WO2023015652A1 - Dispositif d'élimination de thrombus - Google Patents

Dispositif d'élimination de thrombus Download PDF

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Publication number
WO2023015652A1
WO2023015652A1 PCT/CN2021/117585 CN2021117585W WO2023015652A1 WO 2023015652 A1 WO2023015652 A1 WO 2023015652A1 CN 2021117585 W CN2021117585 W CN 2021117585W WO 2023015652 A1 WO2023015652 A1 WO 2023015652A1
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WO
WIPO (PCT)
Prior art keywords
thrombus
bag
stent
net
crushing
Prior art date
Application number
PCT/CN2021/117585
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English (en)
Chinese (zh)
Inventor
夏顺
刘载淳
黄定国
Original Assignee
上海腾复医疗科技有限公司
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.)
Filing date
Publication date
Priority claimed from CN202121844771.0U external-priority patent/CN215606575U/zh
Priority claimed from CN202110907318.8A external-priority patent/CN113599017A/zh
Application filed by 上海腾复医疗科技有限公司 filed Critical 上海腾复医疗科技有限公司
Publication of WO2023015652A1 publication Critical patent/WO2023015652A1/fr

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

Definitions

  • the present application relates to the technical field of medical devices, in particular to a thrombectomy device.
  • Intravascular thrombosis is a systemic disease with a very wide range of pathogenesis, which may affect the upper and lower extremities, visceral vessels and carotid arteries.
  • myocardial infarction can occur; if it occurs in the brain, it can cause cerebral infarction; if it occurs in the lungs, it can cause pulmonary embolism...
  • deaths caused by thrombotic diseases account for 51% of the global death toll , far exceeding the deaths caused by tumors, infectious diseases, and respiratory diseases.
  • the main treatment methods for thrombosis include: anticoagulant drug therapy, interventional operation treatment and surgical operation.
  • anticoagulant drugs can be used for conservative treatment; for patients who cannot be treated by drugs, necessary surgery must be taken.
  • interventional therapy has less trauma, faster recovery, and is more acceptable to patients. The effect of interventional therapy is more limited by interventional devices.
  • thrombosis disease sites due to the diversity of thrombosis disease sites and the complexity of thrombus morphology, existing thrombus removal devices, such as thrombus removal stents, suction catheters, etc., generally have difficulty in completely removing thrombus, low success rate of one-time thrombus removal, and Fragmented thrombus is easy to escape and block the distal branch.
  • the purpose of some embodiments of the present application is to provide a thrombus removal device to solve the problems of low success rate of one-time thrombus removal and easy omission of fragmented thrombus.
  • An embodiment of the present application provides a thrombus removal device, including: a thrombus filter bag, a connecting bracket, and a thrombus crushing mesh bag; the thrombus filtering mesh bag, connecting bracket, and the thrombus crushing mesh bag are radially self-expanding stent structures;
  • the distal end of the thrombus filter mesh bag is closed, and the proximal end is an open end that can be supported on the inner wall of the blood vessel along the circumferential direction, and its open end is connected to the distal end of the connecting bracket;
  • the distal end of the thrombus crushing mesh bag can be supported circumferentially It is located on the inner wall of the blood vessel and connected with the proximal end of the connecting stent; the connecting stent forms a thrombus trapping area in the unfolded state.
  • the thrombus filtering mesh bag, the connecting bracket and the thrombus crushing mesh bag are integrally woven with memory metal wires.
  • the thrombectomy device further includes: a bracket tightening ring; the bracket tightening ring is sheathed on the connecting bracket.
  • the stent constricting ring is a developing ring.
  • the connecting bracket includes: a first bracket segment located between the opening end of the thrombus filtering net bag and the bracket constricting ring, and a second bracket segment located between the stent constricting ring and the thrombus crushing net bag
  • the first stent segment includes: a plurality of twisted rods that are braided by the braided wires of the thrombus filter bag at its open end, and the plurality of twisted rods are formed along the opening end of the thrombus filter bag Evenly distributed in the circumferential direction
  • the second stent segment includes: a plurality of twist rods that are woven from the braided wires of the thrombus crushing mesh bag at its open end, and the plurality of twist rods are woven along the length of the thrombus crushing mesh bag The open ends are evenly spaced circumferentially.
  • the number of twisted rods of the second stent segment is an even multiple of the number of twisted rods of the first stent segment
  • the thrombus crushing net bag is made of several strands of metal wire interlaced, and each strand of metal wire has an even number of wires. .
  • the thrombus filtering mesh pocket is umbrella-shaped in the unfolded state, and its mesh density gradually decreases from the distal end to the proximal end.
  • the thrombus crushing mesh bag is a mesh bag unit, and the mesh bag unit is dome-shaped; or the thrombus crushing mesh bag includes a plurality of mesh bag units connected in sequence from the distal end to the proximal end, and each mesh bag unit has a middle diameter.
  • the large end has a smooth transitional net structure with a small diameter, and the net unit at the proximal end is disc-shaped.
  • the thrombus removal device further includes: a distal developing ring disposed at the distal end of the thrombus filtering net bag and a proximal developing ring disposed at the proximal end of the thrombus crushing net bag; the distal developing ring is also used for collecting The wire at the far end of the thrombus filtering mesh bag is bundled and fixed; the proximal developing ring is also used to bundle and fix the metal wire at the proximal end of the thrombus crushing mesh bag.
  • the thrombus removing device further includes: a guide head and a push tube; the proximal end of the guide head is connected to the far end of the distal developing ring, and the distal end of the pushing tube is connected to the proximal developing ring. Proximally connected.
  • the thrombus retrieval device of the embodiment of the present application is released to the distal end of the thrombus and then automatically unfolds.
  • the thrombus retrieval device is withdrawn, the thrombus crushing net cuts and crushes the thrombus, and the fragmented thrombus enters the thrombus filter mesh through the thrombus capture area , so that the crushed thrombus can be more thoroughly collected into the sheath tube, which not only improves the success rate of thrombus removal at one time, but also makes it difficult for the crushed thrombus to escape, thereby facilitating more thorough removal of the thrombus.
  • Figure 1 is a schematic structural view of a thrombectomy device provided in an embodiment of the present application
  • Fig. 2 is another structural schematic diagram of the thrombus removal device provided by the embodiment of the present application.
  • Fig. 3 is a schematic structural diagram of the mesh density of the thrombus filter bag of the thrombus removal device provided by the embodiment of the present application;
  • Fig. 4 is a schematic structural view of the twist rod of the connecting bracket of the thrombectomy device provided in the embodiment of the present application;
  • Fig. 5 is a schematic structural diagram of a thrombectomy device provided in an embodiment of the present application used in conjunction with a delivery system.
  • proximal end and the distal end mentioned in this application have the same meaning in terms of orientation, that is, in the state of use, the distal end is the end away from the operator, the proximal end is the end close to the operator, and the operator is at the proximal end. Control the thrombectomy device.
  • the embodiment of the present application provides a thrombectomy device 1 for rapid removal of thrombus in a blood vessel.
  • the thrombectomy device can be used in conjunction with the delivery system shown in Figure 5, such as preloaded into the sheath tube 7 of the delivery system shown in Figure 5.
  • the thrombus removal device 1 includes: a thrombus filtering mesh bag 10 , a connecting bracket 11 and a thrombus crushing mesh bag 12 .
  • the thrombus filtering mesh bag 10, the connecting bracket 11 and the thrombus crushing mesh bag 12 are all radially self-expanding stent structures.
  • the distal end of the thrombus filter bag 10 is closed, and the proximal end is an open end capable of being supported on the inner wall of the blood vessel in the circumferential direction, and the open end is connected to the distal end of the connecting bracket 11 .
  • the thrombus filtering net bag 10 can filter and collect broken thrombi.
  • the distal end of the thrombus breaking mesh bag 12 can be supported on the inner wall of the blood vessel along the circumferential direction, and is connected with the proximal end of the connecting bracket 11 .
  • the thrombus crushing net bag 12 can cut and break the thrombus into smaller thrombi, which can be conveniently collected into the thrombus filtering net bag.
  • the connecting stent 11 forms a thrombus trapping area in the unfolded state, and after the fragmented thrombus fills in, it is collected into the thrombus filter bag 10 .
  • the thrombus filtering net bag 10, the connecting bracket 11 and the thrombus crushing net bag 12 can be integrally woven with memory metal wires, so that each of the aforementioned braided structures has good radial self-expandability and shape memory capability. It can be understood that the thrombus filtering net bag 10 , the connecting bracket 11 and the thrombus crushing net bag 12 can also be made by laser cutting process, which is not specifically limited here.
  • the thrombus filtering mesh bag 10 can be made of multiple memory metal wires, such as nickel-titanium alloy wires interlaced, and specifically, a single metal wire can be interlaced to form an umbrella-shaped mesh bag structure, which is gradually reduced in diameter from the open end to the distal end. Sleek transition net pocket structure.
  • the opening end of the thrombus filter bag 10 has a large diameter, and after expansion, it can be well attached and supported on the inner wall of the blood vessel, and can move along the inner wall of the blood vessel.
  • the fragmented thrombus can be collected into the thrombus along the inner wall of the blood vessel. In the filter bag, it can better prevent thrombus from being missed.
  • the blood flow can also pass through the thrombus filtering mesh bag 10 .
  • the mesh density of the thrombus filtering mesh bag 10 may gradually decrease from the distal end to the proximal end.
  • the thrombus filtering net bag 10 can be divided into multiple density segments in the axial direction, and the number of density segments of the thrombus filtering net bag 10 can be determined according to its length.
  • the thrombus filtering mesh bag 10 is divided into three density segments along the axial direction, and the mesh density of the three density segments gradually decreases from the distal end to the proximal end.
  • the mesh structure of the thrombus filtering net bag 10 can not only catch the thrombus well, but also reduce its sheathing resistance.
  • the lengths of the plurality of density segments may gradually decrease from the distal end to the proximal end, that is, the density segment with the highest mesh density at the farthest end has the longest length, so as to better prevent thrombus from escaping.
  • This embodiment does not specifically limit the mesh density distribution structure of the thrombus filter bag, the mesh density of the thrombus filter bag 10 can be the same, or the lengths of different density sections can be the same, as long as the thrombus filtering effect and sheath retraction performance can be guaranteed That's it.
  • the weaving process can not only finely adjust the mesh density, but also has better softness and lower cost.
  • the thrombectomy device 1 also includes a distal developing ring 3 disposed at the distal end of the thrombus filter bag 10 for marking the position of the distal end of the thrombectomy device 10 .
  • the far-end developing ring 3 can also be used for converging and fixing the wire at the far end of the thrombus filter mesh pocket 10, killing two birds with one stone.
  • the thrombus crushing mesh bag 12 and the thrombus filtering mesh bag 10 are an integral weaving structure of memory metal wires.
  • the thrombus crushing net bag 12 is made of interlaced memory metal wires.
  • the interlaced metal wires form a rhombus grid, which is convenient for cutting and crushing thrombus. In this embodiment, there is no specific limitation on the shape of the grid.
  • the thrombus crushing net 12 can be a net unit, which is dome-shaped and has an open end, and the open end can support and attach to the inner wall of a blood vessel.
  • the diameter of the opening end of the thrombus crushing net bag 12 is large, and a smooth transition net bag structure with a diameter gradually decreasing is formed from its opening end to the proximal end.
  • the braided wires of the thrombus crushing mesh bag 12 are gathered and woven at the opening end to form a plurality of twist rods 110 evenly spaced along the circumference of the opening end.
  • the braided structure of the twist rods 110 is shown in FIG. 4 .
  • the thrombectomy device 1 can also include a proximal developing ring 4 for marking the proximal position of the thrombus removing device, and the proximal wire of the thrombus crushing mesh bag 12 can be fixed by the proximal developing ring 4 after being bundled.
  • the thrombus breaking net 12 may include a plurality of net units connected in sequence from the distal end to the proximal end.
  • the net bag unit adjacent to the connecting bracket 11 is dome-shaped, and the net bag unit far away from the connecting bracket 11 is disc-shaped.
  • the thrombus crushing net bag 12 includes two net bag units, respectively the distal net bag unit 120 connected to the proximal end of the connecting bracket 11 and the proximal net bag unit connected to the proximal end of the distal net bag unit 120 121.
  • the distal net unit 120 is a smooth transition net structure whose diameter gradually decreases from the far end to the proximal end, and the proximal net unit 121 is a smooth transition net structure with a large middle diameter and small diameters at both ends.
  • the transition of the distal net bag unit 120 is relatively gentle, so that the distal net bag unit 120 is in the shape of a dome or an umbrella.
  • the transition of the proximal net bag unit 121 is relatively steep, making it a disc-shaped structure.
  • the disc-shaped proximal mesh unit 121 When the disc-shaped proximal mesh unit 121 is withdrawn, it can provide a thrombus cutting surface relatively perpendicular to the axial direction of the blood vessel, and can quickly break up the thrombus. Multiple mesh pocket units can crush the thrombus multiple times, so as to achieve a better thrombus crushing effect.
  • the thrombus crushing net bag 12 can also collect a part of the broken thrombus.
  • the thrombectomy device 1 may further include: a bracket tightening ring 2 , and the bracket tightening ring 2 is sheathed on the connecting bracket 11 , that is, it is sheathed on a plurality of twist rods 110 after being bundled.
  • the stent constricting ring 2 is a developing ring, that is, the stent constricting ring 2 also has a developing function, which can be used to mark the position of the thrombus capture area.
  • the connecting bracket 11 includes: a first bracket segment located between the opening end of the thrombus filtering net bag 10 and the bracket constricting ring 2 , and a second bracket segment located between the stent constricting ring 2 and the thrombus crushing net bag 12 .
  • the first support segment and the thrombus filtering mesh bag 10 form a three-dimensional rhombus structure, and the second support segment and the mesh bag unit adjacent thereto form a three-dimensional rhombus structure.
  • the first support section includes: a plurality of twist rods 110 woven by the braided wires of the thrombus filtering mesh bag 10 gathered at its opening end, and the plurality of twist stems 110 are evenly spaced along the circumference of the opening end of the thrombus filtering mesh bag 10 .
  • the second support section includes: a plurality of twist rods 110 that are gathered and woven at the open end of the thrombus crushing mesh bag 12 by braiding wires, and the plurality of twist rods 110 are evenly spaced along the circumference of the opening end of the thrombus crushing mesh bag 12 . As shown in FIG. 4 , each twist rod can be braided by three strands of braided wire, and each strand of braided wire can contain multiple metal wires.
  • the connecting stent 11 forms a sparse stent structure with a large diameter at both ends and a small diameter in the middle.
  • the sparse stent structure forms a thrombus capture area, which can facilitate the filling and entry of fragmented thrombus.
  • the twisted rod 110 connecting the stent 11 will not be attached to the inner wall of the blood vessel, which can prevent thrombus from being missed due to being squeezed on the blood vessel wall.
  • part of the thrombus can quickly enter the thrombus capture area, and be collected into the sheath containing the thrombus removal device 1 . Openings are formed between the multiple twisted rods 110 of the first stent segment, through which fragmented thrombi can smoothly enter the thrombus filter bag 10, and the thrombus filter bag 10 brings all the thrombus into the sheath.
  • the second bracket segment may also adopt a net structure similar to the distal net unit 120 .
  • the use of twist rod structure can not only simplify the weaving process, but also because the twist rod structure can provide a larger opening, it is beneficial for thrombus to enter the thrombus crushing net bag.
  • the number of twist rods of the second stent segment is an even multiple of the number of twist rods of the first stent segment, and the thrombus crushing net bag 12 is made of several strands of metal wires interlaced, and each strand of metal wires has an even number of wires.
  • the number of twist rods in the second stent segment is twice the number of twist rods in the first stent segment. As shown in Figures 1 and 2, the number of twisted rods in the first bracket section is 4, and the number of twisted rods in the second bracket section is 8.
  • twist rods 110 in the second support section there are more twist rods 110 in the second support section, and more braided nodes can be formed in the circumferential direction of the opening end of the thrombus crushing net bag 12, and the braided wires dispersed from more braided nodes can be easily interlaced to form thrombus Broken net bag12.
  • By merging multiple braiding wires for interlacing weaving it is not only convenient for the thrombus crushing net bag to weave a larger grid structure, but also satisfies Thrombus crushing requirements, and can improve the strength of thrombus crushing net bag, is conducive to crushing harder thrombus.
  • the number of twisted rods in the first stent section is less, which can facilitate the insertion of the thrombus filter into the sheath.
  • the twist rods of the first bracket segment and the second bracket segment may be arc-shaped rods.
  • the thrombectomy device 1 may further include: a guide head 5 and a push tube 6 .
  • the distal end of the guide head 5 is a pointed end, and the proximal end of the guide head 5 is connected with the distal end of the distal developing ring 3, so as to facilitate the advancement of the thrombus removal device in the blood vessel.
  • the far end of the push tube 5 is connected to the near end of the near end developing ring 4 .
  • the mesh bag structure of the thrombectomy device 1 can be pushed out of the sheath or retracted into the sheath by operating the pushing tube 5 .
  • the thrombectomy device In the interventional surgery for pulmonary embolism to remove thrombus, percutaneous puncture under local anesthesia was used to establish an instrument intervention channel in the femoral vein of the affected side.
  • the thrombectomy device After the guide wire is sent to the position passing through the thrombus, the thrombectomy device according to the embodiment of the present application is guided by the guide wire, and travels to the pulmonary embolism in the blood vessel cavity.
  • the sheath tube of the device thrombectomy device 1 is withdrawn, so that the thrombus crushing mesh bag is released at the distal end of the thrombus. And withdraw the thrombectomy device as a whole.
  • the thrombus is cut, squeezed and fragmented under the external force of the thrombus crushing net bag.
  • the fragmented thrombus enters the thrombus capture area, and then Enter the thrombus filtering mesh bag 10 again, and finally be taken out of the body.
  • the embodiments of the present application at least have the following advantages and positive effects:
  • the thrombus retrieval device 1 of the embodiment of the present application is automatically deployed after being released to the distal end of the thrombus.
  • the thrombus retrieval device 1 is withdrawn, the thrombus crushing net cuts and crushes the thrombus, and the fragmented thrombus enters the thrombus capture area, and then The thrombus filter bag is wrapped around the blood vessel wall and then put into the sheath, which not only improves the success rate of one-time thrombus removal, but also makes it difficult to miss the thrombus, so that the thrombus can be removed more thoroughly.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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Abstract

L'invention concerne un dispositif d'élimination de thrombus (1), comprenant : un sac de filtrage de thrombus en filet (10), une endoprothèse de raccordement (11), et un sac de fragmentation de thrombus en filet (12). Le sac de filtrage de thrombus en filet (10), l'endoprothèse de raccordement (11) et le sac de fragmentation de thrombus en filet (12) sont tous des structures de support à auto-expansion radiale. Une extrémité distale du sac de filtrage de thrombus en filet (10) est fermée, et une extrémité proximale du sac de filtrage de thrombus en filet (10) constitue une extrémité d'ouverture pouvant être supportée sur la paroi interne du vaisseau sanguin dans la direction circonférentielle, et l'extrémité d'ouverture du sac de filtrage de thrombus en filet (10) est raccordée à une extrémité distale de l'endoprothèse de raccordement (11). Une extrémité distale du sac de fragmentation de thrombus en filet (12) peut être supportée sur la paroi interne du vaisseau sanguin dans la direction circonférentielle, et est reliée à une extrémité proximale de l'endoprothèse de raccordement (11). L'endoprothèse de raccordement (11) forme une zone de capture de thrombus dans un état déployé. Le dispositif de thrombectomie (1) peut améliorer le taux de réussite de l'élimination ponctuelle de thrombus, et peut prévenir davantage la dispersion du thrombus brisé, de sorte que l'élimination du thrombus est plus complète.
PCT/CN2021/117585 2021-08-09 2021-09-10 Dispositif d'élimination de thrombus WO2023015652A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202121844771.0U CN215606575U (zh) 2021-08-09 2021-08-09 一种取栓装置
CN202110907318.8 2021-08-09
CN202110907318.8A CN113599017A (zh) 2021-08-09 2021-08-09 一种取栓装置
CN202121844771.0 2021-08-09

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WO2023015652A1 true WO2023015652A1 (fr) 2023-02-16

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CN117244158A (zh) * 2023-11-07 2023-12-19 恒壹（北京）医疗科技有限公司 一种机械取栓导管及取栓装置
CN118000836A (zh) * 2024-03-22 2024-05-10 上海融脉医疗科技有限公司 一种血管内取栓网盘支架以及取栓系统

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CN111281484A (zh) * 2020-03-25 2020-06-16 上海腾复医疗科技有限公司 用于肺栓塞血栓清除的滤网组件及血栓抽吸组件
CN212547088U (zh) * 2020-01-22 2021-02-19 北京弘海微创科技有限公司 一种高效取栓器
CN112568967A (zh) * 2020-12-30 2021-03-30 上海融脉医疗科技有限公司 一种多节段网篮式取栓支架及其取栓装置
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US20210137667A1 (en) * 2007-10-26 2021-05-13 Surmodics Md, Llc Intravascular guidewire filter system for pulmonary embolism protection and embolism removal or maceration
CN105476689A (zh) * 2015-12-28 2016-04-13 威海维心医疗设备有限公司 取栓支架装置
CN206333945U (zh) * 2016-08-04 2017-07-18 上海形状记忆合金材料有限公司 一种双向保护取栓器
CN208756265U (zh) * 2018-04-09 2019-04-19 宋朝阳 组合式取栓支架及血栓取出装置
CN212547088U (zh) * 2020-01-22 2021-02-19 北京弘海微创科技有限公司 一种高效取栓器
CN111281484A (zh) * 2020-03-25 2020-06-16 上海腾复医疗科技有限公司 用于肺栓塞血栓清除的滤网组件及血栓抽吸组件
CN112568967A (zh) * 2020-12-30 2021-03-30 上海融脉医疗科技有限公司 一种多节段网篮式取栓支架及其取栓装置

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117244158A (zh) * 2023-11-07 2023-12-19 恒壹（北京）医疗科技有限公司 一种机械取栓导管及取栓装置
CN117244158B (zh) * 2023-11-07 2024-05-28 恒壹（北京）医疗科技有限公司 一种机械取栓导管及取栓装置
CN118000836A (zh) * 2024-03-22 2024-05-10 上海融脉医疗科技有限公司 一种血管内取栓网盘支架以及取栓系统

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