Liquid nitrogen cryoablation system and control method therefor

Abstract

Disclosed in the present disclosure is a liquid nitrogen cryoablation system, comprising a vacuum pipe, a balloon catheter, a backing pump, and a switch assembly. The balloon catheter comprises a vacuum layer, the vacuum pipe being connected to the vacuum layer. The switch assembly comprises a first switch, a second switch, a third switch and a fourth switch. The system further comprises a vacuum cavity and a molecular pump connected to the vacuum cavity, the molecular pump being connected to the backing pump by means of the first switch; the vacuum cavity is connected to the vacuum pipe, the second switch being arranged between the vacuum cavity and the vacuum pipe; the backing pump is connected to the vacuum pipe by means of the third switch; and the fourth switch is connected between the vacuum pipe and the vacuum layer of the balloon catheter. The molecular pump in the vacuum pipe and the backing pump of the device act on each part of the pipe separately or in combination, so that each part in the device can be pre-vacuumized, thereby reducing the time for vacuumizing the vacuum layer of the balloon catheter during the connection of the balloon catheter.

Description

A liquid nitrogen cryoablation system and its control method Technical Field

[0001] This disclosure relates to the field of medical device technology, specifically to a liquid nitrogen cryoablation system and its control method. Background Technology

[0002] Liquid nitrogen cryoablation systems utilize liquid nitrogen to freeze and destroy abnormal cells or diseased tissues, treating various cancers and arrhythmias. During cryoablation surgery, the system requires connection to ablation instruments such as ablation needles and balloon catheters. Taking a liquid nitrogen balloon catheter as an example, liquid nitrogen is introduced into the catheter, creating a low temperature at the treatment site, thereby freezing the diseased tissue. Cryoablation is a common interventional treatment technique. Compared to thermal ablation, it offers higher safety, less irritation and damage to the body's natural cavities, and a lower risk of complications; therefore, this technique is increasingly being used in clinical surgery.

[0003] Before cryotherapy, the device needs to evacuate the vacuum layer of the balloon catheter for insulation. However, existing technology has two problems: First, during surgery, there is a need to replace the external balloon catheter, and after replacement, the vacuum layer of the balloon catheter needs to be evacuated again, which is inefficient. If this operation is performed during surgery, it will prolong the operation time and delay the patient's treatment. Second, since the vacuum device needs to be connected to the vacuum layer of the balloon catheter, and the balloon catheter needs to be inserted into the body cavity, if the vacuum layer of the balloon catheter ruptures during surgery, the vacuum device will directly act on the human body, damaging the vacuum device and endangering the patient's health.

[0004] Therefore, there is an urgent need for a liquid nitrogen cryoablation system that has high vacuuming efficiency and can promptly detect and alarm in the event of balloon rupture. Summary of the Invention

[0005] To overcome the above problems, this disclosure proposes a liquid nitrogen cryoablation system and its control method.

[0006] This disclosure provides a liquid nitrogen cryoablation system, including a vacuum line, a balloon catheter, a backing pump, a switching assembly, and a first vacuum sensor and a second vacuum sensor; the balloon catheter includes a vacuum layer, and the vacuum line is connected to the vacuum layer; the switching assembly includes a first switch, a second switch, a third switch, and a fourth switch; it also includes a vacuum chamber and a molecular pump connected to the vacuum chamber, and the molecular pump and the backing pump are connected via the first switch; the vacuum chamber is connected to the vacuum line, and the second switch is provided between the vacuum chamber and the vacuum line; the backing pump is connected to the vacuum line via the third switch; the fourth switch is connected between the vacuum line and the vacuum layer of the balloon catheter.

[0007] Furthermore, the vacuum chamber is connected to the first vacuum sensor; and / or, the vacuum line is connected to the second vacuum sensor.

[0008] Furthermore, a leak detection device is connected between the fourth switch and the balloon catheter.

[0009] Furthermore, the leak detection device includes a fifth switch, which is disposed between the fourth switch and the balloon catheter and is connected to the atmosphere. The fifth switch controls the connection between the vacuum line and the atmosphere.

[0010] Furthermore, the leak detection device includes a water detection electrode.

[0011] This disclosure provides a control method for a liquid nitrogen cryoablation system, used to control the liquid nitrogen cryoablation system as described above, the control method comprising,

[0012] Step 1: Start the equipment;

[0013] Step 2: Evacuate the vacuum pipeline and check the airtightness based on the feedback value of the second vacuum sensor; if the airtightness check is passed, proceed to Step 3; if the airtightness check is failed, stop the machine and troubleshoot.

[0014] Step 3: Evacuate the vacuum chamber, perform an airtightness check based on the feedback value of the first vacuum sensor, and pre-evacuate the vacuum layer and vacuum tubing of the balloon catheter; if the airtightness check is passed, proceed to Step 4; if the airtightness check is failed, stop the machine for troubleshooting.

[0015] Step 4: Evacuate the vacuum layer of the vacuum tubing and the balloon catheter, and monitor the airtightness based on the feedback value of the second vacuum sensor;

[0016] Step 5: Seal the vacuum chamber to maintain the vacuum level inside the vacuum chamber.

[0017] Furthermore, the step of evacuating the vacuum pipeline and performing an airtightness check based on the feedback value of the second vacuum sensor includes: controlling the first switch and the second switch to open, the third switch and the fourth switch to close, and the molecular pump and the forepump working together to evacuate the vacuum pipeline.

[0018] Furthermore, the vacuum chamber is evacuated, an airtightness check is performed based on the feedback value of the first vacuum sensor, and the vacuum layer and vacuum tubing of the balloon catheter are pre-evacuated, including: controlling the first switch and the second switch to turn off, controlling the third switch and the fourth switch to turn on, the molecular pump evacuating the vacuum chamber, and the forepump pre-evacuating the vacuum tubing and the vacuum layer of the balloon catheter.

[0019] Furthermore, evacuating the vacuum layer of the vacuum tubing and the balloon catheter includes: controlling the first switch, the second switch, and the fourth switch to open, controlling the third switch to close, the vacuum chamber communicating with the vacuum layer of the vacuum tubing and the balloon catheter to form a vacuum evacuation path, and the forepump and the molecular pump working together to operate on the vacuum evacuation path.

[0020] Furthermore, the step of sealing the vacuum chamber to maintain the vacuum level inside the vacuum chamber includes: controlling the first switch and the second switch to turn off to seal the vacuum chamber.

[0021] Technical effects of this disclosure:

[0022] This disclosure, by employing the aforementioned technology, has at least the following positive effects compared to the prior art:

[0023] (1) The liquid nitrogen cryoablation system disclosed herein uses multiple switches to allow the molecular pump and the forepump installed in the vacuum pipeline of the equipment to act individually or in combination on various parts of the pipeline, so that each pipeline in the equipment is pre-evacuated, thereby reducing the time required to evacuate the vacuum layer of the balloon catheter when connecting the balloon catheter.

[0024] (2) The liquid nitrogen cryoablation system disclosed herein has a large capacity vacuum chamber and uses a molecular pump to continuously evacuate the vacuum chamber to maintain a high vacuum level. When connecting the balloon catheter, the vacuum level in the vacuum layer of the balloon catheter can be quickly increased, reducing the time required to evacuate the vacuum layer of the balloon catheter. Attached Figure Description

[0025] To more clearly illustrate the technical solutions within the embodiments of this disclosure or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments recorded in this disclosure. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0026] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments consistent with this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0027] Figure 1 shows a schematic diagram of the connection structure of a liquid nitrogen cryoablation system according to an embodiment of the present disclosure.

[0028] Figure 2 shows a flowchart of a liquid nitrogen cryoablation system control method according to an embodiment of the present disclosure.

[0029] Reference numerals: Vacuum line 11, balloon catheter 12, forepump 13, first switch 141, second switch 142, third switch 143, fourth switch 144, vacuum chamber 15, molecular pump 16, first vacuum sensor 17, second vacuum sensor 18, leak detection device 19, fifth switch 20. Detailed Implementation

[0030] The technical solutions of various embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this disclosure, and not all embodiments. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0031] In the description of this disclosure, it should be understood that, in order to clearly and intuitively present the technical solution of this disclosure, some components are omitted in the accompanying drawings, which are only for illustration and do not constitute a specific limitation of this disclosure.

[0032] As shown in Figure 1, this embodiment provides an ablation system, including a vacuum line 11, a vacuum chamber 15, a balloon catheter 12, a molecular pump 16 connected to the vacuum chamber 15, a backing pump 13 connected to the atmosphere, and a switching assembly. The balloon catheter 12 includes a vacuum layer (not shown), which has a heat insulation function, and the vacuum layer is connected to the vacuum line 11. The switching assembly includes a first switch 141, a second switch 142, a third switch 143, and a fourth switch 144. The molecular pump 16 is connected to the vacuum chamber 15 and can evacuate the vacuum chamber 15, maintaining a high vacuum level within it. The molecular pump 16 and the backing pump 13 are connected via the first switch 141. The vacuum chamber 15 is connected to the vacuum line 11, and a second switch 142 is provided between the vacuum chamber 15 and the vacuum line 11, controlling the connection and disconnection between them. The forepump 13 is connected to the vacuum line 11 via a third switch 143, which controls the connection between the forepump 13 and the vacuum line 11. A fourth switch 144 is provided at the interface of the vacuum line 11, which controls the connection between the vacuum line 11 and the vacuum layer of the balloon catheter 12.

[0033] In some embodiments, a leak detection device 19 is connected between the fourth switch 144 and the balloon catheter 12. The leak detection device 19 can be a water ingress detection sensor or a water detection electrode. The water detection electrode is a positive and negative electrode with a gap. It is non-conductive when no liquid passes through the pipeline. If liquid leaks into the pipeline, the liquid will enter the gap between the positive and negative electrodes, making the positive and negative electrodes conductive, and the water detection electrode will conduct electricity, thereby detecting the leakage of the balloon catheter. If a leak is detected, a liquid leak signal is sent to the controller. The controller issues an alarm signal based on the liquid leak to alert the user and simultaneously controls the fifth switch 20 to open, while all other switches are closed. Since atmospheric pressure is higher than the pressure in the vacuum pipeline 11 inside the device, atmospheric pressure is used to force the liquid out of the ablation system's pipeline.

[0034] The leak detection device 19 includes a fifth switch 20, which is disposed between the fourth switch 144 and the balloon catheter 12 and is connected to the atmosphere. The fifth switch 20 controls the connection and disconnection between the vacuum line 11 and the atmosphere.

[0035] As shown in Figure 2, the control steps of the liquid nitrogen cryoablation system are as follows:

[0036] S11 activates the liquid nitrogen cryoablation system;

[0037] S12 evacuates the vacuum line 11 and checks its airtightness based on the feedback value from the second vacuum sensor 18; it controls the first switch 141 and the second switch 142 to open, and the third switch 143 and the fourth switch 144 to close. The molecular pump 16 and the forepump 13 work together to evacuate the vacuum line 11. At this time, the vacuum line 11, the vacuum chamber 15, the molecular pump 16, and the forepump 13 are connected. The molecular pump 16 and the forepump 13 are turned on to evacuate the vacuum line 11 and the vacuum chamber 15, and the extracted gas is discharged to the atmosphere through the forepump 13.

[0038] The air pressure value obtained from the second vacuum sensor 18 is used to determine the airtightness of the connected instruments in this step. If the air pressure value cannot approach the expected air pressure value achieved by vacuuming, then there is a leak in the equipment in the system, and further investigation is required.

[0039] S13 evacuates the vacuum chamber 15, performs an airtightness check based on the feedback value of the first vacuum sensor 17, and pre-evacuates the vacuum layer of the balloon catheter 12 and the vacuum line 11.

[0040] The first switch 141 and the second switch 142 are turned off, and the third switch 143 and the fourth switch 144 are turned on. The molecular pump 16 evacuates the vacuum chamber 15, and the forepump 13 pre-evacuates the vacuum layer of the vacuum line 11 and the balloon catheter 12. The molecular pump 16 can create a high vacuum environment. The first vacuum sensor is used to detect the gas pressure or vacuum level in the vacuum chamber 15. If the pressure or vacuum level feedback value of the first vacuum sensor 17 does not approach the expected value, there is a possibility of leakage in the vacuum chamber 15, and the machine needs to be stopped for further investigation.

[0041] S14 evacuates the vacuum layer of vacuum line 11 and balloon catheter 12, and performs an airtightness check based on the feedback value of the second vacuum sensor 18.

[0042] Open the first switch 141, the second switch 142, and the fourth switch 144, and close the third switch 143. At this time, the vacuum layer, vacuum tubing 11, vacuum chamber 15, molecular pump 16, and foremi pump 13 of the balloon catheter 12 are sequentially connected to form a vacuuming path. The high-vacuum chamber 15 is connected to the low-vacuum vacuum layer of the balloon catheter 12. Molecules in the low-vacuum vacuum layer of the balloon catheter 12 move towards the high-vacuum vacuum chamber 15, causing the vacuum levels in the balloon catheter 12 and vacuum chamber 15 to converge. The vacuum level in the vacuum layer of the balloon catheter 12 increases, reducing the time required to evacuate the vacuum layer of the balloon catheter 12 and saving surgical time. The airtightness of the equipment in the vacuuming path is checked based on the pressure value fed back by the second vacuum sensor 18. Due to the action of the molecular pump 16, the vacuum level in the equipment within the path further increases (i.e., the pressure value decreases). If the vacuum level of the equipment cannot rise to the expected value, there may be a minor leak in the vacuuming path, requiring further investigation of the equipment in the vacuuming path.

[0043] S15 seals the vacuum chamber 15 to maintain the vacuum level within the vacuum chamber 15.

[0044] The first switch 141 and the second switch 142 are turned off to seal the vacuum chamber 15. The volume of the vacuum chamber 15 is preferably more than forty times the volume of the vacuum layer of the balloon catheter 12. Therefore, evacuating the vacuum chamber 15 is time-consuming and laborious. After sealing the vacuum chamber 15, the second switch 142 is turned on after replacing the balloon catheter 12, connecting the vacuum chamber 15 and the vacuum layer of the replaced balloon catheter 12. This quickly increases the vacuum level of the replaced balloon catheter 12 vacuum layer, making the liquid nitrogen cryoablation system more economical and efficient.

[0045] In some embodiments, the vacuum chamber 15 is connected to the first vacuum sensor 17; in some embodiments, the vacuum line 11 is connected to the second vacuum sensor 18. The connection of the vacuum sensors can monitor the vacuum level inside the device in real time, provide feedback to the controller to control the vacuuming time, and also detect whether there is a leak in the vacuum line 11 or the vacuum chamber 15.

[0046] Other embodiments of this disclosure will readily occur to those skilled in the art upon consideration of the specification and practice of the invention disclosed herein. This disclosure is intended to cover any variations, uses, or adaptations of this disclosure that follow the general principles of this disclosure and include common knowledge or customary techniques in the art not disclosed herein. The specification and examples are to be considered exemplary only, and the true scope and spirit of this disclosure are indicated by the following claims.

[0047] It should be understood that this disclosure is not limited to the precise structures described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of this disclosure is limited only by the appended claims.

Claims

1. A liquid nitrogen cryoablation system, comprising a vacuum line, a balloon catheter, a backing pump, a switching assembly, and a first vacuum sensor and a second vacuum sensor; the balloon catheter includes a vacuum layer, and the vacuum line is connected to the vacuum layer; the switching assembly includes a first switch, a second switch, a third switch, and a fourth switch; characterized in that, It also includes a vacuum chamber and a molecular pump connected to the vacuum chamber, and the molecular pump and the forepump are connected through the first switch; the vacuum chamber is connected to the vacuum pipeline, and a second switch is provided between the vacuum chamber and the vacuum pipeline; the forepump and the vacuum pipeline are connected through the third switch; and the fourth switch is connected between the vacuum pipeline and the vacuum layer of the balloon catheter.

2. The liquid nitrogen cryoablation system according to claim 1, characterized in that, The vacuum chamber is connected to the first vacuum sensor; and / or, the vacuum line is connected to the second vacuum sensor.

3. The liquid nitrogen cryoablation system according to claim 1, characterized in that, A leak detection device is connected between the fourth switch and the balloon catheter.

4. The liquid nitrogen cryoablation system according to claim 3, characterized in that, The leak detection device includes a fifth switch, which is located between the fourth switch and the balloon catheter and is connected to the atmosphere. The fifth switch controls the connection between the vacuum line and the atmosphere.

5. The liquid nitrogen cryoablation system according to claim 4, characterized in that, The leak detection device includes a water detection electrode.

6. A control method for a liquid nitrogen cryoablation system, characterized in that, The control method for controlling the liquid nitrogen cryoablation system according to any one of claims 2-5 includes: Step 1: Start the equipment; Step 2: Evacuate the vacuum pipeline and check the airtightness based on the feedback value of the second vacuum sensor; If the airtightness test is passed, proceed to step three; if the airtightness test is failed, stop the machine and troubleshoot. Step 3: Evacuate the vacuum chamber, perform an airtightness check based on the feedback value of the first vacuum sensor, and pre-evacuate the vacuum layer and vacuum tubing of the balloon catheter; if the airtightness check is passed, proceed to Step 4; if the airtightness check is failed, stop the machine for troubleshooting. Step 4: Evacuate the vacuum layer of the vacuum tubing and the balloon catheter, and monitor the airtightness based on the feedback value of the second vacuum sensor; Step 5: Seal the vacuum chamber to maintain the vacuum level inside the vacuum chamber.

7. The control method for the liquid nitrogen cryoablation system according to claim 6, characterized in that, The step of evacuating the vacuum pipeline and performing an airtightness check based on the feedback value of the second vacuum sensor includes: The first and second switches are turned on, and the third and fourth switches are turned off. The molecular pump and the forepump work together to evacuate the vacuum pipeline.

8. The control method for the liquid nitrogen cryoablation system according to claim 6, characterized in that, The vacuum chamber is evacuated, and an airtightness check is performed based on the feedback value of the first vacuum sensor. The vacuum layer and vacuum tubing of the balloon catheter are also pre-evacuated, including: The first and second switches are turned off, and the third and fourth switches are turned on. The molecular pump evacuates the vacuum chamber, and the forepump pre-evacuates the vacuum layer of the vacuum pipeline and the balloon catheter.

9. The control method for the liquid nitrogen cryoablation system according to claim 6, characterized in that, Evacuating the vacuum layer of the vacuum tubing and the balloon catheter includes: The first switch, the second switch, and the fourth switch are controlled to open, and the third switch is controlled to close. The vacuum chamber is connected to the vacuum pipeline and the vacuum layer of the balloon catheter to form a vacuum pumping passage. The forepump and the molecular pump work together to operate on the vacuum pumping passage.

10. The control method for the liquid nitrogen cryoablation system according to claim 6, characterized in that, The process of sealing the vacuum cavity to maintain the vacuum level within the vacuum cavity includes: The first and second switches are turned off to seal the vacuum chamber.

Images