WO2021089064A2 - Dispositif d'extraction de thrombus et système d'extraction de thrombus pour aorte et artères ramifiées associées - Google Patents

Dispositif d'extraction de thrombus et système d'extraction de thrombus pour aorte et artères ramifiées associées Download PDF

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Publication number
WO2021089064A2
WO2021089064A2 PCT/CN2021/070760 CN2021070760W WO2021089064A2 WO 2021089064 A2 WO2021089064 A2 WO 2021089064A2 CN 2021070760 W CN2021070760 W CN 2021070760W WO 2021089064 A2 WO2021089064 A2 WO 2021089064A2
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WO
WIPO (PCT)
Prior art keywords
tube
guide
thrombus
guide wire
aorta
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PCT/CN2021/070760
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English (en)
Chinese (zh)
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WO2021089064A3 (fr
Inventor
刘昌伟
狄潇
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刘昌伟
狄潇
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Publication of WO2021089064A2 publication Critical patent/WO2021089064A2/fr
Publication of WO2021089064A3 publication Critical patent/WO2021089064A3/fr

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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
    • 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
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A61B2017/00915—Material properties transparent or translucent for radioactive radiation
    • A61B2017/0092—Material properties transparent or translucent for radioactive radiation for X-rays
    • 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
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • 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
    • A61B2017/22051—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 an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22071—Steering
    • 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
    • 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
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop

Definitions

  • This application relates to the field of medical devices, and specifically to a thrombectomy device and thrombectomy system for the aorta and its branch arteries.
  • Embolic lesions of the aorta and its first-level branch arteries have always been a difficult point in vascular surgery.
  • the minimally invasive thrombus aspiration method can extract acute thrombosis, but it cannot handle subacute and chronic thrombus, let alone the tumor thrombus, and there is a risk of thrombus easy to fall off and cause distal embolism;
  • minimally invasive catheter thrombolysis method It can dissolve acute thrombosis and some subacute thrombosis, but it is also unable to deal with tumor thrombus, and there is a high risk of bleeding and the risk of thrombus shedding leading to distal embolism.
  • the purpose of the present application is to provide an aortic and its branch arterial thrombus removal device and thrombus removal system, which can collect thrombus or tumor thrombus after balloon thrombus removal, thereby preventing the risk of distal embolization.
  • the aortic and its branch arterial thrombus removal device includes: a guide tube, a guide wire tube, an outer sheath, and a collection component;
  • the guide wire tube passes through the guide tube, and the front end of the guide wire tube extends from the guide tube;
  • the collection component is arranged at the front end of the guide wire tube, and the collection component includes a filter sleeve, an elastic ring and a binding wire sleeved on the guide wire tube;
  • the mesh bottom of the filter sleeve is arranged on the outer wall of the guide tube, and the mesh opening of the filter sleeve is looped on the elastic ring; one end of the plurality of binding wires is connected to the elastic ring, and the other end Lead through the guide wire tube to the outside of the guide wire tube;
  • the outer sheath is sheathed on the outside of the guide tube and can move along the length direction of the guide tube, so as to retract or release the collection assembly.
  • the filter sleeve can collect the thrombus or tumor thrombus dragged into the aorta by the thrombus removal balloon assembly, and then Utilize the binding thread to close the elastic ring and the filter cover, wrap the filter cover and the elastic ring with the outer sheath, and withdraw the embolization device from the aorta and its branch arteries along the guide wire to complete the embolization process, effectively preventing Risk of distal embolism during embolectomy.
  • the filter sleeve when the elastic ring is in a released state, the filter sleeve has a cone shape.
  • the filter sleeve is in the shape of a funnel, thrombus or tumor thrombus can be intercepted and collected, thereby avoiding the risk of distal embolism.
  • the filter screen cover adopts a membrane structure, and a plurality of through holes are arranged on it; or, the filter screen cover is woven with metal wires.
  • the role of the through hole is to pass blood, thereby avoiding blockage of the aorta in the process of collecting thrombus or tumor thrombus.
  • a guide head is provided on the guide wire tube, and the guide head is in the shape of a cone.
  • the guide head is set in a cone shape, it is convenient to break the tissue and enter the aorta, so that the thrombus removal device can reach the surgical site smoothly.
  • a plurality of threading holes are provided on the peripheral side of the guide wire tube, and the threading holes are communicated with the inside of the guide wire tube.
  • multiple binding threads can be led to the outside through the threading holes and the threading tube in turn, and then the elastic ring can be controlled to close or release through the multiple binding threads.
  • a metal wire that can be identified under X-ray irradiation is wound on the surface of the elastic ring.
  • the metal wire is provided to facilitate the doctor to observe the position of the elastic ring in the human body under X-ray irradiation.
  • a fixing component is provided at the tail end of the guide tube, and the fixing component is used to fix the tail end of the binding wire.
  • the fixing assembly includes a branch catheter and a connector
  • the branch catheter is arranged on the side wall of the guide tube and communicates with the inside of the guide wire tube
  • the connector is detachable from the branch catheter Connection, the connector is used to connect the tie wire.
  • the elastic ring is in a released state, which can be used to collect thrombus or tumor thrombus; when the connector is away from the branch catheter, the tie wire pulls the elastic ring to be in a closed state , To achieve the storage of thrombus or tumor thrombus.
  • the tail end of the guide tube is provided with a water injection hole, which is used to fill liquid between the guide tube and the outer sheath to discharge air, so as to avoid the influence of the air on the human body during the thrombus removal process.
  • the present application provides an aortic thrombus removal system, a thrombus removal balloon assembly, a guide wire, and the thrombus removal device according to any one of the above;
  • the thrombus removal balloon assembly is used to drag the thrombus or tumor thrombus in the branch artery into the aorta;
  • the guide wire is inserted into the guide wire tube in the thrombus removal device, and under the guidance of the guide wire, the thrombus removal device enters the aorta, and then the thrombus or tumor is treated by the filter sleeve. Shut to collect.
  • the filter sleeve can collect the thrombus or tumor thrombus dragged by the thrombus removal balloon assembly into the aorta, and then use the binding thread to make elastic
  • the ring is folded together with the filter cover, the filter cover and the elastic ring are wrapped by the outer sheath, and the aorta and its branch artery thrombus removal device is withdrawn along the guide wire to complete the thrombus removal process. It can not only cooperate with the thrombus removal balloon assembly Removal of tumor thrombus can effectively prevent the risk of distal embolism during thrombus removal.
  • FIG. 1 is a schematic diagram of the aortic and its branch artery embolization device in the released state provided in the first embodiment of the application;
  • FIG. 2 is a schematic diagram of the collection assembly provided in the first embodiment of the application in a folded state
  • FIG. 3 is a schematic diagram of the aortic and its branch artery embolization device provided in the first embodiment of the application in a collapsed state;
  • FIG. 4 is a schematic diagram of a partial structure of the guide wire tube provided in the first embodiment
  • FIG. 5 is a schematic diagram of another structure of the aortic and its branch arterial thrombus removal device provided in the first embodiment of the application;
  • FIG. 7 is a flowchart of steps D to E in the thrombus removal method provided in the second embodiment of the application.
  • FIG. 8 is a flowchart of steps F to H of the aortic and its branch arterial thrombus removal device of another structure in the thrombus removal method provided in the second embodiment of the application;
  • FIG. 9 is a flowchart of steps I to J of the aortic and its branch arterial embolization device adopting another structure in the embolization method provided in the second embodiment of the application.
  • Icon 10-Guide tube; 11-Branch catheter; 12-Connector; 13-Water injection hole; 20-Guide wire tube; 21-Guide head; 22-Thread hole; 30-Outer sheath; 40-Collection assembly; 41 -Filter cover; 411-through hole; 42-elastic ring; 43-binding wire; 50-hard guide wire; 60-plug-removing balloon assembly.
  • connection should be understood in a broad sense, unless otherwise clearly specified and limited.
  • it can be a fixed connection or a detachable connection.
  • Connected or integrally connected it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication between two components.
  • connection should be understood in a broad sense, unless otherwise clearly specified and limited.
  • it can be a fixed connection or a detachable connection.
  • Connected or integrally connected it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication between two components.
  • the specific meanings of the above-mentioned terms in this application can be understood under specific circumstances.
  • the aorta and its branch arterial thrombus removal device provided in the present application, on the one hand, can collect the tumor thrombus when the thrombus removal balloon assembly drags the tumor thrombus to the aorta, so as to realize the thrombus removal of the tumor thrombus; on the other hand, It can also effectively prevent the risk of distal embolism during thrombectomy.
  • the present application provides a thrombus removal device for the aorta and its branch arteries, which includes a guide tube 10, a guide wire tube 20, an outer sheath 30 and a collection assembly 40.
  • the function of the guide wire tube 20 is to pierce a hard guide wire 50.
  • the guide wire tube 20 is inserted into the guide tube 10, and the front end of the guide wire tube 20 extends from the guide tube 10.
  • the guide wire tube 20 is required. It is fixedly connected to the guide tube 10, so that the guide wire tube 20 can drive the guide tube 10 to move;
  • the collection assembly 40 is disposed at the front end of the guide wire tube 20, and the collection assembly 40 includes a filter cover 41, an elastic ring 42 and a binding wire 43 sheathed on the guide wire tube 20.
  • the mesh bottom of the filter sleeve 41 is set on the outer wall of the guide tube 10, and the mesh opening of the filter sleeve 41 is looped on the elastic ring 42; one end of the plurality of binding wires 43 is connected to the elastic ring 42, and the other end passes through the guide wire tube 20 And lead to the outside of the guide wire tube 20;
  • the outer sheath 30 is sleeved on the outside of the guide tube 10 and can move along the length direction of the guide tube 10.
  • the outer sheath 30 can be used to close the filter cover 41 to the inside, thereby facilitating the removal of the thrombus removal device outside the body;
  • the thrombus removal device When the thrombus removal device enters the preset position in the aorta, the outer sheath 30 is moved away from the collection assembly 40, and the collection assembly 40 is released, so that the filter cover 41 can collect thrombus or tumor thrombus.
  • the filter sleeve 41 can drag the embolization balloon assembly into the aorta
  • the thrombus or tumor thrombus is collected, and then the elastic ring 42 and the filter cover 41 are gathered by the binding thread 43, the filter cover 41 and the elastic ring 42 are wrapped by the outer sheath 30, and the rigid guide wire 50 is withdrawn.
  • the thrombus removal device for the aorta and its branch arteries completes the thrombus removal process, not only can cooperate with the thrombus removal balloon assembly to remove the tumor thrombus, but also can effectively prevent the risk of distal embolization during the embolization process.
  • the filter sleeve 41 when the elastic ring 42 is in the released state, the filter sleeve 41 is expanded into a funnel shape, which can intercept and collect thrombus or tumor thrombus, and avoid the risk of distal embolism.
  • the mesh opening position of the filter cover 41 can be set to face the guide head 21.
  • the aorta and its branch arterial thrombus removal device of this type of structure (the first Structure) Mainly suitable for embolism removal from the inferior branch of the aorta;
  • the mesh opening position of the filter cover 41 can also be set back to the guide head 21.
  • the aorta and its branch artery thrombus removal device (the second structure) of this structure is mainly suitable for the aorta Take the bolt from the upper branch.
  • the filter cover 41 adopts a membrane structure, and a plurality of through holes 411 are provided thereon.
  • the function of the through hole 411 is to pass blood, thereby avoiding blockage of the aorta during the process of collecting thrombus or tumor thrombus.
  • the filter cover 41 can also be woven with metal wires.
  • a guide head 21 is provided on the guide wire tube 20, and the guide head 21 is provided at the front end of the guide wire tube 20 and is located upstream of the collection assembly 40, and the guide head 21 is in the shape of a cone.
  • the cone-shaped guide head 21 facilitates breaking the tissue into the aorta, so that the thrombus removal device can reach the surgical site smoothly.
  • a plurality of threading holes 22 are provided on the peripheral side of the guide wire tube 20, and the threading holes 22 are in communication with the inside of the guide wire tube 20.
  • the multiple binding threads 43 connected to the elastic ring 42 can be led to the outside through the threading holes 22 and the threading tube in turn, and then pass through the multiple binding threads 43 Control the folding or releasing of the elastic ring 42.
  • the surface of the elastic ring 42 is wound with a metal wire that can be easily identified under X-ray irradiation.
  • a metal wire that can be easily identified under X-ray irradiation.
  • the edge of the elastic ring 42 can also be set in a wave-shaped structure, so that the elastic ring 42 can be gathered by the tie line 43.
  • a fixing component is provided at the tail end of the guide tube 10, and the fixing component is used to fix the tail end of the tie wire 43.
  • the above-mentioned fixing assembly includes a branch catheter 11 and a connector 12, the branch catheter 11 is arranged on the side wall of the guide tube 10 and communicates with the inside of the guide wire tube 20, and the connector 12 is detachably connected to the branch catheter 11 and connected The head 12 is used to connect the tie wire 43.
  • the tie wire 43 can be introduced into the branch catheter 11 through the guide wire tube 20 and connected to the connector 12. Since the connector 12 is connected to the tie wire 43, when the connector 12 is fixed on the branch catheter 11, it is elastic The ring 42 is in the released state and can be used to collect thrombus or tumor thrombus; when the connecting head 12 is away from the branch catheter 11, the binding wire 43 pulls the elastic ring 42 to be in a retracted state, so as to store the thrombus or tumor thrombus.
  • a water injection hole 13 is also provided at the tail end of the guide tube 10 for filling liquid between the guide tube 10 and the outer sheath 30 to discharge air, thereby avoiding air being brought into the human body during the removal of the thrombus. Danger to the human body.
  • an embodiment of the present application provides an aortic embolization removal system, which includes an embolization removal balloon assembly 60, a rigid guide wire 50, and the embolization removal system provided in the first embodiment above.
  • the device (it can be the plug removal device of the first structure or the plug removal device of the second structure).
  • the thrombus removal balloon assembly 60 is used to drag the thrombus or tumor thrombus in the branch artery into the aorta;
  • the hard guide wire 50 is inserted into the guide wire tube 20 in the thrombus removal device, and the thrombus removal device is inserted into the aorta under the guidance of the hard guide wire 50, and the thrombus or tumor thrombus is treated by the filter cover 41. Collect it.
  • the embolectomy method using the aortic embolization system provided in the present application.
  • the embolization method is applied to the lower aortic branch.
  • the way is to take the bolt; referring to Figure 6 and Figure 7, the steps are as follows:
  • Step A introduce the aorta and its branch artery thrombus removal device from the femoral artery puncture point along the hard guide wire 50 passage;
  • Step B Position the aorta and its branch artery embolization device in the aorta below the opening of the renal artery, and withdraw the outer sheath 30 horizontally, and release the elastic ring 42 and the filter cover 41 in the collection assembly 40 to make the filter cover 41 is in an open mouth state;
  • Step C performing the balloon thrombus removal operation, the thrombus removal is completed, and the thrombus falls into the filter cover 41;
  • Step D Lift the binding wire 43 to adjust the elastic ring 42 and the filter cover 41 to a closed state
  • Step E Push up the outer sheath 30 to wrap the elastic ring 42 and the filter cover 41 into the outer sheath 30;
  • step F the aorta and its branch artery embolization device are withdrawn along the rigid guide wire 50.
  • the embolization method is applied to the upper aortic branch for embolization: the steps are as follows:
  • Step F introduce the aorta and its branch arterial thrombus removal device from the femoral artery puncture point along the hard guide wire 50 passage;
  • Step B Position the aorta and its branch artery embolization device in the aorta below the opening of the renal artery, and withdraw the outer sheath 30 horizontally, and release the elastic ring 42 and the filter cover 41 in the collection assembly 40 to make the filter cover 41 is in an open mouth state;
  • Step C performing the balloon thrombus removal operation, the thrombus removal is completed, and the thrombus falls into the filter cover 41;
  • Step D Lift the binding wire 43 to adjust the elastic ring 42 and the filter cover 41 to a closed state
  • Step E Push down the outer sheath 30 to wrap the elastic ring 42 and the filter cover 41 into the outer sheath 30;
  • step F the aorta and its branch artery embolization device are withdrawn along the rigid guide wire 50.

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  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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Abstract

La présente invention concerne un dispositif d'extraction de thrombus et un système d'extraction de thrombus pour l'aorte et les artères ramifiées associées, se rapportant au domaine des instruments médicaux. Le dispositif d'extraction de thrombus pour l'aorte et les artères ramifiées associées comprend un tube de guidage (10), un tube de fil de guidage (20), une gaine extérieure (30) et un ensemble de collecte (40). Le tube de fil de guidage (20) pénètre dans le tube de guidage (10), et une extrémité avant du tube de fil de guidage (20) s'étend hors du tube de guidage (10). L'ensemble de collecte (40) est disposé à l'extrémité avant du tube de fil de guidage (20), et comprend un manchon à maille de filtre (41) emmanché sur le tube de fil de guidage (20), un anneau élastique (42) et des attaches (43). Une partie inférieure de maille du manchon à maille de filtre (41) est disposée sur une paroi externe du tube de guidage (10), et un anneau d'ouverture de maille de la maille de filtre (41) est disposée sur l'anneau élastique (42). Une extrémité de chacune de la pluralité d'attaches (43) est reliée à l'anneau élastique (42), et l'autre extrémité passe à travers le tube de fil de guidage (20) vers l'extérieur du tube de fil de guidage (20). La gaine extérieure (30) est emmanchée à l'extérieur du tube de guidage (10), et peut se déplacer le long du sens de la longueur du tube de guidage (10), ce qui permet de rétracter ou de libérer l'ensemble de collecte (40). L'invention peut coopérer avec un ensemble ballonnet d'extraction de thrombus en vue d'extraire un thrombus tumoral, et permet de prévenir efficacement le risque d'embolisation d'extrémité distale au cours d'un processus d'élimination de thrombus.
PCT/CN2021/070760 2019-11-08 2021-01-08 Dispositif d'extraction de thrombus et système d'extraction de thrombus pour aorte et artères ramifiées associées WO2021089064A2 (fr)

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CN201911087270.X 2019-11-08
CN201911087270.XA CN110680458A (zh) 2019-11-08 2019-11-08 主动脉及其分支动脉取栓装置及取栓系统

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CN209059350U (zh) * 2018-08-10 2019-07-05 郑州大学第一附属医院 心脏取栓专用网篮装置
CN211131276U (zh) * 2019-11-08 2020-07-31 刘昌伟 主动脉及其分支动脉取栓装置及取栓系统
CN110680458A (zh) * 2019-11-08 2020-01-14 刘昌伟 主动脉及其分支动脉取栓装置及取栓系统

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