CN111803178A

CN111803178A - Embolectomy sleeve and embolectomy balloon catheter assembly kit

Info

Publication number: CN111803178A
Application number: CN202010788579.8A
Authority: CN
Inventors: 华俊; 张余
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-08-07
Filing date: 2020-08-07
Publication date: 2020-10-23

Abstract

The invention relates to an embolectomy sleeve and an embolectomy balloon catheter assembly kit for treating thromboembolic diseases in a percutaneous puncture cavity. The thrombus extraction sleeve comprises a thrombus extraction passage catheter with a thrombus introduction umbrella and an umbrella sleeve release assembly, and the folding compression or release of the thrombus introduction umbrella is controlled by the umbrella sleeve release assembly. The thrombus removal balloon catheter is a single-cavity balloon catheter, and is matched with a guide wire through a guide section side wall guide wire hole, so that the transverse cutting area of the thrombus removal balloon catheter is reduced, the thrombus removal sleeve is matched with the thrombus removal sleeve, thrombus in arteriovenous can be effectively and quickly removed, and the thrombus removal balloon catheter is particularly suitable for being used under the condition that the arteriovenous of four limbs has large load thromboembolism, and a patient benefits.

Description

Embolectomy sleeve and embolectomy balloon catheter assembly kit

Technical Field

The invention relates to a thrombus taking interventional surgical instrument, in particular to a thrombus taking sleeve, a thrombus taking balloon catheter and a thrombus taking balloon catheter assembly kit.

Background

The statements in this section merely provide background information related to the present disclosure and may constitute prior art. In the process of implementing the invention, the inventor finds that at least the following problems exist in the prior art.

With the aging population and the change of life style, the incidence of thromboembolic diseases is increasing year by year. Including arterial thrombosis, and venous thromboembolism. For light thromboembolism, medical anticoagulation and thrombolysis treatment can be adopted, but for acute arterial embolism and venous embolism with a large thrombus load, the medical treatment can not quickly and effectively recover the smoothness of blood vessels.

The current treatment protocols are mainly vascular incision embolectomy in surgical mode, transcatheter contact thrombolysis in interventional mode and percutaneous mechanical embolectomy.

The surgical incision embolectomy belongs to open surgery, and needs to be cut, exposed, separated and cut blood vessels, such as femoral artery, femoral vein or brachial artery incision, and the like, a Fogarty double-cavity embolectomy catheter is used, the catheter is inserted into a thrombus distal end and fills a sacculus cavity, the thrombus is removed by pulling the thrombus through the vascular incision part through the sacculus, the thrombus removal rate is high, and the occluded blood vessel can be quickly opened. However, due to high requirements on operation conditions, a hybrid operating room is needed, surgical professionals trained for many years are needed to operate, the operation wound is large, and the complication of blood vessel incision is more, so that the method is not suitable for being widely developed in most hospitals. With the development of interventional diagnosis and treatment technology, the open surgical embolectomy mode tends to be gradually replaced by interventional intracavity therapy.

The transcatheter contact thrombolysis is a minimally invasive interventional operation, and after the transarteriasis, the thrombolysis catheter is retained in the thrombus, so that the operation is simple and easy to operate, but after the operation, a large dose of thrombolysis agent needs to be continuously administered through the thrombolysis catheter for a long time, so that the operation is not suitable for patients suffering from acute arterial occlusion, the large dose of thrombolysis agent has the risk of bleeding, and part of patients have thrombolysis contraindications. In addition, the therapeutic effect of the regimen is closely related to the time of thrombus formation, the amount of thrombus load and the duration of thrombolysis, and many patients cannot benefit from the regimen.

Percutaneous mechanical embolectomy is also a minimally invasive interventional operation, and at present, two main operation modes exist. Firstly, after the puncture of the artery, a large-cavity catheter is used for intubation to the position of thrombus, and the thrombus is extracted out of the body by using a negative pressure thrombus suction method. The operation mode is labor-consuming and time-consuming, the operation doctors and patients need to receive long-time large-dose ray irradiation, the thrombus incarceration catheter is blocked frequently in a negative pressure state, the mural thrombus is difficult to suck out, and the thrombus removal effect is not ideal. Secondly, the thrombus is mechanically crushed and sucked by using devices such as Angojet and the like through hydromechanics and other modes, but the special extracorporeal control device and the special suction catheter which are needed to be used are extremely expensive, and the crushed thrombus can cause damage to red blood cells and renal damage such as hemoglobinuria and the like after operation, thereby greatly limiting the clinical popularization and application of the thrombus.

Therefore, the development of a low-cost interventional surgical instrument which can rapidly remove thrombus and is simple and convenient to operate has become a research hotspot in recent years. For example, patent publication No. CN108143464A entitled "Thrombus removal catheter and Thrombus remover for Thrombus removal catheter" employs a blocking sheath and a thrombus remover. The far end of the blocking sheath tube is provided with a saccule, and liquid is injected into the saccule cavity to fill the saccule so as to block the blood flow. The thrombus taking device comprises an outer tube and an inner tube, wherein the outer tube and the inner tube are coaxially sleeved with each other, the inner tube is provided with a dense-mesh thrombus taking piece at the far end, the dense-mesh thrombus taking piece of the thrombus taking device is conveyed to the far end of thrombus along a guide wire, the dense-mesh thrombus taking piece is expanded, the outer tube is pulled outwards, the thrombus is collected into a sheath tube of the blocking sheath, and meanwhile, the thrombus is discharged through negative pressure suction. However, in the whole process, when the thrombus is pulled to the occlusion sheath port, the thrombus is easily compressed and embedded between the balloon and the catheter wall, and is difficult to be introduced into the sheath, and if the amount of the thrombus is large, the negative pressure suction efficiency is not high. Meanwhile, in order to reduce the problem that thrombus falls off from the thrombus extractor or thrombus fragments block a far-end blood vessel caused by uneven force of the stent type thrombus extractor on the thrombus, the thrombus extractor adopts a dense mesh stent structure, so that the local diameter is too large, the thrombus is easy to move when the thrombus passes through, and the processing technology of the thrombus extractor is complex. In contrast, balloon thrombectomy has many advantages for peripheral vascular thrombus removal applications. And for example, the patent name of publication No. CN208591096U is "a lower limb arterial embolism minimally invasive intervention thrombectomy balloon catheter assembly kit", which comprises a deformation catheter and a Fogarty catheter extending into the deformation catheter to complete thrombectomy, wherein the deformation catheter comprises an inner tube and an outer tube, the head of the inner tube is provided with a bell mouth which is wrapped by the outer tube to shrink, and the outer tube moves backwards to restore. After the deformation catheter is inserted into a blood vessel, the outer tube moves backwards to the restored horn mouth of the inner tube, the Fogarty catheter is conveyed to the far end of the thrombus along the guide wire, the saccule is expanded, the outer tube is pulled outwards, and then the thrombus can be collected into the deformation catheter. However, in the whole using process, because the head end of the deformed catheter is straight, the local vascular wall is easily damaged by direct use, if the sheath tube is used for guiding, the diameter of the deformed inner tube is smaller due to the triple-tube structure, the thrombus passing capacity is influenced, and the complexity of the operation is increased. And when the plug is taken out, if the position of the movable catheter needs to be adjusted, the operation is more complicated. Meanwhile, the Fogarty catheter used in cooperation is a typical double-lumen catheter, the diameter of the catheter is relatively large, and thrombus is not easy to take out through the catheter.

When the intravascular thrombus is loaded greatly, how to effectively remove the thrombus is the first concern of thrombus removal devices.

Throughout the procedure, the femoral artery access is punctured, a long sheath catheter that can be safely used with a non-surgical exposure incision is typically about 10-12F, and the femoral vein puncture can use a 14-16F catheter sheath (a. here, a catheter that can pass through an outer diameter of 10-12F; b.F, a unit of medical catheter that describes the inside or outside diameter of the catheter, and when not specifically mentioned, typically refers to the outside diameter of the catheter, e.g., 3F equals 3mm circumference, 6F equals 6mm circumference, 3F diameter equals 0.96mm, and 5F diameter equals 1.59mm, since the circumference equals 3.14 x diameter). Of course, in a few cases, larger catheter systems, such as 14-16F, may be used for femoral access, but with increasing diameters, the incidence of complications and difficulty of operation increases dramatically.

Limited by the diameter of the long sheath catheter, the inner diameter of the thrombus removal channel catheter is far smaller than the diameter of a blood vessel and is also smaller than the diameter of thrombus in the blood vessel. The thrombus removal channel catheter is generally a catheter with an outer diameter of 10-12F, and the inner diameter of the catheter is about 2.8-3.2 mm. And the 14-16F outer diameter embolectomy access conduit has an inner diameter of about 3.9-4.6 mm. The diameter of the embolectomy balloon catheter which slides inside the embolectomy channel catheter is also limited. Eyes of a userThe conventional double-lumen balloon catheter used in the past needs to be both filled with liquid and guided to move by a guide wire, as shown in fig. 10. Taking an embolectomy access catheter with an outer diameter of 10-12F as an example, the inner diameter of the catheter is about 2.8-3.2 mm. While the diameter of the 5F double-cavity balloon catheter reaches 1.59mm, and the cross section area is 1.985mm²The inner diameter of the catheter of the embolus access passage is more than half of the inner diameter. If the thrombus taking channel catheter is matched with the double-cavity balloon catheter for use, the balloon catheter body is in the central position in the thrombus taking channel catheter in the full state, thrombus is compressed to be in a thin ring shape around the balloon catheter body, and the size of a gap around the balloon catheter body is only about 0.6mm-0.8 mm. Too small a gap makes it difficult to smoothly guide the thrombus. And the double-cavity catheter is relatively complex in processing technology and high in cost.

When the thrombus is pulled to the thrombus removal passage catheter, in order to more easily remove the thrombus, the diameter of the thrombus removal passage catheter is technically increased or the diameter of a balloon catheter in the thrombus removal passage catheter is reduced. However, if the diameter of the catheter for the thrombus removal channel is increased, the incidence of complications and the difficulty of operation are greatly increased during arterial puncture.

Disclosure of Invention

In view of the above problems, it is an object of the present invention to solve some of the problems of the prior art, or at least to alleviate them.

A embolectomy sleeve comprises

The thrombus taking channel catheter comprises a hollow catheter tube body and a thrombus guiding umbrella connected with the first end of the catheter tube body; the thrombus guide umbrella is of a foldable and compressible elastic umbrella-shaped structure;

an umbrella cover release assembly movable within the embolectomy access catheter, comprising an umbrella cover and a hollow inner tube connected to a first end of the umbrella cover; the outer diameter of the umbrella cover is smaller than the inner diameter of the catheter body 1, and the umbrella cover can be sleeved on the thrombus guide umbrella which is folded and compressed.

Furthermore, the umbrella cover releasing assembly also comprises a hollow front end lead-in body; the first end of the front end lead-in body is connected with the second end of the umbrella cover; the diameter of the second end of the front end leading-in body is smaller than that of the first end, so that blood vessel injury can be avoided.

Furthermore, the front part of the thrombus guide umbrella is provided with a guide umbrella parallel section; when the thrombus guide umbrella is released, the parallel section of the guide umbrella can be closely attached to the vessel wall of the anchoring section.

The bolt taking sleeve also comprises a connecting fixing piece; the connecting and fixing piece comprises a connecting and fixing piece conduit end, a fixing piece side pipe with a three-way switch and a fixing piece handle end locking device; the second end of the catheter body is provided with a passage catheter seat which is detachably connected with the catheter end of the connecting and fixing piece; the rear end of the inner tube is connected with the handle through a sliding rod, and the sliding rod is detachably connected with the fixing piece handle end locking device.

The catheter body is a single-cavity catheter.

The umbrella cover releasing assembly also comprises a guide mounting sleeve; the guide mounting sleeve is in a truncated cone shape and is provided with longitudinal openings.

A thrombus removal balloon catheter comprises

A balloon;

the balloon catheter seat comprises a tube seat and a three-way valve;

the single-cavity balloon catheter comprises a balloon tube body and a guide section, wherein the balloon is positioned between the balloon tube body and the guide section; the first end of the balloon catheter body is communicated with the balloon, and the second end of the balloon catheter body is communicated with the balloon catheter seat; the guide section is connected with the side wall of the sacculus or the first end of the sacculus tube body, and a side wall wire guide hole is formed in the tube wall.

An embolectomy balloon catheter assembly kit comprises an embolectomy sleeve and an embolectomy balloon catheter.

The thrombus taking sleeve is matched with the thrombus taking balloon catheter.

The invention has the following beneficial effects:

1. the thrombus guide umbrella at the front end of the thrombus access catheter is assembled by adopting an integrated umbrella sleeve release assembly, and a front end guide body of the thrombus access catheter is a conical head and can avoid blood vessel injury when being pushed along a guide wire;

2. the thrombus guiding umbrella at the front end of the thrombus access catheter adopts a forward pushing and releasing mode, and after releasing, the umbrella sleeve releasing component is integrally taken out;

3. when the thrombus is removed, after the thrombus is removed from a certain section of blood vessel, the thrombus needs to be moved to the next section of thrombus for thrombus removal operation. The thrombus guiding umbrella in the technical scheme can be assembled again in vitro by using the guiding assembly sleeve, so that the repeated operation of thrombus removal operation is facilitated;

4. the single-cavity embolectomy sacculus adopts a sectional type single-cavity structure instead of a double-cavity structure tube body of a conventional sacculus catheter, so that the cross section area of the tube body of the sacculus can be effectively reduced, and the thrombus can be taken out through the lumen of the catheter. And the processing technology of the single-cavity balloon is relatively simple, which is beneficial to reducing the cost.

5. The whole balloon embolectomy process is carried out in the catheter cavity, so that the operation wound is effectively reduced;

6. this technical scheme synthesizes surgical operation and gets the thrombus and intervenes the advantage of getting the thrombus, improves the design of getting thrombus pipe and sacculus pipe, provides a low-cost novel get thrombus sacculus pipe and route pipe system, can be effectively quick clear away the interior thrombus of arteriovenous, is particularly useful for four limbs arteriovenous to have and uses under the great load thromboembolism, makes the patient benefit.

Drawings

The above-described structure of the invention can be further illustrated by the non-limiting examples given in the following figures.

FIG. 1 is a sectional view of a thrombus-introducing umbrella of the present invention when it is not self-expanding;

FIG. 2 is a schematic view of the thrombus-introducing umbrella of the present invention when it is self-expanding;

FIG. 3 is a sectional view of the thrombus-introducing umbrella of the present invention when it is self-expanded;

FIG. 4 is a schematic view of a single lumen thrombectomy balloon catheter of the present invention;

FIG. 5 is a cross-sectional view of a single lumen thrombectomy balloon catheter passing through the thrombus to the distal end of the thrombus;

FIG. 6 is a cross-sectional view of the single lumen thrombectomy balloon catheter after balloon dilation filling;

FIG. 7 is a cross-sectional view of a single lumen thrombectomy balloon catheter dragging thrombi into a thrombi introduction umbrella;

FIG. 8 is a cross-sectional view of a single lumen thrombectomy balloon catheter dragging thrombi into the shaft of the thrombectomy access catheter;

FIG. 9 is a cross-sectional view of the shaft of the thrombectomy access catheter fully dragging a thrombus into the thrombectomy access catheter;

FIG. 10 is a cross-sectional view of a conventional balloon catheter;

fig. 11 is a schematic view of the guide mounting sleeve of the present invention.

Wherein: 1-a catheter body; 2-thrombus leading-in umbrella; 3-leading in the parallel section of the umbrella; 4-umbrella cover; 5-a front end lead-in body; 6-inner tube; 7-channel catheter hub; 8-connecting a fixing piece; 9-connecting the catheter end of the fixing piece; 10-a fixture handle end locking means; 11-a fixture side tube; 12-a handle; 13-a slide bar; 14-guiding installation sleeve; 15-balloon catheter body; 16-a guide section; 17-side wall wire guide holes; 18-a balloon; 19-balloon catheter hub; 20-a guide wire; 23-Thrombus.

Detailed Description

The present invention will be further described with reference to the accompanying drawings, wherein the embodiments of the present invention are provided for illustrative purpose only and not for limiting the invention, and various alternatives and modifications can be made without departing from the technical spirit of the invention, according to the common technical knowledge and conventional means in the art.

As shown in figure 1, the thrombus removal sleeve is characterized by comprising

The thrombus taking channel catheter comprises a hollow catheter tube body 1 and a thrombus guiding umbrella 2 connected with the first end of the catheter tube body 1; the thrombus guiding umbrella 2 is an elastic umbrella-shaped structure which can be folded and compressed;

the umbrella cover releasing component can move in the embolectomy access catheter 1 and comprises an umbrella cover 4 and a hollow inner tube 6 connected with a first end of the umbrella cover 4; the outer diameter of the umbrella cover 4 is smaller than the inner diameter of the catheter tube body 1, and the umbrella cover can be sleeved on the thrombus guide umbrella 2 which is folded and compressed.

The catheter body 1 is a single-cavity catheter, as shown in fig. 1. The catheter tube body 1 is a sectional thin-wall single-cavity catheter, so that the outer diameter of the catheter tube body 1 is fixed as much as possible, the inner diameter of the hollow catheter tube body is relatively large, the hollow catheter tube body can be matched with a catheter sheath or a guide catheter for use, and the thrombus 23 can conveniently pass through the hollow catheter tube body. And the diameter of the catheter can be 5-14F, preferably 6-12F according to the size of the target blood vessel and is suitable for the removal of thrombus 23 in blood vessels with different calibers. The length of the conduit is between 80 and 120 cm.

The catheter body 1 can be of a multilayer structure and comprises a catheter body inner layer, a catheter body reinforcing layer and a catheter body outer layer which are sequentially distributed from inside to outside; the pipe body enhancement layer can be the braided layer of wire or high strength polymer silk braided layer.

The front end of the catheter tube body 1 is provided with a thrombus guiding umbrella 2, and the umbrella body is connected with the inner wall of the front end of the catheter tube body 1 in various modes such as bonding, welding or fusion welding and is in smooth transition. The umbrella body is made of elastic metal material support, polymer film material or other film materials, and can also be woven by various materials (such as memory alloy, composite materials and the like). The materials are all commonly used materials in the existing medical science, can be selected according to actual conditions, and do not belong to the protection scope of the patent.

When being bound by the umbrella cover 4, the thrombus guiding umbrella 2 is in a non-release state, is compressed into a short pipe shape, and a path for the micro catheter to pass through is reserved in the center; the umbrella cover 4 enters a release state after being separated, can automatically and elastically expand into an umbrella shape, and has certain radial expansion force and longitudinal supporting force. The thrombus guide umbrella 2 is used for guiding thrombus 23 to enter the catheter tube body 1, and the umbrella cover is flat and smooth after being opened, so that the thrombus 23 is prevented from being gathered and accumulated, and the thrombus 23 can pass through the umbrella cover. The diameter of the thrombus-introducing umbrella after release is between 4mm and 16 mm, preferably 6-14 mm.

The front part of the thrombus guide-in umbrella 2 is provided with a guide-in umbrella parallel section 3, as shown in figure 2 or 3 or 5 or 6; when the thrombus guide umbrella 2 is released, the parallel section 3 of the guide umbrella can be closely attached to the vessel wall of the anchoring section. The whole thrombus-introducing umbrella 2 is entirely wrapped with a film-like material. The thrombus guiding umbrella 2 can select different guiding umbrellas aiming at different blood vessels, and generally selects a diameter matched with or slightly larger than the entering blood vessel, so that the parallel section 3 of the guiding umbrellas is tightly attached to the vessel wall of the anchoring section. Because the parallel section 3 of the leading-in umbrella is adopted, the umbrella tip is prevented from acting on the blood vessel when the thrombus 23 leading-in umbrella is flared and self-expands, and the stimulation effect of the head end of the metal support frame of the thrombus leading-in umbrella 2 on the blood vessel wall is greatly reduced. The parallel section 3 of leading-in umbrella closely attaches with the vascular wall, when being favorable to drawing in the leading-in umbrella 2 of thrombus 23, thrombus 23 all gets into the leading-in umbrella 2 of thrombus, can not like the both sides of pipe shaft 1 of pipe scattered hourglass, leads to thrombus 23 remaining in the blood vessel.

Tests prove that the diameter of the thrombus-introducing umbrella 2 is equal to or slightly larger than the inner diameter of a target blood vessel by 1-2mm after being released, and the thrombus-introducing umbrella is well attached to the blood vessel wall of the target blood vessel without damaging the local blood vessel.

The crossed nodes of the umbrella bodies are of an unconstrained free sliding structure.

The umbrella cover releasing component is of an integral structure and is mainly used for restraining or releasing the thrombus guiding umbrella 2. The umbrella cover 4 is moved in a forward pushing manner, so that the thrombus-introducing umbrella 2 expands in a trumpet shape and expands automatically, as shown in fig. 2 or 3. Because the external diameter of chute boot 4 is less than the internal diameter of pipe shaft 1, thrombus leading-in umbrella 2 expansion back, whole chute boot release assembly accessible pipe shaft 1 withdraws and gets a bolt passageway pipe to corresponding internal diameter hollow portion that makes pipe shaft 1 increases, makes things convenient for thrombus 23 to pass through.

The umbrella sleeve 4 may be between 4mm and 20 mm long and between 0.8mm and 3mm in diameter.

A guidewire 20 may be passed within the inner tube 6 for guiding the embolectomy cannula into the intended surgical area.

The umbrella cover release assembly further comprises a hollow front end lead-in body 5, as shown in fig. 1, 2 or 3; the first end of the front end lead-in body 5 is connected with the second end of the umbrella cover 4; the diameter of the second end of the leading-in body 5 is smaller than that of the first end, so that the injury of blood vessels can be avoided.

Because the blood vessel has many bending parts, the head end is straight, causes local vascular wall damage easily. The leading introducer 5 may be tapered as shown in FIG. 2 to avoid vessel damage as the embolectomy cannula is advanced over the guidewire 20. The distal end introduction body 5 may have other shapes that do not easily cause damage to the blood vessel.

The embolectomy sleeve further comprises a connecting fixing piece 8, as shown in fig. 1; the connecting and fixing piece 8 comprises a connecting and fixing piece conduit end 9, a fixing piece side pipe 11 with a three-way switch and a fixing piece handle end locking device 10; the second end of the catheter tube body 1 is provided with a passage catheter seat 7 which is detachably connected with the catheter end 9 of the connecting and fixing part; the rear end of the inner tube 6 is connected with a handle 12 through a sliding rod 13, and the sliding rod 13 is detachably connected with the fixing piece handle end locking device 10.

The conduit end 9 of the connecting fastener can be detachably fixed on the conduit seat 7 (conduit seat 7) at the tail end of the conduit of the passage by screw connection, snap and the like, and can be integrally taken down. The handle end has a locking device 10 with threads or other structures adapted to the sliding rod 13 for locking the handle 12 and the sliding rod 13 so that the chute boot release assembly moves when the entire latch bushing moves.

A fixing member side tube 11 with a three-way switch may be provided at the middle section of the connection fixing member 8 for injecting liquid.

The front end leading-in umbrella 5, the umbrella cover 4, the inner tube 6, the sliding rod 13 and the handle 12 are integrated into a whole and are a whole hollow channel. The lumens were passed using 0.010-0.035 inch guidewires 20, respectively, depending on the system size. Because the inner tube 6 is thin, the rear section of the umbrella cover release assembly can be gradually thickened and fixed on the channel catheter seat 7 of the catheter tube body 1 through the connecting and fixing piece 8.

The chute boot release assembly further comprises a guide mounting sleeve 14; the guide mounting sleeve 14 is in the shape of a truncated cone with longitudinal openings, as shown in fig. 11. The guide attachment cover 14 is used to fold and store the expanded thrombus introduction umbrella 2 outside the human body. The umbrella cover 4 is moved to the front end of the thrombus-introducing umbrella 2, as shown in fig. 2. The inner diameter of the guide installation sleeve 14 is slightly larger than the outer diameter of the catheter tube body 1, thrombus can be guided into the umbrella 2 to be folded and stored after the guide installation sleeve is guided from the back side of the catheter tube body 1, the umbrella sleeve 4 is pulled into the umbrella sleeve, and then the guide installation sleeve is taken out, so that the assembly is completed. The thrombus guiding umbrella 2 can be assembled again in vitro by using the guiding assembly sleeve, so that the thrombus taking operation can be repeatedly used within limited times. The thrombus removal device is suitable for the situation that after thrombus removal from a certain section of blood vessel is finished, the thrombus needs to be moved to the next section of thrombus for continuous thrombus removal.

The longitudinal openings are used to avoid the access catheter hub 7, allowing the guide mounting sleeve 14 to be clearance fitted with the catheter shaft 1.

As shown in fig. 4, the thrombus removal balloon catheter comprises

A balloon 19;

a balloon catheter hub 19 comprising a hub and a three-way valve;

the single-cavity balloon catheter comprises a balloon tube body 15 and a guide section 16, wherein the balloon 19 is positioned between the balloon tube body 15 and the guide section 16; the first end of the balloon catheter body 15 is communicated with the balloon 19, and the second end is communicated with the balloon catheter seat 19; the guide section 16 is connected with the side wall of the sacculus 19 or the first end of the sacculus tube body 15, and a side wall wire guide hole 17 is formed in the tube wall.

The thrombus removal balloon catheter is of a segmented single-cavity structure, and the length of the balloon catheter body 15 is 80-180cm, preferably 100-150 cm.

The guide section 16 is a single-cavity thin tube, and a side wall guide wire hole 17 is close to the end of the saccule 18. The guide wire 20 may be advanced through the sidewall guide wire holes 17 into the guide section 16, as shown in fig. 4 or 5, thereby guiding the entire balloon catheter forward through the guide wire 20.

The sacculus 18 is positioned at the near end of the side wall wire guide hole 17, is of an elastic hollow thin-wall structure and is made of latex, synthetic rubber or elastic polymer, and the single-cavity sacculus catheter is communicated with the sacculus 18. The balloon 18 is a balloon that is minimally or atraumatic to the vessel. The saccule 18 is injected with liquid such as physiological saline or contrast agent through the three-way valve and the saccule tube body 15, the saccule expands to form the function of blocking thrombus removal, and the size of the saccule can be adjusted through the amount of injected liquid. The thrombus 23 can be completely pulled out of the body through the thrombus removal passage catheter by adjusting the filling size of the balloon through the three-way valve of the balloon catheter seat 19, as shown in fig. 6 or 7 or 8 or 9.

The balloon 18 may also be selected to have a suitable diameter depending on the actual blood vessel. The balloon 18 is a well established means of the prior art and filling does not cause damage to the vessel.

Because the guide wire 20 can guide the thrombus removal sacculus catheter to move forwards through the guide section 16 at the front end, the sacculus tube body 15 only needs to adopt a single-cavity catheter and is used for injecting liquid into the sacculus, the cross-sectional area of the sacculus tube body 15 can be effectively reduced, and thrombus 23 can be taken out through the catheter tube body 1. And the processing technology of the single-cavity balloon tube body 15 is relatively simple, which is beneficial to reducing the cost.

The guide section 16 may be fixedly connected to, but not in communication with, the balloon shaft 15. The balloon tube body 15 penetrates through the balloon 18 and is provided with a liquid outlet through which liquid is injected into the balloon 18. Or the guide section 16 may be fixedly connected with the outer wall of the balloon 18 by means of bonding or the like.

An embolectomy balloon catheter assembly kit comprises an embolectomy sleeve and an embolectomy balloon catheter. The thrombus taking sleeve is matched with the thrombus taking balloon catheter.

Because the thrombus taking sacculus catheter adopts a sectional type single-cavity structure instead of a double-cavity structure catheter body of a conventional sacculus catheter, the cross section area of the sacculus catheter body can be effectively reduced, and thrombus can be taken out through a catheter lumen. Under the current technology, the diameter of the single-cavity embolectomy balloon can be smaller than 3F. Calculated as 3F, it has a diameter of about 0.96mm and a cross-sectional area of 0.72mm²And are all less than more than half of the 5F double-cavity balloon catheter. The size of the clearance around the tube body of the balloon catheter is obviously increased to 0.92-1.12mm under the balloon filling state. The thrombus removal speed will be greatly increased.

Therefore, when the catheter is used for thrombus removal, the smaller the diameter of the catheter body of the thrombus removal balloon catheter is, the more favorable the thrombus removal is. Therefore, the thrombus removal by using the thrombus removal channel catheter needs to be matched with a single-cavity thrombus removal balloon catheter for use.

The thrombus removal balloon catheter assembly kit also comprises a long sheath catheter; the inner diameter of the long sheath catheter is slightly larger than the outer diameter of the catheter tube body 1 of the embolectomy channel catheter. The inner diameter of the long sheath catheter is larger than the outer diameter of the catheter body 1 and is used for establishing a surgical vascular channel, so that the thrombus removal access catheter can enter the proximal end of the thrombus 23 through the long sheath catheter and is convenient for the long sheath catheter to exit the blood vessel.

The inner diameter of the long sheath catheter is slightly larger than the outer diameter of the catheter tube body 1 of the thrombus removal channel catheter, and the diameter of the long sheath catheter is reduced as much as possible in the process that the guide wire 20 guides the long sheath catheter to reach the proximal end of the thrombus 23, so that the stimulation of the long sheath catheter to blood vessels (particularly when the long sheath catheter passes through a bent section of the blood vessels) can be reduced.

The specific process of thrombus extraction:

the method comprises the following steps: establishing a thrombectomy channel

After the percutaneous puncture is successful under local anesthesia, the guide wire 20 is followed, the long sheath catheter with the inner diameter slightly larger than the outer diameter of the thrombus taking access catheter is introduced, the long sheath catheter is followed to the proximal end of the lesion blood vessel, the thrombus taking access catheter is sent into the long sheath catheter along the guide wire 20 and is pushed to the proximal end of the thrombus embolus. The locking device 10 at the handle end of the fixing piece is released, the thrombus guiding umbrella release 2 adopts a forward pushing release mode, the catheter body 1 and the guide wire 20 are stabilized, the handle 12 is pushed forward, the handle 12, the sliding rod 13, the inner tube 6, the umbrella sleeve 4 and the front end guiding body 5 integrally move forward, the thrombus guiding umbrella 2 is released and opened in a horn shape, and the parallel section 3 of the guiding umbrella is tightly attached to the vascular wall of the anchoring section, as shown in fig. 3. Then the catheter body 1 is fixed, the handle 12 is retreated, the connecting fixing piece 8 is unscrewed, and the umbrella sleeve releasing assembly can be integrally withdrawn to establish a thrombus removing channel.

Step two: thrombus removal

And (3) retracting the guide wire 20, reintroducing the common (micro) catheter through the thrombus access catheter, leading the guide wire 20 to pass through the thrombus section to the far end of the thrombus 23, confirming that the catheter is accurately positioned in the blood vessel cavity at the far end of the thrombus 23 through radiography, reintroducing the guide wire, and withdrawing the common (micro) catheter. Enters from the front end of the thrombectomy balloon catheter guiding section 16 along the end of the guide wire 20, exits through the side wall guide wire holes 17, as shown in fig. 4, and pushes the balloon thrombectomy catheter along the guide wire 20 to the distal end of the thrombus 23, as shown in fig. 5. The guide wire 20 is withdrawn and the inflated balloon 18 is inflated by the three-way valve injection, thus confining the thrombus embolus between the balloon 18 and the thrombus introduction umbrella 2 at the head end of the embolectomy passage catheter, as shown in fig. 6. The balloon catheter 15 is slowly withdrawn, drawing the thrombus 23 into the thrombus extraction access catheter umbrella and into the catheter as shown in fig. 7. At this time, the balloon 18 is positioned at the thrombus guiding umbrella 2, the filling size of the balloon 18 is adjusted through the three-way valve of the balloon catheter seat 19, the diameter of the balloon 18 is equal to or slightly larger than the inner diameter of the access catheter, and as shown in fig. 8 or 9, the thrombus 23 in the thrombus removal access catheter can be completely pulled out of the body.

The third step: repeat purge operation

And determining whether the thrombus removal process needs to be repeated according to the intravascular contrast result. If the thrombus 23 at the proximal section is cleared and the thrombus 23 still exists at the distal section after thrombus removal through radiography after thrombus removal, the thrombus removal passage catheter can be withdrawn out of the body, the thrombus removal passage catheter and the umbrella sleeve release assembly are assembled together again by using the guide assembly sleeve 14 and enter the proximal end of the thrombus 23 under the guide of the guide wire 20, so that the dragging distance of the balloon 18 can be shortened, and the thrombus removal efficiency is improved.

Manner of removing the thrombectomy catheter:

1. the fixed thrombus-removing access catheter can be kept at the original position, the long sheath catheter is pushed forward, and the thrombus introduction umbrella 2 is accommodated in the long sheath catheter and withdrawn.

2. If the diameter of the thrombus guiding umbrella 2 is the same as the diameter of the anchoring vessel section and no obvious resistance is felt by pulling back, the thrombus taking channel catheter can be directly and slowly dragged to exit.

The fourth step: retraction operation

After the thrombus taking-out operation is finished, the thrombus taking-out channel catheter is withdrawn from the blood vessel according to the taking-out mode of the thrombus taking-out channel catheter. The long sheath catheter can be retained and the decision of whether to proceed further balloon or stent angioplasty can be made based on the intravascular imaging results. Withdrawing the long sheath catheter after operation, and performing local pressurization hemostasis or suture hemostasis by a suturing device to finish the percutaneous puncture intracavity embolectomy of the thromboembolic diseases.

The fixed connection which is not specified can be a connection mode such as riveting, welding, bolt connection and the like, a movable connection can be a connection mode such as hinging and the like.

Claims

1. A thrombus taking sleeve is characterized by comprising

The thrombus taking channel catheter comprises a hollow catheter tube body (1) and a thrombus guiding umbrella (2) connected with the first end of the catheter tube body (1); the thrombus guide umbrella (2) is of a foldable and compressible elastic umbrella-shaped structure;

the umbrella cover release assembly can move in the thrombus removal channel catheter (1) and comprises an umbrella cover (4) and a hollow inner tube (6) connected with the first end of the umbrella cover (4); the outer diameter of the umbrella cover (4) is smaller than the inner diameter of the catheter body (1), and the umbrella cover can be sleeved on the thrombus guide umbrella (2) which is folded and compressed.

2. The embolectomy cannula of claim 1, wherein the umbrella cover release assembly further comprises a hollow leading introducer (5); the first end of the front end lead-in body (5) is connected with the second end of the umbrella cover (4); the diameter of the second end of the front end lead-in body (5) is smaller than that of the first end, so that blood vessel injury can be avoided.

3. The embolectomy cannula of claim 1, wherein the front of the thrombus introduction umbrella (2) is provided with an introduction umbrella parallel section (3); when the thrombus guide umbrella (2) is released, the parallel section (3) of the guide umbrella can be closely attached to the vessel wall of the anchoring section.

4. The embolectomy cannula of claim 1, further comprising a connection fixture (8); the connecting and fixing piece (8) comprises a connecting and fixing piece conduit end (9), a fixing piece side pipe (11) with a three-way switch and a fixing piece handle end locking device (10); the second end of the catheter tube body (1) is provided with a passage catheter seat (7) which is detachably connected with the catheter end (9) of the connecting and fixing part; the rear end of the inner tube (6) is connected with a handle (12) through a sliding rod (13), and the sliding rod (13) is detachably connected with the fixing piece handle end locking device (10).

5. The embolectomy cannula of claim 1, wherein the catheter shaft (1) is a single lumen catheter.

6. The embolectomy cannula of claim 1, wherein the chute boot release assembly further comprises an introducer mounting sleeve (14); the guide mounting sleeve (14) is in a truncated cone shape and is provided with longitudinal openings.

7. A thrombus removal balloon catheter is characterized by comprising

A balloon (18);

a balloon catheter seat (19) comprising a tube seat and a three-way valve;

the single-cavity balloon catheter comprises a balloon tube body (15) and a guide section (16), wherein the balloon (18) is positioned between the balloon tube body (15) and the guide section (16); the first end of the balloon catheter body (15) is communicated with the balloon (18), and the second end is communicated with the balloon catheter seat (19); the guide section (16) is connected with the side wall of the sacculus (18) or the first end of the sacculus tube body (15), and a side wall wire guide hole (17) is formed in the tube wall.

8. An embolectomy balloon catheter assembly kit comprising an embolectomy cannula of any of claims 1 to 6 and an embolectomy balloon catheter of claim 7.

9. The thrombectomy balloon catheter assembly kit of claim 8, wherein the thrombectomy sleeve is adapted to the thrombectomy balloon catheter.