CN117379673A - Balloon dilation catheter and vascular intervention system - Google Patents

Abstract

The application relates to a balloon dilation catheter and a vascular intervention system. The balloon dilation catheter comprises: the device comprises an outer tube, an inner tube, a balloon, a traction wire and a bending adjusting mechanism; the inner tube is penetrated through the outer tube at intervals, and the distal end of the inner tube extends out of the distal end of the outer tube; the balloon is sleeved on the part of the inner tube extending out of the distal end of the outer tube, the distal end of the balloon is connected with the distal end of the inner tube, and the proximal end of the balloon is connected with the distal end of the outer tube; the traction wire penetrates through the space between the inner tube and the outer tube, the distal end of the traction wire extends out of the distal end of the outer tube and is connected with the distal end of the inner tube, and the proximal end of the traction wire extends out of the proximal end of the outer tube and is connected with the bending adjusting mechanism; the bending adjusting mechanism is arranged at the proximal end of the outer tube and/or the inner tube and is used for pulling or releasing the traction wire so that the distal end of the traction wire drives the distal end of the inner tube and the balloon to adjust the bending angle. The bending angle is adjusted through the bending adjusting mechanism, so that the balloon after pressurizing and expanding is well matched with the inner wall of the bending and shaping section. Thus, the balloon can be fully contacted with the guide wire, and a reliable anchoring effect is achieved.

Description

Balloon dilation catheter and vascular intervention system

Technical Field

The application relates to the technical field of medical instruments, in particular to a balloon dilation catheter and a vascular intervention system.

Background

Coronary heart disease (Coronary heart disease, CHD) has become a major health problem in the current society, percutaneous coronary intervention (Percutaneous coronary intervention, PCI) is a very common coronary artery disease blood vessel reconstruction technique, and has become an important means for coronary heart disease treatment due to small trauma and high success rate. The amount of PCI surgery performed in china increases from 75.31 ten thousand zone in 2017 to 96.87 ten thousand zone in 2020, the annual average composite growth rate reaches 8.75%, and 2022 will increase to 143.58 ten thousand zone. Physicians often need to exchange multiple interventional devices during complex PCI procedures.

In the process of retracting the interventional device, the interaction force between the guide wire and the interventional device is likely to cause the guide wire to shift or even withdraw from the lesion position, so that the operation time is further prolonged or the treatment effect is poor. In the past, in order to avoid the occurrence of similar situations, in percutaneous transluminal coronary angioplasty, a pressure pump recoil technique, a guide wire lengthening technique and the like are generally adopted for retraction of an interventional device, but the situations such as difficult operation and the like may occur; still other technical solutions employ balloon dilation catheters, which are inflated to press a guide wire against the inner wall of the guide catheter, thereby realizing the anchoring of the guide wire and making the exchange of the interventional device more convenient.

In the PCI operation process, the guiding catheter is used as a passage instrument for establishing a blood vessel, and in order to achieve better butt joint effect with the coronary artery, the distal end of the guiding catheter often has bending shaping sections with different angles. Because the main body of the balloon is a straight section, the angle of the straight section and the angle of the bending shaping section are not adapted, so that the straight section of the balloon cannot be fully expanded after the balloon is expanded at low pressure, the balloon cannot be fully contacted with the guide wire, and the anchoring effect is poor; the balloon has stronger rigidity in the straight section after high-pressure expansion, and is easy to damage the bending molding section, thereby increasing the operation risk. In addition, due to the fact that the angle of the straight section and the bending section of the balloon is not matched, certain resistance exists when the balloon passes through the bending section; moreover, the balloon is left in the curved shaping section, and the contact surface with the interventional device to be exchanged is increased due to the fact that the angle between the balloon and the curved shaping section is not matched, so that the exchange resistance is increased.

Disclosure of Invention

In view of the foregoing, it is desirable to provide a balloon dilation catheter and a vascular interventional system that address at least one of the above-described problems.

A balloon dilation catheter, the balloon dilation catheter comprising: the device comprises an outer tube, an inner tube, a balloon, a traction wire and a bending adjusting mechanism;

the inner tube is penetrated through the outer tube at intervals, and the distal end of the inner tube extends out of the distal end of the outer tube;

the balloon is sleeved on the part, extending out of the distal end of the outer tube, of the inner tube, the distal end of the balloon is in sealing connection with the distal end of the inner tube, and the proximal end of the balloon is in sealing connection with the distal end of the outer tube;

the traction wire penetrates through the space between the inner tube and the outer tube, the distal end of the traction wire extends out of the distal end of the outer tube and is connected with the distal end of the inner tube, and the proximal end of the traction wire extends out of the proximal end of the outer tube and is connected with the bending mechanism;

the bending adjusting mechanism is arranged at the proximal end of the outer tube and/or the inner tube and is used for pulling or releasing the traction wire so that the distal end of the traction wire drives the distal end of the inner tube and the balloon to adjust the bending angle.

In one embodiment, the balloon dilation catheter comprises a locking mechanism, wherein the locking mechanism has a locking state and an unlocking state, and the locking mechanism can enable the inner wall of the outer tube to be clung to the outer wall of the inner tube when in the locking state; the locking mechanism allows a space between the inner wall of the outer tube and the outer wall of the inner tube when in the unlocked state.

In an embodiment, the locking mechanism comprises a surrounding part and a locking part, the surrounding part is arranged on the periphery of the outer tube in a surrounding mode, the surrounding part is provided with a first end and a second end which are opposite in the circumferential direction, and the first end and the second end are provided with a first relative position relatively close to each other and a second relative position relatively far away from each other; when the locking mechanism is in the locking state, the locking part can lock the first end and the second end at a first relative position so that the surrounding part can hold the outer tube tightly; the locking mechanism is in the released state, the locking portion allowing the first end and the second end to be in the second relative position.

In an embodiment, the locking mechanism comprises a first portion and a second portion, the first portion is arranged on the outer wall of the inner tube, the second portion is arranged on the outer wall of the outer tube, and the first portion has a first position and a second position along the radial direction of the outer tube from outside to inside; the locking mechanism is in the locked state, the first portion is locked with the second portion in the first position, and the second portion allows the first portion to be in the second position when the locking mechanism is in the unlocked state.

In one embodiment, the wall of the inner tube positioned in the balloon is provided with a liquid through hole.

In an embodiment, the bending mechanism comprises a base body and a rotating part, wherein the base body is arranged at the proximal end of the outer tube and/or the inner tube, the rotating part is rotationally connected with the base body, and the proximal end of the traction wire is connected with the rotating part.

In one embodiment, the base is provided with a gripping structure.

In an embodiment, the proximal end of the inner tube extends out of the proximal end of the outer tube, and the bending adjustment mechanism is sleeved on the portion of the inner tube extending out of the proximal end of the outer tube and can adjust the angle around the inner tube.

In one embodiment, the balloon dilation catheter further comprises a stop collar positioned inside the balloon and fixed to the outer wall of the inner tube, and the traction wire passes through the stop collar.

In one embodiment, the balloon dilation catheter further comprises a visualization structure positioned inside the balloon and disposed within the inner tube.

In an embodiment, the middle section of the side wall of the balloon is alternately provided with a concave structure and a convex structure along the axial direction.

In one embodiment, the portion of the inner tube disposed within the balloon is threaded.

In an embodiment, two groups of traction wires are symmetrically arranged on two sides of the axis of the inner tube, and at least one traction wire is arranged in a single group.

A vascular interventional system comprising a guide catheter, a guidewire, and the balloon dilation catheter of any one of the preceding embodiments; the distal end of the guiding catheter is provided with a bending shaping section, and the balloon is used for pressing the guide wire on the inner wall of the bending shaping section; the bending mechanism can adjust the bending angle of the balloon to be matched with the bending shaping section.

The balloon dilation catheter and the vascular intervention system are positioned in the guide catheter during use, when the balloon reaches the bending shaping section, the balloon is in an unpressurized state, the proximal ends of the outer tube and the inner tube are kept motionless, the traction wire is pulled or released through the bending adjusting mechanism, so that the distal end of the traction wire is driven to move, the distal end of the traction wire drives the distal end of the inner tube to bend, and then the distal end of the inner tube and the balloon sleeved on the distal end of the inner tube are bent together. The bending angle is adjusted through the bending adjusting mechanism, so that the bending angle of the distal end of the inner tube and the saccule is matched with the bending angle of the bending shaping section of the guiding catheter. At this time, the balloon is pressurized to expand, so that the balloon after being pressurized and expanded can be well matched with the inner wall of the bending and shaping section in shape and size. Therefore, the saccule can be fully contacted with the guide wire, the guide wire is reliably pressed on the inner wall of the bending molding section, and a reliable anchoring effect is achieved; moreover, the bending molding section is not easy to damage, and the operation risk is reduced. In addition, the bending angle of the balloon is adjusted to be matched with the bending molding section through the bending adjusting mechanism when the balloon is in an unpressurized state, so that the passing resistance can be reduced when the balloon passes through the bending molding section. Moreover, as the bending angle of the balloon is matched with and fully contacted with the bending molding section, the contact between the interventional device to be exchanged and the balloon can be reduced as much as possible, and the exchange resistance is reduced.

Drawings

Fig. 1 is a schematic structural view of a balloon dilation catheter of an embodiment.

Fig. 2 is a schematic view of the balloon dilation catheter of fig. 1 anchoring a guidewire in a guiding catheter and retracting an interventional device.

Fig. 3 is a schematic view of the distal end of the balloon dilation catheter of fig. 1.

Fig. 4 is a schematic structural view of a bending mechanism of the balloon dilation catheter of fig. 1.

Fig. 5 is a schematic view of the locking mechanism of the balloon dilation catheter of fig. 1 in a locked state.

Fig. 6 is a schematic view of the locking mechanism of the balloon dilation catheter of fig. 1 in an unlocked state.

Reference numerals illustrate:

10. a guiding catheter; 11. bending the shaping section; 20. a guide wire; 30. an interventional device;

100. an outer tube;

200. an inner tube; 210. a liquid port; 220. a flexible tip;

300. a balloon; 310. a recessed structure; 320. a protruding structure;

400. traction wire;

500. a bending adjusting mechanism; 510. a base; 511. a grip structure; 520. a rotating part; 521. an operation unit;

600. a locking mechanism; 610. a surrounding part; 611. a first end; 612. a second end; 620. a locking part; 621. a first locking hook; 622. A second locking hook;

700. an infusion connector; 710. A sheath;

800. a limiting ring;

900. developing the structure.

Detailed Description

In order to make the above objects, features and advantages of the present application more comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. This application is, however, susceptible of embodiment in many other forms than those described herein and similar modifications can be made by those skilled in the art without departing from the spirit of the application, and therefore the application is not to be limited to the specific embodiments disclosed below.

In the description of the present application, it should be understood that, if there are terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., these terms refer to the orientation or positional relationship based on the drawings, which are merely for convenience of description and simplification of description, and do not indicate or imply that the apparatus or element referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present application.

Furthermore, the terms "first," "second," and the like, if any, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present application, the terms "plurality" and "a plurality" if any, mean at least two, such as two, three, etc., unless specifically defined otherwise.

In this application, unless explicitly stated and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly. For example, the two parts can be fixedly connected, detachably connected or integrated; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the terms in this application will be understood by those of ordinary skill in the art as the case may be.

In this application, unless expressly stated or limited otherwise, the meaning of a first feature being "on" or "off" a second feature, and the like, is that the first and second features are either in direct contact or in indirect contact through an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that if an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. If an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein, if any, are for descriptive purposes only and do not represent a unique embodiment.

Referring to fig. 1-2, during a PCI procedure, the guide catheter 10 is used as a vascular access device, and a curved shaping segment 11 with different angles is often arranged at the distal end of the guide catheter to achieve better interface with the coronary artery. An embodiment of the present application provides a balloon dilation catheter that may be used to access the guide catheter 10, with the inflation of the balloon 300 pressing the guidewire 20 against the inner wall of the guide catheter 10, enabling anchoring of the guidewire 20 for exchange of the interventional device 30.

With reference to fig. 1 to 5, a balloon dilation catheter of an embodiment of the present application includes: outer tube 100, inner tube 200, balloon 300, traction wire 400, and bend adjustment mechanism 500. The inner tube 200 is inserted through the outer tube 100 at a spaced apart interval, so that a gap is provided between the inner tube 200 and the outer tube 100. The distal end of the inner tube 200 extends beyond the distal end of the outer tube 100. Balloon 300 is sleeved on the portion of inner tube 200 extending out of the distal end of outer tube 100, and the distal end of balloon 300 is in sealing connection with the distal end of inner tube 200, and the proximal end of balloon 300 is in sealing connection with the distal end of outer tube 100. The traction wire 400 is penetrated in the gap between the inner tube 200 and the outer tube 100. And the distal end of the pull wire 400 extends beyond the distal end of the outer tube 100 and is connected to the distal end of the inner tube 200, and the proximal end of the pull wire 400 extends beyond the proximal end of the outer tube 100 and is connected to the bending mechanism 500. The bending mechanism 500 is disposed at the proximal end of the outer tube 100 and/or the inner tube 200, and the bending mechanism 500 may be disposed at the proximal end of the outer tube 100, at the proximal end of the inner tube 200, or at both the proximal ends of the outer tube 100 and the inner tube 200. The bending adjustment mechanism 500 is used for pulling or releasing the traction wire 400, so that the distal end of the traction wire 400 drives the distal end of the inner tube 200 and the balloon 300 to adjust the bending angle.

When the balloon dilation catheter is used, the balloon dilation catheter is positioned in the guiding catheter 10, and when the balloon 300 reaches the bending shaping section 11, the balloon 300 is in an unpressurized state, the proximal ends of the outer tube 100 and the inner tube 200 are kept motionless, the traction wire 400 is pulled or released through the bending adjusting mechanism 500, so that the distal end of the traction wire 400 is driven to move, the distal end of the traction wire 400 drives the distal end of the inner tube 200 to bend, and then the distal end of the inner tube 200 and the balloon 300 sleeved at the distal end of the inner tube 200 are bent together. The bending angle is adjusted by the bending adjustment mechanism 500 such that the bending angle of the distal end of the inner tube 200 and the balloon 300 is adapted to the bending angle of the curved shaping section 11 of the guiding catheter 10. At this time, the balloon 300 is inflated again to expand, so that the inflated and expanded balloon 300 can be well adapted to the shape and size of the inner wall of the curved shaping section 11. In this way, the balloon 300 can fully contact with the guide wire 20, reliably press the guide wire 20 on the inner wall of the bending section 11, and achieve a reliable anchoring effect; moreover, the curved molding section 11 is not easily damaged, reducing the risk of surgery. In addition, since the bending angle of the balloon 300 is adjusted to fit the bending section 11 by the bending mechanism 500 in the non-pressurized state, the passing resistance can be reduced when passing through the bending section 11. Moreover, since the bending angle of the balloon 300 is adapted to and sufficiently contacts the curved molding segment 11, contact between the interventional device 30 to be exchanged and the balloon 300 can be minimized, thereby reducing exchange resistance.

It will be appreciated that the inner tube 200 is bent to one side (referred to as a bending side) by the traction wire 400. During the bending process, the wall of the inner tube 200 facing away from the bending side is closely attached to the inner wall of the outer tube 100, and a space is left between the wall of the inner tube 200 adjacent to the bending side and the outer tube 100.

Referring to fig. 3, in an embodiment, a tube wall of the inner tube 200 inside the balloon 300 is provided with a fluid port 210, so that the inner tube 200 communicates with the balloon 300. Thus, pressure may be increased or decreased from the proximal end of inner tube 200 into balloon 300. Specifically, fluid may be introduced from the proximal end of inner tube 200, and fluid may be introduced into balloon 300 through port 210, thereby inflating balloon 300. Conversely, when pressure is required to be released from the balloon 300, liquid can be extracted from the proximal end of the inner tube 200, so that the liquid in the balloon 300 enters the inner tube 200 through the liquid port 210, and the balloon 300 is released and contracted.

Referring to fig. 1, in one embodiment, the balloon dilation catheter further comprises an infusion connector 700, one end of the infusion connector 700 being connected to and in communication with the proximal end of the inner tube 200, and fluid may be fed or withdrawn from the proximal end of the inner tube 200 through the infusion connector 700.

Referring to FIG. 1, in one embodiment, a sheath 710 is sleeved over the connection between the infusion set 700 and the proximal end of the inner tube 200 to reduce stress concentrations at the connection between the infusion set 700 and the proximal end of the inner tube 200.

In other embodiments, the wall of the inner tube positioned in the balloon is not provided with a liquid through hole, but the infusion connector is connected with the wall of the outer tube, so that a gap between the outer tube and the inner tube is communicated with the infusion connector, and the balloon can be pressurized or depressurized through the infusion connector through the gap between the outer tube and the inner tube.

As previously described, the bending angle is adjusted by the bending mechanism 500 such that the bending angle of the distal end of the inner tube 200 and the balloon 300 is adapted to the bending angle of the curved shaping section 11 of the guiding catheter 10. Balloon 300 is then inflated to expand and anchor guidewire 20. To avoid fluid from flowing from balloon 300 into the gap between outer tube 200 and inner tube 100 during inflation of balloon 300, fluid is lost through the proximal end of the gap between outer tube 200 and inner tube 100, resulting in an inability of balloon 300 to expand steadily. Referring to fig. 1, in one embodiment, the balloon dilation catheter comprises a locking mechanism 600, the locking mechanism 600 having a locked state and an unlocked state, the locking mechanism 600 being capable of bringing the inner wall of the outer tube 100 into close contact with the outer wall of the inner tube 200 when in the locked state. The locking mechanism 600 allows a space between the inner wall of the outer tube 100 and the outer wall of the inner tube 200 when in the unlocked state.

In this embodiment, after the bending angle of the inner tube 200 and the balloon 300 is adjusted by the bending adjustment mechanism 500, the inner wall of the outer tube 100 and the outer wall of the inner tube 200 can be tightly attached by the locking state of the locking mechanism 600, so that the circulation of the gap between the outer tube 100 and the inner tube 200 can be blocked, even if a small amount of liquid in the balloon 300 enters the gap between the outer tube 100 and the inner tube 200, the liquid cannot flow away from the distal end of the gap between the outer tube 100 and the inner tube 200, and the balloon 300 can be stably expanded and kept in the expanded state. Moreover, after the bending angles of the inner tube 200 and the balloon 300 are adjusted by the bending adjustment mechanism 500, the inner wall of the outer tube 100 is tightly attached to the outer wall of the inner tube 200 by the locking state of the locking mechanism 600, so that the inner wall of the outer tube 100 and the outer wall of the inner tube 200 can clamp the traction wire 400 to play a role of wire locking, and the traction wire 400 is locked, namely, the bending angle of the balloon 300 is also locked, so that the balloon 300 can be stably positioned at an angle matched with the bending shaping section 11.

It should be noted that, the outer tube 100 and the inner tube 200 may be made of a material having a certain elasticity, and thus, the outer tube 100 and the inner tube 200 may be switched between the close-contact state and the spaced-apart state by a certain elastic deformation.

It will be appreciated that when the bending angle of the inner tube 200 and the balloon 300 is adjusted by the bending adjustment mechanism 500 before the balloon 300 is pressurized, the locking mechanism 600 is in a released state, and a space is provided between the inner wall of the outer tube 100 and the outer wall of the inner tube 200, so as to facilitate the movement of the traction wire 400.

Referring to fig. 5 and 6, in an embodiment, the locking mechanism 600 includes a surrounding portion 610 and a locking portion 620, where the surrounding portion 610 surrounds the outer tube 100, and the surrounding portion 610 has a first end 611 and a second end 612 that are opposite in a circumferential direction, and the first end 611 and the second end 612 have a first relative position relatively close to each other and a second relative position relatively far away from each other.

In the locked state of the locking mechanism 600, the locking portion 620 can lock the first end 611 and the second end 612 in the first relative position, so that the surrounding portion 610 holds the outer tube 100 tightly. Specifically, in the first relative position, the first end 611 and the second end 612 have a smaller distance therebetween, so that the first end 611 and the second end 612 are relatively close to each other, and therefore, the surrounding area of the surrounding portion 610 is smaller, so that the outer tube 100 can be clasped, so that the outer tube 100 clasps the inner tube 200, and the outer tube 100 is tightly attached to the inner wall of the inner tube 200.

The locking mechanism 600 allows the first end 611 and the second end 612 to be in a second relative position when in the unlocked state. Specifically, in the second relative position, the distance between the first end 611 and the second end 612 is relatively increased in the first relative position, so that the two ends are relatively far apart, and thus the surrounding area of the surrounding portion 610 is increased, so that the outer tube 100 can be loosened, and a space is allowed between the inner wall of the outer tube 100 and the outer wall of the inner tube 200.

The locking state and the releasing state of the locking mechanism 600 are adjusted by the locking part 620, and the outer tube 100 is held tightly or released by the enclosing part 610, so that the inner wall of the outer tube 100 and the outer wall of the inner tube 200 can be conveniently adjusted to be switched between close contact and interval.

It should be noted that, the surrounding portion 610 may be made of a material having a certain elasticity, so that the first end 611 and the second end 612 may be switched between the first relative position and the second relative position by elastic deformation, and the surrounding portion 610 may hug or release the outer tube 100.

As shown in fig. 5 and 6, in an embodiment, the locking part 620 includes a first locking hook 621 and a second locking hook 622. The first locking hook 621 is disposed at the first end 611, and the second locking hook 622 is disposed at the second end 612. By hooking the first locking hook 621 and the second locking hook 622, the first end 611 and the second end 612 can be locked in the first relative position. By separating the first locking hook 621 from the second locking hook 622, the first end 611 and the second end 612 are released, so that the first end 611 and the second end 612 can move away from each other and return to the second relative position.

It should be noted that, the first locking hook 621 and the second locking hook 622 may be made of a material having a certain elasticity, and may allow a certain elastic deformation of the two, so that the two can be switched between the hooked and the disengaged state by the elastic deformation.

In other embodiments, the locking mechanism is not limited to the above structure, but may be other forms.

In another embodiment, the locking mechanism comprises a first portion disposed on the outer wall of the inner tube and a second portion disposed on the outer wall of the outer tube, the first portion having a first position and a second position radially inward of the outer tube, i.e., relatively, the outer wall of the inner tube is relatively closer to the inner wall of the outer tube in the first position and the outer wall of the inner tube is relatively farther from the inner wall of the outer tube in the second position. In this embodiment, the outer wall of the inner tube is closely attached to the inner wall of the outer tube when the first portion is in the first position; the first portion is in the second position with the outer wall of the inner tube spaced relative to the inner wall of the outer tube. When the locking mechanism is in a locking state, the first part is locked with the second part at the first position, so that the outer wall of the inner tube and the inner wall of the outer tube can be locked in a close fit state. The second portion allows the first portion to be in a second position, i.e., allows the outer wall of the inner tube to be in a spaced apart relationship with the inner wall of the outer tube, when the locking mechanism is in the unlocked condition.

Specifically, the first portion can be the screw rod, and the second portion is the nut, and the nut rotates to set up on the outer tube, can rotate the nut, through the position of screw drive adjustment screw rod to make the screw rod switch in first position and second position, and then drive the outer wall of inner tube and hug closely the inner wall of outer tube, perhaps make the outer wall of inner tube keep away from the inner wall of outer tube in order to keep the interval.

In other embodiments, the first and second portions may also be snap-fit components.

Referring to fig. 1 and 4, in an embodiment, the bending mechanism 500 includes a base 510 and a rotating portion 520, the base 510 is disposed at a proximal end of the outer tube 100 and/or the inner tube 200, and the rotating portion 520 is rotatably connected to the base 510. The proximal end of the pull wire 400 is connected to a rotating portion 520.

Since the base 510 is disposed at the proximal end of the outer tube 100 and/or the inner tube 200, the base 510 is immobilized while the proximal end of the outer tube 100 and/or the inner tube 200 is kept stationary, so that the rotating portion 520 can pull or release the proximal end of the traction wire 400 connected thereto and further pull or release the distal end of the traction wire 400 when rotating relative to the base 510, thereby adjusting the bending angle of the balloon 300.

As shown in fig. 1, in one embodiment, the rotating portion 520 is rotatably connected to the base 510 about an axis in a first direction perpendicular to the axial direction of the outer tube 100.

Referring to fig. 4, in one embodiment, the base 510 is provided with a holding structure 511 to facilitate the holding of an operator, so that the operator can hold the base 510 with one hand and rotate the rotating portion 520 with the other hand. The gripping structures 511 are, for example, gripping holes that allow for the insertion of fingers for gripping.

Referring to fig. 4, in an embodiment, the rotating portion 520 is provided with an operating portion 521, and an operator can rotate the rotating portion 520 by rotating the operating portion 521 around the base 510, so as to facilitate operation.

Referring to fig. 1, in an embodiment, the proximal end of the inner tube 200 extends out of the proximal end of the outer tube 100, and the bending adjustment mechanism 500 can adjust the angle around the inner tube 200, so that the bending direction of the balloon 300 can be adjusted around the inner tube 200, so that the bending adjustment of the balloon 300 is more flexible.

Specifically, the base 510 is sleeved on a portion of the inner tube 200 extending out of the proximal end of the outer tube 100 and can be adjusted in angle around the inner tube 200, so that the writing portion 510 can be carried around the inner tube 200 in angle.

The matrix 510 may be disposed between the proximal end of the outer tube 100 and the distal end of the sheath 710.

In other embodiments, the base may be a portion of the inner tube that extends beyond the proximal end of the outer tube.

Referring to fig. 3 and 4, in one embodiment, two sets of traction wires 400 are symmetrically disposed on both sides of the axis of the inner tube 200. At least one, such as one, two, three, etc., of the number of individual sets of traction wires 400. When one group of traction wires 400 is pulled by the bending adjustment mechanism 500, the other group of traction wires 400 is released at the same time, so that the balloon 300 can be bent towards the side where the pulled traction wires 400 are located.

In particular, when two sets of traction wires 400 are connected to the rotating portion 520, they may equally be symmetrically around the rotating portion 520. When the rotating part 520 rotates, one set of traction wires 400 can be pulled while the other set of traction wires 400 is released.

Referring to fig. 3, in one embodiment, the balloon dilation catheter further comprises a stop collar 800, the stop collar 800 being located inside the balloon 300 and secured to the outer wall of the inner tube 200, the pull wire 400 passing through the stop collar 800. Because the inner space of the balloon 300 is larger, the traction wire 400 can be limited at the radial position of the inner tube 200 by making the traction wire 400 pass through the limiting ring 800, which is beneficial for the traction wire 400 to reliably drive the distal end of the inner tube 200 and the balloon 300 to bend.

Referring to fig. 3, in an embodiment, the balloon dilation catheter further includes a developing structure 900, wherein the developing structure 900 is located inside the balloon 300 and is disposed on the inner tube 200, and the inner tube 200 and the balloon 300 are conveniently observed in a bending state under X-rays through the developing structure 900.

Referring to fig. 3, in an embodiment, the middle section of the side wall of the balloon 300 is alternately provided with the concave structures 310 and the convex structures 320 along the axial direction, so that the balloon 300 is easy to bend under the action of the traction wire 400, and the bending angle of the balloon 300 is convenient to adjust. The concave structures 310 and the convex structures 320 alternately arranged in sequence may constitute a zigzag-like or wave-like structure.

The depth of the concave structures 310 is preferably 0.18-0.36 mm, so that a better bending effect of the balloon 300 can be realized, and the guiding catheter 10 can be more fitted.

In an embodiment, the portion of the inner tube 200 disposed in the balloon 300 is provided with threads to increase flexibility, so that the inner tube 200 is easy to bend under the action of the traction wire 400, and the bending angle is convenient to adjust.

In one embodiment, the balloon 300 material is preferably an elastic material such as elastic polyurethane, polyether block polyamide, silicone, or the like. The material has higher flexibility and larger surface friction coefficient, and is beneficial to improving the effect of the anchoring guide wire 20.

In one embodiment, the balloon dilation catheter further includes a flexible tip 220, the flexible tip 220 being secured to the distal end of the inner tube 200, and the flexible tip 220 being more flexible than the distal end of the inner tube 200. By providing the flexible tip 220 at the distal end of the inner tube 200, it is easy to pass through tortuous vessels and is less prone to stabbing the vessel walls.

In one embodiment, the distal end of the pull wire 400 may be secured to the flexible tip 220 so as to be indirectly disposed at the distal end of the inner tube.

In other embodiments, the distal end of the traction wire may not be disposed at the flexible tip, for example, may be disposed at the portion of the inner tube within the balloon, or may be disposed on the visualization structure.

In one embodiment, the traction wire 400 may be made of a metal material with good bending performance, such as nickel-titanium alloy, and may be connected and fixed with the flexible tip 220, the developing structure or the inner tube by laser welding, glue bonding, etc.

An embodiment of the present application also provides a vascular interventional system comprising a guide catheter 10 and a balloon dilation catheter of any of the embodiments described above. The distal end of the guiding catheter 10 has a curved shaping section 11. The balloon 300 is used to compress the guidewire 20 against the inner wall of the curved shaping section 11. The bending adjustment mechanism 500 is used for pulling or releasing the traction wire 400, so that the distal end of the traction wire 400 drives the distal end of the inner tube 200 and the balloon 300 to adjust the bending angle, and the bending angle of the balloon 300 is adjusted to be matched with the bending angle of the bending shaping section 11.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples only represent a few embodiments of the present application, which are described in more detail and are not to be construed as limiting the scope of the claims. It should be noted that it would be apparent to those skilled in the art that various modifications and improvements could be made without departing from the spirit of the present application, which would be within the scope of the present application. Accordingly, the scope of protection of the present application is to be determined by the claims appended hereto.

Claims (14)

1. A balloon dilation catheter, the balloon dilation catheter comprising: the device comprises an outer tube, an inner tube, a balloon, a traction wire and a bending adjusting mechanism;

the inner tube is penetrated through the outer tube at intervals, and the distal end of the inner tube extends out of the distal end of the outer tube;

the balloon is sleeved on the part, extending out of the distal end of the outer tube, of the inner tube, the distal end of the balloon is in sealing connection with the distal end of the inner tube, and the proximal end of the balloon is in sealing connection with the distal end of the outer tube;

the traction wire penetrates through the space between the inner tube and the outer tube, the distal end of the traction wire extends out of the distal end of the outer tube and is connected with the distal end of the inner tube, and the proximal end of the traction wire extends out of the proximal end of the outer tube and is connected with the bending mechanism;

the bending adjusting mechanism is arranged at the proximal end of the outer tube and/or the inner tube and is used for pulling or releasing the traction wire so that the distal end of the traction wire drives the distal end of the inner tube and the balloon to adjust the bending angle.

2. The balloon dilation catheter according to claim 1 comprising a locking mechanism having a locked state and an unlocked state, the locking mechanism enabling the inner wall of the outer tube to be in close proximity to the outer wall of the inner tube when in the locked state; the locking mechanism allows a space between the inner wall of the outer tube and the outer wall of the inner tube when in the unlocked state.

3. The balloon dilation catheter according to claim 2 wherein the locking mechanism comprises a surrounding portion and a locking portion, the surrounding portion surrounding the outer tube, the surrounding portion having circumferentially opposed first and second ends, the first and second ends having a first relative position relatively close to each other and a second relative position relatively far from each other; when the locking mechanism is in the locking state, the locking part can lock the first end and the second end at a first relative position so that the surrounding part can hold the outer tube tightly; the locking mechanism is in the released state, the locking portion allowing the first end and the second end to be in the second relative position.

4. The balloon dilation catheter of claim 2 wherein the locking mechanism comprises a first portion disposed on an outer wall of the inner tube and a second portion disposed on an outer wall of the outer tube, the first portion having a first position and a second position radially inward of the outer tube; the locking mechanism is in the locked state, the first portion is locked with the second portion in the first position, and the second portion allows the first portion to be in the second position when the locking mechanism is in the unlocked state.

5. The balloon dilation catheter according to claim 1 wherein a wall of the inner tube within the balloon is provided with a fluid port.

6. The balloon dilation catheter according to claim 1 wherein the deflection mechanism comprises a base disposed at a proximal end of the outer tube and/or the inner tube and a rotating portion rotatably connected to the base, the proximal end of the traction wire being connected to the rotating portion.

7. The balloon dilation catheter according to claim 6 wherein the base is provided with a gripping structure.

8. The balloon dilation catheter according to claim 1 wherein the proximal end of the inner tube extends beyond the proximal end of the outer tube and the bending mechanism is sleeved over the portion of the inner tube extending beyond the proximal end of the outer tube and is angularly adjustable about the inner tube.

9. The balloon dilation catheter according to claim 1 further comprising a stop ring located inside the balloon and secured to an outer wall of the inner tube, the pull wire passing through the stop ring.

10. The balloon dilation catheter according to claim 1 further comprising a visualization structure located inside the balloon and disposed within the inner tube.

11. The balloon dilation catheter of claim 1 wherein a mid-section of the sidewall of the balloon is sequentially alternating with concave and convex structures along an axial direction.

12. The balloon dilation catheter according to claim 1 wherein a portion of the inner tube disposed within the balloon is threaded.

13. The balloon dilation catheter of claim 1 wherein the inner tube is symmetrically disposed on both sides of the axis of the inner tube with two sets of the traction wires, at least one of the number of traction wires in a single set.

14. A vascular interventional system comprising a guide catheter and the balloon dilation catheter of any one of claims 1-13; the distal end of the guiding catheter is provided with a bending shaping section, and the balloon is used for pressing the guide wire on the inner wall of the bending shaping section; the bending mechanism can adjust the bending angle of the balloon to be matched with the bending shaping section.