CN113425402B - Catheter capable of judging balloon adhesion and ablation system - Google Patents
Catheter capable of judging balloon adhesion and ablation system Download PDFInfo
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- CN113425402B CN113425402B CN202110991873.3A CN202110991873A CN113425402B CN 113425402 B CN113425402 B CN 113425402B CN 202110991873 A CN202110991873 A CN 202110991873A CN 113425402 B CN113425402 B CN 113425402B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
- A61B2018/0022—Balloons
- A61B2018/0025—Multiple balloons
- A61B2018/00255—Multiple balloons arranged one inside another
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
- A61B2018/00375—Ostium, e.g. ostium of pulmonary vein or artery
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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- A61B2018/00791—Temperature
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
- A61B2018/0212—Surgical 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
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Abstract
The invention provides a catheter capable of judging balloon adhesion and an ablation system, wherein the catheter comprises: the balloon structure comprises an outer balloon and an inner balloon positioned in the outer balloon, a gap is formed between the outer balloon and the inner balloon to form a balloon interlayer, the balloon interlayer is composed of at least one monitoring area, the outer balloon is made of a compliant material, and the inner balloon is made of a non-compliant material; a catheter shaft including a first delivery channel for delivering a coolant to the inner balloon and a second delivery channel for delivering a gas to the monitored area; and the detection module is used for detecting a parameter representing the change of the monitoring area, and can reflect whether the balloon structure reaches a preset position or not by comparing the parameter with a preset value. Whether the balloon structure reaches the preset position or not is judged by detecting the change of related parameters in the monitoring area, and whether the balloon structure is tightly attached to the target position or not is further judged, so that the health problem caused by the pulmonary vein occlusion condition detected by X-ray fluoroscopy radiography can be avoided.
Description
Technical Field
The invention relates to the technical field of cryoablation, in particular to a catheter capable of judging balloon adhesion and an ablation system.
Background
Atrial fibrillation (Atrial fibrillation for short) is one of the most common clinical arrhythmia, the incidence rate of the Atrial fibrillation increases with the age, compared with non-Atrial fibrillation patients of the same age, the quality of life of the Atrial fibrillation patients is often poorer, and the Atrial fibrillation patients are often accompanied by diseases such as hypertension and heart failure, so that the thromboembolic complications and the death rate of the Atrial fibrillation patients are higher. To solve this problem, Cryoballoon ablation (Cryoballoon ablation), an ablation procedure, is beginning to be applied clinically. Cryoballoon ablation procedures for the treatment of atrial fibrillation have been studied through numerous clinical trials to demonstrate the same safety and efficacy as radiofrequency ablation techniques, and with fewer complications, to be rapidly accepted in clinical applications.
Different from the traditional radio frequency ablation operation, the freezing balloon ablation operation is to block the balloon to the vestibule of the pulmonary vein and transfer the low-temperature energy to the heart tissue around the balloon, so that the heart tissue around the balloon is directly or indirectly damaged, permanent electric conduction blocking is formed at a specific position in the heart, and the purpose of electrically isolating the pulmonary vein is further achieved. However, in the process of transferring cryogenic energy to the pulmonary veins, a balloon is required to seal the target site and prevent blood flow. However, most of the existing means for examining the occlusion effect are radiographic imaging, which causes patients and doctors to receive more radiation dose during the operation, which is not good for health.
Disclosure of Invention
The invention aims to provide a catheter and an ablation system capable of judging balloon adhesion, which can effectively avoid the body health problem caused by the pulmonary vein occlusion condition detected by X-ray fluoroscopy radiography.
To solve the above technical problem, according to a first aspect of the present invention, there is provided a balloon-abutment judging catheter for performing cryoablation at a target site, comprising:
a balloon structure comprising an outer balloon and an inner balloon located within the outer balloon, a gap being provided between the outer balloon and the inner balloon and forming a balloon barrier, the balloon barrier being comprised of at least one monitoring area, the outer balloon being made of a compliant material and the inner balloon being made of a non-compliant material;
a catheter shaft including a first delivery channel for delivering a coolant to the inner balloon and a second delivery channel for delivering a gas to the monitoring region;
and the detection module is used for detecting a parameter representing the change of the monitoring area, and can reflect whether the balloon structure reaches a preset position or not by comparing the parameter with a preset value.
Optionally, the monitoring area is the entire balloon barrier.
Optionally, the balloon isolation layer includes a plurality of independent monitoring areas, the second conveying channel includes a plurality of sub-channels, the sub-channels correspond to the monitoring areas one to convey gas to each monitoring area, and each monitoring area is provided with the detection module.
Optionally, a plurality of partition plates are arranged in the balloon interlayer, and two ends of each partition plate are respectively connected with the inner wall of the outer balloon and the outer wall of the inner balloon in a sealing manner, so that the balloon interlayer is divided into a plurality of mutually independent monitoring areas.
Optionally, a plurality of independent monitoring regions are uniformly distributed along the circumferential direction of the balloon isolation layer.
Optionally, the parameter includes a pressure in the monitoring area, and the detection module includes a pressure detection unit, where the pressure detection unit is configured to detect the pressure, and reflect whether the balloon structure reaches a predetermined position by comparing the pressure with a predetermined value.
Optionally, the pressure detecting unit includes a pressure sensor, and the pressure sensor is disposed in the balloon partition, attached to the outer wall of the inner balloon, or attached to the inner wall of the outer balloon.
Optionally, the parameter further includes a deformation of the monitoring area, and the detection module further includes a deformation detection unit, where the deformation detection unit is configured to detect the deformation, and by comparing the deformation with a predetermined value, reflect whether the balloon structure reaches a predetermined position.
Optionally, the parameter further includes a temperature of the gas in the monitoring region, and the detection module further includes a temperature detection unit, where the temperature detection unit is configured to detect the temperature, and by comparing the temperature with a predetermined value, reflect whether the balloon structure reaches a predetermined position.
Optionally, the temperature detection unit includes a temperature sensor disposed in the monitoring region, and the temperature sensor is at least partially located at a joint of the inner balloon and the outer balloon.
Optionally, the initial temperature of the gas is between-30 ℃ and 35 ℃.
Optionally, the initial temperature of the gas is between 0 ℃ and 10 ℃.
Optionally, the predetermined value of the temperature is between 36 ℃ and 38 ℃.
In order to solve the technical problem, according to a second aspect of the invention, an ablation system comprising the balloon-abutment judging catheter is further provided.
Optionally, the ablation system further comprises a control module capable of receiving the parameter detected by the detection module and comparing the parameter with a predetermined value to determine whether the balloon structure reaches a predetermined position.
Optionally, the control module is capable of obtaining a dimensional specification of the catheter required for the treatment and obtaining a predetermined value based on the dimensional specification.
Optionally, the control module is capable of obtaining a dimensional specification of the catheter being used, and when the dimensional specification used matches a desired dimensional specification, the control module outputs instructions that may perform a subsequent operation.
Optionally, the ablation system further includes a balloon filling module, and the balloon filling module conveys coolant to the inner balloon through a first conveying channel and conveys gas to the monitoring area through a second conveying channel until the inner balloon and the outer balloon are expanded to a set diameter.
Optionally, the control module outputs an instruction to stop advancing the catheter when a parameter indicative of a change in the monitored area falls within a range of predetermined values.
Optionally, after the catheter is stopped being pushed, the control module vacuums the monitoring area through the second conveying channel so that the inner balloon and the outer balloon are completely attached to each other.
Optionally, the quality of the gas in the monitored area is maintained as the conduit is advanced to the target location.
In order to solve the above technical problem, according to a third aspect of the present invention, there is provided a method for obtaining a predetermined value of the pressure in a monitoring area of a catheter against which a balloon can be determined, the method comprising:
delivering coolant and gas to the inner balloon and the monitoring area through the first delivery channel and the second delivery channel, respectively, and inflating the inner balloon and the outer balloon to a set diameter;
advancing the catheter to the simulated structure of the target location to cause the outer balloon to contact the simulated structure and compress the outer balloon;
when the outer balloon is pressed by the simulation structure and begins to be attached to the inner balloon, the pressure in the monitoring area is detected by the pressure detection unit and recorded as a preset value of the pressure.
Optionally, the conduit has dimensions of various specifications, and a table of variation of the dimensions of the conduit with respect to predetermined values of the pressure is established.
In order to solve the above technical problem, according to a fourth aspect of the present invention, there is provided another method for obtaining a predetermined value of the pressure in a monitoring area of a catheter against which a balloon can be determined, the method comprising:
measuring and calculating the size of the target position through CT heart three-dimensional modeling;
selecting a conduit of a specific size specification according to the size of the target position, wherein the initial pressure of the monitored area of the conduit is known
And initial volume
；
Simulating the plugging effect of the target position, and outputting the extrusion volume of the monitoring area during plugging of the target position
；
Calculating a predetermined value of the pressure of the conduit
：
=
。
In order to solve the above technical problem, according to a fifth aspect of the present invention, there is further provided a readable storage medium, on which a program is stored, the program being executed to implement the method for obtaining the predetermined value of the pressure in the monitoring area of the catheter against which the balloon can be determined.
In the catheter and the ablation system capable of judging the balloon attachment, provided by the invention, the balloon structure is judged to reach the preset position by detecting the change of the parameters in the monitoring area, so that whether the balloon structure is tightly attached to the target position or not is judged, and the body health problem caused by the pulmonary vein occlusion condition detected by X-ray fluoroscopy radiography can be effectively avoided.
Drawings
It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation to the scope of the invention. Wherein:
fig. 1 is a schematic structural diagram of a catheter for determining whether a balloon is attached to the catheter in an initial state according to an embodiment of the present invention.
Fig. 2 is a schematic structural diagram of a catheter against which a balloon can be determined to be in a sealing state according to an embodiment of the present invention.
Fig. 3 is a perspective view of a catheter for determining balloon attachment according to a second embodiment of the present invention.
Fig. 4 is a cross-sectional view of a catheter for determining balloon apposition according to a second embodiment of the present invention.
Fig. 5 is a schematic view of an ablation system provided by an embodiment of the invention.
Fig. 6 is a schematic diagram of a control module according to an embodiment of the present invention.
Fig. 7 is a flowchart of a method for obtaining a predetermined value for determining the pressure of the catheter against which the balloon is attached according to an embodiment of the present invention.
Fig. 8 is a flowchart of another method for obtaining a predetermined value for determining the pressure of the catheter against which the balloon is attached according to an embodiment of the present invention.
The reference signs are:
10-target position; 20-an outer balloon; 30-an inner balloon; 40-monitoring area; 50-a first transport path; 60-a second transport path; 61-sub-channel; 70-a separator;
100-a human-computer interaction module; 200-a control module; 300-a refrigeration module; 400-outer balloon filling module; 500-inner balloon filling module; 600-a detection module; 700-balloon structure.
Detailed Description
To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in greatly simplified form and are not to scale, but are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.
As used in this application, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this disclosure, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. As used in this disclosure, the term "plurality" is generally employed in its sense including "at least one" unless the content clearly dictates otherwise. As used in this disclosure, the term "at least two" is generally employed in a sense including "two or more" unless the content clearly dictates otherwise. Furthermore, the terms "first", "second", "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", "third" may explicitly or implicitly include one or at least two of the features.
The core idea of the invention is to provide a catheter capable of judging balloon attachment, an ablation system, a method for acquiring a preset value of pressure in a monitoring area of the catheter capable of judging balloon attachment and a readable storage medium, so as to solve the problem of body health caused by detecting pulmonary vein occlusion by using X-ray fluoroscopy radiography.
According to a first aspect of the present invention, there is provided a balloon-apposition identifiable catheter for performing cryoablation at a target site, comprising:
a balloon structure comprising an outer balloon and an inner balloon located within the outer balloon, a gap being provided between the outer balloon and the inner balloon and forming a balloon barrier, the balloon barrier being comprised of at least one monitoring area, the outer balloon being made of a compliant material and the inner balloon being made of a non-compliant material;
a catheter shaft including a first delivery channel for delivering a coolant to the inner balloon and a second delivery channel for delivering a gas to the monitoring region;
and the detection module is used for detecting a parameter representing the change of the monitoring area, and can reflect whether the balloon structure reaches a preset position or not by comparing the parameter with a preset value.
According to the second aspect of the invention, an ablation system comprising the balloon-abutment-judging catheter is further provided.
According to a third aspect of the invention, there is also provided a method of obtaining a predetermined value of the pressure in the monitored area of the catheter against which the balloon can be determined,
a method of predetermining a pressure of a monitored region of said conduit, said method comprising:
delivering coolant and gas to the inner balloon and the monitoring area through the first delivery channel and the second delivery channel, respectively, and inflating the inner balloon and the outer balloon to a set diameter;
advancing the catheter to the simulated structure of the target location to cause the outer balloon to contact the simulated structure and compress the outer balloon;
when the outer balloon is pressed by the simulation structure and begins to be attached to the inner balloon, the pressure in the monitoring area is detected by the pressure detection unit and recorded as a preset value of the pressure.
According to a fourth aspect of the present invention, there is provided another method of obtaining a predetermined value of the pressure in a monitoring area of a catheter against which a balloon is to be determined, the method comprising:
measuring and calculating the size of the target position through CT heart three-dimensional modeling;
selecting a conduit of a specific size specification according to the size of the target position, wherein the initial pressure of the monitored area of the conduit is known
And initial volume
；
Simulating the plugging effect of the target position, and outputting the extrusion volume of the monitoring area during plugging of the target position
；
Calculating a predetermined value of the pressure of the conduit
：
=
。
According to a fifth aspect of the present invention, there is also provided a readable storage medium having a program stored thereon, the program, when executed, implementing the method of obtaining a predetermined value of the pressure in a monitored region of a catheter against which a balloon is determined to be in abutment.
According to the configuration, whether the balloon structure reaches the preset position or not is judged by detecting the change of the related parameters in the monitoring area, and then whether the balloon structure is tightly attached to the target position or not is judged, so that the health problem caused by the pulmonary vein occlusion condition detected by X-ray fluoroscopy radiography can be avoided.
The following description refers to the accompanying drawings.
Example one
Referring to fig. 1 and fig. 2, fig. 1 is a schematic structural view of a catheter capable of determining whether a balloon is attached to the catheter in an initial state according to an embodiment of the present invention, and fig. 2 is a schematic structural view of the catheter capable of determining whether the balloon is attached to the catheter in a sealing state according to an embodiment of the present invention. The present embodiment provides a balloon-hugging identifiable catheter for cryoablation at a target site 10, comprising:
a balloon structure comprising an outer balloon 20 and an inner balloon 30 positioned within the outer balloon 20, the outer balloon 20 having a gap with the inner balloon 30 and forming a balloon barrier comprised of at least one monitored area 40, the outer balloon 20 being made of a compliant material, the inner balloon 30 being made of a non-compliant material;
a catheter shaft including a first delivery channel 50 for delivering a coolant to the inner balloon 30 and a second delivery channel 60 for delivering a gas to the monitoring region 40;
a detection module for detecting a parameter indicative of a change in the monitored area 40, wherein a comparison of the parameter with a predetermined value can reflect whether the balloon structure has reached a predetermined position.
Because the outer balloon 20 is made of a compliant material, when the catheter is pushed towards the target position 10, the outer balloon 20 will contact and be pressed against the target position 10, and because the inner balloon 30 is made of a non-compliant material, no elastic deformation occurs, under the condition that the radial size of the target position 10 is fixed, as the pressing strength of the target position 10 to the outer balloon 20 is increased, parameters in the monitoring area 40 are changed accordingly, and by comparing the parameters with a preset value, whether the balloon structure reaches a preset position can be reflected, so that whether the balloon structure is tightly attached to the target position can be judged, and whether the catheter meets the blocking condition of the cryoablation operation can be further judged.
Specifically, the diameter of the inner balloon 30 is larger than the size of the target site 10, while the diameter of the outer balloon 20 is also larger than the size of the target site 10 because the inner balloon 30 is located within the outer balloon 20.
In this embodiment, the inner balloon 30 is preferably concentrically disposed with the outer balloon 20.
In this embodiment, the compliant material includes, but is not limited to, polyurethane, polyethylene, or polyvinyl chloride, and the non-compliant material includes, but is not limited to, polyethylene terephthalate or nylon.
In this embodiment, the monitoring area 40 is the entire balloon barrier.
In this embodiment, the dimensional specifications of the balloon structure should be selected with respect to the size of the target site 10. It should be understood that reference herein to a target site 10 includes, but is not limited to, the ostium of a pulmonary vein, but may also be to other sites where occlusion is desired, such as the left atrial appendage.
With continued reference to fig. 1, the second conveying passage 60 is disposed outside the first conveying passage 50. When the catheter reaches a target position, coolant can be conveyed to the inner balloon 30 through the first conveying channel 50 and gas can be conveyed to the outer balloon 20 through the second conveying channel 60 until the inner balloon 30 and the outer balloon 20 are inflated to a set diameter so as to be used for sealing the target position 10, and at the moment, the coolant and the gas are stopped being conveyed into the inner balloon 30 and the outer balloon 20 continuously so as to ensure that the quality of the gas in the balloon interlayer is unchanged, so that the detection module is prevented from being influenced to detect the change condition of the parameter representing the monitoring area 40.
As a first preferable example of the first embodiment of the present invention, the parameter includes a pressure in the monitoring area 40, and the detecting module includes a pressure detecting unit, and the pressure detecting unit is configured to detect the pressure and reflect whether the balloon structure reaches a predetermined position by comparing the pressure with a predetermined value.
Since the outer balloon 20 is made of a compliant material and the inner balloon 30 is made of a non-compliant material, when the catheter is pushed towards the target position 10, the outer balloon 20 will contact and be pressed against the target position 10, under the condition that the radial size of the target position 10 and the initial pressure in the monitoring area 40 are constant, the pressure in the monitoring area 40 increases as the pressing strength of the target position 10 to the outer balloon 20 increases, and when the pressure detection unit detects that the pressure in the monitoring area 40 reaches a predetermined value, it can be determined whether the balloon structure reaches a predetermined position, so as to satisfy the occlusion condition of the cryoablation operation.
In this embodiment, the pressure detecting unit includes a pressure sensor, and when the volume of the pressure sensor is small, the pressure sensor may be directly disposed in the balloon barrier, attached to the outer wall of the inner balloon 30, or attached to the inner wall of the outer balloon 20. Or a pressure measuring port can be arranged in the balloon interlayer, and the pressure sensor is communicated with the pressure measuring port through the pressure sensor pipeline to measure pressure. The pressure in the monitoring area 40 is detected in real time through the pressure sensor, and when the pressure in the monitoring area 40 is detected to be greater than or equal to a predetermined value of the pressure, the balloon structure reaches a predetermined position, that is, the balloon structure is completely attached to the target position 10, so that the blocking condition of cryoablation is met.
As a second preferred example of the first embodiment of the present invention, the parameter further includes a deformation of the monitored area, and the detection module further includes a deformation detection unit, configured to detect the deformation, and reflect whether the balloon structure reaches the predetermined position by comparing the deformation with a predetermined value. Preferably, the strain detection means is a strain gauge sensor, an ionization type sensor, or the like.
As a third preferred example of the first embodiment of the present invention, the parameter further includes a temperature of the gas in the monitoring area, and the detection module further includes a temperature detection unit, where the temperature detection unit is configured to detect the temperature, and by comparing the temperature with a predetermined value, reflect whether the balloon structure reaches a predetermined position. It should be understood that the temperature of the gas filled in the outer balloon 20 is lower than a predetermined value, and the temperature detecting unit is isolated from the outside after the gas is delivered to the outer balloon 20 through the second delivery passage 60, so that the temperature detected by the temperature detecting unit is lower than the predetermined value. When the plug is pushed to the target position 10, the volume of the outer balloon 20 is compressed, when the plug is close to the target position 10, part of the outer balloon 20 and the inner balloon 30 are pressed together, at the moment, the outer balloon 20, the temperature detection unit and the inner balloon 30 are close to the target position 10, and the temperature measured by the temperature detection unit is higher than the previous temperature due to the heat conduction and is close to the preset value. Therefore, the temperature detection unit can measure whether the temperature of the gas in the monitoring area 40 is near a predetermined value, so as to judge whether the balloon structure reaches a predetermined position, and further judge whether the balloon structure is sealed.
In addition, the temperature detection unit can also detect the treatment temperature of the catheter in the process of cryoablation.
In this embodiment, the temperature detection unit includes a temperature sensor disposed in the monitoring region, and the temperature sensor is at least partially located at a joint of the inner balloon and the outer balloon. So that the measured temperature value is more accurate when the outer balloon 20 is pressed by the target position.
Further, the initial temperature of the gas is between-30 ℃ and 35 ℃, and the predetermined value of the temperature is the temperature at the target site 10, typically between 36 ℃ and 38 ℃. In particular, the lower the temperature of the gas filling the outer balloon 20, the better the occlusion is judged, and the higher the accuracy is, so the temperature of the gas is usually lower than 35 ℃, and more preferably, the initial temperature of the gas is between 0 ℃ and 10 ℃.
It should be understood that, whether the pressure change in the monitored area 40 is detected by the pressure detection unit or the temperature change of the gas in the monitored area 40 is detected by the temperature detection unit to determine whether the balloon structure is completely occluded, these two detection methods may be used independently or in combination to improve the accuracy of the determination, which is not limited in this application.
Example two
The difference from the first embodiment is that, referring to fig. 3 and 4, in the present embodiment, the balloon partition includes a plurality of independent monitoring regions 40, the second conveying channel includes a plurality of sub-channels 61, the sub-channels 61 correspond to the monitoring regions 40 one by one to convey gas to the monitoring regions 40, and the detection module is disposed in each monitoring region 40.
That is, the monitoring areas 40 are independent of each other, and the gas in each monitoring area does not flow through each other. Through the detection module detects the sign respectively the parameter that the monitored area 40 changes can reflect respectively whether the shutoff of each monitored area 40 is accomplished to relevant personnel can be more accurate the shutoff condition of each monitored area 40 of judgement, improve the accuracy that the shutoff was judged.
Further, a plurality of partition plates 70 are arranged in the balloon partition layer, and two ends of each partition plate 70 are respectively connected with the inner wall of the outer balloon 20 and the outer wall of the inner balloon 30 in a sealing manner, so that the balloon partition layer is divided into a plurality of mutually independent monitoring areas 40.
In this embodiment, the number of the partition boards 70 is 8, and the 8 partition boards 70 are distributed at equal intervals along the circumferential direction of the balloon partition layer to divide the balloon partition layer into 8 identical monitoring areas 40, that is, a plurality of independent monitoring areas 40 are uniformly distributed along the circumferential direction of the balloon partition layer. It should be understood that the number and distribution of the baffles 70 are not limited in this application, and they may be distributed at equal intervals or at unequal intervals.
As a first preferred example of the second embodiment of the present invention, the parameter includes a pressure in the monitoring area, the detecting module includes a pressure detecting unit, each of the monitoring areas 40 is provided with the pressure detecting unit, the pressure detecting unit is configured to detect a pressure change in the monitoring area 40, and by comparing the pressure with a predetermined value, whether the balloon structure reaches a predetermined position is reflected.
As a second preferred example of the second embodiment of the present invention, the parameter further includes a deformation of the monitored area, the detection module further includes a deformation detection unit, and the deformation detection unit is disposed in each monitored area 40 and is configured to detect a deformation of the monitored area, and by comparing the deformation with a predetermined value, it is reflected whether the balloon structure reaches a predetermined position.
As a third preferred example of the second embodiment of the present invention, the parameter further includes a temperature of the gas in the monitoring area, the detection module further includes a temperature detection unit, and the temperature detection unit is disposed in each monitoring area 40 and is configured to detect the temperature of the gas in the monitoring area, and by comparing the temperature with a predetermined value, whether the balloon structure reaches a predetermined position is reflected.
Based on the above, the present invention also provides a method for using the catheter capable of determining balloon adhesion, which, with reference to fig. 1 to 4, comprises the following steps:
s1, selecting a catheter with a specific size specification, and acquiring a preset value of a parameter of the catheter, which is used for representing the change of the monitored area;
s2, delivering coolant to the inner balloon 30 through the first delivery channel 50 and delivering gas to the outer balloon 20 through the second delivery channel 60, respectively, until the inner balloon 30 and the outer balloon 20 are inflated to a set diameter;
s3, advancing the catheter towards the target site 10, bringing the outer balloon 20 into contact with the target site 10 and pressing the outer balloon 20;
and S4, stopping advancing the catheter when the detection module detects that the parameter in the monitored area 40 is greater than or equal to the predetermined value.
Further, after stopping advancing the catheter, the occlusion monitoring method further comprises:
a vacuum is drawn through the second delivery channel 60 within the monitoring region 40 to fully conform the inner balloon 30 and the outer balloon 20. Thereby bringing the inner balloon 30 and the outer balloon 20 into close contact for better heat conduction, and then delivering a coolant into the inner balloon 30 through the first delivery channel 50 to start cryoablation.
The invention also provides an ablation system comprising the balloon-clinable catheter.
Specifically, referring to fig. 5, the ablation system includes a human-computer interaction module 100, a control module 200, a refrigeration module 300, a balloon filling module and the catheter capable of determining that the balloon is attached, the balloon filling module includes an outer balloon filling module 400 and an inner balloon filling module 500, the inner balloon filling module 500 is communicated with the first delivery channel to deliver a coolant to the inner balloon of the catheter, the outer balloon filling module 400 is communicated with the second delivery channel to deliver a gas to a monitoring area of the catheter, the refrigeration module 300 is used for performing cryoablation on a target location, and the human-computer interaction module 100 is used for controlling other function modules through the control module 200 by related medical personnel.
The control module 200 can receive the parameter detected by the detection module and compare the parameter to a predetermined value to determine whether the balloon structure has reached a predetermined position.
Further, the control module 200 can obtain a dimensional specification of a catheter required for treatment and obtain a predetermined value according to the dimensional specification.
Further, the control module 200 can obtain the size specification of the catheter used, and when the size specification used matches the required size specification, the control module 200 outputs instructions that the subsequent operation can be performed.
Further, when the parameter indicative of the change in the monitored area falls within a predetermined range of values, indicating that the balloon structure has reached a predetermined position, the control module 200 outputs an instruction to stop advancing the catheter.
After the catheter is stopped from being advanced, the control module 200 evacuates the monitoring area through the second delivery channel to completely fit the inner balloon and the outer balloon.
In this embodiment, when the catheter is advanced to the target position, the quality of the gas in the monitored area is kept unchanged, so as to avoid affecting the detection of the change condition representing the parameter of the monitored area 40 by the detection module.
The human-computer interaction module 100 has a human-computer interaction interface, and can perform operations such as parameter input, command control input, other data entry and maintenance, process monitoring and the like, and also perform real-time parameter display, temperature and pressure display, historical data and diagram display and cryoablation three-dimensional attachment simulation display of a balloon structure.
In a preferred embodiment, with reference to fig. 6, fig. 6 is a schematic diagram of an operation of a control module according to an embodiment of the present invention. The control module 200 collects detection parameters of each pressure sensor and CT or other three-dimensional data, then disperses the collected pressure data into subsets, sets discourse domains of each subset according to a rule base and a database, constructs a fuzzy rule control table, fuzzifies the pressure by selecting a membership function (namely, cryoablation clings to fuzzy reasoning), then defuzzifies three-dimensional simulation reconstruction and clinging analysis output of the clinging condition of the balloon structure, and finally carries out cryoablation clinging simulation display output through the human-computer interaction module 100.
In this embodiment, the control module 200 is, for example, a PLC. Referring to fig. 7, fig. 7 is a flowchart of a method for obtaining a predetermined value of the pressure of the catheter against which the balloon can be determined according to an embodiment of the present invention. The method comprises the following steps:
s1, conveying coolant and gas to the inner balloon and the monitoring area through the first conveying channel and the second conveying channel respectively, and expanding the inner balloon and the outer balloon to set diameters;
s2, advancing the catheter to the simulation structure of the target position to enable the outer balloon to be in contact with the simulation structure and to be pressed;
and S3, when the outer balloon is pressed by the simulation structure to be attached to the inner balloon, detecting the pressure in the monitoring area through a pressure detection unit and recording the pressure as a preset value of the pressure.
First, step S1 is executed, when the catheter reaches the target site, the coolant is delivered to the inner balloon through the first delivery channel and the gas is delivered to the outer balloon through the second delivery channel, respectively, until the inner balloon and the outer balloon are inflated to the set diameter. When the inner balloon and the outer balloon are expanded to a set working state, the continuous conveying of the coolant and the gas into the inner balloon and the outer balloon is stopped, so that the quality of the gas in the monitoring area is consistent, the pressure in the monitoring area is only influenced by the extrusion of a target position, and the accuracy of a pressure test result is ensured.
Step S2 is then performed to advance the catheter toward the target location, bringing the outer balloon into contact with the target location and compressing the outer balloon. When the balloon structure is in a working state, the plugging target position is pushed forcibly, at the moment, the outer balloon contacts the inner wall of the target position first, and deforms under the action of the pushing force, so that the outer diameter of the front half part of the outer balloon is changed to be attached to the inner balloon, meanwhile, the front half parts of the inner balloon and the outer balloon are attached to the target position at the same time, at the moment, the radius of the front half part of the outer balloon is equal to the radius of the inner balloon, the volume of the outer balloon is reduced, and the pressure in a monitoring area is increased.
And finally, executing step S3, detecting the pressure in the monitoring area in real time, when the pressure detection unit detects that the pressure in the monitoring area is greater than or equal to a preset pressure value, representing that the balloon structure reaches a preset position, namely the balloon structure is attached to the target position, the plugging condition of cryoablation is met, recording the pressure in the monitoring area as the preset pressure value, and stopping propelling the catheter.
Since the conduit has dimensions of various specifications, a relation change table of the dimension of the conduit and the predetermined value of the pressure can be established by the method so as to rapidly acquire the predetermined value of the pressure in the monitoring area of the conduit.
It should be understood that, since the tissue of the target site is flexible, the material of the dummy structure used in establishing the table of the dimensional-pressure relationship may be made of a material similar to that of the target site, such as silicone. Because the target position is not in a regular circle shape, in order to more truly reflect the pressure change caused by the structure that the target position extrudes the balloon, when a size-pressure relation change table is established, the outer balloon can be extruded by using a simulation structure. Preferably, in the table of variation of the size-pressure relationship, the size is a direct range value or the predetermined value of the pressure is a pressure range value to simplify the operation.
In addition, the present invention provides another method for obtaining a predetermined value of pressure in a monitoring area of a catheter against which a balloon can be determined, referring to fig. 8, the method includes:
measuring and calculating the size of the target position through CT heart three-dimensional modeling;
selecting a conduit of a specific size specification according to the size of the target position, wherein the initial pressure of the monitored area of the conduit is known
And initial volume
；
Simulating the plugging effect of the target position, and outputting the extrusion volume of the monitoring area during plugging of the target position
；
Calculating a predetermined value of the pressure of the conduit
：
=
。
According to the ideal gas equation: pV = nRT, pV is a constant value when the mass and temperature of the gas in the monitored area is constant, due to the initial pressure
Initial volume of
Value of (A) and extrusion volume
All the measurements are obtained, so the plugging effect of the target position can be simulated according to the extrusion volume
And a predetermined value
Is equal to the initial pressure
And initial volume
The product of (a) yields a predetermined value of the pressure of the conduit
。
It should be understood that the two methods mentioned in the first and second embodiments can be used alone or verified with each other to compare with the predetermined pressure value measured in the actual cryoablation procedure, so as to improve the detection accuracy.
Embodiments of the present invention also provide a readable storage medium having a program stored thereon, where the program is executed to implement a method of obtaining a predetermined value of the pressure of the catheter against which the balloon can be determined.
In summary, embodiments of the present invention provide a catheter and ablation system for cryoablation at a target site, the catheter comprising: a balloon structure comprising an outer balloon and an inner balloon located within the outer balloon, a gap being provided between the outer balloon and the inner balloon and forming a balloon barrier, the balloon barrier being comprised of at least one monitoring area, the outer balloon being made of a compliant material and the inner balloon being made of a non-compliant material; a catheter shaft including a first delivery channel for delivering a coolant to the inner balloon and a second delivery channel for delivering a gas to the monitoring region; and the detection module is used for detecting a parameter representing the change of the monitoring area, and can reflect whether the balloon structure reaches a preset position or not by comparing the parameter with a preset value. Whether the balloon structure reaches the preset position or not is judged by detecting the change of related parameters in the monitoring area, and whether the balloon structure is tightly attached to the target position or not is further judged, so that the problem of body health caused by the fact that the pulmonary vein occlusion condition is detected by X-ray fluoroscopy radiography can be avoided.
It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. It will be apparent to those skilled in the art from this disclosure that many changes and modifications can be made, or equivalents modified, in the embodiments of the invention without departing from the scope of the invention. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention are still within the protection scope of the technical solution of the present invention, unless the content of the technical solution of the present invention is departed from.
Claims (25)
1. A balloon-hugging-identifiable catheter for cryoablation at a target site, comprising:
a balloon structure comprising an outer balloon and an inner balloon located within the outer balloon, a gap being provided between the outer balloon and the inner balloon and forming a balloon barrier, the balloon barrier being comprised of at least one monitoring area, the outer balloon being made of a compliant material and the inner balloon being made of a non-compliant material;
a catheter shaft including a first delivery channel for delivering a coolant to the inner balloon and a second delivery channel for delivering a gas to the monitoring region;
the detection module is used for detecting a parameter representing the change of the monitoring area of the balloon isolation layer, and whether the balloon structure reaches a preset position can be reflected through the comparison of the parameter and a preset value.
2. The balloon-hugely assessable catheter of claim 1, wherein the monitoring area is the entire balloon barrier.
3. The catheter for judging balloon attachment according to claim 1, wherein the balloon partition comprises a plurality of independent monitoring areas, the second delivery channel comprises a plurality of sub-channels, the sub-channels correspond to the monitoring areas one by one to deliver gas to the monitoring areas, and the detection module is arranged in each monitoring area.
4. The catheter for judging balloon attachment according to claim 3, wherein a plurality of partition plates are disposed in the balloon partition layer, and both ends of each partition plate are respectively connected with the inner wall of the outer balloon and the outer wall of the inner balloon in a sealing manner, so as to divide the balloon partition layer into a plurality of mutually independent monitoring areas.
5. The balloon-apposition detectable catheter according to claim 3 or 4, wherein a plurality of independent monitoring regions are uniformly distributed along a circumferential direction of the balloon barrier.
6. The catheter for determining balloon abutment according to any one of claims 1-4, wherein the parameter comprises a pressure in the monitoring area, and the detection module comprises a pressure detection unit for detecting the pressure, and wherein a comparison of the pressure with a predetermined value indicates whether the balloon structure has reached a predetermined position.
7. The balloon-hugely-determinable catheter as claimed in claim 6, wherein the pressure detection unit comprises a pressure sensor disposed within the balloon barrier, attached to an outer wall of the inner balloon or attached to an inner wall of the outer balloon.
8. The catheter for determining balloon attachment according to any one of claims 1-4, wherein the parameter further includes a deformation of the monitored area, and the detection module further includes a deformation detection unit for detecting the deformation and comparing the deformation with a predetermined value to determine whether the balloon structure reaches a predetermined position.
9. The balloon-hugely-determinable catheter of any one of claims 1-4 and 7, wherein the parameter further includes a temperature of the gas in the monitored region, and wherein the detection module further includes a temperature detection unit for detecting the temperature, and wherein a comparison of the temperature with a predetermined value indicates whether the balloon structure has reached a predetermined position.
10. The balloon-apposition detectable catheter according to claim 9, wherein the temperature detection unit comprises a temperature sensor disposed in the monitoring region, the temperature sensor being at least partially located at the apposition of the inner balloon and the outer balloon.
11. The balloon-apposition identifiable catheter of claim 9, wherein the initial temperature of the gas is between-30 ℃ and 35 ℃.
12. The balloon-apposition identifiable catheter of claim 11, wherein the initial temperature of the gas is between 0 ℃ and 10 ℃.
13. The catheter for determining balloon abutment of claim 9, wherein the predetermined value of the temperature is between 36 ℃ and 38 ℃.
14. An ablation system comprising the balloon-huggable catheter of any of claims 1-13.
15. The ablation system of claim 14, further comprising a control module configured to receive the parameter sensed by the sensing module and compare the parameter to a predetermined value to determine whether the balloon structure has reached a predetermined position.
16. The ablation system of claim 15, wherein the control module is capable of obtaining a dimensional specification of a catheter required for treatment and obtaining the predetermined value based on the dimensional specification.
17. The ablation system of claim 16, wherein the control module is capable of obtaining a dimensional specification of a catheter being used, and when the dimensional specification used matches a desired dimensional specification, the control module outputs instructions that a subsequent operation can be performed.
18. The ablation system of any of claims 14-17, further comprising a balloon inflation module that delivers coolant to the inner balloon through a first delivery channel and gas to the monitoring area through a second delivery channel until the inner and outer balloons are inflated to a set diameter.
19. The ablation system of any of claims 15-17, wherein the control module outputs an instruction to stop advancing the catheter when a parameter indicative of a change in the monitored region falls within a range of predetermined values.
20. The ablation system of claim 19, wherein after stopping advancing the catheter, the control module evacuates the monitoring area through the second delivery channel to fully conform the inner balloon and the outer balloon.
21. The ablation system of any of claims 14-17, wherein a mass of gas within the monitored region is maintained as the catheter is advanced to the target location.
22. A method of obtaining a predetermined value of the pressure in a monitored area of the catheter against which a balloon can be determined as claimed in claim 6, the method comprising:
delivering coolant and gas to the inner balloon and the monitoring area through the first delivery channel and the second delivery channel, respectively, and inflating the inner balloon and the outer balloon to a set diameter;
advancing the catheter to the simulated structure of the target location to cause the outer balloon to contact the simulated structure and compress the outer balloon;
when the outer balloon is pressed by the simulation structure and begins to be attached to the inner balloon, the pressure in the monitoring area is detected by the pressure detection unit and recorded as a preset value of the pressure.
23. The method of claim 22, wherein the conduit has dimensions of a plurality of gauges, and wherein the table of changes in the dimensions of the conduit versus the predetermined values of pressure is established.
24. A method of obtaining a predetermined value of the pressure in a monitored area of the catheter against which a balloon can be determined as claimed in claim 6, the method comprising:
measuring and calculating the size of the target position through CT heart three-dimensional modeling;
selecting a conduit of a specific size specification according to the size of the target position, wherein the initial pressure of the monitored area of the conduit is known
And initial volume
；
Simulating the plugging effect of the target position, and outputting the extrusion volume of the monitoring area during plugging of the target position
；
Calculating a predetermined value of the pressure of the conduit
：
=
。
25. A readable storage medium having a program stored thereon, wherein the program when executed implements a method according to any of claims 22-24.
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| CN114344681A (en) * | 2022-01-06 | 2022-04-15 | 苔华(苏州)医疗科技有限责任公司 | Balloon catheter, balloon catheter system, and method and device for measuring and displaying blocking state |
| CN117179853A (en) * | 2023-08-23 | 2023-12-08 | 上海魅丽纬叶医疗科技有限公司 | Automatic judgment method and system for ultrasonic ablation balloon wall attachment |
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