WO2022022223A1 - Blood vessel dredging and cleaning device - Google Patents

Blood vessel dredging and cleaning device Download PDF

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Publication number
WO2022022223A1
WO2022022223A1 PCT/CN2021/104193 CN2021104193W WO2022022223A1 WO 2022022223 A1 WO2022022223 A1 WO 2022022223A1 CN 2021104193 W CN2021104193 W CN 2021104193W WO 2022022223 A1 WO2022022223 A1 WO 2022022223A1
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WO
WIPO (PCT)
Prior art keywords
balloon
thrombus
unit
balloon catheter
thrombectomy
Prior art date
Application number
PCT/CN2021/104193
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French (fr)
Chinese (zh)
Inventor
李永利
田立剑
俞华沣
蒿忠飞
李庆斌
陈明辉
张凯
Original Assignee
山东维心医疗器械有限公司
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Publication of WO2022022223A1 publication Critical patent/WO2022022223A1/en

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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
    • 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
    • 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
    • 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
    • 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
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end

Definitions

  • the present application relates to the technical field of medical devices, and in particular, to a blood vessel dredging and cleaning device.
  • the most common treatment for thrombus in the blood vessel is surgery, and most of the surgical treatment uses catheter thrombectomy.
  • the thrombectomy catheter is provided with a thrombectomy part for pulling the thrombus through the clot site, and the thrombus is pulled out through the thrombectomy device.
  • the bolt retrieval part is a relatively common type of design.
  • CN2003201210610 discloses a venous thrombectomy tube
  • CN201320390510.5 discloses an intravascular thrombectomy device
  • CN2014202557918 discloses a thrombectomy balloon
  • CN201720528621.6 discloses a balloon thrombectomy device
  • CN201822036855 .6 discloses a thrombectomy device, all of which use a balloon on the catheter.
  • the shape of the balloon is spherical or elliptical. After the balloon is expanded, the outer wall of the balloon is attached to the blood vessel wall. out blood vessels.
  • the balloon is set in an oval shape, when the balloon is withdrawn, the friction between the balloon and the blood vessel wall is relatively large, and the damage to the blood vessel wall of the patient is large; Spherical, the contact area between the balloon and the blood vessel wall is small, and some broken thrombi easily flow from the gap between the balloon and the blood vessel wall to the distal end of the blood vessel, causing blood vessel blockage again;
  • the second is that the balloon adheres to the blood vessel wall, and the outer wall of the balloon is smooth Yes, when the thrombus on the vessel wall is relatively hard and viscous, some thrombus adhering to the vessel wall may not be removed when the balloon is withdrawn; when the thrombus is soft, the thrombus is easily divided into small thrombi during thrombectomy.
  • thrombus fragments small thrombus or thrombus fragments easily flow to the distal blood vessels, causing secondary embolism, and the vascular dredging effect is not good; third, the existing balloons cannot completely remove the thrombus once, requiring multiple operations to make the operation difficult. The operation time becomes longer and the surgical risk is increased.
  • the purpose of the present invention is to solve the above-mentioned deficiencies of the prior art, and to provide a blood vessel dredging and cleaning device with novel structure, good thrombus removal effect, and little damage to the blood vessel wall.
  • a blood vessel dredging and cleaning device comprising a balloon catheter, a balloon and a marking ring, the distal end of the balloon catheter is wrapped with a balloon, and the distal end and the proximal end of the balloon are respectively connected to a balloon passing through the balloon.
  • the catheter is fixedly connected, the balloon has a contracted state and an expanded state, the balloon catheter is provided with a marking ring at the distal end and the proximal end of the balloon, and the balloon catheter is provided with a balloon to inflate the balloon
  • the expansion channel and the guide wire guide channel through which the guide wire passes, the tube wall of the balloon catheter is provided with a communication hole, and the balloon expansion channel is communicated with the balloon through the communication hole on the tube wall of the balloon catheter, which is It is characterized in that: the overall shape of the balloon in the inflated state is a truncated cone or a cone, the distal end of the balloon is a large-diameter end, and the proximal end is a small-diameter end, and the balloon is composed of a distal end face and a proximal end face.
  • the distal end face is connected with the tapered side wall arc transitionally
  • the proximal end face is connected with the tapered side wall arc transition
  • the tapered shape of the balloon The sidewalls are provided with unit bolt-removing protrusions at intervals, the unit bolt-removing protrusions have a contracted state and an expanded state, and the unit bolt-removing protrusions are provided with convex cavities, and the convex cavities are connected to the balloon.
  • the distal end of the balloon is attached to the blood vessel wall, which can not only block the flow of thrombus to the distal end of the blood vessel but also greatly reduce the friction of the balloon on the blood vessel wall.
  • the thrombus removal protrusion is provided, and the thrombus with strong viscosity on the vessel wall and the fragmented thrombus in the blood vessel can be attached to the thrombus removal protrusion, and the thrombus removal effect is good.
  • the unit bolt-removing protrusions of the present invention are arranged in an array along the circumference of the balloon to form a unit bolt-removing protrusion ring group, and the unit bolt-removing protrusion ring groups are arranged in a linear array along the axial direction of the balloon, and the adjacent unit bolt-removing protrusions are arranged in a linear array.
  • the unit thrombus removal protrusions of the ring-lifting group are staggered. By staggering the unit thrombus removal protrusions of the adjacent unit thrombus protrusion ring groups, the thrombus can be effectively prevented from reaching the distal end of the balloon during the thrombus removal process.
  • the unit bolt-removing protrusion ring group of the present invention is arranged at the proximal end and the middle part of the balloon, the balloon is provided with at least three unit bolt-removing protrusion ring groups, and the unit bolt-removing protrusion ring group is provided with at least three Six unit thrombectomy protrusions, and the unit thrombectomy protrusion ring group is arranged at the proximal end and the middle of the balloon, so that the thrombus is attached to the thrombus removal protrusion when the balloon catheter is withdrawn, which can effectively reduce the flow to the balloon far away.
  • the thrombus at the end of the vessel is prevented from entering the distal end of the vessel, thereby ensuring a better thrombectomy effect.
  • the unit thrombectomy protrusion of the present invention has a hemispherical shape in an expanded state, and adopts a hemispherical design.
  • the attachment area of the thrombus on the thrombectomy protrusion is increased, and the viscosity on the blood vessel wall is strong.
  • the thrombus will also be scraped off without damaging the vessel wall, and it can also effectively prevent the thrombectomy protrusion from being deformed under the action of resistance when the balloon catheter is withdrawn, resulting in the flow of some thrombus attached to the thrombectomy protrusion. distal blood vessels.
  • the balloon catheter of the present invention is provided with a thrombus collecting disk at the proximal end of the balloon, the thrombus collecting disk has a contracted and expanded state, and the overall shape of the thrombus collecting disk in the expanded state has an opening toward the proximal end of the balloon catheter
  • the outer diameter of the thrombus collection disc is smaller than the outer diameter of the large diameter end of the balloon, and the thrombus collection disc is composed of linear unit thrombectomy cilia, and the unit thrombectomy cilia are centered on the axis line of the balloon catheter Arranged along the circumference of the balloon catheter, the inner end of the unit thrombectomy cilia is fixedly connected with the balloon catheter, and the outer end is a free end.
  • part of the thrombus can be collected through the thrombus collecting disc.
  • the thrombus collecting disc is arranged in an umbrella shape with the opening facing the proximal end of the balloon catheter, which increases the contact area with the thrombus.
  • the thrombus collection rate is high and the thrombus is not easy to fall off during the withdrawal process.
  • the unit thrombus removal cilia of the present invention is composed of upper elastic cilia, lower elastic cilia, and a bending part, the inner end of the upper elastic cilia is fixedly connected with the balloon catheter, and the outer end is bent and connected with the lower elastic cilia through the bending part , the angle between the upper elastic cilia and the outer wall of the balloon catheter is 60-90 degrees, and the angle between the lower elastic cilia and the outer wall of the balloon catheter is 0-45 degrees.
  • the design of this angle further increases the The contact area between the cilia and the thrombus is enlarged, and more thrombi can be collected, and the thrombus is not easy to fall off and flow to the distal end of the balloon during the thrombectomy.
  • the balloon catheter of the present invention is provided with a mesh-shaped thrombus removal bracket on the balloon jacket, the distal end and the proximal end of the thrombus removal bracket are respectively fixedly connected with the balloon catheter, and the thrombus retrieval bracket has a retracted state and the expanded state, the overall shape of the thrombectomy stent in the expanded state is a truncated truncated body or a cone matched with the balloon, and when the thrombectomy stent is provided to make the balloon catheter withdraw, part of the thrombus can be collected by the thrombectomy stent, This further ensures that more thrombi can be removed.
  • the beneficial effects of the present invention are as follows: by setting the balloon into a circular truncated body or a cone, the distal end of the balloon is attached to the blood vessel wall, which can not only block the thrombus from flowing to the distal end of the blood vessel, but also greatly reduce the friction of the balloon on the blood vessel wall.
  • a thrombectomy protrusion is arranged on the balloon, and the thrombus with strong viscosity on the vessel wall and the fragmented thrombus in the blood vessel can be attached to the thrombus removal protrusion, and the thrombus removal effect is good; , so that when the balloon catheter is withdrawn, part of the thrombus can be collected first through the thrombus collecting disk.
  • the thrombus collecting disk is set in an umbrella shape with the opening facing the proximal end of the balloon catheter, which increases the contact area with the thrombus.
  • the thrombus collection rate is high and the return rate is high.
  • the thrombus is not easy to fall off during the withdrawal process; when the balloon catheter is withdrawn by setting the thrombectomy stent, part of the thrombus can be collected by the thrombectomy stent, which further ensures that more thrombi can be removed, ensures the thrombus removal effect, and saves the operation. time and reduce harm to patients.
  • FIG. 1 is a schematic diagram of the overall structure of the balloon and thrombectomy stent of the present invention in an expanded state.
  • Fig. 2 is a side view of the balloon and thrombectomy stent of the present invention in an expanded state. .
  • FIG. 3 is a schematic diagram of the overall structure assembly of the balloon and the thrombectomy stent of the present invention in a retracted state.
  • balloon catheter-1 marking ring-2, stent fixing ring-3, thrombectomy stent-4, balloon-5, distal end face-501, proximal end face-502, tapered side wall-503 , Take the plug cilia-6, the upper elastic cilia-601, the lower elastic cilia-602, the bending part-603, and the plug protrusion-7.
  • a blood vessel dredging and cleaning device comprising a balloon catheter 1, a balloon 5, and a marking ring 2, the distal end of the balloon catheter 1 is wrapped with a balloon 5, and the distal end and the proximal end of the balloon 5 are respectively connected with the piercing ring.
  • the balloon catheter through the balloon is fixedly connected, the balloon 5 has a contracted state and an expanded state, and the balloon catheter 1 is provided with a marking ring 2 at the distal end and the proximal end of the balloon, which is convenient for doctors under X-rays.
  • Development and positioning, the connection method between the marking ring and the balloon catheter is in the prior art, which will not be repeated here.
  • the balloon catheter 1 is provided with a balloon inflation channel for inflating the balloon and a guide wire guide through which the guide wire passes.
  • a channel, a communication hole is provided on the wall of the balloon catheter 1, the balloon inflation channel is communicated with the balloon through the communication hole on the wall of the balloon catheter, and the overall shape of the balloon 5 is in the inflated state It is a circular truncated body or a cone, the distal end of the balloon is a large diameter end, and the proximal end is a small diameter end.
  • the protrusions 7 are formed, the distal end surface 501 is connected with the conical side wall 503 in an arc transition, the proximal end surface 502 is connected with the conical side wall 503 in an arc transition, and the conical side walls of the balloon are spaced apart from each other.
  • the unit bolt-removing protrusion 7 has a contracted state and an expanded state, the unit bolt-removing protrusion 7 is provided with a convex cavity, and the convex cavity is connected to the balloon 5.
  • the distal end of the balloon is attached to the blood vessel wall, which can not only block the flow of thrombus to the distal end of the blood vessel but also greatly reduce the friction of the balloon on the blood vessel wall.
  • the thrombus removal protrusion is provided, and the thrombus with strong viscosity on the vessel wall and the fragmented thrombus in the blood vessel can be attached to the thrombus removal protrusion, and the thrombus removal effect is good.
  • the balloon is configured as a circular frustum, but the balloon can also be configured as a cone.
  • the unit bolt removal protrusions 7 are arranged in an array along the circumference of the balloon 5 to form a unit bolt removal protrusion ring group, and the unit bolt removal protrusion ring groups are arranged in a linear array along the axial direction of the balloon 5.
  • the unit thrombus removal protrusions 7 of the raised ring group are staggered. By staggering the unit thrombus removal protrusions of the adjacent unit thrombus raised ring group, the thrombus can be effectively prevented from reaching the distal end of the balloon during thrombectomy.
  • the unit bolt-removing raised ring group is arranged at the proximal end and the middle part of the balloon 5, the balloon 5 is provided with at least three unit bolt-removing raised ring groups, and the unit bolt-removing raised ring group is at least provided with
  • the six unit thrombectomy protrusions 7 are arranged at the proximal end and the middle of the balloon, so that the thrombus is attached to the thrombus removal protrusion when the balloon catheter 1 is withdrawn, which can effectively reduce the flow to the ball.
  • the thrombus at the distal end of the sac prevents the fragmented thrombus from entering the distal end of the vessel to ensure a better thrombectomy effect.
  • the unit thrombectomy protrusion 7 is hemispherical in shape in the expanded state, and the hemispherical design is adopted.
  • the thrombus will also be scraped off without damaging the blood vessel wall, and it can also effectively prevent the thrombectomy protrusion from deforming under the action of resistance when the balloon catheter is withdrawn, causing some of the thrombus attached to the thrombectomy protrusion to flow to the blood vessel. remote.
  • the balloon catheter is provided with a thrombus collecting disk at the proximal end of the balloon, the thrombus collecting disk has a contracted and expanded state, and the overall shape of the thrombus collecting disk in the expanded state is an umbrella with an opening facing the proximal end of the balloon catheter.
  • the outer diameter of the thrombus collecting disc is smaller than the outer diameter of the large diameter end of the balloon, and the thrombus collecting disc is composed of linear unit thrombectomy cilia 6, and the unit thrombectomy cilia 6 are centered on the axis line of the balloon catheter Arranged along the circumference of the balloon catheter 1, the inner end of the unit thrombectomy cilia 6 is fixedly connected with the balloon catheter 1, and the outer end is a free end.
  • part of the thrombus can be collected first through the thrombus collecting disk.
  • the thrombus collecting disk is set in an umbrella shape with the opening facing the proximal end of the balloon catheter, which increases the contact area with the thrombus.
  • the thrombus collection rate is high and the thrombus is not easy to withdraw during the withdrawal process. fall off.
  • the unit thrombus removal cilia 6 is composed of an upper elastic cilia 601, a lower elastic cilia 602, and a bending portion 603.
  • the inner end of the upper elastic cilia 601 is fixedly connected with the balloon catheter 1, and the outer end is connected to the lower elastic cilia through the bending portion 603.
  • the elastic cilia 602 are connected by bending, the angle between the upper elastic cilia 601 and the outer wall of the balloon catheter 1 is 60-90 degrees, and the angle between the lower elastic cilia 602 and the outer wall of the balloon catheter 1 is 0-90 degrees.
  • the design of this angle further increases the contact area between the cilia and the thrombus for thrombectomy, which can collect more thrombi, and at the same time, the thrombus is not easy to fall off and flow to the distal end of the balloon during the thrombectomy process.
  • the unit thrombus-retrieving cilia 6 are made of high-elasticity polymer materials, so that the unit thrombus-retrieving cilia 6 have a contracted state and an expanded state.
  • the balloon catheter 1 is provided with a mesh-shaped thrombectomy bracket 4 on the outer cover of the balloon 5.
  • the distal end and the proximal end of the thrombus retrieval bracket 4 are fixedly connected to the balloon catheter 1 respectively.
  • 4 has a contracted state and an expanded state, and the overall shape of the thrombectomy stent 4 in the expanded state is a truncated truncated body or a cone that is matched with the balloon.
  • the structure adopted in this embodiment is that the bolus removal stent is composed of a unit left helical stent and a unit right helical stent, and the unit left helical stent and the unit right helical stent are crossed to form a unit network.
  • the size of the unit grid of the thrombectomy stent gradually decreases from the distal end of the balloon to the proximal end of the balloon, and the unit thrombectomy protrusions are arranged in the unit grid.
  • the thrombectomy stent expands with it, and the thrombectomy stent closely fits with the outer wall of the balloon.
  • the spiral design of the right helical stent increases the contact area between the thrombectomy stent and the thrombus, which can block the thrombus from flowing to the distal end of the balloon and achieve more effective thrombus collection.
  • a stent fixing ring 3 is fixedly connected to the distal end and the proximal end of the balloon on the balloon catheter, and the two ends of the thrombectomy stent are fixed on the stent fixing ring.
  • the connection method between the stent fixing ring and the balloon catheter is It is the prior art and will not be repeated here.
  • the inner ends of the thrombus removal cilia are also fixed on the bracket fixing ring.
  • the balloon can be made of rubber, silicone, latex, nylon and other materials;
  • the bolt-removing bracket can be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc.;
  • the bolt-removing cilia can be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc.
  • the diameter of the cilia is between 0.01MM and 0.03MM.
  • the initial state of the balloon is shown in FIG. 3 , the balloon, the thrombectomy stent, and the thrombectomy cilia are in a contracted state, the balloon catheter jacket is provided with a sheath, the balloon is in a contracted state, and the overall shape is a long strip shape, the bolt removal bracket is in the retracted state, and the size of the cell grids on the bolt retrieval bracket is the same.
  • a guide wire is pierced through the guide wire guide channel of the balloon catheter.
  • the sheath tube takes the balloon catheter to the distal end of the thrombus. It enables the doctor to observe the position of the balloon catheter, the retraction of the guide wire and the sheath tube, the cilia of the thrombectomy are expanded and opened under the action of elasticity, and the liquid or gas is injected into the balloon expansion channel to expand the volume of the balloon until it adheres to the blood vessel wall.
  • the thrombectomy stent is inflated with the balloon, the balloon is in a filling state that fits with the vessel wall.
  • both the thrombectomy protrusion and the thrombectomy stent are in an expanded state.
  • the doctor pulls the balloon catheter to retract the balloon catheter.
  • the thrombectomy cilia first contact the distal end of the thrombus, collect a part of the thrombus, the balloon catheter continues to withdraw, and part of the thrombus is attached to the thrombectomy protrusion and the thrombectomy stent, and the balloon moves the thrombus toward the proximal end of the blood vessel, and finally removes the thrombus. Thrombus removal.
  • the beneficial effects of the present invention are as follows: by setting the balloon into a circular truncated body or a cone, the distal end of the balloon is attached to the blood vessel wall, which can not only block the thrombus from flowing to the distal end of the blood vessel, but also greatly reduce the friction of the balloon on the blood vessel wall.
  • a thrombectomy protrusion is arranged on the balloon, and the thrombus with strong viscosity on the vessel wall and the fragmented thrombus in the blood vessel can be attached to the thrombus removal protrusion, and the thrombus removal effect is good; , so that when the balloon catheter is withdrawn, part of the thrombus can be collected first through the thrombus collecting disk.
  • the thrombus collecting disk is set in an umbrella shape with the opening facing the proximal end of the balloon catheter, which increases the contact area with the thrombus.
  • the thrombus collection rate is high and the return rate is high.
  • the thrombus is not easy to fall off during the withdrawal process; when the balloon catheter is withdrawn by setting the thrombectomy stent, part of the thrombus can be collected by the thrombectomy stent, which further ensures that more thrombi can be removed, ensures the thrombus removal effect, and saves the operation. time and reduce harm to patients.

Abstract

A blood vessel dredging and cleaning device, comprising a balloon catheter, a balloon, and mark rings. The balloon is wrapped on a distal end of the balloon catheter. A distal end and a proximal end of the balloon are respectively fixedly connected to the balloon catheter passing through the balloon. The balloon catheter is provided with the mark rings on the distal end and the proximal end of the balloon. The balloon catheter is internally provided with a balloon inflation channel and a guide wire guide channel. A communication hole is provided on a wall of the balloon catheter. The overall shape of the balloon in an inflated state is a truncated cone or a cone. The distal end of the balloon is a large diameter end, and the proximal end of the balloon is a small diameter end. The balloon consists of a distal end surface, a proximal end surface, a tapered side wall, and unit clot retrieval protrusions. The distal end surface is in transition connection to a circular arc of the tapered side wall. The proximal end surface is in transition connection to the circular arc of the tapered side wall. The unit clot retrieval protrusions are arranged on the tapered side wall of the balloon at intervals. Each unit clot retrieval protrusion is provided with a protrusion cavity. The present invention has advantages of novel structure, good blood clot removal effect, small damage to the blood vessel wall, etc.

Description

血管疏通清理装置Vascular dredging device
本申请要求于2020年7月29日提交中国专利局、申请号为202010743507.1、发明名称为“血管疏通清理装置”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。This application claims the priority of the Chinese patent application with the application number 202010743507.1 and the invention titled "vascular dredging and cleaning device" filed with the China Patent Office on July 29, 2020, the entire contents of which are incorporated herein by reference.
技术领域technical field
本申请涉及医疗器械技术领域，特别是涉及一种血管疏通清理装置。The present application relates to the technical field of medical devices, and in particular, to a blood vessel dredging and cleaning device.
背景技术Background technique
血管中因多种因素会导致血栓的形成，进而引起一系列症状和并发症。对血管中的血栓的治疗常见的是手术治疗，手术治疗大多采用导管取栓术，导管取栓术的步骤为在患者的血栓形成的身体部位附近切开血管，***取栓导管并沿血管穿过凝块部位，取栓导管上设置有用于拉拽血栓的取栓部，通过抽拔取栓装置带出凝血块，多次重复后以确定凝血块被清理干净，取栓导管中使用球囊作为取栓部是较为常见的一类设计。A variety of factors can lead to the formation of blood clots in the blood vessels, which in turn cause a series of symptoms and complications. The most common treatment for thrombus in the blood vessel is surgery, and most of the surgical treatment uses catheter thrombectomy. The thrombectomy catheter is provided with a thrombectomy part for pulling the thrombus through the clot site, and the thrombus is pulled out through the thrombectomy device. The bolt retrieval part is a relatively common type of design.
经检索，CN2003201210610公开了一种静脉取栓管，CN201320390510.5公开了一种血管内取栓装置，CN2014202557918公开了一种取栓球囊，CN201720528621.6公开了一种球囊取栓装置，CN201822036855.6公开了一种取栓装置，均采用在导管上设置球囊，球囊的形状为球形或椭圆形，球囊扩张后球囊外壁与血管壁贴合，球囊回撤时将血栓带出血管。After retrieval, CN2003201210610 discloses a venous thrombectomy tube, CN201320390510.5 discloses an intravascular thrombectomy device, CN2014202557918 discloses a thrombectomy balloon, CN201720528621.6 discloses a balloon thrombectomy device, CN201822036855 .6 discloses a thrombectomy device, all of which use a balloon on the catheter. The shape of the balloon is spherical or elliptical. After the balloon is expanded, the outer wall of the balloon is attached to the blood vessel wall. out blood vessels.
现有结构存在的不足之处为：一是球囊设置成椭圆形，在球囊回撤时，球囊与血管壁产生的摩擦较大，对患者血管壁产生的损伤大；球囊设置成球形，球囊与血管壁的接触面积小，部分碎血栓容易从球囊与血管壁的缝隙中流向血管远端，再次造成血管堵塞；二是球囊与血管壁贴合，球囊外壁是光滑的，当血管壁上血栓比较硬，粘性较强时，球囊回撤可能有部分粘在血管壁上的血栓无法被清理掉；当血栓较软，取栓的过程中，血栓容易分成小血栓或血栓碎片，小血栓或血栓碎片容易流向远端血管，造成二次栓塞，血管疏通效果不好；三是现有技术的球囊存在一次无法完全清除 血栓的情况，需要多次操作，使手术操作时间变长，增加了手术风险。The shortcomings of the existing structure are: first, the balloon is set in an oval shape, when the balloon is withdrawn, the friction between the balloon and the blood vessel wall is relatively large, and the damage to the blood vessel wall of the patient is large; Spherical, the contact area between the balloon and the blood vessel wall is small, and some broken thrombi easily flow from the gap between the balloon and the blood vessel wall to the distal end of the blood vessel, causing blood vessel blockage again; the second is that the balloon adheres to the blood vessel wall, and the outer wall of the balloon is smooth Yes, when the thrombus on the vessel wall is relatively hard and viscous, some thrombus adhering to the vessel wall may not be removed when the balloon is withdrawn; when the thrombus is soft, the thrombus is easily divided into small thrombi during thrombectomy. Or thrombus fragments, small thrombus or thrombus fragments easily flow to the distal blood vessels, causing secondary embolism, and the vascular dredging effect is not good; third, the existing balloons cannot completely remove the thrombus once, requiring multiple operations to make the operation difficult. The operation time becomes longer and the surgical risk is increased.
发明内容SUMMARY OF THE INVENTION
本发明的目的是解决上述现有技术的不足，提供一种结构新颖、血栓清除效果好、对血管壁损伤小的血管疏通清理装置。The purpose of the present invention is to solve the above-mentioned deficiencies of the prior art, and to provide a blood vessel dredging and cleaning device with novel structure, good thrombus removal effect, and little damage to the blood vessel wall.
本发明解决其技术问题所采用的技术方案是：The technical scheme adopted by the present invention to solve its technical problems is:
一种血管疏通清理装置，包括球囊导管、球囊、标记环，所述球囊导管的远端包裹有球囊，所述球囊的远端、近端分别与穿过球囊的球囊导管固定连接，所述球囊具有收缩状态和膨胀状态，所述球囊导管上在球囊的远端、近端设有标记环，所述球囊导管内设有使球囊膨胀的球囊膨胀通道及导丝通过的导丝导引通道，所述球囊导管的管壁上设置有连通孔，所述球囊膨胀通道经球囊导管管壁上的连通孔与球囊相连通，其特征在于：所述球囊在膨胀状态下整体形状为圆台体或圆锥体，所述球囊的远端为大径端，近端为小径端，所述球囊由远端端面、近端端面、锥形侧壁、单元取栓凸起组成，所述远端端面与锥形侧壁圆弧过渡连接，所述近端端面与锥形侧壁圆弧过渡连接，所述球囊的锥形侧壁上间隔分布设有单元取栓凸起，所述单元取栓凸起具有收缩状态和膨胀状态，所述单元取栓凸起设有凸起空腔，所述凸起空腔与球囊相连通，通过将球囊设置成圆台体或圆锥体，球囊的远端与血管壁贴合，既可以阻挡血栓流向血管远端又可以大大减少球囊对血管壁的摩擦，在球囊上设置取栓凸起，血管壁上粘性较强的血栓以及血管内的碎片血栓均可附着在取栓凸起上，取栓效果好。A blood vessel dredging and cleaning device, comprising a balloon catheter, a balloon and a marking ring, the distal end of the balloon catheter is wrapped with a balloon, and the distal end and the proximal end of the balloon are respectively connected to a balloon passing through the balloon. The catheter is fixedly connected, the balloon has a contracted state and an expanded state, the balloon catheter is provided with a marking ring at the distal end and the proximal end of the balloon, and the balloon catheter is provided with a balloon to inflate the balloon The expansion channel and the guide wire guide channel through which the guide wire passes, the tube wall of the balloon catheter is provided with a communication hole, and the balloon expansion channel is communicated with the balloon through the communication hole on the tube wall of the balloon catheter, which is It is characterized in that: the overall shape of the balloon in the inflated state is a truncated cone or a cone, the distal end of the balloon is a large-diameter end, and the proximal end is a small-diameter end, and the balloon is composed of a distal end face and a proximal end face. , a tapered side wall, and a unit bolt-taking protrusion, the distal end face is connected with the tapered side wall arc transitionally, the proximal end face is connected with the tapered side wall arc transition, and the tapered shape of the balloon The sidewalls are provided with unit bolt-removing protrusions at intervals, the unit bolt-removing protrusions have a contracted state and an expanded state, and the unit bolt-removing protrusions are provided with convex cavities, and the convex cavities are connected to the balloon. By setting the balloon into a truncated cone or a cone, the distal end of the balloon is attached to the blood vessel wall, which can not only block the flow of thrombus to the distal end of the blood vessel but also greatly reduce the friction of the balloon on the blood vessel wall. The thrombus removal protrusion is provided, and the thrombus with strong viscosity on the vessel wall and the fragmented thrombus in the blood vessel can be attached to the thrombus removal protrusion, and the thrombus removal effect is good.
本发明所述单元取栓凸起沿球囊圆周阵列设置形成单元取栓凸起环组，所述单元取栓凸起环组沿球囊轴向线性阵列设置，所述相邻单元取栓凸起环组的单元取栓凸起错开设置，通过将相邻单元血栓凸起环组的单元取栓凸起错开设置，在取栓的过程可以有效防止血栓到达球囊远端。The unit bolt-removing protrusions of the present invention are arranged in an array along the circumference of the balloon to form a unit bolt-removing protrusion ring group, and the unit bolt-removing protrusion ring groups are arranged in a linear array along the axial direction of the balloon, and the adjacent unit bolt-removing protrusions are arranged in a linear array. The unit thrombus removal protrusions of the ring-lifting group are staggered. By staggering the unit thrombus removal protrusions of the adjacent unit thrombus protrusion ring groups, the thrombus can be effectively prevented from reaching the distal end of the balloon during the thrombus removal process.
本发明所述单元取栓凸起环组设置在球囊的近端和中部，所述球囊上至少设有三个单元取栓凸起环组，所述单元取栓凸起环组至少设有六个单元取栓凸起，将单元取栓凸起环组设置在球囊的近端和中部，以使球囊导 管回撤时血栓附着在取栓凸起上，能够有效减少流向球囊远端的血栓，从而防止碎片血栓进入到血管远端，以确保能起到较好的取栓效果。The unit bolt-removing protrusion ring group of the present invention is arranged at the proximal end and the middle part of the balloon, the balloon is provided with at least three unit bolt-removing protrusion ring groups, and the unit bolt-removing protrusion ring group is provided with at least three Six unit thrombectomy protrusions, and the unit thrombectomy protrusion ring group is arranged at the proximal end and the middle of the balloon, so that the thrombus is attached to the thrombus removal protrusion when the balloon catheter is withdrawn, which can effectively reduce the flow to the balloon far away. The thrombus at the end of the vessel is prevented from entering the distal end of the vessel, thereby ensuring a better thrombectomy effect.
本发明所述单元取栓凸起在膨胀状态下形状为半球形，采用半球形的设计，在取栓的过程中，增大了血栓在取栓凸起上的附着面积，血管壁上粘性强的血栓也会被刮下来且不会损伤血管壁，同时也能有效防止球囊导管回撤时，取栓凸起在阻力的作用下产生形变，导致部分附着在取栓凸起上的血栓流向血管远端。The unit thrombectomy protrusion of the present invention has a hemispherical shape in an expanded state, and adopts a hemispherical design. During the thrombectomy process, the attachment area of the thrombus on the thrombectomy protrusion is increased, and the viscosity on the blood vessel wall is strong. The thrombus will also be scraped off without damaging the vessel wall, and it can also effectively prevent the thrombectomy protrusion from being deformed under the action of resistance when the balloon catheter is withdrawn, resulting in the flow of some thrombus attached to the thrombectomy protrusion. distal blood vessels.
本发明所述球囊导管上在球囊的近端设有血栓收集盘，所述血栓收集盘具有收缩和膨胀状态，所述血栓收集盘在膨胀状态下整体形状呈开口朝向球囊导管近端的伞状，所述血栓收集盘的外径小于球囊大径端的外径，所述血栓收集盘由线形的单元取栓纤毛组成，所述单元取栓纤毛以球囊导管轴心线为中心沿球囊导管圆周阵列设置，所述单元取栓纤毛的内端与球囊导管固定连接，外端为自由端，通过在球囊的近端设置血栓收集盘，以使球囊导管回撤时首先通过血栓收集盘能够收集部分血栓，血栓收集盘设置成开口朝向球囊导管近端的伞状，增大了与血栓的接触面积，血栓收集率高且回撤过程中血栓不容易脱落。The balloon catheter of the present invention is provided with a thrombus collecting disk at the proximal end of the balloon, the thrombus collecting disk has a contracted and expanded state, and the overall shape of the thrombus collecting disk in the expanded state has an opening toward the proximal end of the balloon catheter The outer diameter of the thrombus collection disc is smaller than the outer diameter of the large diameter end of the balloon, and the thrombus collection disc is composed of linear unit thrombectomy cilia, and the unit thrombectomy cilia are centered on the axis line of the balloon catheter Arranged along the circumference of the balloon catheter, the inner end of the unit thrombectomy cilia is fixedly connected with the balloon catheter, and the outer end is a free end. First, part of the thrombus can be collected through the thrombus collecting disc. The thrombus collecting disc is arranged in an umbrella shape with the opening facing the proximal end of the balloon catheter, which increases the contact area with the thrombus. The thrombus collection rate is high and the thrombus is not easy to fall off during the withdrawal process.
本发明所述单元取栓纤毛由上弹性纤毛、下弹性纤毛、弯折部组成，所述上弹性纤毛的内端与球囊导管固定连接，外端经弯折部与下弹性纤毛弯折连接，所述上弹性纤毛与球囊导管外壁之间的夹角为60-90度，所述下弹性纤毛与球囊导管外壁之间的夹角为0-45度，此角度的设计，进一步增大了取栓纤毛与血栓的接触面积，能够收集更多的血栓，同时在取栓过程中血栓不容易脱落流向球囊远端。The unit thrombus removal cilia of the present invention is composed of upper elastic cilia, lower elastic cilia, and a bending part, the inner end of the upper elastic cilia is fixedly connected with the balloon catheter, and the outer end is bent and connected with the lower elastic cilia through the bending part , the angle between the upper elastic cilia and the outer wall of the balloon catheter is 60-90 degrees, and the angle between the lower elastic cilia and the outer wall of the balloon catheter is 0-45 degrees. The design of this angle further increases the The contact area between the cilia and the thrombus is enlarged, and more thrombi can be collected, and the thrombus is not easy to fall off and flow to the distal end of the balloon during the thrombectomy.
本发明所述球囊导管上在球囊外套设有形状为网状的取栓支架，所述取栓支架的远端、近端分别与球囊导管固定连接，所述取栓支架具有收缩状态和膨胀状态，所述取栓支架在膨胀状态整体形状为与球囊相配合的圆台体或圆锥体，通过设置取栓支架以使球囊导管回撤时，部分血栓可以通过取栓支架收集，进一步的确保能取出较多的血栓。The balloon catheter of the present invention is provided with a mesh-shaped thrombus removal bracket on the balloon jacket, the distal end and the proximal end of the thrombus removal bracket are respectively fixedly connected with the balloon catheter, and the thrombus retrieval bracket has a retracted state and the expanded state, the overall shape of the thrombectomy stent in the expanded state is a truncated truncated body or a cone matched with the balloon, and when the thrombectomy stent is provided to make the balloon catheter withdraw, part of the thrombus can be collected by the thrombectomy stent, This further ensures that more thrombi can be removed.
本发明的有益效果为：通过将球囊设置成圆台体或圆锥体，球囊的远端与血管壁贴合，既可以阻挡血栓流向血管远端又可以大大减少球囊对血 管壁的摩擦，在球囊上设置取栓凸起，血管壁上粘性较强的血栓以及血管内的碎片血栓均可附着在取栓凸起上，取栓效果好；通过在球囊的近端设置血栓收集盘，以使球囊导管回撤时首先通过血栓收集盘能够收集部分血栓，血栓收集盘设置成开口朝向球囊导管近端的伞状，增大了与血栓的接触面积，血栓收集率高且回撤过程中血栓不容易脱落；通过设置取栓支架以使球囊导管回撤时，部分血栓可以通过取栓支架收集，进一步的确保能取出较多的血栓，保证了血栓的清除效果，节省手术时间并减少对患者的伤害。The beneficial effects of the present invention are as follows: by setting the balloon into a circular truncated body or a cone, the distal end of the balloon is attached to the blood vessel wall, which can not only block the thrombus from flowing to the distal end of the blood vessel, but also greatly reduce the friction of the balloon on the blood vessel wall. A thrombectomy protrusion is arranged on the balloon, and the thrombus with strong viscosity on the vessel wall and the fragmented thrombus in the blood vessel can be attached to the thrombus removal protrusion, and the thrombus removal effect is good; , so that when the balloon catheter is withdrawn, part of the thrombus can be collected first through the thrombus collecting disk. The thrombus collecting disk is set in an umbrella shape with the opening facing the proximal end of the balloon catheter, which increases the contact area with the thrombus. The thrombus collection rate is high and the return rate is high. The thrombus is not easy to fall off during the withdrawal process; when the balloon catheter is withdrawn by setting the thrombectomy stent, part of the thrombus can be collected by the thrombectomy stent, which further ensures that more thrombi can be removed, ensures the thrombus removal effect, and saves the operation. time and reduce harm to patients.
附图说明Description of drawings
图1是本发明球囊、取栓支架膨胀状态整体结构示意图。FIG. 1 is a schematic diagram of the overall structure of the balloon and thrombectomy stent of the present invention in an expanded state.
图2是本发明球囊、取栓支架膨胀状态结构侧视图。。Fig. 2 is a side view of the balloon and thrombectomy stent of the present invention in an expanded state. .
图3是本发明球囊、取栓支架收缩状态整体结构装配示意图。3 is a schematic diagram of the overall structure assembly of the balloon and the thrombectomy stent of the present invention in a retracted state.
附图标记：球囊导管-1、标记环-2、支架固定环-3、取栓支架-4、球囊-5、远端端面-501、近端端面-502、锥形侧壁-503、取栓纤毛-6、上弹性纤毛-601、下弹性纤毛-602、弯折部-603、取栓凸起-7。Reference numerals: balloon catheter-1, marking ring-2, stent fixing ring-3, thrombectomy stent-4, balloon-5, distal end face-501, proximal end face-502, tapered side wall-503 , Take the plug cilia-6, the upper elastic cilia-601, the lower elastic cilia-602, the bending part-603, and the plug protrusion-7.
具体实施方式detailed description
下面结合附图和实施例对本发明进行说明。The present invention will be described below with reference to the accompanying drawings and embodiments.
一种血管疏通清理装置，包括球囊导管1、球囊5、标记环2，所述球囊导管1的远端包裹有球囊5，所述球囊5的远端、近端分别与穿过球囊的球囊导管固定连接，所述球囊5具有收缩状态和膨胀状态，所述球囊导管1上在球囊的远端、近端设有标记环2，方便医生在X光下显影定位，标记环与球囊导管的连接方式为现有技术，在此不做赘述，所述球囊导管1内设有使球囊膨胀的球囊膨胀通道及导丝通过的导丝导引通道，所述球囊导管1的管壁上设置有连通孔，所述球囊膨胀通道经球囊导管管壁上的连通孔与球囊相连通，所述球囊5在膨胀状态下整体形状为圆台体或圆锥体，所述球囊的远端为大径端，近端为小径端，所述球囊5由远端端面501、近端端面502、锥形侧壁503、单元取栓凸起7组成，所述远端端面501 与锥形侧壁503圆弧过渡连接，所述近端端面502与锥形侧壁503圆弧过渡连接，所述球囊的锥形侧壁上间隔分布设有单元取栓凸起7，所述单元取栓凸起7具有收缩状态和膨胀状态，所述单元取栓凸起7设有凸起空腔，所述凸起空腔与球囊5相连通，通过将球囊设置成圆台体或圆锥体，球囊的远端与血管壁贴合，既可以阻挡血栓流向血管远端又可以大大减少球囊对血管壁的摩擦，在球囊上设置取栓凸起，血管壁上粘性较强的血栓以及血管内的碎片血栓均可附着在取栓凸起上，取栓效果好。此实施例中球囊设置成圆台体，也可将球囊设置成圆锥体。A blood vessel dredging and cleaning device, comprising a balloon catheter 1, a balloon 5, and a marking ring 2, the distal end of the balloon catheter 1 is wrapped with a balloon 5, and the distal end and the proximal end of the balloon 5 are respectively connected with the piercing ring. The balloon catheter through the balloon is fixedly connected, the balloon 5 has a contracted state and an expanded state, and the balloon catheter 1 is provided with a marking ring 2 at the distal end and the proximal end of the balloon, which is convenient for doctors under X-rays. Development and positioning, the connection method between the marking ring and the balloon catheter is in the prior art, which will not be repeated here. The balloon catheter 1 is provided with a balloon inflation channel for inflating the balloon and a guide wire guide through which the guide wire passes. A channel, a communication hole is provided on the wall of the balloon catheter 1, the balloon inflation channel is communicated with the balloon through the communication hole on the wall of the balloon catheter, and the overall shape of the balloon 5 is in the inflated state It is a circular truncated body or a cone, the distal end of the balloon is a large diameter end, and the proximal end is a small diameter end. The protrusions 7 are formed, the distal end surface 501 is connected with the conical side wall 503 in an arc transition, the proximal end surface 502 is connected with the conical side wall 503 in an arc transition, and the conical side walls of the balloon are spaced apart from each other. Distributed with a unit bolt-removing protrusion 7, the unit bolt-removing protrusion 7 has a contracted state and an expanded state, the unit bolt-removing protrusion 7 is provided with a convex cavity, and the convex cavity is connected to the balloon 5. By setting the balloon into a truncated cone or a cone, the distal end of the balloon is attached to the blood vessel wall, which can not only block the flow of thrombus to the distal end of the blood vessel but also greatly reduce the friction of the balloon on the blood vessel wall. The thrombus removal protrusion is provided, and the thrombus with strong viscosity on the vessel wall and the fragmented thrombus in the blood vessel can be attached to the thrombus removal protrusion, and the thrombus removal effect is good. In this embodiment, the balloon is configured as a circular frustum, but the balloon can also be configured as a cone.
所述单元取栓凸起7沿球囊5圆周阵列设置形成单元取栓凸起环组，所述单元取栓凸起环组沿球囊5轴向线形阵列设置，所述相邻单元取栓凸起环组的单元取栓凸起7错开设置，通过将相邻单元血栓凸起环组的单元取栓凸起错开设置，在取栓的过程可以有效防止血栓到达球囊远端。The unit bolt removal protrusions 7 are arranged in an array along the circumference of the balloon 5 to form a unit bolt removal protrusion ring group, and the unit bolt removal protrusion ring groups are arranged in a linear array along the axial direction of the balloon 5. The unit thrombus removal protrusions 7 of the raised ring group are staggered. By staggering the unit thrombus removal protrusions of the adjacent unit thrombus raised ring group, the thrombus can be effectively prevented from reaching the distal end of the balloon during thrombectomy.
所述单元取栓凸起环组设置在球囊5的近端和中部，所述球囊5上至少设有三个单元取栓凸起环组，所述单元取栓凸起环组至少设有六个单元取栓凸起7，将单元取栓凸起环组设置在球囊的近端和中部，以使球囊导管1回撤时血栓附着在取栓凸起上，能够有效减少流向球囊远端的血栓，从而防止碎片血栓进入到血管远端，以确保能起到较好的取栓效果。The unit bolt-removing raised ring group is arranged at the proximal end and the middle part of the balloon 5, the balloon 5 is provided with at least three unit bolt-removing raised ring groups, and the unit bolt-removing raised ring group is at least provided with The six unit thrombectomy protrusions 7 are arranged at the proximal end and the middle of the balloon, so that the thrombus is attached to the thrombus removal protrusion when the balloon catheter 1 is withdrawn, which can effectively reduce the flow to the ball. The thrombus at the distal end of the sac prevents the fragmented thrombus from entering the distal end of the vessel to ensure a better thrombectomy effect.
所述单元取栓凸起7在膨胀状态下形状为半球形，采用半球形的设计，在取栓的过程中，增大了血栓在取栓凸起上的附着面积，血管壁上粘性强的血栓也会被刮下来且不会损伤血管壁，同时也能有效防止球囊导管回撤时，取栓凸起在阻力的作用下产生形变，导致部分附着在取栓凸起上的血栓流向血管远端。The unit thrombectomy protrusion 7 is hemispherical in shape in the expanded state, and the hemispherical design is adopted. The thrombus will also be scraped off without damaging the blood vessel wall, and it can also effectively prevent the thrombectomy protrusion from deforming under the action of resistance when the balloon catheter is withdrawn, causing some of the thrombus attached to the thrombectomy protrusion to flow to the blood vessel. remote.
所述球囊导管上在球囊的近端设有血栓收集盘，所述血栓收集盘具有收缩和膨胀状态，所述血栓收集盘在膨胀状态下整体形状呈开口朝向球囊导管近端的伞状，所述血栓收集盘的外径小于球囊大径端的外径，所述血栓收集盘由线形的单元取栓纤毛6组成，所述单元取栓纤毛6以球囊导管轴心线为中心沿球囊导管1圆周阵列设置，所述单元取栓纤毛6的内端与球囊导管1固定连接，外端为自由端，通过在球囊的近端设置血栓收集盘，以使球囊导管回撤时首先通过血栓收集盘能够收集部分血栓，血栓收集盘 设置成开口朝向球囊导管近端的伞状，增大了与血栓的接触面积，血栓收集率高且回撤过程中血栓不容易脱落。The balloon catheter is provided with a thrombus collecting disk at the proximal end of the balloon, the thrombus collecting disk has a contracted and expanded state, and the overall shape of the thrombus collecting disk in the expanded state is an umbrella with an opening facing the proximal end of the balloon catheter. The outer diameter of the thrombus collecting disc is smaller than the outer diameter of the large diameter end of the balloon, and the thrombus collecting disc is composed of linear unit thrombectomy cilia 6, and the unit thrombectomy cilia 6 are centered on the axis line of the balloon catheter Arranged along the circumference of the balloon catheter 1, the inner end of the unit thrombectomy cilia 6 is fixedly connected with the balloon catheter 1, and the outer end is a free end. When withdrawing, part of the thrombus can be collected first through the thrombus collecting disk. The thrombus collecting disk is set in an umbrella shape with the opening facing the proximal end of the balloon catheter, which increases the contact area with the thrombus. The thrombus collection rate is high and the thrombus is not easy to withdraw during the withdrawal process. fall off.
所述单元取栓纤毛6由上弹性纤毛601、下弹性纤毛602、弯折部603组成，所述上弹性纤毛601的内端与球囊导管1固定连接，外端经弯折部603与下弹性纤毛602弯折连接，所述上弹性纤毛601与球囊导管1外壁之间的夹角为60-90度，所述下弹性纤毛602与球囊导管1外壁之间的夹角为0-45度，此角度的设计，进一步增大了取栓纤毛与血栓的接触面积，能够收集更多的血栓，同时在取栓过程中血栓不容易脱落流向球囊远端。此实施例中单元取栓纤毛6采用高弹性的高分子材料，以使单元取栓纤毛6具有收缩状态和膨胀状态。The unit thrombus removal cilia 6 is composed of an upper elastic cilia 601, a lower elastic cilia 602, and a bending portion 603. The inner end of the upper elastic cilia 601 is fixedly connected with the balloon catheter 1, and the outer end is connected to the lower elastic cilia through the bending portion 603. The elastic cilia 602 are connected by bending, the angle between the upper elastic cilia 601 and the outer wall of the balloon catheter 1 is 60-90 degrees, and the angle between the lower elastic cilia 602 and the outer wall of the balloon catheter 1 is 0-90 degrees. 45 degrees, the design of this angle further increases the contact area between the cilia and the thrombus for thrombectomy, which can collect more thrombi, and at the same time, the thrombus is not easy to fall off and flow to the distal end of the balloon during the thrombectomy process. In this embodiment, the unit thrombus-retrieving cilia 6 are made of high-elasticity polymer materials, so that the unit thrombus-retrieving cilia 6 have a contracted state and an expanded state.
所述球囊导管1上在球囊5外套设有形状为网状的取栓支架4，所述取栓支架4的远端、近端分别与球囊导管1固定连接，所述取栓支架4具有收缩状态和膨胀状态，所述取栓支架4在膨胀状态整体形状为与球囊相配合的圆台体或圆锥体，通过设置取栓支架以使球囊导管回撤时，部分血栓可以通过取栓支架收集，进一步的确保能取出较多的血栓。取栓支架的网状结构设计有多种方式，此实施例中采用的结构为取栓支架由单元左螺旋支架、单元右螺旋支架组成，单元左螺旋支架与单元右螺旋支架交叉设置形成单元网格，所述取栓支架在膨胀状态下单元网格的尺寸从球囊远端至球囊近端逐渐变小，所述单元取栓凸起设在单元网格内，通过此种设计以使球囊膨胀时，取栓支架随着膨胀，取栓支架与球囊外壁紧密配合，部分血栓通过取栓支架收集，有效防止血栓流向球囊远端，在球囊导管回撤时，左螺旋支架、右螺旋支架的螺旋形设计，使得取栓支架与血栓的接触面积变大，能够阻挡血栓流向球囊远端，实现更有效的收集血栓。The balloon catheter 1 is provided with a mesh-shaped thrombectomy bracket 4 on the outer cover of the balloon 5. The distal end and the proximal end of the thrombus retrieval bracket 4 are fixedly connected to the balloon catheter 1 respectively. 4 has a contracted state and an expanded state, and the overall shape of the thrombectomy stent 4 in the expanded state is a truncated truncated body or a cone that is matched with the balloon. When the thrombectomy stent is provided to make the balloon catheter withdraw, part of the thrombus can pass through. The thrombectomy stent is collected to further ensure that more thrombi can be removed. There are many ways to design the mesh structure of the thrombectomy stent. The structure adopted in this embodiment is that the bolus removal stent is composed of a unit left helical stent and a unit right helical stent, and the unit left helical stent and the unit right helical stent are crossed to form a unit network. In the expanded state, the size of the unit grid of the thrombectomy stent gradually decreases from the distal end of the balloon to the proximal end of the balloon, and the unit thrombectomy protrusions are arranged in the unit grid. When the balloon is inflated, the thrombectomy stent expands with it, and the thrombectomy stent closely fits with the outer wall of the balloon. Part of the thrombus is collected by the thrombectomy stent, which effectively prevents the thrombus from flowing to the distal end of the balloon. . The spiral design of the right helical stent increases the contact area between the thrombectomy stent and the thrombus, which can block the thrombus from flowing to the distal end of the balloon and achieve more effective thrombus collection.
此实施例中球囊导管上在球囊的远端、近端处分别固定连接有支架固定环3，取栓支架的两端固定在支架固定环上，支架固定环与球囊导管的连接方式为现有技术，在此不做赘述。此实施例中，取栓纤毛的内端也固定在支架固定环上。In this embodiment, a stent fixing ring 3 is fixedly connected to the distal end and the proximal end of the balloon on the balloon catheter, and the two ends of the thrombectomy stent are fixed on the stent fixing ring. The connection method between the stent fixing ring and the balloon catheter is It is the prior art and will not be repeated here. In this embodiment, the inner ends of the thrombus removal cilia are also fixed on the bracket fixing ring.
球囊可采用橡胶、硅胶、乳胶、尼龙等材质；取栓支架可采用不锈钢、镍钛合金、钴铬合金等材料制成；取栓纤毛可采用不锈钢、镍钛合金、钴铬合金等材料制成，纤毛的直径在0.01MM-0.03MM之间。The balloon can be made of rubber, silicone, latex, nylon and other materials; the bolt-removing bracket can be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc.; the bolt-removing cilia can be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc. The diameter of the cilia is between 0.01MM and 0.03MM.
此实施例中，球囊的初始状态如图3所示，球囊、取栓支架、取栓纤毛为收缩状态，球囊导管外套设有鞘管，球囊在收缩状态，整体形状为长条形，取栓支架在收缩状态，取栓支架上单元网格的尺寸相同。In this embodiment, the initial state of the balloon is shown in FIG. 3 , the balloon, the thrombectomy stent, and the thrombectomy cilia are in a contracted state, the balloon catheter jacket is provided with a sheath, the balloon is in a contracted state, and the overall shape is a long strip shape, the bolt removal bracket is in the retracted state, and the size of the cell grids on the bolt retrieval bracket is the same.
本发明使用时，首先球囊导管的导丝导引通道内穿有导丝，在导丝的引导下，鞘管带着球囊导管到达血栓的远端，标记环起到标记的作用，以使医生能够观察到球囊导管的位置，导丝及鞘管回撤，取栓纤毛在弹力的作用下膨胀打开，向球囊膨胀通道内注入液体或气体使球囊体积膨胀直至与血管壁贴合，取栓支架跟随球囊膨胀，球囊处于与血管壁贴合的充盈状态后，此时取栓凸起、取栓支架均处于膨胀状态，医生拉动球囊导管，使球囊导管回撤，取栓纤毛先与血栓的远端接触，收集一部分血栓，球囊导管继续回撤，部分血栓附着在取栓凸起和取栓支架上，球囊带着血栓朝向血管近端移动，最终将血栓取出。When the present invention is used, first, a guide wire is pierced through the guide wire guide channel of the balloon catheter. Under the guidance of the guide wire, the sheath tube takes the balloon catheter to the distal end of the thrombus. It enables the doctor to observe the position of the balloon catheter, the retraction of the guide wire and the sheath tube, the cilia of the thrombectomy are expanded and opened under the action of elasticity, and the liquid or gas is injected into the balloon expansion channel to expand the volume of the balloon until it adheres to the blood vessel wall. After the thrombectomy stent is inflated with the balloon, the balloon is in a filling state that fits with the vessel wall. At this time, both the thrombectomy protrusion and the thrombectomy stent are in an expanded state. The doctor pulls the balloon catheter to retract the balloon catheter. , the thrombectomy cilia first contact the distal end of the thrombus, collect a part of the thrombus, the balloon catheter continues to withdraw, and part of the thrombus is attached to the thrombectomy protrusion and the thrombectomy stent, and the balloon moves the thrombus toward the proximal end of the blood vessel, and finally removes the thrombus. Thrombus removal.
本发明的有益效果为：通过将球囊设置成圆台体或圆锥体，球囊的远端与血管壁贴合，既可以阻挡血栓流向血管远端又可以大大减少球囊对血管壁的摩擦，在球囊上设置取栓凸起，血管壁上粘性较强的血栓以及血管内的碎片血栓均可附着在取栓凸起上，取栓效果好；通过在球囊的近端设置血栓收集盘，以使球囊导管回撤时首先通过血栓收集盘能够收集部分血栓，血栓收集盘设置成开口朝向球囊导管近端的伞状，增大了与血栓的接触面积，血栓收集率高且回撤过程中血栓不容易脱落；通过设置取栓支架以使球囊导管回撤时，部分血栓可以通过取栓支架收集，进一步的确保能取出较多的血栓，保证了血栓的清除效果，节省手术时间并减少对患者的伤害。The beneficial effects of the present invention are as follows: by setting the balloon into a circular truncated body or a cone, the distal end of the balloon is attached to the blood vessel wall, which can not only block the thrombus from flowing to the distal end of the blood vessel, but also greatly reduce the friction of the balloon on the blood vessel wall. A thrombectomy protrusion is arranged on the balloon, and the thrombus with strong viscosity on the vessel wall and the fragmented thrombus in the blood vessel can be attached to the thrombus removal protrusion, and the thrombus removal effect is good; , so that when the balloon catheter is withdrawn, part of the thrombus can be collected first through the thrombus collecting disk. The thrombus collecting disk is set in an umbrella shape with the opening facing the proximal end of the balloon catheter, which increases the contact area with the thrombus. The thrombus collection rate is high and the return rate is high. The thrombus is not easy to fall off during the withdrawal process; when the balloon catheter is withdrawn by setting the thrombectomy stent, part of the thrombus can be collected by the thrombectomy stent, which further ensures that more thrombi can be removed, ensures the thrombus removal effect, and saves the operation. time and reduce harm to patients.

Claims (7)

  1. 一种血管疏通清理装置，包括球囊导管、球囊、标记环，所述球囊导管的远端包裹有球囊，所述球囊的远端、近端分别与穿过球囊的球囊导管固定连接，所述球囊导管上在球囊的远端、近端设有标记环，所述球囊导管内设有球囊膨胀通道及导丝导引通道，所述球囊导管的管壁上设有连通孔，所述球囊膨胀通道经球囊导管管壁上的连通孔与球囊相连通，其特征在于：所述球囊在膨胀状态下整体形状为圆台体或圆锥体，所述球囊的远端为大径端，近端为小径端，所述球囊由远端端面、近端端面、锥形侧壁、单元取栓凸起组成，所述远端端面与锥形侧壁圆弧过渡连接，所述近端端面与锥形侧壁圆弧过渡连接，所述球囊的锥形侧壁上间隔分布设有单元取栓凸起，所述单元取栓凸起设有凸起空腔，所述凸起空腔与球囊相连通。A blood vessel dredging and cleaning device, comprising a balloon catheter, a balloon and a marking ring, the distal end of the balloon catheter is wrapped with a balloon, and the distal end and the proximal end of the balloon are respectively connected to a balloon passing through the balloon. The catheter is fixedly connected, the balloon catheter is provided with a marker ring at the distal end and the proximal end of the balloon, the balloon catheter is provided with a balloon inflation channel and a guide wire guiding channel, and the tube of the balloon catheter is There is a communication hole on the wall, and the balloon inflation channel is communicated with the balloon through the communication hole on the wall of the balloon catheter, and it is characterized in that: the overall shape of the balloon in the expanded state is a truncated cone or a cone, The distal end of the balloon is a large-diameter end, and the proximal end is a small-diameter end. The balloon is composed of a distal end face, a proximal end face, a tapered side wall, and a unit bolt removal protrusion. Shaped sidewall arc transition connection, the proximal end face and the conical side wall arc transition connection, the conical side wall of the balloon is spaced with unit bolt removal protrusions, the unit bolt removal protrusions A protruding cavity is provided, and the protruding cavity is communicated with the balloon.
  2. 根据权利要求1所述的一种血管疏通清理装置，其特征在于：所述单元取栓凸起沿球囊圆周阵列设置形成单元取栓凸起环组，所述单元取栓凸起环组沿球囊轴向线性阵列设置，所述相邻单元取栓凸起环组的单元取栓凸起错开设置。The blood vessel dredging and cleaning device according to claim 1, wherein the unit thrombus removal protrusions are arranged in an array along the circumference of the balloon to form a unit thrombus removal protrusion ring group, and the unit thrombus removal protrusion ring group is arranged along the circumference of the balloon. The balloons are arranged in an axial linear array, and the unit bolt removal protrusions of the adjacent unit bolt removal protrusion ring groups are staggered.
  3. 根据权利要求2所述的一种血管疏通清理装置，其特征在于：所述单元取栓凸起环组设置在球囊的近端和中部，所述球囊上至少设有三个单元取栓凸起环组，所述单元取栓凸起环组至少设有六个单元取栓凸起。The blood vessel dredging and cleaning device according to claim 2, wherein the unit thrombectomy protrusion ring group is arranged at the proximal end and the middle part of the balloon, and the balloon is provided with at least three unit thrombus removal protrusions The ring group is provided with at least six unit bolt-removing protrusions.
  4. 根据权利要求1或2或3所述的一种血管疏通清理装置，其特征在于：所述单元取栓凸起在膨胀状态下形状为半球形。The blood vessel dredging and cleaning device according to claim 1, 2 or 3, wherein the unit thrombectomy protrusion is hemispherical in shape in an expanded state.
  5. 根据权利要求1或2或3所述的一种血管疏通清理装置，其特征在于：所述球囊导管上在球囊近端设有血栓收集盘，所述血栓收集盘在膨胀状态下整体形状呈开口朝向球囊导管近端的伞状，所述血栓收集盘的外径小于球囊大径端的外径，所述血栓收集盘由线形的单元取栓纤毛组成，所述单元取栓纤毛以球囊导管轴心线为中心沿球囊导管圆周阵列设置，所述单元取栓纤毛的内端与球囊导管固定连接，外端为自由端。A blood vessel dredging and cleaning device according to claim 1, 2 or 3, characterized in that: a thrombus collecting disk is provided on the balloon catheter at the proximal end of the balloon, and the thrombus collecting disk has an overall shape in an expanded state. It is in the shape of an umbrella with an opening facing the proximal end of the balloon catheter, the outer diameter of the thrombus collecting disk is smaller than the outer diameter of the large diameter end of the balloon, and the thrombus collecting disk is composed of linear unit thrombus removal cilia, and the unit thrombus removal cilia are The axis line of the balloon catheter is arranged in an array along the circumference of the balloon catheter, the inner end of the unit thrombectomy cilia is fixedly connected with the balloon catheter, and the outer end is a free end.
  6. 根据权利要求5所述的一种血管疏通清理装置，其特征在于：所述单元取栓纤毛由上弹性纤毛、下弹性纤毛、弯折部组成，所述上弹性纤毛 的内端与球囊导管固定连接，外端经弯折部与下弹性纤毛弯折连接，所述上弹性纤毛与球囊导管外壁之间的夹角为60-90度，所述下弹性纤毛与球囊导管外壁之间的夹角为0-45度。The blood vessel dredging and cleaning device according to claim 5, wherein the unit thrombectomy cilia is composed of an upper elastic cilia, a lower elastic cilia and a bending part, and the inner end of the upper elastic cilia is connected to the balloon catheter. Fixed connection, the outer end is bent and connected with the lower elastic cilia through the bending part, the angle between the upper elastic cilia and the outer wall of the balloon catheter is 60-90 degrees, and the angle between the lower elastic cilia and the outer wall of the balloon catheter is 60-90 degrees. The included angle is 0-45 degrees.
  7. 根据权利要求1或2或3或6所述的一种血管疏通清理装置，其特征在于：所述球囊导管上在球囊外套设有形状为网状的取栓支架，所述取栓支架的远端、近端分别与球囊导管固定连接，所述取栓支架在膨胀状态整体形状为与球囊相配合的圆台体或圆锥体。A blood vessel dredging and cleaning device according to claim 1 or 2 or 3 or 6, wherein the balloon catheter is provided with a mesh-shaped thrombectomy stent on the balloon outer sleeve, and the thrombectomy stent is The distal end and the proximal end of the thrombus are respectively fixedly connected with the balloon catheter, and the overall shape of the thrombectomy stent in the expanded state is a truncated cone or a cone matched with the balloon.
PCT/CN2021/104193 2020-07-29 2021-07-02 Blood vessel dredging and cleaning device WO2022022223A1 (en)

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