CN118924381A - Multistage thrombus clearing device - Google Patents

Abstract

A multi-stage thrombi removal device, comprising: the spiral balloon comprises a balloon body and a shaping tube, the spiral diameter of the distal end of the balloon body is larger than that of the proximal end, the whole balloon body is conical, and the balloon body is straight-cylindrical in a straightening state; the shaping tube comprises an inner tube, a spring ring and a developing ring; the part of the shaping tube positioned in the bag body is of a conical spiral structure; the inner tube is a nickel-titanium alloy tube, and the distal end is connected with a TIP head; the spring ring is wound on the inner tube, and the distal end of the spring ring is fixedly connected with the distal end of the inner tube; the developing rings are arranged at two ends of the plastic tube positioned at the capsule body section; the conveying catheter comprises a traction cavity and a filling cavity, and the part of the plastic pipe positioned in the traction cavity is straight; the operating handle comprises a grab handle, a knob, a filling seat and a guide wire seat; the knob comprises a sliding block and a spiral chute, the spiral chute is positioned on the knob, when the knob is rotated, the sliding block is driven to move back and forth through the spiral chute, the inner tube is connected to the sliding block and extends out of the operating handle, and the extending part is connected with the guide wire seat.

Description

Multistage thrombus clearing device

Technical Field

The invention relates to the field of medical instruments, in particular to a multistage thrombus removing device.

Background

Thrombus is easily caused when blood flow of human body is slow, blood vessel wall is damaged, blood is in a hypercoagulable state, and the like. In vascular surgery emergency treatment, a larger part of patients are emergently treated by sudden venous thrombosis or arterial embolism, if the patients are not treated timely, once the embolism time is too long, limb ischemia amputation and even thrombus shedding exist to cause pulmonary embolism risk, and once the pulmonary embolism risk occurs, the pulmonary embolism risk is greatly threatened to property and life safety of people. Current conventional methods for treating acute ischemic stroke include two broad categories, interventional thrombolysis and mechanical thrombolysis.

The interventional thrombolysis is that a catheter injects a thrombolytic machine into the vicinity of a lesion in a blood vessel where the lesion is located, and a very high thrombolytic agent concentration is formed at the local moment of the lesion, thereby accelerating the thrombolysis speed and further increasing the chance of vascular recanalization. For large and long-length thrombi, very large doses of thrombolytic drug are required to dissolve such large clots, but this is likely to cause complications, is at high risk, and often does not achieve the desired effect. Mechanical embolus removal includes thrombectomy, laser thrombolysis, capture embolus removal and capture mesh embolus removal. Thrombectomy is thorough in thrombus removal, but the damage to the vessel wall is excessive, and various complications are easily caused. The laser thrombus breaking operation has high difficulty, the laser energy is low and ineffective, the blood vessel is damaged when the energy is too high, and various complications are also easy to cause. The capture type thrombus taking operation is simple, the damage to the blood vessel wall is small, but the blood clot can not be covered frequently. The operation of capturing net and taking the thrombus is simple, but the capturing net cannot be used in intracranial blood vessels due to the large volume.

The existing Fogarty thrombus taking balloon catheter is a balloon catheter with a closed front end, the balloon is made of latex materials, and two ends of the balloon can be developed. After the balloon enters the target blood vessel, the balloon is filled, the thrombus in the occluded blood vessel is crushed, and the thrombus can be dragged out of the body along with the balloon. However, the diameter of the blood vessel is changed, when the thrombus is taken from the proximal end to the distal end, the diameter of the blood vessel is changed from large to small, the diameter of the balloon is fixed, and when the balloon is pulled to take the thrombus, the damage to the blood vessel at the distal end is larger; when a thrombus is removed from the distal end to the proximal end, the thrombus is not completely removed from the proximal end. And the Fogarty thrombus taking balloon catheter is a single balloon, and only single thrombus taking is carried out when thrombus taking, sometimes the thrombus taking balloon catheter cannot be completely taken, and multiple thrombus taking is possibly required, so that the vascular injury is large.

When a closed long-length thrombus is formed in a blood vessel, the guide wire cannot pass through, and the balloon catheter cannot be conveyed to the distal end of the thrombus through the guide wire. When the vascular stenosis caused by thrombus is severe, the balloon catheter cannot be effectively delivered through the sheath when the sheath cannot pass through.

Therefore, the thrombus taking balloon catheter which can adapt to the change of the diameter of a blood vessel, can achieve the effect of multiple cleaning by single thrombus taking and can pass through a narrow blood vessel channel is required by the current clinic.

Disclosure of Invention

The invention aims to overcome the defects and provide a multi-stage thrombus removal device.

The technical scheme adopted by the invention is as follows:

A multi-stage thrombi removal device, comprising:

The spiral balloon comprises a balloon body and a shaping tube, wherein the spiral diameter of the far end of the balloon body is larger than that of the near end, the balloon body is in a straight cylinder shape in a straightening state, and the spiral diameter is 1-5 times of the diameter of the balloon body in the straight cylinder state; the shaping tube comprises an inner tube, a spring ring and a developing ring; the part of the plastic tube in the bag body is of a conical spiral structure, the plastic tube in the bag body is positioned at the center of the bag body, and the taper is the same as that of the bag body; the inner tube is a nickel-titanium alloy tube, and the distal end is connected with a TIP head; the spring ring is wound on the inner tube, and the distal end of the spring ring is fixedly connected with the distal end of the inner tube; the developing rings are arranged at two ends of the plastic tube, which are positioned at the capsule body section; the conveying catheter comprises a traction cavity and a filling cavity, the traction cavity is used for passing through the plastic pipe, and the part of the plastic pipe, which is positioned in the traction cavity, is straight; the operating handle comprises a grab handle, a knob, a filling seat and a guide wire seat; the knob comprises a sliding block and a spiral chute, the spiral chute is positioned on the knob, when the knob is rotated, the sliding block is driven to move back and forth through the spiral chute, the inner tube is connected to the sliding block and extends out of the operating handle, and the extending part is connected with the guide wire seat; when the knob is rotated, the inner tube pulls the spring ring, at this time, each layer of the spring ring is tightly attached, and tends to be parallel to each other, and the spring ring tends to be flat as a whole.

Preferably, the capsule is a compliant or semi-compliant material.

Preferably, the TIP head is tapered for guiding the spiral balloon.

Preferably, a guide wire hole is arranged on the TIP head.

Preferably, the distal end of the spring coil and the distal end of the inner tube are connected together by welding.

Drawings

FIG. 1 is a multi-stage thrombi removal device, the present invention;

FIG. 2 is a side view of a spiral balloon;

FIG. 3 is a schematic view of a plastic tube 1;

FIG. 4 is a schematic view of a plastic tube 2;

FIG. 5 is a schematic view of a spring coil;

FIG. 6 illustrates a thrombus removal procedure using the present invention;

Fig. 7 shows another embodiment of a spiral balloon.

Detailed Description

Embodiments of the present invention are described in further detail below with reference to the accompanying drawings and examples. The following examples are illustrative of the invention but are not intended to limit the scope of the invention.

A multi-stage thrombi removal device, comprising:

A spiral balloon 100, wherein the spiral balloon 100 has a conical spiral structure. The spiral balloon 100 includes an outer balloon 120, an inner shaping tube 130, and a TIP head 110 at the head end. Balloon 120 has a tapered spiral configuration with a gradually decreasing spiral diameter from distal to proximal, and an overall tapered shape with a tapered tip connected to delivery catheter 200. The bag body 120 is in a straight cylinder shape when being straightened, the diameters of the whole straight cylinders are the same, and the spiral diameter of the bag body 120 is 1-5 times of the diameter of the straight cylinder in the straightened state; balloon 120 is a compliant and semi-compliant balloon with some amount of deformation.

The plastic tube 130 comprises an inner tube 133, a spring ring 134 and developing rings 131 and 132, wherein the part of the plastic tube 130 positioned in the capsule body 120 is in a spiral structure and is in a conical shape as a whole, and the plastic tube 130 of the part is positioned in the center of the capsule body 120, namely the spiral diameter, the interval of each layer of spiral and the taper of the spiral are the same; the inner tube 133 is a nickel titanium alloy tube, the distal end is connected with a TIPS head, and the lumen of the inner tube 133 is mainly used for passing through a guide wire, so that after the guide wire is in place, the spiral balloon can be conveyed in place along the guide wire. The spring ring is wound on the inner tube, the distal end of the spring ring is fixedly connected with the distal end of the inner tube, and the rest parts can slide mutually. The developing rings are arranged at two ends of the plastic tube, which are positioned at the capsule body section, and are used for developing and positioning. When the plastic tube is in a spiral state, a certain gap exists between each layer of the spring ring, and a certain angle exists between each layer of the spring ring, as shown in fig. 4, when the inner tube is pulled, the spring rings are tightened and are in a parallel state, the gap also disappears, at the moment, the plastic tube is in a flat state when seen from the whole, and when the inner tube is loosened, the plastic tube is in a spiral state again.

An inner hole is arranged in the TIP head and is the same as the plastic tube, so that the guide wire can be conveniently inserted. When the thrombus is conveyed, the vascular stenosis is serious due to the thrombus, and when the mode of conveying the spiral balloon to the distal end of the thrombus through the sheath tube is inappropriate, the whole spiral balloon is changed from a spiral shape to a straight shape by stretching the inner tube 133 so as to facilitate conveying through the thrombus stenosis.

The conical spiral saccule can reduce the damage to the blood vessel, and can increase the number of times of thrombus taking, so that the thrombus taking is cleaner without damaging the blood vessel. When the thrombus is removed, the spiral saccule is often placed at a position close to the heart, and when the thrombus is removed, the spiral saccule moves from the position close to the heart to the distal end, at the moment, the diameter of a blood vessel is from large to small, when the spiral saccule is pulled backwards, a part of thrombus is removed by the spiral saccule section with smaller spiral diameter, at the moment, the thrombus with larger diameter is still in the middle of the spiral saccule section, the thrombus remained on the blood vessel wall is further removed by the spiral saccule section with larger diameter, at the moment, if the thrombus remained on the blood vessel wall, the remaining thrombus is removed by the spiral saccule section with larger diameter, so that the thrombus is taken out in sections, and the problem of unclean thrombus is avoided by single thrombus removal; meanwhile, the cross section of the spiral balloon in the straightened state is far smaller than the diameter of a blood vessel, and the damage to the wall of the blood vessel caused by the overlarge diameter of the spiral balloon in the sampling process can be avoided, because when the inner cavity of the blood vessel is smaller, the stress of the spiral balloon is increased, and at the moment, the spiral balloon is axially stretched so as to reduce the cross section diameter of the whole spiral balloon, thereby avoiding the damage to the wall of the blood vessel.

When the device is manufactured, the spring ring 134 is tightly wound on the outer surface of the inner tube 133, then the required spiral structure is formed by molding through a die, then the distal spring ring 134 and the inner tube 133 are fixed together by welding, the proximal end of the spring ring 134 and the inner tube 133 are free to move, but the spring ring 134 needs to be fixed at the distal end of the conveying catheter 2 so as to play a role in fixation.

The conveying catheter 200 is of a double-cavity structure, the conveying catheter 200 is divided into a traction cavity and a filling cavity, the traction cavity is mainly used for enabling the conveying catheter to smoothly slide in the cavity through a plastic pipe 130, the part of the plastic pipe, which is located in the traction cavity, is in a straight shape, and the filling cavity is mainly used for injecting water into the spiral balloon, so that the spiral balloon is expanded and expanded.

An operation handle 300 including a handle grip 310, a knob 320, a filling seat 330, and a guide wire seat 340; a handle grip 310, mainly for holding operation; the knob 320 comprises a sliding block 321 and a spiral chute 322 on the knob, wherein the sliding block 321 is fixedly connected with the inner tube 133, the sliding block 321 and the gear 322 relatively move by rotating the knob 320, so that the inner tube 133 is driven to move forwards or backwards, the inner tube 133 and the sliding block 321 are fixed and simultaneously penetrate through the sliding block and extend out of an operation handle, and a guide wire seat 340 is connected with the inner tube 133 and is used for inserting guide wires and guiding balloon delivery; the filling seat 330 is mainly used for injecting liquid to fill the balloon or extracting liquid to release the balloon.

In use, the knob 320 is rotated to stretch the molding tube 133 backward, thereby tightening and straightening the spring ring 134 to make the whole capsule 120 become a straight state, and at this time, the transportation is facilitated. When the distal end of the thrombus is reached through the thrombus segment, the knob 320 is rotated again to restore the coil 134 to its original shape, i.e., the spiral shape, at which time the shaping tube 130 also becomes spiral and the spiral balloon is inflated through the inflation seat 330.

In another embodiment, when the guide wire cannot pass through a blood vessel blocked by thrombus, the inner tube 133 can be designed into a solid structure, the guide wire is not needed for guiding when in use, and after the inner tube 133 is pulled and stretched, the balloon is in a straightened state, and thrombus is directly punctured forwards to replace the guide wire.

In another embodiment, when the vessel diameter does not vary much, the entire spiral balloon is of an equal diameter spiral shape, facilitating cleaner removal of the thrombus, as shown in FIG. 7.

In another embodiment, delivery catheter 200 is a single lumen structure, where inner tube 133 passes through the lumen of delivery catheter 200, where inner tube 33 shares the body with the filling lumen, and where fluid enters the balloon from the gap between inner tube 133 and the filling lumen.

The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. The invention is not limited to the embodiments described above, i.e. it is not meant that the invention has to be carried out in dependence on the embodiments described above. It should be apparent to those skilled in the art that any modification of the present invention, equivalent substitution of selected raw materials, addition of auxiliary components, selection of specific modes, etc. fall within the scope of the present invention and the scope of disclosure.

Claims (5)

1. A multi-stage thrombi removal device, comprising:

The spiral balloon comprises a balloon body and a shaping tube, wherein the spiral diameter of the far end of the balloon body is larger than that of the near end, the balloon body is in a straight cylinder shape in a straightening state, and the spiral diameter is 1-5 times of the diameter of the balloon body in the straight cylinder state; the shaping tube comprises an inner tube, a spring ring and a developing ring; the part of the plastic tube in the bag body is of a conical spiral structure, the plastic tube in the bag body is positioned at the center of the bag body, and the taper is the same as that of the bag body; the inner tube is a nickel-titanium alloy tube, and the distal end is connected with a TIP head; the spring ring is wound on the inner tube, and the distal end of the spring ring is fixedly connected with the distal end of the inner tube; the developing rings are arranged at two ends of the plastic tube, which are positioned at the capsule body section;

the conveying catheter comprises a traction cavity and a filling cavity, the traction cavity is used for passing through the plastic pipe, and the part of the plastic pipe, which is positioned in the traction cavity, is straight;

The operating handle comprises a grab handle, a knob, a filling seat and a guide wire seat; the knob comprises a sliding block and a spiral chute, the spiral chute is positioned on the knob, when the knob is rotated, the sliding block is driven to move back and forth through the spiral chute, the inner tube is connected to the sliding block and extends out of the operating handle, and the extending part is connected with the guide wire seat; when the knob is rotated, the inner tube pulls the spring ring, at this time, each layer of the spring ring is tightly attached, and tends to be parallel to each other, and the spring ring tends to be flat as a whole.

2. The multiple level thrombectomy device of claim 1, wherein the balloon is of a compliant or semi-compliant material.

3. The multiple stage thrombi elimination device of claim 1, wherein said TIP head is tapered for guiding said spiral balloon.

4. The multiple level thrombi elimination device of claim 1, wherein said TIP head is provided with a guidewire port.

5. The multiple level thrombi elimination device of claim 1, wherein said distal end of said spring coil and said distal end of said inner tube are joined together by welding.