CN112402005B - Cavity channel cryotherapy system - Google Patents

Cavity channel cryotherapy system Download PDF

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Publication number
CN112402005B
CN112402005B CN202011133619.1A CN202011133619A CN112402005B CN 112402005 B CN112402005 B CN 112402005B CN 202011133619 A CN202011133619 A CN 202011133619A CN 112402005 B CN112402005 B CN 112402005B
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Prior art keywords
refrigerant
pipeline
valve body
negative pressure
control module
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CN112402005A (en
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邢宗江
陆战钶
宋超
陈福旺
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Ningbo Senscure Biotechnology Co ltd
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Ningbo Senscure Biotechnology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00214Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00482Digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00791Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00863Fluid flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231Characteristics of handpieces or probes
    • A61B2018/0262Characteristics of handpieces or probes using a circulating cryogenic fluid

Abstract

The invention discloses a cavity channel freezing treatment system, which comprises a refrigerant conveying pipeline, a guide pipe, a refrigerant return pipeline and a control module, wherein the refrigerant conveying pipeline is connected with the guide pipe; the guide pipe is respectively connected with the refrigerant conveying pipeline and the refrigerant return pipeline; the refrigeration source, the first valve body and the connecting port are sequentially connected through a refrigerant conveying pipeline; the front end of the refrigerant return pipeline is connected with the connecting port, the tail end of the refrigerant return pipeline is connected with the second valve body, and a negative pressure device is arranged between the second valve body and the connecting port in parallel; the guide pipe comprises a pipe body and a freezing unit, and a refrigerant circulation loop is arranged in the pipe body; the control module is respectively and electrically connected with the first valve body, the second valve body and the negative pressure device. The cavity channel freezing treatment system has high freezing efficiency and short operation time, and can accurately and conveniently test the safety of the cavity channel freezing treatment system.

Description

Cavity channel cryotherapy system
Technical Field
The invention relates to the field of medical instruments, in particular to a cavity channel cryotherapy system.
Background
Interventional therapy in natural cavities (such as digestive tracts and air passages) of human bodies has attracted more and more attention by people due to the advantages of micro-invasion, convenient operation and the like, corresponding therapeutic instruments and methods are more and more, the clinical therapeutic effect is widely accepted, and the main application modes include radio frequency ablation and cryoablation.
At present, the radio frequency ablation method is widely applied and rapidly developed. Rf ablation, while successful in several areas, has several major drawbacks including incomplete ablation, often lack of visualization during catheterization, potential overlap during treatment (where some areas receive twice as much energy as others), charring of tissue, and the need for frequent debridement. Cryoablation is a therapeutic method of controllably damaging tissue by freezing local tissue. Compared with radio frequency ablation, cryoablation has the advantages of small operative wound, accurate positioning, hemostasis and analgesia, few postoperative complications, high safety and the like, and is well received by doctors and patients. When the cryoablation is used in an airway, compared with thermal ablation, the cryoablation is not easy to cause cartilage damage, the airway is rarely softened and collapsed, and secondary dynamic stenosis is prevented; cryotherapy is less likely to cause adhesion of the frozen site to surrounding tissue; the freezing treatment with controllable depth is not easy to cause serious injury to the adjacent great vessels and trachea, is not easy to cause perforation bleeding and is beneficial to tissue repair; the cryoablation does not promote the proliferation of granulation tissue and is not easy to generate scar tissue.
The natural airways of the human body have specific functions, such as the lungs, to keep the gas flow and exchange. When cryoablation is performed in the lung, the time of cryoablation operation needs to be strictly controlled to prevent suffocation of a patient from generating risks, so that the freezing efficiency needs to be improved, and an airway needs to be kept smooth as soon as possible. Moreover, because the lung is a closed organ, if the refrigerant leaks in the process of cryotherapy, the refrigerant becomes gas after heat exchange, and the pressure in the lung is increased by the gas, thereby increasing the operation risk.
The conventional freezing treatment system is provided with the negative pressure pump at the refrigerant return end, the returned refrigerant is pumped, the rapid cooling can be realized, the flow of the refrigerant is limited, and when the flow of the refrigerant is large, the refrigerant needs to be matched with the negative pressure pump with higher power, otherwise, the effect is not obvious, and the volume, the installation, the cost and the like are unfavorable. And the backflow refrigerant has strict requirements on ultralow temperature of the negative pressure pump, and has a complex structure and high cost. The freezing unit security test of general cryotherapy system (prevent to reveal), can carry out external test (whether generally look over in normal saline and leak) before using, the operation process is inconvenient, and to the freezing unit of utricule, external test back, the diameter increase is pressed and is held to the utricule, even need fold once more, needs specific frock to accomplish, and the operation is complicated, also can increase the risk of polluting freezing unit. Therefore, it is necessary to design a cryosurgical system with high freezing efficiency, short operation time, and accurate and convenient safety test.
Disclosure of Invention
The invention aims to solve the problems of the existing freezing treatment system and provides a cavity channel freezing treatment system which is high in freezing efficiency, short in operation time and capable of accurately and conveniently testing the safety of the cavity channel freezing treatment system.
In order to achieve the purpose, the invention adopts the following technical scheme:
the cavity channel freezing treatment system comprises a refrigerant conveying pipeline, a guide pipe, a refrigerant return pipeline and a control module; the guide pipe is respectively connected with the refrigerant conveying pipeline and the refrigerant return pipeline;
the refrigeration source, the first valve body and the connecting port are sequentially connected through the refrigerant conveying pipeline, and the refrigeration source is used for providing a refrigerant; the front end of the refrigerant return pipeline is connected with the connecting port, the tail end of the refrigerant return pipeline is connected with the second valve body, and a negative pressure device is arranged between the second valve body and the connecting port in parallel; the pipe comprises a pipe body and a freezing unit, wherein a refrigerant circulation loop is arranged in the pipe body, so that a refrigerant flows in the freezing unit and exchanges heat; the control module is respectively electrically connected with the first valve body, the second valve body and the negative pressure device.
Further, a third valve body is arranged between the first valve body and the connecting port in parallel, and the inlet end of the third valve body is connected with the refrigerant conveying pipeline; a pipeline connecting the inlet end of the third valve body with the refrigerant conveying pipeline is provided with a first temperature sensor; and the third valve body and the first temperature sensor are respectively connected with the control module.
Further, the second valve body is a one-way valve or an electromagnetic valve.
Further, a pipeline of the negative pressure device connected with the refrigerant return pipeline is a spiral pipeline or a foldable pipeline.
Further, the refrigeration source is a self-pressurizing device.
Further, the refrigeration source comprises an air source, a heat exchange device and a refrigerant storage tank, the air source is connected with the heat exchange device through a pipeline, and the heat exchange device is arranged in the refrigerant storage tank.
Further preferably, the refrigeration source further comprises a pressure proportional valve, and the pressure proportional valve is arranged on a connecting pipeline of the air source and the heat exchange device and is electrically connected with the control module.
Further, a second temperature sensor is arranged on the freezing unit of the guide pipe, and the second temperature sensor is electrically connected with the control module.
Furthermore, a vacuum pipeline is also arranged in the pipe body of the guide pipe, and the refrigerant circulation loop is arranged in an inner cavity of the vacuum pipeline; the vacuum pipeline interface is arranged on the connecting port and connected with the vacuum pipeline, and the vacuum interface is connected with the negative pressure device pipeline.
Further, the freezing unit is of a capsule structure and has a contraction state and an expansion state.
Compared with the prior art, the invention has the following advantages:
according to the cavity channel freezing treatment system, the negative pressure device and the second valve body are arranged on the refrigerant return pipeline in parallel, when the freezing treatment is finished, the valve body is closed, the negative pressure device is opened, the bag body of the freezing unit can be subjected to negative pressure to be in a contraction state, and the cavity channel of a human body can be kept smooth rapidly; the negative pressure can also accelerate the separation time of the capsule body and the target tissue, namely, the rewarming time is reduced; the parallel arrangement can ensure that the gas pumped by the negative pressure device during working is a normal-temperature gas channel (non-ultralow-temperature gas or fluid), the requirement on the negative pressure device is reduced, the structure is simple, and the complexity and the cost of the device are reduced; before freezing begins, the device can also check whether the capsule leaks, if the capsule is intact, the negative pressure device should maintain a certain negative pressure, and if the capsule is damaged and leaks, the negative pressure is lower than the negative pressure when the capsule is intact.
According to the cavity cryotherapy system, the third valve body is arranged between the first valve body and the connecting port in parallel, a pre-cooling function can be realized, and the refrigerant is discharged from the third valve body before cryotherapy starts, so that the pipeline can be kept at a low temperature, and the freezing efficiency can be accelerated in the therapy process; the pre-cooling function can be monitored by arranging the temperature sensor, and the pre-cooling function can be stopped when the required temperature is reached, so that the pre-cooling state can be kept and the loss of the refrigerant can be reduced.
Drawings
FIG. 1 is a schematic view of a cryosurgical system for the lumen tract in accordance with example 1 of the present invention;
FIG. 2 is a schematic view of a cryosurgical system for the lumen tract in accordance with example 2 of the present invention;
FIG. 3 is a schematic view of a cryosurgical system for the lumen tract in accordance with example 3 of the present invention;
FIG. 4 is a schematic view of a luminal cryosurgical system of embodiment 4 of the present invention;
FIG. 5 is a schematic view of a cryosurgical system for the lumen tract in accordance with example 5 of the present invention;
fig. 6 is an enlarged view of the catheter in example 5 of the present invention.
Detailed Description
The present invention will be described in detail and specifically with reference to the following examples to facilitate better understanding of the present invention, but the following examples do not limit the scope of the present invention.
Example 1
As shown in fig. 1, the present embodiment provides a system for cryotherapy of a lumen, which includes a refrigerant delivery line 1, a conduit 2, a refrigerant return line 3, and a control module 4; the conduit 2 is respectively connected with the refrigerant conveying pipeline 1 and the refrigerant return pipeline 3;
the refrigeration source 11, the first valve body 12 and the connecting port 13 are sequentially connected through the refrigerant conveying pipeline 1, and the refrigeration source 11 is used for providing a refrigerant;
the refrigerant return line 3 has a front end connected to the connection port 13 and a rear end connected to the second valve body 32, and a negative pressure device 31 is provided in parallel between the second valve body 32 and the connection port 13;
the conduit 2 comprises a pipe body and a freezing unit, wherein a refrigerant circulation loop is arranged in the pipe body, so that the refrigerant flows in the freezing unit and exchanges heat; the freezing unit is of a bag body structure and has a contraction state and an expansion state;
the control module 4 is electrically connected to the first valve body 12, the second valve body 32 and the negative pressure device 31, respectively.
In the cavity channel freezing treatment system, the refrigerant return pipeline is provided with the negative pressure device 31 and the second valve body 32 in parallel, when the freezing treatment is finished, the second valve body 32 is closed, the negative pressure device 31 is opened, the negative pressure of the capsule body of the freezing unit can be changed into a contraction state, and the human cavity channel can be kept smooth rapidly; the negative pressure can also accelerate the separation time of the capsule body and the target tissue, namely, the rewarming time is reduced; the parallel arrangement can ensure that the gas pumped by the negative pressure device 31 during working is a normal-temperature gas channel (non-ultralow-temperature gas or fluid), the requirement on the negative pressure device 31 is reduced, the structure is simple, and the complexity and the cost of the device are reduced; before freezing begins, the device can also check whether the capsule leaks, if the capsule is intact, the negative pressure device 31 should maintain a certain negative pressure, and if the capsule is damaged and leaks, the negative pressure is lower than that in the intact state.
Preferably, the second valve body 32 is a one-way valve or a solenoid valve; more preferably, the second valve body 32 is a one-way valve, which has a simple structure, high stability, easy assembly and disassembly, and low cost.
Preferably, the line connecting the negative pressure device 31 and the refrigerant return line 3 is a spiral line or a foldable line. More optionally, the pipeline is a spiral pipeline, and the spiral design lengthens the connecting pipeline, so that the negative pressure device 31 is more effectively prevented from contacting low temperature; meanwhile, the device is more beneficial to space arrangement and occupies smaller volume.
Example 2
As shown in fig. 2, the present embodiment provides a lumen cryotherapy system, which is different from the lumen cryotherapy system described in embodiment 1 in that: a third valve body 14 is arranged between the first valve body 12 and the connecting port 13 in parallel, and the inlet end of the third valve body 14 is connected with the refrigerant conveying pipeline 1; a first temperature sensor 15 is also arranged on a pipeline connecting the inlet end of the third valve body 14 with the refrigerant conveying pipeline 1; the third valve body 14 and the first temperature sensor 15 are each connected to the control module 4.
In the cavity cryotherapy system, the third valve body 14 is arranged between the first valve body 12 and the connecting port 13 in parallel, so that a pre-cooling function can be realized, and before cryotherapy starts, refrigerant is discharged from the third valve body 14, so that the pipeline can be kept at a low temperature, and the freezing efficiency can be increased in the treatment process. The first temperature sensor 15 may monitor the pre-cooling function, may stop when the required temperature is reached, may maintain the pre-cooling state and may reduce the loss of refrigerant.
Example 3
As shown in fig. 3, the present embodiment provides a lumen cryotherapy system, which is different from the lumen cryotherapy system described in embodiment 1 in that: a second temperature sensor 21 is arranged on the freezing unit of the conduit 2, and the second temperature sensor 21 is electrically connected with the control module 4.
The control module 4 can obtain the condition of the second temperature sensor 21 in real time, and can regulate and control the output of the refrigerant in the freezing treatment; after the treatment, when the capsule is sucked, the power of the negative pressure device 31 can be controlled according to the value of the second temperature sensor 21, for example, when the temperature of the second temperature sensor 21 is low, it indicates that the capsule is closely adhered to the tissue (the temperature of the tissue after freezing is low), at this time, the power of the pressure pump should be small, the peeling force is slowly increased, otherwise, the tissue is easily torn, bleeding and the like are easily caused, otherwise, it indicates that the adhesion is not tight, the power of the negative pressure device 31 should be properly increased, and the feedback and control process can accelerate the rewarming process on the premise of safety.
Example 4
As shown in fig. 4, the present embodiment provides a lumen cryotherapy system, which is different from the lumen cryotherapy system described in embodiment 2 in that: the refrigeration source 11 comprises an air source 111, a heat exchange device 112 and a refrigerant storage tank 113, wherein the air source 111 is connected with the heat exchange device 112 through a pipeline, and the heat exchange device 112 is arranged inside the refrigerant storage tank 113; the refrigeration source 11 further includes a pressure proportional valve 114, and the pressure proportional valve 114 is disposed on the connection pipeline between the air source 111 and the heat exchange device 112, and is electrically connected to the control module 4.
Traditional self-pressurization cold source, its structure is small, connects simple to operate, only needs to add/change a consumptive material of refrigerant in the use, convenient to use. However, since the self-pressurization cold source is a sealing device, the requirement on safety is high, and the stability and convenience of pressure control are insufficient.
The cold source with the structure of the air source 111, the heat exchange device 112 and the refrigerant storage tank 113 is adopted in the embodiment, so that the safety is higher, the refrigerant output is more controllable (because the pressure of the air source 111 can be conveniently and accurately controlled), and the requirement and the cost are lower. The pressure proportional valve 114 is added, so that the pressure output of the air source 111 can be electrically/automatically controlled according to application requirements, and various applications can be more conveniently targeted.
Example 5
As shown in fig. 5, the present embodiment provides a lumen cryotherapy system, which is different from the lumen cryotherapy system described in embodiment 3 in that: a vacuum pipeline is also arranged in the pipe body of the conduit 2, and a refrigerant circulation loop is arranged in the inner cavity of the vacuum pipeline; the connecting port 13 is provided with a vacuum pipeline interface, the vacuum pipeline interface is connected with a vacuum pipeline, and the vacuum pipeline interface is connected with a negative pressure device 31 through a pipeline.
The vacuum pipeline is arranged on the conduit (the refrigerant circulation loop is arranged in the inner cavity of the vacuum pipeline), so that the vacuum state of the conduit can be maintained in real time (the preset heat insulation material and the vacuum sleeve can be effectively prevented from being out of work), the refrigerant is prevented from unexpected heat exchange, the non-bag body position on the conduit body is prevented from being at low temperature, and the safety and the refrigerant use efficiency are improved; the negative pressure device 31 makes full use of, and can realize the negative pressure suction bag body and the heat insulation function of the catheter tube body.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.

Claims (7)

1. A cavity cryotherapy system is characterized by comprising a refrigerant conveying pipeline (1), a conduit (2), a refrigerant return pipeline (3) and a control module (4); the guide pipe (2) is respectively connected with the refrigerant conveying pipeline (1) and the refrigerant return pipeline (3);
the refrigeration source (11), the first valve body (12) and the connecting port (13) are sequentially connected through the refrigerant conveying pipeline (1), and the refrigeration source (11) is used for providing a refrigerant; the front end of the refrigerant return pipeline (3) is connected with the connecting port (13), the tail end of the refrigerant return pipeline is connected with a second valve body (32), and a negative pressure device (31) is arranged between the second valve body (32) and the connecting port (13) in parallel; the conduit (2) comprises a pipe body and a freezing unit, wherein a refrigerant circulation loop is arranged in the pipe body, so that refrigerant flows in the freezing unit and exchanges heat; the control module (4) is electrically connected with the first valve body (12), the second valve body (32) and the negative pressure device (31) respectively;
a third valve body (14) is arranged between the first valve body (12) and the connecting port (13) in parallel, and the inlet end of the third valve body (14) is connected with the refrigerant conveying pipeline (1); a first temperature sensor (15) is arranged on a pipeline connecting the inlet end of the third valve body (14) with the refrigerant conveying pipeline (1); the third valve body (14) and the first temperature sensor (15) are respectively connected with the control module (4);
the second valve body (32) is a one-way valve or an electromagnetic valve; and the pipeline connecting the negative pressure device (31) and the refrigerant return pipeline (3) is a spiral pipeline or a foldable pipeline.
2. The tract cryotherapeutic system of claim 1, wherein the refrigeration source (11) is a self-pressurizing device.
3. The system for the transluminal cryotherapy according to claim 1, wherein the refrigeration source (11) comprises a gas source (111), a heat exchange device (112), and a refrigerant storage tank (113), the gas source (111) being in line with the heat exchange device (112), the heat exchange device (112) being disposed inside the refrigerant storage tank (113).
4. The system for the transluminal cryotherapy according to claim 3, wherein the refrigeration source (11) further comprises a pressure proportional valve (114), the pressure proportional valve (114) being disposed on a connection line between the gas source (111) and the heat exchange device (112) and being electrically connected to the control module (4).
5. The tract cryotherapeutic system according to claim 1, wherein the freezing unit of the catheter (2) is provided with a second temperature sensor (21), the second temperature sensor (21) being electrically connected to the control module (4).
6. The system for the cryosurgical treatment of tracts according to claim 1, wherein a vacuum line is further provided in the body of the catheter (2), the refrigerant circulation circuit being provided in the inner cavity of the vacuum line; the vacuum pipeline interface is arranged on the connecting port (13) and connected with the vacuum pipeline, and the vacuum pipeline interface is connected with the negative pressure device (31) through a pipeline.
7. The system of claim 1, wherein the freezing unit is a balloon structure having a contracted state and an expanded state.
CN202011133619.1A 2020-10-21 2020-10-21 Cavity channel cryotherapy system Active CN112402005B (en)

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CN114288006B (en) * 2021-11-26 2023-06-20 上海玮启医疗器械有限公司 Cryoablation tempering system and method
CN114404019A (en) * 2021-11-30 2022-04-29 宁波胜杰康生物科技有限公司 Stenosis freezing treatment system

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