WO2023088180A1 - 碎栓装置及血栓清除系统 - Google Patents

碎栓装置及血栓清除系统 Download PDF

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Publication number
WO2023088180A1
WO2023088180A1 PCT/CN2022/131365 CN2022131365W WO2023088180A1 WO 2023088180 A1 WO2023088180 A1 WO 2023088180A1 CN 2022131365 W CN2022131365 W CN 2022131365W WO 2023088180 A1 WO2023088180 A1 WO 2023088180A1
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WO
WIPO (PCT)
Prior art keywords
thrombus
bolt
breaking
breaking device
head
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PCT/CN2022/131365
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English (en)
French (fr)
Inventor
刘凯
樊亚明
张贯一
王佳豪
徐晓红
袁振宇
Original Assignee
上海蓝脉医疗科技有限公司
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Publication of WO2023088180A1 publication Critical patent/WO2023088180A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris

Definitions

  • the invention relates to the technical field of medical devices, in particular to a thrombus breaking device and a thrombus removal system.
  • Deep venous thrombosis (DVT) of the lower extremities is a disease caused by abnormal coagulation of blood in the deep veins of the lower extremities.
  • DVT leads to increased venous pressure, obstruction of blood return, lower extremity swelling, pain, and dysfunction.
  • PE pulmonary embolism
  • the drug By taking orally or injecting aspirin, heparin or warfarin, the drug can enter the blood system, effectively dissolve venous thrombosis, and greatly reduce the incidence of deep venous thrombosis and pulmonary embolism.
  • drug prophylaxis also has significant limitations. For conditions such as hemorrhagic constitution, hemorrhagic stroke, severe trauma, pleural hemorrhage, and anticoagulant disorders, it may cause severe body bleeding and endanger the life of the patient. Therefore, the existing catheter-directed thrombolysis (CDT) can deliver thrombolytic drugs (such as urokinase) to the thrombus site in a targeted manner, effectively reducing the thrombus load and reducing the incidence of PTS.
  • thrombolytic drugs such as urokinase
  • CDT treatment of DVT has the problem of long thrombolysis time, which will lead to long-term indwelling catheters, increasing patient discomfort and prolonging hospital stay; repeated blood draws require close monitoring and high-level nursing; for cases with severe swelling or even endangering the survival of limbs , is not conducive to opening the blood flow as soon as possible.
  • CDT is not suitable for patients with high bleeding risk (such as severe hypertension, etc.), and it is not suitable for patients in childbirth and pregnancy.
  • thrombolysis and anticoagulation are prone to wound complications.
  • a mechanical thrombectomy (percutaneous mechanical thrombectomy, PMT) device has appeared in recent years, which is a set of devices used to remove acute and subacute thrombosis in blood vessels.
  • the method is to remove thrombus in blood vessels and restore blood circulation and valve function.
  • PMT is a minimally invasive intraluminal thrombus removal device, which can quickly remove thrombus and restore blood flow.
  • Some existing PMTs use a driver to drive the delivery screw to rotate, and the continuously rotating screw generates negative pressure to suck the thrombus near the working head of the catheter into the catheter, cut it into pieces by the high-speed rotating delivery screw, and discharge it out of the body through the hose.
  • the blood vessel wall will be sucked into the working head during the thrombus suction process, and entangled with the delivery screw, so there is a risk of destroying the vessel wall and causing vessel injury.
  • some PMTs drive the rotor to rotate through the propulsion screw, cut the thrombus near the inlet on the working head, and suck the thrombus into the working head, and the crushed thrombus is discharged through the decomposition catheter under the transmission of the propulsion screw .
  • the rotor has a helical structure, the blood vessel wall will be twisted into the working head during the thrombus suction process, so there is a risk of destroying the blood vessel wall and causing blood vessel damage.
  • the object of the present invention is to provide a thrombus breaking device and a thrombus removal system to solve the problem of how to avoid damage to the blood vessel wall during the thrombus breaking process.
  • the present invention provides a bolt breaking device, including: a bolt breaking unit and a separation unit; wherein,
  • the bolt-breaking unit includes a bolt-retrieving head, a bolt-breaking knife, and a transmission tube; the bolt-retrieving head has a through inner cavity, and the bolt-breaking knife is arranged in the inner cavity, and the bolt-breaking knife and the transmission
  • the distal end of the tube is connected to drive the thrombus breaking knife to rotate when the transmission tube rotates; there is an opening on the side wall of the thrombus removal head, and the opening exposes part of the thrombus breaking knife, so that the thrombus can pass through After the opening enters the inner cavity, it is chopped by the rotating bolt breaking knife;
  • the separation unit is connected to the proximal end of the thrombus removal head, and the separation unit is located between the transmission tube and the thrombus removal head to cover part of the opening.
  • the separation unit includes a connected connecting piece and a baffle; the connecting piece is connected to the proximal end of the bolt removing head, and the proximal end of the baffle is connected to the The distal end of the connector is connected, and the baffle is located between the transmission tube and the bolt removing head to cover part of the opening.
  • the connecting piece has an annular structure, and the connecting piece is fixedly connected to the proximal end of the thrombus removing head.
  • the separation unit further includes a fixing piece, the fixing piece is arranged opposite to the connecting piece; the baffle connects the connecting piece and the fixing piece; The fixing member is spaced apart from the transmission tube.
  • the bolt breaking device there are at least two baffles, and all the baffles are arranged at intervals along the circumferential direction of the connecting member.
  • the outer surface of the baffle is curved.
  • the baffle includes a body and a protrusion extending from part of the side wall of the body; the protrusion and part of the side wall of the body shield a portion the opening.
  • the bolt breaking unit further includes a bar, and the bar is arranged on the side wall of the bolt removing head and blocks part of the opening.
  • the side wall of the thrombus removing head has an outlet, the outlet is in communication with the opening, and the outlet is located along the thrombus removing head along the opening. the upper end of the axis.
  • the thrombus breaking knife has a tubular hollow structure and has at least one blade; wherein, the blade is set toward the side wall of the thrombus removing head.
  • the transmission tube is a hollow tube, and the hollow tube is formed by twisting flexible wires.
  • the thrombus breaking device further includes a conical structure; the conical structure is arranged at the distal end of the thrombus retrieval head, and has a top hole.
  • the thrombus breaking device further includes a guide wire, and the guide wire passes through the transmission tube and the tapered structure in turn, and protrudes through the top hole.
  • the thrombus breaking device further includes a sheath, the distal end of the sheath is connected to the proximal end of the thrombus removing head; the transmission tube runs through the sheath , and spaced apart from the inner wall of the sheath.
  • the present invention also provides a thrombus removal system, including a thrombus breaking module and a suction plug module; wherein,
  • the bolt breaking module includes a driving device and the bolt breaking device; the driving device is connected to the transmission tube to drive the transmission tube to rotate and drive the bolt breaking knife to rotate;
  • the suction plug module includes a suction plug tube and a suction plug device; the proximal end of the suction plug tube is connected with the suction plug device, and the distal end of the suction plug tube is connected with the inner cavity of the thrombus removing head.
  • the present invention provides a thrombus breaking device and a thrombus removal system.
  • the thrombus breaking device includes: a thrombus breaking unit and a separating unit.
  • the separation unit is connected to the proximal end of the thrombus removal head, so that the separation unit and the thrombus removal head are relatively fixed, and the separation unit is located between the transmission tube and the thrombus removal head to cover part of the opening.
  • the separation unit plays a role of blocking the blood vessel wall. That is, during the thrombectomy process, the separation unit can block the blood vessel wall and the venous valve from entering the thrombus removal head, reducing damage to the blood vessel wall and the venous valve.
  • the separation unit when the separation unit blocks the blood vessel wall during the thrombus removal process, it can separate the thrombus attached to the blood vessel wall from the blood vessel wall, thereby increasing the removal efficiency of the thrombus and improving the removal effect of the thrombus.
  • the thrombus breaking knife, the separating unit, and the thrombus removing head form a multi-layer cutting structure, which can realize repeated cutting of thrombus, improve thrombus breaking efficiency, and reduce operation time. Therefore, the thrombus breaking device and thrombus removal system provided by the present invention can not only protect the blood vessel wall from being destroyed during the thrombus breaking process, but also improve thrombus breaking efficiency, reduce operation time and improve thrombus removal effect.
  • Fig. 1 is a schematic structural view of a bolt breaking device in an embodiment of the present invention
  • Fig. 2 is a schematic structural view of a bolt removing head in an embodiment of the present invention
  • Fig. 3 is a schematic top view of a bolt breaking knife in an embodiment of the present invention.
  • Fig. 4 is a schematic diagram of the connection between the separation unit and the transmission pipe in the embodiment of the present invention.
  • Fig. 5-8 is the structural representation of a kind of separation unit in the embodiment of the present invention.
  • Fig. 9 is a schematic diagram of the position of the bar in the embodiment of the present invention.
  • Fig. 10 is a schematic diagram of the position of the outlet in the embodiment of the present invention.
  • Fig. 11 is a schematic structural view of a bolt breaking device in an embodiment of the present invention.
  • 10-bolt breaking unit 101-bolt removal head; 101a-the proximal end of the bolt removal head; 101b-the distal end of the bolt removal head; 102-bolt breaking knife; 103-transmission tube; 104-opening; 106-export;
  • proximal and distal in this article are: “distal” generally refers to the end of the medical device that first enters the patient's body during normal operation, and “proximal” generally refers to the end of the medical device that enters the patient's body during normal operation. The end of the process that is closest to the operator.
  • the thrombus breaking device includes: a thrombus breaking unit 10 and a separating unit 20 .
  • the bolt breaking unit 10 includes a bolt removing head 101 , a bolt breaking knife 102 and a transmission tube 103 .
  • the thrombus removing head 101 has a through inner cavity
  • the thrombus breaking knife 102 is disposed in the inner cavity
  • the distal end of the transmission tube 103 extends into the inner cavity.
  • the bolt breaking knife 102 is connected to the distal end of the transmission tube 103 to drive the bolt breaking knife 102 to rotate when the transmission tube 103 rotates.
  • the separation unit 20 is connected to the proximal end of the thrombus removal head 101, so that the separation unit 20 is relatively fixedly connected to the thrombus removal head 101, and the separation unit 20 is located between the transmission tube 103 and the thrombus removal head 101. between the heads 101 to partially cover the opening 104. Through the arrangement of the separation unit 20, it plays a role of blocking the blood vessel wall.
  • the baffle 202 of the separation unit 20 can prevent the blood vessel wall and the venous valve from entering the thrombectomy head during the thrombectomy process, reducing damage to the blood vessel wall and the venous valve.
  • the separating unit 20 blocks the blood vessel wall during thrombus removal, it can separate the thrombus attached to the blood vessel wall from the blood vessel wall, thereby increasing the thrombus removal efficiency and improving the thrombus removal effect.
  • the thrombus breaking knife 102, the separation unit 20 and the thrombus removing head 101 form a multi-layer cutting structure, which can realize repeated cutting of thrombus, improve thrombus breaking efficiency, and reduce operation time.
  • the thrombus breaking device provided in this embodiment can not only protect the blood vessel wall from being damaged during the thrombus breaking process, but also improve the thrombus breaking efficiency, reduce operation time and improve thrombus removal effect.
  • the separation unit 20 includes a connected connecting piece 201a and a baffle 202, the connecting piece 201a is connected to the proximal end of the bolt removing head 101, and the proximal end of the baffle 202 Connected to the distal end of the connecting piece 201a, the baffle plate 202 is located between the transmission tube 103 and the bolt removing head 101 to partially cover the opening 104 .
  • the connecting piece 201a can be connected to the proximal end of the thrombus removing head 101 by means of interference fit, clamping, etc., so that the connecting piece 201a is relatively fixedly connected to the bolt removing head 101 .
  • the baffle plate 202 and the connecting member 201a can be integrally formed, or fixedly connected by welding or the like. Therefore, the setting of the baffle plate 202 plays a role of blocking the blood vessel wall.
  • the number of baffles 202 may be one or more. Please refer to FIG. 5 , when there is one baffle 202 , the baffle 202 is located between the transmission tube 103 and the bolt removing head 101 to partially cover the opening 104 .
  • the plurality of baffles 202 are evenly distributed along the circumference of the connector 201a, for example, the number of baffles 202 is two, and the two baffles 202 are The connecting parts 201a are arranged at intervals in the circumferential direction to form a gate-shaped gap.
  • Each of the baffles 202 covers part of the opening 104. Compared with covering from one side of the opening 104 and covering both sides at the same time, the unshielded part of the opening 104 can be placed next to the original opening 104. The middle position realizes the adjustment of the opening position.
  • the plug removing head 101 is a hollow pipe with an inner cavity connected at both ends.
  • the hollow pipe is twisted and twisted from flexible filaments.
  • the material of the flexible wire includes but not limited to metal.
  • the thrombus breaking knife 102 and the transmission tube 103 are arranged in the inner cavity, so the thrombus removing head 101 increases the distance between the thrombus breaking knife 102 and the blood vessel wall, and reduces the distance between the blood vessel wall and the thrombus breaking knife 102.
  • the large contact volume plays a role in protecting the vessel wall during thrombus fragmentation.
  • the bolt breaking knife 102 is a tubular hollow structure, which not only occupies a small space, but is convenient to be sleeved on the transmission tube 103 to rotate with it, and can also be equipped with multiple blades to improve cutting efficiency.
  • the hollow design method facilitates the flow of gas and liquid during rotation, reduces rotation resistance, and improves the stability of the bolt breaking device during operation.
  • the bolt breaking knife 102 can be provided with one blade, two blades or multiple blades, and the more blades, the higher the bolt breaking efficiency.
  • the blade is set toward the side wall of the thrombus removing head 101 , that is, toward the opening 104 , so as to be cut when the thrombus enters the lumen through the opening 104 .
  • the separation unit 20 is also disposed in the inner cavity.
  • the connecting piece 201 a in the separating unit 20 is a ring structure, and is sheathed on the transmission tube 103 .
  • the proximal end of the connecting piece 201a is connected with the proximal end 101a of the bolt removing head, and the distal end of the connecting piece 201a is connected with the proximal end of the baffle plate 202, so as to realize the baffle plate 202 when the bolt is broken.
  • the plate 202 can cover part of the opening 104 all the time, so as to block the vessel wall from the outside of the thrombus removing head 101 and prevent the rotating thrombus breaking knife 102 from being twisted into the lumen and causing damage.
  • the separation unit 20 further includes a fixing part 201b.
  • the fixing piece 201b is disposed opposite to the connecting piece 201a, and the connecting piece 201a and the fixing piece 201b are respectively connected to opposite ends of the baffle plate 202 .
  • the fixing member 201b is also an annular structure, sleeved on the distal end of the transmission tube 103, and spaced from the transmission tube 103, that is, the fixing member 201b is not in contact with the transmission tube 103, then When the transmission tube 103 rotates, it will not affect the fixing member 201b, thereby ensuring the static state of the separation unit 20 .
  • the separation unit 20 includes a connecting piece 201 a and the baffle 202 .
  • the connecting piece 201a is connected to the proximal end of the baffle plate 202 and the proximal end 101a of the thrombus removing head, which can also achieve the effect of protecting the blood vessel wall.
  • the number of the baffles 202 may be 1, 2 or 3, etc.
  • the number of the baffles 202 is greater than 1, all the baffles 202 are arranged at intervals along the circumferential direction of the connecting member 201a.
  • the number of the baffles 202 is two.
  • the two baffles 202 are spaced apart from each other along the circumferential direction of the connecting member 201a to form a gate-shaped gap.
  • Each of the baffles 202 covers part of the opening 104. Compared with covering from one side of the opening 104 and covering both sides at the same time, the unshielded part of the opening 104 can be placed next to the original opening 104.
  • the middle position realizes the adjustment of the opening position.
  • the outer surface of the baffle plate 202 is a curved surface, optionally an arc-shaped surface, so as to match the outer contours of the connecting piece 201a and the fixing piece 201b.
  • the baffle 202 may also be an irregular arc-shaped surface.
  • the baffle 202 includes a body 2021 and a protrusion 2022 extending from a part of the sidewall of the body 2021 .
  • the protruding portion 2022 and part of the side wall of the body 2021 shield part of the opening 104, so that the shape and position of the unshielded part of the opening 104 can be changed to obtain different shielding states according to the needs of broken bolts. Good scalability.
  • the bolt breaking unit 10 provided in this embodiment also includes at least one blocking strip 105, which is arranged on the side wall of the bolt removing head 101 and blocks part of the opening 104 .
  • the blocking strip 105 shields part of the opening along the axial direction of the bolt removing head 101.
  • the thrombus breaking process when the blood vessel wall is adsorbed to the opening 104, the volume of the blood vessel wall entering the internal space of the thrombus breaking knife 102 is reduced under the blocking effect of the stop bar 105, and secondly, the thrombus breaking Under the double action of the pushing of the knife 102 and the blocking of the baffle plate 202, the vessel wall will be pushed out of the internal space of the thrombus breaking knife 102, and break away from the opening 104 under the tension of the vessel wall, thereby avoiding It can cause damage to the blood vessel wall, and at the same time, it can separate the thrombus attached to the blood vessel wall from the blood vessel wall.
  • the bar 105 can also play a role in cutting thrombus. Under the rapid rotation of the thrombus cutter 102, both the thrombus and the blood vessel wall are subjected to suction and approach the opening 104, and when the thrombus flows rapidly and touches the bar 105, it is subjected to a relatively large reaction force, so that the thrombus is crushed. Cut to achieve the purpose of breaking bolts. Compared with the soft thrombus in the external tissue, the blood vessel wall has a certain tension and the tissue is tight, so it will not be cut by the bar 105 . On the contrary, the bar 105 can prevent the blood vessel wall from entering the lumen, so as to protect the blood vessel.
  • the retaining strip 105 is integrally formed with the bolt removing head 101 . Therefore, in the thrombus removal process, the thrombus breaking knife 102, the bar 105, the baffle plate 202 and the opening 104 form a multi-layer cutting structure, which can realize repeated cutting of thrombus, improve the efficiency of thrombus breaking, and reduce operation time.
  • the side wall of the plug removing head 101 has an outlet 106 , the outlet 106 communicates with the opening 104 , and the outlet 106 is located along the opening 104 . Take one end of the plug head 101 in the axial direction.
  • the blood vessel wall is adsorbed to the opening 104, on the one hand, under the action of the baffle plate 202, the blood vessel wall cannot be twisted into the thrombus removing head 101 by the thrombus breaking knife 102, On the other hand, under the pushing action of the thrombus breaker 102, the blood vessel wall is pushed to the outlet 106, and is squeezed out of the opening 104 under the blocking effect of the baffle plate 202 and the tension of the blood vessel wall, thereby avoiding It can cause damage to the blood vessel wall, and at the same time, it can separate the thrombus attached to the blood vessel wall from the blood vessel wall.
  • the thrombus breaking device further includes a guide wire 30 , a sheath 40 and a tapered structure 50 .
  • the tapered structure 50 is disposed on the distal end 101b of the thrombus removing head 101, and has a top hole communicating with the inner cavity.
  • the guide wire 30 passes through the transmission tube 103 and the tapered structure 50 in turn, and protrudes through the top hole, so as to play a guiding role when the thrombus breaking device enters the target working area.
  • the distal end of the sheath tube 40 is connected to the proximal end 101 a of the thrombus removing head, and the transmission tube 103 runs through the sheath tube 40 and is spaced from the inner wall of the sheath tube 40 . After the thrombus is shredded, it enters the inner cavity of the thrombus removal head 101 and falls into the thrombus suction module through the gap between the transmission tube 103 and the sheath tube 40 .
  • this embodiment also provides a thrombus removal system, including a thrombus breaking module and a thrombus suction module.
  • the bolt breaking module includes a driving device and the bolt breaking device.
  • the driving device is connected with the transmission pipe 103 to drive the transmission pipe 103 to rotate and drive the bolt breaking knife 102 to rotate.
  • the driving device is a motor.
  • the suction plug module includes a suction plug tube and a suction plug device. The proximal end of the suction plug tube is connected to the suction device, and the distal end of the suction plug tube is connected to the sheath tube 40 and communicates with the lumen of the thrombus removing head 101 .
  • the embosser is a peristaltic pump.
  • the driving device When the driving device is started, it drives the transmission pipe 103 to rotate, drives the bolt breaking knife 102 to rotate, and at the same time starts the bolt suction device to produce a suction effect.
  • the thrombus is sucked, passes through the opening 104, and is shredded by the action of the thrombus breaking knife 102, and then the fragments of the thrombus pass through the inner cavity to the sheath tube 40, and then sucked out through the suction plug tube, and the extraction is completed.
  • the baffle plate 202, the baffle bar 105 and the outlet 106 can all prevent the blood vessel wall from being sucked and damaged, so as to achieve the purpose of protecting the blood vessel wall.
  • the thrombus is cut multiple times through the opening 104, the baffle plate 202, the bar 105 and the thrombus breaking knife 102, which improves the cutting efficiency and improves the thrombus removal effect.
  • the thrombus breaking device includes: a thrombus breaking unit 10 and a separating unit 20 .
  • the separation unit 20 is connected to the proximal end 101a of the thrombus removal head, and the separation unit 20 is located between the transmission tube 103 and the thrombus removal head 101 to cover part of the opening and block the blood vessel wall. That is, the separating unit 20 can block the blood vessel wall and venous valve from entering the thrombectomy head 101 during the thrombectomy process, reducing damage to the blood vessel wall and venous valve.
  • the separation unit 20 can separate the thrombus attached to the blood vessel wall from the blood vessel wall while blocking the blood vessel wall during the thrombus removal process, so as to increase the removal efficiency of the thrombus and improve the removal effect of the thrombus.
  • the thrombus breaking knife 102, the separating unit 20, and the thrombus removing head 101 form a multi-layer cutting structure during thrombus removal, which can realize repeated cutting of thrombus, improve thrombus breaking efficiency, and reduce operation time. Therefore, the thrombus breaking device and thrombus removal system provided in this embodiment can not only protect the blood vessel wall from being damaged during thrombus breaking, but also improve thrombus breaking efficiency, reduce operation time and improve thrombus removal effect.

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Abstract

一种碎栓装置及血栓清除系统，碎栓装置包括：碎栓单元(10)和分离单元(20)。分离单元(20)与取栓头(101)的近端连接，且分离单元(20)的部分位于传动管(103)和碎栓刀(102)之间，以遮蔽部分开口(104)。分离单元(20)的设置，起到阻挡血管壁的作用。在取栓过程中分离单元(20)可以阻隔血管壁和静脉瓣进入取栓头(101)，减少损伤，同时，可将附壁血栓与血管壁分离，增大对附壁血栓的清除效率，提高血栓的清除效果。此外，在取栓过程中碎栓刀(102)、分离单元(20)以及取栓头(101)组成多层切削结构，可实现对血栓的重复切削，提高碎栓效率，减少手术时间。

Description

碎栓装置及血栓清除系统 技术领域
本发明涉及医疗器械技术领域，特别涉及一种碎栓装置及血栓清除系统。
背景技术
下肢深静脉血栓形成(deep venous thrombosis,DVT)是血液在下肢深静脉内不正常凝结引起的疾病。DVT导致静脉压力增高，血液回流受阻，出现下肢肿胀、疼痛及功能障碍，同时存在血栓脱落的风险，而血栓脱落随着血流冲击到达肺动脉，可引起肺栓塞(pulmonary embolism,PE)。DVT若在急性期未得到有效治疗，血栓机化，静脉梗阻，瓣膜功能丧失，静脉反流及静脉高压，形成血栓后综合征(post thrombosis syndrome,PTS)，危及肢体生存、威胁生命安全。
通过口服或注射阿司匹林、肝素或华法林等，可以使药物进入血液系统，有效溶解静脉血栓，大幅降低深度静脉血栓和肺栓塞的发生率。然而，药物预防治疗也存在显著局限性，对于容易出血性体质，出血性脑卒中，严重的创伤，胸腔积血，抗凝血障碍等情况可能会造成严重机体出血，危及患者生命。因此，现有的置管溶栓(catheter-directed thrombolysis，CDT)，可以将溶栓药物(如尿激酶等)定向输送到血栓部位，有效减少血栓负荷量，降低PTS的发生率。但CDT治疗DVT存在溶栓时间长的问题，会导致长时间留置导管，增加病人的不适感，延长住院时间；反复抽血、需要密切监测和高级别护理；对于肿胀严重甚至危及肢体存活的病例，不利于尽快开通血流。并且CDT更不适用于出血风险高的患者(如严重高血压等)，不适合于分娩和妊娠的患者。
因此，对于临床症状相当严重的DVT又不能使用溶栓药物的患者，目前 可采用传统的外科手术进行取栓处理。但传统的外科手术也存在弊端：静脉切开取栓为有创操作，不适于一般情况较差的患者；取栓可能破坏瓣膜功能；有残余血栓，进一步溶栓抗凝易出现伤口并发症。
对此，随着技术的发展，近年来出现了机械血栓清除(percutaneous mechanical thrombectomy，PMT)装置，它是一组用来清除血管内急性和亚急性血栓形成的器械，采用溶解、粉碎、抽吸方式清除血管内血栓，恢复血运循环和瓣膜功能。PMT是微创伤的腔内血栓清除装置，可以快速的清除血栓，恢复血流。现有的一些PMT是通过驱动器驱动输送螺杆旋转，不断旋转的螺杆产生负压，将位于导管工作头附近血栓吸入到导管内部，由高速旋转的输送螺杆剪碎，并由软管排出排出体外。然而，由于导管输送螺杆高速旋转，在抽吸血栓过程中，会将血管壁吸到工作头内，并与输送螺杆发生缠绕，因而存在破坏血管壁，造成血管损伤的风险。或者，一些PMT是通过推进螺旋带动转子转动，将工作头上进入口附近的血栓剪碎，并将血栓吸取至工作头内，被捣碎的血栓在推进螺旋的传输作用下，通过分解导管排出。但同样由于转子为螺旋结构，在抽吸血栓过程中，会将血管壁绞入工作头内，因而存在破坏血管壁，造成血管损伤的风险。
可见，现有的PMT都会造成对血管壁的破坏。因此，需要一种新的碎栓装置及血栓清除系统。
发明内容
本发明的目的在于提供一种碎栓装置及血栓清除系统，以解决如何在碎栓的过程中避免对血管壁的破坏的问题。
为解决上述技术问题，本发明提供一种碎栓装置，包括：碎栓单元和分离单元；其中，
所述碎栓单元包括取栓头、碎栓刀以及传动管；所述取栓头具有贯通的内腔，所述碎栓刀设置于所述内腔中，所述碎栓刀与所述传动管的远端连接，以在所述传动管转动时带动所述碎栓刀旋转；所述取栓头的侧壁上具有开口，所述开口暴露出部分所述碎栓刀，以使得血栓经所述开口进入所述内腔后，经旋转的所述碎栓刀切碎；
所述分离单元与所述取栓头的近端连接，所述分离单元位于所述传动管和所述取栓头之间，以遮蔽部分所述开口。
可选的，在所述的碎栓装置中，所述分离单元包括相连的连接件和挡板；所述连接件的与所述取栓头的近端连接，所述挡板的近端与所述连接件的远端连接，所述挡板位于所述传动管和所述取栓头之间，以遮蔽部分所述开口。
可选的，在所述的碎栓装置中，所述连接件具有环形结构，所述连接件与所述取栓头的近端固定连接。
可选的，在所述的碎栓装置中，所述分离单元还包括固定件，所述固定件与所述连接件相对设置；所述挡板连接所述连接件与所述固定件；所述固定件与所述传动管间隔设置。
可选的，在所述的碎栓装置中，所述挡板至少为两个，所有所述挡板沿着所述连接件的周向相互间隔设置。
可选的，在所述的碎栓装置中，所述挡板的外表面呈曲面。
可选的，在所述的碎栓装置中，所述挡板包括本体以及从所述本体的部分侧壁延伸出的凸出部；所述凸出部和所述本体的部分侧壁遮蔽部分所述开口。
可选的，在所述的碎栓装置中，所述碎栓单元还包括挡条，所述挡条设置于所述取栓头的侧壁上，并遮挡部分所述开口。
可选的，在所述的碎栓装置中，所述取栓头的侧壁具有导出口，所述导 出口与所述开口连通，且所述导出口位于所述开口沿所述取栓头轴向上的一端。
可选的，在所述的碎栓装置中，所述碎栓刀为管状镂空结构，且具有至少一个刀锋；其中，所述刀锋朝向所述取栓头的侧壁设置。
可选的，在所述的碎栓装置中，所述传动管为中空管件，且所述中空管件经柔性丝缠捻而成。
可选的，在所述的碎栓装置中，所述碎栓装置还包括锥形结构；所述锥形结构设置于所述取栓头的远端，且具有与所述内腔相连通的顶孔。
可选的，在所述的碎栓装置中，所述碎栓装置还包括导丝，所述导丝依次贯穿所述传动管和所述锥形结构，并经所述顶孔伸出。
可选的，在所述的碎栓装置中，所述碎栓装置还包括鞘管，所述鞘管的远端与所述取栓头的近端连接；所述传动管贯穿所述鞘管，并与所述鞘管的内壁相间隔。
基于同一发明构思，本发明还提供一种血栓清除系统，包括碎栓模块和吸栓模块；其中，
所述碎栓模块包括驱动装置和所述碎栓装置；所述驱动装置与所述传动管相连，以驱动所述传动管转动并带动所述碎栓刀旋转；
所述吸栓模块包括吸栓管和吸栓器；所述吸栓管的近端与所述吸栓器相连，所述吸栓管的远端与所述取栓头的内腔相连通。
综上所述，本发明提供一种碎栓装置及血栓清除系统。其中，所述碎栓装置包括：碎栓单元和分离单元。所述分离单元与所述取栓头的近端连接，使得所述分离单元与所述取栓头相对固定，且所述分离单元位于所述传动管和所述取栓头之间，以遮蔽部分所述开口。通过所述分离单元的设置，起到阻挡血管壁的作用。即，在取栓过程中所述分离单元可以阻隔血管壁和静脉 瓣进入所述取栓头，减少对血管壁和静脉瓣的损伤。并且，在取栓过程中所述分离单元阻挡血管壁的同时，可以将附着在血管壁上的血栓与血管壁分离，增大血栓的清除效率，提高血栓的清除效果。此外，在取栓过程中所述碎栓刀、所述分离单元以及所述取栓头组成多层切削结构，可以实现对血栓的重复切削，提高碎栓效率，减少手术时间。因此，本发明提供的所述碎栓装置及血栓清除系统不仅可以保护血管壁，避免其在碎栓的过程被破坏，还能够提高碎栓效率，减少手术时间以及提高血栓清除效果。
附图说明
图1是本发明实施例中的碎栓装置的结构示意图；
图2是本发明实施例中的取栓头的结构示意图；
图3是本发明实施例中的碎栓刀的俯视示意图；
图4是本发明实施例中的分离单元与传动管的连接示意图；
图5-8是本发明实施例中的一种分离单元的结构示意图；
图9是本发明实施例中的挡条的位置示意图；
图10是本发明实施例中的导出口的位置示意图；
图11是本发明实施例中的碎栓装置的结构示意图；
其中，附图标记为：
10-碎栓单元；101-取栓头；101a-取栓头的近端；101b-取栓头的远端；102-碎栓刀；103-传动管；104-开口；105-档条；106-导出口；
20-分离单元；201a-连接件；201b-固定件；202-挡板；2021-本体；2022-凸出部；
30-导丝；40-鞘管；50-锥形结构。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且未按比例绘制，仅用以方便、明晰地辅助说明本发明实施例的目的。此外，附图所展示的结构往往是实际结构的一部分。特别的，各附图需要展示的侧重点不同，有时会采用不同的比例。还应当理解的是，除非特别说明或者指出，否则说明书中的术语“第一”、“第二”、“第三”等描述仅仅用于区分说明书中的各个组件、元素、步骤等，而不是用于表示各个组件、元素、步骤之间的逻辑关系或者顺序关系等。
本文中“近端”和“远端”的定义为：“远端”通常指该医疗设备在正常操作过程中首先进入患者体内的一端，而“近端”通常是指该医疗设备在正常操作过程中靠近操作者的一端。
为解决上述技术问题，本实施例提供一种碎栓装置。请参阅图1，所述碎栓装置包括：碎栓单元10和分离单元20。其中，所述碎栓单元10包括取栓头101、碎栓刀102以及传动管103。所述取栓头101具有贯通的内腔，所述碎栓刀102设置于所述内腔中，所述传动管103的远端延伸至所述内腔中。所述碎栓刀102与所述传动管103的远端连接，以在所述传动管103转动时带动所述碎栓刀102旋转。所述取栓头101的侧壁上具有开口104，所述开口104暴露出部分所述碎栓刀102，以使得血栓经所述开口104进入所述内腔后，经旋转的所述碎栓刀102切碎。所述分离单元20与所述取栓头101的近端连接，以使得所述分离单元20与所述取栓头101相对固定连接，又所述分离单元20位于所述传动管103和取栓头101之间，以遮蔽部分所述开口104。通过所述分离单元20的设置，起到阻挡血管壁的作用。
因此，在取栓过程中所述分离单元20的所述挡板202可以阻隔血管壁和静脉瓣进入取栓头，减少对血管壁和静脉瓣的损伤。且在取栓过程中所述分离单元20阻挡血管壁的同时，可以将附着在血管壁上的血栓与血管壁分离，增大血栓的清除效率，提高血栓的清除效果。此外，在取栓过程中所述碎栓刀102、分离单元20以及取栓头101组成多层切削结构，可以实现对血栓的重复切削，提高碎栓效率，减少手术时间。则本实施例提供的所述碎栓装置不仅可以保护血管壁，避免其在碎栓的过程被破坏，还能够提高碎栓效率，减少手术时间以及提高血栓清除效果。
具体地，在本实施例中，所述分离单元20包括相连的连接件201a和挡板202，所述连接件201a与所述取栓头101的近端连接，所述挡板202的近端与所述连接件201a的远端连接，所述挡板202位于所述传动管103和所述取栓头101之间，以遮蔽部分所述开口104。其中，所述连接件201a可以通过过盈配合、卡接等方式与所述取栓头101的近端连接，使得所述连接件201a与所述取栓头101相对固定连接。所述挡板202与所述连接件201a可以一体成型，也可以通过焊接等方式固定连接。因此，通过挡板202的设置，起到阻挡血管壁的作用。
其中，挡板202的数量可以为1个或者多个。请参考图5，当挡板202的数量为一个时，挡板202位于所述传动管103和取栓头101之间，以遮蔽部分所述开口104。当挡板202的数量为多个时，多个挡板202沿着所述连接件201a的周向均匀分布，例如，挡板202的数量为两个，两个所述挡板202沿着所述连接件201a的周向相互间隔设置，形成门形间隙。每一所述挡板202均遮蔽部分所述开口104，相较于从所述开口104一侧遮挡，两侧同时遮挡，可以将未遮蔽的部分所述开口104置于原所述开口104的中间位置，实现对开口位置的调整。
以下结合附图1-11具体介绍本实施例提供的所述碎栓装置：
请继续参阅图1-3，所述取栓头101为中空管件，具有两端连通的内腔。优选的，所述中空管件由柔性丝缠捻而成。所述柔性丝的材质包括但不限于为金属。其中，所述碎栓刀102和所述传动管103设置于所述内腔中，故所述取栓头101增加了碎栓刀102到血管壁的距离，减少了血管壁与碎栓刀102的接触体积，起到了在碎栓过程中保护血管壁的作用。
所述碎栓刀102为管状镂空结构，不仅占用空间小，利于套设在所述传动管103上随之转动，还能够设置多个刀锋，提高切割效率。此外，镂空的设计方式，在旋转过程中便于气液体的流动，降低旋转阻力，提高了碎栓装置在作业过程中的稳定性。进一步的，根据碎栓程度的要求，所述碎栓刀102可设置一个刀锋、两个刀锋或者多个刀锋，刀锋越多碎栓效率越高。并且，所述刀锋朝向所述取栓头101的侧壁设置，即朝向所述开口104的方向，以在血栓经所述开口104进入所述内腔时被切割。
请参阅图1、4和5，所述分离单元20也设置于所述内腔中。优选的，所述分离单元20中的所述连接件201a为环形结构，套设在所述传动管103上。并且，所述连接件201a的近端与所述取栓头的近端101a相连，所述连接件201a的远端与所述挡板202的近端相连，以实现在碎栓时所述挡板202能够始终遮蔽部分所述开口104，以将血管壁阻挡在所述取栓头101的外部，避免被旋转的所述碎栓刀102绞入所述内腔，造成破损。
为进一步对所述挡板202进行限位，保证作业时的稳定性，所述分离单元20还包括固定件201b。所述固定件201b与所述连接件201a相对设置，且所述连接件201a和所述固定件201b分别与所述挡板202相对的两端连接。优选的，所述固定件201b也为环形结构，套设于所述传动管103的远端，与所述传动管103相间隔，即所述固定件201b与所述传动管103不接触，则在 所述传动管103自转时，不会对所述固定件201b产生影响，进而保证了所述分离单元20的静止状态。并且，在所述挡板202受到气液体产生的较大冲击时会发生扭动，在所述固定件201b的牵制下会减少所述挡板202扭动的幅度，保证碎栓装置的稳定性。当然，为了降低成本，简化装置，还可以仅仅设置所述连接件201a，无需所述固定件201b。如图6所示，所述分离单元20包括连接件201a和所述挡板202。所述连接件201a与所述挡板202的近端以及所述取栓头的近端101a连接，同样可以实现保护血管壁的效果。
进一步的，当所述分离单元20还包括固定件201b时，所述挡板202的数量可以为1个、2个或3个等。当所述挡板202的数量大于1时，所有所述挡板202沿着所述连接件201a的周向相互间隔设置。如图7所示的所述挡板202的数量为2。两个所述挡板202沿着所述连接件201a的周向相互间隔设置，形成门形间隙。每一所述挡板202均遮蔽部分所述开口104，相较于从所述开口104一侧遮挡，两侧同时遮挡，可以将未遮蔽的部分所述开口104置于原所述开口104的中间位置，实现对开口位置的调整。
其中，所述挡板202外表面成曲面，可选的为弧形面，以与所述连接件201a及所述固定件201b的外轮廓相适配。并且，除了图4-7所示的规则的弧形面挡板202，所述挡板202还可以为不规则的弧形面。如图8所示，所述挡板202包括本体2021以及从所述本体2021的部分侧壁延伸出的凸出部2022。所述凸出部2022和所述本体2021的部分侧壁遮蔽部分所述开口104，以根据碎栓需要，可实现改变未遮蔽的部分所述开口104的形状和位置，获得不同的遮蔽状态，拓展性好。
为进一步提高阻挡效果，如图9所示，本实施提供的所述碎栓单元10还包括至少一个挡条105，所述挡条105设置于所述取栓头101的侧壁上，并遮挡部分所述开口104。可选的，所述挡条105沿所述取栓头101的轴向上遮蔽 部分所述开口。在碎栓过程中，当血管壁被吸附到所述开口104时，在所述挡条105的阻挡作用下，进入所述碎栓刀102内部空间的血管壁体积减少，其次在所述碎栓刀102的推送和所述挡板202阻隔的双重作用下，血管壁会被推离出所述碎栓刀102的内部空间，并且在血管壁的张力作用下脱离出所述开口104，从而避免对血管壁造成损伤，同时还可以将附着在血管壁上的血栓与血管壁分离。
此外，所述档条105还能够起到切割血栓的作用。在所述碎栓刀102的快速旋转下，血栓和血管壁均受到吸力靠近所述开口104，则血栓快速的流动在接触到所述档条105时，受到较大的反作用力，使得血栓被切割，实现碎栓的目的。而相较于外部组织松软的血栓，血管壁具有一定的张力，且组织紧密，则不会被所述档条105切割。相反，所述档条105能够阻挡血管壁进入所述内腔，实现对血管的保护。优选的，所述挡条105与所述取栓头101一体成型。因而，在取栓过程中所述碎栓刀102、所述档条105、所述挡板202以及所述开口104组成多层切削结构，可以实现对血栓的重复切削，提高碎栓效率，减少手术时间。
进一步的，如图1和10所示，所述取栓头101的侧壁具有导出口106，所述导出口106与所述开口104连通，且所述导出口106位于所述开口104沿所述取栓头101轴向上的一端。在碎栓过程中时，血管壁被吸附到所述开口104时，一方面在所述挡板202的作用下，血管壁不能被所述碎栓刀102绞入所述取栓头101内，另一方面在所述碎栓刀102的推送作用下，血管壁被推至导出口106，在所述挡板202的阻隔作用以及血管壁张力的作用下被挤出所述开口104，从而避免对血管壁造成损伤，同时还可以将附着在血管壁上的血栓与血管壁分离。
请参阅图11，所述碎栓装置还包括导丝30、鞘管40和锥形结构50。所 述锥形结构50设置于所述取栓头101的远端101b，且具有与所述内腔相连通的顶孔。所述导丝30依次贯穿所述传动管103和所述锥形结构50，并经所述顶孔伸出，以在所述碎栓装置进入目标工作区时起到引导的作用。所述鞘管40的远端与所述取栓头的近端101a连接，且所述传动管103贯穿所述鞘管40，并与所述鞘管40的内壁相间隔。血栓经切碎后，进入所述取栓头101的内腔中，并经所述传动管103和所述鞘管40之间的间隙落入吸栓模块中。
基于同一发明构思，本实施例还提供一种血栓清除系统，包括碎栓模块和吸栓模块。其中，所述碎栓模块包括驱动装置和所述碎栓装置。所述驱动装置与所述传动管103相连，以驱动所述传动管103自转并带动所述碎栓刀102旋转。可选的，所述驱动装置为一马达。所述吸栓模块包括吸栓管和吸栓器。所述吸栓管的近端与所述吸栓器相连，所述吸栓管的远端与所述鞘管40相连，且与所述取栓头101的内腔相连通。可选的，所述吸栓器为蠕动泵。
当所述驱动装置启动，驱动所述传动管103自转，并带动所述碎栓刀102旋转，同时启动所述吸栓器，产生抽吸效果。血栓经抽吸，透过所述开口104，经所述碎栓刀102的作用切碎，则血栓的碎片经所述内腔至所述鞘管40，再经吸栓管吸出，即完成取栓。其中，所述挡板202、挡条105以及导出口106均可以避免血管壁被吸入而破坏，实现保护血管壁的目的。同时，血栓经所述开口104、所述挡板202、所述挡条105和所述碎栓刀102的多重切割下，提高了切割效率，提高血栓的清除效果。
综上所述，本实施例提供一种碎栓装置及血栓清除系统。其中，所述碎栓装置包括：碎栓单元10和分离单元20。所述分离单元20与取栓头的近端101a连接，且所述分离单元20位于传动管103和取栓头101之间，以遮蔽部分开口，起到阻挡血管壁的作用。即，在取栓过程中所述分离单元20可以阻隔血管壁和静脉瓣进入所述取栓头101，减少对血管壁和静脉瓣的损伤。
并且，在取栓过程中所述分离单元20阻挡血管壁的同时，可以将附着在血管壁上的血栓与血管壁分离，增大血栓的清除效率，提高血栓的清除效果。此外，在取栓过程中所述碎栓刀102、所述分离单元20以及所述取栓头101组成多层切削结构，可以实现对血栓的重复切削，提高碎栓效率，减少手术时间。因此，本实施例提供的所述碎栓装置及血栓清除系统不仅可以保护血管壁，避免其在碎栓的过程被破坏，还能够提高碎栓效率，减少手术时间以及提高血栓清除效果。
此外还应该认识到，虽然本发明已以较佳实施例披露如上，然而上述实施例并非用以限定本发明。对于任何熟悉本领域的技术人员而言，在不脱离本发明技术方案范围情况下，都可利用上述揭示的技术内容对本发明技术方案作出许多可能的变动和修饰，或修改为等同变化的等效实施例。因此，凡是未脱离本发明技术方案的内容，依据本发明的技术实质对以上实施例所做的任何简单修改、等同变化及修饰，均仍属于本发明技术方案保护的范围。

Claims (15)

  1. 一种碎栓装置，其特征在于，包括：碎栓单元和分离单元；其中，
    所述碎栓单元包括取栓头、碎栓刀以及传动管；所述取栓头具有贯通的内腔，所述碎栓刀设置于所述内腔中，所述碎栓刀与所述传动管的远端连接，以在所述传动管转动时带动所述碎栓刀旋转；所述取栓头的侧壁上具有开口，所述开口暴露出部分所述碎栓刀，以使得血栓经所述开口进入所述内腔后，经旋转的所述碎栓刀切碎；
    所述分离单元与所述取栓头的近端连接，所述分离单元位于所述传动管和所述取栓头之间，以遮蔽部分所述开口。
  2. 根据权利要求1所述的碎栓装置，其特征在于，所述分离单元包括相连的连接件和挡板；所述连接件的与所述取栓头的近端连接，所述挡板的近端与所述连接件的远端连接，所述挡板位于所述传动管和所述取栓头之间，以遮蔽部分所述开口。
  3. 根据权利要求2所述的碎栓装置，其特征在于，所述连接件具有环形结构，所述连接件与所述取栓头的近端固定连接。
  4. 根据权利要求3所述的碎栓装置，其特征在于，所述分离单元还包括固定件，所述固定件与所述连接件相对设置；所述挡板连接所述连接件与所述固定件；所述固定件与所述传动管间隔设置。
  5. 根据权利要求2-4中任一项所述的碎栓装置，其特征在于，所述挡板至少为两个，所有所述挡板沿着所述连接件的周向相互间隔设置。
  6. 根据权利要求2-4中任一项所述的碎栓装置，其特征在于，所述挡板的外表面呈曲面。
  7. 根据权利要求2-4中任一项所述的碎栓装置，其特征在于，所述挡板包括本体以及从所述本体的部分侧壁延伸出的凸出部；所述凸出部和所述本 体的部分侧壁遮蔽部分所述开口。
  8. 根据权利要求1所述的碎栓装置，其特征在于，所述碎栓单元还包括挡条，所述挡条设置于所述取栓头的侧壁上，并遮挡部分所述开口。
  9. 根据权利要求1所述的碎栓装置，其特征在于，所述取栓头的侧壁具有导出口，所述导出口与所述开口连通，且所述导出口位于所述开口沿所述取栓头轴向上的一端。
  10. 根据权利要求1所述的碎栓装置，其特征在于，所述碎栓刀为管状镂空结构，且具有至少一个刀锋；其中，所述刀锋朝向所述取栓头的侧壁设置。
  11. 根据权利要求1所述的碎栓装置，其特征在于，所述传动管为中空管件，且所述中空管件经柔性丝缠捻而成。
  12. 根据权利要求1所述的碎栓装置，其特征在于，所述碎栓装置还包括锥形结构；所述锥形结构设置于所述取栓头的远端，且具有与所述内腔相连通的顶孔。
  13. 根据权利要求12所述的碎栓装置，其特征在于，所述碎栓装置还包括导丝，所述导丝依次贯穿所述传动管和所述锥形结构，并经所述顶孔伸出。
  14. 根据权利要求1所述的碎栓装置，其特征在于，所述碎栓装置还包括鞘管，所述鞘管的远端与所述取栓头的近端连接；所述传动管贯穿所述鞘管，并与所述鞘管的内壁相间隔。
  15. 一种血栓清除系统，其特征在于，包括碎栓模块和吸栓模块；其中，
    所述碎栓模块包括驱动装置和如权利要求1-14中任意一项所述的碎栓装置；所述驱动装置与所述传动管相连，以驱动所述传动管转动并带动所述碎栓刀旋转；
    所述吸栓模块包括吸栓管和吸栓器；所述吸栓管的近端与所述吸栓器相 连，所述吸栓管的远端与所述取栓头的内腔相连通。
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