WO2020258943A1 - 滤器回收保护装置、滤器回收系统及方法、过滤系统 - Google Patents

滤器回收保护装置、滤器回收系统及方法、过滤系统 Download PDF

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Publication number
WO2020258943A1
WO2020258943A1 PCT/CN2020/080769 CN2020080769W WO2020258943A1 WO 2020258943 A1 WO2020258943 A1 WO 2020258943A1 CN 2020080769 W CN2020080769 W CN 2020080769W WO 2020258943 A1 WO2020258943 A1 WO 2020258943A1
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Prior art keywords
filter
sheath
recovery
protection device
assembly
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PCT/CN2020/080769
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English (en)
French (fr)
Inventor
朱永锋
朱清
Original Assignee
上海微创心脉医疗科技股份有限公司
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Publication of WO2020258943A1 publication Critical patent/WO2020258943A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels

Definitions

  • the invention relates to the technical field of medical equipment, in particular to a filter recovery protection device, a filter recovery system and method, and a filter system.
  • VTE Venous thromboembolism
  • DVT deep vein thrombosis
  • PE pulmonary embolism
  • DVT often occurs in the veins of the lower extremities
  • PE is mainly caused by thrombosis in the venous system or the right heart artery and then falls off into the pulmonary artery. It is the main cause of illness and death in patients.
  • anticoagulation therapy has always been the gold standard of VTE treatment, with the purpose of preventing thrombosis and pulmonary embolism, and keeping veins open.
  • a vena cava filter VCF
  • the filter needs to be recovered after a certain period of time.
  • the thrombus intercepted in the filter may fall off and cause pulmonary embolism, causing serious consequences.
  • treatment guidelines do not recommend the recovery of filters with large clots (usually greater than 1 cm in size).
  • filters with large clots usually greater than 1 cm in size
  • the general treatment method is to use the original filter. Place a second filter at the proximal end, and then intervene in thrombolysis.
  • the purpose of the present invention is to provide a filter recovery protection device, a filter recovery system and method, and a filter system to solve the problem of thrombus falling off during the filter recovery process.
  • the present invention provides a filter recovery protection device, including a filter assembly for transporting into the blood vessel, the filter assembly including a bag filter layer and a fixed structure, the bag filter layer has a relatively first The distal end and the first proximal end, the first distal end of the bag filter layer has an opening for allowing thrombus to enter the bag filter layer when the filter is recovered; the fixing structure is arranged at The first distal end is used to adhere to the inner wall of the blood vessel.
  • the fixing structure includes a frame, and the frame is provided at the first distal end of the bag filter layer and is used to adhere to the inner wall of the blood vessel.
  • the fixing structure further includes a positioning member for fixing the filter assembly to the inner wall of the blood vessel.
  • the positioning member includes at least two barbs arranged on the frame, and the at least two barbs are arranged at intervals along the circumferential direction of the frame.
  • the filter component is a compressible component.
  • the filter component In the uncompressed state, the filter component has a tapered structure, and the cross section of the filter component perpendicular to the axis is from the first distal end to the first The proximal end gradually decreases.
  • the filter component is a compressible component, and in an uncompressed state, the frame is in the shape of a fish mouth; or, the frame is elliptical and intersects the axis of the filter component but is not perpendicular; or, The frame is a wave-shaped bracket.
  • the bag filter layer is provided with holes for blood circulation.
  • the shape of the hole is at least one of a circle, an oval, a diamond, and a triangle.
  • the filter recovery protection device further includes a transport assembly, and the transport assembly includes a first sheath, a first sheath dilator, a first guide wire, and an introduction tube set;
  • the outer diameter of the first sheath dilator is smaller than the inner diameter of the first sheath, and the first sheath dilator can penetrate the first sheath and extend from the first sheath, and is Introducing the first sheath into the blood vessel under the guidance of the first guide wire;
  • the introduction tube set is detachably disposed in the first sheath, and is used for accommodating the filter assembly to transport the filter assembly to the proximal end of the filter.
  • the transport assembly further includes a recycling wire connected to the filter assembly for recycling the filter assembly.
  • the introduction tube group includes a pre-installed tube and a push tube;
  • the pre-installed tube is used to accommodate the filter assembly and can be detachably disposed in the first sheath tube;
  • the push tube has a second distal end and a second proximal end opposite to each other, and the second distal end of the push tube is disposed in the pre-installed tube and used to communicate with the first proximal end of the bag filter layer. End contact to push the filter assembly from the pre-installed tube into the first sheath tube.
  • the first sheath tube has a third distal end and a third proximal end opposite to each other, and the third distal end of the first sheath tube is provided with a first imaging ring.
  • the first sheath dilator has an inner cavity extending through the axial direction, and the inner cavity is used for piercing the first guide wire.
  • the present invention also provides a filter recovery system, including a filter recovery device and the aforementioned filter recovery protection device;
  • the filter recovery device is used to recover the filter
  • the filter recovery protection device is used for being arranged at the proximal end of the filter and intercepting thrombus falling from the filter.
  • the filter recovery device includes a second sheath, a catching catheter, and a catcher;
  • the capture catheter is detachably arranged in the second sheath
  • the catcher is arranged in the catching conduit and used to connect with the filter.
  • the filter recovery device further includes a second sheath dilator and a second guide wire;
  • the second sheath dilator is detachably connected with the second sheath and is used for piercing the second guide wire to introduce the second sheath into the blood vessel.
  • the present invention also provides a filter system, including a filter and the filter recovery system as described above.
  • the present invention also provides a filter recovery method, including:
  • the present invention also provides another filter recovery method, including:
  • the filter recovery device of the filter recovery system is used to recover the filter, and the filter assembly is used to intercept thrombus falling from the filter;
  • the filter recovery protection device Compared with the prior art, the filter recovery protection device, filter recovery system and method, and filtration system of the present invention have the following advantages:
  • the filter recovery protection device includes a filter assembly that includes a bag filter layer and a fixed structure.
  • the bag filter layer is arranged at the proximal end of the filter to intercept the filter
  • the fixed structure is used to adhere to the inner wall of the blood vessel when the filter is recovered, so that the bag filter layer can completely intercept the thrombus, thereby preventing large-sized thrombus from entering the vein and causing pulmonary embolism.
  • FIG. 1 is a schematic structural diagram of a filter recovery protection device according to an embodiment of the present invention.
  • the filter assembly is compressed in the transport assembly, and the first sheath and the first sheath dilator are not shown;
  • FIG. 2 is a schematic structural diagram of a filter recovery protection device according to an embodiment of the present invention.
  • the filter assembly is released, and the first sheath and the first sheath dilator are not shown;
  • FIG. 3 is a schematic diagram of the filter recovery system provided by the present invention according to an embodiment of the present invention when recovering filters and thrombus;
  • FIG. 4 is a schematic structural diagram of a filter assembly of a filter recovery protection device according to an embodiment of the present invention.
  • 5a to 5c are schematic diagrams of the deformed structure of the filter assembly of the filter recovery protection device of FIG. 4;
  • 6a is a schematic diagram of the connection relationship between the recovery wire and the filter assembly of the filter recovery protection device according to an embodiment of the present invention
  • 6b is a schematic diagram of the connection relationship between the recovery wire and the filter assembly of the filter recovery protection device according to another embodiment of the present invention.
  • FIG. 7 is a schematic structural view of a first sheath of a filter recovery protection device according to an embodiment of the present invention.
  • FIG. 8 is a schematic structural view of the first sheath dilator of the filter recovery protection device according to an embodiment of the present invention.
  • FIG. 9 is a schematic structural view of the first sheath tube and the first sheath tube dilator of the filter recovery protection device according to an embodiment of the present invention when assembled;
  • FIG. 10 is a schematic diagram of the filter recovery protection device provided by the present invention according to an embodiment of the present invention when recovering filter components;
  • FIGS. 11a and 11b are schematic diagrams when the filter recovery device in the filter recovery system according to an embodiment of the present invention is delivered into a blood vessel;
  • Figures 12a and 12b are schematic diagrams of the filter recovery system according to another embodiment of the present invention when the filter and thrombus are recovered.
  • the core idea of the present invention is to provide a filter recovery protection device, including a filter assembly, the filter assembly includes a bag filter layer and a fixed structure, the bag filter layer has a first distal end and a first proximal end opposite to each other, The first distal end of the bag filter layer has an opening, the opening is used to allow blood clots to enter the bag filter layer when the filter is recovered; the fixing structure is arranged at the first distal end The end is used to fit the inner wall of the blood vessel.
  • the filter recovery protection device is used to be arranged at the proximal end of the filter when the filter is recovered, so as to intercept the thrombus falling from the filter and prevent large-size thrombus from entering the pulmonary artery and causing pulmonary embolism. Moreover, after the filter assembly intercepts the thrombus, the thrombus can be recovered together with the filter assembly, thereby completely eliminating the adverse effects of the thrombus in the human body.
  • distal and proximal refer to the relative position, relative position, and direction of the elements or actions relative to each other from the perspective of the operator who uses the filter recovery protection device and the filter recovery system, although “Remote” and “proximal” are not restrictive, but “distal” usually refers to the end that enters the patient's body first, and “proximal” usually refers to the filter recovery system and filter recovery protection device during normal operation Close to the end of the operator.
  • proximal end and telecentric end refer to the relative position and relative direction of the elements relative to each other from the perspective of the filter relative to the heart. In this context, “proximal end” refers to the end of the filter close to the heart. The “telecentric end” refers to the end of the filter away from the heart.
  • the filter recovery protection device 100 includes a filter assembly 1100.
  • the filter assembly 1100 includes a bag filter layer 1110 and a fixed structure 1120.
  • the bag filter layer 1110 has an opposite first A distal end and a first proximal end.
  • the first distal end has an opening for allowing thrombus in the blood vessel 300 to enter the inner cavity surrounded by the bag filter layer 1110 when the filter 200 is recovered, Furthermore, the thrombus can be intercepted by the bag filter layer 1110; the fixing structure 1120 is arranged at the first distal end and is used to adhere to the inner wall of the blood vessel 300 when the filter 200 is recovered.
  • the thrombus described in this embodiment mainly refers to the thrombus 400 in the blood vessel 300. The following description will take the recovery of thrombus 400 as an example.
  • the filter component 1100 is a compressible component and has an uncompressed state and a compressed state. Before the filter 200 is recovered, the filter assembly 1100 is in a compressed state so as to be transported into the blood vessel 300, and after the filter 200 is recovered, the filter assembly 1100 is in the compressed state so as to facilitate the removal from the blood vessel 300. Withdrawal. When the filter is recovered, the filter assembly 1100 is disposed at the proximal end of the filter 200 and expanded to the uncompressed state, and the fixing structure 1120 is now attached to the inner wall of the blood vessel 300.
  • the filter assembly 1100 can be made of a material with elasticity, so that it can be compressed to the compressed state when a force is applied, and can automatically expand to the uncompressed state after the external force is removed.
  • Specific materials that can be used to make the filter assembly 1100 include polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), and the like. It should be understood that the specific material of the filter assembly 1100 is not limited in the art, as long as it can be compressed and folded and can be used for medical purposes.
  • the filter assembly 1100 is used to intercept the detached thrombus 400, but it should not hinder the flow of blood. Therefore, the bag filter layer 1110 is also formed with a hole 1111 for blood to flow.
  • the bag filter layer 1110 is also formed with a hole 1111 for blood to flow.
  • the size of thrombus 400 is less than 3mm, the possibility of causing pulmonary embolism is low.
  • the size of thrombus 400 entering the blood vessel 300 is greater than or equal to 3mm, it is very likely to cause pulmonary embolism. Therefore, bag filter The layer 1110 should be able to intercept thrombus 400 with a size of 3 mm or more.
  • the size of the hole 1111 is determined according to needs. For example, if the hole 1111 is circular, its diameter may be 0.5-3 mm.
  • the hole 1111 may also be square, triangular, polygonal, or other shapes.
  • a circular hole 1111 is taken as an example to illustrate the size of the hole 1111, which should not constitute a limitation to the present invention.
  • the area of the holes 1111 should be based on the ability to intercept thrombus 400 with a size of 3 mm or more.
  • a fixing structure 1120 is provided at the first distal end of the bag filter layer 1110, so that the filter assembly 1100 can be attached to the inner wall of the blood vessel 300.
  • the bonding here includes not only the case where the first distal end of the bag filter layer 1110 is bonded to the inner wall of the blood vessel 300 without gaps, but also includes the first distal end of the bag filter layer 1110 and the inner wall of the blood vessel 300 When the gap is less than 3mm.
  • the fixing structure 1120 includes a frame 1121, and the frame 1121 is disposed at the first distal end of the bag filter layer 1110 and used to fit the inner wall of the blood vessel 300.
  • the frame 1121 when the filter assembly 1100 is in the open state (that is, the uncompressed state), the frame 1121 may have an oval shape that intersects the axis of the filter assembly 1100 but is not perpendicular.
  • the diameter of the projected circle obtained is preferably not less than the diameter of the blood vessel 300.
  • the diameter of the frame 1121 is generally 15-22 mm.
  • the frame 1121 may also be fish-mouthed as shown in FIG. 5a; or, the frame 1121 may be a wavy support structure as shown in FIG.
  • the frame 1121 may also be It is a spring structure as shown in Figure 5c.
  • the embodiment of the present invention does not limit the specific form of the frame 1121, as long as it can make the first distal end of the bag filter layer 1110 fit the inner wall of the blood vessel 300 so that the inner wall of the blood vessel 300 and the bag
  • the gap at the first distal end of the filter layer 1110 is less than 3 mm or there is no gap at all, and all the thrombus 400 that falls off with a size of more than 3 mm can be intercepted.
  • the fixing structure 1120 further includes a positioning member 1122.
  • the positioning member 1122 is, for example, a barb provided on the frame 1121, which can penetrate the blood vessel
  • the inner wall of 300 is used to fix the filter assembly 1100 on the blood vessel 300 to prevent it from being displaced due to the influence of the flow force of the blood flow, thereby preventing the thrombus 400 from being intercepted.
  • the barbs may be a hook-shaped structure, and the number of the barbs may be multiple and evenly arranged along the circumference of the frame 1121.
  • the positioning member 1122 and the frame 1121 may be connected by welding, mechanical clamping, etc., or may be integrally formed.
  • the filter recovery protection device 100 further includes a transport assembly 1200.
  • the filter assembly 1100 Before the filter 200 is recovered, the filter assembly 1100 may be compressed to the collapsed state (ie, compressed state) and housed in the transport assembly 1200 to be transported by the transport assembly 1200 into the blood vessel 300 And, after the filter 200 is recovered, the filter assembly 1100 may be compressed and housed in the transport assembly 1200 to be transported by the transport assembly 1200 to the outside of the blood vessel 300.
  • the filter assembly 1100 needs to be transported to the proximal end of the filter 200 through the transport assembly 1200, and after the thrombus 400 is intercepted, the filter assembly 1100 It can also be recycled through the transport assembly 1200.
  • the transport assembly 1200 may include a first sheath 1210, a first sheath dilator 1220, a first guide wire 1230, an introduction tube set 1240, and Recycle 1250 silk.
  • the first sheath 1210 includes a first tube body 1211.
  • the first tube body 1211 is of a hollow structure and has a first inner cavity extending through the axial direction, and the first tube
  • the body 1211 has a third distal end and a third proximal end.
  • the third distal end of the first tube body 1211 is provided with a first connecting portion 1212 with a seal (not shown in the figure).
  • the connecting portion 1212 is provided with a first hemostatic valve 1213.
  • the outer diameter of the first tube body 1211 is 10-16F, and its length should be equivalent to the distance from the jugular vein to the proximal end of the filter 200, for example, between 40-60 cm.
  • the third distal end of the first tube body 1211 is also provided with a first developing ring 1214.
  • the first sheath dilator 1220 can directly use a conventional sheath dilator.
  • the length of the first sheath dilator 1220 is 10-50 mm longer than that of the first sheath 1210, and the first sheath dilator 1220 is also of a hollow structure and has a first sheath extending axially.
  • Two lumens, and the first sheath dilator 1220 is used to detachably connect with the first sheath 1210, so that the second lumen of the first sheath dilator 1220 and the first sheath 1210
  • the first guide wire 1230 can be pierced after the first lumen is connected.
  • the first guide wire 1230 can be an existing medical guide wire, and the first guide wire 1230 is detachably set in the first sheath dilator 1220 and used to subsequently guide the filter assembly 1100 into the blood vessel 300.
  • the first guide wire 1230 includes a soft wire section 1231 and a hard wire section 1232, the soft wire section 1231 and the hard wire section 1232 are connected to each other, wherein the soft wire section 1231 is advanced in the blood vessel 300 In the process, it is easy to adapt to the structure of the blood vessel 300 to avoid damage to the blood vessel 300, and the hard wire segment 1232 provides sufficient supporting force for subsequent guiding of other components into the blood vessel 300.
  • the "soft wire segment” referred to here means less rigidity than the "hard wire segment”
  • the “hard wire segment” refers to the hardness greater than the "soft wire segment” .
  • the introduction tube set 1240 is used to accommodate the filter assembly 1100 before recovering the filter 200 and send the filter assembly 1100 into the blood vessel 300 to reach the proximal end of the filter 200.
  • the introduction tube set 1240 includes a pre-installed tube 1241 and a push tube 1242.
  • the pre-installed tube 1241 is a hollow tube, and the filter assembly 1100 can be compressed in the The pre-installed tube 1241.
  • the pre-installed tube 1241 is used to be detachably disposed in the first sheath tube 1210.
  • the push tube 1242 may be a hollow cylindrical tube and has a second distal end and a second proximal end opposite to each other. The second distal end is arranged in the pre-installed tube 1241 and is connected to the bag filter layer 1110. The first proximal end contacts to push the filter assembly 1100 into the first sheath 1210.
  • the recovery wire 1250 may be one or more than two.
  • the recovery wire 1250 is connected to the filter assembly 1100 and is used to recover the filter assembly 1100 after the filter assembly 1100 intercepts the thrombus 400.
  • the recycled wire 1250 and the filter assembly 1100 can be connected in various ways.
  • the recycled wire 1250 can be connected to the bag filter layer 1110 by sewing or bonding. It may also be that the front end of the recycling wire 1250 is bent into a circle as shown in FIG. 6a to be connected to the frame 1121.
  • the recycled wire 1250 and the frame 1121 can also be made into an integral structure to realize the connection between the filter assembly 1100 and the recycled wire 1250, as shown in FIG. 6b.
  • the recovery wire 1250 shown is detachably disposed in the first sheath dilator 1220, and after the first sheath dilator 1220 is withdrawn from the first sheath 1210, the recovery wire 1250 remains in the first sheath dilator 1220. Inside a sheath 1210.
  • the first sheath 1210 is introduced into the blood vessel 300.
  • physiological saline is injected into the first tube body 1211 from the first hemostatic valve 1213 to empty the air in the first tube body 1211.
  • a conventional method is used to puncture the first sheath 1210 along the first guide wire 1230 through the jugular vein, and determine that the front end of the first sheath 1210 is located at the proximal end of the filter 200 according to the position of the first imaging ring 1214 ;
  • first sheath dilator 1220 is withdrawn from the body.
  • the filter assembly 1000 connected with the recovery wire 1250 is compressed to the collapsed state (ie, compressed state), and installed in the pre-installed tube 1241;
  • the filter 200 can be recovered.
  • part of the thrombus 400 is cut by the filter 200 and dropped from the filter 200, and then flows into the filter assembly 1100 with the blood flow.
  • the thrombus 400 with a larger size (above 3mm) can be taken away.
  • the bag filter layer 1110 intercepts, thereby avoiding serious consequences such as pulmonary embolism.
  • the recovery wire 1250 is pulled, and the recovery wire 1250 pulls the filter assembly 1100 into the first sheath 1210 and pulls the filter assembly 1100 along the first sheath 1210. Withdraw from the body; finally, the first sheath 1210 is removed from the body.
  • the filter assembly 1100 When the filter assembly 1100 is recovered, when the filter assembly 1100 is pulled into the first sheath 1210, it is compressed by the force of the inner wall of the first sheath 1210. At the same time, if the filter assembly 1100 intercepts the large-size thrombus 400, the large-size thrombus 400 is wrapped in the bag filter layer 1110 and compressed into a strip along with the filter assembly 1100, and then recovered together with the filter assembly 1100.
  • the present invention also provides a filter recovery system.
  • the filter recovery system includes: a filter recovery device 500 for recovering the filter 200; and the aforementioned filter recovery protection
  • the device 100 is configured to be set at the proximal end of the filter 200 and intercept thrombus 400 falling from the filter 200.
  • the filter recovery device 500 can adopt any existing filter recovery device, and the method of recovering the filter 200 can also be an existing technology. Specifically, as shown in FIG. 3 and FIGS. 11 a and 11 b, the filter recovery device 500 includes a second sheath 5100, a capture catheter 5200 and a capture device 5300.
  • the structure of the second sheath tube 5100 is similar to the structure of the first sheath tube 1210, including a second tube body 5110.
  • the second tube body 5110 has a fourth distal end and a fourth proximal end opposite to each other, and The fourth distal end of the second tube body 5110 is preferably provided with a second developing ring 5111, and the fourth proximal end of the second tube body 5110 is provided with a second connecting portion 5120 with a seal (not shown in the figure).
  • a second hemostatic valve 5130 is provided on the second connecting portion 5120.
  • the catching catheter 5200 is detachably disposed in the second sheath 5100, the catcher 5300 includes a connecting rod 5310 and a ferrule 5320, wherein the connecting rod 5310 is disposed in the catching catheter 5200
  • the ferrule 5320 is arranged at the front end (ie, the distal end) of the connecting rod 5310 and is located outside the capture catheter 5200.
  • a recovery hook 210 is formed on the filter 200. Please refer to Figures 3 and 11a and 11b. When the recovery hook 210 is disposed at the proximal end of the filter 200, the filter recovery device 500 recovers the The process is as follows:
  • the first proximal end of the bag filter layer 1110 is set as an opening, and the first sheath tube 1210 communicates with the first distal end of the bag filter layer 1110.
  • the movement of the circle 5320 enables the filter 200 to be received in the capture catheter 5200 and moved out of the body along the second sheath 5100; finally, the second sheath 5100 is withdrawn from the body to complete the recovery of the filter 200.
  • the diameter of the second sheath tube 5100 should be smaller than the first sheath tube 1210 and smaller than the minimum diameter of the bag filter layer 1110.
  • the filter recovery device 500 when the recovery hook 210 is disposed at the distal end of the filter 200, the filter recovery device 500 further includes a second sheath dilator (in the figure Not shown) and a second guide wire (not shown in the figure).
  • the second sheath dilator is detachably disposed in the second sheath 5100 and is used for threading the second guide wire.
  • the recovery process of the filter 200 in this embodiment is as follows:
  • the second sheath 5100 is punctured along the second guide wire through the femoral vein, and the fourth distal end of the second sheath 5100 is determined to reach the distal center of the filter 200 according to the position of the second imaging ring 5111. end;
  • the present invention also provides a filtration system, which includes a filter 200 and the aforementioned filter recovery system.
  • the present invention also provides a filter recovery method, including:
  • the filter can be fed into the blood vessel by a conventional method.
  • the filter assembly is first compressed, then contained in a transport assembly, and transported by the transport assembly into the blood vessel. After the filter is recovered, the filter assembly is compressed to the collapsed state (ie, compressed state) and contained in the transport assembly to be withdrawn from the body.
  • the transport assembly may include a recycling wire and a first sheath, the recycling wire is arranged in the first sheath and connected with the filter assembly, when the recycling wire is pulled, the filter assembly is The first sheath tube is compressed, and at the same time, the filter assembly enters the first sheath tube and can be withdrawn from the body along the first sheath tube.
  • the present invention also provides another filter recovery method, including:

Abstract

一种滤器回收保护装置(100)、滤器回收系统及方法、过滤系统。滤器回收保护装置(100)包括过滤组件(1100)，过滤组件(1100)包括袋式过滤层(1110)和固定结构(1120)，袋式过滤层(1110)具有相对的第一远端和第一近端，袋式过滤层(1110)的第一远端具有一开口，开口用于在回收滤器(200)时允许血栓(400)进入袋式过滤层(1110)；固定结构(1120)设置在第一远端并用于与血管(300)的内壁贴合可以避免回收滤器(200)时，因血栓(400)进入肺动脉而引起的肺栓塞等严重后果。

Description

滤器回收保护装置、滤器回收系统及方法、过滤系统 技术领域
本发明涉及医疗器械技术领域，具体涉及一种滤器回收保护装置、滤器回收系统及方法、过滤系统。
背景技术
静脉血栓栓塞症(venous thromboembolism，VTE)是一种临床常见疾病，有着较高的发病率和死亡率，包括深静脉血栓形成(deep vein thrombosis，DVT)肺动脉栓塞(pulmonary embolism，PE)。DVT常发生于下肢静脉，而PE则主要是由于静脉系统或右心脉血栓形成后脱落进入肺动脉所致，是患者致病和致死的主要原因。目前，抗凝治疗一直是VTE治疗的金标准，目的是预防血栓形成及肺动脉栓塞，保持静脉通畅。当患者具有抗凝禁忌或出现血合并症时而不再适合抗凝治疗时，植入腔静脉滤器(Vena cava filter，VCF)可有效拦截脱落的血栓，预防致死性肺栓塞的发生。
临床上患者植入腔静脉滤器后，需要在一定的时间后对滤器进行回收，但回收滤器时，滤器中拦截的血栓可能会脱落而引发肺栓塞，造成严重后果。目前，治疗指南上并不推荐回收拦截有大块血栓(通常是指尺寸大于1cm)的滤器，对于拦截有大块血栓(通常是指尺寸大于1cm)的滤器，一般处理方法是在原有滤器的近心端放置第二枚滤器，然后介入溶栓，当第二枚滤器中拦截有大块血栓时，再采用同样的方法处理，即需要在原有滤器的近心端再放置一枚滤器。然而在处理滤器内栓塞时，会超出滤器回收的时间窗，导致滤器被迫转为永久滤器而带来远期并发症的问题。
发明内容
本发明的目的在于提供一种滤器回收保护装置、滤器回收系统及方法、过滤系统，以解决滤器回收过程中血栓脱落的问题。
为实现上述目的，本发明提供的一种滤器回收保护装置，包括用于输送入血管的过滤组件，所述过滤组件包括袋式过滤层和固定结构，所述袋式过 滤层具有相对的第一远端和第一近端，所述袋式过滤层的所述第一远端具有一开口，所述开口用于在回收滤器时允许血栓进入所述袋式过滤层；所述固定结构设置在所述第一远端并用于与血管的内壁贴合。
可选地，所述固定结构包括框架，所述框架设置于所述袋式过滤层的所述第一远端，并用于与所述血管的内壁贴合。
可选地，所述固定结构还包括定位件，用于将所述过滤组件固定于所述血管的内壁。
可选地，所述定位件包括设置在所述框架上的至少两个倒刺，所述至少两个倒刺沿所述框架的周向间隔设置。
可选地，所述过滤组件为可压缩组件，在未压缩状态下，所述过滤组件为锥形结构，且所述过滤组件垂直于轴线的截面从所述第一远端到所述第一近端逐渐减小。
可选地，所述过滤组件为可压缩组件，在未压缩状态下，所述框架呈鱼嘴形；或，所述框架呈椭圆形并与所述过滤组件的轴线相交但不垂直；或，所述框架为波浪形支架。
可选地，所述袋式过滤层上设置有供血液流通的孔洞。
可选地，所述孔洞的形状为圆形、椭圆形、菱形和三角形中的至少一种。
可选地，所述滤器回收保护装置还包括运输组件，所述运输组件包括第一鞘管、第一鞘管扩张器、第一导丝和导入管组；
所述第一鞘管扩张器的外径小于所述第一鞘管的内径，所述第一鞘管扩张器能够贯穿所述第一鞘管并从所述第一鞘管内伸出，并在所述第一导丝的引导下将所述第一鞘管导入血管；
所述导入管组可拆卸地设置于所述第一鞘管内，并用于容纳所述过滤组件以将所述过滤组件运送至所述滤器的近心端。
可选地，所述运输组件还包括回收丝，所述回收丝与所述过滤组件连接，用于回收所述过滤组件。
可选地，所述导入管组包括预装管和推送管；
所述预装管用于容纳所述过滤组件并可拆卸地设置于所述第一鞘管内；
所述推送管具有相对的第二远端和第二近端，所述推送管的所述第二远端设置于所述预装管内并用于与所述袋式过滤层的所述第一近端接触以将所述过滤组件从所述预装管推送至所述第一鞘管内。
可选地，所述第一鞘管具有相对的第三远端和第三近端，所述第一鞘管的所述第三远端设有第一显影环。
可选地，所述第一鞘管扩张器具有沿轴向贯通地延伸的内腔，所述内腔用于穿设所述第一导丝。
为实现上述目的，本发明还提供了一种滤器回收系统，包括滤器回收装置和如前所述的滤器回收保护装置；
所述滤器回收装置用于回收所述滤器；
所述滤器回收保护装置用于设置在所述滤器的近心端并拦截从所述滤器中掉落的血栓。
可选地，所述滤器回收装置包括第二鞘管、抓捕导管和抓捕器；
所述抓捕导管可拆卸地设置于所述第二鞘管内；
所述抓捕器设置在所述抓捕导管内并用于与所述滤器连接。
可选地，所述滤器回收器还包括第二鞘管扩张器和第二导丝；
所述第二鞘管扩张器与所述第二鞘管可拆卸地连接并用于穿设所述第二导丝以将所述第二鞘管导入血管。
为实现上述目的，本发明还提供了一种过滤系统，包括滤器和如前所述的滤器回收系统。
为实现上述目的，本发明还提供了一种滤器回收方法，包括：
提供如上所述的滤器回收保护装置；
将所述滤器回收保护装置的过滤组件输送至血管内并定位于滤器的近心端；
使用滤器回收装置回收所述滤器，所述过滤组件用于拦截从所述滤器中掉落的血栓；以及，
回撤所述过滤组件。
为实现上述目的，本发明还提供了另一种滤器回收方法，包括：
提供如上所述的滤器回收系统；
将所述滤器回收系统的过滤组件输送至血管内并定位于滤器的近心端；
使用所述滤器回收系统的滤器回收装置回收所述滤器，所述过滤组件用于拦截从所述滤器中掉落的血栓；以及，
回撤所述过滤组件。
与现有技术相比，本发明的一种滤器回收保护装置、滤器回收系统及方法、过滤系统具有如下优点：
本发明提供的滤器回收保护装置包括过滤组件，所述过滤组件包括袋式过滤层和固定结构，在回收滤器时，所述袋式过滤层被设置于滤器的近心端以拦截从所述滤器中掉落的血栓，且所述固定结构用于在回收滤器时与血管的内壁贴合，使得袋式过滤层可全面拦截血栓，从而避免大尺寸的血栓进入静脉而引发肺栓塞。
附图说明
图1是本发明根据一实施例所提供的滤器回收保护装置的结构示意图，图中过滤组件被压缩在运输组件内，且第一鞘管及第一鞘管扩张器未示出；
图2是本发明根据一实施例所提供的滤器回收保护装置的结构示意图，图中过滤组件被释放，且第一鞘管及第一鞘管扩张器未示出；
图3是本发明根据一实施例所提供的滤器回收系统回收滤器及血栓时的示意图；
图4是本发明根据一实施例所提供的滤器回收保护装置的过滤组件的结构示意图；
图5a至图5c是图4所述滤器回收保护装置的过滤组件的变形结构示意图；
图6a是本发明根据一实施例所提供的滤器回收保护装置的回收丝与过滤组件的连接关系示意图；
图6b是本发明根据另一实施例所提供的滤器回收保护装置的回收丝与过滤组件的连接关系示意图；
图7是本发明根据一实施例所提供的滤器回收保护装置的第一鞘管的结构示意图；
图8是本发明根据一实施例所提供的滤器回收保护装置的第一鞘管扩张器的结构示意图；
图9是本发明根据一实施例所提供的滤器回收保护装置的第一鞘管和第一鞘管扩张器组装时的结构示意图；
图10是本发明根据一实施例所提供的滤器回收保护装置回收过滤组件时的示意图；
图11a和图11b本发明根据一实施例所提供的滤器回收系统中的滤器回收装置被送入血管时的示意图；
图12a和图12b是本发明根据另一实施例所提供的滤器回收系统回收滤器和血栓时的示意图。
图中：
100-滤器回收保护装置；
1100-过滤组件；
1110-袋式过滤层，1111-孔洞；
1120-固定结构；
1121-框架，1122-定位件；
1200-运输组件；
1210-第一鞘管；
1211-第一管体，1212-第一连接部，1213-第一止血阀，1214-第一显影环；
1220-第一鞘管扩张器；
1230-第一导丝；
1231-软丝段，1232-硬丝段；
1240-导入管组；
1241-预装管，1242-推送管；
1250-回收丝；
200-滤器；
210-回收钩；
300-血管；
400-血栓；
500-滤器回收装置；
5100-第二鞘管；
5110-第二管体，5120-第二连接部，5130-第二止血阀，5111-第二显影环；
5200-抓捕导管；
5300-抓捕器；
5310-连杆，5320-套圈。
具体实施方式
本发明的核心思想在于提供一种滤器回收保护装置，包括过滤组件，所述过滤组件包括袋式过滤层和固定结构，所述袋式过滤层具有相对的第一远端和第一近端，所述袋式过滤层的所述第一远端具有一开口，所述开口用于在回收滤器时允许血管内的血栓进入所述袋式过滤层；所述固定结构设置在所述第一远端并用于与血管的内壁贴合。
所述滤器回收保护装置用于在回收滤器时设置于所述滤器的近心端，以便拦截从滤器中掉落的血栓，避免大尺寸血栓进入肺动脉从而引发肺栓塞。并且该过滤组件拦截血栓后，血栓可随过滤组件一起被回收，进而彻底消除血栓在人体内带来的不良影响。
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明提出的滤器回收保护装置、滤器回收系统及方法、过滤系统作进一步详细的介绍。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明的目的。
如在本说明书和所附权利要求中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数对象“多个”包括两个或两个以上的对象，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以 及术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接，也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。附图中相同或相似的附图标记代表相同或相似的部件。
在本文中，术语“远端”、“近端”是从使用该滤器回收保护装置及滤器回收系统的操作者角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“远端”、“近端”并非是限制性的，但是“远端”通常是指首先进入患者体内的一端，而“近端”通常指该滤器回收系统及滤器回收保护装置在正常操作过程中靠近操作者的一端。术语“近心端”、“远心端”是从滤器相对于心脏的角度来看相对于彼此的元件的相对位置、相对方向，本文中，“近心端”是指滤器靠近心脏的一端，而“远心端”是指滤器远离心脏的一端。
请参阅图1至图3，本实施例提供的滤器回收保护装置100包括过滤组件1100，所述过滤组件1100包括袋式过滤层1110和固定结构1120，所述袋式过滤层1110具有相对的第一远端和第一近端，所述第一远端具有一开口，所述开口用于在回收滤器200时允许血管300内的血栓进入所述袋式过滤层1110包围形成的内腔中，进而所述血栓可被所述袋式过滤层1110拦截；所述固定结构1120设置在所述第一远端并用于在回收滤器200时与所述血管300的内壁贴合。本实施例中所述的血栓主要是指血管300中的血栓400。下文的描述均以回收血栓400为例进行介绍。
详细地，所述过滤组件1100为可压缩组件，具有未压缩状态和压缩状态。在回收滤器200之前，所述过滤组件1100处于压缩状态，以便于被运输至所述血管300内，以及，在回收滤器200之后，所述过滤组件1100处于所述压缩状态，以便于从血管300中撤出。在回收滤器时，所述过滤组件1100被设置于所述滤器200的近心端并膨胀至所述未压缩状态，此时所述固定结构1120与所述血管300的内壁贴合。
所述过滤组件1100可采用具有弹性的材料制作，以使其能够在受力时被压缩至所述压缩状态，并在外力取消后可以自动膨胀至所述未压缩状态。具体可以用于制作过滤组件1100的材料包括聚对苯二甲酸乙二醇酯(PET)、聚四氟乙烯(PTFE)等。应理解，本领域并不限制过滤组件1100的具体材料，能够压缩及收拢并可用于医疗用途即可。
请继续参考图1至图3，作为优选，当所述过滤组件1100处于所述未压缩状态时，其垂直于轴线方向的截面从所述袋式过滤层1110的第一近端到第一远端逐渐增大以形成锥形结构，更便于后续回撤操作。
另外，所述过滤组件1100用于拦截脱落的血栓400，但其不应对血液的流动造成阻碍，因此，在所述袋式过滤层1110上还形成有供血液流通的孔洞1111。一般而言，当血栓400的尺寸小于3mm时引起肺栓塞的可能性较低，换言之，当进入血管300中的血栓400的尺寸大于等于3mm时就极有可能引发肺栓塞，因此，袋式过滤层1110应当能拦截尺寸为3mm以上的血栓400。所述孔洞1111的尺寸根据需要进行确定，例如，若所述孔洞1111为圆形时，其直径可为0.5-3mm。应理解，在实践中，所述孔洞1111还可以是方形、三角形、多边形或其他形状，这里仅以圆形的孔洞1111为例来说明孔洞1111的尺寸，其不应当构成对本发明的限制，在采用其他形状的孔洞1111时，孔洞1111的面积应当以能够拦截尺寸为3mm以上血栓400为准。
请继续参考图3并结合图4，在所述袋式过滤层1110的第一远端设置固定结构1120，以使所述过滤组件1100可与血管300的内壁相贴合，这样一来，所有脱落的尺寸较大(3mm以上)的血栓400均能够被袋式过滤层1110拦截。应理解，这里的贴合既包括袋式过滤层1110的第一远端与血管300的内壁无间隙贴合的情况，也包括袋式过滤层1110的第一远端与所述血管300的内壁间的间隙小于3mm的情况。
具体而言，所述固定结构1120包括框架1121，所述框架1121设置于所述袋式过滤层1110的第一远端，并用于与所述血管300的内壁相贴合。
如图4所示，当所述过滤组件1100处于所述打开状态(即未压缩状态)时，所述框架1121可以呈椭圆形，该椭圆形与所述过滤组件1100的轴线相 交但不垂直。并且，将该椭圆形的框架1121投影至与所述过滤组件1100的轴线相垂直的平面时，得到的投影圆的直径优选不小于血管300的直径。根据实际血管300的直径，框架1121的口径一般为15-22mm。在其他的实施例中，所述框架1121还可以是如图5a所示的鱼嘴状；或，所述框架1121是如图5b所示的波浪形支架结构；或者，所述框架1121还可以是如图5c所示的弹簧结构。总之，本发明实施例并不对框架1121的具体形式做限定，只要其能够使所述袋式过滤层1110的第一远端与所述血管300的内壁相贴合，使得血管300的内壁与袋式过滤层1110的第一远端的缝隙小于3mm或完全不存在缝隙，进而所有脱落的尺寸在3mm以上的血栓400均能够被拦截即可。
进一步地，所述固定结构1120上还包括有定位件1122，重点参考图3和图4，所述定位件1122例如是设置于所述框架1121上的倒刺，所述倒刺可刺入血管300的内壁，以使所述过滤组件1100固定于血管300上，避免其因受血流的流动力影响而发生移位，进而无法拦截血栓400。具体地，所述倒刺可以是钩形结构，其数量可为多个并沿所述框架1121的周向均匀排布。所述定位件1122与所述框架1121可以通过焊接、机械夹紧等方式连接，也可以一体成型。
在进一步的改进方案中，所述滤器回收保护装置100还包括运输组件1200。在回收滤器200之前，所述过滤组件1100可被压缩至所述收拢状态(即压缩状态)并被容置于所述运输组件1200内，以被所述运输组件1200运送至所述血管300中；以及，在回收滤器200之后，所述过滤组件1100可被压缩并容置于所述运输组件1200中，以被所述运输组件1200运送至血管300外。
即，本实施例中，在回收所述滤器200前，所述过滤组件1100需通过所述运输组件1200输送至所述滤器200的近心端，并且在拦截血栓400之后，所述过滤组件1100还能够通过所述运输组件1200回收。
详细地，请参考图1、图2并结合图7至图9，所述运输组件1200可包括第一鞘管1210、第一鞘管扩张器1220、第一导丝1230、导入管组1240和回收丝1250。
请重点参考图7，所述第一鞘管1210包括第一管体1211，所述第一管体1211呈中空结构并具有沿轴向贯通地延伸的第一内腔，同时所述第一管体1211具有相对的第三远端和第三近端，所述第一管体1211的第三远端设置有带密封件(图中未示出)的第一连接部1212，所述第一连接部1212上设置有第一止血阀1213。通常，所述第一管体1211的外径为10-16F，其长度应与从颈静脉到所述滤器200近心端的距离相当，例如在40-60cm之间。此外，所述第一管体1211的第三远端还设置有第一显影环1214。
所述第一鞘管扩张器1220可直接使用常规的鞘管扩张器。在尺寸上，所述第一鞘管扩张器1220的长度较第一鞘管1210要长10-50mm，所述第一鞘管扩张器1220也为中空结构并具有沿轴向贯通地延伸的第二内腔，且所述第一鞘管扩张器1220用于与所述第一鞘管1210可拆卸连接，以使所述第一鞘管扩张器1220的第二内腔和第一鞘管1210的第一内腔连通后可穿设所述第一导丝1230。
所述第一导丝1230可采用现有的医用导丝，该第一导丝1230可拆卸地设置于所述第一鞘管扩张器1220中并用于后续引导过滤组件1100进入血管300。具体地，所述第一导丝1230包括软丝段1231和硬丝段1232，所述软丝段1231和所述硬丝段1232相互连接，其中所述软丝段1231在血管300内推进的过程中便于适应血管300的结构，避免对血管300造成损伤，而所述硬丝段1232则为后续引导其他构件进入血管300时提供足够的支撑力。应理解，此处所指的“软丝段”是指相比于“硬丝段”的硬度更小，同理，“硬丝段”是指相比于“软丝段”的硬度更大。
所述导入管组1240用于在回收滤器200前容纳所述过滤组件1100，并将所述过滤组件1100送入血管300中以到达所述滤器200的近心端。详细地，如图1及图2所示，所述导入管组1240包括预装管1241和推送管1242，所述预装管1241为一中空管，且所述过滤组件1100可压缩于所述预装管1241内。所述预装管1241用于可拆卸地设置在所述第一鞘管1210内。所述推送管1242可为一空心圆柱管并具有相对的第二远端和第二近端，所述第二远端设置于所述预装管1241内并与所述袋式过滤层1110的第一近端接触，以将 所述过滤组件1100推送至所述第一鞘管1210内。
所述回收丝1250可以是一根，也可以是两根以上，所述回收丝1250与所述过滤组件1100连接，用于在过滤组件1100拦截血栓400后回收所述过滤组件1100。所述回收丝1250与所述过滤组件1100可通过多种方式连接，例如，回收丝1250可与所述袋式过滤层1110通过缝合或粘合的方式连接。也可以是如图6a所示的将所述回收丝1250的前端弯曲成圆圈进而与所述框架1121连接。或者，还可以将所述回收丝1250与所述框架1121制作成一体结构以实现过滤组件1100与回收丝1250的连接，即如图6b所示。所示回收丝1250可拆卸地设置于所述第一鞘管扩张器1220中，并且在所述第一鞘管扩张器1220撤出所述第一鞘管1210后，回收丝1250仍保留于第一鞘管1210内。
接下来，结合图1至图12b所示介绍所述滤器回收保护装置的使用方法。
(1)将所述第一鞘管1210导入血管300。
首先，如图9所示，组装第一鞘管1210、第一鞘管扩张器1220及第一导丝1230，其中所述第一鞘管扩张器1220被所述第一连接部1212锁定；
然后，从所述第一止血阀1213向所述第一管体1211内注入生理盐水以排空第一管体1211内的空气。
之后，采用常规方法经颈静脉沿第一导丝1230穿刺导入第一鞘管1210，并根据所述第一显影环1214的位置确定第一鞘管1210的前端位于所述滤器200的近心端；
最后，从体内退出所述第一鞘管扩张器1220。
(2)将所述过滤组件1100导入血管300。
如图1所示，首先将连接有回收丝1250的过滤组件1000压缩至收拢状态(即压缩状态)，并装入所述预装管1241；
然后沿所述第一导丝1230将所述预装管1241插入所述第一鞘管1210的第一连接部1212内，并将所述推送管1242的第二远端从所述第一鞘管1210第三近端插入所述第一鞘管1210内；
之后，推动所述推送管1242，使所述推送管1242的第二远端与装在所述 预装管1241中的袋式过滤层1110的第一近端接触，持续推动所述推送管1242直至所述袋式过滤层1110的第一远端到达所述第一显影环1214处；
随后，固定所述推送管1242并回撤所述第一鞘管1210，使所述过滤组件1100从所述第一鞘管1210内释放并膨胀至打开状态(即未压缩状态)，此时滤器回收保护装置的状态如图2及图3所示；
最后，回撤所述预装管1241和所述推送管1242。
在过滤组件1100膨胀完成之后(即达到未压缩状态)即可开始回收滤器200。在回收滤器200的过程中，部分血栓400被滤器200切割而从滤器200中掉落，进而随血流流入所述过滤组件1100中，其中较大尺寸(3mm以上)的血栓400即可被所述袋式过滤层1110拦截，从而避免引起肺栓塞等严重后果。
(3)回收过滤组件1100。
如图10所示，滤器200回收之后，拉动所述回收丝1250，所述回收丝1250将过滤组件1100拉入所述第一鞘管1210，并沿第一鞘管1210将所述过滤组件1100撤出体外；最后将所述第一鞘管1210移出体外。
在回收过滤组件1100时，过滤组件1100被拉入所述第一鞘管1210时，其受到第一鞘管1210内壁的作用力而压缩。与此同时，若过滤组件1100拦截到大尺寸血栓400，该大尺寸血栓400被包裹于袋式过滤层1110内并随过滤组件1100被压缩成条状而随过滤组件1100一并回收。
至此，滤器200的整个回收过程完成。
基于前述的滤器回收保护装置，本发明还提供了一种滤器回收系统，如图3所示，所述滤器回收系统包括：滤器回收装置500，用于回收滤器200；以及如前述的滤器回收保护装置100，用于设置在所述滤器200的近心端并拦截从滤器200中掉落的血栓400。
所述滤器回收装置500可采用现有的任一种滤器回收装置，回收滤器200的方法也可为现有技术。具体来说，如图3以及图11a和图11b所示，所述滤器回收装置500包括第二鞘管5100、抓捕导管5200和抓捕器5300。其中所述第二鞘管5100的结构与所述第一鞘管1210的结构类似，包括第二管体 5110，所述第二管体5110具有相对的第四远端和第四近端，且第二管体5110的第四远端优选设置有第二显影环5111，第二管体5110的第四近端设置带有密封件(图中未示出)第二连接部5120，所述第二连接部5120上设置有第二止血阀5130。所述抓捕导管5200可拆卸地设置于所述第二鞘管5100内，所述抓捕器5300包括连杆5310和套圈5320，其中所述连杆5310设置于所述抓捕导管5200内，所述套圈5320设置于所述连杆5310的前端(即远端)并位于所述抓捕导管5200的外部。
所述滤器200上形成有回收钩210，请结合图3及图11a和图11b，当所述回收钩210设置于所述滤器200的近心端时，所述滤器回收装置500回收滤器200的过程如下：
所述袋式过滤层1110第一近端设置为开口，并且所述第一鞘管1210与所述袋式过滤层1110的第一远端连通。将所述第二鞘管5100沿所述第一导丝1230插入所述第一鞘管1210并穿出所述过滤组件1100的第一远端；然后撤出所述第一导丝1230，再向所述第二鞘管5100内导入所述抓捕导管5200和所述抓捕器5300直至所述套圈5320被所述回收钩210勾住；之后拉动所述连杆5310进而带动所述套圈5320移动使所述滤器200被收入所述抓捕导管5200中并沿第二鞘管5100移出体外；最后将所述第二鞘管5100撤出体外完成滤器200的回收。这里，所述第二鞘管5100的直径应当小于第一鞘管1210，且小于所述袋式过滤层1110的最小直径。
如图12a和图12b所示，在另一实施例中，所述回收钩210设置于所述滤器200的远心端时，所述滤器回收装置500还包括第二鞘管扩张器(图中未示出)和第二导丝(图中未示出)。所述第二鞘管扩张器可拆卸地设置于所述第二鞘管5100内并用于穿设所述第二导丝。本实施例中所述滤器200的回收过程如下：
首先，组装第二鞘管5100、第二鞘管扩张器和第二导丝；
接着，经股静脉沿第二导丝穿刺导入第二鞘管5100，并根据所述第二显影环5111的位置确定所述第二鞘管5100的第四远端到达所述滤器200的远心端；
接着，撤出所述第二导丝，再将沿所述第二鞘管5100导入所述抓捕导管5200和所述抓捕器5300直至所述套圈5320被所述回收钩210勾住；
接着，拉动所述连杆5310回收滤器200；
最后，将所述第二鞘管5100撤出体外完成滤器200的回收。
此外，本发明还提供了一种过滤系统，其包括滤器200和前述的滤器回收系统。
另外，本发明还提供了一种滤器回收方法，包括：
提供上述的滤器回收保护装置；
将所述过滤组件输送至血管内并定位于所述滤器的近心端；
使用滤器回收装置回收所述滤器，所述过滤组件用于拦截从所述滤器中掉落的栓子；以及，
回撤所述过滤组件。
详细地，所述滤器可通过常规方法送入所述血管。所述过滤组件首先被压缩，然后容置于一运输组件中，并被所述运输组件运送至所述血管内。待滤器回收之后，再将所述过滤组件压缩至所述收拢状态(即压缩状态)并容置于所述运输组件中，以被撤出体外。
这里，所述运输组件可包括回收丝和第一鞘管，所述回收丝设置于所述第一鞘管内并与所述过滤组件连接，当抽拉所述回收丝时，所述过滤组件被所述第一鞘管压缩，同时，过滤组件进入所述第一鞘管并可沿所述第一鞘管撤出体外。
为实现上述目的，本发明还提供了另一种滤器回收方法，包括：
提供如上所述的滤器回收系统；
将所述过滤组件输送至血管内并定位于所述滤器的近心端；
使用所述滤器回收装置回收所述滤器，所述过滤组件用于拦截从所述滤器中掉落的血栓；以及，
回撤所述过滤组件。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的 这些修改和变型属于本发明权利要求极其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (19)

  1. 一种滤器回收保护装置，其特征在于，包括用于输送入血管的过滤组件，所述过滤组件包括袋式过滤层和固定结构，所述袋式过滤层具有相对的第一远端和第一近端，所述袋式过滤层的所述第一远端具有一开口，所述开口用于在回收滤器时允许血栓进入所述袋式过滤层；所述固定结构设置在所述第一远端并用于与血管的内壁贴合。
  2. 根据权利要求1所述的滤器回收保护装置，其特征在于，所述固定结构包括框架，所述框架设置于所述袋式过滤层的所述第一远端，并用于与所述血管的内壁贴合。
  3. 根据权利要求2所述的滤器回收保护装置，其特征在于，所述固定结构还包括定位件，用于将所述过滤组件固定于所述血管的内壁。
  4. 根据权利要求3所述的滤器回收保护装置，其特征在于，所述定位件包括设置在所述框架上的至少两个倒刺，所述至少两个倒刺沿所述框架的周向间隔设置。
  5. 根据权利要求1所述的滤器回收保护装置，其特征在于，所述过滤组件为可压缩组件，在未压缩状态下，所述过滤组件为锥形结构，且所述过滤组件垂直于轴线的截面从所述第一远端到所述第一近端逐渐减小。
  6. 根据权利要求2-4中任一项所述的滤器回收保护装置，其特征在于，所述过滤组件为可压缩组件，在未压缩状态下，所述框架呈鱼嘴形；或，所述框架呈椭圆形并与所述过滤组件的轴线相交但不垂直；或，所述框架为波浪形支架。
  7. 根据权利要求1-5中任一项所述的滤器回收保护装置，其特征在于，所述袋式过滤层上设置有供血液流通的孔洞。
  8. 根据权利要求7所述的滤器回收保护装置，其特征在于，所述孔洞的形状为圆形、椭圆形、菱形和三角形中的至少一种。
  9. 根据权利要求1-5中任一项所述的滤器回收保护装置，其特征在于，所述滤器回收保护装置还包括运输组件，所述运输组件包括第一鞘管、第一 鞘管扩张器、第一导丝和导入管组；
    所述第一鞘管扩张器的外径小于所述第一鞘管的内径，所述第一鞘管扩张器能够贯穿所述第一鞘管并从所述第一鞘管内伸出，并在所述第一导丝的引导下将所述第一鞘管导入血管；
    所述导入管组可拆卸地设置于所述第一鞘管内，并用于容纳所述过滤组件以将所述过滤组件运送至所述滤器的近心端。
  10. 根据权利要求9所述的滤器回收保护装置，其特征在于，所述运输组件还包括回收丝，所述回收丝与所述过滤组件连接，用于回收所述过滤组件。
  11. 根据权利要求9所述的滤器回收保护装置，其特征在于，所述导入管组包括预装管和推送管；
    所述预装管用于容纳所述过滤组件并可拆卸地设置于所述第一鞘管内；
    所述推送管具有相对的第二远端和第二近端，所述推送管的所述第二远端设置于所述预装管内并用于与所述袋式过滤层的所述第一近端接触以将所述过滤组件从所述预装管推送至所述第一鞘管内。
  12. 根据权利要求9所述的滤器回收保护装置，其特征在于，所述第一鞘管具有相对的第三远端和第三近端，所述第一鞘管的所述第三远端设有第一显影环。
  13. 根据权利要求9所述的滤器回收保护装置，其特征在于，所述第一鞘管扩张器具有沿轴向贯通地延伸的内腔，所述内腔用于穿设所述第一导丝。
  14. 一种滤器回收系统，其特征在于，包括滤器回收装置和如权利要求1-13中任一项所述的滤器回收保护装置；
    所述滤器回收装置用于回收所述滤器；
    所述滤器回收保护装置用于设置在所述滤器的近心端并拦截从所述滤器中掉落的血栓。
  15. 根据权利要求14所述的滤器回收系统，其特征在于，所述滤器回收装置包括第二鞘管、抓捕导管和抓捕器；
    所述抓捕导管可拆卸地设置于所述第二鞘管内；
    所述抓捕器设置在所述抓捕导管内并用于与所述滤器连接。
  16. 根据权利要求15所述的滤器回收系统，其特征在于，所述滤器回收装置还包括第二鞘管扩张器和第二导丝；
    所述第二鞘管扩张器与所述第二鞘管可拆卸地连接并用于穿设所述第二导丝以将所述第二鞘管导入血管。
  17. 一种过滤系统，其特征在于，包括滤器和如权利要求14-16中任一项所述的滤器回收系统。
  18. 一种滤器回收方法，其特征在于，包括：
    提供如权利要求1-13中任一项所述的滤器回收保护装置；
    将所述滤器回收保护装置的过滤组件输送至血管内并定位于滤器的近心端；
    使用滤器回收装置回收所述滤器，所述过滤组件用于拦截从所述滤器中掉落的血栓；以及，
    回撤所述过滤组件。
  19. 一种滤器回收方法，其特征在于，包括：
    提供如权利要求14-16中任一项所述的滤器回收系统；
    将所述滤器回收系统的过滤组件输送至血管内并定位于滤器的近心端；
    使用所述滤器回收系统的滤器回收装置回收所述滤器，所述过滤组件用于拦截从所述滤器中掉落的血栓；以及，
    回撤所述过滤组件。
PCT/CN2020/080769 2019-06-28 2020-03-24 滤器回收保护装置、滤器回收系统及方法、过滤系统 WO2020258943A1 (zh)

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CN105662647A (zh) * 2016-02-19 2016-06-15 杭州启明医疗器械有限公司 血栓过滤器
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