WO2023087456A1 - 推送器及包含其的血栓抽吸系统 - Google Patents

推送器及包含其的血栓抽吸系统 Download PDF

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Publication number
WO2023087456A1
WO2023087456A1 PCT/CN2021/138199 CN2021138199W WO2023087456A1 WO 2023087456 A1 WO2023087456 A1 WO 2023087456A1 CN 2021138199 W CN2021138199 W CN 2021138199W WO 2023087456 A1 WO2023087456 A1 WO 2023087456A1
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WO
WIPO (PCT)
Prior art keywords
sheath
distal
proximal
handle
tube
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Application number
PCT/CN2021/138199
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English (en)
French (fr)
Inventor
刘载淳
黄定国
Original Assignee
上海腾复医疗科技有限公司
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Publication of WO2023087456A1 publication Critical patent/WO2023087456A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22035—Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
    • 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
    • A61B2017/22072—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 instrument channel, e.g. for replacing one instrument by the other
    • 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
    • A61B2017/22079—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 suction of debris
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the present application relates to the technical field of medical devices, in particular to a pusher and a thrombus aspiration system including the pusher.
  • vascular disease has become an important factor affecting human health, and interventional thrombectomy is currently a research hotspot in the field of thrombus therapy.
  • Suction thrombectomy has become more and more common in clinical application in recent years, but due to the complexity of vascular anatomy, the current suction catheter is often close to one side of the blood vessel wall during suction, resulting in poor suction effect and blood loss during the suction process. The amount is large and there is a risk of damage to the vessel wall.
  • the purpose of some embodiments of the present application is to provide a pusher and a thrombus suction system including the same, so as to solve the problems of low suction efficiency, large blood loss and easy damage to the vessel wall.
  • the embodiment of the present application provides a pusher, which can be passed through the suction sheath, and the distal end of the suction sheath is provided with a sheath positioning bracket;
  • the pusher is used for the delivery and release of the sheath positioning support;
  • the pusher includes: a push head, which has an annular cavity with an opening towards the proximal end and used to accommodate the sheath positioning support in a compressed state; a push rod , the distal end of which is connected to the proximal end of the push head, the push rod and the push head can pass through the suction sheath, and can move axially relative to the suction sheath; and a driving assembly , the distal end of which is connected to the proximal end of the suction sheath, the driving assembly is fixedly connected with the push rod, and is used to drive the push rod to move distally in the suction sheath to release the sheath Tube positioning bracket.
  • the drive assembly includes: a push handle, which is in a tubular structure, the push rod is passed through the push handle, and the push handle is provided with a sliding lock mechanism; and a push button, which is fixedly connected with the push rod and Cooperating with the slide lock mechanism, the push button is used to drive the push rod to move axially relative to the push handle, and the slide lock mechanism can lock the push button to the push handle.
  • the push handle includes: a handle body and a handle joint fixed at the distal end of the handle body, the handle joint is used to connect the pusher to the proximal end of the sheath tube sealing device;
  • the sliding The lock mechanism includes: a chute symmetrically arranged on the peripheral wall of the handle body and extending in the axial direction, and an elastic locking member fixed in the handle body and extending in the axial direction, the elastic locking member has symmetrically arranged Two sets of racks; each set of racks respectively includes a plurality of serrations evenly distributed along the axial direction;
  • the push button includes two symmetrically arranged operating parts, the outer ends of the operating parts respectively expose the chute,
  • the inner end of the operating part includes: a fixing part connected with the push rod and a locking head pressed against the rack.
  • the distal end of the push head is tapered.
  • an embodiment of the present application provides a thrombus suction system, including: a suction sheath, a sheath positioning bracket, and the pusher as described above; the suction sheath includes a sheath body , the sheath tube positioning bracket is arranged at the distal end of the sheath tube body; the sheath tube positioning bracket is a self-expanding bracket structure with openings at both ends.
  • the diameter of the sheath tube positioning bracket gradually decreases from the distal end to the proximal end, and the sheath tube positioning bracket is braided by memory wire.
  • the proximal end of the sheath tube body is sealed and connected to the distal end of the sheath tube sealing device through a sheath tube connector;
  • the sheath tube connector includes: a sheath tube connector and a stress diffusion tube;
  • the sheath tube connector is sheathed
  • the proximal end of the sheath tube body is sealed and fixedly connected with the distal end of the sheath tube sealing device;
  • the stress diffusion tube is sleeved on the proximal end of the sheath tube body and the sheath tube connector.
  • the suction sheath also includes a sheath sealing device located at the proximal end of the sheath body;
  • the sheath sealing device includes: a distal handle pressing part, an elastic handle, a flexible membrane tube, an infusion set, and The proximal pressure head;
  • the elastic handle includes: a distal seat, a proximal seat and an elastic member; the distal seat, the proximal seat and the elastic member are fixedly connected to an integral elastic cylindrical valve housing;
  • the flexible membrane tube is A smooth tubular structure with a smooth inner wall, which passes through the elastic cylindrical valve housing. The distal end of the flexible membrane tube is sealed and connected with the distal seat, and the proximal end of the flexible membrane tube is sealed with the proximal seat.
  • the components include: a multi-way joint connected to the proximal end of the sheath tube body, the proximal end of the multi-way joint is provided with a distal insertion part extending in the axial direction; the distal insertion part is inserted into the flexible membrane tube At the far end, a distal sealing ring is interposed between the outer periphery of the distal end of the sheath tube body, the proximal end of the multi-way joint is provided with a distal insertion part extending in the axial direction; the distal insertion part is inserted into the flexible membrane tube At the far end, a distal sealing ring is interposed between the outer periphery of the dis
  • the distal handle pressing part also includes: a distal annular boss arranged between the distal insertion part and the sheath tube body; the proximal pressing head also includes a The proximal annular boss at the proximal end of the insertion part; the distal inner wall of the distal seat of the elastic handle is provided with a distal annular groove matched with the distal annular boss; the multi-way joint and the The distal seat is fixedly connected through the distal annular boss and the distal annular groove; the proximal inner wall of the proximal seat of the elastic handle is provided with a proximal annular recess matched with the proximal annular boss.
  • the groove, the proximal pressure head and the proximal seat are fixedly connected through the proximal annular boss and the proximal annular groove.
  • the thrombus aspiration system further includes a side aspiration component connected to the multi-way connector.
  • the present application at least has the following advantages and positive effects:
  • the sheath positioning bracket at the distal end of the suction sheath is received and released by the pusher.
  • the suction port is centered to avoid damage to the blood vessel wall caused by the suction sheath deflecting to one side, and it can also expand the suction port to improve the efficiency of thrombus suction and help reduce blood loss during the suction process.
  • FIG. 1 is a schematic structural diagram of a thrombus aspiration system provided in an embodiment of the present application
  • Fig. 2 is a partial cross-sectional structural schematic diagram of the sheath tube positioning support in the released state in the thrombus aspiration system provided by the embodiment of the present application;
  • FIG. 3 is a schematic structural diagram of the pusher provided in Embodiment 1 of the present application.
  • Fig. 4 is a partial cross-sectional structural schematic diagram of Fig. 3;
  • FIG. 5 is a schematic structural view of the thrombus aspiration system provided in Embodiment 2 of the present application.
  • Fig. 6 is a partial cross-sectional structural schematic diagram of Fig. 5;
  • FIG. 7 is a schematic diagram of an exploded structure of the thrombus aspiration system provided in Embodiment 2 of the present application.
  • FIG. 8 is a schematic structural view of the elastic handle of the thrombus aspiration system provided in Embodiment 2 of the present application;
  • FIG. 9 is a schematic structural view of the distal handle pressing member of the thrombus aspiration system provided in Embodiment 2 of the present application.
  • FIG. 10 is a schematic structural view of the flexible membrane tube of the thrombus aspiration system provided in Embodiment 2 of the present application;
  • 11a and 11b are structural schematic diagrams of the distal seat of the elastic handle in the thrombus aspiration system provided by the embodiment of the present application;
  • 12a and 12b are schematic structural views of the proximal seat of the elastic handle in the thrombus aspiration system provided by the embodiment 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. Control the sheath seal.
  • the embodiment of the present application provides a pusher 2 that can be used in conjunction with a thrombus suction system.
  • the thrombus suction system includes: a suction sheath 1 , and a sheath positioning bracket 11 is provided at the distal end of the suction sheath 1 .
  • the pusher 2 can be passed through the suction sheath 1 and used for delivery and release of the sheath positioning bracket 11 .
  • the pusher 2 of the embodiment of the present application includes: a push head 21 , a push rod 22 and a driving assembly.
  • the pushing head 21 has an annular cavity with an opening facing the proximal end and used for accommodating the sheath positioning bracket 11 in a compressed state, so that it can be accommodated in the pushing head 21 from the distal end of the sheath positioning bracket 11 . Further, the distal end of the pushing head 21 is tapered, that is, the pushing head 21 has a tapered tip, which can improve the guiding and pushing ability of the suction sheath 1 in the blood vessel.
  • the distal end of the push rod 22 is connected to the proximal end of the push head 21 , and the push head 21 and the push rod 22 can pass through the suction sheath 1 and can move axially relative to the suction sheath 1 .
  • the push head 21 can be fixed on the distal end of the push rod 22 by welding, gluing or thermal fusion.
  • the distal end of the driving assembly can be connected to the proximal end of the suction sheath 1 , the driving assembly is fixedly connected with the push rod 22 and used to drive the push rod 22 to move distally in the suction sheath 1 to release the sheath positioning bracket 11 .
  • the drive assembly may include: a push handle and a push button 25 .
  • the push handle has a tubular structure, and the push rod 22 passes through the push handle and can move axially relative to the push handle.
  • the push handle is provided with a slide lock mechanism, and the push button 25 is fixedly connected with the push rod 22 and cooperates with the slide lock mechanism.
  • the push button 25 is used to drive the push rod 22 to move axially relative to the push handle, and the slide lock mechanism can lock the push button 25 on Push the handle.
  • the push head 21 reaches the target thrombus position, it is only necessary to push the push button 25 to make the push rod 22 drive the push head 21 to move to the far end to release the sheath tube positioning bracket 11.
  • the slide lock mechanism can The push button 25 is automatically locked on the push handle to prevent the pusher 2 from moving in the suction sheath 1 .
  • the push handle may include: a handle body 24 and a handle joint 23 fixed at the distal end of the handle body 24 , the handle joint 23 is used to connect the pusher 2 to the proximal end of the suction sheath 1 .
  • the handle joint 23 can be screwed to the proximal end of the suction sheath 1 .
  • the sliding lock mechanism includes: a chute symmetrically arranged on the peripheral wall of the handle body 24 and extending in the axial direction, and an elastic locking member fixed in the handle body 24 and extending in the axial direction.
  • the elastic locking member has two sets of symmetrically arranged teeth. strip.
  • Each set of racks respectively includes a plurality of saw teeth 26 uniformly distributed along the axial direction.
  • the push button 25 includes two symmetrically arranged operating parts, the outer end 251 of each operating part is respectively exposed to the chute, and the inner end of the operating part includes: a fixing part 253 connected with the push rod 22 and a locking part pressed against the rack. Head 252.
  • the push button 25 can move in the handle body along the chute.
  • the rack can be made of elastic material, and pushing the outer end of the push button 25 to overcome the resistance of the rack to the locking head 252 at the inner end of the push button can make the push rod 22 move axially relative to the push handle.
  • Push button 25 can be locked on the push handle by the locking effect of rack.
  • the shape of the serrations 26 facilitates the distal movement of the push button and prevents the proximal movement of the push button.
  • the push rod when the push button is not pushed, the push rod can be locked on the push handle, and when the push button is pushed, it can be automatically unlocked and the push head can be moved distally to release the sheath positioning bracket, which is convenient to operate.
  • Embodiment 2 of the present application provides a thrombus suction system, which can be used to suck thrombus in a blood vessel.
  • the thrombus aspiration system of the embodiment of the present application includes: a suction sheath 1 , a sheath positioning bracket 11 and the pusher 2 as described in the first embodiment.
  • the suction sheath 1 includes: a sheath tube body 12 and a sheath tube sealing device 3 , the distal end of the sheath tube sealing device 3 is sealingly connected with the proximal end of the sheath tube body 12 .
  • the sheath positioning stent 11 is a self-expanding stent structure with openings at both ends.
  • the sheath positioning stent 11 is in a cylindrical structure. When it is released and expanded, it can be attached to and supported on the inner wall of the blood vessel, so that the distal end of the sheath body 12 can The mouth is located in the center of the blood vessel, which can prevent the sheath body 12 from being drawn to the side of the blood vessel and damage the blood vessel wall; at the same time, the sheath positioning bracket 11 also provides a larger suction port for the suction sheath 1, which can improve the overall suction. Improve suction efficiency and reduce blood loss during surgery.
  • the diameter of the sheath positioning bracket 11 gradually decreases from the distal end to the proximal end, which not only facilitates the centering of the distal opening of the sheath body, but also provides a larger thrombus suction port.
  • the sheath tube positioning bracket 11 can be braided by memory wire.
  • the material of the memory wire is, for example, nickel-titanium alloy wire with good shape memory.
  • the sheath tube sealing device 3 is arranged at the proximal end of the sheath tube body 12 and is sealingly connected with the proximal end of the sheath tube body 12 .
  • the sheath tube sealing device 3 has an openable lumen (i.e. a sealed channel), and the lumen of the sheath tube sealing device 3 communicates with the lumen of the sheath tube body 12. When the sheath tube sealing device is opened, the suction sheath tube 1 can be used For thrombus aspiration.
  • the sheath sealing device 3 When instruments such as the pusher 2 are inserted into the suction sheath 1 , the sheath sealing device 3 can reliably seal it, and at the same time, the sheath sealing device 3 can also close the suction channel of the suction sheath 1 .
  • the sheath tube sealing device 3 includes: a distal handle pressing member 31 , an elastic handle 32 , a flexible membrane tube 34 , an infusion set and a proximal pressure head 333 .
  • the elastic handle 32 includes: a distal seat 321 , a proximal seat 324 and an elastic member 325 .
  • the distal seat 321 , the proximal seat 324 and the elastic member 325 are fixedly connected to form an integral elastic cylindrical valve casing.
  • the distal seat 321 , the proximal seat 324 and the elastic member 325 are integrated by encapsulation process, the manufacturing process is simple, and the structure is firm.
  • the flexible membrane tube 34 is a tubular structure with a smooth inner wall.
  • the flexible membrane tube 34 is installed in the elastic cylindrical valve housing.
  • the distal end of the flexible membrane tube 34 is in sealing connection with the distal seat 321.
  • the seat 324 is sealingly connected so that a sealed space is formed between the elastic cylindrical valve housing and the flexible membrane tube 34 .
  • the inner wall of the flexible membrane tube 4 encloses the sealing channel of the sealing device.
  • the infusion component is connected with the elastic cylindrical valve housing and used for adjusting the sealing pressure in the sealing space.
  • the pressure in the sealed space can be adjusted by changing the amount of fluid (gas or liquid) in the sealed space through the infusion set, thereby changing the sealing pressure acting on the flexible membrane tube 34 .
  • the flexible membrane tube 4 can shrink and expand circumferentially, so that the flexible membrane tube 4 can shrink circumferentially to close the sealing passage, or expand circumferentially into a sealing passage adapting to the shape and size of the introduction instrument, And the elastic member 25 can elastically deform radially with the contraction and expansion of the flexible membrane tube 4 . That is, the flexible membrane tube 4 is made of a soft material, and can shrink and relax in the circumferential direction. The flexible membrane tube 4 realizes different sizes of the sealed passages by shrinking and relaxing in the circumferential direction instead of its own elastic deformation.
  • the flexible membrane tube 4 can achieve circumferential shrinkage by folding under the action of sealing pressure due to its own flexible structure, and can shut off the sealed channel; when it is necessary to introduce instruments of a certain shape and size through the sealed channel,
  • the flexible membrane tube 4 can be stretched (deployed) in the circumferential direction and form a sealed channel with the shape and size of the adapter under pressure, so as to achieve good sealing.
  • the elastic member 25 can shrink radially as the flexible membrane tube 4 shrinks, and expand radially when expanding, that is, the elastic member 25 can shrink as the sealing channel decreases and expand as the sealing channel increases.
  • the elastic deformation of the elastic member 25 The function can adaptively adjust the sealing pressure when forming sealing channels of different sizes, so as to maintain good and stable sealing performance.
  • the elastic member 325 can shrink or expand in the radial direction to form the required channel size of the device, so the radial deformation range of the elastic member 325 can determine the size range of the sealed channel.
  • the radial deformation of the elastic member 325 can also make the sealing pressures received by instruments of different sizes close, so as to maintain a good sealing effect all the time.
  • the elastic member 325 can shrink radially, so that the diameter of the sealing passage changes from 5 mm to 2 mm.
  • the pressure in the sealed space is relatively close, so the sealing force received by instruments of different sizes is relatively consistent, and a good sealing effect can be maintained.
  • the distal end of the distal handle pressing part 31 is connected to the proximal end of the sheath tube body 12, and its proximal end is connected to the distal end of the distal seat 321 of the elastic handle 32, so as to realize the sealing between the sheath tube body 12 and the sheath tube sealing device 3 connect.
  • the distal handle pressing member 31 is also used for sealingly connecting the flexible membrane tube 34 to the elastic cylindrical valve housing.
  • the proximal indenter 33 is arranged at the proximal end of the elastic handle 32, and the distal end of the proximal indenter 33 is used as the outer end of the suction sheath 1, and can be connected with a pusher or a suction pump.
  • the near-end pressure head 33 is fixedly connected with the near-end seat 324 of the elastic handle 32, and is connected with the near-end of the flexible film tube 34, and also cooperates with the near-end seat 324 to realize the contact between the near-end of the flexible film tube 34 and the near-end seat 324. Sealed connection.
  • the distal handle pressing member 31 includes: a multi-way joint, the proximal end of the multi-way joint is provided with a distal insertion portion 312 extending in the axial direction, and a multi-way joint and a distal insertion The distal annular boss 311 between the parts 312.
  • the multi-way joint has a tubular structure.
  • the distal insertion portion 312 is inserted into the distal end of the flexible membrane tube 34, and a distal sealing ring 3251 is sandwiched between the outer circumference of the distal end of the flexible membrane tube 34 and the inner wall of the elastic cylindrical valve housing, so that the flexible membrane tube 34 The distal end is airtightly connected with the distal end of the elastic handle 32 .
  • the distal inner wall of the distal seat 321 of the elastic handle 32 is provided with a distal annular groove 3212 matched with the distal annular boss 311.
  • the distal handle pressing member 31 and the distal seat 321 are engaged and fixedly connected by the distal annular boss 311 and the distal annular groove 212 . Therefore, by inserting the distal insertion part 312 into the distal end of the flexible membrane tube 34, and pressing and fitting with the distal sealing ring 3251, a seal can be realized between the distal end of the flexible membrane tube 34 and the distal end of the elastic cylindrical valve housing.
  • connection through the cooperation of the distal annular boss 311 and the distal annular groove 3212 of the distal seat 321, the connection and fixation of the distal handle pressing part 31 and the elastic handle 32 can be realized, and at the same time, it can also be assisted in fixing with glue.
  • the assembly steps are simple and easy to operate.
  • a guide portion 314 is provided at the proximal end of the distal insertion portion 312 .
  • the guide portion 314 at the proximal end of the distal insertion portion 312 has a constricted structure, and its diameter gradually decreases from the distal end to the proximal end, which facilitates the insertion of the distal insertion portion 312 into the flexible membrane tube 34 .
  • the proximal indenter 33 has a tubular structure, and a proximal insertion portion 332 extending in the axial direction and a proximal annular boss 331 disposed at a proximal end of the proximal insertion portion 332 are disposed at a distal end thereof.
  • the proximal insertion part 332 is inserted into the proximal end of the flexible membrane tube 34, and a proximal sealing ring 3252 is sandwiched between the proximal outer periphery of the flexible membrane tube 34 and the inner wall of the elastic cylindrical valve housing, so that the flexible membrane tube 34
  • the proximal end is in airtight connection with the proximal end of the elastic cylindrical valve housing.
  • the proximal inner wall of the proximal seat 324 of the elastic handle 32 is provided with a proximal annular groove 3242 that cooperates with the proximal annular boss 331, and the proximal pressure head 33 and the proximal seat 324 pass through the proximal annular boss 331 and the proximal end.
  • the annular groove 3242 is fixedly connected. Therefore, by inserting the proximal insertion part 332 into the proximal end of the flexible membrane tube 34, and pressing and fitting with the proximal sealing ring 3252, a seal can be realized between the proximal end of the flexible membrane tube 34 and the proximal end of the elastic cylindrical valve housing.
  • the connection and fixation of the proximal indenter 33 and the elastic handle 32 can be realized, and it can also assist Glue fixed, the assembly steps are simple and easy to operate.
  • the distal end of the proximal insertion portion 332 is provided with a guide portion 333 .
  • the guide portion 333 at the distal end of the proximal insertion portion 332 is also a constricted structure, which facilitates the insertion of the proximal insertion portion 332 into the flexible membrane tube 34 .
  • the flexible membrane tube 34 can also be sealed and connected with the elastic cylindrical valve body in other ways.
  • the connection structure between the sheath tube body 12 and the sheath tube sealing device 3 is also not limited to the boss and slot matching method described in this embodiment.
  • the sheath tube connector 13 sealably connects the proximal end of the sheath tube body with the distal end of the sheath tube sealing device.
  • the sheath connector 13 may include: a sheath joint 132 and a stress diffusion tube 131 .
  • the sheath tube joint 132 is sheathed on the proximal end of the sheath tube body 12 and is tightly and fixedly connected with the distal end of the sheath tube sealing device 3 .
  • the proximal end of the sheath tube joint 132 is inserted into the distal end of the multi-way joint of the distal handle pressing part 31, and the proximal outer periphery of the sheath tube joint 132 is in contact with the distal end of the multi-way joint of the distal handle pressing part 31.
  • the circles are sealed and connected by a sealing ring 133 .
  • the stress diffusion tube 131 is sheathed on the proximal end of the sheath tube body 12 and the sheath tube joint 132 .
  • the part of the stress diffusion tube 131 sleeved on the sheath body 12 gradually increases in diameter along its axial direction from the distal end to the proximal end, and the part of the stress diffusion tube 131 sleeved on the sheath joint 132 is columnar, which can prevent the suction sheath from Bending occurs during use.
  • the distal seat 321 is provided with a distal rubber covering structure
  • the elastic member 325 is integrally glued to the distal seat 321 through the distal rubber covering structure
  • the proximal seat 324 is provided with a proximal rubber covering structure.
  • the elastic member 325 is integrally glued to the proximal seat 324 through the proximal rubber-covering structure, so that the elastic member is firmly combined with the distal seat 321 and the proximal seat 324 .
  • the rubber covering structure at the distal end adopts a spoke-shaped rubber covering structure.
  • the spoke-shaped rubber-covering structure includes: an annular outer seat 3211, an annular inner seat 3214 coaxially arranged in the annular outer seat 3211, and a plurality of ring-shaped outer seats 3211 and annular inner seats 3214 arranged at intervals in the circumferential direction. The connection between the rubber ribs 3215.
  • a glue-filling gap is formed between the annular outer seat body 3211, the ring-shaped inner seat body 3214, and a plurality of connecting rubber ribs 3215, and the gel at the distal end of the elastic member 325 is melted and filled and solidified in the glue-filling gap, so that the distal end of the elastic member 325 is in contact with the glue-filling gap.
  • the distal seat 321 is firmly integrated.
  • annular outer seat body 3211 of the distal seat 321 is provided with a through hole 3216
  • the annular inner seat body is provided with an opening 3217 , which respectively serve as channel structures for connecting with the perfusion hole 3253 of the elastic member 325 to form a perfusion channel.
  • the distal seat 321 is provided with an infusion interface 3213 connected to the infusion set, the infusion set includes an infusion tube 322 and a two-way sealing valve 323, and the two ends of the infusion tube 322 are respectively connected to the infusion structure 213 and the two-way sealing valve 323
  • the other end of the two-way sealing valve 323 can be connected with a syringe or the like.
  • the distal end of the elastic member 325 is provided with a perfusion hole 3253 communicating with the infusion port 3213 .
  • the distal sealing ring 3251 is provided with a sealing ring channel communicating with the perfusion hole 3253 .
  • the distal insertion portion 312 is provided with an escape pit 314 corresponding to the sealing ring channel, and the escape pit 314 communicates with the sealing space.
  • the infusion interface 3213 , the perfusion hole 3253 , the channel on the distal seat 321 and the sealing ring channel are sequentially connected to form a perfusion channel, and the sealing ring channel is facing the avoidance pit 314 , thereby communicating with the sealed space through the escape recess 314 .
  • the rubber covering structure at the proximal end also adopts a spoke-shaped rubber covering structure.
  • the spoke-shaped rubber-covering structure includes: an annular outer seat 3241, an annular inner seat 3243 coaxially arranged in the annular outer seat 3241, and a plurality of ring-shaped outer seats 3241 and annular inner seats 3243 arranged at intervals along the circumferential direction.
  • a glue-filled gap is formed between the annular outer base body 3241 , the annular inner base body 3243 and the plurality of connecting ribs 3244 .
  • the gel at the proximal end of the elastic member 325 is melted and solidified in the glue filling gap, so that the proximal end of the elastic member 325 and the proximal seat 324 are firmly combined.
  • the distal seat 321 and the proximal seat 324 can be made of non-elastomeric materials, preferably PP, PC, ABS and the like.
  • the elastic member 325 can be made of elastomer materials, preferably silica gel, rubber, TPU, etc., and the three are firmly integrated into one body through the encapsulation process.
  • the elastic member 325 can adopt a shrinking cylindrical structure with two ends being large and the middle being small, which not only facilitates radial deformation to form the required size of the sealing channel, but also serves as an operating handle for easy gripping.
  • the flexible membrane tube 34 is a hose that is impermeable to water or gas and has low elongation both in the circumferential and axial directions.
  • the flexible membrane tube 34 may include an outer layer 342 and an inner layer 341 having a smooth sealing surface.
  • the inner layer 341 and the outer layer 342 form a flexible composite membrane tube structure.
  • the sealing surface refers to the surface of the inner layer 341 facing the instrument passing through the sheath sealing device.
  • the outer surface of the inner layer 341 has a low coefficient of friction and can be made of expanded polytetrafluoroethylene (EPTFE for short).
  • the outer layer 342 can be made of flexible polymer materials, preferably fluorinated ethylene propylene copolymer (Fluorinated ethylene propylene, referred to as FEP) or elastomeric materials, such as thermoplastic polyurethane elastomer rubber (Thermoplastic polyurethanes, referred to as TPU). And its length should not be less than the distance between the guide part 16 on the distal insertion part 312 and the end surface of the guide part 33 of the proximal insertion part 332. Seal off the suction channel.
  • FEP fluorinated ethylene propylene copolymer
  • TPU thermoplastic polyurethanes
  • sheath tube sealing device 3 may also adopt other seal structures that can be switched off, which is not specifically limited here.
  • the thrombus aspiration system may further include a side aspiration component connected with a multi-way connector.
  • the side suction assembly includes: a suction pipe 141 and a two-way suction valve 142 . After the axial suction channel of the suction sheath is closed by the sheath tube sealing device 3, thrombus suction can be performed through the side suction assembly, thereby greatly improving the convenience of clinical use.
  • the working principle of the thrombus aspiration system in the embodiment of the present application is as follows: push the suction sheath 1 to the designated suction site, push the push button 25 of the pusher 2, and drive the pusher head 21 to the far side
  • the end moves to release the sheath tube positioning bracket 11.
  • the sheath tube positioning bracket 11 After the sheath tube positioning bracket 11 is released, it expands and adheres to the blood vessel wall.
  • the opening of the sheath tube positioning bracket 11 can face the thrombus.
  • the side pumping assembly When inhaling, the side pumping assembly can be closed, and the two-way sealing valve 323 connected to the infusion assembly through the syringe is closed after drawing negative pressure on the sheath tube sealing device 3, the inner cavity of the sheath tube sealing device 3 is opened, and the proximal end of the sheath tube sealing device The external end of the pressure head 33 is connected with a negative pressure suction pump to perform thrombus suction.
  • the sheath tube sealing device is filled with gas or liquid to close the inner cavity, and then the two-way suction valve 142 of the side suction assembly is opened for suction.
  • the embodiments of the present application at least have the following advantages and positive effects:
  • the sheath positioning bracket at the distal end of the suction sheath is received and released by the pusher.
  • the suction port is centered to avoid damage to the blood vessel wall caused by the suction sheath deflecting to one side, and it can also expand the suction port to improve the efficiency of thrombus suction and help reduce blood loss during the suction process.

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Abstract

一种推送器(2)及包含其的血栓抽吸系统，该系统包括：抽吸鞘管(1)、鞘管定位支架(11)以及推送器(2)。抽吸鞘管(1)包括鞘管本体(12)，鞘管定位支架(11)设置于鞘管本体(12)远端；鞘管定位支架(11)为两端开口的自膨式支架结构。推送器(2)包括：推送头(21)、推送杆(22)以及驱动组件。推送头(21)具有开口朝向近端且用于收容呈压缩状态的鞘管定位支架(11)的环形腔。推送杆(22)的远端与推送头(21)的近端相连，推送杆(22)和推送头(21)可穿设于抽吸鞘管(1) 内，并可相对抽吸鞘管(1)轴向移动。驱动组件与推送杆(22)相连，并用于驱动推送杆(22)在抽吸鞘管(1)内向远端移动以释放鞘管定位支架(11)。其可使得抽吸鞘管(1)居中抽吸，且可扩大抽吸口，提高抽吸效率。

Description

推送器及包含其的血栓抽吸系统
交叉引用
本申请引用于2021年11月17日递交的名称为“推送器及包含其的血栓抽吸系统”的第202111360924.9号中国专利申请，其通过引用被全部并入本申请
技术领域
本申请涉及医疗器械技术领域，特别涉及一种推送器及包含其的血栓抽吸系统。
背景技术
血管疾病成为影响人类健康的重要因素，介入取栓是目前血栓治疗领域的研究热点。
抽吸取栓在近几年的临床应用中越发普遍，但由于血管解剖形态的复杂性，目前的抽吸导管在抽吸时往往紧贴一侧血管壁，抽吸效果不佳、抽吸过程失血量较大，且有损伤血管壁的风险。
发明内容
本申请部分实施例的目的在于提供一种推送器及包含其的血栓抽吸系统，以解决抽吸效率低、失血量大且容易损伤血管壁的问题。
为解决上述技术问题，根据本申请的一个方面，本申请实施例提供了一种推送器，可穿设于抽吸鞘管，所述抽吸鞘管的远端设有鞘管定位支架；所述推送器用于所述鞘管定位支架的输送和释放；所述推送器包括：推送头，其具有开口朝向近端且用于收容呈压缩状态的所述鞘管定位支架的环形腔；推送杆，其远端与所述推送头的近端相连，所述推送杆和所述推送头可穿设于所述抽吸鞘管，并可相对所述抽吸鞘管轴向移动；以及驱动组件，其远端连接所述抽吸鞘管的近端，所述驱动组件与所述推送杆固定连接，并用于驱动所述推送杆在所述抽吸鞘管内向远端移动以释放所述鞘管定位支架。
另外，所述驱动组件包括：推送手柄，呈管状结构，所述推送杆穿设于所述推送手柄，所述推送手柄设有滑锁机构；及推钮，其与所述推送杆固定连接并与所述滑锁机构配合，所述推钮用于驱动所述推送杆相对所述推送手柄轴向移动，所述滑锁机构能够将所述推钮锁定于所述推送手柄。
另外，所述推送手柄包括：手柄本体以及固设于所述手柄本体远端的手柄接头，所述手柄接头用于将所述推送器连接于所述鞘管密封装置的近端；所述滑锁机构包括：对称设置于所述手柄本体周壁且沿轴向延伸的滑槽以及固设于所述手柄本体内且沿轴向延伸的弹性锁止件，所述弹性锁止件具有对称设置的两组齿条；每组所述齿条分别包括多个沿轴向均匀分布的锯齿；所述推钮包括两个对称设置的操作部，所述操作部的外端分别露出所述滑槽，所述操作部 的内端包括：与所述推送杆相连的固定部以及抵压于所述齿条的锁止头。
另外，所述推送头远端呈锥形。
根据本申请的第二方面，本申请实施例提供了一种血栓抽吸系统，包括：抽吸鞘管、鞘管定位支架以及如上所述的推送器；所述抽吸鞘管包括鞘管本体，所述鞘管定位支架设置于所述鞘管本体远端；所述鞘管定位支架为两端开口的自膨式支架结构。
另外，所述鞘管定位支架的直径由远端到近端逐渐减小，且所述鞘管定位支架采用记忆金属丝编织而成。
另外，所述鞘管本体近端通过鞘管连接件密封连接于所述鞘管密封装置的远端；所述鞘管连接件包括：鞘管接头以及应力扩散管；所述鞘管接头套设于所述鞘管本体近端并与所述鞘管密封装置的远端密封固定连接；所述应力扩散管套设于所述鞘管本体近端以及所述鞘管接头。
另外，所述抽吸鞘管还包括设于所述鞘管本体近端的鞘管密封装置；所述鞘管密封装置包括：远端手柄压紧件、弹性手柄、柔性膜管、输液组件以及近端压头；所述弹性手柄包括：远端座、近端座以及弹性件；所述远端座、近端座以及弹性件固定连接一体式弹性筒状阀壳；所述柔性膜管为内壁光滑的管状结构且穿设于所述弹性筒状阀壳内，所述柔性膜管的远端与所述远端座密封连接，所述柔性膜管的近端与所述近端座密封连接，以使所述弹性筒状阀壳和所述柔性膜管之间形成密封空间；所述柔性膜管内壁围成所述密封装置的密封通道；所述输液组件与所述弹性筒状阀壳相连并用于调节所述密封空间内的密封压力；在所述密封压力的作用下，所述柔性膜管能够周向收缩和舒张，以使所述柔性膜管能够周向收缩至关闭所述密封通道，或者周向展开成自适应导入 器械的形状和尺寸的密封通道；且所述弹性件能够随所述柔性膜管的收缩和舒张而发生径向弹性形变；所述远端手柄压紧件包括：与所述鞘管本体近端相连的多通接头，所述多通接头近端设有沿轴向延伸的远端插入部；所述远端插入部插入至所述柔性膜管的远端，所述柔性膜管的远端外周与所述弹性筒状阀壳的内壁之间夹设有远端密封环，以使所述柔性膜管的远端与所述弹性筒状阀壳的远端之间密封连接；所述近端压头呈管状结构，且其远端设有沿轴向延伸的近端插入部；所述近端插入部插入至所述柔性膜管的近端，所述柔性膜管的近端外周与所述弹性筒状阀壳的内壁之间夹设有近端密封环，以使所述柔性膜管的近端与所述弹性手柄的近端之间密封连接。
另外，所述远端手柄压紧件还包括：设于所述远端插入部和所述鞘管本体之间的远端环形凸台；所述近端压头还包括设于所述近端插入部的近端的近端环形凸台；所述弹性手柄的远端座的远端内壁设有与所述远端环形凸台配合的远端环形凹槽；所述多通接头以及所述远端座通过所述远端环形凸台及所述远端环形凹槽固定连接；所述弹性手柄的近端座的近端内壁设有与所述近端环形凸台配合的近端环形凹槽，所述近端压头以及所述近端座通过所述近端环形凸台以及所述近端环形凹槽固定连接。
另外，所述血栓抽吸系统还包括与所述多通接头相连的侧抽组件。
由上述技术方案可知，本申请至少具有如下优点和积极效果：
本申请实施例的血栓抽吸系统中，通过推送器收纳并释放抽吸鞘管远端的鞘管定位支架，鞘管定位支架释放后膨胀支撑于血管壁，不仅可使抽吸鞘管的抽吸口居中，避免抽吸鞘管偏向一侧抽吸对血管壁造成的损伤，而且还可扩大抽吸口，提高血栓抽吸效率，有利于减少抽吸过程失血量。
附图说明
一个或多个实施例通过与之对应的附图中的图片进行示例性说明，这些示例性说明并不构成对实施例的限定，附图中具有相同参考数字标号的元件表示为类似的元件，除非有特别申明，附图中的图不构成比例限制。
图1为本申请实施例提供的血栓抽吸系统的结构示意图；
图2为本申请实施例提供的血栓抽吸系统中鞘管定位支架处于释放状态的局部剖面结构示意图；
图3为本申请实施例一提供的推送器的结构示意图；
图4为图3的局部剖面结构示意图；
图5为本申请实施例二提供的血栓抽吸系统的结构示意图；
图6为图5的局部剖面结构示意图；
图7为本申请实施例二提供的血栓抽吸系统的分解结构示意图；
图8为本申请实施例二提供的血栓抽吸系统的弹性手柄的结构示意图；
图9为本申请实施例二提供的血栓抽吸系统的远端手柄压紧件的结构示意图；
图10为本申请实施例二提供的血栓抽吸系统的柔性膜管的结构示意图；
图11a、11b为本申请实施例提供的血栓抽吸系统中弹性手柄的远端座的结构示意图；
图12a、12b为本申请实施例提供的血栓抽吸系统中弹性手柄的近端座的结构示意图。
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请部分实施例进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
除非特别说明，本申请中提及的近端、远端在朝向上具有相同含义，即使用状态下，远端为远离操作者的一端，近端为靠近操作者的一端，操作者在近端控制鞘管密封装置。
请参阅图1～图4所示，本申请实施例提供了一种推送器2，可与血栓抽吸系统配合使用。血栓抽吸系统包括：抽吸鞘管1，抽吸鞘管1的远端设有鞘管定位支架11。推送器2可穿设于抽吸鞘管1，并用于鞘管定位支架11的输送和释放。
本申请实施例的推送器2包括：推送头21、推送杆22及驱动组件。
推送头21具有开口朝向近端且用于收容呈压缩状态的鞘管定位支架11的环形腔，便于从鞘管定位支架11的远端将其收纳于推送头21内。进一步地，推送头21远端呈锥形，即推送头21具有锥形尖端，可提高抽吸鞘管1在血管中的导向和推进能力。
推送杆22的远端与推送头21的近端相连，推送头21和推送杆22可穿设于抽吸鞘管1内，并可相对抽吸鞘管1轴向移动。推送头21可通过焊接、胶粘或者热融合方式固定于推送杆22远端。
驱动组件的远端可连接抽吸鞘管1的近端，驱动组件与推送杆22固定连接，并用于驱动推送杆22在抽吸鞘管1内向远端移动以释放鞘管定位支架11。
请参阅图1～图2，在使用时，将推送器2穿设于抽吸鞘管1内，将抽吸 鞘管1远端的鞘管定位支架11收纳于推送头21的环形腔内，并将驱动组件的远端与抽吸鞘管1的近端相连。接着再将抽吸鞘管1推送至血栓抽吸位置，通过驱动组件驱动推送杆22带动推送头21在抽吸鞘管2内沿轴向朝远端移动以释放鞘管定位支架11，使鞘管定位支架11远端开口正对血栓。然后将推送器2整体回撤直至完全撤出抽吸鞘管1。
驱动组件可以包括：推送手柄以及推钮25。推送手柄呈管状结构，推送杆22穿设于推送手柄，并可相对推送手柄轴向移动。推送手柄设有滑锁机构，推钮25与推送杆22固定连接并与滑锁机构配合，推钮25用于驱动推送杆22相对推送手柄轴向移动，滑锁机构能够将推钮25锁定于推送手柄。当推送头21到达目标血栓位置时，只需要推动推钮25即可使推送杆22带动推送头21向远端移动以释放鞘管定位支架11，当松开推钮25时，滑锁机构可自动将推钮25锁定在推送手柄上，防止推送器2在抽吸鞘管1内移动。
推送手柄可包括：手柄本体24以及固设于手柄本体24远端的手柄接头23，手柄接头23用于将推送器2连接于抽吸鞘管1的近端。手柄接头23可螺接至抽吸鞘管1的近端。
滑锁机构包括：对称设置于手柄本体24周壁且沿轴向延伸的滑槽以及固设于手柄本体24内且沿轴向延伸的弹性锁止件，弹性锁止件具有对称设置的两组齿条。每组齿条分别包括多个沿轴向均匀分布的锯齿26。推钮25包括两个对称设置的操作部，每个操作部的外端251分别露出滑槽，操作部的内端包括：与推送杆22相连的固定部253以及抵压于齿条的锁止头252。推钮25可沿滑槽在手柄本体内移动。齿条可采用弹性材料制成，推动推钮25外端克服齿条对推钮内端锁止头252的阻力即可使推送杆22相对推送手柄轴向移动。通过齿条 的锁止作用可将推钮25锁定在推送手柄上。锯齿26的形状可便于推钮向远端移动，且可防止推钮向近端移动。
本申请实施例的推送器，在不推动推钮时，推送杆可锁定在推送手柄上，在推动推钮时，可自动解锁并使推送头向远端移动释放鞘管定位支架，操作便捷。
请参阅图1～图2、图5～图6，本申请实施例二提供了一种血栓抽吸系统，可用于血管内血栓的抽吸。本申请实施例的血栓抽吸系统包括：抽吸鞘管1、鞘管定位支架11以及如实施例一所述的推送器2。抽吸鞘管1包括：鞘管本体12以及鞘管密封装置3，鞘管密封装置3远端与鞘管本体12近端密封连接。
鞘管定位支架11为两端开口的自膨式支架结构，鞘管定位支架11呈筒状结构，当其被释放膨胀后可贴附并支撑于血管内壁，从而使鞘管本体12远端管口居于血管中心位置，可避免鞘管本体12偏向血管一侧抽吸而损伤血管壁；同时，鞘管定位支架11还为抽吸鞘管1提供了更大的抽吸口，可提高整体抽吸效率，减少手术过程中的失血量。进一步地，鞘管定位支架11的直径由远端到近端逐渐减小，不仅便于鞘管本体远端开口居中，而且可提供较大的血栓抽吸口。鞘管定位支架11可采用记忆金属丝编织而成。记忆金属丝的材质比如是形状记忆能力佳的镍钛合金丝。
鞘管密封装置3设置于鞘管本体12近端，并与鞘管本体12近端密封连接。鞘管密封装置3具有可通断的内腔(即密封通道)，鞘管密封装置3的内腔与鞘管本体12的内腔连通，在鞘管密封装置打开时，抽吸鞘管1可用于血栓抽吸。在推送器2等器械穿设于抽吸鞘管1内时，鞘管密封装置3可对其进行可靠地密封，同时，鞘管密封装置3还可以关闭抽吸鞘管1的抽吸通道。
请参阅图1、图5以及图7，鞘管密封装置3包括：远端手柄压紧件31、弹性手柄32、柔性膜管34、输液组件以及近端压头333。
请参阅图8，弹性手柄32包括：远端座321、近端座324以及弹性件325。远端座321、近端座324以及弹性件325固定连接成为一体式弹性筒状阀壳。远端座321、近端座324与弹性件325采用包胶工艺结合为一体，制作工艺简单，结构牢固。
柔性膜管34为内壁光滑的管状结构，柔性膜管34穿设于弹性筒状阀壳内，柔性膜管34的远端与远端座321密封连接，柔性膜管34的近端与近端座324密封连接，以使弹性筒状阀壳和柔性膜管34之间形成密封空间。柔性膜管4内壁围成密封装置的密封通道。
输液组件与弹性筒状阀壳相连并用于调节密封空间内的密封压力。通过输液组件改变密封空间内流体(气体或液体)的量可以调节密封空间内的压力，从而改变作用在柔性膜管34上密封压力。
在密封压力的作用下，柔性膜管4能够周向收缩和舒张，以使柔性膜管4能够周向收缩至关闭密封通道，或者周向展开成自适应导入器械的形状和尺寸的密封通道，且弹性件25能够随柔性膜管4的收缩和舒张而发生径向弹性形变。即，柔性膜管4由软性材料制作形成，并能够周向收缩和舒张，柔性膜管4通过周向收缩和舒张而非自身的弹性形变来实现不同的密封通道的大小，当密封通道内不需导入器械时，柔性膜管4由于自身的柔性结构能够在密封压力作用下通过折叠等实现周向收缩，并能够关断密封通道；当需要通过密封通道导入一定形状和尺寸的器械时，柔性膜管4能够周向舒张(展开)并在压力作用下形成适配器械形状和尺寸的密封通道，实现良好的密封。弹性件25能够 随柔性膜管4收缩而径向收缩，膨胀而径向膨胀，即弹性件25能够随密封通道减小而收缩，随密封通道增大而膨胀，因此，弹性件25的弹性形变作用可在形成不同大小的密封通道时自适应地调节密封压力，以保持良好、稳定的密封性能。弹性件325能够沿径向收缩或膨胀以形成器械所需的通道大小，因此弹性件325的径向形变范围可决定密封通道的尺寸范围。同时，弹性件325的径向形变还可使不同尺寸的器械受到的密封压力接近，从而始终保持良好的密封效果。比如，前后多次分别通过鞘管密封装置3的器械的外径分别为5mm、2mm时，弹性件325可径向收缩，使得密封通道的直径由原来的5mm变成2mm。同时，密封空间内的压力较为接近，因此，不同尺寸器械受到的密封力较为一致，均能保持较好的密封效果。
远端手柄压紧件31的远端与鞘管本体12近端连接，其近端与弹性手柄32的远端座321的远端相连，以实现鞘管本体12与鞘管密封装置3的密封连接。同时，远端手柄压紧件31还用于将柔性膜管34密封连接至弹性筒状阀壳。近端压头33设置于弹性手柄32的近端，近端压头33的远端作为抽吸鞘管1的外端，可以与推送器或者抽吸泵等相连。近端压头33与弹性手柄32的近端座324固定连接，与柔性膜管34的近端连接，同时还与近端座324配合实现柔性膜管34近端与近端座324之间的密封连接。
请参阅图6～图9所示，远端手柄压紧件31包括：多通接头、多通接头近端设有沿轴向延伸的远端插入部312、设于多通接头和远端插入部312之间的远端环形凸台311。多通接头呈管状结构。远端插入部312插入至柔性膜管34的远端内，柔性膜管34的远端外周与弹性筒状阀壳的内壁之间夹设有远端密封环3251，以使柔性膜管34的远端与弹性手柄32的远端之间密封连接。弹 性手柄32的远端座321的远端内壁设有与远端环形凸台311配合的远端环形凹槽3212。远端手柄压紧件31以及远端座321通过远端环形凸台311及远端环形凹槽212卡合固定连接。从而通过将远端插入部312插入至柔性膜管34远端内，并与远端密封环3251相互挤压配合即可使柔性膜管34远端与弹性筒状阀壳远端之间实现密封连接，同时，通过远端环形凸台311与远端座321的远端环形凹槽3212配合，即可实现远端手柄压紧件31与弹性手柄32的连接固定，同时也可以辅助胶水固定，装配步骤简单且易操作。
进一步地，远端插入部312近端还设有导向部314。远端插入部312近端的导向部314为缩口结构，其直径从远端到近端逐渐减小，可便于将远端插入部312插入至柔性膜管34内。
近端压头33呈管状结构，且其远端设有沿轴向延伸的近端插入部332以及设于近端插入部332的近端的近端环形凸台331。近端插入部332插入至柔性膜管34的近端内，柔性膜管34的近端外周与弹性筒状阀壳的内壁之间夹设有近端密封环3252，以使柔性膜管34的近端与弹性筒状阀壳的近端之间密封连接。弹性手柄32的近端座324的近端内壁设有与近端环形凸台331配合的近端环形凹槽3242，近端压头33以及近端座324通过近端环形凸台331以及近端环形凹槽3242固定连接。从而通过将近端插入部332插入至柔性膜管34近端内，并与近端密封环3252相互挤压配合即可使柔性膜管34近端与弹性筒状阀壳近端之间实现密封，同时，通过近端压头33的近端环形凸台331与近端座324的近端环形凹槽3242配合，即可实现近端压头33与弹性手柄32的连接固定，同时也可以辅助胶水固定，装配步骤简单且易操作。
进一步地，近端插入部332的远端设有导向部333。该近端插入部332 远端的导向部333也为缩口结构，可便于将近端插入部332插入至柔性膜管34内。
需要说明的是，柔性膜管34也可以通过其他方式与弹性筒状阀体密封连接。鞘管本体12与鞘管密封装置3的连接结构也不限于本实施例所述的凸台、卡槽配合方式。
鞘管连接件13将鞘管本体近端与鞘管密封装置远端密封连接。鞘管连接件13可包括：鞘管接头132、应力扩散管131。鞘管接头132套设于鞘管本体12近端并与鞘管密封装置3的远端密封固定连接。具体地，鞘管接头132近端插入至远端手柄压紧件31的多通接头远端内，鞘管接头132的近端外周与远端手柄压紧件31的多通接头的远端内周之间通过密封环133密封连接。
应力扩散管131套设于鞘管本体12近端以及鞘管接头132。应力扩散管131套设于鞘管本体12的部分沿自身轴向由远端到近端直径逐渐增加，应力扩散管131套设于鞘管接头132的部分呈柱状，可防止抽吸鞘管在使用中发生弯折。
远端座321设有远端包胶结构，弹性件325通过远端包胶结构与远端座321一体式包胶连接，近端座324设有近端包胶结构。弹性件325通过近端包胶结构与近端座324一体式包胶连接，使得弹性件与远端座321和近端座324牢固地结合在一起。
请参阅图11a、11b所示，远端包胶结构采用轮辐状包胶结构。轮辐状包胶结构包括：环形外座体3211、同轴设置于环形外座体3211内的环形内座体3214以及多个沿周向间隔设置于环形外座体3211和环形内座体3214之间的连接包胶筋3215。环形外座体3211、环形内座体3214以及多个连接包胶筋3215 之间形成填胶空隙，弹性件325远端部分胶体熔融填充并固化于填胶空隙内，使得弹性件325远端与远端座321牢固结合为一体。
需要说明的是，远端座321的环形外座体3211设有通孔3216，环形内座体设有开口3217，分别作为通道结构以便与弹性件325的灌注孔3253连接形成灌注通道。
请参阅图8所示，远端座321设有连接输液组件的输液接口3213，输液组件包括输液管322以及二通密封阀323，输液管322两端分别与输液结构213和二通密封阀323连接，二通密封阀323另一端可连接注射器等。弹性件325的远端设有连通输液接口3213的灌注孔3253。远端密封环3251设有连通灌注孔3253的密封环通道。远端插入部312上设有与密封环通道对应的避让凹坑314，避让凹坑314与密封空间连通。输液接口3213、灌注孔3253、远端座321上的通道以及密封环通道依次连通形成灌注通道，且密封环通道正对避让凹坑314，从而通过避让凹坑314连通密封空间。
请参阅图12a、12b所示，近端包胶结构也采用轮辐状包胶结构。轮辐状包胶结构包括：环形外座体3241、同轴设置于环形外座体3241内的环形内座体3243以及多个沿周向间隔设置于环形外座体3241和环形内座体3243之间的连接包胶筋3244。环形外座体3241、环形内座体3243以及多个连接包胶筋3244之间形成填胶空隙。弹性件325近端部分胶体熔融填充并固化于填胶空隙内，使得弹性件325近端与近端座324牢固地结合在一起。
需要说明的是，本实施例对于近端以及远端包胶结构不做具体限制，只要能够将弹性件与远端座、近端座牢固包胶结合在一起即可。
远端座321和近端座324可以采用非弹性体材料制成，优选PP、PC、 ABS等。弹性件325可以采用弹性体材料制成，优选硅胶、橡胶、TPU等，三者通过包胶工艺牢固结合为一体。弹性件325可以采用两端大中间小的收缩筒状结构，不仅便于产生径向形变以形成所需的密封通道大小而且作为操作手柄便于握持。
柔性膜管34为不透水或者气体且周向以及轴向均具有低延伸率的软管。如图10所示，柔性膜管34可以包括外层342以及具有光滑密封表面的内层341。内层341以及外层342形成柔性复合膜管结构。密封表面是指面向通过鞘管密封装置的器械的内层341表面。内层341的外表面摩擦系数低，可以采用膨体聚四氟乙烯(expanded Polytetrafluoro ethylene，简称EPTFE)制成，外层342可采用柔性高分子材料制成，优选氟化乙烯丙烯共聚物(Fluorinated ethylene propylene，简称FEP)或弹性体材料，例如热塑性聚氨酯弹性体橡胶(Thermoplastic polyurethanes，简称TPU)。且其长度应不小于远端插入部312上的导向部16与近端插入部332的导向部33的端面间的距离，柔性膜管34的轴向长度应能满足在其径向舒张后能够密封关闭抽吸通道。
需要说明的是，鞘管密封装置3也可以采用其他可通断的密封结构，在此不做具体限制。
请参阅图6，血栓抽吸系统还可以包括与多通接头相连的侧抽组件。侧抽组件包括：抽吸管141以及二通抽吸阀142。通过鞘管密封装置3将抽吸鞘管的轴向抽吸通道关闭后，可以通过侧抽组件进行血栓抽吸，从而大大提升了临床使用的便利性。
结合图1、图2及图5，本申请实施例的血栓抽吸系统的工作原理如下：推送抽吸鞘管1到达指定抽吸部位，推动推送器2推钮25，带动推送头21向 远端移动释放鞘管定位支架11，鞘管定位支架11释放后膨胀并贴附血管壁，旋动手柄接头23使推送器2与抽吸鞘管1分离，将推送器2从抽吸鞘管1中完整撤出。此时，鞘管定位支架11开口可正对血栓。在抽吸时，可关闭侧抽组件，通过注射器连接输液组件的二通密封阀323对鞘管密封装置3抽负压后关闭，鞘管密封装置3内腔开通，鞘管密封装置的近端压头33外端接负压抽吸泵即可进行血栓的抽吸。亦或对鞘管密封装置充入气体或者液体使其内腔关闭，然后开启侧抽组件的二通抽吸阀142进行抽吸。
基于上述技术方案，本申请实施例至少具有以下优点和积极效果：
本申请实施例的血栓抽吸系统中，通过推送器收纳并释放抽吸鞘管远端的鞘管定位支架，鞘管定位支架释放后膨胀支撑于血管壁，不仅可使抽吸鞘管的抽吸口居中，避免抽吸鞘管偏向一侧抽吸对血管壁造成的损伤，而且还可扩大抽吸口，提高血栓抽吸效率，有利于减少抽吸过程失血量。
本领域的普通技术人员可以理解，上述各实施例是实现本申请的具体实施例，而在实际应用中，可以在形式上和细节上对其作各种改变，而不偏离本申请的精神和范围。

Claims (10)

  1. 一种推送器，可穿设于抽吸鞘管，所述抽吸鞘管的远端设有鞘管定位支架；所述推送器用于所述鞘管定位支架的输送和释放；所述推送器包括：
    推送头，其具有开口朝向近端且用于收容呈压缩状态的所述鞘管定位支架的环形腔；
    推送杆，其远端与所述推送头的近端相连，所述推送杆和所述推送头可穿设于所述抽吸鞘管，并可相对所述抽吸鞘管轴向移动；以及
    驱动组件，其远端连接所述抽吸鞘管的近端，所述驱动组件与所述推送杆固定连接，并用于驱动所述推送杆在所述抽吸鞘管内向远端移动以释放所述鞘管定位支架。
  2. 根据权利要求1所述的推送器，其中，所述驱动组件包括：
    推送手柄，呈管状结构，所述推送杆穿设于所述推送手柄，所述推送手柄设有滑锁机构；及
    推钮，其与所述推送杆固定连接并与所述滑锁机构配合，所述推钮用于驱动所述推送杆相对所述推送手柄轴向移动，所述滑锁机构能够将所述推钮锁定于所述推送手柄。
  3. 根据权利要求2所述的推送器，其中，所述推送手柄包括：手柄本体以及固设于所述手柄本体远端的手柄接头，所述手柄接头用于将所述推送器连接于所述鞘管密封装置的近端；
    所述滑锁机构包括：对称设置于所述手柄本体周壁且沿轴向延伸的滑槽以及固设于所述手柄本体内且沿轴向延伸的弹性锁止件，所述弹性锁止件具有对称设置的两组齿条；每组所述齿条分别包括多个沿轴向均匀分布的锯齿；
    所述推钮包括两个对称设置的操作部，所述操作部的外端分别露出所述滑槽，所述操作部的内端包括：与所述推送杆相连的固定部以及抵压于所述齿条的锁止头。
  4. 根据权利要求1所述的推送器，其中，所述推送头远端呈锥形。
  5. 一种血栓抽吸系统，包括：抽吸鞘管、鞘管定位支架以及如权利要求1至4所述的推送器；
    所述抽吸鞘管包括鞘管本体，所述鞘管定位支架设置于所述鞘管本体远端；
    所述鞘管定位支架为两端开口的自膨式支架结构。
  6. 根据权利要求5所述的血栓抽吸系统，中，，所述鞘管定位支架的直径由远端到近端逐渐减小，且所述鞘管定位支架采用记忆金属丝编织而成。
  7. 根据权利要求5所述的血栓抽吸系统，其中，所述鞘管本体近端通过鞘管连接件密封连接于所述鞘管密封装置的远端；
    所述鞘管连接件包括：鞘管接头以及应力扩散管；所述鞘管接头套设于所述鞘管本体近端并与所述鞘管密封装置的远端密封固定连接；
    所述应力扩散管套设于所述鞘管本体近端以及所述鞘管接头。
  8. 根据权利要求5所述的血栓抽吸系统，其中，所述抽吸鞘管还包括设于所述鞘管本体近端的鞘管密封装置；
    所述鞘管密封装置包括：远端手柄压紧件、弹性手柄、柔性膜管、输液组件以及近端压头；
    所述弹性手柄包括：远端座、近端座以及弹性件；所述远端座、近端座以及弹性件固定连接形成一体式弹性筒状阀壳；
    所述柔性膜管为内壁光滑的管状结构且穿设于所述弹性筒状阀壳内，所述柔性膜管的远端与所述远端座密封连接，所述柔性膜管的近端与所述近端座密封连接，以使所述弹性筒状阀壳和所述柔性膜管之间形成密封空间；所述柔性膜管内壁围成所述密封装置的密封通道；
    所述输液组件与所述弹性筒状阀壳相连并用于调节所述密封空间内的密封压力；在所述密封压力的作用下，所述柔性膜管能够周向收缩和舒张，以使所述柔性膜管能够周向收缩至关闭所述密封通道，或者周向展开成自适应导入器械的形状和尺寸的密封通道；且所述弹性件能够随所述柔性膜管的收缩和舒张而发生径向弹性形变；
    所述远端手柄压紧件包括：与所述鞘管本体近端相连的多通接头，所述多通接头近端设有沿轴向延伸的远端插入部；所述远端插入部插入至所述柔性膜管的远端，所述柔性膜管的远端外周与所述弹性筒状阀壳的内壁之间夹设有远端密封环，以使所述柔性膜管的远端与所述弹性筒状阀壳的远端之间密封连接；
    所述近端压头呈管状结构，且其远端设有沿轴向延伸的近端插入部；所述近端插入部插入至所述柔性膜管的近端，所述柔性膜管的近端外周与所述弹性筒状阀壳的内壁之间夹设有近端密封环，以使所述柔性膜管的近端与所述弹性手柄的近端之间密封连接。
  9. 根据权利要求8所述的血栓抽吸系统，其中，所述远端手柄压紧件还包括：设于所述远端插入部和所述鞘管本体之间的远端环形凸台；所述近端压头还包括设于所述近端插入部的近端的近端环形凸台；
    所述弹性手柄的远端座的远端内壁设有与所述远端环形凸台配合的远端环形凹槽；所述多通接头以及所述远端座通过所述远端环形凸台及所述远端环形凹槽固定连接；
    所述弹性手柄的近端座的近端内壁设有与所述近端环形凸台配合的近端环形凹槽，所述近端压头以及所述近端座通过所述近端环形凸台以及所述近端环形凹槽固定连接。
  10. 根据权利要求8所述的血栓抽吸系统，其中，所述血栓抽吸系统还包括与所述多通接头相连的侧抽组件。
PCT/CN2021/138199 2021-11-17 2021-12-15 推送器及包含其的血栓抽吸系统 WO2023087456A1 (zh)

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