoelectric module 134, and constitute the heat spreader module 200 of heat exchange arrangement 138.Exemplary electrothermal module 134 is TEC The dash number 1MD03-036-4 of Microsystems GmbH has close to 20mm2Electrothermal module hot side area occupied.
Catheter tip 132A is designed to ensure the minimum temperature difference across adjacent assemblies in order to freeze tissue.Cause This, catheter tip 132A utilizes high-level gap fill material, with the thermal coefficient k within the scope of about 10w/m DEG C.Properly Gap fill material especially include the hot epoxy paste shape adhesive ME7159 of ultra-high conducting of AI thecnologyInc, www.aithecnology.com。
Catheter tip 132A includes duct wall 180, and with longitudinal cut 181, the longitudinal cut 181 is with conduit side Wall 180 extends, for storing longitudinal electrothermal module 134 and heat spreader module 200.Electrothermal module 134 has electrothermal module hot side 136, opposed with electrothermal module cold side 137, electrothermal module cold side 137 faces duct wall 180, with cryoablation catheter side wall 180, To cryoablation catheter dome 133.Catheter tip 132A includes:First gap filling material layer 182 is used for electrothermal module cold side 137 are mounted on duct wall 180;And the second gap filling material layer 183, for heat spreader module 200 to be mounted on heat In electric module hot side 136.Gap fill material layer 182 and 183 has thickness L, and thickness L is usually in 50 μm to 100 μm of range It is interior.Heat spreader module 200 has the lower wall 201 for facing electrothermal module hot side 136.
This catheter tip configuration introduces two additional temperature difference t2 and Δ t3 so that the calculation of hot side temperature Thot It is as follows:
(1) Thot=Tin+ Δs t1+ Δs t2+ Δs t3
Wherein Δ t2 is the temperature difference at 183 both ends of the second gap filling layer, and calculation is as follows:
And wherein Δ t3 is the temperature difference at 201 both ends of lowest surface of heat spreader module 200, and is estimated as 3 DEG C, this is Due to the about 400Kw/m from electrothermal module hot side 136 to lower wall 2012Very high heat flux density.
Assuming that heat spreader module 200 has heat transfer coefficient h=10000w/m2DEG C, and heat exchange area Ah is equal to heat The hot side area occupied 20mm of electric module2=20 × 10-6m2, then according to equation (3).
Based on the above technical detail, the calculation of Δ t2 is as follows:
After the value of Tin, Δ t1, Δ t2 and Δ t3 are updated in equation (1), electrothermal module hot side 136 has following heat Side temperature Thot:
T3=5 DEG C+2 DEG C+3 DEG C+37 DEG C=47 DEG C of Thot=Tin+ Δ t1+ Δ t2+ Δs
So that its electrothermal module cold side 137 has according to equation (2) is higher than cryogenic temperature:
Tcold=Thot-35 DEG C=47 DEG C -35 DEG C=+ 12 DEG C
For illustrative purpose, in order to which catheter tip 132A is chilled to -17 DEG C, hot side temperature Thot must terminate in 18 ℃.It can realize that this point, heat spreader module 200 have 94mm by providing heat spreader module 2002Heat exchange area Ah, So that convection current temperature difference t1 is:
And therefore hot side temperature Thot is:
T3=5 DEG C+2 DEG C+3 DEG C+8 DEG C=18 DEG C of Thot=Tin+ Δ t1+ Δ t2+ Δs
To obtain desired electrothermal module cold side cryogenic temperature:
Tcold=Thot-35 DEG C=18 DEG C -35 DEG C=- 17 DEG C
The first gap filling material layer 182 that electrothermal module cold side 137 is mounted on duct wall 180 will be had to be absorbed Human body thermal energy Q1 from have tissue to be frozen be transmitted to heat exchange arrangement 138.As described above, Q1 is in about 1.5W and 2W Between, this is about a quarter for the thermal energy Q that heat exchange arrangement 138 must be dissipated to from electrothermal module hot side 136.Between first Gap encapsulant layer 182 generates about 0.5 DEG C of insignificant temperature drop at its both ends so that duct wall 180 and conduit dome 133 temperature is almost the same with electrothermal module cold side 137.
Fig. 6 to Figure 14 illustrates five kinds of different heat spreader modules 200, can be readily designed to have than electrothermal module At least four times larger heat exchange area of hot side area occupied.
Fig. 6 and Fig. 7 illustrates catheter tip 132A, has lateral electrothermal module and heat spreader module 200, radiator mould Block 200 is embodied as coiled radiator 202.Coiled radiator 202 includes coil pipe 203, is coiled in central cylindrical core 204 On, central cylindrical core 204 is mounted in electrothermal module hot side 136.Coil pipe 203 has the average diameter AD1 of about 2.5mm With whole tubular length LI, wherein:
L1=Π x AD1x N
Wherein N is the number of turns around core 204.The coiled radiator 202 of 8 circles has heat exchange area Ah=II × 0.5 × 63=99mm2
Fig. 8 shows catheter tip 132A, has longitudinal electrothermal module 134 and heat spreader module 200, heat spreader module 200 are embodied as porous radiator 206.Porous radiator 206 can be formed by a series of Heat Conduction Materials, such as metal, carbon substrate Material and the like.Porous radiator 206, which has, passes through its material specific area (m2/ gram) determine heat exchange area.
Fig. 9 and Figure 10 shows catheter tip 132A, has longitudinal electrothermal module 134 and heat spreader module 200, radiator Module 200 is embodied as finned radiator 207.Finned radiator 207 includes base member 208, with many fins 209.There is finned radiator 207 heat exchange area Ah, wherein Ah=2 × [NF × B+ (NF-1) × S] × L, wherein NF to be Fin number, B are fin heights, the interval between S fins, and L is fin length.
Figure 11 and Figure 12 illustrates catheter tip 132B, has lateral electrothermal module 134 and heat spreader module 200, dissipates Hot device module 200 is also embodied as coiled radiator 202.Coiled radiator 202 includes coil pipe 211, has two or more Winding 212, for example, by the operative connection process Installation of welding in electrothermal module hot side 136.Coil pipe 211 has about Whole tubular length between the pipe fitting internal diameter and about 40mm to 60mm of 0.5mm so that its heat exchange area is approximately equal to 90mm2
Figure 13 and Figure 14 shows catheter tip 132B, has lateral electrothermal module 134 and heat spreader module 200, heat dissipation The radiator that device module 200 is embodied as horizontal wire net means 214 stacks 213.Figure 13 and Figure 14 displaying conducting wires net means 214, It uses the form of conducting wire Dropbox, usually the diameter with about 2mm to 3mm, and is formed by the metal of 0.11mm thickness.It dissipates Hot device stacks 213 and may include same vertical conducting wire net means.Conducting wire net means can be formed as different shape, especially include square Shape, ellipse and the like.
The usually netted density with 100 conducting wires of per inch of conducting wire Dropbox 214.It for example, can be from California, USA The TWP of Berkeley 94710, Inc. buy dash number 100x100C0022W48T made of copper.Radiator stacks 213 About 30 disks, total height are 3mm to 3.5mm.Radiator, which stacks 213, has the heat exchange area determined by N × AS, Middle N is disk number, and AS is the total surface area of each conducting wire Dropbox.
The jet impulse embodiment of heat exchange arrangement
Jet impulse module is based on one or more impacts of the coolant fluid jet stream to shock surface, in order to provide than dissipating Hot device module more effectively heat is transmitted, so that catheter tip can be chilled to than heat spreader module more by jet impulse module Low cryogenic temperature.
Figure 15, Figure 16 A and Figure 16 B shows, which open, rinses cryoablation catheter 130A, with catheter tip 132A, catheter tip 132A has lateral electrothermal module 134 and jet impulse module 300, constitutes heat exchange arrangement 138, is used to form ice hockey IB. Jet impulse module 300 includes shell 301, is sealed on electrothermal module 134 to form heat exchange cavity 302.Shell 301 can To be formed by non-thermally conductive material, such as biological plastics, the biocompatible materials of ratio such as platinum, iridium and the like are cheaply very It is more.What shell 301 can be manufactured by being suitable for the low cost process (such as micro-injection molding) of medical part.In addition, shell Body 301 can be answered by the plastics compatible with the ceramic wafer of electrothermal module with low thermal coefficient of expansion with reducing heat during operation Power.
Jet impulse module 300 includes single-nozzle 303, for preferably by coolant fluid jet stream in impact site It is directly impinging at 304 in electrothermal module hot side 136, electrothermal module hot side 136 constitutes shock surface.Nozzle 303 has nozzle Internal diameter D and shock height H with electrothermal module hot side 136 apart.Nozzle usually has within the scope of 0.3mm to about 0.7mm Nozzle inside diameter D and from the shock height H in the range of about 0.3mm to about 0.7mm.
The each coolant fluid jet stream of Figure 16 B shows causes the heat on imaginary round impact zone 306 to be transmitted, circular impact area 306 have impact zone radius R, but the shape in real impact area 306 is by 301 limit of shell.But each coolant fluid is penetrated Stream has the round impact zone 307 of effective imagination, and maximum impact area radius is twice of the size of nozzle inside diameter D, is more than this A radius, the heat in the annular section between impact zone 306 and 307 are transmitted and can be greatly decreased.Therefore, if R>3D is then added Nozzle is thermodynamically worth, preferably to remove any annular section beyond impact zone 307.Therefore, jet impulse Module 300 may include the array of single-nozzle 303 or the nozzle 303 of m × n, wherein at least one of m and n>1, this is depended on The size and size of electrothermal module hot side 136.
Jet impulse module 300 has heat transfer coefficient h, depends on following two ratios:
First, ratio H/D, in the case where maximum volume flow is 35cc/min and specific specific nozzle diameter, When the speed of the coolant fluid jet stream flowed out from nozzle 303 is when from about 1.5m/sec to the range of about 7.0m/sec, Ratio H/D is preferably in the range of from about 0.5 to about 1.5.
Second, ratio R/D, preferably in the range of 2≤R/D≤4, because nozzle is too close to that manufacture can be allowed to become each other Must be complicated, and it is interfering with each other to may result in its corresponding coolant fluid jet stream.
Aforementioned jet impulse paper elaborates that jet impulse module 300 has the heat transfer coefficient h according to equation:
Wherein Nu is so-called nusselt number, and k is the thermal coefficient of jet impulse fluid, and D is as unit of rice Nozzle inside diameter.For example, 0.9%NaCl physiological saline has thermal coefficient k ≈ 0.58w/m DEG C.
Aforementioned jet impulse paper is also stated calculates nusselt number Nu according to equation (5):
(5) Nu=0.75 × Re1/2×Pr1/3
Wherein Re is Reynolds number, and Pr is Pulan top number.
Jet impulse module 300 according to the present invention have from about 400 to about 1400 in the range of Reynolds number, from Pulan top number in the range of about 9 to about 11, and from about 35,000w/m2DEG C arrive about 55,000w/m2DEG C range Interior heat transfer coefficient h, this it is more three times greater than the heat transfer coefficient of heat spreader module with six times between.
Different from heat spreader module 200, jet impulse module 300 has between hot side temperature Thot and coolant fluid The single temperature difference, i.e. convection current temperature difference t1 make Thot=Tin+ Δs t1.Convection current temperature drop Δ t1 is calculated according to equation (3), wherein hot Exchange area A is equal to hot side area occupied.
The open irrigating catheter tip 132A of Figure 17 and Figure 18 displayings, it includes jet impulse module 311, the jet impulse Module 311 has 1 × 3 array 312 of nozzle 313, is used for from TEC identical with the heat spreader module 200 of Fig. 5 Microsystems GmbH dash number 1MD03-036-4 electrothermal modules 314 carry out hot transmission.Each nozzle 313 has nozzle Internal diameter D=0.40mm and shock height H=0.40mm so that each nozzle 313 has 0.5<D/H<Ratio D/ in 1.5 ranges H=1.TEC Microsystems GmbH dash numbers 1MD03-036-4 has 2.8mm width, 6.6mm length and approaches 20mm2Hot side area occupied.
Jet impulse module 311 needs three nozzles 313 actually to carry out hot transmission along the length of electrothermal module 314, As explained referring to following calculating now:
Jet impulse module 311 has the nozzle 313 there are three spaced at equal intervals along its length so that each impact zone radius R =1.15, adjacent nozzles 313 are spaced apart 2.3mm, and the respective opposite ends with electrothermal module 314 of two end nozzles 313 It is spaced apart 1.15mm.Therefore, ratio R/D will be 1.15/0.40=2.75, therefore this is that can connect within the scope of the optimal value of R/D It receives.
Hot biography is effectively performed along the width of electrothermal module 314 possibly also with single-nozzle 313 in jet impulse module 311 It passs, as explained in being calculated now following second:
Jet impulse module 311 has single central nozzle 313 along its width so that its impact zone radius R=2.8mm/2 =1.4mm, and ratio R/D is 1.4/0.40=3.5, and this is within the scope of acceptable R/D.
In the case of jet impulse module 311, Reynolds number has 410 values, and Pulan top number has all values so that According to equation (5) Nu=34 and according to equation (4), heat transfer coefficient h=34 × 0.58/0.4 × 10-3=49000w/m2 ℃.As limited, Ah=Af is cooled down in jet impulse and therefore according to equation (3), jet impulse module 314 has pair Flow temperature difference t1:
Electrothermal module hot side 136 has t1=5 DEG C+8 DEG C=13 DEG C of hot side temperature Thot=Tin+ Δs so that electrothermal module Cold side 137 has -35 DEG C=- 22 DEG C of Tcold=Thot-35 DEG C of cold-side temperature=13 DEG C, this is in expected cryogenic temperature range It is interior.
Figure 19 shows circulation conduit tip 132B, the jet stream with lateral electrothermal module 134 and with single-nozzle 303 Impact module 300.
Cryoablation catheter designs
Figure 20 to Figure 27 illustrates the different characteristic of cryoablation catheter according to the present invention.The feature does not exclude each other , and cryoablation catheter can include one or more of the combination of feature.In addition, cryoablation catheter may include longitudinal electrothermal module or transverse direction Electrothermal module.Also, cryoablation catheter may include heat spreader module or jet impulse module.
Figure 20 is the hangover portion of area for cryoablation catheter tip 132B to form the circulating frozen conduit 130B of ice hockey IB Longitudinal section, hangover portion of area be deployed in behind its guiding catheter dome 133.Cryoablation catheter 130B includes metallic plate 160, with heat Electric 137 high heat conduction of module cold side contact.Metallic plate 160 has peripheral cylindrical surface 160A, for freezing the people being in contact with it Body tissue.The length of the catheter tip 132B of conduit dome 133 is extended to from metallic plate 160 preferably by the non-of such as polyamide High conductivity material is made.For needing the clinical application of electric conductivity, conduit dome 133 that can be made of metal.
Figure 21 is the open longitudinal section for rinsing cryoablation catheter 130A, and the open cryoablation catheter 130A that rinses has catheter tip 132A, it includes longitudinal electrothermal module 134A and transverse direction electrothermal module 134B and heat exchange arrangement 138, be used at the same from this two A electrothermal module 134A and 134B carries out hot transmission.Electrothermal module 134A and 134B can be considered as with single hot side, hot side Area occupied is equal to the summation of its each hot side area occupied.
Figure 22 and Figure 23 illustrate it is open rinse cryoablation catheter system 100A, it includes it is open rinse cryoablation catheter 130A and RF melts device 114, and for executing RF ablations in treatment site, RF ablation devices 114 are connected to dome 133 with conducting wire 150.
Figure 24 and Figure 25 illustrates open flushing cryoablation catheter system 100A, and cryoablation catheter 130A is rinsed it includes open, It carries harvester 161 with catheter tip 132A, catheter tip 132A, for acquiring patient information in treatment site. Exemplary harvester 161 especially includes sensor, the camera and the like for sensing physiological parameter.Exemplary sensor Especially include ultrasonic sensor, pressure gauge and the like.Controller 103 is connected to harvester by signal wire 162 161。
Figure 26 and Figure 27 illustrates circulating frozen conduit system 100B, and it includes blank pipe chambers 163, for drawing in therapentic part Enter operation tool.Such operation tool may, for example, be the biopsy syringe needle 165 for being connected to external suction pump.
Although describing the present invention relative to a limited number of embodiment, it is to be appreciated that in the appended claims In the range of can carry out the present invention many variations, modification and other application.

Claims (13)

1. a kind of cryoablation catheter for cryoablation catheter system, it includes external coolant fluid sources, for transmitting downstream cooling Agent fluid stream, the cryoablation catheter include:
(a) elongated flexible parts of vessels, with short rigid conduit tip, for being introduced into therapentic part;
(b) at least one electrothermal module, with electrothermal module hot side and electrothermal module cold side, the electrothermal module cold side and institute State the thermal conductivity outer surface heat contact of catheter tip;
(c) coolant fluid supply pipe is connect with the external coolant fluid source stream, is used for the downstream coolant flow Body stream is transmitted to the catheter tip;And
(d) the heat exchange arrangement at the catheter tip, for receiving incoming downstream cold from the coolant fluid supply pipe But agent fluid stream to cool down the electrothermal module hot side, and transmits the coolant fluid stream of outflow,
Heat exchange arrangement has a heat transfer coefficient h and heat exchange area Ah, and can according to lower relation of plane across Convection current temperature difference t1 is formed between its coolant fluid stream and the electrothermal module hot side
Wherein Q is to carry out heat from the electrothermal module hot side to the coolant fluid stream to transmit required total heat energy, and Δ T1 is in the range of from 4 DEG C to 10 DEG C so that the heat exchange arrangement can freeze the outer surface of the catheter tip Cryogenic temperature to from -15 DEG C to -30 DEG C, to freeze tissue in the therapentic part,
It is characterized in that
The wherein described catheter tip has the institute of high-termal conductivity outer surface and the electrothermal module cold side and the catheter tip State the high heat conduction contact of high-termal conductivity outer surface.
2. cryoablation catheter according to claim 1, wherein heat exchange arrangement with the electrothermal module hot side heat by connecing Tactile heat spreader module is constituted, and the heat spreader module has from 5000w/m2DEG C arrive 10,000w/m2Heat in the range of DEG C Carry-over factor h, and the electrothermal module hot side has hot side area occupied Af, and the heat spreader module has heat exchange Area Ah, it is more at least four times larger than the hot side area occupied Af.
3. cryoablation catheter according to claim 2, wherein heat exchange arrangement includes finned radiator.
4. cryoablation catheter according to claim 2, wherein heat exchange arrangement includes coiled radiator.
5. cryoablation catheter according to claim 2, wherein heat exchange arrangement includes the heat sink stack of conducting wire net means It is folded.
6. cryoablation catheter according to claim 2, wherein heat exchange arrangement includes porous radiator.
7. cryoablation catheter according to claim 1, wherein heat exchange arrangement includes jet impulse module, the jet stream It includes at least one nozzle to impact module, for impinging cooling agent fluid jet, the shock surface and institute on shock surface The thermo-contact of electrothermal module hot side is stated, to carry out hot transmission from the electrothermal module hot side,
At least one of wherein described at least one nozzle nozzle has nozzle inside diameter D and the impact apart from the shock surface Height H, for limiting the ratio D/H from 0.5 to 1.5 in range.
8. the cryoablation catheter according to any one of claim 1 to 7, for freezing the portion of hangover area of the catheter tip and It is not its guiding catheter dome.
9. the cryoablation catheter according to any one of claim 1 to 7, wherein at least one electrothermal module includes longitudinal Electrothermal module and lateral electrothermal module.
10. the cryoablation catheter according to any one of claim 1 to 7, wherein the catheter tip is used for comprising RF electrodes Melt purposes.
11. the cryoablation catheter according to any one of claim 1 to 7 is used wherein the catheter tip includes harvester In in treatment site acquisition patient information.
12. the cryoablation catheter according to any one of claim 1 to 7, wherein the parts of vessels includes at least one sky Tube chamber, for operation tool to be introduced into the therapentic part.
13. a kind of cryoablation catheter system being suitable for the cryoablation catheter according to any one of claim 1 to 12.
CN201380076100.6A 2013-04-30 2013-04-30 The cooling duct of electrothermal module with coolant fluid cooling Expired - Fee Related CN105377167B (en)

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WO2019022955A1 (en) * 2017-07-28 2019-01-31 Kci Licensing, Inc. Systems and methods for temperature-contrast therapy
US10756598B2 (en) 2017-10-02 2020-08-25 Ge Aviation Systems Llc Method and apparatus for cooling a rotor assembly
CN110215276A (en) * 2019-07-16 2019-09-10 孙悦 A kind of refrigerating plant for treating preauricular flstula
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