CN110559022B - Medical asymmetric balloon catheter with manipulator - Google Patents

Medical asymmetric balloon catheter with manipulator Download PDF

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Publication number
CN110559022B
CN110559022B CN201910367273.2A CN201910367273A CN110559022B CN 110559022 B CN110559022 B CN 110559022B CN 201910367273 A CN201910367273 A CN 201910367273A CN 110559022 B CN110559022 B CN 110559022B
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Prior art keywords
balloon catheter
manipulator
balloon
lumen
protection pipeline
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CN201910367273.2A
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CN110559022A (en
Inventor
张智超
郑璇珠
朱文裕
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Shanghai Keci Medical Technology Co ltd
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Shanghai Keci Medical Technology Co ltd
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Priority to CN201910367273.2A priority Critical patent/CN110559022B/en
Publication of CN110559022A publication Critical patent/CN110559022A/en
Priority to PCT/CN2020/086727 priority patent/WO2020221129A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B2017/0237Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for heart surgery

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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 provides a medical asymmetric balloon catheter with a manipulator, which comprises a balloon catheter part, a manipulator part and a protection pipeline, wherein the force generated by the manipulator is converted into torque through a braided tube coated outside the catheter and is uniformly transmitted to a bending balloon to control the positioning and the orientation of the balloon catheter, the protection pipeline protects a natural cavity from being damaged in the operation process, and the direction of a traction device can be controlled.

Description

Medical asymmetric balloon catheter with manipulator
Technical Field
The invention relates to medical equipment, in particular to a medical asymmetric balloon catheter device with a manipulator, which is used when a natural cavity channel is required to be retracted in an operation.
Background
At present, three natural orifice bending or deflection technologies and natural orifice traction control exist in the market, and one is to force the natural orifice to bend or deflect by utilizing the memory capacity of nickel-titanium alloy. The nickel-titanium alloy wire is in the shape of an S-shaped hard metal wire in a body temperature environment. In an environment below 4 ℃, the nickel-titanium alloy wire is in the form of a flexible metal wire. When in use, a user firstly carries out external cooling to soften the nickel-titanium alloy wire and then inserts the nickel-titanium alloy wire into a natural cavity of a patient through a hose, then carries out heat exchange with the body temperature, and after the nickel-titanium alloy wire is hardened, the nickel-titanium alloy wire is restored to an S shape so as to achieve bending or deflection of the natural cavity, and a large amount of cold saline needs to be poured to soften the wire and then is extracted after the use is finished. This embodiment is controlled by the operator to determine the pulling effect, without a reliable directional control unit, which is not controllable.
The other is to force the natural lumen to bend or deflect by means of mechanical deformation plus inflation of the outer balloon, which technique uses a mechanical pulling structure to bend the target segment into a C-shape, with the bent trigger in the manipulator's hand, and the bent portions at the two ends of the catheter, respectively. The mechanical structure bent into a C shape does not provide enough force to pull the tissue due to the limited diameter of the catheter, so the purpose of pulling the natural cavity is achieved by filling the balloon with the outer coating so that the diameter of the bent part is enlarged, the scheme does not have good control over the direction, and the whole diameter of the catheter is large before the use due to the mode of adding the mechanical structure and the balloon, and the patient is uncomfortable when entering the natural cavity of the patient.
Thirdly, the deformation of the mechanical structure and negative pressure air suction are utilized to force the natural cavity to bend or deviate, the mechanical traction structure bends the target section into a C shape, the negative pressure air suction device is added to force the natural cavity to be adsorbed on the guide pipe and then bend, and the guide pipe directly drives the natural cavity to bend. The negative pressure adsorption of the technical scheme can solve the problem that the whole cavity can not be observed, but the technical scheme does not verify whether the natural cavity can be damaged or not, and the pulling direction of the natural cavity is also uncontrollable.
Therefore, the medical instrument which can not only cause damage to the natural cavity channel in the operation, but also safely pull the natural cavity channel through a narrow channel and simultaneously realize controllable direction and controllable position is required to be developed, so that a user can accurately control the device to control the deviation of the natural cavity channel.
Disclosure of Invention
The invention aims to provide a medical asymmetric balloon catheter device with an accurate manipulator, which is designed for natural cavity traction based on the problems, so that the possible damage to natural cavity traction caused by the current technical conditions is reduced, and the problem that the natural cavity traction is uncontrollable is solved.
In order to achieve the above object, the present invention provides a medical asymmetric balloon catheter device with an accurate manipulator, comprising a balloon catheter part, a manipulator part and a protection pipeline, wherein the balloon catheter has the functions of bending traction and accurate control of a target bending position; the force generated by the manipulator is converted into torque through the braided tube coated outside the catheter and is uniformly transmitted to the bending balloon to control the positioning and the orientation of the balloon catheter, and the manipulator has a self-locking function.
The balloon catheter penetrates through the protection pipeline and the controller, one ends of the balloon catheter and the controller are fixedly connected relatively, the other ends of the protection pipeline and the controller are fixedly connected relatively, and relative movement between the balloon catheter and the protection pipeline is controlled by the controller. The multi-cavity tube penetrates through the whole balloon catheter, the multi-cavity tube is covered by the braided tube, glue is used for bonding or welding between the braided tube and the multi-cavity tube to be tightly nested, and the braided tube is ensured to enable torque transmission of the whole catheter and the like to enable the rotation angle of each section of the balloon catheter to be consistent. The tee joint is connected with the multi-cavity tube, and one cavity of the tee joint is connected with an independent cavity of the multi-cavity tube and the inner cavity of the anchoring balloon. The other cavity of the tee joint is connected with the other independent cavity of the multi-cavity tube and the inner cavity of the bending saccule. The pressure pump fills the anchoring balloon and the bending balloon with liquid through the two cavities of the tee joint respectively. The anchoring balloon is positioned at the distal end of the balloon catheter and is inflated to fix the distal end of the balloon catheter relative to the natural lumen. After the curved balloon is inflated, the curved balloon is curved and migrates away from the natural orifice. One control mode of the manipulator is a pull-out axial movement. The linear sliding handle is adjusted to drive the whole balloon catheter to move to a proper position along the axial direction and lock. The slide button controls the lock to be separated from the main rotating shaft, so that the main rotating shaft has a rotational degree of freedom. The rotating top cover controls the rotation of the main rotating shaft, and the balloon catheter is driven by the braided tube to achieve an ideal bending direction. The release slide locks the direction of curvature of the balloon catheter. The manipulator end-holder may immobilize the manipulator relative to the fixture or the patient's body. One control mode of the manipulator is a rotary axial movement type. The handle rotates to move axially to drive the whole balloon catheter to move to a proper position along the axial direction. After the balloon catheter reaches a proper position, the axial position of the balloon catheter is locked and fixed by the set screw. And after the rotating through hole stepped shaft or the handle is controlled to drive the balloon catheter to rotate to a proper direction, the spring and the driven part jointly lock the through hole stepped shaft or the handle to rotate. The manipulator end-holder may immobilize the manipulator relative to the fixture or the patient's body. The outer layer of the protection pipeline is soft, so that the loss of a natural cavity channel is avoided; the inner layer is smooth, so that the catheter can conveniently enter the natural cavity.
By adopting the scheme provided by the invention, the natural cavity can be accurately and controllably retracted when the natural cavity is required to be retracted in the operation, thereby facilitating the operation and reducing the retraction loss of the natural cavity.
The invention has the meaning that the natural cavity can be accurately and controllably retracted when the natural cavity is required to be retracted in the operation.
For example, in atrial fibrillation ablation procedures, an atrial esophageal fistula is a very fatal complication. It has been demonstrated that the occurrence of an atrial esophageal fistula can be avoided when the esophagus can be accurately retracted more than 2cm from the heart side. The present invention can eliminate a fatal complication of the procedure. In addition, there are literature documents that demonstrate the improvement of the physician's intraoperative efficiency and postoperative success rate.
In order to make the above objects, features and embodiments of the present invention more comprehensible, the following detailed description of the structural design and operation procedures of the present invention is given with reference to the accompanying drawings.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 is a schematic diagram of the present invention.
Fig. 2 is a schematic view of one embodiment of a balloon catheter.
Fig. 3 is a schematic view of the external structure of the drawing axial-movement manipulator.
Fig. 4 is a schematic view of the internal structure of fig. 3.
Fig. 5 is a schematic outline view of the drawing axial-movement manipulator.
Fig. 6 is a schematic view of the external structure of the rotary axial moving manipulator.
Fig. 7 is a schematic view of the internal structure of the rotary axial movement manipulator.
Fig. 8 is a schematic outline view of the rotary-axial-movement manipulator.
Reference numerals in the drawings: 1. balloon catheter, 2, protection, 3, manipulator, 5, controller, 11, multi-lumen tube, 12, anchoring balloon, 13, bending balloon, 14, braided tube, 15, straight sliding handle, 31, pair lock, 32, spring, 33, spring stop, 34, housing, 35, main shaft, 36, top cap, 37, sliding button, 38, set screw, 51, upper part of manipulator housing, 52, cover, 53, spring, 54, follower, 55, through hole stepped shaft, 56, set screw
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. The components of the embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be made by a person skilled in the art without making any inventive effort, are intended to be within the scope of the present invention.
The present invention is described in further detail below with reference to the drawings to enable those skilled in the art to practice the invention by referring to the description.
Referring first to fig. 1, fig. 1 is a schematic diagram of the present invention, and one embodiment of the present invention includes a balloon catheter 1, a protection pipeline 2 and a manipulator 3. The protection pipeline 2 is sleeved outside the balloon catheter 1, one ends of the balloon catheter 1 and the controller 3 are relatively and fixedly connected, the other ends of the protection pipeline 2 and the controller 3 are relatively and fixedly connected, and the relative movement between the balloon catheter 1 and the protection pipeline 2 is controlled by the controller 3.
Referring next to fig. 2 again, fig. 2 is a schematic view of the balloon catheter 1, wherein the multi-lumen tube 11 extends through the entire balloon catheter 1, the anchoring balloon 12 is positioned at the distal end of the balloon catheter 1, and inflation after inflation secures the distal end of the balloon catheter 1 relative to the natural lumen. The bending balloon 13 is adjacent to the anchoring balloon 12 and serves as a core traction component, and is inflated and bent after filling so as to achieve the purpose of traction away from a natural cavity. The braided tube 14 encloses the balloon catheter 1, and the two components are glued or welded to ensure tight nesting. The braided tube 14 may allow for uniform torque transfer throughout the catheter so that the rotation angle of each section of the balloon catheter 1 is uniform. The linear sliding handle 15 is tightly connected with the braided tube 14, and the linear sliding handle 15 is matched and connected with the manipulator 3, namely, the linear sliding handle 15 can slide along the axis direction of the catheter in the manipulator 3. The tee is connected to the multilumen tubing 11, one lumen of the tee is connected to one lumen of the multilumen tubing 11, and this lumen is connected to the lumen of the anchoring balloon 12, and the other lumen of the tee is connected to the other independent lumen of the multilumen tubing 11 and to the lumen of the bending balloon 13. The pressure pump fills the anchoring balloon 12 and the bending balloon 13 with liquid through the two lumens of the tee, respectively.
Fig. 3 is a schematic view of the external structure of the drawing axial moving type manipulator, fig. 4 is a schematic view of the internal structure of fig. 3, in which the main shaft 35 penetrates the whole manipulator 3, the top cover 36 is connected to the proximal end of the main shaft 35 and has a through hole at the center thereof, and the through hole and the linear sliding handle 15 are engaged with each other. The top cover 36 has threaded holes for threading set screws 56. The linear slide handle 15 is freely slidable in the through hole, and when slid to the target position, the position of the linear slide handle 15 is locked by rotating the set screw 56. One side of the counter lock 31 cooperates with a slot in the housing so that the counter lock 31 can slide in the axial direction of the device. When the lock 31 is slid proximally by an external force, the lock 31 presses the spring and disengages from the main shaft 35. At this time, the main shaft 35, the top cover 36 and the linear sliding handle 15 can be rotated together. When the external force on the lock 31 is removed, the compressed spring pushes the lock 31 distally, where the ramp on the lock 31 drives the ramp on the main shaft 35 to eventually reengage the lock 31 and the main shaft 35. In the engaged state, the main shaft 35, the top cover 36 and the linear slide handle 15 cannot rotate.
Fig. 5 is a schematic outline view of the drawing axial-movement manipulator. The holders 41 are mounted at both ends of the manipulator 3, and can fix the manipulator 3 to a fixture or the body of a patient. The slide button 37 is connected to the lock 31, and when the slide button 37 slides, the lock 31 slides similarly.
Fig. 6 is a schematic view of the external structure of the rotary axial moving manipulator. Where 51 is the upper part of the housing of the manipulator 3.
Fig. 7 is a schematic view of the internal structure of the rotary axial movement manipulator. The through hole stepped shaft 55 is geared, the through hole and the linear sliding handle 15 are engaged with each other, the linear sliding handle 15 is freely slid in the through hole, and after the target position is slid, the position of the linear sliding handle 15 is locked by rotating the set screw 56. The circle of the shaft with the largest outer diameter of the gear through hole stepped shaft 55 is marked with 0-360 degrees. Follower 54 is received through the outer aperture in the upper half of the housing and a spring is received from the outer aperture in the upper half of the housing with one end of the spring abutting follower 54 and sealing the outer aperture in the upper half of the housing with cover 52. When an external force is applied at this time to rotate the geared through-hole stepped shaft 55 or the linear sliding handle 15, they rotate together. When rotated to a certain angle, the follower 54 is subjected to the radial force of the geared through-hole stepped shaft 55 upwards, and the spring is contracted by the radial force of the follower 54; after a certain angle, the follower 54 is not subjected to radial force of the stepped shaft 55 with the gear through hole, and then the follower 54 and the spring are restored to the original state, so that self-locking is performed.
Fig. 8 is a schematic outline view of the rotary-axial-movement manipulator. Wherein the holders 41 are mounted at both ends of the manipulator 3, so that the manipulator 3 can be fixed to a fixture or the body of a patient.
The following is an example of a specific application of the invention: the protection pipeline 2 is firstly arranged in a natural cavity channel of a target; after the balloon catheter 1 passes through the manipulator 3, the balloon catheter 1 and the manipulator 3 integrally pass through the protection pipeline 2 to enter a natural cavity and are connected with the protection pipeline 2; the manipulator 3 and the patient are relatively fixed by the fixer 41, and the whole device and the target natural cavity are relatively fixed at the moment; the whole balloon catheter 1 is driven to axially move by adjusting the linear sliding handle 15; by image observation, when the balloon catheter 1 reaches the expected position, the set screw 38 is rotated to fix the axial position of the balloon catheter 1; sliding the slide button 37 causes the lock 31 to slide so as to disengage the lock 31 from the main shaft 35, rotating the top cover 36 to drive the bending direction of the balloon catheter 1 to a desired direction, and releasing the slide button 37 so as to lock the balloon catheter 1 in the bending direction; filling the anchoring balloon 12 with liquid through the tee joint 16, so that the distal end of the balloon catheter 1 and the natural lumen are fixed; the curved balloon 13 is inflated through the tee joint 16 so that the balloon catheter 1 can retract the natural lumen in the desired direction.
The following is another embodiment of a specific application: firstly, a protection pipeline 2 firstly enters a natural cavity of a target; after the balloon catheter 1 passes through the manipulator 5, the balloon catheter 1 and the manipulator 5 integrally pass through the protection pipeline 2 to enter a natural cavity and are connected with the protection pipeline 2; the manipulator 5 and the patient are relatively fixed by the fixer 41, and the whole device and the target natural cavity are relatively fixed at the moment; the whole balloon catheter 1 is driven to move along the axial direction by rotating the linear sliding handle 15; by image observation, when the balloon catheter 1 reaches the expected position, the set screw 56 is rotated to fix the axial position of the balloon catheter 1; the through hole stepped shaft 55 with the gear or the linear sliding handle 15 is rotated for a certain angle, the bending direction of the balloon catheter 1 is driven to reach the expected direction, and the locking piece locks the movement of the through hole stepped shaft or the linear sliding handle; filling the anchoring balloon 12 with liquid through the tee joint 16, so that the distal end of the balloon catheter 1 and the natural lumen are fixed; the curved balloon 13 is inflated through the tee joint 16 so that the balloon catheter 1 can retract the natural lumen in the desired direction.
The foregoing is merely illustrative of the present invention, and the present invention is not limited thereto, and any person skilled in the art will readily recognize that variations or substitutions are within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims (9)

1. The medical asymmetric balloon catheter with the manipulator comprises a balloon catheter, the manipulator and a protection pipeline, and is characterized in that a bending balloon is arranged on the balloon catheter, and is inflated and bent to one side after filling, so that a basic traction function is realized; the balloon catheter is coated with a braided tube, and the braided tube can convert the force generated by the manipulator into torque and uniformly transmit the torque to the bending balloon to control the positioning and the orientation of the balloon catheter; the balloon catheter is sleeved by a protection pipeline, the inner wall of the protection pipeline is made of a smooth material, the outer surface of the protection pipeline is made of an ultra-soft material, a channel is formed to protect a natural cavity from being damaged in the operation process, the balloon catheter can smoothly pass through the protection pipeline, the operation controller is a drawing axial moving operation controller, the structure is that a main rotating shaft penetrates through the whole operation controller, a top cover is connected with the proximal end of the main rotating shaft, the centers of the top cover and the main rotating shaft are through holes, and the through holes are matched with a linear sliding handle; the top cover is provided with a threaded hole for screwing in a set screw; the linear sliding handle can freely slide in the through hole, and when the linear sliding handle slides to a target position, the position of the linear sliding handle is locked by rotating the set screw; one side of the counter lock is matched with a groove on the shell, so that the counter lock can slide along the axial direction of the device; when the opposite lock slides towards the near end under the external force, the opposite lock can squeeze the spring and is separated from the main rotating shaft, and the main rotating shaft, the top cover and the linear sliding handle can rotate together; when the external force on the lock is removed, the compressed spring can push the lock to the far end, and at the moment, the inclined surface on the lock can drive the inclined surface on the main rotating shaft to finally reengage the lock and the main rotating shaft, and in the engaged state, the main rotating shaft, the top cover and the linear sliding handle cannot rotate.
2. The medical asymmetric balloon catheter with manipulator of claim 1, wherein the curved balloon is a collapsible compressed balloon before inflation that can become a curved C-balloon after inflation.
3. The medical asymmetrical balloon catheter with a manipulator according to claim 1, wherein the balloon catheter is fixedly connected with one end of the manipulator, the protection pipeline is fixedly connected with the other end of the manipulator, and the relative movement between the balloon catheter and the protection pipeline is controlled by the manipulator.
4. The medical asymmetric balloon catheter with manipulator of claim 1, wherein the balloon catheter comprises an anchoring balloon at a distal end of the balloon catheter, the distal end of the balloon catheter being fixed relative to the natural lumen after inflation.
5. The medical asymmetrical balloon catheter with manipulator according to claim 4, wherein the balloon catheter comprises a multi-lumen tube extending axially through the entire balloon catheter, a tee joint is provided and connected with the multi-lumen tube, one lumen of the tee joint is connected with one independent lumen of the multi-lumen tube and the lumen of the anchoring balloon, the other lumen of the tee joint is connected with the other independent lumen of the multi-lumen tube and the lumen of the bending balloon, and the pressure pump fills the anchoring balloon and the bending balloon with liquid through the two lumens of the tee joint, respectively.
6. The medical asymmetric balloon catheter with manipulator of claim 1, wherein the manipulator comprises a holder for relatively securing the relative position of the manipulator and the patient's body.
7. The medical asymmetric balloon catheter with manipulator of claim 1, wherein the manipulator has a linear slide and locking structure to manipulate and fix the axial position of the balloon catheter in the natural lumen.
8. The medical asymmetric balloon catheter with manipulator of claim 1, wherein the manipulator has a rotating assembly and locking structure to manipulate and fix the bending direction of the balloon catheter.
9. The medical asymmetric balloon catheter with the manipulator comprises a balloon catheter, the manipulator and a protection pipeline, and is characterized in that a bending balloon is arranged on the balloon catheter, and is inflated and bent to one side after filling, so that a basic traction function is realized; the balloon catheter is coated with a braided tube, and the braided tube can convert the force generated by the manipulator into torque and uniformly transmit the torque to the bending balloon to control the positioning and the orientation of the balloon catheter; the balloon catheter is sleeved with a protection pipeline, the inner wall of the protection pipeline is made of a smooth material, the outer surface of the protection pipeline is made of an ultra-soft material, a channel is formed to protect a natural cavity from being damaged in the operation and control process, the balloon catheter can smoothly pass through the protection pipeline, and the operation and control device is a rotary axial moving type operation and control device and has the following structure:
the through hole stepped shaft is provided with a gear, the through hole is matched with the linear sliding handle, the linear sliding handle can slide freely in the through hole, and after the target position is slid, the position of the linear sliding handle is locked by rotating the set screw;
the circle of the through hole stepped shaft with the gear with the largest outer diameter is marked with scales;
the driven piece is placed in the outer hole of the upper half part of the shell, then a spring is placed in the outer hole of the upper half part of the shell, one end of the spring is next to the driven piece, and finally the cover seals the outer hole of the upper half part of the shell;
when external force is applied to rotate the through hole stepped shaft with the gear or the linear sliding handle, the through hole stepped shaft with the gear or the linear sliding handle rotates together; when the driven member rotates to a certain angle, the driven member is upwards stressed by the radial force of the through hole stepped shaft with the gear, and the spring is contracted due to the radial force of the driven member; then after rotating a certain angle, the driven piece is not subjected to radial force of the through hole stepped shaft with the gear, and then the driven piece and the spring can restore to the original state for self-locking.
CN201910367273.2A 2019-04-30 2019-04-30 Medical asymmetric balloon catheter with manipulator Active CN110559022B (en)

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CN201910367273.2A CN110559022B (en) 2019-04-30 2019-04-30 Medical asymmetric balloon catheter with manipulator
PCT/CN2020/086727 WO2020221129A1 (en) 2019-04-30 2020-04-24 Medical asymmetrical balloon catheter having a manipulator

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CN201910367273.2A CN110559022B (en) 2019-04-30 2019-04-30 Medical asymmetric balloon catheter with manipulator

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CN110559022B true CN110559022B (en) 2023-11-24

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