CN107361816B

CN107361816B - Pulmonary embolism protection and thrombus removing device

Info

Publication number: CN107361816B
Application number: CN201710699995.9A
Authority: CN
Inventors: 朱玉红
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-08-16
Filing date: 2017-08-16
Publication date: 2023-08-22
Anticipated expiration: 2037-08-16
Also published as: CN107361816A

Abstract

A system device with thrombus filtering, pulmonary embolism protection and thrombus removal functions, which is characterized in that: comprises a thrombus filter screen and a thrombus taking basket, wherein the thrombus filter screen comprises an outer net, an inner net and a conveying total sheath; the inner net passes through the outer net cavity, the outer net can pass through the conveying main sheath, the thrombus taking basket can pass through the inner net cavity, and the inner net, the outer net and the thrombus taking basket are provided with parts which can be unfolded and retracted.

Description

Pulmonary embolism protection and thrombus removing device

Technical Field

The invention relates to the field of medical equipment, in particular to a thrombus protection and removal device, and specifically relates to a pulmonary embolism protection and thrombus removal device.

Background

Venous thromboembolism (Venous thromboembolism, VTE) is a common potentially fatal emergency, including deep venous thrombosis and pulmonary embolism, with a incidence of 4% to 20%; acute pulmonary embolism (Acute pulmonary embolism, APE) has become a common cardiovascular system disease in China, the death rate is 30%, and acute large-area pulmonary arterial embolism is a common cause of sudden death. In the united states, pulmonary artery embolism has a annual incidence of 60 ten thousand, a mortality rate of 25% -30%, and is one of three common fatal cardiovascular diseases, mainly due to high incidence rate of deep vein thrombosis (deep venous thrombosis, DVT); meanwhile, if the deep vein thrombosis can not be cleared in time, a syndrome after the deep vein thrombosis is formed in the future, the lesion part is obviously swollen, blackened and skin ulcerated, and the life quality of patients is seriously influenced. Therefore, the method is a great challenge for timely removing deep venous thrombosis (especially central venous thrombosis) and preventing pulmonary embolism caused by thrombus shedding.

Vena Cava Filter (VCF) (also known as Vena cava filter) is a device designed to prevent deep vein thrombosis from falling off and pulmonary embolism, and is mainly used for protecting lower limb deep vein thrombosis despite various filters; for the thrombus of the superior vena cava, the brachiocephalic vein, the jugular vein and the subclavian vein, and the thrombus of the inferior vena cava, especially the thrombus of the inferior vena cava above the level of the renal vein, the vena cava filter screen often cannot fully play a protective role due to small anchoring space; meanwhile, the filter screen itself cannot remove thrombus. Capturex thrombus filter is a thrombus filter device which is recently introduced by Straub medical company (Switzerland) and can be used for superior and inferior vena cava, european CE certification is already obtained, and clinical application is not yet put into practice in China; if the thrombus is blocked, the thrombus can be removed by matching with the thrombus removing device, so that the medical cost is increased. Chinese patent nos. CN201210484480.4 and CN201610093259.4 are filters for preventing arterial calcified plaque, thrombus and other emboli from falling off during operation, but they are designed for arterial lesions, especially aortic emboli, and are not deep venous thrombus removal and interception.

Percutaneous transluminal thrombectomy (Transluminal removal of thrombus, TRT) has the advantages of less trauma, quick recovery, etc., compared to surgical thrombolysis, and common methods are contact catheter thrombolysis, fogarty balloon catheter thrombolysis, and percutaneous mechanical thrombectomy (Percutaneous mechanical thrombectomy, PMT). However, the recurrence rate of the Fogarty balloon catheter after the thrombus extraction operation is high, and the Fogarty balloon catheter is rarely adopted at present; the contact catheter has long thrombolysis time and is easy to remain thrombus, and the effect is often unsatisfactory; the Percutaneous Mechanical Thrombectomy (PMT) device principle is divided into rotary turbine (Amplatz, trellis) and hydrodynamic (Oasis) devices and ultrasound ablation (EKOS) devices. Market in 2008S thrombus aspiration catheters (used in conjunction with Straub medical power system) (switzerland), the approved market-approved Angiojet thrombi removal device in China (united states) in 2011, are PMT devices recently adopted in clinic, mainly for peripheral blood vessels. Most of these devices are complex and expensive and are currently used in only a few hospitals. Meanwhile, whatever percutaneous intracavitary thrombus removal device cannot intercept the shed thrombus, and a vena cava filter is often placed before operation to prevent pulmonary embolism.

At present, the method for intercepting and removing the deep venous thrombosis is as follows: vena cava filter implantation, surgical thrombolysis, thrombolysis treatment, and catheter thrombolysis.

The implantation of the vena cava filter is to place a vascular sheath through puncturing the femoral vein or the jugular vein, conduct inferior vena cava radiography to judge the diameter of the inferior vena cava and whether the inferior vena cava thrombus exists or not, and position the level of the renal vein; the filter is delivered into the inferior vena cava (1 cm below the renal vein) by a guiding device through the vascular sheath, and after the successful release of the filter is confirmed by radiography, the guiding device and the vascular sheath are removed. (schematic drawings used herein, photographs used alone, it is contemplated that only the schematic diagram of FIG. 3 may be retained)

Existing filters can be generally classified into temporary filters, permanent filters, and recyclable filters. The permanent filters commonly used internationally are mainly Greenfield (Boston, usa), vena Tech LP (b. Braun, germany), simon (Bard, usa), birds negk (Cook, usa) and the like, which have disadvantages in that long-term implantation into the body may cause complications such as inferior Vena cava perforation, filter displacement, inferior Vena cava occlusion due to secondary thrombosis, and the like, thus limiting the application thereof.

Temporary filters used in China are mainly TempoFi lter II filters ((B. Braun, germany), which have the defects that if larger thrombus is blocked, thrombolysis is needed again or a permanent filter is additionally arranged, the medical cost is obviously increased, and the operation is difficult.

The recyclable filters used in China are mainly: optEasefilter (Cordis, U.S.), the Recovery filter (Bard, U.S.), gunther Tulip filter (Cook, U.S.), denali filter (Bard, U.S.), shenzhen recoverable filter, etc. Chinese patent No. CN106725996A, CN106725997A, CN106618794A, CN106310392A, CN105943197A, CN105193521a, etc., discloses that various filters are recyclable filters. The common disadvantages are that: (1) Once the filter captures the embolus, the thrombolysis is continued, the intracorporeal retention time is prolonged (the intracorporeal retention time of the filter is short and is generally only 2 to 3 weeks), and the filter is not easy to take out due to adhesion of the filter to the vessel wall; if the thrombus is large and can not be dissolved, the thrombus is forced to stay in the body for a long time; (2) The filter needs to be taken out and needs corresponding operation technology, so that the medical cost is increased; (3) No matter which filter can remove thrombus, if thrombus is to be removed, thrombolysis and the like are combined, corresponding equipment is required to be provided, and the medical cost is obviously increased; (4) For the thrombus at the proximal end of the inferior vena cava, the superior vena cava, the brachiocephalic vein, the jugular vein and the subclavian vein, the vena cava filter screen often cannot play a protective role due to small anchoring space; (5) inferior vena cava diameter >35mm is a filter implantation contraindication.

Filter implantation complications: such as no opening during the implantation of the filter, breakage of the filter metal branch, inclination of the filter after implantation, perforation of the inferior vena cava, falling off of the filter, thrombosis of the inferior vena cava around the filter, etc. The occurrence rate of thrombosis around the filter is 2% -30%, for example, the thrombosis can cause pulmonary embolism; if thrombus can not be removed, the lower vena cava blocking syndrome can be complicated, so that the lower limb is obviously swollen, and the skin of the lower leg is blackened and ulcerated after a long time. .

Surgical removal of the embolus, a Fogarty balloon catheter is commonly used to remove the embolus via femoral vein dissection. Firstly, sterilizing, spreading a sterile towel, then locally removing the towel, cutting soft tissues such as inguinal skin on one side, dissecting and cutting femoral vein, inserting the femoral vein through the femoral vein by using a Fogarty balloon catheter, taking out the iliac vein thrombus, and assisting in extruding and driving the thrombus or taking out the femoral popliteal vein thrombus by forward motion.

The operation thrombus taking has the following defects: (1) A lower vena cava filter is implanted in advance before operation to prevent pulmonary embolism caused by thrombus shedding; (2) Soft tissues such as inguinal skin and the like are required to be cut by operation, femoral veins are dissected and separated, and the wounds such as thrombolysis, thrombolysis and the like are relatively large compared with a catheter; (3) Technically, the operation needs to be finished by a surgeon, and the interventional department doctor cannot independently finish the operation; (4) The postoperative recurrence rate is high, and the existing operations are seldom performed to remove thrombus except for serious deep venous thrombosis such as femoral edema and the like.

Thrombolytic therapy, which includes both systemic thrombolysis and catheter-contact thrombolysis.

Systemic thrombolysis is a thrombolytic drug pumped into urokinase, recombinant tissue plasminogen activator (Recombinant tissue plasminogen activator, r-tPA) and the like via peripheral veins (e.g., dorsum of foot) to dissolve the thrombus.

Catheter contact thrombolysis is usually carried out by puncturing a deep vein (such as femoral vein) to put into a vascular sheath, putting a guide wire and a catheter through the vascular sheath, selecting a corresponding vein to reach deep vein thrombosis, putting into a thrombolysis catheter, and pumping thrombolysis drugs such as urokinase, r-tPA and the like through the thrombolysis catheter to directly dissolve the thrombus.

Thrombolytic therapy has the following disadvantages: (1) A vena cava filter is usually implanted before operation to prevent pulmonary embolism caused by thrombus falling off; (2) Thrombolysis is incomplete, thrombolysis time window is required in thrombolysis drug specifications to be within 12 hours of thrombosis, and the thrombosis is usually 3-5 days or even longer when a patient visits, and new and old thrombi are often mixed, so that the thrombi can not be completely dissolved; the systemic thrombolysis is systemic medication, the concentration of the medicine at the thrombus position is low, and the thrombolysis rate is lower; (3) The duration is long, thrombolysis needs to last for 2-3 days, and if necessary, 5-7 days; (4) The risk of bleeding during thrombolysis is high, with 3-fold increase in intracranial hemorrhage.

In addition, thrombolysis has a number of contraindications: 1) Recent (< 14 days) has active bleeding (gastric and duodenal ulcers, hemoptysis, hemorrhoids, hemorrhage, etc.), surgery, biopsy, cardiopulmonary resuscitation (external heart massage, intracardiac injection, tracheal intubation), failure to perform vascular puncture of the compression site, and history of trauma; 2) A history of severe trauma or receiving a major operator in the near 4 weeks; 3) A history of active internal bleeding of the cranium or a history of cerebral infarction in about 3 months; 4) High blood pressure (systolic >180mmHg, diastolic >110 mmHg) which is difficult to control, or those which cannot exclude aortic dissection aneurysms; 5) Pregnancy, bacterial endocarditis, mitral valve lesions and atrial fibrillation and a high suspicion of thrombosis in the left heart chamber; 6) Diabetic with retinopathy; 7) Severe liver and kidney dysfunction and progressive disease, hypofibrinogenemia; 8) The dosage for the elderly should be cautious.

Catheter suction plug: comprises a catheter direct-suction plug,S-catheter and AngioJet catheter, etc.

The direct catheter thrombus suction is to place an 8F guiding catheter (or a long sheath) into the proximal end of a deep vein or fresh thrombus which forms thrombus through a femoral vein, and suck the thrombus through negative pressure generated by external suction of a syringe; or after the thrombus is disintegrated by stirring through a pigtail catheter, the thrombus is sucked out through a guiding catheter (or a long sheath).

The S catheter is required to be matched with a Straub power system for use for thrombolysis and is placed through femoral veinThe S catheter reaches the deep venous proximal end of the formed thrombus or the inside of the maximum fresh thrombus, and the proximal end of the catheter is connected with an external Straub power system. />The S catheter body is provided with a high-speed rotating spiral body, and the Straub power system can generate a rotating speed of 40000r/min and is communicated with the rotating speedNegative pressure is generated through the suction device, and thrombus is removed through suction.

The Angiojet suction bolt system is mainly composed of a driving device and a suction bolt catheter, and is a therapeutic apparatus with medicine-machinery coupling. Working principle: the AngioJet thrombus-absorbing catheter is placed into deep vein through femoral vein to form thrombus, the driving device generates pulse pressure to inject physiological saline through the AngioJet catheter, and the physiological saline is reversely sprayed at high speed through the catheter head end side hole to flush the thrombus, and meanwhile, a low pressure area is locally generated to suck the disintegrated thrombus out of the catheter discharge hole.

The disadvantage of direct catheter aspiration is: (1) A lower vena cava filter is usually implanted before operation to prevent pulmonary embolism caused by thrombus shedding; (2) The efficiency is low, small blocks or a small amount of thrombus can be sucked at one time, and repeated thrombus suction is needed for large blocks and a large amount of thrombus; (3) The residual thrombus is more, and the thrombus can not be completely removed in most cases, and the combined thrombolysis method and the like are needed.

The S catheter, the AngioJet catheter stopper has the following disadvantages: (1) A lower vena cava filter is implanted before operation to prevent pulmonary embolism caused by thrombus shedding; (2) Expensive, ->The S catheter is used in combination with the Straub power system except for patients who pay +.>In addition to the cost of S catheters (about 3 ten thousand yuan each), hospitals are required to be equipped with a Straub power system (about 70 ten thousand yuan); the AngioJet catheters were each about 2.8 ten thousand yuan; the hospital needs to be provided with a driving device (about 100 ten thousand yuan or more); (3) The thrombus suitable for intravascular filling is often incomplete in sucking the thrombus with large pipe diameters such as coanda thrombus, superior vena cava and the like due to the limited pipe diameter, and the purpose of completely removing the thrombus cannot be achieved; (4) The blood loss is more, and the blood loss of the patient is about 120-200 ml in each operation. (5) Part of the red blood cells are destroyed during the catheterization process of the Angiojet catheter, and the patient develops hemoglobinuria and even renal insufficiency.

As is clear from the above discussion, all of the conventional thrombus filtering devices, thrombus removing techniques, thrombus filtering devices and thrombus removing devices in the above patent documents have one or more drawbacks. Accordingly, there is a need for further improvements in the art, and it is desirable to design a system device that combines thrombus filtering and thrombus removal.

Disclosure of Invention

In order to solve the technical problems, the invention aims to provide a system device with thrombus filtering, pulmonary embolism protection and thrombus removal functions in blood vessels. The device combines thrombus interception and thrombus removal, has simple structure, convenient operation, safety and reliability, and is favorable for reducing medical cost and operation complications. Specifically, the invention provides a system device with thrombus filtering, pulmonary embolism protection and thrombus removal functions, which is characterized in that: comprises a thrombus filter screen and a thrombus taking basket; wherein the thrombus filter screen comprises an outer screen, an inner screen and a conveying total sheath; the inner net passes through the outer net cavity, the outer net can pass through the conveying main sheath, the thrombus taking basket can pass through the inner net cavity, and the inner net, the outer net and the thrombus taking basket are provided with extensible and retractable parts.

Further, it is characterized in that: the outer net comprises an outer net body, an outer net sheath tube, a conversion buckle and a hemostatic valve, wherein the outer net body is an expandable and recyclable part of the outer net and is in a cone shape, the proximal end of the outer net body is fixedly connected with the wall of the distal end of the outer net sheath tube to form a through opening corresponding to the inner diameter of the outer net sheath tube, the through opening is communicated with the lumen of the outer net sheath tube, and the proximal end of the outer net sheath tube is connected with the hemostatic valve through the conversion buckle.

Further, it is characterized in that: the inner net comprises an inner net body, an inner net sheath pipe and a hemostatic valve, wherein the inner net body is an expandable and recyclable part of the inner net, the proximal end of the inner net body is fixedly connected with the wall of the distal end of the inner net sheath pipe, a through opening corresponding to the inner diameter of the inner net sheath pipe is formed and communicated with the inner net sheath pipe cavity, and the proximal end of the inner net sheath pipe is connected with the hemostatic valve.

Further, it is characterized in that: the thrombus taking basket comprises a net bag, a basket opening, a basket beam, a wire receiving and delivering cable and a handle, wherein the basket opening is an expandable part of the thrombus taking basket and comprises 1-3 scaly structures formed by metal wires; the tops of the scale structures are respectively connected with a receiving and sending steel cable through a basket beam; the basket beam is preferably made of shape memory materials or high-elasticity materials, one end of the basket beam is fixedly connected with the basket opening, and the other end of the basket beam is converged and fixedly connected with the receiving and delivering steel cable; the net bag is a soft silk screen which is connected with the basket mouth and is tightly woven.

Further, it is characterized in that: in the thrombus filter screen, the inner diameter and the outer diameter of a conveying main sheath, an outer net sheath tube, an inner net sheath tube and a thrombus taking basket conveying sheath are sequentially reduced, so that the thrombus filter screen can sequentially pass through the upper-stage sheath tube, and the tube cavities of the thrombus filter screen are coaxial.

Further, it is characterized in that: the conveying main sheath is a sheath tube with larger diameter, and a conveying channel is provided for releasing and recovering an outer net and an inner net; the outer net sheath tube can pass through the inner cavity of the conveying main sheath tube and can also provide a conveying and recycling channel for the inner net; the inner mesh sheath tube can pass through the inner mesh sheath tube cavity and can also provide a conveying and recycling channel for the thrombus taking basket and the like.

Further, it is characterized in that: the net body comprises one or more longitudinal ridges to form a cone-shaped framework, and the net body is provided with longitudinal supporting force and is covered with a shape memory material or a silk yarn material with more flexibility to form a net structure.

Further, it is characterized in that: the net body is formed by a cone-shaped net structure formed by carving, shaping or braiding a shape memory material.

Further, it is characterized in that: the hemostatic valve can be taken down from the proximal section of the outer net sheath, and after the hemostatic valve is taken down, the outer net sheath can be connected with the switching steel cable through the switching buckle so as to take out the conveying total sheath; then the hemostatic valve is connected, so that the external net can retain emboli such as filtered thrombus in the body for a long time.

Further, it is characterized in that: one end of the conversion steel cable is connected with a fixed conversion bolt, and can be connected with a conversion buckle at the near section of the outer net sheath pipe so as to conveniently take out a conveying total sheath of the thrombus filter screen; when the external net is required to be retracted, the conversion steel cable can be connected again, the conveying main sheath is conveyed into the blood vessel of the person along the conversion steel cable, and the external net is retracted.

The invention has the following effects:

the technical scheme of the invention has the following advantages:

firstly, the condition that the existing vena cava filter or thrombus filter only has thrombus filtering effect and the thrombus removing device only can remove thrombus is changed, and a systematic device combining thrombus interception and thrombus removal is designed to achieve the purposes of protecting pulmonary embolism and removing thrombus;

secondly, a thrombus filter screen (thrombus interception part) can be conveyed to an upper vena cava (comprising a proximal end thereof) and a lower vena cava (comprising a proximal end thereof) so as to intercept the threat from systemic venous emboli;

thirdly, the thrombus filter screen is divided into an inner net and an outer net, has double-layer protection, and can intercept and take out a large amount of thrombus even if the thrombus falls off; meanwhile, the thrombus filter screen can intercept smaller emboli than the traditional filter, and the efficiency is higher;

fourthly, the thrombus filter screen has good flexibility and radial supporting force and good adherence, and the thrombus filter screen with the same specification can adapt to central veins with different diameters;

fifthly, the thrombus filter screen has good longitudinal support, and even if one end of the thrombus filter screen is placed in the right atrium, the thrombus filter screen does not drift along with blood flow;

sixthly, the thrombus filter screen does not have barbs designed for preventing the traditional vena cava filter from shifting, and has little damage to the wall of the blood vessel;

seventh, the thrombus filtering outer net is longer, and has double supports of the filter screen and the sheath, so that the thrombus filtering outer net has good stability and is not easy to shift;

eighth, the thrombus filter screen is connected with hollow sheath tube, the thrombus taking basket (thrombus taking part) can reach thrombus position through sheath tube, and thrombus is taken out through sheath tube, so as to realize the combination of thrombus taking and thrombus preventing;

ninth, the thrombus taking basket has good compliance, and the thrombus taking basket with the same specification can adapt to the change of the diameter of a blood vessel in a certain range; simultaneously, a thrombus taking basket with smaller diameter can be provided to adapt to the requirement of a blood vessel with smaller diameter;

tenth, the thrombus taking basket is provided with a longer net bag, can accommodate a large amount of thrombus and has high thrombus removing efficiency;

eleven, the thrombus taking basket can take thrombus from the proximal end of thrombus and can take thrombus from the distal end of thrombus, so that the thrombus taking device is flexible and convenient;

twelve, the thrombus removing process is safe, and even if thrombus falls off in operation, the pulmonary embolism is not caused due to the protection of the thrombus filter screen;

thirteen of the thrombus filter screen and the thrombus taking basket are placed and retracted, so that the thrombus filter screen is safe and reliable;

fourteen external driving devices are not needed, the cost is low, and the medical expense and hospital burden of patients can be reduced. .

Description of the drawings:

fig. 1 is a diagram of an external network structure of the present invention, wherein a is a front view, and B is a right view.

Fig. 2 is a diagram of the intranet structure of the present invention.

Fig. 3 is a schematic structural view of an example of the outer net, inner net and thrombus removal basket of the present invention assembled together.

Fig. 4 is a schematic structural view of an inner mesh body, an inner mesh sheath, an outer mesh body, and an outer mesh sheath in the present invention, which are accommodated in a conveying sheath.

Fig. 5 is a schematic structural diagram of an inner mesh body, an inner mesh sheath, an outer mesh body, and an outer mesh sheath of the present invention accommodated in a conversion sheath.

Fig. 6 is a schematic structural view of an example of a switching cable of the outer wire sheath of the present invention.

Fig. 7 is a schematic structural view of an example of the thrombus removal basket of the present invention, wherein a is a front view and B is a right side view.

Fig. 8 is a schematic view showing an example of the thrombus-removing basket of the present invention preloaded with the delivery sheath.

Fig. 9 is a schematic view showing an example of removal of a right brachiocephalic vein, superior vena cava, thrombus via the right femoral vein.

Fig. 10 is a schematic view showing an example of removal of a right brachiocephalic vein, superior vena cava thrombus via the right internal jugular vein.

Fig. 11 is a schematic view showing an example of taking out a large thrombus fallen out to an inner mesh body via a right femoral vein.

The specific embodiment is as follows:

the terms "distal" and "proximal" herein refer to a position relative to an operator, with the side remote from the operator being the "distal" and the side near the operator being the "proximal";

as shown in fig. 1-8, the system device with thrombus filtering, pulmonary embolism protection and thrombus removal functions comprises a thrombus filter screen and a thrombus taking basket; the thrombus filter screen comprises a conveying main sheath 1, an outer screen and an inner screen; the thrombus taking basket comprises a net bag 18, a basket opening 19, a basket beam 20, a wire rope 21 and a handle 22.

As shown in fig. 1, the outer net comprises an outer net body 2, an outer net sheath tube 4, a conversion buckle 8 and a hemostatic valve 9. The outer net body 2 is cone-shaped, the proximal end of the outer net body is fixedly connected with the wall of the distal end of the outer net sheath tube 4, a through opening corresponding to the inner diameter of the outer net sheath tube 4 is formed, and the through opening is communicated with the lumen of the outer net sheath tube 4; the proximal end of the outer net sheath tube 4 is connected with a hemostatic valve 9 through a conversion buckle 8; the method comprises the steps of carrying out a first treatment on the surface of the The hemostatic valve 9 may be removable from the proximal end of the outer mesh sheath 4 or may be connected by a switch button 8. The outer net body 2 comprises a plurality of longitudinal ridges 6 to form a cone-shaped framework, provides longitudinal supporting force, and is covered with a shape memory material or silk yarn material with more flexibility to form a net structure 7; preferably, the longitudinal ridges 6 may be engraved or shaped from one or more pieces of shape memory material or highly elastic material. Preferably, the number of the longitudinal ridges is 6-12. The outer net body 2 can also be formed by a cone-shaped net structure made of shape memory materials through carving, molding or braiding so as to intercept emboli such as fallen thrombus. Preferably, the outer mesh body 2 contains an X-ray opaque substance, the position of which can be monitored by Digital Subtraction Angiography (DSA).

Fig. 2 shows the inner mesh of the thrombus filter screen of the present invention, which comprises an inner mesh body 3, an inner mesh sheath 5 and a hemostatic valve 13. The net body 3 of the inner net is similar to the net body 2 of the outer net, the proximal end of the net body is fixedly connected with the wall of the distal end of the inner net sheath 5, a through opening corresponding to the inner diameter of the inner net sheath 5 is formed, and the through opening is communicated with the lumen of the inner net sheath 5. The proximal end of the inner mesh sheath tube 5 is connected with a hemostatic valve 13. The inner net body 3 can also be formed into a longitudinal ridge 14 by carving or molding one or more pieces of shape memory material or high-elasticity material, and is covered with shape memory material or silk yarn material with more flexibility to form a net structure 15; the inner net body 13 can also be formed by a cone-shaped net structure formed by carving, shaping or braiding shape memory materials so as to intercept emboli such as fallen thrombus. Preferably, the intranet mesh 3 contains an X-ray opaque substance, and the position of the intranet 3 can be monitored by Digital Subtraction Angiography (DSA).

The outer net 13 and the inner net 15 are tightly attached to the inner wall of the blood vessel after being opened, can intercept the fallen thrombus in the thrombus taking process, provide double protection effects, and can be used together or independently; the inner net 15 can intercept the fallen thrombus, provide a protection effect, and can be matched with the thrombus taking basket to take out the thrombus; the inner net and the outer net have enough radial supporting force to ensure good adherence, so that thrombus is firstly intercepted by the inner net and taken out; if the internal net fails to intercept the fragile thrombus in the operation, the thrombus is ensured to be intercepted by the external net, and the pulmonary embolism is prevented.

Fig. 3 shows an example of the thrombus filter screen of the present invention assembled together with an outer screen, an inner screen and a thrombus removal basket. The outer net sheath tube 4 of the thrombus filter screen is arranged in the conveying main sheath 1, the inner net sheath tube 5 is arranged in the outer net sheath tube 4, the thrombus taking basket is arranged at the far end of the inner net sheath tube through the inner net sheath tube 5, and the outer net body 2, the inner net body 3 and the thrombus taking basket openings 18 are all unfolded.

Fig. 4 shows an example state in which the inner mesh body 3, the inner sheath 5, the outer mesh body 2, and the outer mesh sheath 4 of the present invention are housed in the transport main sheath 1. The conveying main sheath 1 is a sheath pipe with larger diameter, and provides a conveying channel for releasing and recovering an outer net and an inner net; the outer net sheath tube 4 can pass through the cavity of the conveying main sheath 1 and can also provide a conveying and recycling channel for an inner net; the inner net sheath tube 5 can pass through the cavity of the outer net sheath tube 4 and can also provide a conveying and recycling channel for a thrombus taking basket and the like; after the conveying main sheath 1 is conveyed to the proximal end of the venous thrombosis, the inner net body 3 and the outer net 2 can be conveyed to the proximal end of the venous thrombosis through the conveying main sheath 1, so as to intercept emboli such as the thrombosis.

Fig. 5 shows an example state in which the inner net 3, the inner sheath 5, the outer net 2, and the outer net sheath 4 are accommodated in the conversion sheath 16. Before being delivered to a vein where thrombus is formed, the inner net body 3 and the outer net body 2 are accommodated in the conversion sheath 16; when needed in the process of intercepting thrombus in clinical application, the conversion sheath 16 can be sent into the delivery main sheath 1 through the hemostatic valve 17 of the delivery main sheath 1, and then can be delivered to the proximal end of venous thrombus.

Fig. 6 shows a switching cable 11 of the outer wire sheath 4 according to the invention. After the hemostatic valve 9 at the proximal end of the outer net sheath 4 is removed from the proximal end of the outer net sheath 4, the outer net sheath 4 can be connected with a conversion steel cable 11 through a conversion buckle 8 so as to take out the conveying total sheath 1; then the hemostatic valve 9 is connected, so that the external net can keep emboli such as filtered thrombus in the body for a long time; the handle 12 is arranged at the proximal end of the conversion steel cable 11, so that the operation is convenient; the far end of the outer net sheath tube 4 is connected with a fixed conversion bolt 10, and can be connected with a conversion buckle 8 at the near end of the outer net sheath tube 4 so as to take down the conveying main sheath 1 from the outside of the outer net sheath tube 4, so that the outer net can be left in the body for a long time to filter emboli; when the external net is required to be retracted, the conversion steel cable 11 can be connected again, the conveying main sheath 1 is conveyed into the blood vessel along the conversion steel cable 11 and the external net sheath tube 4, and the external net is retracted.

Fig. 7 shows an example of a schematic structure of a thrombolytic basket according to the present invention, which comprises a net bag 18, a basket opening 19, a basket beam 20, a wire rope 21 and a handle 22. The basket opening 19 is formed by 1-3 squama structures formed by metal wires, the squama structures are formed by two diamond structures formed by metal wires, the center of the proximal end of the squama structure protrudes and is connected with the basket beam, so that the basket opening is easy to shrink along with the retraction of the basket beam, the basket opening can be tightly attached to the inner wall of a blood vessel after being opened, the top of the squama structure is respectively connected with a receiving and delivering steel cable 21 through a basket beam 20, and the basket opening can be opened after being released from a delivery sheath 24 and can be folded through an intranet sheath tube 5; the basket beams 20 are 1 to 3, preferably made of shape memory materials or high-elasticity materials, one end of each basket beam is fixedly connected with the basket opening 19, and the other end of each basket beam is converged and fixedly connected with the receiving and delivering steel cable 21; the net bag 18 is a soft silk screen which is connected with the basket mouth 19 and is tightly woven, can accommodate and take out thrombus and has strong deformability; the bottom of the net may be connected to the wire rope 21 by suspension wires 23, which may be made of metal wires. When the net bag is made of metal wires, suspension wires are not needed to be connected; the handle 22 is connected with the wire rope 21, which is convenient for conveying, withdrawing and taking-out the thrombus basket. The end of the net bag 18, the basket opening 19, contains an X-ray opaque substance and the position of the inner net 3 can be monitored by means of a digital subtraction angiography DSA.

The wire rope 21 has a certain hardness and is deformable; the device is used for conveying and retracting the thrombus taking basket to complete the thrombus removing task;

the conveying sheath 24 is a sheath containing a hollow inner core, the conveying sheath can reach the distal end of thrombus along a preset guide wire, and the inner core has the function of supporting and expanding the conveying sheath 24; after the guide wire and the inner core are withdrawn, a conveying channel can be provided for releasing and recovering the thrombus taking basket (the guide wire is a common interventional device and provides a guiding function for other interventional devices to enter a blood vessel);

the handle 22 of the thrombus removing basket is connected with the wire rope 21 for convenient operation in the process of conveying and withdrawing the thrombus removing basket;

in the thrombus filter screen, the lumen of the conveying main sheath 1, the outer net sheath tube 4, the inner net sheath tube 5 and the thrombus taking basket conveying sheath tube 24 are coaxial, and the inner diameter and the outer diameter of the conveying main sheath tube are sequentially reduced, so that the thrombus filter screen can sequentially pass through the sheath tube of the previous stage.

In the thrombus filter screen, locking devices are arranged between the proximal end of the main conveying sheath 1 and the outer net sheath tube 4 and between the outer net sheath tube 4 and the inner net sheath tube 5, and after the outer net reaches the position, the locking devices can prevent the proximal end of the main conveying sheath 1 and the outer net sheath tube 4 and between the outer net sheath tube 4 and the inner net sheath tube 5 from mutual displacement.

The components of the thrombus filter screen, such as the outer screen, the inner screen, the thrombus taking basket and the like, contain X-ray impermeable substances, and the positions of the X-ray impermeable substances can be monitored by a Digital Subtraction Angiography (DSA) to know the positions of the thrombus filter screen, such as the outer screen, the inner screen and the thrombus taking basket;

according to the thrombus filter screen disclosed by the invention, the surfaces of the conveying main sheath 1, the outer net sheath tube 4, the outer net, the inner net sheath tube 5, the conveying sheath tube 24 of the inner net and the thrombus taking basket, the basket opening 19, the basket beam 20 and the receiving and delivering steel cable 21 are coated with a certain lubricating coating, so that the pushing resistance is reduced by the lubricating coating, and the operability of an instrument is better; preferably, the coating material is a PTFE coating or a hydrophilic coating.

The main conveying sheath 1, the outer net sheath tube 4, the inner net sheath tube 5 and the conveying sheath tube 24 of the thrombus removing basket are made of polymer materials, such as polytetrafluoroethylene;

fig. 8 shows an example of the present invention with the embolic basket preloaded in the delivery sheath 24. The thrombus taking basket is preloaded in the conveying sheath 24, and can be conveniently conveyed to the far end of the venous thrombus through the inner net sheath 5, the outer net sheath 4 or the vascular sheath which is placed in the vein, so as to take out the thrombus.

The operation of the device according to the invention is described below with reference to the accompanying drawings:

fig. 9 shows an example of removal of a right brachiocephalic vein, superior vena cava, thrombus via the right femoral vein. Puncture through the right femoral vein 25, put into the delivery sheath 1, establish the right femoral vein to the superior vena cava 27 via the inferior vena cava 26; inserting the pre-installed inner net and outer net conversion sheath 16 into the hemostatic valve 17 of the delivery main sheath 1, delivering the inner net body 3 and the outer net body 2 to the proximal end of thrombus 28 in the superior vena cava 27 through the delivery main sheath 1, and retracting the delivery main sheath 1 to expand the inner net body 3 and the outer net body 2 so as to intercept emboli such as thrombus which may fall off; a locking device is not marked between the proximal end of the main conveying sheath 1 and the outer net sheath tube 4 and between the outer net sheath tube 4 and the inner net sheath tube 5, and when the outer net and the inner net reach the positions, the locking device can prevent the proximal end of the main conveying sheath 1 and the outer net sheath tube 4 and the inner net sheath tube 5 from shifting mutually; the conveying sheath 24 of the pre-installed thrombus taking basket is delivered to the right brachiocephalic vein and the right internal jugular vein 29 at the far end of the thrombus of the superior vena cava through the internal network sheath 5, the conveying sheath 24 is retracted to release the thrombus taking basket opening 19 and the net bag 18, the thrombus taking basket handle 22 is held by hand, the thrombus taking basket is retracted, the thrombus bag in the right brachiocephalic vein and the superior vena cava is taken into the net bag 18 through the thrombus taking basket opening 19, the thrombus taking basket is continuously retracted, and the thrombus 28 is taken out of the body through the internal network net body 3 and the internal network sheath 5. If the thrombus is not removed once, the thrombus can be removed by using the thrombus removing basket for multiple times until the thrombus is completely removed. And then withdrawing the inner net and the outer net through the conveying main sheath 1, and finally withdrawing the conveying main sheath 1, and pressurizing and binding the puncture points to complete the whole process of thrombus taking.

Fig. 10 shows an example of removal of a right brachiocephalic vein, superior vena cava, thrombus via the right internal jugular vein 29. Puncture through the right femoral vein 25, put into the delivery sheath 1, establish the right femoral vein to the superior vena cava 27 via the inferior vena cava 26; the conversion sheath 16 of the pre-installed inner net body 3 and the pre-installed outer net body 2 is inserted into the hemostatic valve 17 of the conveying main sheath 1, the inner net and the outer net are conveyed to the proximal end of thrombus 28 in the superior vena cava 27 through the conveying main sheath 1, and the conveying main sheath 1 is retracted to expand the inner net body and the outer net body so as to intercept emboli such as thrombus which may fall off; the thrombus is punctured through the right internal jugular vein 29, a vascular sheath tube is not marked, the conveying sheath tube 24 of the pre-installed thrombus taking basket is conveyed to the proximal end of the thrombus of the right brachiocephalic vein and the superior vena cava through the vascular sheath tube, the conveying sheath tube 24 is retracted to release the thrombus taking basket opening 19 and the net bag, the thrombus taking basket handle 22 is held by hands, the thrombus taking basket is retracted, the thrombus is taken into the net bag through the thrombus taking basket opening, the conveying sheath tube 24 is pushed forward to close the basket opening 19, the thrombus taking basket is retracted continuously, and the thrombus 28 is taken out of the body through the vascular sheath tube. The thrombus can be removed by using the thrombus removing basket for a plurality of times until the thrombus is completely removed.

Fig. 11 shows an example of a large thrombus that has fallen off to the inner mesh body 3 via the right femoral vein. If the large thrombus falls off to the net body 3 of the inner net in the thrombus taking process, the conveying sheath 24 preloaded with the thrombus taking basket can be conveyed to the far end of the thrombus 28 of the net body 3 of the inner net through the inner net sheath 5 arranged on the femoral vein 25 on the right side, the conveying sheath 24 is retracted to release the thrombus taking basket opening 19 and the net bag 18, the thrombus taking basket handle 22 is held by hand, the thrombus taking basket is retracted, the thrombus 28 in the net body 3 is taken out through the thrombus taking basket opening pocket, and the thrombus 28 is taken out of the body through the inner net sheath 5; the thrombus can be removed for multiple times by using the thrombus removing basket. If a small amount of residual thrombus scraps are not taken out, the residual thrombus scraps can be taken out together in the process of recovering the intranet; even if thrombus fragments 30 overflow from the inner net body 3, the thrombus fragments can be intercepted by the outer net body 2 and can be taken out together in the process of withdrawing the outer net. Catheter thrombolysis can also be placed through the outer mesh sheath 4. Finally, the inner net and the outer net are retracted through the conveying general sheath 1, and finally the conveying general sheath 1 is withdrawn, and the puncture point is pressurized and bound, so that the whole process of thrombus taking is completed.

If other diagnosis and treatment operations are needed, the outer net sheath pipe 4 can be connected through the conversion steel cable 11 of the outer net sheath pipe, and the conveying main sheath 1 is removed from the outer net sheath pipe; the inner net is retracted through the outer net sheath tube 4, and then a guide wire, a contrast catheter, a thrombolysis catheter and the like are placed through the outer net sheath tube 4 to carry out corresponding diagnosis and treatment operations. The external network can be left in the vena cava for a long time to prevent pulmonary embolism. When the outer net is required to be withdrawn, the conversion steel cable 11 is connected again, the delivery main sheath 1 is delivered into the blood vessel along the conversion steel cable 11 and the outer net sheath tube 4, the outer net is withdrawn, and the delivery main sheath 1 is withdrawn, so that the operation is completed.

Compared with the prior art, the invention not only has thrombus filtering and pulmonary embolism protection functions, but also has a thrombus removing basket for removing thrombus, thus combining thrombus prevention and removal; the thrombus filter screen is double-layered, so that the embolic protection is realized in the thrombus taking process;

the thrombus filter screen comprises an outer screen, an inner screen and the like, wherein the outer screen and the inner screen are formed by conical cylindrical longitudinal ridges to form a framework, longitudinal supporting force is provided, and a recoverable silk screen-like structure is covered; the thrombus taking basket has simple structure, free retraction and high thrombus taking efficiency. The invention does not need to be equipped with an external driving device, has low manufacturing cost and is beneficial to reducing the medical cost of patients and the burden of hospitals.

The thrombus filter screen provided by the invention has a double-layer structure comprising an inner net and an outer net, and the two can be matched for use and can be used independently.

The device and its components of the present invention are not only applicable to venous systems, but also arterial systems.

The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present invention, which are intended to be comprehended within the scope of the present invention. In addition, although specific terms are used in the present specification, these terms are merely for convenience of description and do not set any limit to the present invention.

Claims

1. A system device with thrombus filtering and thrombus removing functions, which is characterized in that: comprises a thrombus filter screen and a thrombus taking basket; wherein the thrombus filter screen comprises an outer screen, an inner screen and a conveying total sheath; the inner net passes through the outer net cavity, the outer net can pass through the conveying main sheath, the thrombus taking basket can pass through the inner net cavity, and the inner net, the outer net and the thrombus taking basket are provided with extensible and retractable parts;

the outer net comprises an outer net body, an outer net sheath tube, a conversion buckle and a hemostatic valve, wherein the outer net body is an expandable and recyclable part of the outer net and is in a cone shape, the proximal end of the outer net body is fixedly connected with the wall of the distal end of the outer net sheath tube to form a through opening corresponding to the inner diameter of the outer net sheath tube, the through opening is communicated with the lumen of the outer net sheath tube, and the proximal end of the outer net sheath tube is connected with the hemostatic valve through the conversion buckle;

the inner net comprises an inner net body, an inner net sheath pipe and a hemostatic valve, wherein the inner net body is an expandable and recyclable part of the inner net, the proximal end of the inner net body is fixedly connected with the wall of the distal end of the inner net sheath pipe to form a through opening corresponding to the inner diameter of the inner net sheath pipe, the through opening is communicated with the inner net sheath pipe cavity, and the proximal end of the inner net sheath pipe is connected with the hemostatic valve;

the thrombus taking basket comprises a net bag, a basket opening, a basket beam, a receiving and delivering steel cable and a handle, wherein the basket opening is an expandable part of the thrombus taking basket and is connected with the receiving and delivering steel cable through the basket beam; the basket beam is made of shape memory material or high elastic material, one end of the basket beam is fixedly connected with the basket opening, and the other end of the basket beam is converged and fixedly connected with the receiving and delivering steel cable; the net bag is a soft silk screen which is connected with the basket mouth and is tightly woven.

2. The system arrangement according to claim 1, characterized in that: in the thrombus filter screen, the inner diameter and the outer diameter of a conveying main sheath, an outer net sheath tube, an inner net sheath tube and a thrombus taking basket conveying sheath are sequentially reduced, so that the thrombus filter screen can sequentially pass through the upper-stage sheath tube, and the tube cavities of the thrombus filter screen are coaxial.

3. The system arrangement according to claim 1, characterized in that: the conveying main sheath is a sheath tube and provides a conveying channel for releasing and recovering an outer net and an inner net; the outer net sheath tube can pass through the inner cavity of the conveying main sheath tube and can also provide a conveying and recycling channel for the inner net; the inner mesh sheath tube can pass through the inner mesh sheath tube cavity and can also provide a conveying and recycling channel for the thrombus taking basket and the like.

4. The system arrangement according to claim 1, characterized in that: the net body comprises one or more longitudinal ridges to form a cone-shaped framework, and the net body is provided with longitudinal supporting force and is covered with a shape memory material or a silk yarn material with more flexibility to form a net structure.

5. The system arrangement according to claim 4, characterized in that: the net body is formed by a cone-shaped net structure formed by carving, shaping or braiding a shape memory material.

6. The system arrangement according to claim 1, characterized in that: the hemostatic valve can be taken down from the proximal section of the outer net sheath, and after the hemostatic valve is taken down, the outer net sheath can be connected with the switching steel cable through the switching buckle so as to take out the conveying total sheath; then the hemostatic valve is connected, so that the external net can keep the in-vivo filtering emboli for a long time.

7. The system arrangement according to claim 6, characterized in that: one end of the conversion steel cable is connected with a fixed conversion bolt, and can be connected with a conversion buckle at the near section of the outer net sheath pipe so as to conveniently take out a conveying total sheath of the thrombus filter screen; when the external net is required to be retracted, the conversion steel cable can be connected again, the conveying main sheath is conveyed into the blood vessel of the person along the conversion steel cable, and the external net is retracted.