GB2572046A

GB2572046A - Device for monitoring cavity integrity during a medical procedure

Info

Publication number: GB2572046A
Application number: GB1900967.9A
Authority: GB
Inventors: Stenzel Eric; Brennan Paul; Keegan Eamonn
Original assignee: IDOMAN TEORANTA
Current assignee: IDOMAN TEORANTA
Priority date: 2019-01-24
Filing date: 2019-01-24
Publication date: 2019-09-18
Also published as: GB201900967D0; WO2020152011A1

Abstract

The device comprises a distal flexible bladder 1 and a proximal section having a connecting member 2 joining the distal bladder in a liquid-tight system. A treatment liquid inside the system flows between the distal bladder and proximal section allowing the bladder to deflate when the treatment liquid is moved out. A pressurizing mechanism applies variable pressure to the proximal section to initiate liquid flow. A heater element is controlled to heat the treatment liquid in the proximal section. A pressure sensor 8 detects a pressure level for the treatment liquid within the liquid-tight system. A controller is operably connected to the pressurizing mechanism, the heater and the pressure sensor to control treatment. Changes in pressure values detect an anomalous condition. The proximal section comprises a syringe 3 with a syringe chamber having a heater which collapses as the syringe plunger is operated.

Description

Device for monitoring cavity integrity during a medical procedure

Field

The present invention relates to a device for monitoring cavity integrity during a medical procedure.

Background

EP 1 259 180 81 discloses a device for facilitating necrosis of tissue comprising: a distal flexible bladder; a proximal section; a single-lumen catheter joining the distal bladder and proximal section in a liquid-tight system; and a liquid inside the system to flow between the distal bladder and proximal section, wherein the liquid is in an amount that permits the distal bladder to substantially deflate when the liquid is moved out of the distal bladder; a pressurizing mechanism to apply variable pressure to the proximal section to initiate liquid flow out of the proximal section and into the distal bladder; and a heater element controlled for heating of the liquid in the proximal section.

In performing a medical procedure, such as a thermal endometrial ablation within the uterus, such a device can be inserted within the uterine cavity so that heated liquid is transferred within the substantially closed system between the proximal section and the distal flexible bladder in either direction as needed to complete the medical procedure. When heated liquid in the proximal section is applied under pressure, this inflates the distal flexible bladder to substantially conform to the inner geometry of the uterine cavity.

Such devices can include a pressure sensor to ensure that the liquid within the system does not exceed an upper desired or safe pressure limit.

An undesirable situation can occur during a uterine procedure where the uterine cavity is or can become perforated, torn or otherwise compromised. Should such a situation occur, there is a potential for a portion of the distal flexible bladder to pass through the perforated, torn or otherwise compromised uterus to an area outside of the uterus. When such a situation occurs, there is potential for thermal damage to untargeted or undesired tissue or organs such as the bowel.

Some systems such as those available from Minerva Surgical Inc, such as disclosed in US2018/303404; or Novacept Inc., such as disclosed in US6554780 evaluate the integrity of a uterine cavity before an ablation procedure by introducing a probe into a patient's uterine cavity, providing a flow of a fluid, such as CO2 or Argon through the probe into the uterine cavity and monitoring the rate of the flow to characterize the uterine cavity as perforated or non-perforated based on a change in the flow rate.

Such systems however, do not allow for detection of a compromised cavity or change in cavity state during a treatment procedure.

As such, it is desirable to be able to detect a situation where a cavity such as the uterus has become, or is suspected to be, compromised.

Summary

According to a first aspect of the present invention there is provided a device for monitoring cavity integrity during a medical procedure according to claim 1.

Embodiments of the device can be used to detect procedural anomalies or undesirable situations during a thermal ablation procedure to prevent or limit injury to the patient.

Embodiments can detect a potentially compromised uterus through measurement, calculation or otherwise quantifying pressure of treatment liquid within the device. In some embodiments the volume of the treatment liquid within the device or the flow of treatment liquid through the device at any time point during an ablation procedure can be measured, calculated or otherwise quantified to assist in detecting a potentially compromised uterus. A part of this detection can involve quantifying a change of pressure, volume or flow at a point in time during a procedure or a change over a time period during a procedure. In some cases, the time period can comprise a rolling window.

In some embodiments, treatment is applied across a number of cycles of inflating and deflating a distal bladder and detecting a potentially compromised uterus can comprise comparing measurements of pressure and possibly volume or flow from one treatment cycle with those from a previous cycle to determine if any changes have occurred.

Should the device determine that a potential anomaly has occurred, the device can take action to prevent or limit any undesired damage to untargeted tissue or organs. Such an action can include the transfer of the treatment liquid from the distal flexible bladder into a proximal section of the device outside of the cavity; or any action to return the device to a safe condition before allowing the procedure to continue or aborting the procedure.

According to a second aspect there is provided a device for facilitating necrosis of tissue according to claim 22.

Embodiments according to this aspect provide improved heating of treatment liquid prior to, during or between treatment cycles of the device.

Brief Description of the Drawings

Various embodiments of the invention will now be described, by way of example, in which:

Figure 1 shows schematically layout of a device according to an embodiment of the present invention.

Description of the Embodiment

Referring now to Figure 1, there is shown a schematically device for monitoring cavity integrity during a medical procedure according to an embodiment of the present invention. Physically the device can have a form factor similar to the device of EP 1 259 180 Bl except instead of a proximal section comprising a flexible bladder housed within a pneumatic chamber, a syringe (3) is employed.

Thus, a distal flexible bladder (1) is connected to a fluidic connecting member (2). Also connected to the fluidic connecting member (2) is another fluidic connecting member (7) that is fluidically connected to a pressure sensor (8).

Typically, the distal flexible bladder (1) is formed of an elastically expandable material, for example, a biocompatible silicone elastomer, whereas the connecting members (2) and (7) tend to comprise a more rigid biocompatible material. For example, the connecting member (7) can be a flexible silicone tube - but not as flexible as the distal bladder. The distal bladder (1) is typically highly elastic so that it readily conforms with the internal surface of a cavity and so that a majority of pressure measured by the sensor (8) is derived from back pressure applied by the cavity wall.

At the proximal end of the fluidic connecting member (2) is the syringe (3), a chamber of which contains liquid which can be heated. In the embodiment, the distal bladder (1), connecting member (2), connecting member (7) and syringe chamber form a substantially liquid-tight system.

Examples of liquids which can be used in the system include: Glycerine, Triglycerides (such as Oleic Acid), Fluoro/Silicone liquid compounds and mineral oils.

Any suitable method can be used to heat the liquid within the chamber including direct heating with an element integral to the syringe chamber, radiative or conductive heating with an element external to the syringe chamber or indirect heating such as inductive heating. In the case of direct heating, in one embodiment, a flexible and collapsible heating coil can be incorporated longitudinally within the syringe chamber with electrical contacts for the heating coil passing through the chamber wall to allow electrical power to be provided to the heating coil. Using a flexible and collapsible heating coil, enables the syringe plunger to compress the heating coil when providing heated treatment fluid to the distal bladder (1), whereas when the plunger is retracted, the coil can expand to expose a maximum heating surface to the treatment liquid to most effectively heat or re-heat the treatment liquid. In other embodiments, rather than a coil, a foldable, accordion type, heating element could be employed. In either case, the heating element can be formed of any suitable material and can either be metallic or even polymeric or a combination of the two.

As well as the heater, one or more temperature sensors can be provided to indicate the temperature of liquid within the liquid-tight system.

Typical operating temperature ranges for the liquid are between approximately 90 to 180 Deg C as needed to provide a temperature at the balloon I tissue interface of approximately 70 to 100 Deg C.

In the embodiment, the syringe (3) includes a plunger and either: a proximal end of the plunger is connected to, or the plunger is formed as, a threaded shaft (4) of a known thread pitch. In either case, the proximal end of the threaded shaft (4) is connected to a bi-directional drive motor (5) which is used to move the plunger in and out of the syringe chamber either: to apply pressure and initiate liquid flow from the syringe chamber through the connecting member (2) into the distal bladder (1); or to remove liquid from the distal bladder (1) as needed.

In the embodiment, at the proximal end of the bi-directional motor (5) is a motor encoder (6) that is used to indicate rotation of the motor (5) corresponding to movement of the syringe plunger to an optical emitter/sensor (9), so enabling the axial position of the plunger within the syringe (3) to be determined. (It will nonetheless be appreciated that any suitable sensor equivalent to the encoder (6)emitter/sensor (9) arrangement can be used to determine the axial position of the plunger within the syringe (3).)

An exemplary encoder (6) comprise a circular disk (6) connected to an end of the drive motor (5). The disk can have one or more holes or slots to allow light to pass through. An optical emitter/sensor (9) is position to surround the rotating face of the circular disk of the motor encoder (6) such that the light emitted from one side of the optical emitter/sensor (9) can pass through a hole or slit on the circular disk of the motor encoder (6) to provide a series of electrical pulses from the optical emitter/sensor (9) each time a hole or slot rotates through the emitted light.

If the circular disk of the motor encoder (6) has one hole or slot, each full rotation of the circular disk on the motor encoder (6) will result in one electrical pulse being detected. If the circular disk of the motor encoder (6) has multiple holes or slots, for example of the order of 100 holes/slots, each full rotation of the circular disk on the motor encoder (6) will result in multiple electrical pulses being detected. Thus, depending on the encoder, one full rotation of the shaft can be linked to one or more counts of the encoder.

As the threaded shaft (4) is of a known pitch, in threads per millimetre, each full or partial rotation of the threaded shaft (6) will move the plunger within the syringe (3) a known distance. As the internal dimensions of the syringe (6) are known, the volume of liquid displaced by movement of the plunger within the syringe (6) can be determined and quantified from this movement/counts.

In the embodiment, the bi-directional drive motor (5) has a gear reduction drive which is used to convert a high motor rotation velocity (RPM = rotations per minute) with a low generated rotational torque (N*M = Newton * Meters) into a reduced rotation velocity of the threaded shaft (4) but with an increased rotational torque. For example, a motor can rotate at 10,000 RPM at 0.01 N*M torque while the gear reduction provides 2 RPM with 50 N*M torque.

The use of gear reduction is beneficial for a number of reasons including the use of a high-speed smaller motor to produce a higher torque with a reduced speed and the ability to conduct the rotational counting with the motor encoder (6) and optical emitter/sensor (9) at the high rotational speed portion of the motor. For example, even with a single slot encoder (6), a 10,000 RPM motor with 0.01 N*M torque will produce 10,000 counts with the motor encoder (6) and optical emitter/sensor (9) while the threaded shaft (4) will only rotate twice. Such an arrangement can increases the accuracy of the calculated position of the plunger within the syringe (3) by a factor of 5,000.

As the motor is bi-directional, the position of the plunger within the syringe (3) can be calculated or quantified by adding or subtracting the optical emitter/sensor (9) pulses according to the direction the motor is rotating.

Each of the pressure sensor (8), the motor (5), emitter/sensor (9), heater and temperature sensor are connected to an electronic device controller (not shown) running dedicated control software and typically mounted on a custom printed circuit board (PCB) along with any additional components, such as a memory, display and operating buttons, needed to operate the device.

An example of the operation of the device during a complete endometrial ablation procedure could include the following steps:

1. System check of electronics and systems.

2. Preheating the fluid within the syringe (3) to a desired temperature.

3. Complete a series of mixing cycles to substantially homogenise the temperature of the liquid within the substantially closed liquid system. These mixing cycles bring the system to a predefined pressure by transferring liquid from the syringe (3) into the distal bladder (1) then immediately withdrawing the liquid back into the syringe (3). The series of mixing cycles may be one or a predetermined multiple number of exchanges.

4. Start the treatment procedure by transferring liquid from the syringe (3) into the distal bladder (1) while bringing the system to a predefined pressure and adjusting the position of the syringe plunger as needed to maintain the system at the predefined pressure. An exemplary pressure setpoint can be about 220mm Hg +/- 20mmHg.

5. Maintain the pressure for a predetermined time, then withdraw the liquid back into the syringe (3) to mix and re-homogenise the liquid temperature.

6. Repeat steps 4 and 5 a predefined number of times with predefined treatment times. Such treatment times might be between approximately 30 seconds and 60 seconds and in some cases, times might increase from a starting time for a first one or more cycles to a maximum time for later cycles. Each treatment cycle of steps 4 and 5 may occur with substantially no delay between inflation/deflation of the distal bladder (1) or these exchanges may include predefined delays between inflations/deflations.

7. Store procedural time, temperatures and pressures in the device to allow subsequent examination of how the treatment was completed possibly by offloading this information to an external computing device.

In one embodiment, when the device starts the thermal ablation portion of the procedure, step 4 above, the pressure sensor (8) is used to measure the pressure within the system in a substantially continuous manner. This pressure measurement is used by the device controller software for multiple purposes including, but not limited to:

A) Transferring sufficient heated liquid from the syringe (3) through the fluidic connecting member (2) into the distal bladder (1) to bring the substantially closed system to the pre-defined pressure.

B) Monitoring the pressure within the system through fluidic connecting member (7) to enable the device controller to maintain the system at the pre-defined pressure by moving the plunger within syringe (3) forward or backward as needed to provide the pre-defined system pressure.

C) Monitoring the pressure within the system for a level of change over a time period during a portion of the procedure. This change can be in one or more forms such as:

a) A pressure change over a set time period exceeding a predetermined allowable change. An example of this could be where the pressure within the system changes by 30mmHg over any ten second rolling window period.

b) A pressure change faster than above but over a shorter moving window. An example of this could be where the pressure within the system changes by 10mmHg over any 5 second rolling window period.

c) A pressure change faster than the examples above. An example of this could be where the pressure within the system changes by 5mmHg over a moving 1 second window.

Note that the exemplary pressure changes provided above can be within individual treatment exchange cycles or over multiple treatment exchange cycles.

As will be appreciated, if a cavity becomes perforated during a procedure or if the distal bladder (1) comes into contact with a perforation and begins to expand outside of the cavity during a procedure, then the pressure measured by the sensor (8) will tend to drop, at least instantaneously.

The pressure drop can be measured against an immediately previous measurement or the pressure drop can be measured against a corresponding pressure measurement at the same time in a previous treatment cycle. In any case, if the pressure drop exceeds a threshold value, for example, such as provided above, the device can abort the procedure

In summary, the pressure sensor (8) is used to monitor the pressure within the substantially closed system. The system is brought up to the predefined pressure, the pressure is monitored throughout the process, the system self-adjusts to maintain the system at the predefined pressure, the device monitors changes in pressure overtime(s) and compares these to predefined pressure change limits and the device either completes the endometrial ablation procedure or aborts the procedure at any point in the event of an undesirable condition being detected.

In another embodiment, in addition to measuring pressure, the volume of liquid transferred from the syringe can be calculated and quantified and used to assist in detecting an undesirable condition.

In this case, as before, during a treatment cycle, heated liquid is transferred until the system reaches a predefined system pressure. If in the event a predetermined volume is transferred but the predetermined system pressure has not been reached, there may be an anomaly situation where the uterus is perforated, torn or otherwise compromised, or the distal bladder (1) was misplaced into an untargeted area (such as into a fallopian tube). In this case, if a predefined volume level is reached before the system obtains the predefined pressure, the procedure is aborted with the drive motor (6) engaged to transfer the heated liquid back into the syringe (3).

Separately, during a treatment cycle, with the predefined system pressure having been obtained without exceeding the maximum predefined maximum liquid use, a change of volume during a given time period can be compared to predefined limits to determine if an anomaly situation has occurred.

Some examples of this monitoring include:

A) When the device is ready to start the treatment cycles, the device will deliver heated liquid to/from the distal bladder (1) to a predetermined system pressure. The change of volume between treatment cycles can be monitored and should a volume of liquid from one treatment cycle to another exceed a predetermined volume change, the device will abort the procedure and substantially withdraw the heated liquid back into the syringe.

B) After the mixing cycles have completed, the treatment procedure starts and the distal bladder (1) is inflated with heated liquid until the predefined system pressure is obtained. If the volume of liquid transferred exceeds the volume used during the mixing cycles by a predefined volume difference, the device aborts and substantially withdraws the heated liquid back into the syringe (3).

C) When the mixing cycles have completed, the timed treatment cycles then begin. During this time, the distal bladder (1) is filled with the heated liquid to a predefined system pressure, the heated liquid remains in the distal bladder (1) fora predefined time period where additional liquid, if needed, is either transferred into or withdrawn from the distal bladder (1) to maintain the system pressure within the predefined operating window. The change of liquid volume is quantified through calculation and/or measurement during the timed cycle where the change of volume during a time window within the timed cycle is maintained. Should a volume change per predefined time window during that timed cycle be exceeded, the device aborts and substantially withdraws the heated liquid back into the syringe (3). An example could include a procedure abort in response to an increase liquid volume of 10ml from the start to the finish of the timed cycle with or without achieving the required pressure, a procedural abort if the liquid volume changes 5ml during a 10 second running window within the timed cycle or a 2ml volume change over a 5 second running window within the timed window.

D) After the series of timed treatment cycles have begun, if the starting volume of a subsequent timed treatment cycle exceeds the final volume of the preceding volume by a predefined volume change, the device aborts and substantially withdraws the heated liquid back into the syringe (3). An example of this could be where the first timed treatment cycle finishes with 10ml liquid transferred into the distal bladder (1) but the second timed treatment cycle starts with 15ml of liquid transferred into the distal bladder (1), the device aborts, if a 5ml change limit between timed treatment cycles is set as a limit, and the liquid is substantially withdrawn back into the syringe (3).

E) Across multiple timed treatment cycles, if the volume during any time point of any timed treatment cycle exceeds the final volume used during the first treatment cycles exceeds a predefined volume change, the device aborts and substantially withdraws all the liquid back into the syringe (3). An example of this could be where total volume change limit of 10ml is applied across all timed treatment cycles where timed treatment cycle 1 starts with 7ml of liquid and finishes having used 10ml of liquid, the liquid is exchanged and the second timed treatment cycle starts with 14ml of liquid and finishes having used 15ml of liquid and the third timed treatment starts with 16ml of liquid but at some point during the third timed cycle, exceeds 17ml of liquid which leads to an abort condition. As the first timed treatment cycle begins with 7mI of liquid and the third timed treatment cycles used more than 17ml of liquid, the total allowable liquid volume change limit of 10ml is exceeded and the abort condition is reached.

F) Across all cycles and liquid transfers, if a predefined total liquid volume limit is exceeded, the device aborts and the liquid is substantially withdrawn from the distal bladder (1) into the syringe (3). So, for example, a fixed limit of 30ml of liquid transferred at any one time point can be set for mixing cycles or timed treatment cycles, and if this is exceeded the device will abort and withdraw substantially all the liquid from the distal bladder (1) back into the syringe (3).

Finally, in still further embodiments of the present invention in addition to the pressure sensor (8) and either in addition or as an alternative to the volume sensor (6,9), there can be provided a flow sensor (not shown) for determining a rate of liquid flow through the fluidic connecting member (2).

Such a flow measurement can be used to determine if during a mixing or treatment cycle a flow of liquid through the system exceeds a threshold. As in the cases of pressure and volume above, a number of flow thresholds can be employed. So for example, there can be an upper safety flow rate which if exceeded at any time indicates an anomalous condition, for example, a fault in the distal bladder (1).

Alternatively, a lower flow rate in excess of a given lower threshold for maintaining a pressure at the predetermined level during a treatment cycle could also indicate an anomalous condition such as a perforation.

As has been explained above, measurements of pressure and possibly volume or flow rate of treatment liquid can be used in a number of ways to determine if an anomalous condition is occurring during a treatment process. So, for example, instantaneous measurement values can be compared with absolute thresholds, or changes in measured values within a given cycle or between cycles can be compared with thresholds. Still more sophisticated techniques employing pattern matching in either a single dimension of pressure, volume or flow or across multiple dimensions of pressure, volume or flow including employing trained classifiers or artificial neural networks can also be used to detect any one or more anomalous conditions.

It will also be appreciated that the variants of the above described embodiments can include extended functionality and can, for example, be configured for conducting a pre- or post- treatment cavity check using a fluid other than the treatment liquid.

In such an embodiment, an air pump incorporated within the device can pass pressurized air through a solenoid controlled valve to deliver filtered room air under pressure through an air tube running along the fluid connecting member (2) to a distal end of the device to inflate the cavity which is to be treated to a pre-defined pressure, with each of the air pump and solenoid controlled valve being programmatically controlled by the device controller as required. A separate sensor than used for sensing the pressure of heated treatment fluid during a treatment cycle is required to determine when the pre-determined pressure is provided. The valve can be closed, and the system pressure measured for a pre-determined time perhaps as little as 2-3 seconds - to determine if the cavity is correct and suitable for treatment. System volume can also be measured, for example, by tracking the amount of air pumped into the cavity to achieve the pre-determined pressure and again this can be used to determine if the cavity is correct and suitable for treatment. For conducting such a cavity integrity check, a target air pressure, might be in the region of 70 - 110 mmHg. Once the check is complete, the solenoid controlled valve can be actuated by the device controller and air can be bled from the system through the air tube before, in the case of a pre-check, allowing treatment to proceed as described above. Alternatively, in the case of a post- treatment check, the air pressure and/or volume measurements can be recorded and/or compared with those from a pre-check to check the continuing integrity of the cavity.

In variants of such an embodiment, rather than compressed air, CO2 or Argon could be used such as disclosed in US2018/303404 or US6554780 referred to above,

In still further variants of the above described embodiments, a UV light source could be used in order to kill bacteria and/or to sterilize air being used for the pre- or posttreatment cavity check.

Claims

Claims:

1. A device comprising: a distal flexible bladder; a proximal section; a connecting member joining the distal bladder and proximal section in a liquid-tight system; and a treatment liquid inside the system to flow between the distal bladder and proximal section, wherein the treatment liquid is in an amount that permits the distal bladder to substantially deflate when the treatment liquid is moved out of the distal bladder; a pressurizing mechanism to apply variable pressure to the proximal section to initiate liquid flow out of the proximal section and into the distal bladder; a heater element controlled for heating of the treatment liquid in the proximal section; a pressure sensor for detecting a pressure level of the treatment liquid within said liquid-tight system; and a controller operably connected to said pressurizing mechanism, said heater and said pressure sensor, said controller being configured to monitor measured values including pressure values provided by said pressure sensor during a medical procedure and being responsive to a change in said measured values for detecting an anomalous condition of a cavity to which treatment is applied.

2. A device according to claim 1 wherein said controller is responsive to a drop in measured pressure values for detecting an anomalous condition of said cavity.

3. A device according to claim 1 further comprising a volume sensor for measuring a volume of fluid within said proximal section and wherein said controller is responsive to an increase in measured volume values at a given measured pressure value for detecting an anomalous condition of said cavity.

4. A device according to claim 1 further comprising a flow sensor for measuring a flow of liquid between said proximal section and said distal bladder and wherein said controller is responsive to a flow rate above a given value at a given measured pressure value for detecting an anomalous condition of said cavity.

5. A device according to claim 1 further comprising a volume sensor for measuring a volume of fluid within said proximal section and a flow sensor for measuring a flow of liquid between said proximal section and said distal bladder and wherein said controller is responsive to a flow rate above a given value at a given measured pressure or volume for detecting an anomalous condition of said cavity.

6. A device according to claim 1 wherein said controller is configured to apply treatment over a plurality of cycles of inflating and deflating said distal bladder and wherein measurements from one cycle are compared to measurements from a previous cycle for detecting an anomalous condition of said cavity.

7. A device according to claim 1 wherein said controller is configured to apply treatment over a plurality of cycles of inflating and deflating said distal bladder and wherein measurements from one cycle are compared to previous measurements within a cycle for detecting an anomalous condition of said cavity.

8. A device according to claim 1 wherein said controller is configured to compare measurements with one or more pre-determined thresholds for detecting an anomalous condition of said cavity.

9. A device according to claim 8 wherein each pre-determined threshold is associated with a time window of a given length.

10. A device according to claim 9 wherein each pre-determined threshold is proportional to the length of the associated time window.

11. A device according to claim 1 wherein said proximal section comprises a syringe including a chamber forming a component of said liquid-tight system and a plunger operably connected to said pressurizing mechanism.

12. A device according to claim 11 further comprising a volume sensor operably connected to said plunger.

13. A device according to claim 1 wherein said distal flexible bladder is formed of an elastomeric material.

14. A device according to claim 1 wherein said liquid comprises any of: Glycerine, Triglyceride, Oleic Acid, Fluoro/Silicone liquid compounds or mineral oils.

15. A device according to claim 1 further comprising a temperature sensor configured to measure a temperature of said liquid.

16. A device according to claim 11 wherein said heater comprises a collapsible heater disposed within said syringe chamber, said heater being arranged to collapse as said syringe plunger is operated to displace treatment liquid from said chamber into said distal bladder and to expand as said syringe plunger is operated to move treatment liquid out of said distal bladder into said chamber.

17. A device as claimed in claim 16 wherein a surface area of said heater exposed to said treatment liquid is greater when said heater is in an expanded state than when said heater is in a collapsed state.

18. A device as claimed in claim 16 wherein said heater is longitudinally disposed within said syringe chamber and is configured to expand and collapse longitudinally within said syringe chamber.

19. A device as claimed in claim 16 wherein said heater comprises one of: a coiled spring; or a foldable element.

20. A device as claimed in claim 1 further comprising a second source of compressed fluid and a fluid conduit for providing compressed fluid from said source towards a distal end of said device, said second source being controllable to inflate said cavity to a pre-determined pressure of said compressed fluid for detecting a condition of a cavity in which said distal bladder is located.

21. A device as claimed in claim 1 wherein said compressed fluid comprises any one of: filtered air; CO2; or Argon.

22. A device comprising: a distal flexible bladder; a proximal section; a connecting member joining the distal bladder and proximal section in a liquid-tight system; and a treatment liquid inside the system to flow between the distal bladder and proximal section, wherein the treatment liquid is in an amount that permits the distal bladder to substantially deflate when the treatment liquid is moved out of the distal bladder; a pressurizing mechanism to apply variable pressure to the proximal section to initiate liquid flow out of the proximal section and into the distal bladder; a heater element controlled for heating of the treatment liquid in the proximal section; a pressure sensor for detecting a pressure level of the treatment liquid within said liquid-tight system; and a controller operably connected to said pressurizing mechanism, said heater and said pressure sensor, wherein said proximal section comprises a syringe including a chamber forming a component of said liquid-tight system and a plunger operably connected to said pressurizing mechanism and said heater comprises a collapsible heater disposed within said syringe chamber, said heater being arranged to collapse as said syringe plunger is operated to displace treatment liquid from said 5 chamber into said distal bladder and to expand as said syringe plunger is operated to move treatment liquid out of said distal bladder into said chamber.