CN113925594B - Balloon catheter - Google Patents
Balloon catheter Download PDFInfo
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- CN113925594B CN113925594B CN202111203541.0A CN202111203541A CN113925594B CN 113925594 B CN113925594 B CN 113925594B CN 202111203541 A CN202111203541 A CN 202111203541A CN 113925594 B CN113925594 B CN 113925594B
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- channel
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- 238000013507 mapping Methods 0.000 claims abstract description 30
- 238000001514 detection method Methods 0.000 claims abstract description 15
- 239000008280 blood Substances 0.000 claims description 18
- 210000004369 blood Anatomy 0.000 claims description 18
- 238000005452 bending Methods 0.000 claims description 15
- 238000002679 ablation Methods 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 8
- 238000012544 monitoring process Methods 0.000 claims description 6
- 238000006243 chemical reaction Methods 0.000 claims description 4
- 238000004781 supercooling Methods 0.000 claims description 4
- 230000003139 buffering effect Effects 0.000 claims description 3
- 239000004020 conductor Substances 0.000 claims description 3
- 230000013011 mating Effects 0.000 claims description 2
- 230000006698 induction Effects 0.000 claims 2
- 230000000149 penetrating effect Effects 0.000 claims 1
- 238000007710 freezing Methods 0.000 abstract description 6
- 230000008014 freezing Effects 0.000 abstract description 6
- 230000010354 integration Effects 0.000 abstract 1
- 230000001105 regulatory effect Effects 0.000 description 7
- 210000003492 pulmonary vein Anatomy 0.000 description 5
- 238000001356 surgical procedure Methods 0.000 description 4
- 230000000740 bleeding effect Effects 0.000 description 3
- 230000001276 controlling effect Effects 0.000 description 3
- 238000001816 cooling Methods 0.000 description 3
- 238000013461 design Methods 0.000 description 3
- 238000005057 refrigeration Methods 0.000 description 3
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 238000004891 communication Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 208000001034 Frostbite Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 210000002615 epidermis Anatomy 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 210000005077 saccule Anatomy 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 230000002123 temporal effect Effects 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
Classifications
-
- 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
-
- 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
- A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
- A61B2018/0022—Balloons
-
- 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
- A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
- A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
- A61B2018/00285—Balloons
-
- 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
- A61B2018/00571—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
-
- 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
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
-
- 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
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00863—Fluid flow
-
- 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
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00898—Alarms or notifications created in response to an abnormal condition
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Otolaryngology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The invention discloses a balloon catheter, comprising: a body and a conduit; the catheter includes: an inner tube and an outer tube; one end of the outer tube is provided with an inner balloon and an outer balloon; a plurality of temperature sensing elements are uniformly distributed on the inner wall of the inner balloon; a plurality of mapping flexible electrodes are uniformly distributed on the outer wall of the outer balloon; an inner balloon pressure sensor and a pressure sensor between the inner balloon and the outer balloon are arranged in the body; the internal air pressure of the inner balloon is adjusted in real time through the detection data of the pressure sensor of the inner balloon; the air pressure in the space between the inner balloon and the outer balloon is monitored in real time by the detection data of the inner balloon pressure sensor and the outer balloon pressure sensor. The sacculus pipe of this scheme is with mapping function and freezing function integration in same pipe, has saved operation time to can be in real time and accurate detection human body ablates the temperature at position, the security performance is higher, can also monitor the service condition of interior sacculus simultaneously, in order to further improve the practical security of pipe.
Description
Technical Field
The invention relates to the technical field of medical cryoablation, in particular to a balloon catheter.
Background
The existing medical catheter is simple in structure, the pressure detection positions in the balloon are an air inlet end and an air return end of the device, the pressure in the balloon can not be determined through the back-pumping air pressure and the input air flow, namely, the detected pressure value is far from the pressure value in the actual use area, the detection value is inaccurate, and the safety of the balloon operation is not high. At present, a mapping catheter and a cryocatheter used in the cryoablation treatment process are 2 types of surgical consumables, the mapping catheter needs to be assembled in advance before surgery, and the mapping catheter adopts a proximal locking mode, so that repeated positioning is needed when the balloon moves, and the surgery duration and the surgery risk are increased. In addition, the end part of the temperature sensing element of the current medical catheter is designed on the inner side of the balloon and has a distance of 10-20mm from the actual ablation position, so that the temperature actually contacted with the surface of a human body cannot be intuitively detected, but is indirectly calculated through a certain proportion difference value, and the monitored temperature value is inaccurate.
Disclosure of Invention
Aiming at the technical problem that the existing medical cryoablation technology is not perfect, the invention provides a balloon catheter, which has the technical scheme that:
A balloon catheter, comprising: a body and a conduit; the catheter is inserted into the body; the catheter includes: an inner tube for inputting one of a developer, a guide wire lumen or a mapping catheter, and an outer tube sleeved on the outer periphery of the inner tube; one end of the outer tube is provided with an inner balloon and an outer balloon sleeved on the outer side of the inner balloon to protect the inner balloon; a channel is formed between the inner tube and the outer tube; an air inlet pipe for inflating the inner balloon to expand the inner balloon, a plurality of temperature sensing elements, a blood sensing resistor and a plurality of mapping flexible electrodes are arranged in the channel; the air inlet pipe and the blood sensing resistor extend out of the channel and enter the inner saccule; a plurality of temperature sensing elements are uniformly distributed on the inner wall of the inner balloon so as to detect the temperature of a working area at the end part of the catheter in real time; a plurality of mapping flexible electrodes are uniformly distributed on the outer wall of the outer balloon so as to complete the conversion of the ablation position when the positions of the inner balloon and the outer balloon are readjusted; an inner balloon pressure sensor for monitoring the air pressure in the inner balloon and an inner balloon-outer balloon pressure sensor for monitoring the air pressure in the space between the inner balloon and the outer balloon are arranged in the body; the internal air pressure of the inner balloon is adjusted in real time through the detection data of the pressure sensor of the inner balloon; monitoring the air pressure in the space between the inner balloon and the outer balloon in real time by the detection data of the pressure sensors of the inner balloon and the outer balloon so as to monitor the working state of the inner balloon in real time; and an air return channel for returning air to the interior of the inner balloon is also arranged in the channel.
Further, the internal air pressure of the inner balloon is controlled by an air inlet device connected with the air inlet pipe and an air return adjusting device connected with the air return channel so that the outer diameter of the inner balloon is kept unchanged.
Further, the burst pressure of the outer balloon is greater than the burst pressure of the inner balloon.
Further, the southern hemisphere of the inner balloon is connected with the outer tube; the end of the temperature sensing element extends to the northern hemisphere of the inner balloon away from the outer tube; according to the parts which are detected by the temperature sensing elements to be too high and not cooled in time, the cryoablation treatment is carried out again by rotating, pushing and bending the balloon catheter to adjust the position; and according to the position where the temperature supercooling is detected by the plurality of temperature sensing elements, the refrigerating temperature of the position is increased by controlling the gas flow.
Further, one end of the air inlet pipe extending into the inner balloon is spirally wound on the outer side of the inner pipe.
Further, air holes for air outlet are uniformly distributed at one end of the air inlet pipe.
Further, the other end of the blood sensing resistor is connected with a blood detection sensor.
Further, a branching structure is arranged in the body; the branching structure is provided with: a first cavity channel provided with a first one-way valve and a second cavity channel provided with a second one-way valve; the space between the inner balloon and the outer balloon is communicated with a first one-way valve and a second one-way valve; the preset action pressure value of the second one-way valve is larger than that of the first one-way valve; when the gas pressure in the pressure channel between the inner balloon and the outer balloon is smaller than the action pressure value preset by the first one-way valve, the first one-way valve and the second one-way valve stop working; when the pressure of the gas in the pressure channel between the inner balloon and the outer balloon is larger than the action pressure value preset by the first one-way valve and smaller than the action pressure value preset by the second one-way valve, the first one-way valve starts to discharge the gas into the gas return channel; when the pressure of the gas in the pressure channel between the inner balloon and the outer balloon is larger than the preset action pressure value of the second one-way valve, the second one-way valve starts to discharge the gas into the outside air.
Further, the wall of the outer tube is formed with: one end is used for communicating the inside of interior sacculus and the interior sacculus pressure chamber way of interior sacculus pressure sensor is connected to the other end and one end is used for communicating the space between interior sacculus and the outer sacculus and the interior outer sacculus pressure chamber way of interior outer sacculus pressure sensor is connected to the other end.
Further, the two ends of the pressure cavity between the inner balloon and the outer balloon are closed; the wall of the outer tube is provided with a side hole for communicating the pressure cavity between the inner balloon and the outer balloon and the space between the inner balloon and the outer balloon.
Further, the pipe wall of the outer pipe is also provided with two traction wire cavities for the traction wires to pass through; one end of the traction wire is connected with the end of the outer tube to pull and adjust the bending degree of the end of the outer tube.
Further, the branching structure is further provided with: the device comprises two traction wire outlets respectively used for communicating two traction wire channels, an inner pipe channel used for allowing an inner pipe to pass through so as to be inserted into an outer pipe, an inner balloon pressure channel used for communicating the inner balloon pressure channel and an inner balloon pressure sensor, an inner balloon pressure channel used for communicating the inner balloon pressure channel and an outer balloon pressure channel and an inner balloon pressure sensor, a leading-through channel used for allowing a temperature sensing element, a blood sensing resistor and a mapping flexible electrode to pass through, an outer pipe used for allowing an outer pipe to be inserted, an air return channel used for communicating an air return channel and an inner balloon pressure channel used for communicating a space between the inner balloon and the outer balloon and an inner balloon pressure channel of a first check valve and a second check valve.
Further, the body is also provided with an outer tube bending structure for adjusting the bending degree of one end of the outer tube; the outer tube adjusting structure includes: an adjusting wheel rotatably connected to the body; the adjusting wheel is provided with two locking seats oppositely in the radial direction; the other ends of the two traction wires, which are far away from one end of the outer tube, are respectively fixed to the two locking seats.
Further, the body is also provided with an inner pipe pushing structure for pushing the inner pipe; the inner tube pushing structure is a pushing sleeve sleeved on the periphery of the inner tube; the push sleeve is formed with a push rail for mating with a push conductor formed by the body to enable the push sleeve to slide stably along the body.
Further, the body is also formed with a limit protrusion for limiting the pushing stroke of the pushing sleeve so as to ensure the safety of pushing the inner tube; the push sleeve is formed with a push limiting groove for cooperation with the limiting projection.
Further, the body is also formed with a positioning protrusion for positioning the position of the inner tube after pushing; the push sleeve is formed with a detent for cooperating with the detent projection to prevent sliding of the inner tube.
Further, a buffer sleeve is arranged between the pushing sleeve and the outer tube for buffering pushing operation of the pushing sleeve so as to avoid too fast pushing of the inner tube; the two ends of the buffer sleeve are respectively connected with the other ends of the pushing sleeve and the outer tube.
Further, the inner wall of the inner tube is provided with a miniature balloon; the micro balloon is communicated to the air inlet tube to clamp the mapping catheter in the inner tube after the air inlet tube is inflated.
Advantageous effects
Compared with the prior art, the technical scheme provided by the invention has the following beneficial effects:
The balloon catheter provided by the invention integrates the mapping function and the freezing function in the same structure, namely the mapping catheter and the freezing catheter are integrated in the same catheter, so that the position conversion of cryoablation can be completed only by readjusting the balloon of the catheter during operation, the operation time is saved, the bleeding probability is reduced, the positioning is accurate, repeated operation is not needed, and the operation process is simple and quick. Meanwhile, after the mapping catheter and the freezing catheter are integrated, the original inner diameter of the cavity channel of the mapping catheter can be changed into 0.89mm from the original inner diameter of 1.3, so that the diameter of the freezing catheter is reduced, and a sheath tube with smaller outer diameter can be adopted, thereby reducing tissue damage or bleeding.
The balloon catheter provided by the invention has the advantages that the plurality of temperature sensing elements are uniformly arranged on the northern hemisphere of the inner balloon far away from the outer tube and are close to the actual action position, so that the temperature of the ablation part of a human body can be accurately detected in real time, and the safety performance is higher. According to the parts which are detected by the temperature sensing elements to be too high and not cooled in time, the position of the parts is adjusted by rotating the balloon catheter to carry out cryoablation treatment again; and according to the position where the temperature supercooling is detected by the plurality of temperature sensing elements, the refrigerating temperature of the position is increased by controlling the gas flow.
The balloon catheter provided by the invention can also monitor the service condition of the inner balloon so as to further improve the use safety of the catheter. The inner balloon pressure sensor is arranged in the body of the balloon catheter, so that the pressure in the inner balloon can be monitored in real time and can be guaranteed to always reach the optimal pressure range, the inner balloon is guaranteed not to collapse in the refrigeration process, and the position movement of the inner balloon caused by over expansion is avoided. Meanwhile, the outer balloon sleeved on the periphery of the inner balloon can protect the inner balloon, and the pressure sensor between the inner balloon and the outer balloon arranged in the body can detect the gas pressure between the inner balloon and the outer balloon in real time, so that the working state of the inner balloon can be judged in real time, namely, whether the inner balloon is damaged or not is judged.
Drawings
FIG. 1 is a schematic view of the entirety of a balloon catheter according to an embodiment of the present invention, showing the contracted and expanded states of the inner and outer balloons;
fig. 2 is a schematic view of the internal structures of the inner balloon and the outer balloon of the balloon catheter according to the embodiment of the present invention, in which an enlarged schematic view of the internal air inlet pipe of the balloon is shown;
FIG. 3 is a schematic view of the internal structure of the balloon catheter of FIG. 1;
FIG. 4 is a schematic view of an inner tube pushing structure of the balloon catheter of FIG. 3;
FIG. 5 is a schematic view in cross-section of the mounting structure of the inner and outer tubes of the balloon catheter of FIG. 1;
FIG. 6 is a schematic view of the mounting structure of the inner and outer tubes of the balloon catheter of FIG. 1;
FIG. 7 is a schematic view of another view of the mounting structure of the inner and outer tubes of the balloon catheter of FIG. 1;
FIG. 8 is a schematic illustration of the branching structure of the interior of the balloon catheter of FIG. 3;
FIG. 9 is a schematic view of another view of the branching structure of the interior of the balloon catheter of FIG. 3;
FIG. 10 is a schematic structural view of an outer tube bending structure of the balloon catheter of FIG. 3;
fig. 11 is a schematic view of the mounting structure of the inner and outer balloons of the balloon catheter of fig. 2.
Balloon catheter 10, body 11, inner tube 12, outer tube 13, side hole 131, channel 14, inner balloon 15, outer balloon 16, northern hemisphere 161, southern hemisphere 162, air inlet tube 17, air hole 171, temperature sensing element 18, blood sensing resistor 19, mapping flexible electrode 20, inner balloon pressure channel 21, inner balloon pressure sensor 22, inner and outer inter-balloon pressure channel 23, inner and outer inter-balloon pressure sensor 24, return air channel 25, blood sensing sensor 26, pull wire channel 27, pull wire 28, wire separation structure 29, pull wire outlet 291, inner tube channel 292, inner balloon pressure channel 293, inner and outer inter-balloon pressure channel 294, guide wire channel 295, outer tube channel 296, return air channel 297, first chamber 298, first one-way valve (not shown), second chamber 299, second one-way valve (not shown), outer tube bending structure 30, regulating wheel 301, locking seat 302, locking screw 303, push sleeve 31, push guide rail 311, limit protuberance 111, push defining groove 312, positioning protuberance 313, positioning protuberance, buffer portion 33, buffer portion 37, and mini-channel 37, interface 37, and sealing interface portion 37.
Detailed Description
For a further understanding of the present invention, the present invention will be described in detail with reference to the drawings and examples.
The application is described in further detail below with reference to the drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the application and are not limiting of the application. It should be noted that, for convenience of description, only the portions related to the application are shown in the drawings. The first, second, etc. words are provided for convenience in describing the technical scheme of the present application, and have no specific limitation, and are all generic terms, and do not constitute limitation to the technical scheme of the present application. It should be noted that, without conflict, the embodiments of the present application and features of the embodiments may be combined with each other. In the description of the present application, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. Unless specifically stated or limited otherwise, the terms "mounted," "connected," and "coupled" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present application will be understood in specific cases by those of ordinary skill in the art. The technical schemes in the same embodiment and the technical schemes in different embodiments can be arranged and combined to form a new technical scheme without contradiction or conflict, which is within the scope of the application.
Examples
As shown in fig. 1 to 11, a balloon catheter 10 according to the present embodiment includes: a body 11 and a catheter. The catheter is inserted into the body 11, the body 11 is held by a worker, and the catheter is mounted on the body 11 to perform surgical treatment. Wherein, the pipe includes: an inner tube 12 and an outer tube 13. The inner tube 12 is used to input one of a developer, a guidewire lumen, or a mapping catheter 41. That is, the balloon catheter 10 can be used conveniently by feeding one of the developer, guidewire or mapping catheter 41 through the inner tube 12 depending on the purpose of the operation. The outer tube 13 is mounted on the body 11, and the inner tube 12 is inserted into the outer tube 13 from one end of the body 11, i.e. after the mounting is completed, the outer tube 13 is sleeved on the outer periphery of the inner tube 12. An inner balloon 15 and an outer balloon 16 are provided at one end of the outer tube 13. Inflation of the inner balloon 15 causes the outer wall of the inner balloon 15 to support and conform to the inner wall of the pulmonary vein. The outer balloon 16 is sleeved on the outer side of the inner balloon 15 to protect the inner balloon 15, so that the working state of the inner balloon 15 is more stable. That is, in normal operation of the balloon catheter 10, the inner balloon 15 is inflated to support the outer balloon 16 to expand together, the outer balloon 16 is tightly adhered to the outer wall of the inner balloon 15, and a vacuum is formed between the outer balloon 16 and the inner balloon 15. When the inner balloon 15 is ruptured during operation, the gas in the inner balloon 15 flows between the inner balloon 15 and the outer balloon 16, and the inner balloon 15 and the outer balloon 16 as a whole can be kept in the operating state due to the protection of the outer balloon 16. This can prevent the local cooling effect from being reduced due to the local poor adhesion between the balloon and the inner wall of the pulmonary vein caused by the air leakage and collapse of the whole body constituted by the outer balloon 16 and the inner balloon 15. Similarly, since the surface of the balloon is condensed on the inner wall of the pulmonary vein at low temperature during the refrigeration process, if the balloon collapses, the outer wall of the balloon tears the inner wall of the pulmonary vein, and the outer balloon 16 is arranged on the periphery of the inner balloon 15, so that the situation can be avoided.
Further, an inner balloon pressure sensor 22 and an inner and outer balloon pressure sensor 24 are also provided in the body 11. The inner balloon pressure sensor 22 is used to monitor the air pressure inside the inner balloon 15. The inner and outer balloon 16 pressure sensors are used to monitor the air pressure in the space between the inner balloon 15 and the outer balloon 16. The external device connected to the balloon catheter 10 adjusts the air pressure inside the inner balloon 15 in real time through the detection data of the inner balloon pressure sensor 22 to ensure that the pressure inside the inner balloon 15 always reaches the optimal pressure range, thereby ensuring that the inner balloon 15 is not collapsed and excessively expanded during the cooling process, and avoiding the position movement and danger of the inner balloon 15 caused by the excessive expansion. If the balloon is inflated in the refrigeration process, the inner wall surface of the pulmonary vein is directly expanded along with the balloon and even is propped and split, so that the epidermis is damaged, and internal bleeding and even thrombus can be caused in severe cases.
The external device connected to the balloon catheter 10 can also monitor the air pressure in the space between the inner balloon 15 and the outer balloon 16 in real time through the detection data of the pressure sensor 24 between the inner balloon and the outer balloon, so as to monitor the working state of the inner balloon 15 in real time, i.e. can determine whether the inner balloon 15 is damaged or broken in real time. If the pressure sensor 24 detects the pressure of the gas between the inner and outer balloons, it indicates that the inner balloon 15 is ruptured, and the gas in the inner balloon 15 flows into the outer balloon 16.
As a preferred embodiment, a branching structure 29 is provided within the body 11. The branching structure 29 is provided with: a first channel 298 and a second channel 299. A first one-way valve is disposed in the first channel 298 and a second one-way valve is disposed in the second channel 299. The space between inner balloon 15 and outer balloon 16 communicates with the first one-way valve via first lumen 298 and with the second one-way valve via second lumen 299. The preset acting pressure value of the second one-way valve is larger than the preset acting pressure value of the first one-way valve, that is, the gas pressure for opening the first one-way valve is smaller than the gas pressure for opening the second one-way valve. When the gas pressure between the inner balloon 16 and the outer balloon 16 is smaller than the action pressure value preset by the first one-way valve, the first one-way valve and the second one-way valve stop working, and at the moment, the fact that the whole formed by the outer balloon 16 and the inner balloon 15 can work normally is proved, and potential safety hazards are avoided temporarily. When the gas pressure between the inner and outer balloons 16 is greater than the preset acting pressure value of the first one-way valve and less than the preset acting pressure value of the second one-way valve, it is proved that the whole body formed by the outer balloon 16 and the inner balloon 15 has been inflated, and the surplus gas needs to be discharged, and at this time, the first one-way valve starts to discharge the gas into the gas return cavity 297 for gas recovery. When the gas pressure between the inner and outer balloons 16 is greater than the preset acting pressure value of the second one-way valve, it is proved that the whole body formed by the outer balloon 16 and the inner balloon 15 has been excessively inflated, and at this time, the second one-way valve starts to discharge the gas into the outside air. Through such a mode, under the condition that the inner balloon 15 is excessively inflated to rupture and expand, through the circuitous adjustment of the first one-way valve and the second one-way valve, the whole balloon can be prevented from being excessively expanded, the balloon still can be in a stable working state, time is striven for cryoablation treatment, and the operation risk is reduced.
As a specific embodiment, the air inlet device connected with the air inlet pipe 17 and the air return adjusting device connected with the air return channel 25 control the internal air pressure of the inner balloon 15 so as to keep the outer diameter of the inner balloon 15 unchanged, namely, ensure that the outer diameter of the balloon is kept consistent when the pressure of the inner balloon 15 is inflated, ablated and the pressure of the ablation balloon of the re-compounded constant pressure balloon is greater than the inflation pressure by 5psi, and the outer diameter is kept unchanged.
In this scenario, the burst pressure of outer balloon 16 is greater than the burst pressure of inner balloon 15. The outer balloon 16 is a more strong semi-compliant balloon and the inner balloon 15 is a compliant balloon. The outer balloon 16 has burst pressure far greater than that of the inner balloon 15 through the design of thickness, material and structure, and the burst pressure of the inner balloon 15 is greater than that of the normal working balloon. The design can further ensure the safety of the work of the freezing sacculus. As a specific structure, a passage 14 is formed between the inner tube 12 and the outer tube 13. Within the channel 14 are an air inlet tube 17 for inflating the inner balloon 15 to expand it, a plurality of temperature sensing elements 18, a blood sensing resistor 19 and a plurality of mapping flexible electrodes 20. The air inlet tube 17 and the blood sensing resistor 19 extend out of the channel 14 into the inner balloon 15. The inner wall of the inner balloon 15 is uniformly distributed with a plurality of temperature sensing elements 18 to detect the temperature of the working area of the catheter tip in real time. The outer wall of the outer balloon 16 is evenly distributed with a plurality of mapping flexible electrodes 20 to complete ablation site conversion upon repositioning of the inner balloon 15 and outer balloon 16. A return air channel 25 is also provided in the channel 14. The return air passage 25 is a return air passage 25 for returning air to the inside of the inner balloon 15.
Further, the southern hemisphere 162 of the inner balloon 15 is connected to the outer tube 13. The end of the temperature sensing element 18 extends to the northern hemisphere 161 of the inner balloon 15, which is remote from the outer tube 13. This arrangement allows the end of the temperature sensing element 18 for sensing temperature to be located in the temporal ablation working region with more accurate sensing data. If the temperature sensing element 18 detects that the temperature of a certain part is too high, that is, the part is not cooled in time, a worker can observe the detection data through external equipment connected with the balloon catheter 10, and then the temperature sensing element 18 detects that the part which is too high and is not cooled in time carries out cryoablation treatment on the part again by rotating, pushing and bending the position adjusting part of the balloon catheter 10. If the temperature sensing element 18 detects a temperature supercooled portion, the external device connected to the balloon catheter 10 may raise the cooling temperature of the portion by controlling the gas flow rate of the external gas delivery device connected to the balloon catheter 10 according to the temperature sensing element 18 detecting the temperature supercooled portion.
In this scheme, temperature sensing element 18 is located interior sacculus 15 inner wall, and adopts 2 upper and lower evenly distributed's designs, detects the temperature numerical value through two temperature sensing elements 18 to carry out the proportion calculation to 2 numerical values, obtain the mean temperature. When the average temperature detected by the 2 temperature sensing elements 18 exceeds 5 ℃, an external system connected with the balloon catheter 10 gives an abnormal warning, so that the temperature of the actual ablation position can be visually observed, and whether the ablation is uniformly cooled or not can be judged. Therefore, the sequelae of severe frostbite caused by the supercooling of the local temperature of the area to be ablated can be avoided, and the problem that cells cannot be killed after the temperature is returned due to the overhigh local position temperature of the area to be ablated can be avoided.
As a specific embodiment, the other end of the blood sensing resistor 19 is connected to a blood detection sensor 26.
As a specific embodiment, the wall of the outer tube 13 is formed with: an inner balloon pressure lumen 21 and an inner-outer balloon pressure lumen 23. One end of the inner balloon pressure lumen 21 is for communicating with the interior of the inner balloon 15, and the other end is connected to an inner balloon pressure sensor 22. One end of the inner and outer inter-balloon pressure passages 23 is used to communicate the space between the inner balloon 15 and the outer balloon 16, and the other end is connected to the inner and outer inter-balloon pressure sensor 24. Both ends of the pressure channel 23 between the inner and outer balloons are closed by a blocking structure 40. The wall of the outer tube 13 is formed with side holes 131. The side holes 131 serve to communicate the space between the inner and outer inter-balloon pressure passages 23 and the inner and outer balloons 15 and 16. In this way, in the case that the inner balloon 15 is not ruptured, the space between the inner balloon 15 and the outer balloon 16 can be ensured to be in a vacuum state, that is, the outer balloon 16 is ensured to be closely attached to the outer wall of the inner balloon 15 when the inner balloon 15 works.
As a specific embodiment, the wall of the outer tube 13 is also formed with two traction wire lumens 27. Two pull wire lumens 27 are provided for two pull wires 28 to pass through, respectively. One end of the traction wire 28 is connected to the end of the outer tube 13 to pull and adjust the camber of the end of the outer tube 13.
As a specific embodiment, the branching structure 29 is further provided with: two traction wire outlets 291, an inner tube passage 292, an inner balloon pressure passage 293, an inner-outer inter-balloon pressure passage 294, a threading passage 14, an outer tube 296, a return air chamber 297 and an inner-outer inter-balloon pressure passage 294. The two traction wire outlets 291 are respectively communicated with the two traction wire cavity passages 27 for the two traction wires 28 to pass out. The inner tube passage 292 is used for passing the inner tube 12 therethrough to insert the outer tube 13. The inner balloon pressure channel 293 is used to communicate the inner balloon pressure lumen 21 with the inner balloon pressure sensor 22. The inner and outer inter-balloon pressure passages 294 serve to communicate the inner and outer inter-balloon pressure passages 23 with the inner and outer inter-balloon pressure sensors 24. The lead-through channel 14 is used to communicate with a lead-through lumen 37 through which the temperature sensing element 18, the blood sensing resistor 19 and the mapping flexible electrode 20 pass. The outer tube channel 296 is used for insertion of the outer tube 13. The air return channel 297 is used for communicating with the air return channel 25, an air inlet and return communicating pipe 39 is arranged in the body 11, and the air inlet pipe 17 and the air return channel 25 are both communicated with the air inlet and return communicating pipe 39, and are further connected to external air inlet equipment and air return equipment through the air inlet and return communicating pipe 39. The inner and outer inter-balloon pressure passages 294 are used to communicate the space between the inner balloon 15 and the outer balloon 16 with the first check valve and the second check valve, that is, the first check valve is connected to the inner and outer inter-balloon pressure passages 294 through the first chamber 298 and the second check valve is connected to the inner and outer inter-balloon pressure passages 294 through the second chamber 299.
As a specific embodiment, one end of the air inlet pipe 17 extending into the inner balloon 15 is spirally wound on the outer side of the inner pipe 12, and air holes 171 for air outlet are uniformly distributed at one end of the air inlet pipe 17. This can ensure uniformity and stability of inflation while improving the inflation efficiency of the inner balloon 15. As a specific embodiment, the body 11 is further provided with an outer tube bending adjustment structure 30 for adjusting the bending of one end of the outer tube 13. Specifically, the outer tube 13 adjusting structure includes: the regulating wheel 301 connected to the body 11 is rotated. The adjustment wheel 301 is provided with two locking seats 302 opposite in the radial direction. The other ends of the two traction wires 28, which are remote from the end of the outer tube 13, are respectively fixed to the two locking seats 302 by locking screws 303. That is, one end of the traction wire 28 is connected to one end of the outer tube 13 and the other end is connected to the locking seat 302, so that when the regulating wheel 301 is rotated with respect to the body 11, the regulating wheel 301 pulls the traction wire 28 through the locking seat 302, thereby bending one end of the outer tube 13 by the traction wire 28. The greater the rotation amplitude of the regulating wheel 301, the greater the degree of bending of one end of the outer tube 13. Since the two locking seats 302 for fixing the two traction wires 28 are oppositely disposed in the radial direction of the regulating wheel 301, one end of the outer tube 13 is straightened or one end of the outer tube 13 is bent in the opposite direction after the regulating wheel 301 is reversely rotated.
As a specific embodiment, the body 11 is further provided with an inner tube 12 pushing structure for pushing the inner tube 12. Specifically, the pushing structure of the inner tube 12 is a pushing sleeve 31 sleeved on the outer periphery of the inner tube 12. The push sleeve 31 is formed with a push rail 311, and the push sleeve 31 is guided to slide by the push rail 311 in cooperation with a push conductor formed by the body 11, so that the push sleeve 31 stably pushes the inner tube 12 along the body 11.
Further, the body 11 is also formed with a limit projection 111. The limit projection 111 is used for limiting the pushing stroke of the pushing sleeve 31 to ensure the pushing safety of the inner tube 12. The push sleeve is formed with a push defining groove 312 for cooperation with the limit projection 111. When pushing the inner tube 12, pushing the pushing sleeve 31 to the groove wall at one end of the pushing limiting groove 312 abuts against the limiting protrusion 111, the inner tube 12 is pushed, so that the operation is safer, and the inaccuracy of the pushing position caused by the overlarge pushing stroke of the inner tube 12 can be avoided.
Further, the body 11 is also formed with a positioning protrusion 112 for positioning the position of the inner tube 12 after pushing. The push sleeve is formed with a detent 313 for cooperating with the detent projection 112 to prevent sliding of the inner tube 12 when pushed into place. This enables the inner tube 12 to be held in the working position. Since the push sleeve 31 and the body 11 are made of materials that are easily deformed, the positioning protrusion 112 can be smoothly engaged into the positioning groove 313 by the external force. In addition, the push sleeve 31 is also formed with a push portion 314. The pushing portion 314 is used for pushing the pushing sleeve 31 by a worker to slide the pushing sleeve 31.
As a specific embodiment, a buffer sleeve 32 is provided between the push sleeve 31 and the outer tube 13. The buffer sleeve 32 is used for buffering the pushing operation of the pushing sleeve 31 to avoid the pushing of the inner tube 12 from being too fast, so that the safety of the pushing operation is further ensured. Specifically, the body 11 further has an inner lumen 38 for passing the inner tube 12 therethrough and protecting the inner tube 12. The inner lumen channel 38 is connected to an inner lumen channel 292 of the junction structure 29. Two ends of the buffer sleeve 32 are respectively connected with one ends of the pushing sleeve 31 and the inner lumen channel 38.
As a preferred embodiment, the inner wall of the inner tube 12 is provided with a micro balloon 33. The micro balloon 33 is circumferentially disposed on the inner wall of the inner tube 12. Is communicated to the air inlet tube 17 to clamp the mapping catheter 41 within the inner tube 12 after the air inlet tube 17 has been inflated. This enables precise positioning of the distal end of the mapping catheter 41, ensuring operational stability. The mapping catheter 41 may be normal to the micro balloon when it is deflated. The end of the body 11 is provided with a first interface 34 for the developer or mapping catheter 41 to enter, a second interface 35 for air intake or return and a third interface 36 for connecting wires, which are distributed in a fan shape when the installation is completed, so as to increase the operation space of the balloon catheter 10, and make the operation more flexible. One end of the intake return air communication tube 39 is connected to the second joint.
Further, one end of the intake and return air pipe is connected to the branching structure 29 and the other end is connected to the second joint, thereby being connected to an external intake device and return air device through the second joint. The air inlet pipe 17 is arranged in the air inlet and return pipe and is distributed in a local spiral line in the branching structure 29, so that the air inlet pipe 17 is prevented from being damaged or blocked due to poor stress pulling in the pushing process.
The temperature sensing element 18 in this embodiment is a thermocouple and the mapping flexible electrode 20 is a mapping resistance wire.
The invention and its embodiments have been described above by way of illustration and not limitation, and the invention is illustrated in the accompanying drawings and described in the drawings in which the actual structure is not limited thereto. Therefore, if one of ordinary skill in the art is informed by this disclosure, the structural mode and the embodiments similar to the technical scheme are not creatively designed without departing from the gist of the present invention.
Claims (13)
1. A balloon catheter, comprising: a body and a conduit; the catheter is inserted into the body; characterized in that the catheter comprises: an inner tube for inputting one of a developer, a guide wire lumen or a mapping catheter, and an outer tube sleeved on the periphery of the inner tube; an inner balloon and an outer balloon sleeved on the outer side of the inner balloon are arranged at one end of the outer tube so as to protect the inner balloon; a channel is formed between the inner tube and the outer tube; an air inlet pipe for inflating the inner balloon to expand the inner balloon, a plurality of temperature sensing elements, a blood induction resistor and a plurality of mapping flexible electrodes are arranged in the channel; an air return channel for returning air to the interior of the inner balloon is also arranged in the channel; the air inlet pipe and the blood induction resistor extend out of the channel and enter the inner balloon; the inner wall of the inner balloon is uniformly distributed with a plurality of temperature sensing elements so as to detect the temperature of a working area at the end part of the catheter in real time; a plurality of mapping flexible electrodes are uniformly distributed on the outer wall of the outer balloon so as to complete ablation position conversion when the positions of the inner balloon and the outer balloon are readjusted; an inner balloon pressure sensor for monitoring the air pressure in the inner balloon and an inner balloon pressure sensor and an outer balloon pressure sensor for monitoring the air pressure in the space between the inner balloon and the outer balloon are arranged in the body; the method comprises the steps of adjusting the air pressure in the inner balloon in real time through detection data of an inner balloon pressure sensor; monitoring the air pressure in the space between the inner balloon and the outer balloon in real time by the detection data of the pressure sensors of the inner balloon and the outer balloon so as to monitor the working state of the inner balloon in real time;
a branching structure is arranged in the body; the branching structure is provided with: a first cavity channel provided with a first one-way valve and a second cavity channel provided with a second one-way valve; the space between the inner balloon and the outer balloon is communicated with the first one-way valve and the second one-way valve; the preset action pressure value of the second one-way valve is larger than that of the first one-way valve; when the gas pressure in the pressure channel between the inner balloon and the outer balloon is smaller than the action pressure value preset by the first one-way valve, the first one-way valve and the second one-way valve stop working; when the gas pressure in the pressure channel between the inner balloon and the outer balloon is larger than the action pressure value preset by the first one-way valve and smaller than the action pressure value preset by the second one-way valve, the first one-way valve starts to discharge the gas into the return air cavity; when the pressure of the gas in the pressure channel between the inner balloon and the outer balloon is larger than the preset action pressure value of the second one-way valve, the second one-way valve starts to discharge the gas into the outside air;
The pipe wall of the outer pipe is formed with: an inner balloon pressure channel with one end used for communicating the interior of the inner balloon and the other end connected with the inner balloon pressure sensor, and an inner and outer balloon pressure channel with one end used for communicating the space between the inner balloon and the outer balloon and the other end connected with the inner and outer balloon pressure sensor;
The two ends of the pressure cavity channel between the inner balloon and the outer balloon are closed; the wall of the outer tube is provided with a side hole for communicating the pressure cavity between the inner balloon and the outer balloon and the space between the inner balloon and the outer balloon;
the tube wall of the outer tube is also provided with two traction wire cavities for the traction wires to pass through; one end of the traction wire is connected with the end part of the outer tube so as to pull and adjust the bending degree of the end part of the outer tube;
The branching structure is also provided with: the device comprises an inner tube, an outer tube, an inner balloon pressure channel, an outer balloon pressure channel, a temperature sensing element, a blood sensing resistor, a flexible electrode, an outer tube, an air return channel, a first check valve and a second check valve, wherein the inner tube is used for being communicated with two traction wire outlets of the traction wire channels, the inner tube channel is used for the inner tube to penetrate so as to be inserted into the outer tube, the inner balloon pressure channel is used for being communicated with the inner balloon pressure channel and the inner balloon pressure sensor, the inner balloon pressure channel is used for being communicated with the inner balloon pressure channel and the outer balloon pressure channel of the inner balloon pressure sensor, the outer balloon pressure channel is used for being communicated with the inner balloon pressure channel and the outer balloon pressure channel of the first check valve and the second check valve, and the temperature sensing element, the blood sensing resistor and the flexible electrode are respectively used for penetrating channels, the outer tube is used for being inserted into the outer tube, the air return channel is used for being communicated with the space between the inner balloon and the outer balloon.
2. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
And controlling the internal air pressure of the inner balloon by an air inlet device connected with the air inlet pipe and an air return adjusting device connected with the air return channel so as to keep the outer diameter of the inner balloon unchanged.
3. The balloon catheter of claim 2, wherein the balloon catheter is configured to be positioned over the patient,
The burst pressure of the outer balloon is greater than the burst pressure of the inner balloon.
4. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
The southern hemisphere of the inner balloon is connected with the outer tube; the end of the temperature sensing element extends to the northern hemisphere of the inner balloon away from the outer tube; according to the parts which are detected by the temperature sensing elements to be too high and not cooled in time, performing cryoablation treatment again by rotating, pushing and bending the balloon catheter to adjust the position; and according to the position where the temperature sensing elements detect the supercooling, controlling the gas flow to raise the refrigerating temperature of the position.
5. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
One end of the air inlet pipe, which extends into the inner balloon, is spirally wound on the outer side of the inner pipe.
6. The balloon catheter of claim 5, wherein the balloon catheter is configured to move,
And air holes for air outlet are uniformly distributed at one end of the air inlet pipe.
7. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
The other end of the blood sensing resistor is connected with a blood detection sensor.
8. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
The body is also provided with an outer tube bending structure for adjusting the bending degree of one end of the outer tube; the outer tube adjustment structure includes: an adjusting wheel rotatably connected to the body; the adjusting wheel is provided with two locking seats oppositely in the radial direction; the other ends of the two traction wires, which are far away from one end of the outer tube, are respectively fixed to the two locking seats.
9. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
The body is also provided with an inner pipe pushing structure for pushing the inner pipe; the inner pipe pushing structure is a pushing sleeve sleeved on the periphery of the inner pipe; the push sleeve is formed with a push rail for mating with a push conductor formed by the body to enable the push sleeve to stably slide along the body.
10. The balloon catheter of claim 9, wherein the balloon catheter is configured to be positioned over the patient,
The body is also provided with a limiting protrusion for limiting the pushing stroke of the pushing sleeve so as to ensure the safety of pushing the inner tube; the push sleeve is formed with a push limiting groove for being matched with the limiting protrusion.
11. The balloon catheter of claim 10, wherein the balloon catheter is configured to be positioned over the patient,
The body is also provided with a positioning protrusion for positioning the position of the inner tube after pushing; the push sleeve is formed with a positioning groove for cooperating with the positioning protrusion to prevent the inner tube from sliding.
12. The balloon catheter of claim 9, wherein the balloon catheter is configured to be positioned over the patient,
A buffer sleeve is arranged between the pushing sleeve and the outer tube and used for buffering pushing operation of the pushing sleeve so as to prevent the inner tube from being pushed too fast; and two ends of the buffer sleeve are respectively connected with the pushing sleeve and the other end of the outer tube.
13. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
The inner wall of the inner tube is provided with a miniature balloon; the micro balloon is communicated to the air inlet tube to clamp the mapping catheter within the inner tube after the air inlet tube inflates the air inlet tube.
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| CN202111203541.0A CN113925594B (en) | 2021-10-15 | 2021-10-15 | Balloon catheter |
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| CN202111203541.0A CN113925594B (en) | 2021-10-15 | 2021-10-15 | Balloon catheter |
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| CN115153812A (en) * | 2022-07-15 | 2022-10-11 | 苏州海宇新辰医疗科技有限公司 | Ablation device and preparation method of compatilizer |
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