阅读说明：本技术 具有操控器的医用非对称球囊导管 (Medical asymmetric balloon catheter with manipulator ) 是由 张智超 郑璇珠 朱文裕 于 2019-04-30 设计创作，主要内容包括：本发明提供了具有操控器的医用非对称球囊导管,包括球囊导管部分、操控器部分和保护管路,操控器产生的力通过包覆在导管外的编织管转化为扭矩均匀传递到弯曲球囊控制球囊导管的定位和定向,保护管路保护自然腔道免于操作过程中受损伤,能实现牵拉装置方向可控。(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 force generated by the manipulator is converted into torque through a braided tube coated outside the catheter and is uniformly transmitted to a bent balloon to control the positioning and orientation of the balloon catheter, the pipeline is protected from damage in the operation process, and the direction of a traction device can be controlled.)

1. The medical asymmetric balloon catheter with the manipulator comprises a balloon catheter, the manipulator and a protection pipeline, and is characterized in that the balloon catheter is provided with a bending balloon, and the bending balloon is inflated and bent to one side after being inflated so as to realize a basic drawing function; the woven tube is coated outside the balloon catheter, and can convert the force generated by the manipulator into torque to be uniformly transmitted to the bending balloon to control the positioning and orientation of the balloon catheter; the balloon catheter is sleeved with the protection pipeline, the inner wall of the protection pipeline is made of smooth materials, the outer surface of the protection pipeline is made of ultra-soft materials, a channel is formed to protect a natural cavity channel from being damaged in the operation and control process, and the balloon catheter can smoothly pass through the protection pipeline.

2. The asymmetric medical balloon catheter with manipulator according to claim 1, wherein the curved balloon, which is a collapsible balloon before filling, can become a curved and larger diameter C-shaped balloon after filling.

3. The asymmetric balloon catheter for medical use with an actuator as claimed in claim 1, wherein the balloon catheter and the actuator are fixedly connected to each other at one end, the protection tube and the actuator are fixedly connected to each other at the other end, and the relative movement between the balloon catheter and the protection tube is controlled by the actuator.

4. The asymmetric medical balloon catheter with manipulator according to claim 1, wherein the balloon catheter includes an anchoring balloon at a distal end of the balloon catheter, the anchoring balloon being inflated to fix the distal end of the balloon catheter relative to the natural orifice.

5. The asymmetric medical 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 three-way tube connected to the multi-lumen tube, a lumen of the three-way tube connected to a separate lumen of the multi-lumen tube and an inner lumen of the anchoring balloon. The other cavity of the three-way valve is connected with the other independent cavity of the multi-cavity tube and the inner cavity of the bending saccule, and the pressure pump is respectively filled with liquid through the two cavities of the three-way valve to enable the anchoring saccule and the bending saccule to be full.

6. The asymmetric balloon catheter for medical use with a manipulator according to claim 1, wherein the manipulator comprises a holder for relatively fixing the manipulator and the body of the patient.

7. The asymmetric medical balloon catheter as claimed in claim 1, wherein the manipulator has a linear slide and a locking structure for manipulating and fixing the axial position of the balloon catheter in the natural orifice.

8. The asymmetric medical balloon catheter as claimed in claim 1, wherein the manipulator has a rotation component and a locking structure for manipulating and fixing the bending direction of the balloon catheter.

9. The asymmetric balloon catheter for medical use with a manipulator according to claim 1, wherein the manipulator is a pull axial translation manipulator having the following structure,

The main rotating shaft penetrates through the whole manipulator,

The top cover is connected with the near 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 the linear sliding handle; the top cover is provided with a threaded hole for screwing in the fastening screw;

The linear sliding handle can freely slide in the through hole, and after 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 lock is matched with the groove on the shell, so that the lock can slide along the axial direction of the device; when the counter lock slides towards the near end under the action of external force, the counter lock can extrude 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; after external force on the lock is removed, the compressed spring can push the lock to the far end, the inclined plane on the lock can drive the inclined plane on the main rotating shaft to finally re-engage the lock and the main rotating shaft, the top cover and the linear sliding handle cannot rotate in the engaged state.

10. The asymmetric medical balloon catheter as in claim 1, wherein the manipulator is a rotational axial translation manipulator having 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 freely slide in the through hole, and after the target position is slid, the position of the linear sliding handle is locked by rotating the fastening screw;

Scales are marked on one circle of the maximum outer diameter shaft of the through hole stepped shaft with the gear;

The driven piece is put in through the outer hole of the upper half part of the shell, then the spring is put in from the outer hole of the upper half part of the shell, one end of the spring is close to the driven piece, and finally the outer hole of the upper half part of the shell is sealed by the cover;

When the external force is applied to the through hole stepped shaft with the gear or the linear sliding handle to rotate, the through hole stepped shaft with the gear or the linear sliding handle rotates together; when the driven part rotates to a certain angle, the driven part is upwards stressed by the radial force of the through hole stepped shaft with the gear, and the spring is contracted by the radial force of the driven part; then after rotating a certain angle, the driven part does not receive the radial force of the through hole stepped shaft with the gear, and the driven part and the spring can restore to the original state to carry out self-locking.

Technical Field

the invention relates to a medical instrument, in particular to a medical asymmetric balloon catheter device with a manipulator, which is used when a natural cavity needs to be retracted in an operation.

Background

at present, three natural orifice bending or deflecting technologies and traction control for the natural orifice exist in the market, and one is to force the natural orifice to bend or deflect by utilizing the memory capacity of the nickel-titanium alloy. The nickel-titanium alloy wire is in an S-shaped hard metal wire shape in a body temperature environment. In the environment below 4 ℃, the nickel-titanium alloy wire is in a flexible metal wire shape. When the cooling type natural orifice tube is used, a user cools the nickel-titanium alloy wire in vitro to soften the nickel-titanium alloy wire and then inserts the nickel-titanium alloy wire into a natural orifice of a patient through a hose, the nickel-titanium alloy wire is restored to be S-shaped after being hardened along with heat exchange between the nickel-titanium alloy wire and body temperature, so that the natural orifice is bent or deflected, and a large amount of cold saline is required to be poured to soften the wire and then be drawn out after the use. This solution is intended to be used by operators for determining the pulling effect, without reliable directional control units, which is not controllable.

The other is to use the deformation of a mechanical structure and the expansion of an outer balloon to force the natural cavity channel to bend or deflect, the technology uses a mechanical pulling structure to bend the target section into a C shape, and a bent trigger is arranged at the two ends of the catheter respectively with the bent part in the hand of an operator. Because the diameter of the catheter is limited, the mechanical structure which is bent into the C shape can not provide enough strength to pull the tissue, the diameter of the bent part of the catheter is enlarged by filling the externally-coated balloon, so that the purpose of pulling and moving the natural orifice is achieved, the direction of the scheme is not well controlled, and the mode that the mechanical structure and the balloon are used enables the overall diameter of the catheter to be large before use, so that the patient feels uncomfortable when entering the natural orifice of the patient.

The third is that the deformation of the mechanical structure and the negative pressure air exhaust are utilized to force the natural cavity to bend or deviate, the target section is bent into a C shape by the mechanical drawing structure, the negative pressure air exhaust device is added to force the natural cavity to be adsorbed on the guide pipe and then bent, and the guide pipe directly drives the natural cavity to bend. The problem that the whole cavity channel cannot be observed can be solved through negative pressure adsorption of the technical scheme, but whether the natural cavity channel is damaged or not is not verified through the technical scheme, and the traction direction of the natural cavity channel is also not controllable.

Therefore, there is a need to develop a medical device which can not cause damage to the natural orifice in the operation, can safely draw the natural orifice through a narrow passage, and can realize direction control and position control, so that a user can accurately control the device to control the deviation of the natural orifice.

Disclosure of Invention

The invention aims to provide a medical asymmetric balloon catheter device with an accurate manipulator, which is designed for natural orifice traction based on the problems, so that the damage to the natural orifice traction caused by the current technical conditions is reduced, and the problem of uncontrollable traction to the natural orifice is solved.

In order to achieve the above object, the present invention provides a medical asymmetric balloon catheter device with a precise manipulator, which comprises a balloon catheter portion, a manipulator portion and a protection pipeline, wherein the balloon catheter has the functions of bending traction and precise 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 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 end of the balloon catheter is fixedly connected with one end of the controller relatively, the other end of the protection pipeline is fixedly connected with the other end of the controller 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 braided tube covers the multi-cavity tube, the braided tube and the multi-cavity tube are bonded by glue or are welded and tightly nested, and the braided tube can ensure that the torque of the whole catheter is transmitted by equal torque so as to ensure that the rotation angle of each section of the balloon catheter is consistent. The three-way is connected with the multi-cavity tube, and one cavity of the three-way is connected with one independent cavity of the multi-cavity tube and the inner cavity of the anchoring saccule. The other cavity of the three-way is connected with the other independent cavity of the multi-cavity tube and the inner cavity of the bending saccule. The pressure pump is respectively filled with liquid through two cavities of the tee joint to enable the anchoring saccule and the bending saccule to be full. The anchoring balloon is positioned at the distal end of the balloon catheter, and the distal end of the balloon catheter is fixed relative to the natural orifice after inflation. The bending saccule is bent and moved away from the natural orifice after being inflated. One way of controlling the manipulator is by a pull-out axial movement. And adjusting the linear sliding handle to drive the whole balloon catheter to move to a proper position along the axial direction and lock. The slide button controls the counter lock to be separated from the main rotating shaft, so that the main rotating shaft has rotational freedom. The rotating top cover controls the rotation of the main rotating shaft, and the balloon catheter is driven to achieve an ideal bending direction through the braided tube. The slide button is released to lock the bending direction of the balloon catheter. The manipulator end retainers may immobilize the manipulator relative to the fixture or the patient's body. One control method of the manipulator is a rotary axial movement. The handle rotates and moves 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 fastening screw. After the balloon catheter is driven to rotate to a proper direction by controlling the rotating through hole stepped shaft or the handle, the spring and the driven part are jointly locked to rotate the through hole stepped shaft or the handle. The manipulator end retainers may immobilize the manipulator relative to the fixture or the patient's body. The outer layer of the pipeline is protected to be soft, and the loss of natural cavities and ducts is avoided; the inner layer is smooth, and the catheter can conveniently enter a natural cavity.

By adopting the scheme provided by the invention, the natural orifice can be accurately and controllably retracted when the natural orifice needs to be retracted in an operation, the operation is convenient to carry out, and the pulling loss of the natural orifice is reduced.

The invention has the significance that the natural orifice can be accurately and controllably retracted when the natural orifice needs to be retracted in an operation.

In atrial fibrillation ablation procedures, for example, an atrioesophageal fistula is a fatal complication. Documents have demonstrated that when the oesophagus can be retracted exactly over 2cm from the heart margin, it is possible to avoid atrial oesophageal fistulas. The present invention can eliminate one of the fatal complications of this procedure. In addition, it has been documented that it can improve the intraoperative efficiency and postoperative success rate of the physician.

In order to make the aforementioned objects, features and embodiments of the present invention more comprehensible, the following detailed description of the structural design and operational procedures of the present invention is provided in conjunction with the accompanying drawings.

Drawings

in order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.

FIG. 1 is a schematic 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 pull axial translation manipulator.

Fig. 4 is a schematic view of the internal structure of fig. 3.

Fig. 5 is a schematic drawing of the profile of a pull axial travel manipulator.

Fig. 6 is a schematic diagram of an external structure of a rotary axial moving manipulator.

Fig. 7 is a schematic view of the internal structure of the rotary axial translation manipulator.

Fig. 8 is a schematic view of the profile of a rotary axial translation manipulator.

Reference numbers in the figures: 1. balloon catheter, 2 protective tubing, 3 manipulator, 5 controller, 11 multi-lumen tube, 12 anchoring balloon, 13 bending balloon, 14 braided tube, 15 linear sliding handle, 31 pair lock, 32 spring, 33 spring stopper, 34 shell, 35 main rotating shaft, 36 top cover, 37 sliding button, 38 fastening screw, 51 manipulator shell upper half, 52 cover, 53 spring, 54 follower, 55 through hole stepped shaft, 56 fastening screw

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. The components of 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 present invention, 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 derived by a person skilled in the art from the embodiments of the present invention without making any creative effort, shall fall within the protection scope of the present invention.

the present invention is further described in detail below with reference to the drawings so that those skilled in the art can implement the invention with reference to the description.

referring first to fig. 1, fig. 1 is a schematic view of the present invention, and one embodiment of the present invention includes a balloon catheter 1, a protection tube 2 and a manipulator 3. The protection pipeline 2 is sleeved outside the balloon catheter 1, one end of the balloon catheter 1 is fixedly connected with one end of the controller 3 relatively, the other end of the protection pipeline 2 is fixedly connected with the other end of the controller 3 relatively, and the relative motion between the balloon catheter 1 and the protection pipeline 2 is controlled by the controller 3.

Referring next to fig. 2, fig. 2 is a schematic view of the balloon catheter 1, in which the multi-lumen tube 11 extends through the entire balloon catheter 1, the anchoring balloon 12 is located at the distal end of the balloon catheter 1, and the distal end of the balloon catheter 1 is fixed relative to the natural orifice by inflation. The bending balloon 13 is adjacent to the anchoring balloon 12 and is a core traction component, and the core traction component is expanded and bent after being inflated so as to achieve the purpose of pulling open the natural orifice. The braided tube 14 covers the balloon catheter 1, and the two parts are bonded by glue or welded to ensure tight nesting. The braided tube 14 allows uniform torque transmission throughout the catheter so that the balloon catheter 1 rotates at a uniform angle for each cross-section. The linear sliding handle 15 is tightly connected with the braided tube 14, and the linear sliding handle 15 is connected with the manipulator 3 in a matching way, namely the linear sliding handle 15 can slide in the manipulator 3 along the axial direction of the catheter. The tee is connected to the multi-lumen tube 11, one lumen of the tee is connected to one lumen of the multi-lumen tube 11, and this lumen is connected to the lumen of the anchoring balloon 12, and the other lumen of the tee is connected to another independent lumen of the multi-lumen tube 11 and to the lumen of the bending balloon 13. The pressure pump can fill the anchoring balloon 12 and the bending balloon 13 by respectively filling liquid through two cavities of the tee joint.

Fig. 3 is a schematic view showing an external structure of a withdrawn axial-type manipulator, and fig. 4 is a schematic view showing an internal structure of fig. 3, in which a main spindle 35 extends through the entire manipulator 3, and a top cover 36 is connected to proximal ends of the main spindle 35 and has a through hole at its center, and the through hole is engaged with a linear slide handle 15. The cap 36 has a threaded hole for receiving a set screw 56. The linear slide handle 15 is freely slidable in the through hole, and after sliding to a target position, the position of the linear slide handle 15 is locked by rotating the set screw 56. One edge of the counter lock 31 cooperates with a groove in the housing so that the counter lock 31 can slide in the axial direction of the device. When the pair of latches 31 is slid proximally by an external force, the pair of latches 31 compress the spring and disengage from the main shaft 35. The main shaft 35, the top cover 36 and the linear sliding handle 15 can be rotated together. When the force on the lock 31 is removed, the compressed spring pushes the lock 31 distally, and the ramp on the lock 31 drives the ramp on the main shaft 35 to eventually re-engage the lock 31 with the main shaft 35. In the engaged state, the main shaft 35, the top cover 36 and the linear sliding handle 15 cannot rotate.

Fig. 5 is a schematic drawing of the profile of a pull axial travel manipulator. The holders 41 are mounted at both ends of the manipulator 3 to allow the manipulator 3 to be fixed to a fixture or a patient's body. 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 diagram of an external structure of a rotary axial moving manipulator. Of which 51 is the upper housing half of the manipulator 3.

Fig. 7 is a schematic view of the internal structure of the rotary axial translation manipulator. The through hole stepped shaft 55 is provided with a gear, and the through hole is engaged with the linear slide handle 15, and the linear slide handle 15 can freely slide in the through hole, and after the target position is slid, the position of the linear slide handle 15 is locked by rotating the set screw 56. A 0-360 degree scale is marked on one circle of the maximum outer diameter shaft of the through hole stepped shaft 55 with the gear. The follower 54 is placed through the outer opening in the upper half of the housing, the spring is placed through the outer opening in the upper half of the housing with one end of the spring abutting the follower 54, and finally the outer opening in the upper half of the housing is sealed with the cover 52. When the external force is applied at this time, the geared through-hole stepped shaft 55 or the linear slide handle 15 rotates together. When the driven part 54 rotates to a certain angle, the driven part 54 is upwards forced by the radial force of the through hole stepped shaft 55 with the gear, and the spring is contracted by the radial force of the driven part 54; after the driven member 54 rotates a certain angle, the driven member 54 and the spring will return to the original state to perform self-locking after the driven member 54 does not receive the radial force of the through hole stepped shaft 55 with the gear.

Fig. 8 is a schematic view of the profile of a rotary axial translation manipulator. In which holders 41 are mounted at both ends of the manipulator 3 to allow the manipulator 3 to be fixed to a fixture or a patient's body.

The following is an example of a specific application of the present invention: the protective pipeline 2 firstly enters a natural cavity of a target; after the balloon catheter 1 passes through the controller 3, the balloon catheter 1 and the controller 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 move along the axial direction by adjusting the linear sliding handle 15; through image observation, when the balloon catheter 1 reaches the expected position, the axial position of the balloon catheter 1 is fixed by rotating the set screw 38; sliding the slide button 37 to slide the lock 31 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 the desired direction, and releasing the slide button 37 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 far end of the balloon catheter 1 and the natural orifice are fixed; then the curved balloon 13 is inflated through the tee 16, so that the balloon catheter 1 can retract the natural orifice in an expected direction.

The following is another example of a specific application: firstly, the 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 orifice 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; through image observation, when the balloon catheter 1 reaches an expected position, the axial position of the balloon catheter 1 is fixed by rotating the set screw 56; the through hole stepped shaft 55 with the gear or the linear sliding handle 15 rotates for a certain angle to drive the bending direction of the balloon catheter 1 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 far end of the balloon catheter 1 and the natural orifice are fixed; then the curved balloon 13 is inflated through the tee 16, so that the balloon catheter 1 can retract the natural orifice in an expected direction.

The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present invention, and all the changes or substitutions should be covered within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.