WO2019001245A1 - 机械血栓清除装置 - Google Patents

机械血栓清除装置 Download PDF

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Publication number
WO2019001245A1
WO2019001245A1 PCT/CN2018/090482 CN2018090482W WO2019001245A1 WO 2019001245 A1 WO2019001245 A1 WO 2019001245A1 CN 2018090482 W CN2018090482 W CN 2018090482W WO 2019001245 A1 WO2019001245 A1 WO 2019001245A1
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WIPO (PCT)
Prior art keywords
tube
transmission tube
thrombus
sheath
suction
Prior art date
Application number
PCT/CN2018/090482
Other languages
English (en)
French (fr)
Inventor
韩建超
张琳琳
丁双喜
史增佐
樊亚明
李中华
苗铮华
Original Assignee
微创心脉医疗科技（上海）有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by 微创心脉医疗科技（上海）有限公司 filed Critical 微创心脉医疗科技（上海）有限公司
Priority to EP18824650.8A priority Critical patent/EP3646806B1/en
Publication of WO2019001245A1 publication Critical patent/WO2019001245A1/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
    • 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
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • 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
    • A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • 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
    • A61B2017/22038—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 a guide wire
    • 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
    • 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
    • A61B2017/22082—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 after introduction of a substance
    • A61B2017/22084—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 after introduction of a substance stone- or thrombus-dissolving
    • 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
    • A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • 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
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A61B2017/320775—Morcellators, impeller or propeller like means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • the invention relates to the technical field of medical instruments, and in particular to a mechanical thrombus removing device.
  • Deep venous thrombosis is a disease caused by abnormal blood clotting in the deep veins of the lower extremities.
  • DVT causes increased venous pressure, blocked blood flow, swelling, pain and dysfunction of the lower extremities, and there is a risk of thrombus detachment.
  • the thrombus detachment reaches the pulmonary artery with blood flow impact, which can cause pulmonary embolism (PE).
  • PE pulmonary embolism
  • the drug can enter the blood system, effectively dissolve venous thrombosis, and significantly reduce the incidence of deep vein thrombosis and pulmonary embolism.
  • Catheter-directed thrombolysis can deliver thrombolytic drugs (such as urokinase) to the thrombus site, effectively reduce the thrombus load, early recovery of intravenous positive blood flow, relieve or relieve venous obstruction It protects the morphology and function of venous valve, blocks the pathological process of PTS, and reduces the incidence of PTS.
  • thrombolytic drugs such as urokinase
  • CDT treatment of DVT has a long time for thrombolysis (average thrombolysis time 53.4 hours), which will lead to long-term indwelling catheter, increase patient discomfort, prolong hospitalization; repeated blood draw, close monitoring and high-level care; Cases with severe swelling and even endangering limb survival are not conducive to opening blood flow as soon as possible; bleeding risk of thrombolytic drugs; CDT is not suitable for patients with high bleeding risk (such as severe hypertension), and is not suitable for post-partum and pregnant patients. .
  • thrombectomy is suitable for patients with clinically severe DVT and thrombolytic drugs.
  • the disadvantage is that the venous incision is an invasive operation, which is not suitable for patients with poor general condition; the thrombectomy may destroy the function of the valve; there is residual thrombus, and further thrombolysis and anticoagulation may cause wound complications.
  • PMT percutaneous mechanical thrombectomy
  • U.S. Patent No. 2014/0088610 A1 discloses the construction of a mechanical thrombus removal device comprising a catheter having a plurality of side holes at the top end, a separate conduit for infusion of liquid inside the conduit and a plurality of conduits at the top of the conduit. Small hole.
  • the high-pressure physiological saline is poured into the independent pipe to spray the physiological saline in the small hole at the top of the pipe.
  • the high-speed jetted physiological saline cooperates with the top hole of the catheter to generate the Bernoulli effect, and the thrombus is sucked into the catheter through the side hole.
  • the high-speed jetted saline breaks up the inhaled large thrombus and is excreted by vacuum suction. After the operation, the thrombolytic drug can be injected into the blood vessel through the catheter to reduce the residual thrombus.
  • the patent solves the problem of pumping and excreting thrombus, but due to its design features, high-speed jetted saline is ejected through the side hole of the catheter, destroying red blood cells in the blood, and these damaged red blood cells are not All pumping to the body, prone to hematuria, renal failure and other complications; high-speed saline stimulates the blood vessel wall, easy to cause neurological disorders; the channel of thrombolytic drugs after surgery and the thrombus aspiration channel is the same channel, part of the pumping The thrombus to the catheter re-enters the body due to drug perfusion, reducing the thrombectomy effect.
  • WO 2011/024124 A1 discloses a mechanical thrombus removal device structure having a catheter with a side hole at the top end and a spiral structure inside the catheter, which operates under high speed rotation of the spiral structure to form a negative pressure which will be located at the side hole of the catheter.
  • the nearby thrombus is inhaled into the catheter, and the spiral structure cooperates with the side hole of the catheter to cut the inhaled thrombus to achieve the purpose of fragmentation, and finally the thrombus is excreted.
  • the device is carried out inside the catheter, the device solves the problem of hematuria.
  • the rotation speed of the spiral structure is too fast during pumping, the temperature of the catheter is too high, and the guide wire is broken, causing adverse reactions; due to its design features, The thrombolytic drug cannot be infused through the device.
  • the present invention provides a mechanical thrombus removal device, including the mechanical thrombus removal device
  • the bolting head being connected to the sheath connecting piece through the sheath tube;
  • a bolting system comprising a rotary drive device, a transmission tube and a fragmentation knife, the proximal end of the transmission tube being connected to the rotary drive device, the distal end being connected to the fragmentation knife, the transmission tube being along the sheath tube a lumen of the connector and the sheath extends into the plug head; under the driving action of the rotary driving device, the transmission tube rotates and drives the bobbin cutter to rotate, and the bobbin head has been sucked The thrombus is broken; and
  • a suction plug system comprising a suction device and a suction tube, the proximal end of the suction tube being connected to the suction device, the distal end being connected to the sheath connection, and the transmission tube and the sheath being formed
  • the cavity is in communication with the suction tube to form a suction tube lumen.
  • the mechanical thrombus removal device further comprising a drug perfusion system
  • the drug perfusion system comprising a syringe and an infusion tube, the proximal end of the infusion tube being connected to the syringe, the infusion tube being far The end is in communication with the transmission tube, and the drug reaches the thrombus portion via the transmission tube and the bolt removal head.
  • the rotary drive device is a hollow shaft motor, and the hollow shaft motor is mounted on an outer side of the transmission tube;
  • the rotary driving device includes: a rotation motor, a first gear and a second gear, the first gear is mounted on an outer side of the transmission tube and meshes with the second gear, and the second gear is mounted on the rotation On the output shaft of the motor.
  • the suction device is a peristaltic pump
  • the suction tube is a hose.
  • the sheath connector is a three-chamber structure, and the transmission tube passes through a distal cavity and a proximal cavity of the sheath connector, the sheath connector The side cavity connects the distal end of the suction tube, and the sheath connector further includes a sealing structure for sealing the suction tube lumen.
  • the distal end of the infusion tube communicates with the transmission tube via the sheath connector, or the distal end of the infusion tube is connected via a transmission end connector Communicating with the transmission tube.
  • the transmission tube includes: a front end transmission tube, an intermediate transmission tube and a tail end transmission tube that are sequentially connected, and the bobbin cutter is fixed on the front end transmission tube And being received in the plugging head; the intermediate transmission tube is received in the sheath tube and the sheath connecting member; and the tail end transmission tube is connected to the rotary driving device.
  • the intermediate transmission tube is a spiral tube
  • the spiral tube is further provided with an inner tube
  • the inner tube covers the spiral tube and the front end transmission tube and the The connection part of the tail end transmission pipe.
  • the distal end of the end portion of the transmission tube is fixed to the transmission tube by a cooperation of a fixing cap and a sealing ring, and the connecting end of the transmission tube is connected
  • the proximal end is fixed to the distal end of the transmission tube by the cooperation of the locking cap and the sealing ring, and the proximal end of the connecting end of the transmission tube and the proximal end of the locking cap are provided with a guide wire hole.
  • the guide wire hole serves as a passage for the guide wire to enter and exit and communicates with the transmission tube.
  • the locking cap has a matching thread with the connecting end of the transmission tube, and the screw is tightened or loosened by controlling the locking cap. Open to adjust the closing or opening of the guide wire hole.
  • the plug head is a hollow member and has a proximal end and a distal end, and the distal end of the plug head has a conical curved structure and has a top hole.
  • the proximal end of the plug includes at least one side hole for the plug.
  • the fragmentation knife is a tubular hollow structure, including at least one blade, the fragmentation knife is located in the inner cavity of the bolting head, and the position of the blade edge Corresponding to the position of the plug side hole.
  • the distal end of the transmission tube includes a first side hole, and the first side hole cooperates with an inclined hole on the bolt receiving head, the medicine The thrombus site is reached via the first side hole and the oblique hole.
  • the mechanical thrombus removal device includes a suction device and a suction tube, and the suction system of the present invention provides a negative pressure in a manner different from the high speed rotation of the existing spiral structure.
  • the way of forming the siphon provides the negative pressure, and the negative pressure required for the suction bolt can be formed without rotating at a high speed, thereby effectively reducing the problem that the speed of the existing spiral structure forming the negative pressure is too fast, causing the temperature to be too high and causing the guide wire to break. .
  • the thrombus system and the bolting system of the present invention are two independent systems, which effectively avoid the mutual influence of the thrombus and the bolting process; the bolting process is carried out in the plug head, which effectively reduces the occurrence of hematuria and kidney in the patient.
  • the probability of complication and the incidence of vascular perforation also employs a separate drug perfusion system that can infuse thrombolytic drugs into the lesion at any time during the surgical procedure, thereby avoiding the problem that the thrombus that has been drawn into the catheter re-enters the patient due to drug perfusion.
  • the invention also improves the plugging head, increases the thrombolysis area, and improves the thrombolysis efficiency.
  • the invention also provides a mechanical thrombus removing device integrating the infusion thrombolytic drug, the negative pressure suction plug and the mechanical crushing plug, which can significantly accelerate the thrombectomy process, shorten the operation time, reduce the pain of the patient, and expand the scope of the surgery.
  • FIG. 1 is a schematic structural view of a mechanical thrombus removing device according to an embodiment of the present invention
  • FIG. 2 is a schematic structural view of a plugging head according to an embodiment of the present invention.
  • Figure 3 is a cross-sectional view taken along line A-A of Figure 2;
  • FIG. 4 is a schematic structural view of a broken knives according to an embodiment of the present invention.
  • Figure 5 is a cross-sectional view showing a sheath connecting member in an embodiment of the present invention.
  • FIG. 6 is a cross-sectional view showing a connecting end of a transmission pipe at an end according to an embodiment of the present invention
  • Figure 7 is a partial cross-sectional view showing a transmission tube in an embodiment of the present invention.
  • FIG. 8 is a schematic structural view of a rotary driving device according to an embodiment of the present invention.
  • Fig. 9 is a schematic view showing another structure of a rotary driving device in an embodiment of the present invention.
  • Mechanical thrombus removal device-1000 peristaltic pump-1340; hose-1310; pump head-1320; sheath tube-1120; bolt head-1110; top hole-1111; oblique hole-1112; bolt side hole-1113; Collection container-1330; transmission tube-1270; first side hole-1221; perfusion hole-1251; front end transmission tube-1220, intermediate transmission tube-1240; tail end transmission tube-1250; inner tube 1260; rotary drive device-1140 Rotary motor-1141; first gear-1252; second gear-1142; transmission tube end connection piece-1150; broken bolt knife-1210; blade front-1211; syringe-1180; infusion tube-1160; 1170; sheath connector-1130; positioning ring-1230; fixing cap-1131, 1151; sealing ring-1132, 1152; locking cap-1153; sealing ring-1154; guide wire hole -1155.
  • proximal and distal are defined as “distal” generally refers to the end of the medical device that first enters the patient during normal operation, while “proximal” generally refers to the normal operation of the medical device. Approaching the operator's end during the process.
  • FIG. 1 is a schematic structural view of a mechanical thrombus removal device of the present invention.
  • the mechanical thrombus removal device 1000 includes: a bolting head 1110, a suction plug system and a fragmentation system, the bolting head 1110 is connected to the sheath connector 1130 through a sheath 1120;
  • the suction plug system includes a suction device and a suction tube, the proximal end of the suction tube is connected to the suction device, the distal end is connected to the sheath connector 1130, and a cavity formed between the transmission tube of the fragmentation system and the sheath 1120
  • the body is in communication with the suction tube to form a suction tube lumen.
  • the suction device in the suction plug system shown in this embodiment is a peristaltic pump 1340, which is a hose 1310, and further includes a collection container 1330 for collecting thrombus, the hose
  • the distal end of the 1310 is in communication with the proximal end of the sheath 1120
  • the proximal end of the hose 1310 is in communication with the collection container 1330
  • the distal end of the sheath 1120 is in communication with the thrombectomy head 1110;
  • the peristaltic pump 1340 Under the negative pressure generated by the peristaltic pump 1340, the thrombus sucked by the bolting head 1110 is transferred into the collection container 1330 through the sheath 1120 and the hose 1310.
  • the peristaltic pump 1340 further includes a pump head 1320 that is mounted on the pump head 1320 and that is switched between a squeezed state and a non-extrusion state as the pump head 1320 rotates.
  • the peristaltic pump 1340 operates as if a fluid-filled hose 1310 was squeezed with a finger, and the peristaltic pump 1340 is also replaced by a pump head 1320 instead of a finger as the finger moves forward to slide the fluid forward.
  • the hose 1310 is alternately squeezed and released by the pump head 1320 to pump fluid.
  • the pump head 1320 presses the hose 1310 the hose 1310 relies on its own tension to form a negative pressure as the pump head 1320 moves. Flow under the action of negative pressure.
  • the fluid in the hose 1310 is a thrombus and/or blood.
  • the peristaltic pump is used as the source for generating the negative pressure, and the rotation speed of the pump head 1320 is not high.
  • the hose 1310 is preferably a silicone tube; the collection container 1330 is preferably a collection bag.
  • the manner of providing negative pressure in this embodiment includes, but is not limited to, a peristaltic pump based method, and a person skilled in the art can also provide a negative pressure to remove the thrombus by using a negative pressure drainage bag or the like.
  • the bolting system includes: a rotary driving device 1140, a transmission tube 1270, and a fragmentation knife 1210.
  • the transmission tube 1270 and the fragmentation knife 1210 are not shown in FIG. 1, and will be described in detail below in conjunction with FIGS. 2-7. .
  • the proximal end of the transmission tube 1270 is connected to the rotary driving device 1140
  • the distal end of the transmission tube 1270 is connected to the fragmentation knife 1210
  • the transmission tube 1270 is along the sheath connecting piece 1130.
  • the lumen of the sheath 1120 extends into the ejecting head 1110; under the driving action of the rotary driving device 1140, the transmission tube 1270 rotates and drives the bobbin blade 1210 to rotate.
  • the thrombus of the plug head 1110 is taken to break the plug.
  • FIG. 4 is a schematic structural view of a fragmentation knife.
  • the fragmentation knife 1210 is a tubular hollow structure, the fragmentation knife 1210 includes at least one blade 1211, the fragmentation knife 1210 is located in the lumen of the bolting head 1110, and the blade 1211 The position corresponds to the position of the bolt-out side hole 1113 of the bolting head 1110.
  • the mechanical thrombus removal device 1000 further includes a drug perfusion system including a syringe 1180 and an infusion tube 1160, the proximal end of the infusion tube 1160 being coupled to the syringe 1180
  • the distal end of the infusion tube 1160 is in communication with the transmission tube 1270 via the sheath connector 1130 or the distal end of the infusion tube is in communication with the transmission tube via a transmission tube end connection, the syringe 1180
  • the thrombolytic drug carried in the medium reaches the thrombus through the transmission tube 1270 and the thrombectomy head 1110, and softens or dissolves the thrombus at the thrombus.
  • the drug perfusion system further includes a one-way valve 1170 disposed on the infusion tube 1160 to control a flow direction of the liquid to be delivered in the infusion tube 1160.
  • the distal end of the infusion tube is in communication with the transmission tube via the sheath connection, or the distal end of the infusion tube is in communication with the transmission tube via a transmission end connection.
  • FIG. 6 is a schematic cross-sectional view of the connecting end of the transmission tube.
  • the transmission tube tail is matched by the cooperation of the fixing cap 1151 and the sealing ring 1152.
  • the distal end of the end connector 1150 is fixed to the transmission tube 1270 (only the end end transmission tube 1250 of the transmission tube 1270 is shown); and the transmission tube tail is matched by the cooperation of the locking cap 1153 and the sealing ring 1154.
  • the proximal end of the end connector 1150 is locked and secured outside the end of the transmission tube 1270.
  • the proximal end of the transmission tube end connector 1150 and the proximal end of the locking cap 1153 are respectively provided with a guide wire hole 1155 as a passage for the guide wire to enter and exit and communicate with the transmission tube 1270 .
  • the locking cap 1153 and the transmission tube tail end connecting member 1150 are fixed by a matching screw, and the guiding wire hole 1155 is adjusted by controlling the tightening or loosening of the locking cap 1153. Close or open. When the locking cap 1153 is tightened, the guide wire hole 1155 is closed, so that the end of the transmission tube 1270 is sealed; when the locking cap 1153 is released, the guide wire hole 1155 is opened and allowed The guide wire is in and out.
  • the transmission tube 1270 extending into the end portion of the transmission tube end 1150 has at least one perfusion hole 1251, which provides a thrombolytic drug in the infusion tube 1160 into the transmission tube.
  • the path to 1270 is not limited to.
  • the respective workflows of the thrombectomy system, the thrombectomy system, and the drug perfusion system in the mechanical thrombus removal device 1000 of the present invention are specifically as follows.
  • the suction plugging process of the suction plug system is: the suction device (the peristaltic pump 1340 in this embodiment) generates a negative pressure ⁇ the plug head 1110 sucks the thrombus under the action of the negative pressure ⁇ the thrombus enters the body cavity of the sheath tube 1120 ⁇ the thrombus passes through the suction tube (Hose 1310 in this embodiment) is delivered to the proximal end collection container 1330 to collect thrombus.
  • the bolting process of the bolt breaking system is: the rotary driving device 1140 works ⁇ the driving tube 1270 rotates ⁇ the rotating bolt knife 1210 rotates ⁇ the thrombus of the inhalation bolting head 1110 is broken.
  • the workflow of the drug perfusion system is: injecting thrombolytic drug into syringe 1180 ⁇ infusion tube 1160 delivering thrombolytic drug ⁇ transmission tube 1270 continues to deliver thrombolytic drug ⁇ thrombolytic drug is discharged through thrombectomy head 1110 ⁇ softening of thrombus at the thrombus site Or dissolve.
  • the mechanical thrombus removing device of the invention integrates drug perfusion, aspiration thrombus and mechanical thrombolysis, and combines the processes of various systems to know that the thrombolytic drug is perfused through a cavity (ie, a transmission tube) independent of the thrombus (sheath). Therefore, the thrombolytic drug can be perfused to the thrombus at the same time as or before the thrombus and thrombus aspiration, so that the thrombus is dissolved or softened, and as many acute and subacute thrombi as possible blocking the blood vessel are aspirated to the outside, and Does not cause the thrombus to re-enter the blood vessel due to perfusion, reducing the effect of thrombectomy.
  • the thrombolytic drug can be perfused into the blood vessel after the thrombus and the thrombus is aspirated to dissolve a small amount of residual thrombus, reducing the recurrence rate of the thrombus.
  • the specific structure of the rotary driving device 1140 includes but is not limited to the following two types.
  • the rotary driving device 1140 is a hollow shaft motor, and the hollow shaft motor is mounted on the outer side of the transmission tube 1270 (only the tail end transmission tube 1250 is shown), in other words.
  • the hollow shaft motor uses a transmission tube 1270 as a rotating shaft.
  • the transmission tube 1270 is driven to rotate, thereby driving the bobbin blade 1210 fixed to the distal end of the transmission tube 1270. Rotating, the thrombus around the fragmentation knife 1210 is broken.
  • the rotary driving device 1140 includes a rotation motor 1141, a first gear 1252, and a second gear 1142.
  • the first gear 1252 is mounted on the outside of the transmission tube 1270 (equivalent to The transmission tube 1270 serves as a shaft of the first gear 1252 and meshes with the second gear 1142, and the second gear 1142 is mounted on an output shaft of the rotary motor 1141.
  • the output shaft rotates to drive the second gear 1142 to rotate, and the first gear 1252 is engaged with the second gear 1142.
  • the first gear 1252 Rotating motion is also performed under the transmission of the second gear 1142, thereby driving the transmission tube 1270 to rotate, thereby driving the bobbin blade 1210 fixed to the distal end of the transmission tube 1270 to rotate.
  • a thrombus that enters the thrombectomy head 1110 and is located around the fragmentation knife 1210 is broken.
  • FIG. 5 is a schematic cross-sectional view of the sheath connector.
  • the sheath connector 1130 is a three-chamber structure including a distal lumen, a proximal lumen, and a side lumen, the transmission tube 1270 passing through the distal lumen and the proximal lumen of the sheath connector 1130 (ie, the transmission tube 1270 is The sheath connector 1130 acts as a medium into the lumen of the sheath 1120, and the side lumen of the sheath connector 1130 connects the distal end of the suction tube (the hose 1310 in Figure 1).
  • the sheath connector 1130 acts as a medium for communication with the sheath 1120 as a separate system (plugging system, bolting system, drug perfusion system), similar to the function of a joint.
  • the bolt removal system and the bolting system are connected by a sheath connector 1130.
  • the bolting system and the drug infusion system are connected by the transmission tube end connector 1150, but those skilled in the art know that the connection method is only one.
  • a preferred attachment means, the thrombectomy system and the thrombectomy system, and the drug perfusion system can all be connected by a sheath connector 1130.
  • the transmission tube 1270 is a hollow tubular structure, and the body cavity of the transmission tube 1270 serves as a delivery path of the guide wire and a perfusion path of the thrombolytic drug.
  • the distal end of the transmission tube 1270 includes a first side hole 1221, and the first side hole 1221 cooperates with an inclined hole 1112 on the bolting head 1110, and the medicine passes through the first side hole 1221 and The oblique hole 1112 reaches the thrombus site.
  • the sheath connector 1130 further includes a lumen for sealing the suction tube lumen (ie, a cavity formed between the transmission tube and the sheath tube and the suction tube) a sealing structure comprising a fixing cap 1131 and a sealing ring 1132, to which the transmission tube 1270 extending through the sheath connector 1130 is fixed by the cooperation of the fixing cap 1131 and the sealing ring 1132 On piece 1130.
  • a lumen for sealing the suction tube lumen ie, a cavity formed between the transmission tube and the sheath tube and the suction tube
  • a sealing structure comprising a fixing cap 1131 and a sealing ring 1132, to which the transmission tube 1270 extending through the sheath connector 1130 is fixed by the cooperation of the fixing cap 1131 and the sealing ring 1132 On piece 1130.
  • the transmission tube 1270 includes: a front end transmission tube 1220, an intermediate transmission tube 1240 and a tail end transmission tube 1250 that are sequentially connected.
  • the bobbin blade 1210 is fixed to the front end transmission tube 1220 and is accommodated.
  • the intermediate transmission tube 1240 is received in the sheath tube 1120 and the sheath connector 1130; the tail end transmission tube 1250 is coupled to the rotary driving device 1140.
  • the at least one first side hole 1221 is opened in a circumferential direction of the front end transmission tube 1220; the at least one filling hole 1251 is opened at a remaining end end extending and fixed in the transmission tube end connection 1150 Drive tube 1250.
  • the front end transmission tube 1220 is preferably a fixed tube for transmitting a rotary motion; the intermediate transmission tube 1240 is a spiral tube, and the spiral tube can be bent and deformed to a certain extent to relieve the tail end transmission tube 1250.
  • an inner tube 1260 is further disposed in the spiral tube, and the inner tube 1260 covers the spiral tube and the front end transmission tube 1220 and the tail end transmission tube.
  • the connection position of the 1250 (refer to Figure 7 for details).
  • the bolting head 1110 is a hollow member and has a proximal end and a distal end, and the proximal end of the bolting head includes at least one bolting side hole 1113.
  • the bolting head The proximal end of the 1110 has an annular structure; the distal end of the bolting head has a conical curved structure and has at least one inclined hole 1112 and a top hole 1111.
  • the plug side hole 1113 serves as a path for the thrombus to enter the plug head 1110; wherein the bobbin blade 1210 is located in the inner cavity of the bolt removing head 1110, and the position of the blade tip 1211 and the take-up The position of the plug side hole 1113 corresponds.
  • the oblique hole 1112 and the top hole 1111 serve as a path for injecting the thrombolytic drug into the thrombus head, and the plurality of oblique holes 1112 can effectively increase the thrombolytic drug and the thrombolytic drug only by the top hole 1111 to the thrombus. The area of contact with the thrombus.
  • the inclined hole 1112 is formed by perforating in a direction inclined to the surface of the conical curved structure, and the area of the thrombolytic drug in contact with the thrombus is increased compared to the perforation in a direction perpendicular to the surface of the conical curved structure. Increases the efficiency of thrombolysis.
  • the sheath tube 1120 is connected to the bolting head 1110 through a positioning ring 1230 .
  • the positioning ring 1230 is a hollow tubular structure, and the positioning ring 1230 is sleeved and fixed on the outer side of the transmission tube 1270 .
  • the fragmentation knife 1210 is adjacent to the position of the fragmentation knife 1210.
  • the sheath tube 1120 is a single layer tube or a multilayer composite tube.
  • a metal braid layer is included in the layer structure.
  • each component can be fabricated by machining, injection molding (extrusion) molding, and/or laser engraving; the fixed connection between the different components can be laser A welding or glue bonding manner, for example, the front end transmission tube 1220, the intermediate transmission tube 1240, and the tail end transmission tube 1250 are sequentially welded by laser to form a transmission tube 1270, and the fragmentation knife 1210 is laser welded. It is fixed to the front end transmission tube 1220, and the hose is attached to the sheath tube coupling 1130 by glue bonding. Since no improvement to the technical solution of the present invention is involved, no further details are provided herein.
  • the thrombectomy head 1110 of the mechanical thrombus removal device 1000 is placed in the physiological saline, the peristaltic pump 1340 is started to stop the peristaltic pump when the physiological saline is visible in the collection container 1330, and the syringe 1180 is connected to the one-way valve 1170, so that The syringe 1180 is connected to the infusion tube 1160, and the suction into the syringe 1180 is started to see that the physiological saline stops pumping, and the air in the mechanical thrombus removing device 1000 is evacuated;
  • the blood vessel is punctured, and the bolting head 1110 of the mechanical thrombus removing device 1000 and at least a portion of the sheath tube 1120 are transported along the guide wire (optional) to the lesion (thrombus) site, and the locking cap 1153 is tightened to rotate the driving device.
  • the suction device (peristaltic pump 1340 in this embodiment) and the syringe 1180 are left outside the body; the syringe 1180 is pumped with the thrombolytic drug (for example, urokinase), communicates with the check valve 1170, presses the syringe 1180, and the thrombolytic drug passes through the infusion solution.
  • the thrombolytic drug for example, urokinase
  • the tube 1160 reaches the inside of the transmission end connector 1150 and enters the inner cavity of the transmission tube 1270 from the filling hole 1251, and then passes through the inner end of the tail end transmission tube 1250, the inner transmission tube 1240 inner cavity, the front end transmission tube 1220 inner cavity, and passes through After the first side hole 1221, the top hole 1111 of the plug head and the inclined hole 1112 reach the lesion (thrombus) site, the thrombolytic drug softens or dissolves the thrombus after contacting the thrombus; after about 10 minutes, the rotary driving device is activated.
  • the crushing knife 1210 is driven to rotate by the driving tube 1270; then the peristaltic pump is started, and the negative pressure formed by the inner cavity of the sheath 1120 is sucked by the hose 1310 when being squeezed, and the thrombus is passed through the bolt.
  • the side hole 1113 is sucked into the inside of the plug head 1110, and the rotating blade 1211 and the fixed plug side hole 1113 cooperate to chop the thrombus sucked into the inside of the plug head 1110, and then suck the chopped thrombus by the negative pressure provided by the peristaltic pump 1340. In vitro and delivered to collection container 1330.
  • the thrombectomy head 1110 of the mechanical thrombus removal device 1000 can be moved back and forth along the guide wire according to the specific position of the intravascular thrombus to improve the thrombectomy efficiency; at the same time, the thrombolytic drug can be infused into the thrombus portion through the syringe 1180 as needed. .
  • the rotary drive 1140 is turned off, then the peristaltic pump is turned off, and finally all of the devices are withdrawn from the body.
  • the mechanical thrombus removal device has the following beneficial effects:
  • the method of providing negative pressure by the suction plug system provides a negative pressure different from the high-speed rotation of the existing spiral structure to form a siphon, and the negative pressure required for the suction plug can be formed without high-speed rotation, thereby effectively reducing the existing spiral
  • the process of forming a negative pressure in the structure is too fast, causing the temperature to be too high and causing the wire to break;
  • Integrating infusion thrombolytic drugs, negative pressure suction plugs and mechanical crushing plugs, and using these methods can significantly accelerate the thrombectomy process, shorten the operation time and reduce the pain of patients;
  • the perfusion of the thrombolytic drug is independent of the lumen of the transmission tube other than the aspiration thrombus, so that the thrombolytic drug can be infused into the lesion at any time during the surgical procedure, thereby avoiding having been pumped to the thrombectomy head
  • the problem that the thrombus re-enters the patient due to drug perfusion;
  • the broken broach is located in the lumen of the plug, which can effectively reduce the incidence of vascular perforation.

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Abstract

本发明提供了一种机械血栓清除装置，所述机械血栓清除装置中吸栓系统包括吸取装置以及吸栓管，基于该结构的吸栓系统提供负压的方式区别于现有基于螺旋结构的高速旋转形成虹吸的方式提供负压方式，无需高速旋转即可形成满足吸栓所需的负压，从而有效的降低现有螺旋结构形成负压的过程转速过快致使温度过高而导致导丝断裂的问题。此外，本发明的吸栓系统和碎栓系统为两个相互独立的系统，有效避免吸栓与碎栓过程的相互影响；碎栓过程在取栓头内进行，有效降低了患者发生血尿及肾衰并发症的概率及血管穿孔的发生率。

Description

机械血栓清除装置 技术领域
本发明涉及医疗器械技术领域，特别涉及一种机械血栓清除装置。
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。与此同时，药物预防治疗也存在显著局限性，对于容易出血性体质，出血性糖尿病，出血性脑卒中，神经手术，严重的创伤，胸腔积血，颅内出血造成的盆骨和下肢骨折，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。
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，早期恢复静脉内正向血流，解除或缓解静脉梗阻，保护静脉瓣膜形态和功能，阻断PTS发生的病理过程，降低PTS的发生率。但CDT治疗DVT存在溶栓时间长(平均溶栓时间53.4小时)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；溶栓药物的出血风险；CDT不适用于出血风险高的患者(如严重高血压等)，也不适合于分娩后和妊娠的患 者。
传统外科手术取栓适用于临床症状相当严重的DVT又不能使用溶栓药物的患者。其劣势在于：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。
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是介入式腔内血栓清除装置，可以快速的清除血栓，恢复血流、挽救瓣膜功能。
美国专利US2014/0088610 A1公开了一种机械血栓清除装置的结构，该结构由一根顶端有多个侧孔的导管，其导管内部有一个独立的管道输送灌注液体并在管道顶端设置有多个小孔。工作时，在独立管道内部灌注高压生理盐水，使生理盐水于管道顶端的小孔喷射出来，高速喷射的生理盐水与导管顶端侧孔配合产生伯努利效应将血栓通过侧孔吸入导管内，同时高速喷射的生理盐水将吸入的大块血栓击碎并通过负压抽吸排出体外，术后还可以通过导管向血管内灌注溶栓药物以减少残留血栓。该专利解决了将血栓抽吸及排出体外的问题，但由于其设计特点，高速喷射的生理盐水会通过导管侧孔喷出，破坏血液中的血红细胞，而这些被破坏的血红细胞又没有被全部抽吸至体外，容易发生血尿、肾衰等并发症；高速的生理盐水刺激血管壁，易引起神经失常；其术后灌注溶栓药物的通道与血栓抽吸的通道是同一通道，部分抽至导管的血栓由于药物灌注导致再次进入体内，降低取栓效果。
WO2011/024124 A1公开了一种机械血栓清除装置结构，该结构具有一根顶端有侧孔的导管和位于导管内部的螺旋结构，其工作时依靠螺旋结构的高速旋转形成负压将位于导管侧孔附近的血栓吸入导管内，且该螺旋结构与导管侧孔配合对吸入的血栓进行切削，达到碎栓的目的，最终将血栓排出体外。该装置由于其碎栓均在导管内部进行，解决了血尿的问题，但由于其抽 吸时螺旋结构转速过快，易导致导管温度过高、导丝断裂，引起不良反应；由于其设计特点，无法通过该装置灌注溶栓药物。
针对现有的机械血栓清除装置的不足，本领域技术人员一直在寻找解决的方法。
发明内容
本发明的目的在于提供一种机械血栓清除装置，以弥补使用现有技术中机械血栓清除装置存在的不足。
为解决上述技术问题，本发明提供一种机械血栓清除装置，所述机械血栓清除装置包括
取栓头，所述取栓头通过鞘管与鞘管连接件连接；
碎栓系统，包括旋转驱动装置、传动管及碎栓刀，所述传动管的近端与所述旋转驱动装置连接，远端与所述碎栓刀连接，所述传动管沿所述鞘管连接件及鞘管的管腔延伸至所述取栓头内；在所述旋转驱动装置的驱动作用下，所述传动管旋转并带动所述碎栓刀旋转，对已吸入所述取栓头的血栓进行碎栓；以及
吸栓系统，包括吸取装置及吸栓管，所述吸栓管的近端与所述吸取装置连接，远端与所述鞘管连接件连接，所述传动管与所述鞘管之间形成的腔体与所述吸栓管连通形成吸栓管腔。
可选的，在所述的机械血栓清除装置中，还包括药物灌注系统，所述药物灌注系统包括注射器及输液管，所述输液管的近端与所述注射器连接，所述输液管的远端与所述传动管连通，药物经由所述传动管及所述取栓头到达血栓部位。
可选的，在所述的机械血栓清除装置中，所述旋转驱动装置为一空心轴马达，所述空心轴马达安装在所述传动管的外侧；或者
所述旋转驱动装置包括：旋转马达、第一齿轮及第二齿轮，所述第一齿轮安装于所述传动管的外侧且与所述第二齿轮啮合，所述第二齿轮安装于所 述旋转马达的输出轴上。
可选的，在所述的机械血栓清除装置中，所述吸取装置为蠕动泵，所述吸栓管为软管。
可选的，在所述的机械血栓清除装置中，所述鞘管连接件为三腔结构，所述传动管穿过所述鞘管连接件的远腔和近腔，所述鞘管连接件的侧腔连接所述吸栓管的远端，所述鞘管连接件还包括用于密封吸栓管腔的密封结构。
可选的，在所述的机械血栓清除装置中，所述输液管的远端经由所述鞘管连接件与所述传动管连通，或者所述输液管的远端经由传动管尾端连接件与所述传动管连通。
可选的，在所述的机械血栓清除装置中，所述传动管包括：顺次连通的前端传动管、中间传动管及尾端传动管，所述碎栓刀固定于所述前端传动管上且容置于所述取栓头内；所述中间传动管容置于所述鞘管和鞘管连接件内；所述尾端传动管与所述旋转驱动装置连接。
可选的，在所述的机械血栓清除装置中，所述中间传动管为螺旋管，所述螺旋管内还设置有内管，所述内管覆盖所述螺旋管与所述前端传动管和所述尾端传动管的连接部位。
可选的，在所述的机械血栓清除装置中，所述传动管尾端连接件的远端通过固定帽和密封圈的配合固定于所述传动管上，所述传动管尾端连接件的近端通过锁紧帽和密封环的配合固定于所述传动管的远端，且所述传动管尾端连接件的近端及所述锁紧帽的近端均设置有导丝孔，所述导丝孔作为导丝出入的通道且与所述传动管连通。
可选的，在所述的机械血栓清除装置中，所述锁紧帽与所述传动管尾端连接件之间具有相配合的螺纹，通过控制所述锁紧帽沿所述螺纹拧紧或松开以调节所述导丝孔的闭合或打开。
可选的，在所述的机械血栓清除装置中，所述取栓头为中空构件且具有近端和远端，所述取栓头的远端为锥形曲面结构且具有一顶孔，所述取栓头的近端包括至少一个取栓侧孔。
可选的，在所述的机械血栓清除装置中，所述碎栓刀为管状镂空结构，包括至少一个刀锋，所述碎栓刀位于所述取栓头的内腔，且所述刀锋的位置与所述取栓侧孔的位置相对应。
可选的，在所述的机械血栓清除装置中，所述传动管的远端包括第一侧孔，所述第一侧孔与所述取栓头上的一斜孔相配合，所述药物经由所述第一侧孔以及所述斜孔到达血栓部位。
在本发明所提供的机械血栓清除装置中，所述机械血栓清除装置中吸栓系统包括吸取装置以及吸栓管，本发明的吸栓系统提供负压的方式区别于现有螺旋结构的高速旋转形成虹吸的方式提供负压，无需高速旋转即可形成满足吸栓所需的负压，从而有效的降低现有螺旋结构形成负压的过程转速过快致使温度过高而导致导丝断裂的问题。此外，本发明的吸栓系统和碎栓系统为两个相互独立的系统，有效避免吸栓与碎栓过程的相互影响；碎栓过程在取栓头内进行，有效降低了患者发生血尿及肾衰并发症的概率及血管穿孔的发生率。本发明还采用了独立的药物灌注系统，可于手术过程的任何时候向病变部位灌注溶栓药物，避免了已被抽至导管中的血栓因药物灌注而再次进入患者体内的问题。本发明还对取栓头进行改进，增加溶栓面积，提高溶栓效率。本发明还提供了集灌注溶栓药物、负压吸栓、机械碎栓于一体的机械血栓清除装置，可以显著加速取栓过程，缩短手术时间，减轻患者痛苦，也扩大了手术适用范围。
附图说明
图1是本发明一实施例中机械血栓清除装置的结构示意图；
图2是本发明一实施例中取栓头的结构示意图；
图3是图2中沿A-A方向的剖面示意图；
图4是本发明一实施例中碎栓刀的结构示意图；
图5是本发明一实施例中鞘管连接件的剖面示意图；
图6是本发明一实施例中传动管尾端连接件的剖面示意图；
图7是本发明一实施例中传动管的局部剖面示意图；
图8是本发明一实施例中旋转驱动装置的一种结构示意图；
图9是本发明一实施例中旋转驱动装置的另一种结构示意图。
图中：
机械血栓清除装置-1000；蠕动泵-1340；软管-1310；泵头-1320；鞘管-1120；取栓头-1110；顶孔-1111；斜孔-1112；取栓侧孔-1113；收集容器-1330；传动管-1270；第一侧孔-1221；灌注孔-1251；前端传动管-1220、中间传动管-1240；尾端传动管-1250；内管1260；旋转驱动装置-1140；旋转马达-1141；第一齿轮-1252；第二齿轮-1142；传动管尾端连接件-1150；碎栓刀-1210；刀锋-1211；注射器-1180；输液管-1160；单向阀-1170；鞘管连接件-1130；定位环-1230；固定帽-1131，1151；密封圈-1132，1152；锁紧帽-1153；密封环-1154；导丝孔-1155。
具体实施方式
以下结合附图和具体实施例对本发明提出的机械血栓清除装置作进一步详细说明。根据下面说明和权利要求书，本发明的优点和特征将更清楚。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实施例的目的。
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。
请参考图1，其为本发明的机械血栓清除装置的结构示意图。所述的机械血栓清除装置1000包括：取栓头1110、吸栓系统及碎栓系统，所述取栓头1110通过鞘管1120与鞘管连接件1130连接；所述吸栓系统包括吸取装置及吸栓管，所述吸栓管的近端与所述吸取装置连接，远端与所述鞘管连接件1130连接，所述碎栓系统的传动管与所述鞘管1120之间形成的腔体与所述吸栓管连通形成吸栓管腔。
其中，在本实施例中所示的吸栓系统中的所述吸取装置为蠕动泵1340，所述吸栓管为软管1310，此外还包括用于收集血栓的收集容器1330，所述软管1310的远端与所述鞘管1120的近端连通，所述软管1310的近端与所述收集容器1330连通，所述鞘管1120的远端与所述取栓头1110连通；在所述蠕动泵1340产生的负压作用下，所述取栓头1110吸入的血栓经所述鞘管1120、所述软管1310被传输至所述收集容器1330内。进一步地，所述蠕动泵1340还包括泵头1320，所述软管1310安装于泵头1320上，并随所述泵头1320的旋转带动下在挤压状态和非挤压状态之间切换。
所述蠕动泵1340的工作过程如同用手指夹挤一根充满流体的软管1310，随着手指向前滑动管内流体向前移动，所述蠕动泵1340也是这个原理只是由泵头1320取代了手指。通过泵头1320对软管1310交替进行挤压和释放来泵送流体，泵头1320对软管1310进行挤压时，随着泵头1320的移动，软管1310依靠自身张力形成负压，流体在负压的作用下流动。本实施例中，软管1310中的流体为血栓和/或血液。采用蠕动泵作为产生负压的源头，对于泵头1320的旋转速度要求不高，相比现有螺旋结构的高速旋转形成虹吸以提供抽吸血栓所需的负压而言，大大降低了形成负压的过程所产生的温度，从而避免因温度过高导致导丝断裂的问题。所述软管1310优选为硅胶管；所述收集容器1330优选为收集袋。本实施例中提供负压的方式包括但不局限于基于蠕动泵的方式，本领域技术人员还可以使用负压引流袋等方式提供负压以将血栓清除。
所述碎栓系统包括：旋转驱动装置1140、传动管1270及碎栓刀1210，其中，传动管1270及碎栓刀1210在图1中未示出，将于下文配合图2-7进行详述。具体的，所述传动管1270的近端与所述旋转驱动装置1140连接，所述传动管1270的远端与所述碎栓刀1210连接，所述传动管1270沿所述鞘管连接件1130及鞘管1120的管腔延伸至所述取栓头1110内；在所述旋转驱动装置1140的驱动作用下，所述传动管1270旋转并带动所述碎栓刀1210旋转，对已吸入所述取栓头1110的血栓进行碎栓。
其中，本实施例中请参考图3和图4，图4是碎栓刀的结构示意图。如图4所示，所述碎栓刀1210为管状镂空结构，所述碎栓刀1210包括至少一个刀锋1211，所述碎栓刀1210位于所述取栓头1110内腔，且所述刀锋1211的位置与所述取栓头1110的取栓侧孔1113的位置相对应。
在本发明的另一实施例中，所述机械血栓清除装置1000还包括药物灌注系统，所述药物灌注系统包括注射器1180及输液管1160，所述输液管1160的近端与所述注射器1180连接，所述输液管1160的远端经由所述鞘管连接件1130与所述传动管1270连通或者所述输液管的远端经由传动管尾端连接件与所述传动管连通，所述注射器1180中承载的溶栓药物经由所述传动管1270及所述取栓头1110到达血栓部位，对血栓部位的血栓进行软化或溶解。优选的，药物灌注系统还包括单向阀1170，所述单向阀1170设置于所述输液管1160上，以控制所述输液管1160中输送液体的流通方向。所述输液管的远端经由所述鞘管连接件与所述传动管连通，或者所述输液管的远端经由传动管尾端连接件与所述传动管连通。
请参考图6，图6是传动管尾端连接件的剖面示意图。如图6所示，为了确保所述传动管1270延伸并固定于所述传动管尾端连接件1150中的稳固性及密封性，通过固定帽1151和密封圈1152的配合将所述传动管尾端连接件1150的远端固定于所述传动管1270上(图中仅示出传动管1270的尾端传动管1250)；并通过锁紧帽1153和密封环1154的配合将所述传动管尾端连接件1150的近端锁紧固定于所述传动管1270的末端外。所述传动管尾端连接件1150的近端及所述锁紧帽1153的近端均设置有导丝孔1155，所述导丝孔1155作为导丝出入的通道且与所述传动管1270连通。优选的，所述锁紧帽1153与所述传动管尾端连接件1150之间通过相配合的螺纹固定，通过控制所述锁紧帽1153的拧紧或松开以调节所述导丝孔1155的闭合或打开。当所述锁紧帽1153拧紧时，所述导丝孔1155闭合，使所述传动管1270的末端被密封；当所述锁紧帽1153松开时，所述导丝孔1155打开并可允许导丝出入。
如图6所示，延伸至所述传动管尾端连接件1150内的所述传动管1270 上具有至少一个灌注孔1251，所述灌注孔1251提供了输液管1160中的溶栓药物进入传动管1270的路径。
本发明的机械血栓清除装置1000中的吸栓系统、碎栓系统和药物灌注系统各自的工作流程具体如下。
吸栓系统的吸栓流程为：吸取装置(本实施中为蠕动泵1340)产生负压→取栓头1110在负压作用下抽吸血栓→血栓进入鞘管1120的体腔→血栓通过吸栓管(本实施例中为软管1310)向近端输送→收集容器1330收集血栓。
碎栓系统的碎栓流程为：旋转驱动装置1140工作→传动管1270旋转→带动碎栓刀1210旋转→对吸入取栓头1110的血栓进行碎栓。
药物灌注系统的工作流程为：注射器1180中注入溶栓药物→输液管1160输送溶栓药物→传动管1270继续输送溶栓药物→溶栓药物经由取栓头1110排出→到达血栓部位对血栓进行软化或溶解。
本发明的机械血栓清除装置集药物灌注、抽吸血栓、机械碎栓于一体，结合各个系统的流程可知溶栓药物通过独立于抽吸血栓(鞘管)的腔体(即传动管)进行灌注，因此可在碎栓和抽吸血栓的同时或之前，将溶栓药物灌注在血栓处，以使血栓溶解或软化，将尽可能多的堵塞血管的急性、亚急性血栓抽吸至体外，且不会导致血栓因灌注而再次进入血管内，降低取栓效果。此外，还可以在碎栓和抽吸血栓之后将溶栓药物灌注在血管内，以将少量的残余血栓溶解，降低血栓的复发率。
本实施例中，所述旋转驱动装置1140的具体结构包括但不局限于以下两种。
构型一：如图8所示，所述旋转驱动装置1140为一空心轴马达，所述空心轴马达安装在所述传动管1270(图中仅示出尾端传动管1250)的外侧，换言之，所述空心轴马达以传动管1270作为旋转轴，在所述空心轴马达运行时，驱动所述传动管1270进行旋转运动，进而带动固定于传动管1270的远端的所述碎栓刀1210旋转，对所述碎栓刀1210周围的血栓进行碎栓。
构型二：如图9所示，所述旋转驱动装置1140包括：旋转马达1141、第 一齿轮1252及第二齿轮1142，所述第一齿轮1252安装于所述传动管1270外侧(相当于以传动管1270作为第一齿轮1252的轴)且与所述第二齿轮1142啮合，所述第二齿轮1142安装于所述旋转马达1141的输出轴上。所述旋转马达1141工作时，输出轴旋转，驱动所述第二齿轮1142随之做旋转运动，由于所述第一齿轮1252与所述第二齿轮1142的啮合，因此，所述第一齿轮1252在所述第二齿轮1142的传递作用下也进行旋转运动，进而带动所述传动管1270进行旋转运动，从而带动固定于所述传动管1270的远端的所述碎栓刀1210旋转，对已进入取栓头1110并位于所述碎栓刀1210周围的血栓进行碎栓。
请参考图1和图5，图5为鞘管连接件的剖面示意图。所述鞘管连接件1130为三腔结构，包括远腔、近腔和侧腔，所述传动管1270穿过所述鞘管连接件1130的远腔和近腔(即所述传动管1270以所述鞘管连接件1130作为进入所述鞘管1120的管腔的媒介)，所述鞘管连接件1130的侧腔连接所述吸栓管(图1中为软管1310)的远端。所述鞘管连接件1130作为各个系统(取栓系统、碎栓系统、药物灌注系统)与所述鞘管1120连通的媒介，类似接头的作用。在本实施例中，取栓系统和碎栓系统通过鞘管连接件1130连接，碎栓系统和药物灌注系统通过传动管尾端连接件1150连接，但是本领域技术人员可知上述连接方式仅为一种优选的连接方式，取栓系统和碎栓系统以及药物灌注系统可以都通过鞘管连接件1130连接。
如图3所示，所述传动管1270为中空管状结构，所述传动管1270的体腔作为导丝的输送路径和溶栓药物的灌注路径。所述传动管1270的远端包括第一侧孔1221，所述第一侧孔1221与所述取栓头1110上的一斜孔1112相配合，所述药物经由所述第一侧孔1221以及所述斜孔1112到达血栓部位。
如图5所示，所述鞘管连接件1130还包括用于密封吸栓管腔(即所述传动管与所述鞘管之间形成的腔体与所述吸栓管连接形成的管腔)的密封结构，所述密封结构包括固定帽1131和密封圈1132，通过固定帽1131和密封圈1132的配合将延伸穿过所述鞘管连接件1130的传动管1270固定于所述鞘管连接 件1130上。
本实施例中，所述传动管1270包括：顺次连通的前端传动管1220、中间传动管1240及尾端传动管1250，所述碎栓刀1210固定于所述前端传动管1220上且容置于所述取栓头内；所述中间传动管1240容置于所述鞘管1120和鞘管连接件1130内；所述尾端传动管1250与所述旋转驱动装置1140连接。具体的，所述至少一个第一侧孔1221开设于前端传动管1220的周向上；所述至少一个灌注孔1251开设于延伸并固定于所述传动管尾端连接件1150内的剩余部分尾端传动管1250上。其中，所述前端传动管1220优选为一固定管，用于传递旋转运动；所述中间传动管1240为一螺旋管，所述螺旋管可在一定程度上弯曲变形，缓解经尾端传动管1250传递的旋转作用力，避免管体断裂。为了增加传动管1270各段管体之间的密封性，所述螺旋管内还设置有内管1260，所述内管1260覆盖所述螺旋管与所述前端传动管1220和所述尾端传动管1250的连接部位(具体可参考图7)。
请参考图2及图3，所述取栓头1110为中空构件且具有近端和远端，所述取栓头的近端包括至少一个取栓侧孔1113，优选的，所述取栓头1110的近端呈圆环状结构；所述取栓头的远端为锥形曲面结构且具有至少一个斜孔1112和一顶孔1111。其中，所述取栓侧孔1113作为血栓进入取栓头1110内的路径；其中，所述碎栓刀1210位于所述取栓头1110的内腔，且所述刀锋1211的位置与所述取栓侧孔1113的位置相对应。所述斜孔1112和所述顶孔1111作为所述取栓头灌注溶栓药物的路径，比起仅由顶孔1111向血栓输送溶栓药物，多个斜孔1112能够有效增加溶栓药物与血栓的接触面积。所述斜孔1112是通过倾斜于锥形曲面结构表面的方向打孔形成，相比垂直于锥形曲面结构表面的方向打孔而言，增大了所灌注的溶栓药物与血栓接触的面积，提高了溶栓效率。
请继续参考图3，所述鞘管1120通过定位环1230与所述取栓头1110连接，所述定位环1230为中空管状结构，所述定位环1230套接固定于所述传动管1270的外侧且临近所述碎栓刀1210，以限制所述碎栓刀1210的位置。 其中，所述鞘管1120为单层管材或多层复合管材。所述鞘管1120为多层复合管材时，其层结构中包括金属编织层。
在制备本实施例中机械血栓清除装置的各个部件时，每个部件均可通过机械加工、注塑(挤出)成型和/或激光雕刻等加工方式制作；不同部件之间的固定连接可采用激光焊接或胶水粘接的方式，例如所述前端传动管1220、所述中间传动管1240和所述尾端传动管1250之间通过激光依次焊接组成传动管1270，所述碎栓刀1210通过激光焊接固定在所述前端传动管1220上，所述软管通过胶水粘接安装在所述鞘管连接件1130上。由于不涉及对本发明技术方案的改进，此处不作过多赘述。
为了较好的理解本发明的机械血栓清除装置，下面结合图1详细阐述机械血栓清除装置1000应用的过程，具体过程如下：
手术开始前，将机械血栓清除装置1000的取栓头1110放置于生理盐水中，启动蠕动泵1340至收集容器1330中可见生理盐水时停止蠕动泵，将注射器1180连接到单向阀1170上，使得注射器1180和输液管1160连接，开始抽吸至注射器1180中可见生理盐水停止抽吸，排空机械血栓清除装置1000中的空气；
手术过程中，穿刺血管，将机械血栓清除装置1000的取栓头1110及至少部分鞘管1120沿导丝(另购)输送到达病变(血栓)部位，旋紧锁紧帽1153，将旋转驱动装置1140、吸取装置(本实施中为蠕动泵1340)及注射器1180等留置于体外；注射器1180抽吸溶栓药物(例如尿激酶)后与单向阀1170联通，按压注射器1180，溶栓药物通过输液管1160到达传动管尾端连接件1150内部并从灌注孔1251进入传动管1270内腔，然后依次通过尾端传动管1250内腔、中间传动管1240内腔、前端传动管1220内腔，并通过第一侧孔1221、取栓头的顶孔1111和斜孔1112后到达到病变(血栓)部位，溶栓药物与血栓接触后对血栓进行软化或溶解血栓；大约10分钟后，启动旋转驱动装置1140，通过传动管1270带动碎栓刀1210进行旋转；随后启动蠕动泵，通过软管1310在被挤压时抽吸鞘管1120内腔所形成的负压作用，将血栓通过取栓侧孔1113 吸入取栓头1110内部，旋转的刀锋1211和固定的取栓侧孔1113配合将吸入取栓头1110内部的血栓切碎，随后通过蠕动泵1340提供的负压将切碎的血栓吸出体外并输送至收集容器1330内。手术过程中，可根据血管内血栓的具体位置沿导丝前后移动机械血栓清除装置1000的取栓头1110，提高取栓效率；同时，可根据需要随时通过注射器1180将溶栓药物灌注入血栓部位。
血栓抽吸完毕后，关闭旋转驱动装置1140，随后关闭蠕动泵，最后将所有器件一同撤出人体。
综上，机械血栓清除装置具有以下有益效果：
(1)吸栓系统提供负压的方式区别于现有螺旋结构的高速旋转形成虹吸的方式提供负压，无需高速旋转即可形成满足吸栓所需的负压，从而有效的降低现有螺旋结构形成负压的过程转速过快致使温度过高而导致导丝断裂的问题；
(2)集灌注溶栓药物、负压吸栓、机械碎栓于一体，同时使用这几种方式可以显著加速取栓过程，缩短手术时间，减轻患者痛苦；
(3)方便医生根据患者的情况在手术过程中选择其中一种或多种方式结合取栓，扩大了机械血栓清除装置的适用范围；
(4)溶栓药物的灌注采用独立于抽吸血栓之外的传动管的管腔，因此，可在手术过程的任何时候向病变部位灌注溶栓药物，避免了已被抽吸至取栓头中的血栓因药物灌注而再次进入患者体内的问题；
(5)碎栓在取栓头内部进行，避免对血液中细胞的破坏，大大降低了患者发生血尿及肾衰并发症的概率；
(6)碎栓刀位于取栓头的内腔，可有效降低血管穿孔的发生率。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。

Claims (13)

  1. 一种机械血栓清除装置，其特征在于，包括：
    取栓头，所述取栓头通过鞘管与鞘管连接件连接；
    碎栓系统，包括旋转驱动装置、传动管及碎栓刀，所述传动管的近端与所述旋转驱动装置连接，远端与所述碎栓刀连接，所述传动管沿所述鞘管连接件及鞘管的管腔延伸至所述取栓头内；在所述旋转驱动装置的驱动作用下，所述传动管旋转并带动所述碎栓刀旋转，对已吸入所述取栓头的血栓进行碎栓；以及
    吸栓系统，包括吸取装置及吸栓管，所述吸栓管的近端与所述吸取装置连接，远端与所述鞘管连接件连接，所述传动管与所述鞘管之间形成的腔体与所述吸栓管连通形成吸栓管腔。
  2. 如权利要求1所述的机械血栓清除装置，其特征在于，还包括药物灌注系统，所述药物灌注系统包括注射器及输液管，所述输液管的近端与所述注射器连接，所述输液管的远端与所述传动管连通，药物经由所述传动管及所述取栓头到达血栓部位。
  3. 如权利要求1所述的机械血栓清除装置，其特征在于，所述旋转驱动装置为一空心轴马达，所述空心轴马达安装在所述传动管的外侧；或者
    所述旋转驱动装置包括：旋转马达、第一齿轮及第二齿轮，所述第一齿轮安装于所述传动管的外侧且与所述第二齿轮啮合，所述第二齿轮安装于所述旋转马达的输出轴上。
  4. 如权利要求1所述的机械血栓清除装置，其特征在于，所述吸取装置为蠕动泵，所述吸栓管为软管。
  5. 如权利要求1所述的机械血栓清除装置，其特征在于，所述鞘管连接件为三腔结构，所述传动管穿过所述鞘管连接件的远腔和近腔，所述鞘管连接件的侧腔连接所述吸栓管的远端，所述鞘管连接件还包括用于密封吸栓管腔的密封结构。
  6. 如权利要求2所述的机械血栓清除装置，其特征在于，所述输液管的远端经由所述鞘管连接件与所述传动管连通，或者所述输液管的远端经由传动管尾端连接件与所述传动管连通。
  7. 如权利要求1所述的机械血栓清除装置，其特征在于，所述传动管包括：顺次连通的前端传动管、中间传动管及尾端传动管，所述碎栓刀固定于所述前端传动管上且容置于所述取栓头内；所述中间传动管容置于所述鞘管和鞘管连接件内；所述尾端传动管与所述旋转驱动装置连接。
  8. 如权利要求7所述的机械血栓清除装置，其特征在于，所述中间传动管为螺旋管，所述螺旋管内还设置有内管，所述内管覆盖所述螺旋管与所述前端传动管和所述尾端传动管的连接部位。
  9. 如权利要求6所述的机械血栓清除装置，其特征在于，所述传动管尾端连接件的远端通过固定帽和密封圈的配合固定于所述传动管上，所述传动管尾端连接件的近端通过锁紧帽和密封环的配合固定于所述传动管的远端，且所述传动管尾端连接件的近端及所述锁紧帽的近端均设置有导丝孔，所述导丝孔作为导丝出入的通道且与所述传动管连通。
  10. 如权利要求9所述的机械血栓清除装置，其特征在于，所述锁紧帽与所述传动管尾端连接件之间具有相配合的螺纹，通过控制所述锁紧帽沿所述螺纹拧紧或松开以调节所述导丝孔的闭合或打开。
  11. 如权利要求1所述的机械血栓清除装置，其特征在于，所述取栓头为中空构件且具有近端和远端，所述取栓头的远端为锥形曲面结构且具有一顶孔，所述取栓头的近端包括至少一个取栓侧孔。
  12. 如权利要求11所述的机械血栓清除装置，其特征在于，所述碎栓刀为管状镂空结构，包括至少一个刀锋，所述碎栓刀位于所述取栓头的内腔，且所述刀锋的位置与所述取栓侧孔的位置相对应。
  13. 如权利要求2所述的机械血栓清除装置，其特征在于，所述传动管的远端包括第一侧孔，所述第一侧孔与所述取栓头上的一斜孔相配合，所述药物经由所述第一侧孔以及所述斜孔到达血栓部位。
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