阅读说明：本技术 一种血栓清除系统 (Thrombus removing system ) 是由 马国睿 吴锋 张凌风 于 2019-09-23 设计创作，主要内容包括：本发明实施例提供了一种血栓清除系统,该系统通过在连通导管的头端设置可收缩和可膨胀的血管封堵机构,可以在血管封堵机构处于释放状态时,与血管壁紧密贴合并将血管进行短暂封堵,能够阻止血管内的血液流动对血栓造成冲击,通过在牵引导丝上设置可收缩和可膨胀的血栓抓捕机构,可以在血栓抓捕机构处于释放状态时,对血管壁进行充分地支撑扩张,有利于对血栓进行抓捕,通过在牵引导丝的远端设置可收缩和可膨胀的碎片拦截机构,可以在碎片拦截机构处于释放状态时,对血液中的血栓碎片进行过滤清除,防止其流动至血管远端位置,符合临床使用的需要。(The embodiment of the invention provides a thrombus clearing system, which is characterized in that a retractable and expandable blood vessel blocking mechanism is arranged at the head end of a communicating catheter, so that the blood vessel blocking mechanism can be tightly attached to a blood vessel wall and temporarily block the blood vessel when being in a release state, the blood flow in the blood vessel can be prevented from impacting thrombus, the retractable and expandable thrombus catching mechanism is arranged on a traction guide wire, so that the blood vessel wall can be fully supported and expanded when the thrombus catching mechanism is in the release state, the thrombus can be caught, and the retractable and expandable fragment catching mechanism is arranged at the far end of the traction guide wire, so that thrombus fragments in blood can be filtered and cleared when the fragment catching mechanism is in the release state, the fragment catching mechanism is prevented from flowing to the far end of the blood vessel, and the requirement of clinical use is met.)

1. A thrombus removal system, comprising:

a recovery conduit (1);

the conveying conduit (2) is movably sleeved in the recovery conduit (1);

the communicating conduit (3) is movably sleeved in the conveying conduit (2);

the traction guide wire (4) is arranged on a central axis in the communication catheter (3), moves along the direction of the central axis relative to the communication catheter (3), and is provided with a traction end and a pushing end, and the traction guide wire (4) is provided with two ends;

the blood vessel plugging mechanism (5), the blood vessel plugging mechanism (5) is fixedly arranged at the head end of the communicating catheter (3), and the blood vessel plugging mechanism (5) is a collapsible and expandable balloon structure;

the thrombus capturing mechanism (6) is fixedly arranged on the traction guide wire and between the pushing end and the blood vessel plugging mechanism (5), and the thrombus capturing mechanism (6) is a retractable and expandable net body structure;

the fragment intercepting mechanism (7), the fragment intercepting mechanism (7) is fixedly arranged at the far end of the traction guide wire (4), and the fragment intercepting mechanism is a collapsible and expandable basket body structure; and

and the developing link (8), wherein the developing link (8) is fixedly wound on the communicating conduit (3) and the traction guide wire (4).

2. A thrombectomy system according to claim 1, wherein said balloon structure is substantially cylindrical when deflated and substantially spherical when inflated.

3. A thrombectomy system according to claim 1, wherein said balloon structure is a polymer layer comprising pvc layer, polyurethane layer, nylon layer, PET layer, PEBAX layer, etc.

4. A thrombectomy system according to claim 1, wherein said mesh structure is in a shape of a mesh tube when contracted and a circular shuttle when expanded.

5. A thrombectomy system according to claim 1, wherein said mesh structure is a wire mesh comprising stainless steel mesh, ni-ti alloy mesh, co-cr alloy mesh, ta alloy mesh, ti alloy mesh, etc.

6. A thrombectomy system according to claim 1, wherein said basket structure is net-shaped when collapsed and circular-shaped when expanded.

7. A thrombectomy system according to claim 1, wherein said basket structure is a wire basket comprising stainless steel, nitinol, cobalt chromium, tantalum and titanium alloy baskets.

8. A thrombectomy system according to claim 7, wherein said wire basket is covered with a polymer film.

9. The thrombus removal system according to claim 8, wherein the polymer film has round holes with a diameter of 80 to 160 μm uniformly distributed thereon.

10. A thrombectomy system according to claim 1, wherein the visualization step (8) comprises a first visualization step, a second visualization step and a third visualization step.

Technical Field

The invention belongs to the technical field of vascular disease treatment devices, and particularly relates to a thrombus removal system.

Background

Thrombus is a blood clot formed by abnormal aggregation of blood vessels in different proportions of visible components such as red blood cells, platelets, fibrin and leukocytes in blood under the pathological conditions of secondary intrinsic or extrinsic coagulation systems. Thrombi can not only form within blood vessels in any part of the body, but also spread throughout various tissues and organs of the human body. After thrombosis, it causes the occlusion of blood vessels and the blockage of blood flow, causing ischemia and even necrosis of the related tissues and organs, and thus producing the corresponding symptoms of tissue and organ dysfunction. The large-area myocardial infarction, arteriovenous vessel occlusion, ischemic stroke and other related cardiovascular diseases caused by thrombosis become common diseases and frequently encountered diseases in clinic, and extremely high fatality rate and disability rate are caused to a large number of patients.

Aiming at the clinical problems, a drug thrombolysis method is mostly adopted for treatment in the early stage, but the method is only suitable for thrombus with small volume, the treatment effect on large-volume thrombus occlusion is not ideal, the conditions of slow thrombolysis speed, low blood vessel recanalization rate, long lumen recanalization time, poor prognosis effect and the like are mainly clinically shown, and only about 3-5% of patients are usually suitable for drug thrombolysis treatment. In recent years, a mechanical thrombus extraction method has been the focus of research in the field of thrombus treatment, wherein an thrombus extraction device is conveyed to the vicinity of thrombus, and then the thrombus is captured by the thrombus extraction device and removed from the body. The mechanical thrombus taking method has short operation time, few related complications, complete thrombus removal and good prognosis effect, but most of the thrombus taking devices clinically used at present are of a single-layer bracket type structure, so that the capturing efficiency of the thrombus is low, and the thrombus needs to be fixed by repeatedly pushing and pulling during thrombus taking operation, so that massive thrombus is easy to form fragments to fall off and flow to the far end of a blood vessel, and the risk of reocclusion of the blood vessel of a patient is greatly increased.

Disclosure of Invention

In order to solve the problems in the prior art, the embodiment of the invention provides a thrombus removal system, and when the system works, thrombus and thrombus fragments can be thoroughly removed under the auxiliary positioning of a developing link through the combined cooperation of a blood vessel blocking mechanism, a thrombus capture mechanism and a fragment intercepting mechanism. The embodiment of the invention also provides a use method of the thrombus removal system.

In order to achieve the purpose, the embodiment of the invention adopts the following technical scheme:

a thrombus removal system, comprising:

a recovery conduit;

the conveying conduit is movably sleeved in the recovery conduit;

the communicating conduit is movably sleeved in the transmission conduit;

the traction guide wire is arranged on a central axis in the communicating catheter and moves along the direction of the central axis relative to the communicating catheter, and the traction guide wire is provided with two ends of a traction end and a pushing end;

the blood vessel plugging mechanism is fixedly arranged at the head end of the communicating catheter and is of a collapsible and expandable balloon structure;

the thrombus catching mechanism is fixedly arranged on the traction guide wire and between the propelling end and the blood vessel plugging mechanism, and is of a retractable and expandable net body structure;

a debris intercepting mechanism fixedly disposed at a distal end of the pull guidewire, the debris intercepting mechanism being a collapsible and expandable basket structure; and

and the developing link is fixedly wound on the communicating conduit and the traction guide wire.

In the thrombus removal system, the recovery catheter, the transmission catheter, the communication catheter, the traction guide wire, the blood vessel plugging mechanism, the thrombus capture mechanism, the fragment interception mechanism and the developing link can be coaxially arranged. In the non-operating state, the mechanisms are all retracted in the recovery duct. When in working state, the control device sends a recovery catheter containing a transmission catheter, a communicating catheter and a traction guide wire to the vicinity of thrombus along the blood vessel, the recovery catheter is locked by the control device, the delivery catheter containing the communicating catheter and the traction guide wire is pushed to pass through the thrombus, the traction guide wire is locked by the control device, and under the auxiliary positioning of the developing link, the communicating catheter is withdrawn to a proper distance, so that the blood vessel plugging mechanism arranged on the communicating catheter and the thrombus catching mechanism arranged on the traction guide wire can be accurately positioned at two ends of thrombus, then the communicating catheter and the traction guide wire are locked by the control device, the transmission catheter is withdrawn to an outlet of the recovery catheter, and the blood vessel plugging mechanism arranged at the head end of the communicating catheter, the thrombus catching mechanism arranged on the traction guide wire and the fragment intercepting mechanism arranged at the far end of the traction guide wire are sequentially released into the blood vessel.

The blood vessel plugging mechanism is of a capsule structure, is in a round tube shape during contraction, is in a round sphere shape during expansion, and can be tightly attached to a blood vessel wall and temporarily plug the blood vessel when being released into the blood vessel, so that the blood flow in the blood vessel can be prevented from impacting the thrombus, and the thrombus is captured by the thrombus capture mechanism conveniently.

The thrombus capture mechanism is of a net body structure, is in a net pipe shape when being contracted and is in a circular shuttle shape when being expanded, and when the blood vessel capture mechanism is released into a blood vessel, the blood vessel capture mechanism can fully support and expand the blood vessel wall, thereby being beneficial to capturing thrombus.

The fragment intercepting mechanism is of a basket body structure, is in a net pipe shape when being contracted, is in a round bag shape when being expanded, and can filter and remove thrombus fragments in blood when being released into the blood vessel so as to prevent the thrombus fragments from flowing to the far end position of the blood vessel.

Through controlling means locking intercommunication pipe and traction guide wire, pour into liquid such as normal saline into the blood vessel shutoff mechanism of intercommunication pipe head end in, make its release back and vascular wall close fitting and carry out short time shutoff with the blood vessel, can prevent that the blood flow in the bloodline from leading to the fact the impact to the thrombus to the mechanism is caught the thrombus to the thrombus of being convenient for.

The control device locks the recovery catheter, the transmission catheter and the communication catheter, the traction guide wire is slowly withdrawn, in the withdrawal process, the thrombus catching mechanism arranged on the traction guide wire catches thrombus and pushes the thrombus towards the near end direction, and meanwhile, the fragment intercepting mechanism arranged at the far end of the traction guide wire filters and clears thrombus fragments to prevent the thrombus fragments from flowing to the far end position of the blood vessel.

The recovery catheter and the transmission catheter are locked by the control device, liquid such as physiological saline and the like in the blood vessel plugging mechanism at the head end of the communication catheter is pumped out to be contracted, the traction guide wire is continuously withdrawn, so that the thrombus capture mechanism arranged on the traction guide wire and the fragment interception mechanism arranged at the far end of the traction guide wire are continuously pushed towards the near end direction, at the moment, the thrombus is completely embedded and captured by the thrombus capture mechanism, and thrombus fragments are also filtered and removed by the fragment interception mechanism.

The recovery catheter is locked by the control device, and the transmission catheter, the communication catheter, the blood vessel plugging mechanism, the thrombus catching mechanism, the captured thrombus and debris intercepting mechanism and the filtered thrombus debris are sequentially withdrawn into the recovery catheter.

The thrombus removing system is completely and stably withdrawn to the outside of the body through the control device, so that the removal work of thrombus and thrombus fragments is completely finished, and the blood flow in the blood vessel is recovered to a normal running state.

The developing link mainly has the following three functions: (1) the developing link is adopted to accurately position the blood vessel plugging mechanism, the thrombus capture mechanism and the fragment interception mechanism in the thrombus removal system, so that an operator can clearly observe the positions of the blood vessel plugging mechanism, the thrombus capture mechanism and the fragment interception mechanism in a blood vessel under X-rays through the arrangement of the developing link, and the operator can accurately and thoroughly complete the removal work of thrombus and thrombus fragments; (2) the developing link is adopted to wind the communicating catheter, so that the integral pushing and pulling capacity of the communicating catheter can be obviously increased, the connection strength of the blood vessel plugging mechanism and the communicating catheter can be improved, and the safety of the thrombus removal system during use can be more effectively enhanced; (3) the developing link is adopted to wind on the traction guide wire, so that the integral pushing and drawing capabilities of the traction guide wire can be obviously increased, the connection strength of the thrombus catching mechanism, the fragment intercepting mechanism and the traction guide wire can be improved, and the safety of the thrombus clearing system during use can be more effectively enhanced.

Preferably, the balloon structure is in the shape of a circular tube when deflated and in the shape of a sphere when inflated. The effect is when the blood vessel shutoff mechanism is released to the blood vessel, can closely paste with the vascular wall and carry out the short time shutoff with the blood vessel, can prevent that the blood flow in the blood vessel from causing the impact to the thrombus to the mechanism is caught the thrombus to the thrombus of being convenient for.

Further preferably, the capsule structure is a polymer layer, and the polymer layer includes a polyvinyl chloride layer, a polyurethane layer, a nylon layer, a PET layer, a PEBAX layer, and the like.

It is further preferred that the balloon structure is inflated and brought into close contact with the vessel wall by injecting a liquid such as saline into the balloon structure when released into the vessel.

Preferably, the net body structure is in a net pipe shape when being contracted and in a circular shuttle shape when being expanded. The function is that when the blood vessel catching mechanism is released into the blood vessel, the blood vessel wall can be fully supported and expanded, and the blood vessel catching mechanism is favorable for catching thrombus.

Further preferably, the mesh body structure is a metal wire mesh, and the metal wire mesh comprises a stainless steel mesh, a nickel-titanium alloy mesh, a cobalt-chromium alloy mesh, a tantalum alloy mesh, a titanium alloy mesh and the like.

It is further preferred that the mesh area of the proximal portion of the mesh structure is larger and the mesh area of the distal portion is smaller when the mesh structure is released into the blood vessel, so as to provide better embedding and fixation when capturing thrombus.

Preferably, the basket structure is in a net pipe shape when being contracted and in a round bag shape when being expanded. The function is that when the debris intercepting mechanism is released into the blood vessel, thrombus debris in the blood can be filtered and removed, and the thrombus debris can be prevented from flowing to the position far away from the blood vessel.

Further preferably, the basket body structure is a wire basket, and the wire basket comprises a stainless steel basket, a nickel-titanium alloy basket, a cobalt-chromium alloy basket, a tantalum alloy basket, a titanium alloy basket and the like.

Further preferably, the surface of the wire basket is covered with a polymer film, and the polymer film comprises a polyurethane film, a polycarbonate film, a polypropylene film, a polytetrafluoroethylene film, a nylon film and the like.

More preferably, the polymer film is uniformly distributed with round holes with the diameter of 80-160 mu m.

Evenly set up the effect of round hole on the polymer film and filter the interception after the round hole screening with the thrombus piece in the blood, but can let blood pass the normal circulation of round hole.

Preferably, the developing link includes a first developing link, a second developing link, and a third developing link.

Further preferably, the developing link is made of gold or an alloy thereof, platinum or an alloy thereof, tungsten or an alloy thereof, and tantalum or an alloy thereof.

Further preferably, the first visualization link is disposed on the communication conduit and at a proximal end of the blood vessel occlusion mechanism.

Further preferably, the second visualization link is disposed on the traction guide wire and at two ends of the thrombus capture mechanism.

Further preferably, the third visualization element is disposed on the pull guidewire distal to the debris intercepting means.

When the blood vessel plugging mechanism, the thrombus catching mechanism and the fragment intercepting mechanism in the thrombus clearing system are simultaneously in a release state, different appearance structures can be presented so as to exert respective specific use functions, thrombus and thrombus fragments can be thoroughly cleared, and the thrombus clearing system is simple and convenient to operate, accurate in positioning and quick in opening and meets the requirements of clinical use.

The invention has the advantages of

1. In the thrombus removal system provided by the embodiment of the invention, the head end of the communicating catheter is provided with the retractable and expandable blood vessel plugging mechanism, so that the blood vessel plugging mechanism can be tightly attached to the blood vessel wall and can plug the blood vessel for a short time when being in a release state, and the blood flow in the blood vessel can be prevented from impacting thrombus;

2. in the thrombus clearing system provided by the embodiment of the invention, the retractable and expandable thrombus catching mechanism is arranged on the traction guide wire, so that the blood vessel wall can be sufficiently supported and expanded when the thrombus catching mechanism is in a release state, and the thrombus can be caught;

3. in the thrombus removal system provided by the embodiment of the invention, the retractable and expandable fragment intercepting mechanism is arranged at the far end of the traction guide wire, so that thrombus fragments in blood can be filtered and removed when the fragment intercepting mechanism is in a release state, and the thrombus fragments are prevented from flowing to the far end position of a blood vessel;

4. in the thrombus removal system provided by the embodiment of the invention, thrombus and thrombus fragments can be thoroughly removed under the auxiliary positioning of a developing link through the combined cooperation of the blood vessel plugging mechanism, the thrombus capturing mechanism and the fragment intercepting mechanism;

5. in the thrombus removal system provided by the invention, when the blood vessel occlusion mechanism, the thrombus capture mechanism and the fragment interception mechanism are simultaneously in a release state, different appearance structures can be presented so as to exert respective specific use functions, and the thrombus removal system is simple and convenient to operate, accurate in positioning and quick in opening and meets the requirements of clinical use.

Drawings

FIG. 1 is a schematic view of a thrombus removal system according to an embodiment of the present invention in a contracted state.

Figure 2 is a schematic view of a thrombus removal system according to an embodiment of the present invention as it expands.

Fig. 3 is a structural diagram of a developing link of the thrombus removal system according to an embodiment of the present invention.

Figure 4 is a schematic representation of the operation of a thrombus removal system according to an embodiment of the present invention prior to its passage through a thrombus.

FIG. 5 is a schematic view of the thrombus removal system after it has passed through the thrombus, in accordance with an embodiment of the present invention.

FIG. 6 is a schematic view of the positioning of the overall mechanism in a thrombectomy system according to an embodiment of the present invention.

FIG. 7 is a schematic view showing the operation of the overall mechanism of the thrombus removal system when expanded according to the embodiment of the present invention.

FIG. 8 is a schematic view of the blood vessel occlusion mechanism of a thrombectomy system according to an embodiment of the present invention being expanded.

Figure 9 is a schematic illustration of the operation of a thrombus removal system to capture thrombus and filter thrombus debris in accordance with an embodiment of the present invention.

Fig. 10 is a schematic view showing the operation of the blood vessel occlusion mechanism in the thrombus removal system according to the embodiment of the present invention.

FIG. 11 is a schematic diagram of the thrombus removal system configured to remove thrombus and thrombus fragments from a body according to an embodiment of the present invention.

FIG. 12 is a schematic view showing the state where the blood flow returns to normal operation after the thrombus and thrombus fragments are completely removed according to the embodiment of the present invention.

Detailed Description

The embodiment of the invention provides a thrombus removal system which comprises a recovery catheter, a transmission catheter, a communication catheter, a traction guide wire, a blood vessel plugging mechanism, a thrombus capture mechanism, a fragment intercepting mechanism and a developing link. The embodiment of the invention also provides a use method of the thrombus removal system.

In order to better understand the above technical solutions, the above technical solutions will be described in detail with reference to specific embodiments. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not limiting of the invention. It should be further noted that, for the convenience of description, only some but not all of the elements associated with the present invention are shown in the drawings. It should also be noted that the following description uses the terms "proximal" and "distal", where "proximal" refers to the end closer to the operator and "distal" refers to the end further from the operator.