WO2023173534A1 - 经导管肺动脉取栓系统用取栓器 - Google Patents
经导管肺动脉取栓系统用取栓器 Download PDFInfo
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- WO2023173534A1 WO2023173534A1 PCT/CN2022/089411 CN2022089411W WO2023173534A1 WO 2023173534 A1 WO2023173534 A1 WO 2023173534A1 CN 2022089411 W CN2022089411 W CN 2022089411W WO 2023173534 A1 WO2023173534 A1 WO 2023173534A1
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- Prior art keywords
- thrombectomy
- distal
- stent
- proximal
- wire
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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
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
Definitions
- the invention belongs to the technical field of medical devices, and specifically relates to a thrombectomy device for a transcatheter pulmonary artery thrombectomy system.
- Pulmonary Embolism refers to a pulmonary circulation disorder caused by the obstruction of the pulmonary artery or its branches by detached thrombus or other substances. PE is an extremely dangerous clinical emergency. The mortality rate of untreated pulmonary embolism is 20-30%. It is the third leading cause of death among cardiovascular diseases after coronary heart disease and stroke. , with the characteristics of high morbidity, high mortality, high recurrence, and high missed diagnosis. More than 10 million cases are diagnosed globally each year, of which 1 million occur in the United States and more than 700,000 in France, Italy, Germany, Spain, Sweden and the United Kingdom. At present, the traditional methods for treating pulmonary embolism include drug therapy and thrombolytic therapy.
- the diameter of the self-expanding network disk of the thrombectomy stent in the prior art is designed with reference to the diameter of the pulmonary aorta of clinical patients. After self-expansion, the network disk can directly fit the blood vessel wall and capture the thrombus to the maximum extent.
- the most distal self-expanding network disk will inevitably be introduced into the bilateral pulmonary branches, because the expanded outer diameter of the network disk is much larger than the trunk diameter of the branches, and the pulmonary branch vessels
- the internal path is rugged and the channel has irregular bends and shapes. It requires too much control over the direction of the self-expanding network plate.
- the radial support force on the branch vessel wall increases accordingly, which also increases the probability of vascular damage. For this reason, it is necessary to improve it to overcome the shortcomings in practical applications.
- the present invention is aimed at the technical problem that thrombectomy devices in the prior art are prone to damage blood vessels when used to capture aortic thrombus close to both pulmonary branches, and aims to provide a thrombectomy device for a transcatheter pulmonary artery thrombectomy system.
- a thrombectomy device for transcatheter pulmonary artery thrombectomy system including a thrombectomy stent; a guide head located at the distal end of the thrombectomy stent;
- the thrombectomy bracket is made of wire harness and has a mesh.
- the distal outer diameter of the thrombectomy bracket is smaller than the proximal outer diameter.
- the thrombectomy bracket is provided with a fixed sleeve;
- a push tube the distal end is located inside the thrombectomy stent, the proximal end is connected to the operating end of the thrombectomy system, the push tube is a hollow structural member with openings at both ends;
- a control part the proximal end of which passes through the thrombectomy bracket and extends to the operating end of the thrombectomy system, and the distal end is fixedly connected to the distal end of the thrombectomy bracket and the guide head.
- the control member is connected to the inside of the guide head
- the thrombectomy device is provided with at least one distal fixed sleeve
- the distal wire harness of the control member and the thrombectomy bracket passes through the distal end.
- the fixed sleeve is connected as one body
- the distal outer surface of the distal fixed sleeve is connected to the inside of the proximal end of the guide head, so that the distal outer wall of the control piece, the distal wire harness of the thrombectomy bracket and the The guide heads are connected as one body through the distal fixed sleeve.
- connection method between the distal fixed sleeve and the guide head, the thrombectomy bracket, and the control member is one of hot melt bonding, barb connection, protruding connection, or protruding connection.
- the proximal end of the control member extends through the interior of the push tube to the operating end of the thrombectomy system, and the distal end of the control member extends out of the push tube and passes through the thrombectomy bracket and
- the guide head is fixedly connected, and the control part is provided with a channel for the guide wire to pass through.
- the distance by which the distal end of the control member protrudes from the distal end of the thrombectomy bracket is 5 mm to 20 mm, preferably 12 mm to 18 mm, and more preferably 13 mm to 15 mm.
- the proximal end of the control member exceeds the proximal end of the push tube by at least 80 mm, and the thrombectomy stent fits the control member The pieces remain parallel.
- a gasket is provided in the push tube, and a through hole is provided in the middle of the washer.
- the control member passes through the through hole to ensure the coaxiality of the push tube and the control member.
- control part is a piston control part made of one or more of PEBAX or PTFE polymer materials.
- the thrombectomy device is further provided with at least one proximal fixed sleeve, and the proximal wire harness of the thrombectomy bracket is inserted into the gap between the proximal fixed sleeve and the push tube to fix the retriever. Tie the proximal harness of the stent.
- the proximal fixed sleeve, the thrombus retrieval stent, and the push tube are connected by one or more of hot melt bonding, barbed connection, protruding connection, or protruding connection.
- the proximal wire harness of the thrombectomy stent is provided with a developing ring, and the push tube, the proximal wire harness of the thrombectomy stent and the developing ring are connected as one through the proximal fixed sleeve .
- the distance between the developing ring and the proximal network disk end surface of the thrombectomy stent does not exceed 5 mm.
- the guide head includes:
- a cylindrical connector the distal end is connected to the proximal end of the arc-shaped head, and the proximal end is internally connected to the distal end of the control member and the distal wire harness of the thrombus retrieval bracket;
- the guide head is a hollow integrated structure with openings at both ends, and a guide head through hole for passing a guide wire runs through the guide head along the axial direction of the guide head.
- the guide head is made of one or more of PEBAX or PTFE polymer materials.
- the wire harness is made of any one of nickel-titanium alloy, platinum-iridium alloy or platinum-tungsten alloy or a mixture of multiple metal materials;
- the diameter range of the metal material is 0.10mm ⁇ 0.13mm.
- the thrombectomy stent is woven by a knitting machine, and the aperture size of the mesh is controlled by adjusting the PPI value of the knitting machine.
- the thrombectomy stent is a self-expanding metal stent.
- the thrombectomy stent includes:
- At least two network disks are integrally made of the wire harness and have mesh holes. They are hollow inside and can be in an expanded or contracted state;
- the outer diameters of at least two of the network disks increase sequentially from the distal end to the proximal end.
- the proximal and distal ends of each of the network disks are in a gathered structure.
- the end has a gathered distal harness.
- the proximal wire harness and the distal wire harness between two adjacent network disks are integrally connected after being shaped by a mold during heat setting to form a network disk connection section, and the network disk connection section is covered with the fixing sleeve, and the wire harnesses between two adjacent network disks are connected into one body through the fixed sleeve.
- connection method between the fixed sleeve and the network disk connection section is one or more of hot melt bonding, barb connection, protruding connection or protruding connection.
- the push tube passes through the central axes of at least two of the network disks, and the distal end port of the push tube does not exceed the distal end port of the most distal fixed sleeve.
- the thrombectomy system is also provided with at least one pull-wire structure, and the pull-wire structure includes:
- a pull wire the proximal end of the pull wire is controlled by the operating end of the thrombectomy system, there is at least one pull wire, and the distal end of the pull wire is provided with a blocking member;
- a wire control ring the wire control ring is located at least at the distal end of the control member, the wire control ring is provided with blocking holes in the circumferential direction consistent with the number of the pulling wires, the blocking holes limit the blocking movement of pieces.
- control member is also provided with an outwardly protruding concave hole, the concave hole is located at the distal end of the control member, and at least one of the concave holes is provided in the circumferential direction, and the concave hole is located at the distal end of the control member.
- the pull wire of the pull wire structure is controlled in the concave hole, and the connection method between the wire control ring and the control member is bonding, threaded connection, snap connection or protruding connection. one or more.
- the positive and progressive effect of the present invention is that the present invention uses a thrombectomy device for transcatheter pulmonary artery thrombectomy system, which has the following advantages:
- connection and fixation are simple and convenient, and the deformation problem of the thrombectomy stent is greatly reduced, so that the thrombectomy stent has a better expansion state and can It captures the thrombus to the maximum extent and can also easily gather it.
- shrinkage deformation is buffered to avoid the loss of thrombus, which is also convenient for doctors to operate and reduces the operation time.
- Figure 1 is a structural perspective view of the present invention
- Figure 2 is a front view of Figure 1;
- Figure 3 is a cross-sectional view of Figure 2;
- Figure 4 is a partially enlarged schematic diagram of position A in Figure 3;
- Figure 5 is a perspective view of a structure except for the introducer sheath in Figure 1;
- Figure 6 is a perspective view of a structure except the inner sheath in Figure 5;
- Figure 7 is a perspective view of the structure in Figure 6 except for the proximal fixed sleeve;
- Figure 8 is a structural schematic diagram of a thrombectomy stent of the present invention.
- Figure 9 is a front view of Figure 8.
- Figure 10 is a schematic diagram of part of the structure in Figure 1;
- Figure 11 is a structural schematic diagram of the distal fixed sleeve of the present invention.
- Figure 12 is a schematic diagram of the connection between the guide head, the control part and the push tube according to the present invention.
- Figure 13 is a partial connection diagram in Figure 12;
- Figure 14 is a partially enlarged schematic view of B in Figure 13;
- Figure 15 is a structural perspective view of the line control loop of the present invention.
- Figure 16 is a structural perspective view of the cable structure of the present invention.
- Figure 17 is a schematic diagram of the connection between the control part and the cable structure of the present invention.
- Figure 18 is a schematic diagram of the connection between the cable structure and the recessed hole of the present invention.
- Figure 19 is a schematic diagram of the right side of Figure 18;
- Figure 20 is a schematic diagram of the left side of Figure 18;
- Figure 21 is another structural perspective view of the present invention.
- Figures 22 and 23 are schematic diagrams of the process of obtaining thrombus by the thrombectomy device in Figure 21.
- a thrombectomy device for transcatheter pulmonary artery thrombectomy system includes a thrombectomy stent 100, a push tube 300 and a control part 400.
- a thrombectomy device used in a transcatheter pulmonary artery thrombectomy system includes a thrombectomy stent 100, a guide head 200, a push tube 300, a control member 400, and a development ring 500.
- the thrombectomy stent 100 is made of a wire harness and has a mesh.
- the distal outer diameter of the thrombectomy stent 100 is smaller than the proximal outer diameter.
- the thrombectomy stent 100 is provided with a fixed sleeve.
- thrombectomy stent 100 has at least a proximal and distal end in a gathered configuration, such that the proximal end has a gathered proximal harness and the distal end has a gathered distal harness.
- the wire harness is made of any one or a mixture of multiple metal materials selected from nickel-titanium alloy, platinum-iridium alloy, or platinum-tungsten alloy; the diameter of the metal material ranges from 0.10 mm to 0.13 mm.
- the thrombectomy stent 100 when manufacturing the thrombectomy stent 100, it is preferably knitted by a knitting machine, and the aperture size of the mesh is controlled by adjusting the PPI value of the knitting machine.
- the thrombectomy stent 100 is a self-expanding metal stent, and the thrombectomy stent 100 moves along the axial direction through the control member 400 to adjust and limit the expansion or contraction of the thrombectomy stent 100 .
- the thrombus removal bracket 100 includes at least two network disks 110 .
- the at least two network disks 110 are integrally made with wire harnesses and have mesh holes.
- the network disks 110 are hollow inside.
- the network disks 110 Can be in an expanded or contracted state.
- the outer diameters of at least two network disks 110 increase sequentially from the distal end to the proximal end, and the increasing process may adopt a linear increasing method.
- Both the proximal end and the distal end of each network disk 110 have a gathered structure.
- Each network disk 110 has a gathered proximal wire harness at the proximal end, and each network disk 110 has a gathered distal wire harness at the distal end.
- the thrombectomy stent 100 of the present invention is structurally designed with multiple mesh disks 110 with different outer diameters, aiming to seize the pulmonary artery thrombus close to both pulmonary branches.
- the most distal mesh disk 110 can penetrate into both pulmonary branches without any obstruction without damaging the branch blood vessels. wall, which solves the problem that the self-expanding large network disk cannot be released smoothly inside the pulmonary branches, and slows down the damage caused by the release of the network disk to the blood vessel wall.
- network disks 110 which are respectively network disk 111, network disk 112 and network disk 113 from the proximal end to the far end.
- the outer diameter of the three network disks 110 gradually decreases from the proximal end to the distal end, that is, the outer diameter of the most proximal network disk 111 is the largest, and the outer diameter of the most distal network disk 113 is the smallest.
- the proximal wire harness of the network disk 111 serves as the proximal wire harness of the thrombectomy stent 100 and is wrapped in the distal inner wall of the push tube 300, and is preferably connected as a whole through a proximal fixed sleeve.
- the distal wire harness of the network disk 113 serves as the distal wire harness of the thrombectomy bracket 100 and is wrapped on the distal outer wall of the control member 400, and is preferably fixedly connected to the proximal interior of the guide head 200 through a distal fixed sleeve.
- the proximal wire harness and the distal wire harness between two adjacent network disks 110 are integrally connected after being shaped by a mold during heat setting to form a network disk connection section.
- the outer cover of the network disk connection section is provided with a fixed sleeve 610, and the wire harnesses between two adjacent network disks 110 are connected into one body through the fixed sleeve 610.
- the present invention uses two adjacent network disks 110 to control the deformation amount.
- a fixed sleeve 610 is added to define the inner diameter between the network disks 110, so that the network disks 110 can be well expanded when released, and the network disks 110 can be well withdrawn into the inner sheath tube when being tightened. .
- connection method between the fixing sleeve 610 and the network disk connection section is one or more of hot melt bonding, barb connection, protruding connection or protruding connection.
- network disks 110 there are three network disks 110, which are respectively network disk 111, network disk 112 and network disk 113 from the proximal end to the far end.
- Fixed sleeves 610 are installed between the network disks 111 and 112 and between the network disks 112 and 113 .
- the distal end of the push tube 300 passes through the central axes of at least two network disks 110 , and the distal end port of the push tube 300 does not exceed The distal port of the most distal fixed sleeve 610.
- the guide head 200 is located at the distal end of the thrombectomy stent 100 .
- the guide head 200 includes an integrally made arcuate head 210 and a cylindrical connector 220.
- the distal diameter of the arcuate head 210 is smaller than the proximal diameter.
- the diameter of the cylindrical connector 220 is the same as the diameter of the proximal end of the arc head 210.
- the distal end of the cylindrical connector 220 is connected to the proximal end of the arc head 210.
- the cylindrical connector 220 is hollow inside.
- the proximal end of 220 internally connects the distal end of the control member 400 and the distal wiring harness of the thrombectomy stent 100 .
- the guide head 200 is a hollow integrated structure with openings at both ends, and a guide head through hole 230 for passing the guide wire passes through the guide head 200 in the axial direction.
- the guide head 200 is made of one or more blends of PEBAX or PTFE polymer materials.
- the distal end of the push tube 300 is located inside the thrombectomy stent 100, and the proximal end of the push tube 300 is connected to the operating end of the thrombectomy system.
- the push tube 300 is a hollow structural member with openings at both ends.
- the thrombectomy device is also provided with at least one proximal fixed sleeve 620 , and the proximal wire harness of the thrombectomy bracket 100 is inserted between the proximal fixed sleeve 620 and the push tube 300 gap to fix the proximal wire harness of the thrombectomy stent 100.
- connection method between the proximal fixation sleeve 620, the thrombectomy stent 100, and the push tube 300 is one or more of hot melt bonding, barbed connection, protruding connection, or protruding connection.
- a development ring 500 is provided on the proximal wire harness of the thrombectomy stent 100 , and the push tube 300 , the proximal wire harness of the thrombectomy stent 100 and the development ring 500 are fixed by a proximal end.
- the sets of 620 are connected into one body.
- the distance between the developing ring 500 and the proximal network disk end surface of the thrombectomy stent 100 does not exceed 5 mm, preferably between 4 mm and 5 mm.
- the length of the proximal fixation sleeve 620 is 3 cm to 4 cm.
- the proximal end of the control member 400 passes through the thrombectomy stent 100 and extends to the operating end of the thrombectomy system.
- the distal end of the control member 400 is connected to the distal end of the thrombectomy stent 100 and the guide head 200 Fixed connection.
- the axial movement of the control member is controlled by the operating end of the thrombectomy system.
- the thrombectomy bracket 100 and the guide head 200 are driven.
- control member 400 is on the same axis as the thrombectomy stent 100, and the control member 400 limits the expansion or contraction of the thrombectomy stent 100.
- control component 400 is connected to the inside of the guide head, and the control component 400 is connected to the distal wire harness of the thrombectomy bracket 100 through the distal fixation sleeve 630.
- the outer surface of the distal fixed sleeve 630 is connected to the proximal interior of the guide head 200, so that the distal outer wall of the control part 400, the distal wire harness of the thrombectomy bracket 100 and the guide head 200 are connected through the distal fixed sleeve 630.
- connection method between the distal fixation sleeve 630, the guide head 200, the thrombus retrieval bracket 100, and the control member 400 is one or more of hot melt bonding, barbed connection, protruding connection, or protruding connection. .
- the distal fixed sleeve 630 is a hollow sleeve with openings at both ends.
- the inner diameter of the distal end is smaller than the inner diameter of the proximal end, so that the proximal end can better accommodate the distal end of the thrombectomy stent 100 .
- end wire harness it can be set outside the control part 400.
- the proximal end of the control member 400 extends through the interior of the push tube 300 to the operating end of the thrombectomy system.
- the distal end of the control member 400 extends from The push tube 300 passes through the thrombus retrieval bracket 100 and is fixedly connected to the guide head 200.
- the control part 400 is provided with a channel for the guide wire to pass through.
- the distance by which the distal end of the control member 400 protrudes from the distal end of the thrombectomy bracket 100 is 5 mm to 20 mm, preferably 12 mm to 18 mm, and more preferably 13 mm to 15 mm.
- the proximal end of the control member 400 exceeds the proximal end of the push tube 300 by at least 80 mm, and the thrombectomy stent 100 is attached to the control member 400 and remains parallel. .
- a gasket is provided in the push tube 300, and a through hole is provided in the middle of the washer.
- the control member 400 passes through the through hole to ensure the coaxiality of the push tube 300 and the control member 400.
- control member 400 is a piston control member 400 made of one or more of PEBAX or PTFE polymer materials.
- the thrombectomy system is also provided with at least one pull-wire structure 700 , and multiple pull-wire structures 700 can be provided according to the curvature requirements of the control member. Since the present invention is used in pulmonary branch blood vessels, especially when the target thrombus is near the pulmonary aorta bifurcation, the control member may need to be bent, or even need to form an S-shaped control member to enter the pulmonary branch blood vessel where the template thrombus is located, and the above-mentioned pull wire Structure 700 is used to bend the control member.
- the pull wire structure 700 includes a pull wire 710 and a wire control ring 720 .
- the proximal end of the pulling wire 710 is controlled by the operating end of the thrombectomy system.
- the wire control ring 720 is located at least at the distal end of the control member 400.
- the wire control ring 720 is provided with a number of blocking holes 721 consistent with the number of pull wires 710 in the circumferential direction.
- the blocking holes 721 limit the movement of the blocking member 711. .
- the wire-control ring 720 in at least one pull-wire structure 700 is disposed at the far end of the control member 400, and the wire-control rings 720 in other pull-wire structures 700 can be set outside the control member 400 as needed. .
- the control member 400 is also provided with an outwardly protruding concave hole 410.
- the concave hole 410 is located at the distal end of the control member 400, and the concave hole 410 is located on the circumference of the control member 400.
- the wire control ring 720 located at the distal end preferably includes a distal ring 722 and a proximal ring 723 made in one piece, and the outer diameter of the distal ring 722 is not larger than that of the control member 400.
- the outer diameter of the proximal ring 723 is smaller than the outer diameter of the control member 400 , and the proximal end of the distal ring 722 is integrally connected to the distal end of the proximal ring 723 .
- the line control ring 720 located at other positions can be a circular ring with the same outer diameter and inner diameter, and the circular ring is sleeved outside the control member 400 .
- the pull wire 710 is controlled within the recessed hole 410 .
- the pulling wire 710 can be passed through the concave hole 410 from the distal end and then connected to the operating end of the thrombectomy system.
- connection method between the wire control ring 720 and the control member 400 is one or more of adhesive, threaded connection, snap connection or protruding connection.
- the working principle of the present invention is as follows: the distal end of the control member 400 passes through the thrombectomy bracket 100 and is fixedly connected to the guide head 200 together with the thrombectomy bracket 100, and the proximal end of the control member 400 passes through the push tube 300 to the thrombectomy system.
- the operating end pushes the push tube 300 through the operating end so that the thrombectomy stent 100 is separated from the inner sheath and returns to a free state, and the control part 400 is pulled through the operating end to control the relative extension of the thrombectomy stent 100 so that the thrombectomy stent 100 fits the inner wall of the blood vessel more closely;
- the push tube 300 is pulled to cause the guide head 200 to retract to the distal port of the inner sheath.
- the thrombus retriever can collect the thrombus as much as possible through multiple stretching and contractions to collect or remove the thrombus to the outer catheter sheath. the goal of. After the thrombus is collected, the thrombectomy system is withdrawn.
- control member 400 is used to axially guide the thrombectomy stent 100 and prevent the thrombectomy stent 100 from being stuck relative to the inner sheath when the push tube 300 collects the thrombectomy stent 100; Control the tightening and release of the thrombectomy stent.
- FIG 21 shows a thrombectomy device of the present invention.
- the thrombus removal bracket 100 of the thrombus removal device is made of wire harness and has a mesh.
- the thrombectomy bracket 100 has three network disks 110.
- the outer diameter of each network disk 110 gradually decreases from the proximal end to the distal end, and the wire harnesses between two adjacent network disks 110 are connected into one body through the fixing sleeve 610.
- the guide head 200 is located at the distal end of the thrombectomy stent 100 .
- the guide head 200 is a hollow integrated structure with openings at both ends, and a guide head through hole for passing a guide wire passes through the guide head 200 in the axial direction.
- the distal end of the push tube 300 is located inside the thrombectomy stent 100, and the proximal end of the push tube 300 is connected to the operating end of the thrombectomy system.
- the push tube 300 is a hollow structural member with openings at both ends.
- the proximal wire harness of the thrombectomy stent 100 is inserted into the gap between the proximal fixed sleeve 620 and the push tube 300 to fix the proximal wire harness of the thrombectomy stent 100 .
- the proximal wire harness of the thrombectomy stent 100 is provided with a developing ring, and the push tube 300 , the proximal wire harness of the thrombectomy stent 100 and the developing ring are connected as a whole through a proximal fixed sleeve 620 .
- the proximal end of the control member 400 passes through the thrombectomy stent 100 and the push tube 300 in sequence and extends to the operating end of the thrombectomy system.
- the distal outer wall of the control member 400 , the distal wire harness of the thrombectomy stent 100 and the guide head 200 pass through The distal fixed sleeve 630 is connected as one body.
- the thrombectomy device in Figure 21 is wrapped in the inner sheath tube, and the entire device reaches and exceeds the vicinity of the target thrombus 910 through the outer introducer sheath 810 channel established by the delivery system in the pulmonary artery thrombectomy system, because the target thrombus 910 is close to both lungs.
- the thrombectomy device passes through the target thrombus 910 under the guidance of the guide wire, reaches the pulmonary branch vessel 920, and extends approximately 15 mm to 20 mm beyond the fork of the branch vessel.
- the thrombectomy stent 100 is released, and the three network disks 110 self-expand to fill the blood vessel, and the network disks 110 fit the blood vessel wall 930; then hold the proximal part of the control member 400 and slowly pull it axially toward the proximal direction until The thrombectomy stent 100 grabs and pulls the target thrombus 910 into the outer introducer sheath 810 channel.
- the most proximal self-expanding network disk 110 has a large diameter and is soft, which buffers the shrinkage and deformation of the middle self-expanding network disk 110 during the withdrawal process; the middle self-expanding network disk 110 has a moderate density and can grab the target thrombus 910 and withdraw it into the within the sheath.
- the diameter of the most distal network disk 110 is similar to the trunk diameter of the pulmonary branches. During the release process, the blood vessels will not receive obvious radial support force, thus avoiding damage to the pulmonary branch blood vessels.
- the outer catheter sheath 810 is introduced into the human body and reaches near the proximal end of the target thrombus 910.
- the thrombectomy device of the present invention is wrapped in the inner sheath tube 820, and the inner sheath tube 820 reaches the vicinity of the target thrombus 910 through the channel established by the outer sheath system and passes through the target thrombus 910, reaching about 20mm of the pulmonary branch 920, and then gradually releases the thrombectomy stent 100.
- the thrombectomy stent 100 does not need to be completely released until the thrombectomy stent 100
- the expanded outer diameter of the network disk 110 just fits the distal end surface of the target thrombus 910, and the thrombus retrieval stent 100 is stopped and fixed. Adjust the position of the outer introducer sheath 810 so that the port of the outer introducer sheath 810 is as close to the proximal end face of the thrombus as possible.
- the connected three-way valve is opened, and the port of the outer catheter sheath 810 close to the proximal end surface of the thrombus absorbs the thrombus through the suction force formed by the negative pressure, and the semi-expanded thrombus retrieval stent 100 simultaneously fixes the target thrombus 910.
- the outer sheath system is then slowly pulled out toward the proximal end, and the target thrombus 910 is straightened away from the pulmonary branch fork.
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Abstract
一种经导管肺动脉取栓系统用取栓器，属于医疗器械技术领域，包括一取栓支架（100）；一引导头（200），位于取栓支架（100）的远端；取栓支架（100）为线束制成且具有网孔，取栓支架（100）的远端外径小于近端外径，取栓支架（100）设有固定套610）；还包括：一推送管（300），远端位于取栓支架（100）的内部，近端连接于取栓系统的操作端，推送管（300）为两端开口的中空结构件；一控制件（400），近端穿过取栓支架（100）并延伸至取栓系统的操作端，远端与取栓支架（100）的远端和引导头（200）固定连接，在控制件（400）轴向移动时，带动取栓支架（100）和引导头（200）。通过优化取栓支架（100）结构设计，解决了现有支架在抓取双肺支脉附近的主动脉血栓过程中损伤双肺支脉的问题。
Description
本发明属于医疗器械技术领域，具体涉及一种经导管肺动脉取栓系统用取栓器。
肺栓塞(Pulmonary Embolism,PE)是指由脱落的血栓或其他物质阻塞肺动脉或其分支引起的肺循环障碍。PE是临床上极为凶险的急重症，未经治疗的肺栓塞死亡率为20-30％，是心血管疾病中仅次于冠心病和中风的第三位的死亡原因第三大心血管死亡原因，具有发病率高、致死率高、复发性高、漏诊性高的特点。全球每年诊断的病例数超过1000万，其中100万例发生在美国，70多万例发生在法国、意大利、德国、西班牙、瑞典和英国。目前治疗肺栓塞的传统方法有药物治疗、溶栓治疗，而常规的抗凝和药物溶栓治疗为肺栓塞的基础治疗，可以控制轻中度PE患者症状的进展，但对大面积PE患者溶栓无法提供快速、有效的治疗，并且出血风险高。微创介入治疗能够克服传统治疗方法的弊端，是治疗急性肺栓塞是目前极具前景的技术。
现有技术中取栓支架的自膨胀网盘直径是参考临床患者的肺主动脉直径设计的，自膨胀后网盘可以直接贴合血管壁并最大限度地抓取血栓。但是对于在靠近双肺支脉的主动脉血栓来说，最远端的自膨胀网盘不可避免的导入双肺支脉，由于网盘膨胀后的外径较支脉干径大太多，且肺支脉血管内部路径崎岖，通道弯折形状不规则，需要过多的对自膨胀网盘收取的方向进行调控，同时对支脉血管壁的径向支撑力相应增大，也增大血管损伤的概率。为此，有必要对其进行改进，以克服实际应用中的不足。
发明内容
本发明针对现有技术中的取栓器在用于靠近双肺支脉的主动脉血栓的抓取时，容易损伤血管的技术问题，目的在于提供一种经导管肺动脉取栓系统用取栓器。
一种经导管肺动脉取栓系统用取栓器，包括一取栓支架；一引导头，位于所述取栓支架的远端；
所述取栓支架为线束制成且具有网孔，所述取栓支架的远端外径小于近端外径，所述取栓支架设有固定套；
还包括：
一推送管，远端位于所述取栓支架的内部，近端连接于取栓系统的操作端，所述推送管为两端开口的中空结构件；
一控制件，近端穿过所述取栓支架并延伸至取栓系统的操作端，远端与所述取栓支架的远端和引导头固定连接，在所述控制件轴向移动时，带动所述取栓支架和所述引导头。
作为优选方案，所述控制件连接于所述引导头的内部，所述取栓器设有至少一远端固定套，所述控制件与所述取栓支架的远端线束通过所述远端固定套连接为一体，所述远端固定套的远端外表面连接于所述引导头的近端内部，致使所述控制件的远端外壁、所述取栓支架的远端线束和所述引导头之间通过所述远端固定套连接为一体。
作为优选方案，所述远端固定套与所述引导头、所述取栓支架、所述控制件的连接方式为热熔粘结、倒刺连接、突刺连接或凸起连接中的一种或多种。
作为优选方案，所述控制件的近端穿过所述推送管内部延伸至取栓系统的操作端，所述控制件的远端外伸于所述推送管并穿过所述取栓支架与所述引导头固定连接，所述控制件设有一通道，用于导丝穿过。
作为优选方案，所述控制件的远端外伸出所述取栓支架远端的距离为5mm～20mm，优选为12mm～18mm，更优选为13mm～15mm。
作为优选方案，在所述取栓支架轴向拉伸至最大位移时，所述控制件的近端超出所述推送管的近端至少80mm的长度，所述取栓支架贴合于所述控制件保持平行。
作为优选方案，所述推送管内设有一垫圈，所述垫圈的中部设有一通孔，所述控制件穿过所述通孔，以保证所述推送管和控制件的同轴度。
作为优选方案，所述控制件为采用PEBAX或PTFE高分子材料中的一种或者多种混合而成的活塞式控制件。
作为优选方案，所述取栓器还设有至少一近端固定套，所述取栓支架的近端线束插入所述近端固定套与所述推送管之间的间隙，以固定所述取栓支架的近端线束。
作为优选方案，所述近端固定套与所述取栓支架、所述推送管的连接方式为热熔粘结、倒刺连接、突刺连接或凸起连接中的一种或多种。
作为优选方案，所述取栓支架的近端线束上设有一显影环，所述推送管、所述取栓支架的近端线束和所述显影环之间通过所述近端固定套连接为一体。
作为优选方案，所述显影环与所述取栓支架的近端网盘端面的距离不超过5mm。
作为优选方案，所述引导头包括一体制成的：
一弧形头部，远端直径小于近端直径；
一柱形连接体，远端与所述弧形头部的近端连接，近端内部连接所述控制件的远端和所述取栓支架的远端线束；
所述引导头为两端开口的中空一体结构，沿所述引导头的轴向贯穿一用于穿过导丝的引导头通孔。
作为优选方案，所述引导头由PEBAX或PTFE高分子材料中的一种或者多种混合制成。
作为优选方案，所述线束为镍钛合金、铂铱合金或铂钨合金中的任意一种或者多种金属材料混合而成；
所述金属材料直径范围为0.10mm～0.13mm。
作为优选方案，所述取栓支架由编织机编织而成，通过调整所述编织机的PPI数值控制所述网孔的孔径大小。
作为优选方案，所述取栓支架为自膨胀金属支架。
作为优选方案，所述取栓支架包括：
至少两个网盘，经所述线束一体制成且具有网孔，内部中空，可呈膨胀状态或收缩状态；
至少两个所述网盘的外径由远端到近端方向依次增大，每个所述网盘的近端和远端均为收拢结构，在近端具有收拢的近端线束，在远端具有收拢的远端线束。
作为优选方案，相邻两个所述网盘之间的近端线束和远端线束在热定型时经模具定形后一体连接形成网盘连接段，所述网盘连接段外套设有所述固定套，相邻两个所述网盘之间的线束通过所述固定套连接为一体。
作为优选方案，所述固定套与所述网盘连接段的连接方式为热熔粘结、倒刺连接、突刺连接或凸起连接中的一种或多种。
作为优选方案，所述推送管穿过至少两个所述网盘的中心轴线，所述推送管的远端端口不超过最远端的所述固定套的远端端口。
作为优选方案，所述取栓系统还设有至少一拉线结构，所述拉线结构包括：
一拉线，所述拉线的近端受控于取栓系统的操作端，所述拉线至少为一条，所述拉线的远端设有阻挡件；
一控线环，所述控线环至少位于所述控制件的远端，所述控线环圆周方向上设有与所述拉线条数一致的阻挡孔，所述阻挡孔限制所述阻挡件的运动。
作为优选方案，所述控制件还设有向外凸出的凹孔，所述凹孔位于所述控制件的远端，所述凹孔在圆周方向上至少设有一个，所述凹孔在轴向方向上至少设有一排，所述凹孔在轴向方向上的每排所述凹孔与圆周方向上的数量一致。
作为优选方案，所述拉线结构的所述拉线受控于所述凹孔内，所述控线环与所述控制件的连接方式为粘结、螺纹连接、卡合连接或凸起连接中的一种或多种。
本发明的积极进步效果在于：本发明采用经导管肺动脉取栓系统用取栓器，具有如下优点：
1、通过优化取栓支架结构设计，解决了现有支架在抓取双肺支脉附近的主动脉血栓过程中损伤双肺支脉的问题；
2、通过优化取栓支架与引导头、推送管和控制件之间的连接关系，连接固定简单方便，还大大降低了取栓支架的变形问题，使得取栓支架具有较好的膨胀状态，可以最大限度的攫取血栓，也可以容易聚拢，在撤回时，收缩变形得到缓冲，避免血栓的流失，也便于医生操作，降低手术时间。
图1为本发明的一种结构立体图；
图2为图1的主视图；
图3为图2的剖视图；
图4为图3中A处的部分放大示意图；
图5为图1中除外导管鞘外的一种结构立体图；
图6为图5中除内鞘管外的一种结构立体图；
图7为图6中除近端固定套外的一种结构立体图；
图8为本发明取栓支架的一种结构示意图；
图9为图8的主视图；
图10为图1中的部分结构示意图；
图11为本发明远端固定套的一种结构示意图；
图12为本发明引导头、控制件和推送管之间的连接示意图；
图13为图12中的部分连接示意图；
图14为图13中B处的部分放大示意图；
图15为本发明控线环的一种结构立体图；
图16为本发明拉线结构的一种结构立体图；
图17为本发明控制件和拉线结构之间的一种连接示意图；
图18为本发明拉线结构和凹孔之间的一种连接示意图；
图19为图18的右侧示意图；
图20为图18的左侧示意图；
图21为本发明的另一种结构立体图；
图22和图23为图21中的取栓器获取血栓时的过程示意图。
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解，下面结合具体图示进一步阐述本发明。
参照图1至图21，一种经导管肺动脉取栓系统用取栓器，包括取栓支架100、推送管300和控制件400。
在一些实施例中，经导管肺动脉取栓系统用取栓器，包括取栓支架100、引导头200、推送管300、控制件400和显影环500。
参照图1至图9，取栓支架100为线束制成且具有网孔，取栓支架100的远端外径小于近端外径，取栓支架100上设置有固定套。
在一些实施例中，取栓支架100至少近端和远端为收拢结构，致使在近端具有收拢的近端线束，在远端具有收拢的远端线束。
在一些实施例中，线束为镍钛合金、铂铱合金或铂钨合金中的任意一种或者多种金属材料混合而成；金属材料直径范围为0.10mm～0.13mm。
在一些实施例中，在制作取栓支架100时，优选由编织机编织而成，通过调整编织机的PPI数值控制网孔的孔径大小。
在一些实施例中，取栓支架100为自膨胀金属支架，取栓支架100通过控制件400沿轴向移动来调整限制取栓支架100的膨胀或收缩。
在一些实施例中，参照图8和图9，取栓支架100包括至少两个网盘110，至少两个网盘110经线束一体制成且具有网孔，网盘110内部中空，网盘110可呈膨胀状态或收缩状态。至少两个网盘110的外径由远端到近端方向依次增大，增大过程可以采用线性增大的方式。每个网盘110的近端和远端均为收拢结构，每个网盘110在近端具有收拢的近端线束，每个网盘110在远端具有收拢的远端线束。
本发明的取栓支架100通过多个外径不同的网盘110结构设计，旨在攫取靠近双肺支脉的肺动脉血栓，最远端的网盘110可以无障碍深入双肺支脉且不损害支脉血管壁，解决了自膨胀大网盘在肺支脉内部无法顺利释放的问题，减缓网盘释放对血管壁的伤害。
在一些实施例中，如图9中所示，具有三个网盘110，从近端至远端分别为网盘111、网盘112和网盘113。三个网盘110从近端至远端外径逐渐缩小，即最近端的网盘111的外径最大，最远端的网盘113外径最小。网盘111的近端线束作为取栓支架100的近端线束包覆在推送管300的远端内壁中，且优选通过近端固定套连接为一体。网盘113的远端线束作为取栓支架100的远端线束包覆在控制件400的远端外壁上，且优选通过远端固定套固定连接引导头200的近端内部。
在一些实施例中，参照图7至图9，相邻两个网盘110之间的近端线束和远端线束在热定型时经模具定形后一体连接形成网盘连接段，参照图1，网盘连接段外套设有固定套610，相邻两个网盘110之间的线束通过固定套610连接为一体。
当网盘110为多个且为自膨胀结构时，在释放和收回过程中，较为容易变形，这种变形量较大，为了变形量的可控，本发明通过在相邻两个网盘110之间增设固定套610来圈定网盘110间的内径尺寸，既能使得网盘110在释放时可很好的膨胀，也可将网盘110在收束时很好的回撤至内鞘管内。
在一些实施例中，固定套610与网盘连接段的连接方式为热熔粘结、倒刺连接、突刺连接或凸起连接中的一种或多种。
在一些实施例中，如图7中所示，具有三个网盘110，从近端至远端分别为网盘111、网盘112和网盘113。在网盘111和网盘112之间、网盘112和网盘113之间均套设有固定套610。
在一些实施例中，参照图3，当取栓支架100具有多个网盘110时，推送管300的远端穿过至少两个网盘110的中心轴线，推送管300的远端端口不超过最远端的固定套610的远端端口。
参照图1至图7、图10，引导头200位于取栓支架100的远端。
在一些实施例中，参照图5和图12，引导头200包括一体制成的弧形头部210和柱形连接体220，弧形头部210的远端直径小于近端直径。柱形连接体220的直径与弧形头部210的近端直径相同，柱形连接体220的远端与弧形头部210的近端连接，柱形连接体220内部中空，柱形连接体220的近端内部连接控制件400的远端和取栓支架100的远端线束。引导头200为两端开口的中空一体结 构，沿引导头200的轴向贯穿一用于穿过导丝的引导头通孔230。
在一些实施例中，引导头200由PEBAX或PTFE高分子材料中的一种或者多种混合制成。
参照图1至图7，推送管300远端位于取栓支架100的内部，推送管300的近端连接于取栓系统的操作端，推送管300为两端开口的中空结构件。
在一些实施例中，参照图1中图7、图10，取栓器还设有至少一近端固定套620，取栓支架100的近端线束插入近端固定套620与推送管300之间的间隙，以固定取栓支架100的近端线束。
在一些实施例中，近端固定套620与取栓支架100、推送管300的连接方式为热熔粘结、倒刺连接、突刺连接或凸起连接中的一种或多种。
在一些实施例中，参照图3和图7，取栓支架100的近端线束上设有显影环500，推送管300、取栓支架100的近端线束和显影环500之间通过近端固定套620连接为一体。
在一些实施例中，显影环500与取栓支架100的近端网盘端面的距离不超过5mm，优选在4mm～5mm之间。
在一些实施例中，近端固定套620的长度为3cm～4cm。
参照图1至图7、图10，控制件400的近端穿过取栓支架100并延伸至取栓系统的操作端，控制件400的远端与取栓支架100的远端和引导头200固定连接。控制件的轴向移动受控于取栓系统的操作端，在控制件400轴向移动时，带动取栓支架100和引导头200。
在一些实施例中，控制件400与取栓支架100在同一轴线上，控制件400限制取栓支架100的膨胀或收缩。
在一些实施例中，参照图1至图7、参照图10和图11，控制件400连接于引导头的内部，控制件400与取栓支架100的远端线束通过远端固定套630连接为一体，远端固定套630外表面连接于引导头200的近端内部，致使控制件400的远端外壁、取栓支架100的远端线束和引导头200之间通过远端固定套630连接为一体。
在一些实施例中，远端固定套630与引导头200、取栓支架100、控制件400的连接方式为热熔粘结、倒刺连接、突刺连接或凸起连接中的一种或多种。
在一些实施例中，参照图11，远端固定套630为两端开口内部中空的套件，其远端的内径小于近端内径，以使近端内部可更好的容纳取栓支架100的远端线束情况下可套设在控制件400外。
在一些实施例中，参照图21，控制件400的近端穿过推送管300内部延伸至取栓系统的操作端，参照图10、图12和图13，控制件400的远端伸出于推送管300并穿过取栓支架100后与引导头200固定连接，控制件400设有一通道，用于导丝穿过。
在一些实施例中，控制件400的远端外伸出取栓支架100远端的距离为5mm～20mm，优选为12mm～18mm，更优选为13mm～15mm。
在一些实施例中，在取栓支架100轴向拉伸至最大位移时，控制件400的近端超出推送管300的近端至少80mm的长度，取栓支架100贴合于控制件400保持平行。
在一些实施例中，推送管300内设有垫圈，垫圈的中部设有通孔，控制件400穿过通孔，以保 证推送管300和控制件400的同轴度。
在一些实施例中，控制件400为采用PEBAX或PTFE高分子材料中的一种或者多种混合而成的活塞式控制件400。
在一些实施例中，参照图4、参照图12至图20，取栓系统还设有至少一拉线结构700，拉线结构700可以根据控制件的弯曲度需求设置有多个。由于本发明用于肺支脉血管中，特别当目标血栓在肺主动脉岔口附近时，可能需要将控制件进行弯折，甚至需要控制件形成S型进入模板血栓所在的肺支脉血管中，上述拉线结构700用于将控制件进行弯折。拉线结构700包括拉线710和控线环720。
参照图16至图19，拉线710的近端受控于取栓系统的操作端，拉线710至少为一条，拉线710的远端设有阻挡件711。参照图15至图20，控线环720至少位于控制件400的远端，控线环720圆周方向上设有与拉线710条数一致的阻挡孔721，阻挡孔721限制阻挡件711的运动。
当拉线结构700设置有多个时，至少一个拉线结构700中的控线环720设置在控制件400的远端，其他拉线结构700中的控线环720可以根据需要套设在控制件400外。
在一些实施例中，参照图13、图14、图18至图20，控制件400还设有向外凸出的凹孔410，凹孔410位于控制件400的远端，凹孔410在圆周方向上至少设有一个，凹孔410在轴向方向上至少设有一排述凹孔410在轴向方向上的每排凹孔410与圆周方向上的数量一致。
在一些实施例中，参照图4和图15，位于远端的控线环720优选包括一体制成的远端环722和近端环723，远端环722的外径不大于控制件400的外径，近端环723的外径小于控制件400的外径，远端环722的近端与近端环723的远端一体连接。这样的设计，使得控制件400的远端套设在近端环外，并被远端环限位。位于其他位置的控线环720可以采用一圈外径和内径相同的圆环，该圆环套设在控制件400外。
在一些实施例中，拉线710受控于凹孔410内。具体实施时，可以将拉线710自远端从凹孔410穿过后与取栓系统的操作端连接。
在一些实施例中，控线环720与控制件400的连接方式为粘结、螺纹连接、卡合连接或凸起连接中的一种或多种。
本发明工作时的工作原理为：控制件400的远端穿过取栓支架100后和取栓支架100一起与引导头200固定连接，控制件400近端穿过推送管300至取栓系统的操作端，经操作端推动推送管300使得取栓支架100脱离内鞘管恢复自由状态，经操作端拉动控制件400控制取栓支架100的相对延伸量使得取栓支架100更加贴合血管内壁；收束时，拉动推送管300，使得引导头200收缩至内鞘管的远端端口处，取栓器可通过多次拉伸和收缩尽可能的收集血栓来达到收集或清除血栓至外导管鞘的目的。血栓收取完毕后，收回取栓系统。在本发明使用过程中，控制件400用于取栓支架100的轴向导向以及推送管300收取取栓支架100的过程中预防取栓支架100相对于内鞘管的卡死；由推送管300控制取栓支架的收束与释放。
在一些实施例中，参照图21，为本发明的一种取栓器，该取栓器的取栓支架100为线束制成且 具有网孔，取栓支架100具有三个网盘110，三个网盘110从近端至远端外径逐渐缩小，相邻两个网盘110之间的线束通过固定套610连接为一体。引导头200位于取栓支架100的远端。引导头200为两端开口的中空一体结构，沿引导头200的轴向贯穿一用于穿过导丝的引导头通孔。推送管300远端位于取栓支架100的内部，推送管300的近端连接于取栓系统的操作端，推送管300为两端开口的中空结构件。取栓支架100的近端线束插入近端固定套620与推送管300之间的间隙，以固定取栓支架100的近端线束。取栓支架100的近端线束上设有显影环，推送管300、取栓支架100的近端线束和显影环之间通过近端固定套620连接为一体。控制件400的近端依次穿过取栓支架100和推送管300并延伸至取栓系统的操作端，控制件400的远端外壁、取栓支架100的远端线束和引导头200之间通过远端固定套630连接为一体。
实施例一：
参照图4，图21的取栓器被裹覆在内鞘管内，整体通过肺动脉取栓系统中的输送系统建立的外导管鞘810通道抵达并超出目标血栓910附近，由于目标血栓910靠近双肺支脉，取栓器借助导丝，在其引导下穿过目标血栓910抵达肺支脉920并超出支脉岔口约15mm-20mm。随即释放取栓支架100，三个网盘110自膨胀充盈血管内，网盘110与血管壁930贴合；再手握控制件400近端部分，沿轴向向近端方向缓慢抽拉，直至取栓支架100将目标血栓910抓取并拉入外导管鞘810通道。最近端的自膨胀网盘110盘径偏大，质软，在回撤过程中使得中间自膨胀网盘110收缩变形得到缓冲；中间自膨胀网盘110的密度适中，攫取目标血栓910并回撤入鞘管内。最远端的网盘110盘径与肺支脉干径相近，释放过程中血管不会受到明显的径向支撑力，避免了肺支脉血管的损伤。
实施例二：
参照图5，当目标血栓在肺主动脉岔口附近时，将外导管鞘810导入人体内并抵达目标血栓910近端附近，本发明的取栓器裹覆在内鞘管820内，内鞘管820通过外鞘系统建立的通道抵达目标血栓910附近并穿过目标血栓910，抵达肺支脉920的20mm左右，而后逐步释放取栓支架100，取栓支架100不需要完全释放，直至取栓支架100的网盘110膨胀的外径刚好与目标血栓910远端端面贴合，停止继续释放取栓支架100并固定。调整外导管鞘810位置，使得外导管鞘810端口尽可能贴近血栓近端端面。
抽吸器抽真空后，打开连通的三通阀，紧贴血栓近端面的外导管鞘810端口通过负压形成的吸力吸取血栓，同步半扩张的取栓支架100固定住目标血栓910的最远端，随即缓慢将外鞘系统朝近端拉出，将目标血栓910拉直远离肺支脉岔口的位置。
关闭连接抽吸器的三通阀，完全释放取栓支架100后抓取血栓回撤至外导管鞘810内。
以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的只是说明本发明的原理，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。
Claims (20)
- 一种经导管肺动脉取栓系统用取栓器，包括一取栓支架；一引导头，位于所述取栓支架的远端；其特征在于，所述取栓支架为线束制成且具有网孔，所述取栓支架的远端外径小于近端外径，所述取栓支架设有固定套；还包括：一推送管，远端位于所述取栓支架的内部，近端连接于取栓系统的操作端，所述推送管为两端开口的中空结构件；一控制件，近端穿过所述取栓支架并延伸至取栓系统的操作端，远端与所述取栓支架的远端和引导头固定连接，在所述控制件轴向移动时，带动所述取栓支架和所述引导头。
- 如权利要求1所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述控制件连接于所述引导头的内部，所述取栓器设有至少一远端固定套，所述控制件与所述取栓支架的远端线束通过所述远端固定套连接为一体，所述远端固定套的远端外表面连接于所述引导头的近端内部，致使所述控制件的远端外壁、所述取栓支架的远端线束和所述引导头之间通过所述远端固定套连接为一体。
- 如权利要求2所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述远端固定套与所述引导头、所述取栓支架、所述控制件的连接方式为热熔粘结、倒刺连接、突刺连接或凸起连接中的一种或多种。
- 如权利要求1所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述控制件的近端穿过所述推送管内部延伸至取栓系统的操作端，所述控制件的远端外伸于所述推送管并穿过所述取栓支架与所述引导头固定连接，所述控制件设有一通道，用于导丝穿过。
- 如权利要求4所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述控制件的远端外伸出所述取栓支架远端的距离为5mm～20mm，优选为12mm～18mm，更优选为13mm～15mm。
- 如权利要求4所述的经导管肺动脉取栓系统用取栓器，其特征在于，在所述取栓支架轴向拉伸至最大位移时，所述控制件的近端超出所述推送管的近端至少80mm的长度，所述取栓支架贴合于所述控制件保持平行。
- 如权利要求6所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述推送管内设有一垫圈，所述垫圈的中部设有一通孔，所述控制件穿过所述通孔，以保证所述推送管和控制件的同轴度。
- 如权利要求1所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述控制件为采用PEBAX或PTFE高分子材料中的一种或者多种混合而成的活塞式控制件。
- 如权利要求1所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述取栓器还设有至少一近端固定套，所述取栓支架的近端线束插入所述近端固定套与所述推送管之间的间隙，以固定所述取栓支架的近端线束。
- 如权利要求9所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述取栓支架的近端线束上设有一显影环，所述推送管、所述取栓支架的近端线束和所述显影环之间通过所述近端固定套连接为一体。
- 如权利要求10所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述显影环与所述取 栓支架近端网盘端面的距离不超过5mm。
- 如权利要求1所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述引导头包括一体制成的：一弧形头部，远端直径小于近端直径；一柱形连接体，远端与所述弧形头部的近端连接，近端内部连接所述控制件的远端和所述取栓支架的远端线束；所述引导头为两端开口的中空一体结构，沿所述引导头的轴向贯穿一用于穿过导丝的引导头通孔。
- 如权利要求1所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述取栓支架由编织机编织而成，通过调整所述编织机的PPI数值控制所述网孔的孔径大小；所述取栓支架为自膨胀金属支架。
- 如权利要求1至13中任意一项所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述取栓支架包括：至少两个网盘，经所述线束一体制成且具有网孔，内部中空，可呈膨胀状态或收缩状态；至少两个所述网盘的外径由远端到近端方向依次增大，每个所述网盘的近端和远端均为收拢结构，在近端具有收拢的近端线束，在远端具有收拢的远端线束。
- 如权利要求14所述的经导管肺动脉取栓系统用取栓器，其特征在于，相邻两个所述网盘之间的近端线束和远端线束在热定型时经模具定形后一体连接形成网盘连接段，所述网盘连接段外套设有所述固定套，相邻两个所述网盘之间的线束通过所述固定套连接为一体。
- 如权利要求15所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述固定套与所述网盘连接段的连接方式为热熔粘结、倒刺连接、突刺连接或凸起连接中的一种或多种。
- 如权利要求15所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述推送管穿过至少两个所述网盘的中心轴线，所述推送管的远端端口不超过最远端的所述固定套的远端端口。
- 如权利要求1所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述取栓系统还设有至少一拉线结构，所述拉线结构包括：一拉线，所述拉线的近端受控于取栓系统的操作端，所述拉线至少为一条，所述拉线的远端设有阻挡件；一控线环，所述控线环至少位于所述控制件的远端，所述控线环圆周方向上设有与所述拉线条数一致的阻挡孔，所述阻挡孔限制所述阻挡件的运动。
- 如权利要求18所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述控制件还设有向外凸出的凹孔，所述凹孔位于所述控制件的远端，所述凹孔在圆周方向上至少设有一个，所述凹孔在轴向方向上至少设有一排，所述凹孔在轴向方向上的每排所述凹孔与圆周方向上的数量一致。
- 如权利要求19所述的经导管肺动脉取栓系统用取栓器，其特征在于，所述拉线结构的所述拉线受控于所述凹孔内，所述控线环与所述控制件的连接方式为粘结、螺纹连接、卡合连接或凸起连接中的一种或多种。
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| CN113974777A (zh) * | 2021-11-24 | 2022-01-28 | 苏州励顶生物科技有限公司 | 一种取栓装置 |
| CN217338727U (zh) * | 2022-03-18 | 2022-09-02 | 晨兴(南通)医疗器械有限公司 | 经导管肺动脉取栓系统用取栓支架 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116983534A (zh) * | 2023-09-27 | 2023-11-03 | 山东百多安医疗器械股份有限公司 | 一种硅橡胶导管耐高压辅助装置 |
| CN116983534B (zh) * | 2023-09-27 | 2023-12-08 | 山东百多安医疗器械股份有限公司 | 一种硅橡胶导管耐高压辅助装置 |
| CN117731362A (zh) * | 2024-01-09 | 2024-03-22 | 苏州中天医疗器械科技有限公司 | 一种远端血栓移除器 |
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