Safety device for cryoablation probe

Abstract

In one embodiment, a method for detecting leaks in the shaft of a refrigeration ablation system includes arranging a vacuum pump to be in fluid communication with a return pipe and a supply pipe, evacuating the supply pipe and the return pipe, measuring the vacuum pressure in the supply pipe and the return pipe after evacuating for a predetermined time, and analyzing the vacuum pressure to enable identification of leaks in the system.

Claims

1. A method for detecting a leak in a shaft of a cryoablation system, wherein the shaft includes a supply pipe, a return pipe, and an expansion chamber at the distal end of the shaft, and the shaft is configured to allow a working fluid to move from the proximal end of the shaft to the distal end, expand in the expansion chamber, and return to the proximal end of the shaft through the supply pipe and the return pipe, and the method is: The vacuum pump is positioned to be in fluid communication with the return pipe and the supply pipe. Vacuuming the supply pipe and the return pipe, After evacuating the system for a predetermined period of time, measure the vacuum pressure in the supply pipe and the return pipe. If the vacuum pressure is below the threshold pressure value, it is determined that there is no leakage in the shaft, and If the vacuum pressure exceeds the threshold pressure value, it is determined that there is a leak in the shaft. A method for providing this.

2. The method according to claim 1, further comprising recording a leak indication when it is determined that there is a leak in the shaft.

3. The method according to claim 1, wherein the threshold pressure value is approximately 0.05 Torr (6.67 Pa).

4. The method according to claim 1, wherein the predetermined time is approximately 10 seconds to approximately 45 seconds.

5. The method according to claim 1, further comprising continuously monitoring the vacuum pressure for a predetermined period of time when evacuating the supply pipe and the return pipe.

6. The method according to claim 5, further comprising determining that the shaft is not closed at the distal end when a continuous increase in the vacuum pressure relative to the ambient pressure is measured.

7. To monitor the initial rise in the aforementioned vacuum pressure, After the initial rise in the vacuum pressure, monitor whether the vacuum pressure has stabilized at a value exceeding the threshold pressure value, and To determine that there is a leak in the aforementioned shaft, The method according to claim 5, further comprising:

8. To monitor the initial rise in the aforementioned vacuum pressure, After the initial rise in the vacuum pressure, monitor that the vacuum pressure has stabilized at a value below the threshold pressure value, and To determine that there is no leakage in the aforementioned shaft, The method according to claim 5, further comprising:

9. To monitor the initial rise in the aforementioned vacuum pressure, To measure the rate of change in the initial rise of the vacuum pressure, and If the rate of change exceeds the threshold rate, it is determined that the shaft is damaged. The method according to claim 5, further comprising:

10. The method according to claim 1, wherein the method is performed before the cryoablation system is introduced into the patient.

11. The method according to claim 1, wherein the method is performed after the cryoablation system has been introduced into the patient, during or after maneuvering the cryoablation system to the treatment site.

12. The method according to claim 1, wherein the method is performed after the first cryoablation treatment is completed using the cryoablation system and before the second cryoablation treatment is performed using the cryoablation system.

13. A cryoablation system, The working gas circuit, Vacuum chamber and A vacuum pump configured to evacuate either the operating gas circuit or the vacuum chamber, A console configured to switch the vacuum pump between the operating gas circuit and the vacuum chamber, A pressure sensor configured to measure the vacuum pressure in the operating gas circuit, Equipped with, The aforementioned console is Switch the vacuum pump to the operating gas circuit, The vacuum pump is controlled to evacuate the operating gas circuit. After evacuating for a predetermined period of time, the vacuum pressure in the operating gas circuit is measured by the pressure sensor. If the vacuum pressure exceeds a threshold pressure value, it is determined that the shaft is damaged. A cryoablation system is further configured as follows.

14. The cryoablation system according to claim 13, wherein the console is further configured to evacuate the working gas circuit and to continuously monitor the vacuum pressure for a predetermined period of time.

15. The cryoablation system according to claim 14, wherein the console is further configured to determine that the shaft is not closed at its distal end when measuring a continuous increase in the vacuum pressure relative to the ambient pressure.

16. The aforementioned console is The initial rise in the vacuum pressure is monitored, After the initial rise in vacuum pressure, the system monitors whether the vacuum pressure has stabilized at a value exceeding the threshold pressure value. It is determined that there is a leak in the aforementioned shaft. The cryoablation system according to claim 14, further configured as follows.

17. A cryoablation system, Precooler fluid circuit, Working fluid circuit and Vacuum circuits and, The shaft and The shaft is equipped with, An insulating portion in which the vacuum circuit is defined within the insulating portion, Expansion chamber and The expansion chamber includes, A supply pipe having a distal outlet within the expansion chamber, wherein fluid from the working fluid circuit moves through the supply pipe and expands within the expansion chamber, A first layer configured to contain the fluid from the working fluid circuit, A second layer, configured to increase the radial strength of the expansion chamber, Includes, A cryoablation system wherein the shaft has a lower burst strength in the insulating portion at a first position and a higher burst strength in the expansion chamber at a second position.

18. The cryoablation system according to claim 17, wherein the shaft includes an inner metal tube, the first layer is sealed to the inner metal tube at the distal end of the inner metal tube, and the first position is the sealing position between the first layer and the inner metal tube.

19. The cryoablation system according to claim 17, wherein the first layer comprises PET and the second layer comprises a polymer or braided material.

20. The cryoablation system according to claim 17, further comprising a burst valve at the first position.

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