WO2023087455A1 - Dispositif de recanalisation vasculaire - Google Patents

Dispositif de recanalisation vasculaire Download PDF

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Publication number
WO2023087455A1
WO2023087455A1 PCT/CN2021/138193 CN2021138193W WO2023087455A1 WO 2023087455 A1 WO2023087455 A1 WO 2023087455A1 CN 2021138193 W CN2021138193 W CN 2021138193W WO 2023087455 A1 WO2023087455 A1 WO 2023087455A1
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WO
WIPO (PCT)
Prior art keywords
balloon
shaped
thrombus
basket
cutting
Prior art date
Application number
PCT/CN2021/138193
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English (en)
Chinese (zh)
Inventor
刘载淳
黄定国
Original Assignee
上海腾复医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202122815143.6U external-priority patent/CN216439267U/zh
Priority claimed from CN202111360565.7A external-priority patent/CN113951976A/zh
Application filed by 上海腾复医疗科技有限公司 filed Critical 上海腾复医疗科技有限公司
Publication of WO2023087455A1 publication Critical patent/WO2023087455A1/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
    • 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
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions

Definitions

  • the present application relates to the technical field of medical devices, in particular to a blood vessel opening device.
  • vascular disease has become the number one fatal disease in my country, and vascular embolism has become the main pathogenic factor in vascular disease.
  • ischemic stroke pulmonary embolism
  • pulmonary embolism and lower extremity venous embolism have a total of more than 5 million new cases each year.
  • thrombectomy device for interventional thrombectomy has many advantages such as less trauma, short postoperative recovery time, fewer complications after treatment, and good surgical effect, and is more acceptable to patients.
  • the existing balloon can only expand the stenosis, and there is a risk of plaque detachment.
  • the doctor needs to use the distal umbrella to prevent the risk of plaque detachment and blockage. The operation is more cumbersome; The effect of direct suction, rheological suction or mechanical thrombectomy also needs to be improved.
  • the purpose of some embodiments of the present application is to provide a blood vessel opening device to solve the problems of cumbersome operation and poor thrombus removal effect of existing blood vessel opening devices.
  • the embodiment of the present application provides a blood vessel opening device, comprising: a balloon catheter and a thrombectomy stent; the balloon catheter has an expandable and contractible capsule; part; the thrombus cutting part is connected with the balloon catheter, the thrombus cutting part is arranged around the outer wall of the balloon body, and can expand and contract with the balloon body; the thrombus removal basket is expandable and In the contracted stent structure, the thrombectomy basket is located at the distal end of the balloon and fixed on the balloon catheter.
  • the balloon catheter also includes a tube fixedly connected to the tubular lumen of the balloon, and both ends of the tube protrude from the balloon;
  • the thrombus cutting part includes a plurality of The cutting rods on the outer wall of the balloon are arranged at intervals in the circumferential direction of the balloon, and the proximal end and the distal end of the cutting rods are both fixedly connected to the tubular body.
  • the cutting rod is an S-wave rod, and the S-wave rod extends in an S-wave along the axial direction of the capsule; the S-wave rod includes a plurality of arc-shaped rod segments, and different arc-shaped rod segments clamp The balloon body makes the S-shaped rod lean against the outer wall of the balloon.
  • the crests and crests, troughs and troughs of the plurality of S-shaped rods are arranged close to each other along the circumferential direction of the capsule, and adjacent S-shaped rods do not interfere with each other when expanding and expanding with the balloon.
  • the bolt-retrieving basket includes a basket cutting portion and a collecting portion that are smoothly connected sequentially from the proximal end to the distal end;
  • the basket cutting part includes a plurality of first V-shaped bars and a plurality of second V-shaped bars; the opening of the first V-shaped bars is larger than the opening of the second V-shaped bars, and the first V-shaped bars
  • the size of the first V-shaped rod is larger than the size of the second V-shaped rod; the plurality of first V-shaped rods are connected circumferentially and axially to form a circumferential closed-loop cylindrical structure; the openings of the second V-shaped rods are all towards the near end, and the open end of the second V-shaped bar is butted with the open end of the first V-shaped bar whose opening faces the distal end to form a grid.
  • the collection part includes a plurality of bending links; the distal ends of the plurality of bending links are convergingly connected to the distal end of the tubular body; the proximal ends of the plurality of bending links are respectively connected in parallel
  • a plurality of distal connection nodes to the basket cutting portion, the plurality of distal connection nodes are respectively the crest of the second V-shaped bar and the connection between the second V-shaped bar and the opening towards the distal end.
  • a connecting node between the first V-shaped bars are respectively the crest of the second V-shaped bar and the connection between the second V-shaped bar and the opening towards the distal end.
  • the basket cutting part also includes a plurality of fixed connecting rods; the proximal end of the basket cutting part is the first V-shaped bar with the opening facing the proximal end, and the distal ends of the fixed connecting rods are connected to the fixed connecting rods respectively.
  • the distal end of the first V-shaped rod at the proximal end of the basket cutting part is connected, and the proximal ends of a plurality of the fixed connecting rods surround and are fixed on the tube body; the plurality of fixed connecting rods form the Opening in the cutout of the basket.
  • the capsule is cylindrical, and its two ends are frustum-shaped when inflated, and the two ends of the cutting rod respectively include connecting sections;
  • the connecting section includes an extension section whose length matches the frustum-shaped capsule.
  • the shape of the junction of the capsule parts matches.
  • the thrombectomy bracket also includes a ball head guide wire arranged at the distal end of the thrombectomy basket and extending in the axial direction; the ball head guide wire includes: a ball head and a ball head and the The elastic telescopic structure between the distal ends of the thrombectomy bracket.
  • the elastic stretch structure is a spring structure made of memory metal or stainless steel.
  • the thrombus cutting part arranged around the outer wall of the balloon catheter can expand and contract synchronously with the balloon, so the expansion effect of the balloon can be used to better cut the thrombus.
  • the thrombus retrieval basket is set at the distal end of the capsule, which can not only collect the dislodged thrombus to prevent it from blocking the distal blood vessel, but also can cut and collect thrombus through the thrombus retrieval basket again when the vascular opening device is withdrawn by dragging the balloon catheter , to achieve the effect of secondary thrombus removal.
  • the blood vessel opening device of the embodiment of the present application is simple in structure and easy to operate, and can improve the removal effect of acute, subacute, and chronic thrombus and plaque.
  • FIG. 1 is a schematic structural view of the expanded state of the blood vessel opening device provided in Embodiment 1 of the present application;
  • FIG. 2 is a schematic structural view of the balloon of the vessel opening device provided in Embodiment 1 of the present application in a contracted state;
  • FIG. 3 is a schematic structural view of the thrombectomy stent of the vessel opening device provided in Embodiment 1 of the present application;
  • FIG. 4 is a schematic structural view of the thrombectomy stent of the vessel opening device provided in Embodiment 2 of the present application.
  • proximal end and the distal end mentioned in this application have the same meaning in terms of orientation, that is, in the state of use, the distal end is the end away from the operator, the proximal end is the end close to the operator, and the operator is at the proximal end. Controls the vascular access device.
  • a blood vessel opening device provided by an embodiment of the present application can cooperate with a delivery system to realize rapid removal of intravascular blocking materials such as plaque and thrombus.
  • the vessel opening device of the embodiment of the present application mainly includes: a balloon catheter 1 and a thrombectomy stent 2.
  • the balloon catheter 1 has an expandable and contractible balloon body 10 and a tubular body 11 fixedly connected to the tubular lumen of the balloon body 10. Both ends of the tubular body 11 protrude from the balloon body 10, which can facilitate the fixing of the thrombectomy support 2 On the tube body 11 , it is convenient to integrally fix the thrombectomy bracket 2 on the balloon catheter 1 .
  • the balloon catheter 1 is also provided with a fluid channel (not shown in the figure) for injecting fluid into the balloon body 10 or withdrawing fluid from the balloon body 10, so as to expand or deflate the balloon body.
  • the fluid channel of the balloon catheter 1 can be set in a manner known to those skilled in the art, which will not be repeated here.
  • the balloon body 10 (i.e., the balloon) of the balloon catheter 1 can provide a strong radial expansion force when inflated.
  • the thrombus cutting part 21 of the thrombus retrieval stent 2 cooperates with the balloon body 10 to make the balloon body 10
  • the radial expansion force during expansion concentrates on the thrombus cutting part 21 , which has a greater effect of cutting thrombus or plaque, and it is easier to cut and separate thrombus or plaque.
  • the inflation degree of the balloon can also be controlled according to the actual vessel size, so as to more flexibly meet the thrombus cutting requirements of vessels of different sizes.
  • the balloon catheter 1 can use a semi-compliant or non-compliant balloon to ensure the balloon's expansion performance and safety in use.
  • the expansion pressure of the balloon is concentrated on the thrombus cutting part (21).
  • the balloon body 10 of the balloon catheter 1 may be in the shape of a cylinder, and the two ends of the balloon body 10 may be in the shape of a truncated cone when inflated.
  • the barrel diameter between the two ends of the cylindrical capsule 10 may be the same.
  • the diameter of the cylindrical balloon 10 can also gradually increase from the distal end to the proximal end, so as to adapt to changes in the size of blood vessels.
  • the thrombectomy support 2 includes: a thrombus retrieval basket and a thrombus cutting part 21 , both of which are connected to the balloon catheter 1 . Both the thrombus removal basket and the thrombus cutting part 21 can be fixedly connected to the tube body 11 of the balloon catheter 1 , and the thrombectomy support 2 can move synchronously with the balloon catheter 1 when the balloon catheter 1 is dragged.
  • the thrombus cutting part 21 is connected with the balloon catheter 1, and the thrombus cutting part 21 is arranged around the outer wall of the balloon body 10, and can expand and contract with the balloon body 10, so that the expansion of the balloon body 10 can act on the thrombus cutting part 21 and move along the diameter of the thrombus cutting part 21. Cut the thrombus in the opposite direction, so that the balloon catheter 1 not only has the effect of dilating the stenosis, but also can cut the thrombus.
  • the thrombectomy basket is an expandable and contractible stent structure, and the thrombectomy basket is located at the distal end of the capsule body 10 and fixed on the balloon catheter 1 .
  • the thrombus retrieval basket can collect the shed plaque or thrombus, and can move with the balloon catheter 1 when dragging the balloon catheter 1 to realize secondary cutting and collect the thrombus, so that Improve thrombus removal effect.
  • the thrombus cutting part 21 may include a plurality of cutting rods 212 arranged on the outer sidewall of the balloon body 10 at intervals along the circumference of the balloon body 10 .
  • a plurality of cutting rods 212 can be evenly spaced apart along the circumference of the balloon body 10, and each cutting rod 212 can extend along the length of the balloon body 10, so that the thrombus cutting part 21 can be cut from multiple positions in the peripheral direction of the balloon body 10, And cut thrombus in the whole length direction of capsule body 10.
  • the cutting rod 212 can adopt a rod-shaped structure with a non-linear transition. After the balloon is deflated, it can be close to the outside of the balloon. During the expansion process of the balloon, it can be deployed by matching the diameter of the balloon through its own stretching and deformation ability, so as to achieve cutting Effects of blood clots or plaques.
  • the cutting rod 212 may be an S-wave rod, which extends in an S-wave along the axial direction of the capsule 10, and the S-wave rod includes a plurality of arc-shaped rod segments, and different arc-shaped rod segments clamp the capsule 10 to Make the S-shaped rod lean against the outer wall of the capsule 10, as shown in FIG. 2 .
  • the S-shaped rod is arranged in such a way that it can lean against or be close to the capsule body, so that it can expand and contract better with the capsule body, so that the expansion force of the capsule body 10 can better act on the thrombus cutting part 21. It is beneficial to better cut thrombus.
  • the S-shaped rod has two arc-shaped rod segments 2121, and each arc-shaped rod segment can be processed into a three-dimensional shape that can fit the surrounding wall of the capsule body 10 and extend in an S shape.
  • the two arc-shaped rod segments 2121 The balloon body 10 is clamped from different sides of the balloon body 10 respectively, so that the cutting part 21 can always be held on the balloon body 10 when the balloon body 10 expands and contracts.
  • the curved rod section 2121 of the S-wave rod has the largest bending range.
  • the arc-shaped rod segment 2121 of the S-wave rod is gradually stretched by the axial pulling force generated by the expansion of the capsule body 10.
  • the arc-shaped rod segment 2121 of the S-wave rod It is close to the outer wall of the balloon body 10 and slides radially and axially, and the bending range reaches a minimum when the balloon body 10 is inflated, as shown in FIG. 1 .
  • the S-wave rod may also include more arc-shaped rod segments, which is not limited here.
  • the crests, crests, troughs and troughs of the plurality of S-shaped rods are arranged close to each other along the circumferential direction of the capsule 10 , and adjacent S-shaped rods do not interfere with each other when the balloon 10 expands and expands. Therefore, it is convenient to arrange more cutting rods on the capsule body 10 to better cut thrombus.
  • Both the proximal end and the distal end of the cutting rod 212 are fixedly connected with the tube body 11 to fix the thrombus cutting part 21 on the balloon catheter 1 .
  • the cutting rod 212 can be welded to the tube body 11 through the welding part 211 at its proximal end and the welding part 213 at its distal end, or bonded to the tube body 11 by glue, so that the thrombus cutting part 21 and the balloon catheter 1 are firm combine together.
  • Both ends of the cutting rod 212 respectively include connecting sections.
  • the connection section includes an extension section 2122 whose length matches the frustum-shaped capsule body, a fixed section 2123 fixed on the outer wall of the cylindrical capsule body, and a bending portion connecting the extension section 2122 and the fixing section 2123.
  • the shape of the bending section is It matches the shape of the junction of the truncated cone-shaped capsule body and the cylindrical capsule body.
  • the cutting rod 212 is fixed on the balloon body 10 through the fixing section 2123 , which helps the cutting rod 212 to maintain its position on the outer wall of the balloon body 10 during expansion and contraction.
  • the fixing section 2123 may not be fixedly connected with the capsule body 10 , but only needs to be attached to the surface of the capsule body 10 .
  • the thrombus cutting part may also include a plurality of cutting rods fixed on the outer wall of the capsule at intervals along the circumference of the capsule, the cutting rods may be linear, and the cutting rods may be fixed on On the outer wall of the capsule, it can also expand and contract synchronously with the capsule.
  • the bolt-retrieving basket includes a basket cutting portion 22 and a collecting portion 23 that are smoothly connected successively from the proximal end to the distal end.
  • the surrounding wall of the basket cutting part 22 has a grid structure, and the proximal end of the basket cutting part 22 has an opening.
  • the outer diameter of the basket cutting part 22 is larger than the outer diameter of the shrunk thrombus cutting part 21, and can be close to the inner wall of the blood vessel by its own supporting force.
  • the collecting part 23 can be a dense mesh structure, which can facilitate the filtration and collection of fine thrombi and prevent the thrombus from escaping.
  • the basket cutting part 22 may include a plurality of first V-shaped bars 221 and a plurality of second V-shaped bars 222 .
  • the opening of the first V-shaped bar 221 is larger than the opening of the second V-shaped bar 222
  • the size of the first V-shaped bar 221 is larger than that of the second V-shaped bar 222 .
  • a plurality of first V-shaped rods 221 are connected circumferentially and axially to form a circumferential closed-loop cylindrical structure.
  • the openings of the second V-shaped rods 222 are all facing the proximal end, and the opening ends of the second V-shaped rods 222 are abutted with the opening ends of the first V-shaped rods 221 whose openings are facing the distal end to form a grid.
  • the arrangement of the second V-shaped bar 222 effectively increases the mesh density of the cutting portion of the basket and the strength of the basket.
  • the basket cutting part 22 may further include a plurality of fixed links 223 .
  • the proximal end of the basket cutting portion 22 is a first V-shaped bar 221 with an opening towards the proximal end, and the distal ends of the fixed connecting rods 223 are respectively connected to the distal ends of the first V-shaped bar 221 at the proximal end of the basket cutting portion 22.
  • a proximal end of a fixed link 223 surrounds and is fixed on the tube body 11 .
  • the number of the fixed links 223 may be the same as the number of the cutting rods 212 , and the proximal ends of the fixed links 223 are respectively connected to the distal ends of the cutting rods 212 .
  • the thrombus retrieval basket and the thrombus cutting part 21 can be made of nickel-iron pipe material through an integrated laser cutting process, so that the welding part 211 at the proximal end of the capsule body 10 and the welding part 213 at the distal end of the capsule body 10 can pass through.
  • the thrombus retrieval basket and the thrombus cutting part 21 are fixed on the balloon catheter 1 to ensure the transmission of finishing force during the pushing and withdrawing process of the vascular opening device.
  • the thrombus retrieval basket and the thrombus cutting part can also be made separately, and fixed on the tube body 11 respectively.
  • the opening of the basket cutting part 22 is formed between a plurality of fixed connecting rods 223, thrombus can enter and be collected in the thrombus retrieval net basket through its opening.
  • the collecting part 23 may include a plurality of bending links 231 , and the distal ends of the plurality of bending links 231 are convergingly connected to the distal end of the tube body 11 .
  • the proximal ends of the plurality of bent connecting rods 231 are respectively connected in parallel to the plurality of distal connection nodes of the basket cutting portion 22, and the plurality of distal connection nodes are respectively the peaks of the second V-shaped bar and the second V-shaped bar.
  • the connection node with the first V-shaped rod whose opening faces the distal end enables the collecting part 23 to form a dense grid structure, thereby effectively filtering and intercepting thrombus.
  • the distal end of the tube body 11 of the balloon catheter 1 can also be a tip structure with a tapered transition, so that not only can the volume of the distal end of the thrombectomy basket be reduced, but also the thrombus storage space of the collecting part 23 can be increased.
  • the thrombectomy bracket 2 also includes a ball guide wire 24 arranged at the distal end of the thrombectomy basket and extending axially.
  • the ball head guide wire 24 may include: a ball head 241 and an elastic telescopic structure 242 arranged between the ball head 241 and the distal end of the bolt retrieval basket.
  • the elastic stretch structure can be a spring structure made of memory metal or stainless steel.
  • the ball head 241 can be spherical or ellipsoidal.
  • the circular or elliptical ball head 241 can play a guiding role, and the elastic stretch structure 242 of the ball head guide wire 24 can limit the amount of propulsion force acting on the inner wall of the blood vessel during the advancing process. This can protect the blood vessel wall and prevent damage to the intima of the blood vessel.
  • the structure of the thrombectomy bracket of this embodiment is basically the same as that of the first embodiment, both including a thrombus retrieval basket and a thrombus cutting part 21, the difference is that the thrombectomy device of this embodiment does not include Ball tip guide wire.
  • the delivery system of the vascular opening device can adopt other methods to establish a thrombectomy channel, such as establishing a thrombectomy channel through a guide wire that can pass through the balloon catheter and the thrombectomy stent and pass through the distal end thereof.
  • the vascular opening device In the thrombectomy treatment, the vascular opening device reaches the designated lesion along the catheter, and the catheter is withdrawn to release the thrombectomy stent 2, so that the thrombectomy basket is close to the inner wall of the blood vessel, and then continues to withdraw until the balloon 10 in the balloon catheter 1 All are exposed, as shown in FIG. 1 , at this time, the thrombus cutting portion 21 of the thrombus retrieval bracket 2 is in close contact with the outer wall of the balloon.
  • the balloon body 10 is filled and expanded, and the multiple S-shaped cutting rods 212 of the thrombus cutting part 21 expand together with the balloon to cut the thrombus or plaque on the vessel wall, and the shed emboli or plaque enters the thrombus retrieval stent 2.
  • the balloon is retracted to the initial state, the catheter is stabilized, the vascular access device is retracted as a whole, and the thrombus or plaque passing by is further excised by the cutting part of the basket in the thrombectomy stent, and the excised thrombus or plaque enters and is removed Collected in the thrombectomy basket, the vascular opening device continues to withdraw completely into the catheter until it is completely pulled out of the body to achieve the removal of blood vessels or plaques.
  • the embodiments of the present application at least have the following advantages and positive effects:
  • the expansion of the balloon can drive the thrombus cutting part to perform the first thrombus removal and collection, and then drag the balloon catheter to perform the second thrombus removal and collection through the thrombus retrieval basket.
  • the operation is very simple, and the second thrombectomy operation can be completed, and better removal effect can be achieved for different thrombus types or plaques.

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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

La présente invention concerne un dispositif de recanalisation vasculaire comprenant un cathéter à ballonnet (1) et une endoprothèse de retrait de thrombus (2), le cathéter à ballonnet (1) est pourvu d'un ballonnet extensible et rétractable (10) ; et l'endoprothèse de retrait de thrombus (2) comprend un panier de retrait de thrombus et une partie de coupe de thrombus (21) ; la partie de coupe de thrombus (21) est reliée au cathéter à ballonnet (1), et la partie de coupe de thrombus (21) est agencée autour d'une paroi latérale externe du ballonnet (10) et peut se dilater et se contracter avec le ballonnet (10) ; et le panier de retrait de thrombus présente une structure d'endoprothèse extensible et rétractable, et est situé au niveau d'une extrémité distale du ballonnet (10) et agencé fixement sur le cathéter à ballonnet (1). Dans le dispositif, le ballonnet (10) et la partie de coupe de thrombus (21) sont intégrés, de façon à ce qu'un thrombus puisse être mieux coupé sous l'action de la dilatation du ballonnet, et le panier de retrait de thrombus peut recueillir le thrombus détaché et effectuer une coupe secondaire pour retirer le thrombus. Le dispositif présente non seulement une structure simple, mais il est également pratique à utiliser et peut améliorer un effet de retrait du thrombus.
PCT/CN2021/138193 2021-11-17 2021-12-15 Dispositif de recanalisation vasculaire WO2023087455A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202111360565.7 2021-11-17
CN202122815143.6U CN216439267U (zh) 2021-11-17 2021-11-17 血管开通装置
CN202111360565.7A CN113951976A (zh) 2021-11-17 2021-11-17 血管开通装置
CN202122815143.6 2021-11-17

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WO2023087455A1 true WO2023087455A1 (fr) 2023-05-25

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117244158A (zh) * 2023-11-07 2023-12-19 恒壹（北京）医疗科技有限公司 一种机械取栓导管及取栓装置
CN117618753A (zh) * 2024-01-25 2024-03-01 浙江巴泰医疗科技有限公司 球囊导管及其制造方法

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