Leakage protection system, pressure balancing system, and precipitator with valve function for ablation applications

Abstract

An ablation device comprising an ablation applicator adapted for ablating material from an object upon delivery of an ablation medium to the ablation applicator in an ablation mode, an ablation medium supply line adapted for supplying the ablation medium to the ablation applicator in the ablation mode, an ablation medium drain line adapted for draining the ablation medium received from the ablation applicator in the ablation mode, and a closure mechanism adapted for selectively enclosing a predefined volume in a fluidic path upon operating the ablation device in a no-flow mode or upon detecting a leak in the fluidic path, the fluidic path including the ablation applicator and being defined between the ablation medium supply line and the ablation medium drain line.

Claims

1. An ablation device, comprising: a boiling chamber adapted for boiling an ablation medium for ablating material from an object; an ablation medium drain line adapted for draining the ablation medium received from the boiling chamber; a flow impedance arranged between the boiling chamber and the ablation medium drain line; an ablation medium conveying unit adapted for conveying the ablation medium to the boiling chamber, through the flow impedance and to the ablation medium drain line; wherein the ablation medium conveying unit and the flow impedance are adapted so that the ablation medium has an average flow velocity in the flow impedance of at least 50% of the speed of sound.

2. The ablation device according to claim 1, wherein the flow impedance is adapted as a constricted opening between the boiling chamber and a suction chamber of the ablation medium drain line via which suction chamber boiled ablation medium is sucked off.

3. The ablation device according to claim 2, wherein a cross-section of the boiling chamber is smaller than a cross-section in the suction chamber.

4. The ablation device according to claim 2, wherein a pressure in the suction chamber is smaller than a pressure in the flow impedance.

5. The ablation device according to claim 1, wherein a pressure in the boiling chamber is larger than a pressure in the flow impedance.

6. The ablation device according to claim 1 further comprising: an ablation applicator adapted for ablating material from an object upon delivery of the ablation medium to the ablation applicator in an ablation mode, the ablation medium drain line being adapted for draining the ablation medium received from the ablation applicator in the ablation mode; an ablation medium supply line adapted for supplying the ablation medium to the ablation applicator in the ablation mode; and a closure mechanism adapted for selectively enclosing a predefined volume in a fluidic path upon operating the ablation device in a no-flow mode or upon detecting a leak in the fluidic path, the fluidic path including the ablation applicator and being defined between the ablation medium supply line and the ablation medium drain line.

7. The ablation device according to claim 1, wherein the boiling chamber and an amount of ablation medium used are adapted such that at a proximal end of the boiling chamber all ablation medium is boiled into its gaseous phase.

8. The ablation device according to claim 1, the ablation medium is nitrous oxide.

9. The ablation device according to claim 2, wherein at the proximal end of the flow impedance there is a step-like increase to a significantly larger cross-section of the suction chamber.

10. The ablation device according to claim 1, wherein the boiling chamber pressure is chosen above a triple point pressure of the ablation medium.

11. The ablation device according to claim 1, further comprising: a flow sensor measuring a flow of the ablation medium.

12. The ablation device according to claim 1, further comprising: a pressure sensor monitoring a difference of pressure between a surrounding medium and a vacuum in an ablation medium line.

13. The ablation device according to claim 1, further comprising: a miniaturized pressure transducer in the suction chamber.

14. The ablation device according to claim 1, further comprising: a leakage detector for detecting a leakage during freezing.

15. The ablation device according to claim 14, wherein the leakage detector is one of a blood sensor, a pressure sensor, a flow sensor or a boiling temperature sensor.

16. The ablation device according to claim 1, wherein the boiling chamber pressure is larger than 878 mbar absolute.

17. The ablation device according to claim 1, wherein a flow rate of the ablation medium is in a range between 0.05 g/s and 0.5 g/s.

18. An ablation method, comprising: conveying an ablation medium to a boiling chamber from a conveying unit through a flow impedance and to an ablation medium drain line; boiling the ablation medium in the boiling chamber for ablating material from an object; draining the ablation medium received from the boiling chamber in the ablation medium drain line; impeding the flow with the flow impedance arranged between the boiling chamber and the ablation medium drain line; and conveying the ablation medium with an average flow velocity of at least 50% of the speed of sound to the boiling chamber, through the flow impedance and to the ablation medium drain line through the flow impedance.

19. The method according to claim 18, wherein the ablation medium is conveyed with a flow rate in a range between 0.05 g/s and 0.5 g/s.

20. The method of claim 18, wherein the ablation medium is nitrous oxide and the boiling chamber pressure is larger than 878 mbar absolute.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention will be described in more detail hereinafter with reference to examples of embodiment but to which the invention is not limited.

(2) FIG. 1 illustrates an ablation device according to an exemplary embodiment of the invention.

(3) FIG. 1a illustrates an ablation device according to another exemplary embodiment of the invention.

(4) FIG. 2 illustrates a diagram showing a time dependence of a system pressure during operating an ablation device according to an exemplary embodiment of the invention.

(5) FIG. 3 illustrates a catheter including an ablation medium supply line and an ablation medium drain line of an ablation device according to an exemplary embodiment of the invention.

(6) FIG. 4 illustrates an environment of a drain valve of an ablation device according to an exemplary embodiment of the invention.

(7) FIG. 5 illustrates a boiling chamber and a flow impedance of a catheter of an ablation device according to an exemplary embodiment of the invention.

(8) FIG. 6 illustrates a precipitator of an ablation device according to an exemplary embodiment of the invention.

(9) FIG. 7 illustrates a handle of an ablation device according to an exemplary embodiment of the invention.

DETAILED DESCRIPTION

(10) The illustration in the drawing is schematically. In different drawings, similar or identical elements are provided with the same reference signs.

(11) Before describing exemplary embodiments of the invention in further detail, some basic considerations of the present inventors regarding operation modes of ablation devices will be explained. Based on these considerations, exemplary embodiments of the invention have been developed.

(12) For the time preceding or following an actual ablation procedure, no refrigerant flow occurs in an ablation device. A corresponding operation mode may be denoted as no-flow condition. Thus, without suitable technical measures, the vacuum source would deliver its maximal pressure difference to air (typically more than 0.7 bar exhaustion pressure, p) as the vacuum pumps work at (almost) zero flow. During a typical catheter intervention, a cryoablation device may be in the no-flow condition for by far the major part of the time.

(13) Throughout this application, the term exhaustion pressure is used for the difference of pressure, p, between the surrounding medium (blood or air) and a vacuum in an ablation medium line. It is defined to be positive for a vacuum condition. Absolute pressures are marked by p.

(14) A pressure difference between an interior and an exterior of ablation medium lines leads to mechanical forces onto the low pressure stream of the cryoablation device. These forces require proper physical dimensions of all components (for example wall thickness for tubing) and, in particular, it increases the likelihood to damage the components during the intervention by kinking and similar effects.

(15) Another operation mode of an ablation device may be denoted as flow condition (or ablation condition). During freezing (continuous refrigerant flow), proper technical measures would be desirable for controlling or limiting the exhaustion pressure p. If the absolute pressure p in the boiling chamber drops below the triple point pressure of the refrigerant, a transition from the liquid phase to the solid phase starts (for example if carbon dioxide is the cooling medium this condition is termed dry ice). This reduces the thermal coupling of the refrigerant with outer jacket of the boiling chamber and, thus, also with the tissue which should be treated. Furthermore, the solid ice particles might lead also to a (partial or complete) clogging in the low pressure stream of the catheter. Apart from flow rate, the absolute pressure p in the boiling chamber is also influenced by other physical parameters such as the absolute pressure in the atmosphere or a change of the back flow resistance for instance due to squeezing of the tubing.

(16) In an embodiment of the invention and in view of the foregoing, a low pressure exhaustion system for cryoablation is provided. Such a system may be configured for cryoablation (therapeutic destruction of tissue by the application of extreme cold). A low pressure exhaustion system or method (moderate vacuum) exhausts the used, gaseous refrigerant from a cryoablation system. This ensures that in the case of a catheter leak no refrigerant can enter the patient's body.

(17) The described exhaustion system includes mechanisms which limit the exhaustion pressure for zero flow and flow conditions to a moderate level. These methods do not necessarily need the implementation of elaborated controlling mechanisms. Furthermore, holding the exhaustion pressure at a moderate level for no-flow and flow condition, the risk of a hemorrhagic shock is reduced. Moreover, the described effects for no flow condition and flow condition may also serve as a safety mechanism in the event of an electrical power outage.

(18) A cryo-ablation system may comprise a cryo-console housing the refrigerant tank, instrumentation and control, and a cryo-ablation catheter connected to the console by a connection line and cables.

(19) In the following, referring to FIG. 1, an ablation device 1 according to an exemplary embodiment of the invention will be described.

(20) Generally, symbol 3 denotes sensors, symbol 5 denotes displays, symbol 7 denotes actuators, and symbol 9 denotes adjustment elements.

(21) Ablation device 1 comprises an ablation applicator 40 in the form of a cryocatheter (or simply a catheter) adapted for ablating material from tissue of a patient upon delivery of an ablation medium such as a cryofluid to the ablation applicator 40 in an ablation mode (i.e. an operation mode of the ablation device 1 in which tissue is actually ablated by freezing).

(22) Ablation device 1 further comprises an ablation medium supply line 31, 33 adapted for supplying the ablation medium to the ablation applicator 40 in the ablation mode, and an ablation medium drain line 32 adapted for draining the ablation medium received from the ablation applicator 40 in the ablation mode.

(23) A closure mechanism formed by valves 21, 22 and a pressure sensor 82 (capable of detecting a pressure, for instance in bar) is provided which operates as a safety mechanism to prevent damage in case of a leakage and which is adapted for selectively enclosing a predefined volume in a fluidic path of ablation medium supply line 31, 33 and ablation medium drain line 32. Closing the predefined volume, which can otherwise be in fluid communication with the other components of the ablation device 1, may be triggered by changing an operation mode to a no-flow mode, i.e. upon operating the ablation device 1 in a no-flow mode.

(24) Closing the predefined volume may be triggered, additionally or alternatively, by the event of a leakage in the ablation device 1 (for instance directly detected in the fluidic path by a blood sensor or the like, or indirectly detected by recognizing that a system parameter is indicative of the presence of a leakage).

(25) The closure mechanism comprises supply valve 21 arranged in the ablation medium supply line 33 upstream of the ablation applicator 40. The supply valve 21 is adapted for being opened for supplying the ablation medium from supply tank or container 11 to the ablation applicator 40 and for being closed for contributing to the enclosing of the predefined volume. A refrigerant, as an example for an ablation medium, is stored in supply tank 11. A bottle valve 103 and a main valve 25 allow for selectively enabling or disabling supply of refrigerant. Reference numeral 105 denotes a bottle pressure manometer, and reference numeral 107 denotes a bottle pressure sensor. A weighing machine 87 may be functionally coupled to supply tank 11 for detecting in due time when an amount of refrigerant stored in supply tank 11 falls below a critical level.

(26) The closure mechanism additionally comprises drain valve 22 arranged in the ablation medium drain line 32 downstream of the ablation applicator 40. The drain valve 22 is adapted for being opened for draining the ablation medium and for being closed for contributing to the enclosing of the predefined volume. A vacuum manometer arranged downstream the drain valve 22 is denoted with reference numeral 119.

(27) The supply valve 21 and the drain valve 22 are both adapted as normally-closed magnetic valves, which are normally (i.e. in the absence of an actuation signal) in a closed state and are only brought to the opened state upon applying a dedicated actuation signal. The closure mechanism is adapted for closing the drain valve 22 subsequently and with a defined delay to the closing of the supply valve 21 upon transiting from a flow mode to a no-flow mode. The closure mechanism is further adapted for opening the drain valve 22 prior to opening of the supply valve 21 upon transiting from a no-flow mode to a flow mode.

(28) Pressure sensor 82 is arranged in the ablation medium drain line 32 upstream (related to a flowing direction of ablation medium) the drain valve 22 and is adapted for sensing closure of the drain valve 22 and for triggering opening of the supply valve 21 with a predefined time delay. The pressure sensor 82 is adapted for sensing a leakage (indicated by a pattern of the flow which is characteristically modified by a leak) and, upon detecting the leakage, for closing the supply valve 21.

(29) The ablation device 1 comprises an impurity filter 76 arranged within the predefined volume downstream the ablation applicator 40 and is adapted for filtering impurities such as blood, dirt or dust from the ablation medium.

(30) The ablation device 1 additionally comprises a precipitator 68 arranged within the predefined volume downstream the ablation applicator 40 and is adapted for precipitating impurities from the ablation medium. Preferably but not necessarily, such a precipitator 68 is configured as shown in FIG. 6.

(31) The ablation device 1 comprises an ablation medium conveying unit 62 (such as a vacuum pump) adapted for conveying the ablation medium through the fluidic path and being arranged downstream of the ablation medium drain line 32. A drain container 66 is arranged downstream (related to a flowing direction of ablation medium) the drain valve 22 and in parallel to the ablation medium conveying unit 62. The drain valve 22 is arranged so that, in its closed state, the predefined volume is decoupled from the ablation medium conveying unit 62.

(32) The ablation device 1 comprises a bypass line 92 having a bypass valve 23 which is a normally-open valve. The bypass line 92 connects container 11 containing the ablation medium with the ablation medium drain line 32 bypassing the predefined volume, i.e. preventing directing the ablation medium through the ablation applicator 40.

(33) A conditioner (precooling and pressure reduction of the ablation medium) 109 allows conditioning the ablation device 1 and includes, inter alia, a first heat exchanger 111 and a second heat exchanger 113. Furthermore, conditioner 109 comprises a pressure reducer 115 and a high pressure sensor 81.

(34) Moreover, a third heat exchanger 117 (a second precooling unit) is connected in parallel to a throttle 73 and is arranged downstream the conditioner 109.

(35) In the following, operation of the ablation device 1 will be explained.

(36) Freezing is started by opening the supply valve or cooling valve 21. A dip pipe is used for guiding the refrigerant in its liquid phase through the high pressure stream connection line 31 to the ablation applicator or catheter 40. Passing a throttle, a pressure drop occurs and the refrigerant vaporizes in boiling chamber 42. The wasted, gaseous refrigerant is guided through the ablation medium drain line (or low pressure connection line) 32 and the opened drain valve or vacuum valve 22 to vacuum pump 62 which actively blows it into the air or into the vacuum system of a hospital 64.

(37) Upon stopping freezing, the cooling valve 21 is first closed and with a short temporal delay, bypass valve 23 is opened, guiding the remaining refrigerant in the high pressure stream via a throttle 73 directly to the vacuum pump 62 (fast turn off of freezing). A properly dimensioned vacuum chamber 66 ensures that the transient peak of refrigerant flow does not create an over pressure with respect to the atmosphere at the connection of the vacuum pump 62 with the low pressure return of the cryoablation system.

(38) A check valve 72 avoids that the transient bypass flow streams back into the catheter 40. Once all refrigerant has been removed from the high pressure line, the vacuum source (formed by vacuum pump 62 and/or vacuum system of hospital 64) again evacuates the vacuum chamber 66 for providing a high exhaustion pressure p (typically more than 0.7 bar). The vacuum pump 62 may be controlled in order to provide a defined low pressure level. Alternatively it may be operated without control loop feedback providing a sufficiently large exhaustion pressure. In another embodiment, the vacuum system of hospital 64 is the only vacuum source.

(39) For limiting the amount of sucked blood in the case that a leakage occurs in the time span the time preceding or following an ablation (no flow condition) the following measures may be taken:

(40) When connecting the catheter 40 to control instrumentation and after each freeze, the exhaustion pressure p in the vacuum chamber 66 will rise from a low value to a high value as the evacuation of the vacuum chamber 66 (and the low pressure lines 32) progresses. The cross sections of the low pressure stream are dimensioned sufficiently large to transport the nominal refrigerant flow of the ablation device 1. Thus, for the considered no-flow condition the pressure in the boiling chamber 42 approximately equals the pressure in the vacuum chamber 66 and in the entire low pressure pathway.

(41) Low pressure sensor 82 monitors this low pressure. In the shown embodiment, pressure sensor 82 is arranged directly adjacent to valve 22. Alternatively, sensor 82 may be arranged at another appropriate position such as between reference numerals 32 and 68. Once a preselected exhaustion pressure p.sub.p is obtained, the vacuum valve 22 may be closed. The preselected exhaustion pressure p.sub.p may be selected just large enough that leakages can be properly detected. This pressure may be preselected to be in the range of 0.05 bar and 0.6 bar and more particularly between 0.25 bar and 0.5 bar.

(42) Once the catheter 40 and the connection lines 32, 31 are completely separated from the vacuum pump 62, the pressure in the part left from the drain valve 22 (vacuum chamber pressure p.sub.V) and right from the drain valve 22 (boiling chamber pressure p.sub.B) are independent from each other. The vacuum chamber pressure p.sub.V takes a high value with proceeding evacuation. In contrast (under the idealized assumption of perfect sealing) the boiling chamber pressure p.sub.B in the catheter 40 will remain constant and equal to the preselected value chamber pressure p.sub.p. As the lumina at the boiling chamber pressure p.sub.B (catheter 40 and connection lines) are not connected to the vacuum pump 62, they may be termed unconnected lumina. Real sealing cannot avoid small remaining leakage which leads to a small decrease of the boiling chamber pressure p.sub.B (typically less than 2 mbar/second). This almost constant pressure difference to the ambient is monitored by sensor 82. In case of a leakage due to damage (for example a mechanical injury in the outer jacket of the catheter 40) the surrounding medium (for example air, blood or a saline solution) will be sucked into the unconnected lumina. Thus, the pressure p.sub.B quickly drops to almost zero (typically more than 6 mbar/second). Using proper threshold values for the boiling chamber exhaustion pressure p.sub.B and its time derivatives, a safety system can detect the error condition and disable the start of a freeze and activate adequate warnings or error messages.

(43) During a catheter intervention the catheter 40 may be disconnected from the connection line 32 or the connection line 32 may be disconnected from the ablation device 1 during the no flow phase. This corresponds to a leakage with an extremely fast drop of the boiling chamber pressure (typically more than 100 mbar/second). It may be desirable that this operator enforced disconnection (which does not go along with damage of the components) is distinguished from a harm of the ablation system. Thus another threshold might be used in the safety system for suppressing an alarm or warning in the case of an intended disconnection of a component from the ablation system. However, a corresponding message may be displayed by the system in the described scenario.

(44) Precipitator (or liquid separator) 68 and impurity filter (or particle filter) 76 may be included for protecting the instrumentation in the low pressure stream for being polluted by blood or dust sucked from the environment.

(45) Referring now to FIG. 1a, an ablation device 1 according to another embodiment is shown. Here the mechanical pressure reducer 115 of FIG. 1 has been replaced by an electronically controllable adjustment device 115a, which can be used to adjust the high pressure and/or the flow rate to the catheter 40. This adjustment device 115a for example may contain a moveable plunger within a narrow nozzle (not shown). A magnetic coil can be used for moving the plunger forward and backward within the nozzle, modulating the flow resistance in a desired fashion. An electronically adjustable pressure drop and thus, a modulation of the flow rate become possible. Multiple-purpose members which can be implemented as an adjustment device 115a according to an embodiment of the invention are, as such, manufactured and commercially available for example by Bronkhorst High-Tech B.V. (Netherlands) and available as mass flow controllers or pressure controllers. In the shown embodiment the adjustment device (or adjustable pressure reducer) 115a has been placed outside of the precooling unit 109 in a case in which is not designed for operating at low temperatures. However, if an adjustment device 115a is implemented which is designed for operating at low temperatures, such an adjustment device 115a may also be arranged within this precooling unit.

(46) The electronically adjustable device 115a may contribute to keep the flow rate within tighter limits with varying ambient conditions (such as temperature) and refrigerant filling level compared to a pressure reducer with a rigidly fixed output pressure. This may contribute also to keeping the pressure levels in the low pressure exhaustion system within predefined levels and contributes thus to the stability and safety of the system. In one embodiment the adjustment device 115a may be controlled by the output signal of the flow sensor 82 and in another embodiment by the output signal of the pressure sensor 81. In yet another preferred embodiment the flow rate measured by flow sensor 82 defines a set value for the pressure output controlled by the adjustment device 115a (cascade control of flow and pressure).

(47) Here, the set-point for flow and/or pressure can be set to zero (or a small value) in the waiting period between two freezes which provides an additional safety feature. If the supply valve 21 opens due to failure the adjustable device 115a may then be in the configuration in which it displays its highest flow resistance and limits thus pressure and flow to a small value. Here, the safety of the system can be further increased by opening the by-pass valve 23 in the stand-by mode between two freeze cycles. In this case the small residual flow obtained by a failure of valve 21 is guided almost completely into the low pressure drain. Additionally also supply valve 25 may be closed for stopping refrigerant supply in the case of failure of valve 21. Similarly, for a failure in which supply valve 21 does not close at the end of the freezing cycle, the electronically adjustable device 115a and/or valve 25 can be used for terminating refrigerant supply.

(48) The electronically adjustable device 115a may be designed only for reducing the supply bottle pressure only up to a maximal pressure difference. The maximal pressure difference may be 25 bar and more particularly 10 bar. In this situation it may be a challenge to re-open the electronically adjustable device 115a when the pressure in the refrigerant supply line drops below a critical value. Here a by-pass line 33a containing a narrow throttle 33b may be switched in parallel to the electronically adjustable device 115a. If the lumen diameter of the throttle 33b is smaller than 0.1 mm and more particularly smaller than 0.06 mm its flow resistance is high enough for not disturbing the operation of the electronically adjustable device 115a during freezing. In the standby phase between two freeze cycles the by-pass 33a enables a small flow parallel to the adjustment device 115a. Typically within 10 to 30 seconds after closing valve 21 the pressure difference across the bypass 33a becomes negligible. In the embodiment shown in FIG. 1a, a high pressure connection 33c of the by-pass 33a may be connected to a connection port of the adjustment device 115a which is intended for ventilating gas bubbles away from the adjustment device 115a. A particle filter 76a is foreseen for protecting the narrow lumina in adjustment device 115a and the high pressure path to the catheter 40 from plugging.

(49) In the following, referring to FIG. 2, a diagram 200 showing a time (plotted along an abscissa 202) dependence of a system pressure (plotted along an ordinate 204) during operating the ablation device 1 according to an exemplary embodiment of the invention will be described.

(50) In FIG. 2, the exhaustion pressure p measured by a low pressure sensor 82 is exemplarily plotted over time t. In the depicted diagram 200, the ablation device 1 is initially (time t0) in the no-flow phase, and the exhaustion pressure is in between two predefined values p1 and p2 slowly decreasing due to residual leakage. For starting a freeze, the vacuum valve or drain valve 22 is opened at time t1, and the exhaustion pressure rises quickly due to the effect of the vacuum pump 62 and the vacuum chamber 66. Thus, the controlling system can verify the correct opening of drain valve 22 and start freezing by opening the supply valve or cooling valve 21 at time t2. During freezing (flow condition) a transient transition to an almost constant exhaustion pressure takes place. This approximately constant value is not necessarily between the limits p1 and p2.

(51) When stopping freezing, first the cooling valve 21 is closed at t3 and the bypass valve 23 is opened at t4. The predefined time span between t3 and t4 will be kept short (typically below one second) and may even become zero. Due to the high peak like flow through, the exhaustion pressure sharply drops to a small value which can become also negative.

(52) Here, it is believed that the minimum of the exhaustion pressure is determined by basically three parameters. The volume of the vacuum chamber 66 (which may be in the order of 0.5 liter to 20 liters and more particularly in the order of 1.5 to 6 liters), the mass of the refrigerant which has to be exhausted from the high pressure stream (which may be smaller than the product of the nominal catheter refrigerant mass flow rate times 30 seconds, and more particularly smaller than the nominal flow rate times 15 seconds) and the peak value of the transient flow through bypass valve 23 (which may be in the order of two to twenty times the nominal catheter flow rate). This peak flow may be adjusted by the throttle 73. The volume of the vacuum chamber 66 may be larger than the volume of the evaporated refrigerant exhausted from the high pressure stream at room temperature and more particularly larger than twice this volume. The bypass throttle 73 and the vacuum chamber 66 may be directly connected to the vacuum pump 62 (or the vacuum system of the hospital 64 if the only source is the clinic vacuum system). This avoids any peak flow across the components 22, 68, 74, 76, 82, 84 and keeps the pressure drop in the catheter back stream as small as possible.

(53) Once the high pressure stream is emptied, the bypass line 92 is closed again at t5. The time span from t4 to t5 can be set to a predefined value. Alternatively the high pressure can be observed by pressure sensor 81, and bypass valve 23 is closed if the pressure has fallen below a threshold. Also the increase of the exhaustion pressure can be used for triggering the closing of bypass valve 23. Due to the effect of the vacuum pump 62, the exhaustion pressure increases until the upper threshold p2 is reached. Then the vacuum valve 22 is closed again and p decreases only slowly due to the residual leakage (no-flow condition). If the lower limit p1 is reached again the vacuum is restored by opening (t7) and closing (t8) drain valve 22. Here the time t8t7 can be set to a predefined value.

(54) By closing the valves 21 and 22 the unconnected lumina are defined by the space between the closed valves 21, 22 with a well defined volume V.sub.0. Assuming that the remaining gaseous refrigerant within the unconnected lumina behaves like an ideal gas at constant temperature (absolute temperature of approximately 285 K to 315 K for room temperature or body temperature) the volume of the medium sucked into the unconnected lumen is limited to the value V.sub.B=V.sub.0p.sub.B/p.sub.0 where p.sub.0 denotes the atmospheric pressure. In the worst case (with respect to hemorrhagic shock) all medium sucked into the disconnected lumen is blood. Thus, V.sub.B yields the maximal volume of blood which can be sucked in the case of a leakage. By proper technical dimensioning of the parameters (volume V.sub.0, boiling chamber exhaustion pressure p.sub.B) the amount of blood taken from the body in a fault condition can be limited to a desired value.

(55) In one embodiment the low pressure part of the console may be geometrically arranged below the table on which the patient is lying (for example at an about one meter lower level). Here in case of a leakage blood might be sucked in the connection line between the console and the catheter and an additional hydrostatic pressure difference p.sub.H might be effective. In this case the volume of the medium sucked into the unconnected lumen is limited to the value V.sub.B=V.sub.0(p.sub.B+p.sub.H)/p.sub.0. Thus, an additional pressure may be considered when dimensioning the system. Assuming that the level of the low pressure part is about one meter below the patient and the density of blood is about 1 g/cm.sup.3 the hydrostatic pressure difference is in the order of 0.1 bar.

(56) In the following, referring to FIG. 3, the catheter 40 including the ablation medium supply line 31 and the ablation medium drain line 32 of the ablation device 1 according to an exemplary embodiment of the invention will be described.

(57) In FIG. 3 the volumes are schematically shown. The catheter 40 is indicated by its refrigerant supply line 41 and its outer sealing jacket 47. Connectors 53 and 54 provide a detachable connection to the connection lines for the refrigerant supply and return pathway. The volume within the catheter 40 (supply and return) defines V.sub.C. The connection lines also comprise supply line 31 and an outer jacket (shown as 32) which defines the return pathway. Connectors 51 and 52 provide a detachable connection to the cryo-console. The ablation medium supply line 33 is between the connector 51 and supply valve 21. The return pathway 34 is between the connector 52 and drain valve 22. The volume between the valves 21 and 22 and the connectors 53 and 54 with the catheter 40 defines V.sub.L. When the valves 21 and 22 are closed, the volumes V.sub.C and V.sub.L are not connected to the vacuum pump 62. In the case of a leakage L, blood 49 might be sucked into the catheter 40 and the connection lines (volume V.sub.B, hatched area).

(58) The volume V.sub.0 is the sum of the catheter volume V.sub.C and the volume of the connection lines V.sub.L. Typically V.sub.L is bigger than V.sub.C, and V.sub.C is approximately in the range from 5 ml to 25 ml. In one embodiment the parameters are selected such that the volume of the sucked blood 49 V.sub.B is slightly larger than the volume of the catheter 40 V.sub.C (for example V.sub.B is 110% of V.sub.C). Thus, making the connection lines in a transparent fashion the blood 49 becomes visible at the connection between the catheter 40 and the supply. As this part is continuously in the view of the operator the damage becomes immediately visible and other sources of error such as open connectors can be readily excluded. The amount of visible blood 49 is in the order of tens of milliliters which can be accepted. As a coarse indicator the volume of sucked blood 49 should not, in an embodiment, exceed 100 ml. More preferably, the sucked volume V.sub.B should be smaller than about 50 ml so that the corresponding loss of blood 49 is not dangerous for the patient.

(59) In one embodiment the catheter handle of the catheter is made in a transparent or translucent fashion, by using a transparent or translucent material for the components defining the cover of the handle. Thus, blood becomes already visible when entering the catheter handle. In other words a smaller amount of blood sucked from the patient's body becomes visible.

(60) The ablation device 1 may also take a defined safe state in the case of an unexpected electric power outage. Thus, in one embodiment supply valve 21 is a normally closed valve meaning that without the application of electric current the supply valve 21 is closed, inhibiting the delivery of the refrigerant. For disconnecting the patient from the vacuum in the case of a power outage also drain valve 22 might be a normally closed valve. Proper measures have to be taken that no high pressure occurs in the catheter 40 if drain valve 22 closed unexpectedly during freezing. Here, a pressure relief valve 74 in the low pressure part of the cryoablation system (for example in the catheter handle and/or in the cryo-console) may be used. This pressure relief valve 74 may be adapted to open if a predefined moderate over-pressure (below 0.5 bar, more particularly below 0.3 bar) occurs in the refrigerant back stream pathway. Additionally or independently a part of the controlling system may by battery powered in order to ensure a controlled shutdown in the case of a black out.

(61) An additional supply valve 25 can be used for disconnecting the refrigerant tank 11 from the remaining cryo-ablation device 1. This can be used for disconnecting the catheter 40 from the refrigerant supply 11 in the case that supply valve 21 does not close at the end of the freezing cycle. Additionally the bypass valve 23 can be opened in this condition for further hampering any undesired flow to the catheter 40.

(62) In one embodiment the bypass valve 23 is a normally open valve which is actively closed during freezing, while in another embodiment is normally closed. For avoiding that the ohmic power dissipation of additional supply valve 25 heats the refrigerant a plug valve (ball valve) can be used which is moved by an actuator (electric motor or pneumatic drive) from the closed to the open position, and vice versa.

(63) In the following, referring to FIG. 4, an environment 400 of the drain valve 22 of the ablation device 1 according to an exemplary embodiment of the invention will be described.

(64) A second vacuum valve 24 in series with a nozzle 54 is in parallel to the vacuum valve 22. Upon opening second vacuum valve 24, a small flow occurs from the catheter 40 to the vacuum pump 62 (or more generally vacuum source). This will slowly increase the exhaustion pressure p.sub.B detected by a low pressure sensor 82. By this embodiment p.sub.B can be altered any time to a desired value. Thus, in the case of a small residual leakage the preselected exhaustion pressure p2 can be restored at any time.

(65) In yet another embodiment (dashed lines in FIG. 4) another valve 26 in series with another nozzle 56 provides a flow path to atmosphere 402. Opening valve 26 slowly decreases the exhaustion pressure. The valve 26 is closed when a desired value is reached. By the use of additional valves with throttles the exhaustion pressure can be kept within tight limits.

(66) For starting freezing the vacuum valve 22 and cooling valve 21 are opened as described above. Operating the catheter 40 at constant physical parameters (for instant constant high pressure in the supply, constant temperature of the liquid refrigerant in the supply) an almost constant refrigerant flow rate will occur after a short transient initial starting phase. For defined physical parameters, this flow depends mainly on the type of catheter 40 used.

(67) In the following, referring to FIG. 5, a boiling chamber 42 and a flow impedance 44 of a catheter 40 of the ablation device 100 according to an exemplary embodiment of the invention will be described.

(68) As can be taken from FIG. 5, flow impedance 44 is selectively introduced between boiling chamber 42 and an ablation medium drain line connected to a suction chamber 46. The ablation applicator 40 comprises the boiling chamber 42 for boiling the ablation medium for ablating material from the object. The flow impedance 44 is arranged directly between the boiling chamber 42 and the suction chamber 46 of the ablation medium drain line (not shown). The ablation medium conveying unit 62 and the flow impedance 44 may be adapted so that the ablation medium has an average flow velocity in the flow impedance 44 being very close to the acoustic velocity. Around the position of the flow impedance 44, a flow may be constant and the pressure conditions (particularly the characteristic of vacuum) may vary.

(69) In FIG. 5 a configuration is shown which reduces the influence of the exhaustion pressure in the vacuum chamber 66 p.sub.V onto the pressure in the boiling chamber 42 by taking advantage of the chocked flow phenomenon. It is assumed that the refrigerant mass flow rate m in the catheter 40 is constant and close to a known value depending on the catheter type. When designing a cryoablation catheter 40, an aim is to operate it with as little flow as needed as the flow increases the catheter dimensions. Thus, not more refrigerant is used as can boil out in the boiling chamber 42 so that basically no unused liquid refrigerant is running back the low pressure stream.

(70) In other words, at a proximal end 42a of the boiling chamber 42 all refrigerant should be boiled into its gaseous phase. An additional structure may be foreseen for completely boiling out the refrigerant. Downstream from the boiling chamber 42 the flow path is shaped to bottleneck structure or flow impedance 44 with a cross-section only a little bit smaller than in the boiling chamber 42. Due to the mass continuity in the flow the highest flow velocity is obtained at the bottleneck 44. There are two design goals for the dimensioning of the bottleneck 44. First, for the given mass flow rate it should be narrow enough that the refrigerant flow velocity equals its theoretical maximum namely the speed of sound. Second it should be wide enough that the absolute pressure p.sub.44 within the bottleneck 44 is slightly below the triple point pressure of the refrigerant (for example p.sub.44 is approximately 90% of the triple point pressure).

(71) At the proximal end of the bottleneck 44 a step-like increase to a significantly larger cross-section of suction chamber or catheter shaft 46 is desired. In other words, the designed geometry should not form a Laval nozzle like shape (the chocked flow phenomenon only occurs when supersonic flow is avoided). Due to the almost step like change of the cross-section no reaction of the shaft pressure p.sub.46 on the sonic flow in the bottleneck 44 occurs as long as p.sub.42>p.sub.44 (chocked flow phenomenon). The pressure in the boiling chamber 42 is slightly larger than in the bottleneck 44, p.sub.42>p.sub.44. The boiling chamber 42 pressure p.sub.42 is determined by the ratio of the cross sections in the boiling chamber 42 and the bottleneck 44 (p.sub.42=kp.sub.44, where k is a constant >1 depending on the cross sections). Thus, variations of the shaft pressure will not influence the boiling pressure as long as the vacuum created by the vacuum source 62 is strong enough for creating a shaft pressure p.sub.46<p.sub.44. Here the pressure sensor 82 monitors the exhaustion pressure p in the console. As long this value is above a defined value, it is possible to estimate that the absolute pressure in the shaft is small enough. Additionally the refrigerant flow measured by flow sensor 84 in combination with the flow resistance of the shaft and the connection lines can be used for determining an even more accurate estimate of the shaft pressure. The term flow may denote a mass transfer per time, for example in g/s. For instance, the flow may be in a range between 0.05 g/s and 0.5 g/s (for instance for the example of nitrous oxide as a refrigerant). Optionally a miniaturized pressure transducer may be used in the shaft.

(72) If the boiling chamber pressure is chosen only slightly above the triple point pressure the ration of the cross sections should be slightly above one. In another embodiment this ratio might equal one.

EXAMPLE

(73) Atmospheric pressure 1000 mbar absolute Triple point pressure N.sub.2O 878 mbar absolute choice p.sub.44=800 mbar absolute; k=1.1.fwdarw.p.sub.42=880 mbar (boiling chamber pressure absolute); p.sub.46<800 mbar absolute.fwdarw.exhaustion pressure p.sub.S is >0.2 bar.

(74) If a leakage occurs during a freeze, the exhaustion pressure will suck blood 49 into the catheter 40. This will affect the parameters of operation (temperatures, flow rate, pressures) and the safety system will terminate the ablation. Thus, the system is brought to the zero-flow condition. The leakage will be detected by the safety system described above. Additionally, blood detectors can be used for detecting leakage during freezing. Such detectors may be build using optical sensors (the back stream is guided between an visible or infrared light source and a photosensitive detector), impedance sensors (blood is detected by an ohmic current flow between two wires), capacitive sensors (blood is detected by an increase of the capacity between to insulated wires), ultra sound sensors (blood is detected by an increase of the transmitted signal amplitude), force sensors (blood is collected in a liquid separator and weighted), etc.

(75) In case of a leakage during icing, blood may be sucked from the patient's body into an interior lumen of the catheter 40 as a consequence of the negative pressure. This may change the operation parameters of the catheter 40 (flow, temperature, pressures). This may activate the protection system.

(76) Upon trying to reactivate the catheter 40 again from an idle mode, the above-described leakage detection may be activated.

(77) In the following, referring to FIG. 6, an exemplary embodiment of a precipitator 68 for the ablation device 1 will be described.

(78) FIG. 6 shows a precipitator 68 for precipitating impurities from an ablation medium. The precipitator 68 comprises an inlet 102 adapted for being supplied with the ablation medium which may comprise impurities, an outlet 104 adapted for draining the ablation medium after at least partial removal of the potential impurities, and an impurity removal chamber 122 for at least partially removing the impurities from the ablation medium and being arranged between the inlet 102 and the outlet 104.

(79) A floating body 114 and a sealing 118 are coupled to one another and are arranged in or at the impurity removal chamber 122. The sealing 118 is adapted for sealing the impurity removal chamber 122 in the presence of a negative pressure in the impurity removal chamber 122. The floating body 114 is adapted for being lifted within the impurity removal chamber 122 in the presence of a liquid in the impurity removal chamber 122, thereby forcing the coupled sealing 118 to allow fluid communication between an interior and an exterior of the impurity removal chamber 122.

(80) More specifically, the precipitator 68 comprises a stud 116 coupling the floating body 114 and the sealing 118. The precipitator 68 further comprises a biasing element 120 exerting a biasing force on the floating body 116 and the sealing 118.

(81) Liquid separator 68 provides a complementary turn-off of the vacuum in the case that a leakage occurs during the flow condition. An outer body 112 has the fluid inlet 102 and the fluid outlet 104 and is fixed to an upper plate 110 in a sealed fashion. Floating body 114 is fixed on stud 116 such that a conic (or properly shaped) upper stud portion 116a is above the plate 110 and an elongated lower portion 116b is within the body 112. A spring 120 slightly presses the upper stud 116a against a sealing 118 between the stud and the plat 110 such that the volume inside the body 112 and the plate 110 is sealed. Upon evacuation the force on the sealing increases as the pressure drops in the inner volume.

(82) If blood is sucked during the flow condition (or even no-flow condition) the liquid is collected below the floating body 114. Note that the liquid separator 68 should be mounted with a correct vertical orientation and the gap between the floating body 114 and the wall of body 112 has to be sufficiently large. If a certain amount of blood is collected the uplift of the liquid will exceed the sum of force of the spring 120 and the force of the pressure difference between inside an outside and elevate the floating body 114. Thus, air streams into the volume decreasing the exhaustion pressure to almost zero.

(83) If a large part of the inner volume is filled by the floating body 114, the lift force will be close to the theoretically achievable maximum and the volume which is filled by gas during normal operation becomes small. As this gas volume contributes to volume V.sub.L in FIG. 3, thus, the gas volume inside body 112 should be kept small (below 100 ml and more particularly below 20 ml) this construction is well suited for the embodiment shown in FIG. 1. The area A on which the exhaustion pressure p creates a force is determined by the outer border of the sealing 118. In FIG. 6, this area is exemplarily indicated for sealing ring 118 by a hatched area. The Volume V.sub.F of the floating body 114 should be V.sub.F>A p/+F.sub.S, whereas is the density of blood which can be approximated by the density of liquid water and F.sub.S is the force produced by the spring 120.

(84) The surfaces in direct contact with blood may be coated by a coagulation inhibitor for avoiding clotting of the blood. When air streams into the volume within body 112 after the elevation of the stub 116a sound due to the air stream may occur providing also an acoustic signal for the error condition. A proper shape of the upper stud structure 116a may provide an easy to recognize acoustic warning.

(85) Other embodiments of the liquid separator are possible. In one embodiment the separated liquid might be collected in a cup-like structure located within body 112. This cup like structure may act via a compensator lever on the stud 116. The stud 116 may be lifted when the weight of liquid in the cup exceeds a certain limit. The length of the lever can be used for properly trimming the forces.

(86) In yet another embodiment the floating body 112 will close the fluid outlet 104 when lifted by the separated medium instead of acting on a stud 116.

(87) FIG. 7 illustrates a handle 200 of an ablation device according to an exemplary embodiment of the invention.

(88) FIG. 7 illustrates a handle 200 for handling an ablation applicator by a physician. The handle 200 comprises an optically transparent material so that blood entering the handle 200 in case of a leakage becomes quickly visible to the physician. The handle 200 may comprise or consist of a distal portion 202 and a proximal portion 201. A relative longitudinal displacement of the two handle parts 201, 202 may be translated to a manipulation of the catheter shape in the distal part such as deflection of a distal segment or formation of a geometric structure such as a loop. Here also other mechanical designs such as a sliding lever can be used for realizing a mechanical function of the handle 200. All outer enclosures of the handle 200 can be made from a transparent or translucent material such as for example polycarbonate. The catheter shaft 203 contains the refrigerant draining lumen. In the handle 200 this lumen is connected to a draining tubing 47 (sealing outer jacket of the return path). A pressure relive valve 74 may be a portion of the draining pathway. The components 47 and 74 are drawn in a hatched style, indicating that they can be seen through the transparent or translucent material of the components 201 and 202. Here the visual impression can vary for a clear view (for example in the case that the surfaces of 201 and 202 are smooth) to a kind of smeared silhouette in the case of a dimmish material (for example in the case that the surfaces of handle parts 201 and 202 are rough). It is possible that a modest coloring or staining is added to the transparent or translucent material preserving enough transparency that at least a contour of the draining pathway 47 is visible. In case of a leakage blood might be sucked into a portion of the draining lumen 47 (shaded area). Do to the transparent or translucent material of components 201 and 202 it can be visually recognized within the handle 200.

(89) It should be noted that the term comprising does not exclude 10 other elements or steps and the a or an does not exclude a plurality. Also elements described in association with different embodiments may be combined.

(90) It should also be noted that reference signs in the claims shall not be construed as limiting the scope of the claims.