WO2023070515A1 - 导管泵 - Google Patents

导管泵 Download PDF

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Publication number
WO2023070515A1
WO2023070515A1 PCT/CN2021/127377 CN2021127377W WO2023070515A1 WO 2023070515 A1 WO2023070515 A1 WO 2023070515A1 CN 2021127377 W CN2021127377 W CN 2021127377W WO 2023070515 A1 WO2023070515 A1 WO 2023070515A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
shaft
distal end
distal
proximal
Prior art date
Application number
PCT/CN2021/127377
Other languages
English (en)
French (fr)
Inventor
张家良
托马斯乔治·罗根
付建新
刘刚
Original Assignee
苏州心擎医疗技术有限公司
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
Application filed by 苏州心擎医疗技术有限公司 filed Critical 苏州心擎医疗技术有限公司
Priority to PCT/CN2021/127377 priority Critical patent/WO2023070515A1/zh
Priority to CN202111574903.7A priority patent/CN114225213B/zh
Priority to CN202220416000.XU priority patent/CN217960999U/zh
Priority to CN202220394766.2U priority patent/CN217960998U/zh
Priority to CN202222863344.8U priority patent/CN219251391U/zh
Priority to CN202222863343.3U priority patent/CN219251396U/zh
Priority to CN202222863349.0U priority patent/CN219251398U/zh
Priority to CN202222863348.6U priority patent/CN219251397U/zh
Priority to CN202211339308.XA priority patent/CN116059524A/zh
Publication of WO2023070515A1 publication Critical patent/WO2023070515A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81—Pump housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/818—Bearings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body

Definitions

  • the invention relates to the field of medical devices, in particular to a heart assisting device, and more particularly to an interventional catheter pump and a pump body thereof.
  • Heart failure is a life-threatening disease, and once it progresses to an advanced stage, the one-year mortality rate is about 75%.
  • ventricular assist device technology Given the limited number of heart donors in advanced heart failure, ventricular assist device technology has emerged as a viable therapeutic or alternative treatment option between erected subjects and transplant surgery.
  • adverse events caused by current technology still limit the use of ventricular assist devices in the treatment of critically ill subjects.
  • Adverse events related to blood injury such as hemolytic neurological events, stroke, and in-pump thrombosis, accounted for 20% of these adverse events, which were mainly attributed to excessive physiological stress in rotary blood pumps and flow stagnation.
  • blood compatibility can be improved through hydraulic design optimization, for a rotary blood pump with blood-immersed bearings, direct contact between rotating and stationary parts is unavoidable, and it is difficult to injure blood Adverse events played a substantial role in improvement.
  • an object of the present invention is to provide a catheter pump for assisting heart failure, so as to significantly reduce adverse events of blood damage.
  • the present invention adopts the following technical solutions:
  • a catheter pump comprising:
  • a pump body including: a pump casing connected to the distal end of the catheter, and an impeller housed in the pump casing; the pump casing includes: a bracket, and a film covering partly covering the bracket;
  • a proximal bearing located at the proximal end of the bracket
  • the distal bearing is arranged at the distal end of the bracket
  • the drive shaft includes: a first shaft rotatably penetrated in the conduit, and a second shaft connected to the impeller; the stiffness of the second shaft is greater than that of the first shaft;
  • the proximal end of a shaft is connected to the rotating shaft of the motor, and the distal end is connected to the proximal end of the second shaft; the proximal end and the distal end of the second shaft are respectively installed in the proximal bearing and the distal end bearing.
  • the proximal end of the bracket is provided with a proximal bearing chamber; the proximal bearing supports the proximal end of the second shaft in the proximal bearing chamber.
  • the proximal end of the stent is provided with a secondary connecting tube connected to the distal end of the catheter; the secondary connecting tube constitutes the proximal bearing chamber, and the proximal bearing is built into the secondary connecting tube.
  • the proximal end of the stent is provided with a connecting secondary tube; the proximal bearing chamber is connected to the distal end of the catheter; the proximal bearing chamber is fixedly sleeved in the connecting secondary tube.
  • the connecting secondary pipe and the support are integrally structured.
  • the proximal end of the bracket is also provided with a limit piece axially spaced from the proximal bearing; a stopper is fixed on the drive shaft; the stopper is located between the proximal bearing and the limiter, and is The proximal bearing and the limiting member are axially limited.
  • the limiting member is another proximal bearing; or, the limiting member is a retaining ring fixed in the proximal bearing chamber.
  • the limiting member is another proximal bearing.
  • the stopper is located between the two proximal bearings.
  • the limiting member is a retaining ring fixedly arranged in the proximal bearing chamber; the gap width between the retaining ring and the driving shaft is larger than that between the proximal bearing and the driving shaft gap width.
  • said retaining ring is located proximally of said proximal bearing.
  • the stopper is a stop ring fixedly sleeved on the drive shaft.
  • the proximal end of the stopper is limited by contact with the limiter, and the distal end of the stopper is limited by contact with the proximal bearing.
  • the stopper and the proximal bearing clamp the stopper without play, so that the second shaft is fixed.
  • the stopper is axially movably arranged between the proximal bearing and the limiter, and the proximal bearing and the limiter limit the axial movement range of the stopper.
  • the first shaft is a braided structure.
  • the first shaft includes a plurality of braided layers nested layer by layer; each layer of the braided layer is formed by helically wound wire.
  • the helical direction (helical extension direction of the helical winding wire) of two adjacent braided layers is opposite.
  • the first shaft is provided with a helical structure on its outer wall; the direction of rotation of the helical structure is opposite to that of the drive shaft. Specifically, when viewed from the proximal end to the distal end, when the first shaft rotates clockwise, the helical structure is a left-handed thread, or, when the first shaft rotates counterclockwise, the helical structure is Right hand thread.
  • the helical structure is a helical groove or a helical protrusion.
  • the helical structure is formed by weaving.
  • the direction of rotation of the outermost braided layer is opposite to the direction of rotation of the drive shaft.
  • the helix direction of the outermost braided layer is a left-handed helical structure, or, when the drive shaft rotates counterclockwise, the most The direction of rotation of the braided layer of the outer layer is a right-handed helical structure.
  • the shaft connection part is located on the proximal side of the distal end surface of the stopper (the first proximal bearing or the retaining ring). At this time, the stopper is located at the far dead center position.
  • the proximal end of the second shaft forms the connection part by reducing its diameter; the distal end of the connection part has a diameter reduction step; Located on the proximal side of the distal end face of the limiting member.
  • the axial distance between the diameter reduction step and the distal end surface of the first shaft is greater than the distance between the stopper and the limiter. Axial spacing.
  • the stopper when the stopper is in contact with the limiter, there is a certain distance between the diameter-reducing step and the distal end surface of the first shaft.
  • the radial thickness of the reduced-diameter step is smaller than the wall thickness of the conduit wall of the mating channel.
  • the inner wall of the distal end of the first shaft is expanded to form the matching channel; the proximal end of the matching channel has a diameter-expanding step; the radial thickness of the expanding diameter step is greater than that of the shaft connection The wall thickness of the part.
  • the axial distance between the diameter-expanding step and the proximal end surface of the connecting part is greater than that of the stopper and the axial distance between the limiter.
  • the distal end of the bracket is connected with a distal bearing chamber with a built-in distal bearing; when the pump body is switched between the expanded state and the retracted state, the distal bearing chamber and the distal bearing slide relative to the second shaft and keep supporting the second shaft. two axes.
  • the distal end of the bracket is provided with a plurality of connecting legs arranged in the circumferential direction; the plurality of connecting legs are connected to the distal bearing chamber around the circumference of the distal bearing chamber.
  • the outer wall of the far-end bearing chamber is provided with a receiving groove for the connecting legs to be embedded; located in the holding tank.
  • the ferrule is a heat-shrinkable tube.
  • the accommodating groove includes a plurality of slots extending in the axial direction, and an annular slot connecting the distal ends of the plurality of slots; the connecting leg includes a rod embedded in the slot and an embedded into the leg end in the annular groove.
  • the leg end and the rod body form a T-shaped structure.
  • the distal end bearing chamber includes a protruding section and a binding section; the protruding section is located at the proximal side of the binding section, the outer diameter of the protruding section is smaller than the outer diameter of the binding section, the There is a diameter-reducing step between the extending section and the binding section; the receiving groove is set on the outer wall of the binding section; the hoop is fixedly sleeved outside the binding section; the distal bearing is built in in the extension section.
  • the impeller includes a hub fixedly sleeved on the second shaft, and blades set on the hub.
  • said hub is glued to said second shaft.
  • the second shaft has an exposed portion whose wall surface is exposed in the bracket; at least part of the wall surface of the exposed portion is provided with a first helical structure extending helically along the axial direction; the helical direction of the first helical structure is the same as that of the second The axes rotate in the same direction. That is, viewed from the proximal end to the distal end, when the second shaft rotates clockwise, the first helical structure is a right-handed thread, or, when the second shaft rotates counterclockwise, the The first helix is a left-handed helix.
  • the first helical structure is a helical groove or a helical protrusion.
  • said first helical formation is located distally of the hub.
  • the second shaft has a first non-exposed portion sleeved in the hub; at least part of the wall surface of the first non-exposed portion is provided with a concave structure.
  • the concave structure is a spiral groove provided on the wall surface of the first non-exposed portion.
  • the helical groove extends continuously from the distal end of the hub to the proximal end of the hub.
  • the second shaft has a second non-exposed portion sleeved in the distal bearing chamber, at least part of the wall surface of the second non-exposed portion is provided with a second helical structure, and the helical direction of the second helical structure is the same as The rotation direction of the second shaft is the same. That is, viewed from the proximal end to the distal end, when the second shaft rotates clockwise, the second helical structure is a right-handed thread, or, when the second shaft rotates counterclockwise, the The second helix is a left-handed helix.
  • a spiral groove is provided on the wall of the second shaft; the spiral groove extends continuously from the proximal end of the hub to the distal end of the second shaft; the direction of rotation of the spiral groove is consistent with that of the second shaft same direction of rotation. That is, viewed from the proximal end to the distal end, when the second shaft rotates clockwise, the helical groove is a right-handed thread, or, when the second shaft rotates counterclockwise, the helical groove For left-hand thread.
  • a catheter pump comprising:
  • the pump body has a folded state and an unfolded state, including: a pump casing connected to the distal end of the catheter, an impeller housed in the pump casing and driven by the drive shaft;
  • the distal bearing chamber is connected to the distal end of the pump casing and has a distal bearing built in;
  • the distal end of the drive shaft passes through the hub of the impeller and extends into the distal bearing
  • the drive shaft includes a first shaft and a second shaft; the stiffness of the second shaft is greater than that of the first shaft; the proximal end of the first shaft is in drive connection with the rotating shaft of the motor; The distal end of the first shaft is connected to the proximal end of the second shaft; the impeller is fixedly sleeved on the second shaft.
  • the distal end of the bracket slides along the drive shaft together with the distal bearing chamber and the distal bearing.
  • the distal end of the bracket slides along the second shaft together with the distal bearing chamber and the distal bearing.
  • the distal end surface of the drive shaft is located at the far side of the proximal end surface of the distal bearing.
  • the distal end surface of the second shaft is located on the far side of the proximal end surface of the distal bearing.
  • the distal end surface of the drive shaft is located distally of the distal end surface of the distal bearing.
  • the distal end surface of the second shaft is located at the far side of the distal end surface of the distal bearing.
  • the distance between the distal end surface of the drive shaft and the proximal end surface of the distal bearing is L1; in the retracted state, the distance between the distal end surface of the drive shaft and the proximal end surface of the distal bearing is The distance is L2, and L1 is greater than L2.
  • the distance between the distal end surface of the second shaft and the proximal end surface of the distal bearing is L1; in the folded state, the distance between the distal end surface of the second shaft and the distal bearing is nearly The distance between the end faces is L2, and L1 is greater than L2.
  • the distal end of the distal bearing chamber is connected with an atraumatic support.
  • the distal bearing chamber is provided with a blocking member for the guide wire to pass through; the blocking member can maintain the blocking state at its position before and after the guide wire passes through.
  • a blocking member is provided between the distal end of the drive shaft and the proximal end of the atraumatic support; the blocking member can pass through the guide wire; The occluded state of the position is maintained before and after the guide wire passes.
  • the proximal end of the atraumatic supporting member is provided with an intruding portion protruding into the distal end of the distal bearing chamber, and the intruding portion is bonded to the distal end of the distal bearing chamber.
  • the outer wall of the protruding portion and/or the inner wall of the distal end of the distal bearing chamber is provided with a glue holding groove.
  • the glue-holding groove is a spiral groove or a linear groove extending in the axial direction or an arc groove extending in the circumferential direction.
  • a catheter pump comprising:
  • the pump body includes: a pump casing, an impeller housed in the pump casing and driven by the drive shaft; the pump casing includes: a bracket, a film covering the bracket partially; wherein, the proximal end of the bracket A connecting secondary pipe is provided, and the connecting secondary pipe is provided with a joint part that runs through at least part of its wall thickness, and the joint part contains a joint material that flows into it after being melted and solidified, and the joint material is arranged on the the distal end of the catheter.
  • a catheter pump comprising:
  • a pump body including: a pump casing, an impeller housed in the pump casing and driven by the drive shaft; the pump casing includes: a bracket, a film partially covering the bracket; wherein, the proximal end of the bracket A connecting secondary pipe is provided, and the connecting secondary pipe is provided with a joint part penetrating at least part of its wall thickness, and the distal end of the catheter is provided with a hot-melt solidified joint material accommodated in the joint part.
  • the secondary connection tube is sheathed on the outside of the distal end of the catheter, and an intermediate connection sleeve is sheathed on the outside of the secondary connection tube, and the bonding material is formed by curing the intermediate connection sleeve after melting.
  • part of the intermediate connecting sleeve is located at the proximal side of the connecting secondary tube and is fixedly sleeved outside the catheter.
  • part of the intermediate connecting sleeve is hot-melted and adhesively sleeved on the outer wall of the catheter, or part of the intermediate connecting sleeve is glued to the outer wall of the catheter, or, the outer wall of the catheter is provided with a receiving portion
  • the intermediate connection sleeve is formed by heat-melting and then solidifying into a protruding inset groove.
  • the bonding material is a structure in which part of the catheter is formed by heat melting or thermocompression.
  • the melting point of the bonding material is the same or close to the melting point of the material of the catheter.
  • the bonding material is made of the same material as the conduit, or both the bonding material and the conduit are resin materials.
  • the joint part includes a limit recess opened on the wall of the secondary tube, and the joint material includes a connection protrusion formed by hot-melt solidification; the connection protrusion fixes the catheter and the bracket at least axially by snapping into the limit groove .
  • the distal end of the connecting secondary tube includes a first connecting portion with a limiting recess; the distal end of the catheter includes a second connecting portion with a connecting protrusion; the second connecting portion is sleeved outside the first connecting portion, and the connecting protrusion snap into the limit groove.
  • the second connecting portion flows part of the conduit material into the limiting recess by heat melting, and then solidifies to form a connecting protrusion.
  • the second connection part also has an adhesive surface that is bonded to the first connection part.
  • the bonding surface is formed after the second connecting portion is solidified by heat melting.
  • the limiting recess penetrates through the wall of the connecting secondary pipe in the radial direction.
  • the position-limiting depression includes a plurality of connecting holes arranged on the secondary connecting pipe and radially penetrating through the wall of the secondary connecting pipe.
  • the connecting hole is a long hole extending in the circumferential direction; a plurality of connecting holes are arranged in parallel along the axial direction of the connecting secondary pipe.
  • two adjacent connecting holes are at least partially staggered in the axial direction.
  • two adjacent connecting holes are at least partially overlapped in the axial direction.
  • two adjacent connecting holes have overlapping portions in the axial direction; the circumferential length of the overlapping portions is greater than the axial width of the connecting holes.
  • the connecting hole has a first overlapping portion and a second overlapping portion axially overlapping with the adjacent connecting hole; the first overlapping portion has a first hole end, and the second overlapping portion has a second hole end; the first overlapping portion
  • the circumferential lengths of the portion and the second coincident portion are equal.
  • connection hole has a first hole end and a second hole end in the circumferential direction; the first hole end and the second hole end have end spacers; the circumferential length of the end spacers is less than Half of the perimeter of the location.
  • connection hole has a first hole end and a second hole end in the circumferential direction; the first hole end and the second hole end have end spacers; the circumferential length of the end spacers is greater than the The axial width of the connecting hole.
  • connection holes there is a hole spacer between two adjacent connection holes; the circumferential width of the hole spacer is smaller than the axial width of the connection hole.
  • the connecting holes on both axial sides of a connecting hole are axially aligned.
  • a third connecting portion is further provided on the inner side of the first connecting portion in the radial direction; the connecting protrusion passes through the limiting recess and is bonded or integrated with the third connecting portion.
  • the third connection part is made of the same material as the second connection part.
  • the third connection part is integrated with the catheter.
  • the catheter wall at the distal end of the catheter is provided with a clamping wall socket; the radially outer tube wall of the clamping wall socket is the second connecting part, and the radially inner tube wall of the clamping wall socket is The wall is the third connecting part; the clamping wall insertion hole forms an insertion opening for the first connecting part to be inserted on the end surface of the distal end of the catheter.
  • the connecting secondary tube is further provided with a positioning part on the far side of the first connecting part; the positioning part positions the proximal bearing located in the connecting secondary tube; the proximal bearing is sleeved outside the drive shaft to support the drive shaft in rotation;
  • the outer wall of the end bearing is provided with a matching part engaged with the positioning part; the positioning part and the matching part form a buckle structure.
  • the positioning portion includes a plurality of radially inwardly protruding male buckles arranged in the circumferential direction; the matching portion includes a buckle on the outer wall of the proximal bearing that is snapped into by the male buckles groove.
  • a retaining ring is fixed on the proximal side of the proximal bearing inside the connecting secondary pipe; the retaining ring is in contact with the distal end surface of the third connecting part to limit; the retaining ring is in contact with the distal end surface of the third connecting part;
  • the separation distance between the drive shafts is greater than the separation distance between the proximal bearing and the drive shafts.
  • a proximal bearing supporting the drive shaft is provided in the secondary connecting pipe.
  • a method for assembling a bracket and a catheter of a catheter pump The catheter is used to pass through a drive shaft that drives the impeller to rotate, and the bracket is used to support and expand the film to form a rotating space for containing the impeller; the proximal end of the bracket is provided with There is a connecting secondary tube, the connecting secondary tube is provided with a joint part that runs through at least part of its wall thickness, and the distal end of the catheter is provided with a material part; wherein, the assembly method includes: covering the material part on the outside the joint, heat-melt the material part to form a flow material flowing into the joint, and solidify the flow material to form a connection structure connecting the catheter and the stent.
  • the material portion is naturally cooled to solidify the flowing material.
  • the material part is integrally provided at the distal end of the catheter; wherein, the assembling method includes: sheathing the distal end of the catheter on the outside of the connecting secondary tube, and heat-melting the distal end of the catheter A portion of the catheter material is allowed to flow into the junction, and the material that flows into the junction is cured to form a connecting structure connecting the catheter and the stent.
  • the distal end of the catheter is provided with a clamping wall socket; the distal end of the catheter has an outer tube wall radially outside the clamping wall socket, and has an inner tube wall radially inside the clamping wall socket; wherein, the The assembly method includes: inserting the connecting secondary pipe into the clamping wall socket so that the joint part is located in the clamping wall socket, heat-melting the outer pipe wall to make part of the conduit material flow into the joint part, solidify and flow into the clamping wall socket The material of the junction forms a connecting structure connecting the catheter and the stent.
  • a catheter pump comprising:
  • a pump body including: a pump casing, an impeller housed in the pump casing and driven by the drive shaft; the pump casing includes: a bracket, and a membrane partially covering the bracket;
  • the distal bearing chamber has a built-in distal bearing, and the distal end of the drive shaft is passed through the distal bearing; wherein, the proximal end of the bracket is connected to the distal end of the catheter, and the distal end is formed with a plurality of Interval connection legs, a plurality of connection legs are embedded in the receiving grooves of the outer wall of the distal bearing chamber.
  • the outer fixing sleeve of the distal bearing is provided with a hoop; the hoop is arranged outside the distal bearing chamber and the connecting leg to limit the connecting leg in the receiving groove.
  • the accommodating groove includes a plurality of slots extending in the axial direction, and an annular slot connecting the distal ends of the plurality of slots; the connecting leg includes a rod embedded in the slot and an embedded into the leg end in the annular groove.
  • the outer diameter of is smaller than the outer diameter of the binding section, and a diameter-reducing step is provided between the extending section and the binding section; the accommodating groove is arranged on the outer wall of the binding section; the hoop The sleeve is fixedly sleeved outside the binding section; the distal end bearing is built into the extending section.
  • a method for assembling a pump body of a catheter pump the pump body includes a bracket, an impeller shaft provided with an impeller, and a distal bearing chamber; wherein, the distal end of the bracket is formed with a plurality of spaced connecting legs, and the distal The end bearing chamber is provided with a receiving groove; wherein, the pump body assembly method includes: radially opening a plurality of the connecting legs, and connecting the impeller shaft and the distal bearing chamber from the distal end of the bracket to the proximal end thereof.
  • the connecting leg When passing through, the connecting leg is placed in the receiving groove for positioning, and the connecting leg is limited in the receiving groove when the hoop is sleeved on the outer bearing chamber of the distal end.
  • the distal end of the impeller shaft is passed through the distal bearing chamber; after radially opening a plurality of the connecting legs, the impeller shaft and the distal bearing chamber are moved together from the distal end of the bracket to the proximal end wear.
  • a plurality of connecting legs are radially opened, and the impeller shaft is passed through from the distal end of the support to the proximal end thereof, and then the distal bearing chamber is sent from the distal end of the support to the multiple A connecting leg surrounds and is inserted by the distal end of the impeller shaft.
  • the plurality of connecting legs are opened radially, the distal bearing chamber is sent into the plurality of connecting legs and the receiving groove is aligned with the connecting legs, and the connecting legs are placed on the connecting legs. Position in the receiving slot.
  • the heat-shrinkable tube is sheathed in the outer bearing chamber of the distal end and is heat-shrunk to form the cuff.
  • the present invention has the following beneficial effects:
  • An embodiment of the present disclosure provides a catheter pump, the catheter pump has a motor, a catheter whose proximal end is connected to the motor through a coupler, a drive shaft passing through the catheter, whose proximal end is connected to the motor shaft; and a pump body.
  • the pump body includes: a pump casing, an impeller arranged in the pump casing and connected to the distal end of the drive shaft; the pump casing includes: a bracket connected to the distal end of the catheter at the proximal end, and a film covering the bracket partially; connected to the distal end of the bracket non-invasive support.
  • An embodiment of the present disclosure provides a catheter pump.
  • the first shaft is covered with braided gaps to connect the inside and outside of the first shaft, thereby simultaneously forming an internal and external flow channel for the perfusate to flow. Realize the large-area flow of perfusate and avoid excessive perfusion pressure.
  • the internal and external channels formed by the first shaft through the braided structure flow out at the proximal and distal sides of the impeller respectively, preventing blood from entering the catheter and the drive shaft, stabilizing the blood flow in the pump, reducing the impact on pump efficiency and the occurrence of thrombus risks of.
  • the distal end bearing slides relative to the drive shaft and keeps supporting the drive shaft, preventing the drive shaft from The bearing is protruded inside, which is convenient for the axial extension and folding of the pump body.
  • One embodiment of the present disclosure provides a drive shaft of a catheter pump.
  • a helical groove or a helical protrusion is formed on the outer surface and/or inner surface (outer wall and/or inner wall) of at least part of the length of the drive shaft, and the helical groove or The rotation direction of the protrusion is consistent with the rotation direction of the drive shaft to form a pump effect, pump the perfusate to the distal end, prevent blood from entering at the distal end of the catheter, and avoid thrombus formation at the distal end of the catheter.
  • a connecting secondary tube is provided at the proximal end of the stent, and the connecting secondary tube is provided with a joint part penetrating through at least part of its wall thickness, and the joint part contains a hot melt
  • the bonding material that flows into it and solidifies, the bonding material is arranged at the distal end of the catheter, the thermally melted and solidified bonding material forms at least an axial limit fixation of the catheter and the stent, thereby realizing the stent and the catheter.
  • a mechanical connection which provides a stronger connection than a chemical connection in the form of glue.
  • an embodiment of the present disclosure provides a connection method between a catheter and a stent, by constructing a matching limiting recess and a connecting protrusion between the stent and the catheter, thereby forming a mechanical axial limit and a circumferential limit.
  • the mechanical connection between the stent and the catheter is realized, and the connection strength is higher than that of the chemical connection in the form of glue.
  • the use of the limiting recess can not only save the bonding material at the connecting part of the stent and the catheter, provide more deformation space for deformation, make the connecting part have better flexibility, but also increase the connecting area of the catheter and the stent, so that An axial stop or fixing structure is formed between the catheter and the stent, thereby at least improving the axial connection strength between the catheter and the stent.
  • One embodiment of the present disclosure provides a connection method between the distal bearing chamber and the non-invasive support, by setting an adhesive groove at the distal end of the distal bearing chamber and/or the proximal end of the non-invasive support, thereby increasing the amount of glue The amount and joint area, thereby improving the connection strength between the two.
  • One embodiment of the present disclosure provides a second shaft structure in the pump body. At least the outer wall of the second shaft at the exposed part of the bracket is formed with a helical groove or a helical protrusion. The helical structure is in line with the rotation direction of the drive shaft. Similarly, to form a pump effect, the blood is pumped into the pump casing, so as to prevent the blood from entering the distal bearing chamber in reverse and avoid the formation of thrombus.
  • One embodiment of the present disclosure provides a second shaft structure in the pump body.
  • a spiral groove is formed on the outer wall of the part of the second shaft in the hub cavity.
  • An embodiment of the present disclosure provides a design method of the perfusate input flow channel, wherein the perfusate flows forward in the gap (outer flow channel) between the catheter and the drive shaft, because the first shaft of the drive shaft is liquid permeable structure. Therefore, while the perfusate flows forward, it infiltrates into the inner flow channel of the first shaft. Under the action of the perfusate, blood can be prevented from entering the distal bearing chamber or the non-invasive support, avoiding possible adverse effects such as thrombosis, and at the same time Lubricate the bearings supporting the drive shaft to ensure smooth operation of the bearings.
  • An embodiment of the present disclosure provides a pump body of a catheter pump.
  • the coating does not produce tensile deformation in the radially expanded state, and the coating has strong deformation resistance, and can stably restrain and maintain support in the radially expanded state.
  • the shape of the component maintains the pump clearance, so that the pump body maintains better pump efficiency.
  • An embodiment of the present disclosure provides a novel structure for the distal end of the bracket of a catheter pump.
  • a dispersed leg structure is formed at the distal end of the bracket, which facilitates the installation of the impeller and the impeller shaft (second shaft) at the distal end of the bracket. ), providing a reliable solution for manufacturing and assembling with better practicability for the unfolded and folded pump body.
  • Fig. 1 is a schematic structural diagram of an interventional catheter pump provided by an embodiment of the present invention
  • Fig. 2 is the front view of Fig. 1;
  • Fig. 3 is a perspective view of Fig. 1 without a coating
  • Fig. 4 is the front view of Fig. 3;
  • Fig. 5 is an enlarged view of the pump body without coating in Fig. 4;
  • Fig. 6 is a partially enlarged view of Fig. 5;
  • Fig. 7 is an enlarged view of the pump body without a coating in Fig. 3;
  • Fig. 8 is a schematic diagram of the structure of the pump body in Fig. 2;
  • Fig. 9 is a partial sectional view of Fig. 8.
  • Figure 10 is a perspective view of Figure 8.
  • Fig. 11 is a perspective view of the coating of Fig. 8.
  • Figure 12 is a front view of Figure 11;
  • Fig. 13 is a schematic diagram of the pump body of an interventional catheter pump provided by another embodiment of the present disclosure.
  • Fig. 14 is a graph showing the diameter change of 6 different pump bodies of the present disclosure under fluid back pressure
  • Fig. 15 is a cross-sectional view of a pump body structure provided by an embodiment of the present disclosure.
  • Figure 16 is a partially enlarged view of Figure 15;
  • Figure 17 is a partially enlarged view of Figure 15;
  • Figure 18 is a partially enlarged view of Figure 15;
  • Fig. 19 is a cross-sectional view of a pump body structure provided by an embodiment of the present disclosure.
  • Figure 20 is a partially enlarged view of Figure 19;
  • Figure 21 is a partially enlarged view of Figure 19;
  • Fig. 22 is a cross-sectional view of the structure of the pump body provided by an embodiment of the present disclosure without a coating;
  • Fig. 23 is a schematic perspective view of the bracket in Fig. 22;
  • Fig. 24 is a schematic diagram of the connection secondary pipe structure of Fig. 23;
  • Fig. 25 is a schematic diagram of a stent structure provided by an embodiment of the present disclosure.
  • Fig. 26 is an enlarged schematic diagram of part of the supporting grid in Fig. 25;
  • Fig. 27 is a schematic diagram of cooperation between the distal end of the bracket and the distal bearing chamber in Fig. 25;
  • Fig. 28 is a cross-sectional view of the structure of the pump body provided by an embodiment of the present disclosure without a coating;
  • Fig. 29 is an enlarged schematic diagram of the connection structure of the first shaft and the second shaft 355 in Fig. 28;
  • Fig. 30 is an enlarged schematic diagram of the connection structure between the second shaft and the distal bearing chamber in Fig. 28;
  • Fig. 31 is a schematic diagram of the connection between the stent in Fig. 29 and the catheter.
  • proximal, distal and anterior and posterior used in the present invention are relative to the clinician who manipulates the catheter pump.
  • proximal and distal refer to the part relatively close to the clinician
  • distal refers to the part relatively far away from the clinician.
  • the extracorporeal part is proximal and posterior
  • intervening intracorporeal part is distal and anterior.
  • the catheter pump of the present invention defines “axial” or “axial extension direction” with the extension direction of the output shaft or connecting shaft, drive shaft 300, first shaft 350, and second shaft 355, and the drive shaft 300 includes the first shaft 350 and The second shaft 355 , the axial direction of the driving shaft 300 refers to the axial direction when the driving shaft 300 is adjusted to extend straight.
  • the terms “inner” and “outer” used in the present invention are relative to the axially extending centerline, the direction relatively close to the centerline is “inner”, and the direction relatively far away from the centerline is “outer”.
  • the catheter pump of the embodiment of the present invention is used for assisting heart failure, and can pump blood to the heart to realize part of the blood pumping function of the heart.
  • catheter pumps pump blood from the left ventricle into the aorta to support circulation, reduce the workload on the subject's heart, or provide additional continuous pumping if the heart's pumping capacity is insufficient Hemodynamic support.
  • the catheter pump can also be inserted into other target locations of the subject as desired, such as the right ventricle, blood vessels, or inside other organs, by means of interventional surgery.
  • the catheter pump includes a drive assembly 1 and a working assembly.
  • the drive assembly 1 includes a housing and a motor accommodated in the housing and having an output shaft.
  • the working assembly includes a conduit 3 , a drive shaft 300 passing through the conduit 3 , and a pump body 4 driven by the drive shaft 300 .
  • the driving assembly 1 is arranged at the proximal end of the catheter 3 , connected to the catheter 3 through the coupler 2 , and connected to the pump body 4 through the first shaft 350 passing through the catheter 3 .
  • the driving assembly 1 provides power for the working assembly to drive the working assembly to realize the blood pumping function.
  • the pump body 4 can be delivered to a desired position of the heart such as the left ventricle to pump blood through the catheter 3 , including a pump housing 363 with a blood inlet 403 and a blood outlet 402 , and an impeller 410 accommodated in the pump housing 363 .
  • the impeller 410 is used to provide power for the flow of blood, and the pump housing 363 includes at least a membrane 401 defining a blood flow channel.
  • the pump body 4 has an intervention configuration as well as a working configuration.
  • the pump casing 363 and the impeller 410 are in a radially retracted state, so that the pump body 4 can intervene in the vasculature of the subject with a first outer diameter and/or deliver .
  • the pump casing 363 and the impeller 410 are in a radially expanded state, so that the pump body 4 can deliver blood at a desired position with a second outer diameter dimension larger than the first outer diameter dimension.
  • the pump body 4 includes a radially folded state and a radially expanded state, and the pump casing 363 is operable to switch between the radially folded state and the radially expanded state. Compared with the unstressed state, the coating 401 does not undergo tensile deformation when the pump casing 363 is in the radially expanded state.
  • the impeller 410 includes a hub 412 connected to the distal end of the drive shaft 300 and blades 411 supported on the outer wall of the hub 412 .
  • the blades 411 are wrapped on the outer wall of the hub 412 and at least partly in contact with the inner wall of the pump casing 363 .
  • the blades 411 extend radially outward from the hub 412 and are spaced from the inner wall of the pump casing 363 , preventing the pump casing 363 from affecting the rotation of the blades 411 and preventing the rotation of the blades 411 from damaging the pump casing 363 .
  • the pump housing 363 also includes a bracket 404 for supporting the deployed membrane 401 .
  • the bracket 404 can be set inside the covering film 401 or outside the covering film 401 to support the covering film 401 .
  • the bracket 404 contacts the inner wall of the membrane 401 and expands radially to support and expand the membrane 401 .
  • the covering film 401 in the unstressed state does not produce tensile deformation compared with the covering film 401 in the radially expanded state of the pump casing 363 without stress.
  • the radial expansion state of the pump casing 363 without force is a natural expansion state when the impeller 410 does not rotate.
  • the radially deployed state includes a corresponding naturally deployed state when the impeller 410 is not rotating.
  • the critical point stress at which the coating 401 is stretched and deformed is greater than or equal to the force exerted by the support 404 on the pump casing 363 when it is in a naturally unfolded state. In this way, when only the stent 404 exerts a radial support and expansion force on the coating 401 , since the critical force for tensile deformation of the coating 401 has not been reached, the coating 401 does not undergo tensile deformation in a naturally unfolded state.
  • the radially deployed state also includes a working state corresponding to the rotation of the impeller 410 .
  • the stress at the critical point of tensile deformation of the coating 401 is greater than or equal to the blood back pressure caused by the rotation of the impeller 410 when the pump body 4 is in the maximum working condition The force applied to the film 401.
  • the maximum operating condition of the pump body 4 corresponds to the maximum rotational speed of the impeller 410 under rated power.
  • the pump flow corresponds to the maximum value, and the blood back pressure is also at the maximum value.
  • the maximum value of the blood back pressure still does not exceed the critical point stress of the tensile deformation of the coating 401, and the coating 401 still does not produce tensile deformation when the impeller 410 is rotating, so as to avoid pump clearance Change, stable pump efficiency.
  • the material strength of the covering film 401 itself is sufficient to resist the external expansion force of the stent 404, and then the circumferential tensile deformation of the covering film 401 is 0 when the pump casing 363 is switched from the radially collapsed state to the naturally unfolded state. Produce circumferential tensile deformation.
  • the material strength of the coating 401 itself is sufficient to resist the force exerted on it by the blood back pressure caused by the rotation of the impeller 410, so that the circumferential tension of the coating 401 when the pump casing 363 is switched from the naturally expanded state to the working state is sufficient.
  • the stretch variable is 0.
  • the tensile deformation of the coating 401 in the present invention refers to the length deformation of the coating 401 in the circumferential direction.
  • the circumferential length becomes larger.
  • the flattening of the wrinkles due to the expansion of the stent 404 does not belong to the stretching of the membrane 401 .
  • Wrinkles of the film 401 are often caused by shrinkage. Due to the radial constraint effect of the folded sheath, the membrane 401 is forcibly compressed and folded, thereby causing wrinkles. Of course, this does not rule out the wrinkles of the covering film 401 caused by other factors. For example, it may be formed during manufacture, or self-deformed during placement, or during testing, and so on. Wrinkles may be in the form of eg creases, (fine) wrinkles.
  • the film 401 is made of TPU (thermoplastic polyurethane elastomer) or PEBAX or PTFE (polytetrafluoroethylene).
  • the cover film 401 is made of block polyetheramide resin material such as PEBAX.
  • the coating 401 has no loss of mechanical properties under repeated deformation, is fatigue-resistant, has good rebound and elastic recovery properties, and precise dimensional stability. Furthermore, under the support of the bracket 404, no tensile deformation occurs, and the pump clearance is stably maintained.
  • the coating 401 bears and resists the radial expansion force of the bracket 404 by its own material, and does not produce tensile deformation when the pump casing 363 is in a naturally expanded state, and the tensile deformation is circumferential tensile deformation.
  • the inner diameter or inner cross-sectional area of the membrane 401 in the unstressed state is the same as that in the naturally unfolded state, and has not changed.
  • the membrane 401 is a cylindrical structure that is not supported by the bracket 404 when the pump casing 363 is not stressed. It can also be understood that, compared with the state of stretching the film 401 from the inside to the outside by the support 404 in the natural unfolded state, no stretching deformation occurs, and the stretching deformation amount is 0.
  • the natural unfolding state is compared with the working state in which the impeller 410 rotates to drive the fluid.
  • the impeller 410 rotates to drive blood to flow
  • the blood will generate a certain radial expansion force (fluid back pressure) on the membrane 401 .
  • the pump body 4 includes a radially collapsed state suitable for delivery in the subject's vasculature, a naturally unfolded state corresponding to when the impeller 410 does not rotate, and a working state corresponding to when the impeller 410 rotates.
  • the pump body 4 is switched from the naturally unfolded state to the working state, the blood back pressure on the membrane 401 caused by the rotation of the impeller 410 causes the folds of the membrane 401 to be at least partially flattened.
  • the above-mentioned diameter increase rate of the membrane 401 is the diameter change rate of the membrane 401 when the pump casing 363 is in a naturally unfolded state compared to the working state.
  • the flexibility of the material of the film 401 largely determines the number of wrinkles and the degree of undulation. That is, the worse the flexibility of the material of the coating 401 , the more the number of wrinkles and the greater the undulation of the coating 401 may be.
  • the increase rate of the diameter of the coating 401 is closer to 3%.
  • the better the flexibility of the material of the coating 401 the fewer the number of wrinkles and the smaller the undulation of the coating 401 , and the more the increase rate of the diameter of the coating 401 deviates from 3% when the wrinkles are flattened.
  • the effect of the flattening of the wrinkles on the increase rate of the diameter of the film 401 Contribution may be close to 0.
  • the membrane 401 is integrally formed and can be expanded by the stent 404 .
  • the distal opening of the membrane 401 and the area of the distal end of the stent 404 not covered by the membrane 401 together constitute the blood inlet 403 of the pump casing 363 .
  • the distal end of the covering film 401 is also provided with a connecting strip 19 , and the distal end of the connecting strip 19 is connected to the distal bearing chamber 6 .
  • the connecting strip 19 When the covering film 401 is in a radially expanded state, the connecting strip 19 is roughly in a stretched state.
  • the far and near ends of the film 401 are respectively fixed by the connecting strip 19 and the connecting sleeve 16 of the proximal end 17 of the film 401, so that the film 401 is in an overall straight state in the axial direction, so as to smooth out the wrinkles of the film 401 as much as possible , to provide the smoothest possible inner wall. It is well known that a smooth inner wall is beneficial to the hydraulic performance of the pump.
  • the distal end 18 of the membrane 401 can also be connected to the bracket 404 .
  • the inner wall of the distal end 18 of the membrane 401 is bonded to the outer wall of the stent 404 , and shrinks and expands together with the stent 404 .
  • the bracket 404 When the pump casing 363 is in a naturally unfolded state, the bracket 404 has a contact support portion that contacts the membrane 401 .
  • the stent 404 includes a substantially conical stent 404 proximal end 121 and a stent 404 distal end 123, and a substantially cylindrical Bracket 404 section 122 . Wherein, at least part of the axial length of the bracket 404 section 122 constitutes a contact support portion.
  • the covering film 401 is sheathed outside the bracket 404 section 122 , and is contacted and supported by the bracket 404 section 122 to form a stable cylindrical pump casing 363 .
  • the distal end 18 (end face) of the graft 401 does not protrude beyond the segment 122 of the stent 404 .
  • the impeller 410 rotates to drive blood flow and a natural deployed state in which the impeller 410 is stationary. Due to the different states of the blood (stationary and flowing), the forces acting on the membrane 401 are different. Furthermore, when the impeller 410 rotates and drives the blood to flow, there is not only the supporting force of the stent 404 on the membrane 401, but also the radial push (fluid back pressure) on the membrane 401 caused by the blood being driven by the impeller 410 .
  • the film 401 is flattened due to wrinkles, so that the circumferential direction of the film 401 There is some degree of elongation. This elongation is due to the flattening of the wrinkles, but the coating 401 itself is not stretched and deformed in the circumferential direction.
  • the diameter of the membrane 401 when the pump body 4 is in a working state is larger than the diameter of the pump body 4 in a naturally unfolded state.
  • the diameter is the diameter of the inner cavity enclosed by the coating 401 .
  • In the working state due to the existence of fluid back pressure, at least part of the folds of the coating 401 are flattened, so that the cross-sectional shape of the surrounding internal cavity becomes more circular, and the inner wall of the coating 401 becomes smoother, thereby making the coating
  • the diameter of 401 increases.
  • the blood back pressure exerted on the membrane 401 caused by the rotation of the impeller 410 causes the wrinkles of the membrane 401 to be at least partially flattened.
  • the blood back pressure on the membrane 401 caused by the rotation of the impeller 410 causes the folds of the membrane 401 to be at least partially flattened. This wrinkle is flattened so that the increase rate of the diameter of the covering film 401 does not exceed 3%, further does not exceed 2%, and even does not exceed 1%.
  • the increase rate of the diameter can be seen from the change of the diameters of the 6 groups of coatings 401 (wherein, 1#-A to 3#-C represent the names of different coatings 401 ) under different back pressures in FIG. 14 .
  • each graph shows the diameter of the membrane 401 under two pressure end points and a roughly intermediate pressure. It can be seen from each graph that with the increase of the back pressure, the circumferential direction of the covering film 401 is elongated to a certain extent, but the increase in diameter is within 0.1 mm.
  • the diameter of the coating 401 does not increase.
  • the diameter of the membrane 401 may sometimes remain unchanged or even decrease under a certain pressure range.
  • the coating 401 has a circular but not strictly circular cross-sectional shape in a naturally unfolded state.
  • Corrugations include radially inward depressions and may also have radially outward protrusions. If the selected diameter measurement points are two convex points, the initially measured diameter is larger, and after the folds are flattened, the convexities are flattened, resulting in a phenomenon that the diameter decreases despite the increase of the back pressure.
  • At least a part of the contact support portion is separated from the membrane 401 in a working state.
  • some of the folds of the film 401 are further flattened, and the inner diameter increases to separate from the contact support part.
  • the toughness of the coating 401 itself, no tensile deformation occurs. Further flattening of the wrinkles makes the coating 401 elongate in the circumferential direction, but the variation of the elongation is less than 3%. The change in the circumferential elongation is small, and the gap between the impeller 410 and the coating 401 can still be maintained under the working state, so that the pump efficiency can be maintained continuously and stably.
  • the contact support part provides a circumferential support force for the coating 401 without providing radial and circumferential relative movement constraints, allowing the coating 401 to produce radial or circumferential relative movement relative to the contact support part, so that the coating 401
  • the location in contact with the contact support or bracket 404 changes during deployment.
  • the coating 401 includes a cylindrical section 110 and a proximal tapered section 111 located at the proximal end of the cylindrical section 110 .
  • the axial length of the cylindrical section 110 is greater than that of the proximal tapered section 111.
  • the length of the blood outlet 402 extends from the proximal conical section 111 to the cylindrical section 110 .
  • the proximal end of the proximal tapered section 111 is provided with a connecting sleeve 16 , and the connecting sleeve 16 is connected to the outer wall of the catheter 3 , thereby realizing the connection of the distal end 18 of the membrane 401 .
  • the connecting sleeve 16 can be connected to the conduit 3 by bonding, or hot-melting, or crimping.
  • the connection position between the membrane 401 and the catheter 3 or the connection sleeve 16 is located near the proximal bearing chamber 340 .
  • Part of the blood outlet 402 is located in the proximal tapered section 111 , and another part of the blood outlet 402 is located in the cylindrical section 110 , and a plurality of blood outlets 402 are arranged in the circumferential direction.
  • the blood output from some of the blood outlets 402 located in the cylindrical section 110 forms a centrifugal flow, and the outward flow of multiple blood outlets 402 can stabilize the position of the pump body 4 and stabilize the blood flow.
  • the blood output from the part of the blood outlet 402 located in the proximal conical section 111 roughly forms an axial flow, which together with the part of the blood outlet 402 of the cylindrical section 110 ensures the flow rate of the blood outlet 402 and avoids flow loss.
  • At least part of the axial length of the blood outlet 402 gradually decreases in circumferential width from the distal end to the proximal end.
  • the circumferential width of part of the blood outlet 402 located in the proximal conical section 111 gradually decreases as it extends from the distal end to the proximal end, and the other part of the blood outlet 402 located in the cylindrical section 110 extends from the distal end to the proximal end. Its circumferential width gradually increases as the end extends proximally. As shown in FIG. 13 , in one embodiment, along the direction extending from the distal end to the proximal end, the circumferential width of the blood outlet 402 gradually decreases.
  • the part of the blood outlet 402 located in the proximal tapered section 111 is the rear blood outlet 21
  • the other part of the blood outlet 402 located in the cylindrical section 110 is the front blood outlet 20 .
  • the length of the part of the blood outlet 402 in the proximal conical section 111 is greater than the length of the part in the cylindrical section 110 . That is, the length of the rear blood outlet part 21 is greater than the length of the front blood outlet part 20 .
  • the circumferential width of the front blood outlet part 20 is greater than or equal to the maximum circumferential width of the rear blood outlet part 21 for at least part of its (axial) length.
  • the circumferential width of the downstream position is smaller than or equal to the circumferential width of the upstream position.
  • the proximal end of the blood outlet 402 has a smaller circumferential width than the distal end thereof.
  • the bracket 404 or a single bracket 404 is integrally formed, the bracket 404 and the membrane 401 are separate structures, and at least a part of the bracket 404 is located inside the membrane 401 and contacts the inner wall of the membrane 401 .
  • the bracket 404 When the pump casing 363 is radially expanded without force, the bracket 404 is radially constrained by the membrane 401 and is not fully expanded.
  • the stent 404 is made of memory alloy. After losing the constraint of the sheath tube, the stent 404 restores its shape and stretches the membrane 401 until it is restrained by the membrane 401 and cannot continue to stretch. At this time, the bracket 404 provides a radially outward supporting force to the coating 401 , and the coating 401 relies on its own toughness to resist the deformation of the bracket 404 , does not produce tensile deformation, and maintains shape stability.
  • the folding and unfolding process of the pump body 4 is as follows: During the process of inserting the pump body 4 into the left ventricle, the pump body 4 is in a radially restrained state (folded state) due to the externally applied radial restraint force. Alternatively, the pump head 4 is collapsed only during intervention in the subject's vasculature.
  • bracket 404 uses its own memory characteristics and the blades 411 of the impeller 410 are released by energy storage to expand autonomously, so the pump body 4 automatically assumes its unconstrained shape (expanded state).
  • the stent 404 of the present invention is not limited to a single stent 404 in the membrane 401 , and may also include a plurality of stents 404 dispersedly arranged at different positions in the axial direction to support different parts of the membrane 401 .
  • the bracket 404 has a grid structure, and the design of the multi-mesh holes, especially the diamond-shaped mesh, facilitates the folding and unfolding of the bracket 404 .
  • the impeller 410 is accommodated in the bracket 404 and located in the membrane 401 .
  • the stent 404 is supported on the distal end 18 of the membrane 401 , its distal end or the distal end 123 of the tapered stent 404 is located outside the distal end 18 of the membrane 401 , and the proximal end 121 of the tapered stent 404 and the segment 122 of the stent 404 are located in the membrane 401 .
  • the impeller 410 is arranged on the second shaft 355 , the second shaft 355 is arranged in the bracket 404 , and the distal end is rotatably supported in the distal bearing chamber 6 .
  • the bracket 404 is a spindle structure and provides a supporting space for accommodating the impeller 410 .
  • the proximal end of the stent 404 is connected to the distal end of the catheter 3 , and the proximal end 17 of the membrane 401 is sheathed on the outer wall of the catheter 3 at the proximal side of the stent 404 .
  • the catheter 3 is connected to the proximal end 17 of the bracket 404 through the proximal bearing chamber 340 at its distal end.
  • the proximal bearing chamber 340 is provided with proximal bearings 331 , 332 for rotationally supporting the drive shaft 300 .
  • the distal bearing chamber 6 is arranged at the distal end of the driving shaft 300 and supports the rotation of the distal end of the driving shaft 300 through the distal bearing 62 .
  • the bracket 404 maintains the distance between the proximal bearing chamber 340 and the distal bearing chamber 6 , thereby providing stable rotational support for the second shaft 355 .
  • the distal end of the distal bearing chamber 6 is connected with an atraumatic support member 5 .
  • the non-invasive support member 5 is a flexible tube structure, which is shown as a flexible protrusion with an arc-shaped or coiled end, so that the non-invasive support member 5 is supported on the inner wall of the ventricle in a non-invasive or non-damaging manner, and the pump body 4
  • the blood inlet 403 of the pump body is separated from the inner wall of the ventricle, so as to prevent the suction port of the pump body 4 from adhering to the inner wall of the ventricle due to the reaction force of the blood during the working process, so as to ensure the effective area of pumping.
  • the inner diameter of the hollow lumen 502 of the non-invasive support member 5 is equal to the outer diameter (diameter) of the guide wire, or slightly larger than the outer diameter of the guide wire.
  • the inner diameter of the hollow lumen 502 of the noninvasive support member 5 is 1-1.2 times the diameter of the guide wire.
  • the inner diameter of the hollow lumen 502 is small enough (approximately 0.2-0.9mm), and the resistance of blood entering the lumen is relatively large, which prevents blood from entering the pump body 4 through the non-invasive support member 5, reduces damage to the blood, and facilitates the passage of blood.
  • the blood inlet 403 is input into the pump body 4 .
  • the proximal end of the atraumatic support member 5 is inserted into the distal bearing chamber 6 to form a distal stop for the second shaft 355 .
  • the distal end of the second shaft 355 slidably extends into the distal bearing chamber 6 and is rotatably supported.
  • the proximal end surface of the atraumatic support member 5 constitutes a limit step for limiting the distal end of the second shaft 355 in the distal bearing chamber 6 .
  • the proximal end of the non-invasive support member 5 and the inner wall of the distal bearing chamber 6 can be fixed by bonding. Specifically, the proximal end of the non-invasive support member 5 extends into the distal end of the distal bearing chamber 6 , and is bonded to the distal inner wall of the distal bearing chamber 6 .
  • the proximal outer wall of the non-invasive support 5 and/or the inner wall of the distal bearing chamber 6 are equipped with Glue tank. Increase the amount of glue filled between the two through the glue tank, thereby improving the connection strength between the two.
  • the glue-holding groove is arranged on the proximal outer wall of the non-invasive support member 5 , or on the inner wall of the distal bearing chamber 6 .
  • the glue holding groove can be in various forms, such as discretely distributed dotted grooves, long groove structure or spiral groove.
  • the glue holding groove may be a plurality of linear grooves extending in the axial direction, and the plurality of linear grooves are arranged in parallel along the circumferential direction.
  • the proximal end of the non-invasive support member 5 is cylindrical, and recessed structures are distributed on its side wall to increase the adhesive bonding area and improve the connection strength between the distal bearing chamber 6 and the non-invasive support member 5 Effect.
  • the recessed structure may be a trench or groove, which has a shape such as a circular groove, a polygonal groove, or even an irregularly shaped groove.
  • the distal inner wall of the distal bearing chamber 6 may also have the same concave structure as that of the proximal end of the atraumatic support member 5 , which will not be repeated here.
  • a stopper step is arranged in the distal bearing chamber 6 .
  • the stopper step is formed by a convex structure or a reduced diameter inside the distal bearing chamber 6 .
  • the inside of the distal bearing chamber 6 is a stepped hole, and the stopper step is a reduced-diameter step formed by reducing the diameter.
  • the hole section of the hole section is used for installing the distal end bearing 62, and the distal end opposite to it is used for the proximal insertion assembly and position limiting of the non-invasive support member 5.
  • the distal bearing chamber 6 is provided with a blocking member 550 that can be passed through by a guide wire.
  • the blocking member 550 is located between the stop step and the proximal end of the non-invasive support member 5 and is sandwiched between the two. Furthermore, the blocking member 550 is limited by the stopper step and the proximal end of the atraumatic support member 5, and is kept at this position, and the position is blocked for the guide wire to pass in and out.
  • the location is blocked by the blocking member 550 to prevent the blood from entering the pump body 4 through the non-invasive support member 5 when pumping blood, thereby affecting the effect of blood pumping.
  • the pump body 4 is collapsible. From the perspective of relieving the subject's pain and facilitating intervention, it is desirable that the size of the pump body 4 be small. In order to provide a strong auxiliary function for the subject, it is desired that the pump body 4 has a large flow rate, which generally requires a large size of the pump body 4 .
  • the pump body 4 has a smaller folded size and a larger expanded size, so as to reduce the pain of the subject during the intervention/transportation and facilitate the intervention, as well as provide a large flow rate. Two aspects of demand.
  • the multi-mesh design of the stent 404 can achieve better folding and unfolding by virtue of the memory properties of nickel-titanium alloy.
  • the blade 411 is made of soft elastic material, and stores energy when being folded, and releases the energy stored in the blade 411 to unfold the blade 411 after the external restraint is removed.
  • the pump body 4 is folded by means of external constraints, and after the constraints are removed, the pump body 4 realizes self-deployment.
  • the "collapsed state” refers to the state in which the pump body 4 is radially constrained, that is, the state in which the pump body 4 is radially compressed and folded to a minimum radial size under external pressure.
  • the “expanded state” refers to the state in which the pump body 4 is not constrained radially, that is to say, the state in which the bracket 404 and the impeller 410 are deployed radially outward to the maximum radial size.
  • the retraction of the pump body 4 is realized by the radial restraint force exerted by the folded sheath.
  • the impeller 410 included in the pump body 4 is accommodated in the pump casing 363 . Therefore, in essence, the folding process of the pump body 4 is: the folded sheath exerts a radial constraint force on the pump casing 363 , and when the pump casing 363 compresses radially, it exerts a radial constraint force on the impeller 410 .
  • the pump casing 363 is directly retracted under the action of the folding sheath, while the impeller 410 is directly retracted under the action of the pump casing 363 .
  • the impeller 410 has elasticity. Therefore, despite being in a retracted state, the impeller 410 is retracted to store energy so that it always has a tendency to expand radially, and then the impeller 410 will contact the inner wall of the pump casing 363 and exert a reaction force on the pump casing 363 .
  • the foldable bracket 404 expands the supporting elastic membrane 401 under the action of its own memory characteristics until the restraint of the membrane 401 cannot continue to expand, and the impeller 410 automatically Expand.
  • the outer diameter of the impeller 410 is smaller than the inner diameter of the pump housing 363 .
  • the pump clearance size be kept at a small value.
  • the outer diameter of the impeller 410 is slightly smaller than the inner diameter of the bracket 404 serving as the bracket 404 , so that the pump clearance is as small as possible under the condition that the impeller 410 rotates without hitting a wall.
  • the main means of maintaining the pump clearance is the support strength provided by the bracket 404 and the tensile deformation resistance of the coating 401.
  • the support strength and the toughness of the coating 401 can resist the back pressure of the fluid (blood) without excessive pressure. deformation, and then keep the shape of the pump casing 363 stable, then the pump clearance is also kept stably.
  • the multi-mesh design of the bracket 404 combined with the material of the memory alloy facilitates folding and unfolding.
  • the bracket 404 includes a substantially cylindrical main body section 40 , and substantially conical inlet sections 41 and outlet sections 42 located at two axial ends of the main body section 40 .
  • Mesh holes are distributed on the main body section 40 , the inlet section 41 and the outlet section 42 , and the mesh area of the main body section 40 is smaller than that of the inlet section 41 and/or the outlet section 42 .
  • the coating 401 is interference fit with the stent 404, the distal end of the coating 401 extends from the main body section 40 of the stent 404, the stent 404 and the coating 401 partially overlap in the axial direction, the coating 401 covers most of the stent 404, and only the entrance section 41 is exposed A blood inlet 403 is formed.
  • the proximal end of the membrane 401 is glued to the catheter 3 , and the blood outlet 402 is located at the proximal end of the membrane 401 .
  • the outer wall of the main body section 40 contacts the inner wall of the coating 401 to support the expansion of the coating 401 during expansion.
  • the (at least one) mesh of the main body section 40 has two axially generally opposite first apices 505 , and two pairs of circumferentially generally opposite second apexes 504 .
  • the spacing between the two pairs of second vertices 504 is approximately equal, but smaller than the spacing between the two first vertices 505 .
  • the long-axis direction of the mesh of the main body section 40 is consistent with the axial direction of the bracket 404, and the mesh can be elongated according to the long-axis direction to realize the radial contraction of the bracket 404, which can better adapt to the axial telescopic deformation, and complete the bracket 404 and
  • the controllable and smooth contraction of the covering film 401 can be successfully completed after the desired operation is completed in the body, thereby facilitating removal from the body.
  • the largest dimension of the mesh of the main body section 40 in the axial direction is larger than the largest dimension in the circumferential direction thereof.
  • the maximum size in the circumferential direction of the mesh of the main body segment 40 is 1.2 times to 3 times the maximum size in the axial direction.
  • the two points providing the circumferential dimension are generally circumferentially opposite, and the two points providing the axial dimension are generally axially opposite.
  • the mesh of the main body section 40 is a plurality of supporting meshes 50, and the supporting meshes 50 are closed polygonal holes to form a stable supporting structure and stabilize the pump clearance.
  • the supporting mesh 50 is a polygonal hole with at least two unequal side lengths.
  • the polygonal hole may be an irregular polygonal hole or a mirror-symmetrical polygonal hole, which is not limited in this application.
  • the supporting mesh 50 is a mirror-symmetric structure mesh, and the length direction of the smallest edge is parallel to the axial direction, including two parallel first edges 501 and two parallel second edges 502 .
  • the second vertex 504 is located at least one end point of the second edge 502
  • the first vertex 505 is located at least one end point of the first edge 501 .
  • the supporting mesh 50 may be a quadrangular hole such as a rhombus hole, or may be a hexagonal hole.
  • the supporting mesh 50 has two axial first vertices 505, respectively forming a front crest 510a and a rear crest of a zigzag structure for the first edge 501 and the second edge 502. 510b.
  • the two second vertices 504 are arranged opposite to each other in the circumferential direction, and the first side edge 501 and the second side edge 502 respectively form the left crest and the right crest of the zigzag structure.
  • the supporting mesh 50 also includes two third edges 503 parallel to the axial direction.
  • a third edge 503 is connected between a first edge 501 and a second edge 502, and the first edge 501, the second edge 502, and the third edge 503 form a closed hexagonal support mesh 50.
  • the axial dimension of the support mesh 50 is increased by the third edge 503, so that the axial dimension of the support mesh 50 is the main dimension, and then when it is retracted into the sheath, it can be smoothly folded in the axial direction, reducing the time for folding. resistance.
  • the length of the second edge 502 is equal to the length of the first edge 501
  • the length of the third edge 503 is smaller than the length of the second edge 502 .
  • the third edge 503 is the smallest edge supporting the mesh 50 and provides the smallest edge length of the mesh.
  • the two axial end points of the third edge 503 respectively form the second apex 504, the axial rear end point of the third edge 503 shares with a first edge 501, and the shared end forms a second apex 504, the third The axial distal end point of the edge 503 is shared with a second edge 502 , and the common end point forms another second apex 504 .
  • the circumferential distance between the two third edges 503 is the distance between the two circumferentially opposite second vertices 504 .
  • the common endpoint of the first edge 501 and the second edge 502 forms a first vertex 505 .
  • At least one edge in the first edge 501, the second edge 502, and the third edge 503 is a linear edge as a whole, and a plurality of edges of the mesh form a polygonal mesh, and the edge is overall linear, It can be a straight line without bending as shown in Fig. 11 and Fig. 12 .
  • the edge can also be a straight edge that can still be regarded as a polygon intuitively while allowing a certain slight bending, such as the edge shown in FIG. 13 .
  • edges of the polygonal meshes are linear in structure as a whole.
  • the length range of the first edge 501 is 1mm-2mm
  • the length range of the third edge 503 is 0.15mm-0.35mm
  • the length ratio of the first edge 501 and the third edge 503 ranges from 3:1 to 5: 1.
  • the first apex 505 and the second apex 504 are provided with first and second rounded structures respectively, so that the edge of the support mesh 50 can be smoothly transitioned to form a stable support structure.
  • the arc length of the first rounded structure is greater than the arc length of the second rounded structure.
  • the above values include all values from the lower value to the upper value in increments of one unit for the lower and upper values, with a separation of at least two units between any lower value and any higher value That's it.
  • the stated length of the first edge 501 is in the range of 1mm-2mm, preferably 1.1-1.9mm, more preferably 1.2-1.8mm, and further preferably 1.3-1.7mm.
  • 1mm-2mm preferably 1.1-1.9mm, more preferably 1.2-1.8mm, and further preferably 1.3-1.7mm.
  • a plurality of supporting meshes 50 are sequentially arranged along the circumferential direction to form a supporting eye ring ( 50 a , 50 b , 50 c ), and a plurality of supporting eye rings are arranged along an axial direction to form a main body section 40 .
  • the first edges 501 and the second edges 502 are alternately arranged to form a sawtooth ring 520 in a sawtooth structure, and two axially adjacent sawtooth rings 520 are opposed to form a supporting annular ring.
  • the body section 4050 has three supporting annular rings 50a, 50b, 50c arranged in the axial direction.
  • the sawtooth ring 520 has a front tooth top 510a facing the inlet section 41 and a rear tooth top 510b facing the outlet section 42.
  • a plurality of sawtooth rings 520 are arranged in the circumferential direction.
  • the crest 510 a is arranged opposite to the rear crest 510 b of the other sawtooth ring 520 in the axial direction.
  • each supporting eyelet includes a plurality of hexagonal supporting meshes 50 arranged in the circumferential direction.
  • each supporting eyelet includes a plurality of rhombic supporting meshes 50 arranged in the circumferential direction.
  • the inlet section 41 is located at the front side of the main body section 40 and at the far end of the foldable support 404, and the mesh of the inlet section 41 extends longer between the axial ends than the supporting mesh 50 axial length.
  • the mesh of the inlet section 41 is a flow mesh for blood to flow in.
  • the extension length of the mesh of the inlet section 41 is the extension length from the front end to the rear end of the mesh, not the radial projection length on the axis.
  • the axial length of the supporting mesh 50 in this embodiment is equal to the radial projection length on the axis.
  • the mesh holes of the inlet section 41 include first flow mesh holes 52a and second flow mesh holes 52b alternately distributed along the circumferential direction, and the length of the first flow mesh holes 52a is shorter than the length of the second flow mesh holes 52b.
  • the first flow mesh hole 52a is a closed hole, and the second flow mesh hole 52 is a non-closed hole.
  • the distal end of the inlet section 41 is provided with a front connecting portion 44, which has a dispersed structure or a petal structure (split structure), which can expand in the radial direction to facilitate the impeller 410 to be loaded into the bracket 404 from the distal end.
  • the front connecting part 44 includes a plurality of connecting legs 45 scattered in the circumferential direction, the connecting legs 45 are in a T-shaped structure, and there is a leg gap between two adjacent connecting legs 45, and the leg gap extends from the front connecting part 44 to
  • the inlet section 41 and thus the inlet section 41 also has a dispersed structure or a split structure.
  • Each first flow mesh 52a constitutes a petal body, and the inlet section 41 has a plurality of spaced first flow meshes 52a in the circumferential direction, and two adjacent first flow meshes 52a are separated by a second filter. Mesh 52b.
  • the connecting leg 45 expands outward in the radial direction, it pulls (edges of) the first overflow mesh hole 52a, and spreads the inlet section 41 radially together, so as to facilitate the assembly of the impeller 410 .
  • the far end of the connecting leg 45 has a leg end 452 with a circumferential dimension larger than the leg body 451, the connecting leg 45 can be snapped into the slot 602 on the outer wall of the far-end bearing chamber 6, and the far end of the slot 602 is connected to a The annular groove 603, the leg rod body 451 of the connecting leg 45 is snapped into the slot 602, the leg end 452 is snapped into the annular groove 603, and the scattered multiple connecting legs 45 are fixed in the distal bearing chamber through the hoop 61 6 on.
  • the distal bearing chamber 6 has a stepped tubular structure, and has an extending section 605 extending into the inlet section 41 of the bracket 404 and a binding section 606 outside the inlet section 41.
  • the outer diameter of the protruding section 605 is smaller than the outer diameter of the binding section 606 , forming a proximally reduced diameter step 607 .
  • a plurality of locking grooves 602 extending in the axial direction are provided on the outer wall of the binding section 606 , and the plurality of locking grooves 602 are parallel to each other and arranged in the circumferential direction.
  • a plurality of parallel slots 602 are evenly distributed in the circumferential direction.
  • the depth of the locking groove 602 does not exceed the height of the diameter reducing step 607 .
  • the depth of the locking groove 602 is approximately equal to the (radial) protrusion height of the diameter-reducing step. In this way, the protruding section 605 facilitates the folding of the stent 404, so that the stent 404 is smoothly folded into the sheath.
  • the height of the connecting leg 45 does not exceed the slot 602 . That is, the height of the connecting leg 45 is below the depth of the slot 602 , and then when the connecting leg 45 is snapped into the slot 602 , the connecting leg 45 does not exceed the wall of the binding section 606 , reducing the generation of extra protrusions.
  • the distal end of the locking groove 602 leads into the annular receiving groove 603 , the outrigger body 451 snaps into the linear fitting groove 602 , and the leg end 452 snaps into the annular groove 603 .
  • the side of the leg end 452 is placed in the annular groove 603.
  • the side of the leg end 452 is an arc, and the arc of the arc is equal to the arc of the outer wall of the binding section 606, or, the arc of the arc is The radius of curvature is equal to the radius of the tethering section 606 .
  • the hoop 61 is a sleeve with a cylindrical structure, which is fixedly set outside the binding section 606, and fastens the connecting legs 45 in the slot 602 of the binding section 606 to prevent multiple connecting legs 45 from popping out of the slot 602 .
  • the ferrule 61 is formed by heating a heat-shrinkable tube. Specifically, after inserting the connecting leg 45 into the clamping groove 602 and the annular groove 603, the heat-shrinkable tube is sleeved outside the distal bearing chamber 6, and then the heating process is performed, and the diameter of the heat-shrinkable tube shrinks, and the connecting leg The legs 45 are wrapped around the distal bearing chamber 6 to form a hoop 61 .
  • the distal end of the distal bearing chamber 6 is provided with a spherical structure or a rounded structure to facilitate non-invasive intervention in blood vessels in the body.
  • the distal end of the binding section 606 forms a limiting step to limit the distal end of the cuff 61 .
  • the distal bearing 62 is arranged in the extension section 605 of the distal bearing chamber 6 to prevent the second shaft 355 from coming out of the distal bearing 62 when moving axially, and maintain the rotational support state of the distal bearing 62 to the second shaft 355 .
  • the distal end of the second shaft 355 protrudes from the distal bearing 62 and is located on the distal side of the distal bearing 62 .
  • the ferrule 61 and the binding section 606 can be fixed by threaded connection.
  • threads may be provided on the outer wall of the binding section 606 , and the hoop 61 can be assembled and disassembled by rotating the hoop 61 .
  • anti-rotation pins can also be used for fixing between the hoop 61 and the binding section 606, so as to avoid relative rotation between the two.
  • the assembly method of the pump body 4 is: S1, radially open a plurality of connecting legs 45; S2, pass the second shaft 355 and the distal bearing chamber 6 from the distal end of the bracket 404 to its proximal end; S3, connect the The supporting leg 45 is placed in the groove on the outer wall of the distal bearing chamber 6 for positioning; S4, when the hoop 61 is sleeved outside the distal bearing chamber 6, the connecting supporting leg 45 is limited in the groove.
  • step S1 the connecting leg 45 can be clamped by hand or a clamp and pulled outward, so that a plurality of connecting legs 45 are radially opened, and the front port 46 of the front connecting sleeve 1644 (the front port 46 is a plurality of legs
  • the end 452 is enlarged to facilitate the insertion of the impeller 410.
  • the connecting leg 45 will pull the petal body formed by the first flow mesh 52a on the inlet section 41 to open together, so that the impeller 410 and the second shaft 355 can be put into the support. 404 inside.
  • the second shaft 355 passes through the proximal end until the proximal end of the second shaft 355 passes through the proximal end bearing and stops.
  • the second shaft 355 and the distal bearing chamber 6 can be threaded successively, or can be threaded synchronously (moving together).
  • the second shaft 355 can be assembled with the distal bearing chamber 6 first, and then moved together and inserted into the bracket 404 .
  • the distal end of the second shaft 355 is first passed through the distal bearing chamber 6, and then the plurality of connecting legs 45 are radially opened, and the second shaft 355 and the distal bearing chamber 6 are removed from the distal end of the bracket 404 together. The end moves proximally and penetrates.
  • the impeller 410 is fixedly sleeved on the second shaft 355 .
  • the impeller 410 is sleeved on the second shaft 355, and glue is applied between the hub 412 and the second shaft 355, and the glue is cured Finally, the impeller 410 is fixed on the second shaft 355 .
  • the second shaft 355 and the distal bearing chamber 6 pass through successively. Specifically, after radially opening a plurality of connecting legs 45, the second shaft 355 is first passed through from the far end of the bracket 404 to its proximal end, and then the far-end bearing chamber 6 is sent from the far end of the bracket 404 to the Surrounded by a plurality of connecting legs 45 and inserted by the distal end of the second shaft 355 . Wherein, after the proximal end of the second shaft 355 is passed through and positioned in the proximal bearing, the distal bearing chamber 6 is assembled.
  • a plurality of connecting legs 45 are radially opened, the distal bearing chamber 6 is sent into a plurality of connecting legs 45 and the receiving groove is aligned with the connecting legs 45, and the connecting legs 45 are placed in the accommodation. positioned in the slot.
  • the distal end bearing chamber 6 is fed into the position surrounded by the plurality of connecting legs 45 and stops, the plurality of connecting legs 45 are gathered and placed in the receiving groove one by one.
  • a heat-shrinkable tube is sleeved outside the distal bearing chamber 6 to form a ferrule 61 after heat-shrinking.
  • the blocking member 550 provided in the distal bearing chamber 6 can be passed through by a guide wire. After the guide wire is withdrawn, the blocking member 550 resumes the blocking state.
  • the blocking member 550 can be made of sealing rubber or silica gel.
  • the blocking member 550 is attached to the guide wire to maintain the sealing state.
  • the blocking member 550 Resetting will close the threading hole, and still maintain the blocking state at the position.
  • the blocker 550 is located distally of the distal bearing 62 and, distally of the distal end of the second shaft 355 . There is a certain distance between the blocking member 5 and the distal end of the second shaft 355 to provide an axial movement margin of the second shaft 355 for the second shaft 355 to move axially.
  • the second flow mesh hole 52 b extends from the inlet section 41 to the front connecting portion 44 until an opening 523 is formed at the end of the front connecting portion 44 , and the opening 523 is formed between the two leg ends 452 .
  • Part of the second flow mesh holes 52 b are located at the inlet section 41 , and some of the second flow mesh holes 52 b are located at the front connecting portion 44 .
  • the gap between the two connecting legs 45 constitutes a part of the second flow mesh 52b located at the front connecting portion 44, which is filled by the outer wall protrusion of the distal bearing chamber 6 during installation.
  • the circumferential width of the first flow mesh hole 52a gradually decreases as it extends from the front tooth top 510a toward the junction, and the front junction 525 or the first flow mesh hole 52a does not exceed the transition between the inlet section 41 and the secondary pipe 43 .
  • the second flow mesh hole 52 b includes a front section 521 whose circumferential width remains constant in the axial direction and a rear section 522 whose circumferential width gradually decreases in the axial direction away from the main body section 40 . Wherein, the front section 521 is located at the front connecting portion 44 .
  • the rear section 522 has substantially constant circumferential width as it extends axially.
  • the change rate of the circumferential width of the section (rear section 522 ) of the second flow mesh hole 52 b between the front tooth top 510 a and the intersection point at different positions in the axial direction is less than 10%.
  • the circumferential width of the rear section 522 is greater than or equal to the circumferential width of the front section 521, and there is a transition position between the rear section 522 and the front area, and the transition narrowing position is roughly located between the entrance section 41 and the front section.
  • the transition position of the connecting portion 44 is positioned in the embodiment shown in FIG. 25 .
  • the entrance section 41 includes a plurality of front stretching ribs 528 extending from the front tooth top 510a to the forward connecting portion 44; two adjacent front stretching ribs 528 merge at the ends away from the main body section 40 to form a front meeting point 525 ; a plurality of front meeting points 525 are connected or extended to the connecting leg 45 in one-to-one correspondence.
  • the number of the front tensile ribs 528 is equal to the number of the front crests 510 a of a sawtooth ring 520 , and is twice the number of the connecting legs 45 .
  • the outlet section 42 is substantially similar to the inlet section 41, except that the third flow mesh hole 51a and the fourth flow mesh hole 51b are closed holes. Wherein, the outlet section 42 is located at the proximal end of the foldable support 404 . The mesh of the outlet section 42 extends longer between the axial ends than the axial length of the supporting mesh 50 .
  • the meshes of the outlet section 42 include third flow meshes 51a and fourth flow meshes 51b alternately distributed along the circumferential direction, the shapes or areas of the third flow meshes 51a and the fourth flow meshes 51b are different, The length of the third flow mesh hole 51a is shorter than the length of the fourth flow mesh hole 51b.
  • the proximal end of the outlet section 42 is provided with a connecting secondary tube 43 , which is fixed on the catheter 3 or the proximal bearing chamber by hot-melt or glue, so as to realize the proximal fixation of the bracket 404 .
  • the connecting secondary tube 43 may be provided with a locking hole 431 for buckling the catheter 3 or the outer wall of the proximal bearing chamber 340 .
  • the fourth flow mesh 51b extends from the outlet section 42 to the connecting secondary pipe 43 and forms a closed hole end at the connecting secondary pipe 43 .
  • Part of the fourth flow mesh 512 is located at the outlet section 42
  • part of the fourth flow mesh 511 is located at the connecting secondary pipe 43 .
  • the fourth flow mesh hole 51b extends to the rear end and does not exceed the clamping hole 431 on the secondary pipe 43 .
  • the outlet section 42 includes a plurality of rear stretching ribs 518 extending backward from the rear tooth top 510b, and two adjacent rear stretching ribs 518 meet at the proximal end to form a rear meeting point.
  • a plurality of rear junctions are connected to one by one or extended to the rear spacer as shown in FIG. 25 , and a part of the fourth flow mesh 511 located in the connecting secondary pipe 43 is formed between two adjacent rear spacers.
  • the number of rear stretching ribs 518 is equal to the number of rear crests 510b of a sawtooth ring 520, and is twice the number of connecting legs 45 or rear spacer bars.
  • the circumferential width of the third overflow mesh 51a gradually decreases as it extends from the rear tooth top 510b toward the rear intersection, and the rear intersection or the second overflow mesh 52b does not exceed the transition portion between the outlet section 42 and the secondary pipe 43 .
  • the circumferential width of the fourth flow mesh hole 51b at the part connecting the secondary pipe 43 remains unchanged in the axial direction, and the circumference of the section between the rear tooth top 510b and the rear intersection point of the fourth flow mesh hole 51b
  • the change rate of the width at different axial positions is less than 10%.
  • the bracket 404 in FIG. 23 is different from the grid of the bracket 404 in FIG. 25 , the rear stretching rib 518 of the outlet section 42 extends to the rear side and does not enter the connecting secondary pipe 43 .
  • the third flow mesh holes 51 a and the fourth flow mesh holes 51 b are basically distributed in the outlet section 42 of the bracket 404 , and extend proximally without exceeding the transition portion between the outlet section 42 and the connecting secondary pipe 43 .
  • An outer flow channel 600 is formed between the outer wall of the drive shaft 300 and the inner wall of the conduit 3 , and the drive shaft 300 is provided with an inner flow channel 800 extending therewith.
  • the outer channel 600 is provided with a first outlet 608 at the distal end of the catheter 3
  • the inner channel 800 is provided with a second outlet 810 at the distal end of the drive shaft 300 .
  • the distal end of the inner flow channel 800 is provided with a diffusion section 820 , and the port of the diffusion section 820 is the second discharge port 810 .
  • the diffuser section 820 is in the shape of a trumpet hole, and its cross-sectional area gradually increases as it extends from the proximal end to the distal end.
  • At least one of the outer flow channel 600 and the inner flow channel 800 communicates with the perfusate input part 20 , and the perfusate is input into the outer flow channel 600 and the inner flow channel 800 through the perfusate input part 20 .
  • the wall of the drive shaft 300 is provided with a communication portion connecting the inner flow channel 800 and the outer flow channel 600 , the outer flow channel 600 and the inner flow channel 800 are separated by the wall of the drive shaft 300 and communicated through the communication portion.
  • the output structure can be simplified, and it is easy to manufacture.
  • the flow area of the perfusate can be increased through the communication part, the perfusion pressure can be reduced, and the adverse effects caused by excessive perfusion pressure can be avoided, and it can also ensure The perfusion flow ensures the normal and smooth progress of the interventional operation.
  • the communication part comprises a wall of the drive shaft 300 within the conduit 3 through which at least part of the length of the drive shaft 300 is permeable.
  • the outer flow channel 600 extends from the proximal end of the catheter 3 to the distal end of the catheter 3
  • the inner flow channel 800 extends from the proximal end of the drive shaft 300 to the distal end of the drive shaft 300, and both the outer flow channel 600 and the inner flow channel 800 are continuous flow channels .
  • the cross section of the outer flow channel 600 is roughly a (circular) annular structure.
  • the cross-sectional shape of the inner runner 800 can be circular or polygonal, or even irregular. In this embodiment, the cross-section of the inner channel 800 is circular, and the catheter 3 and the drive shaft 300 are arranged coaxially when the catheter 3 is straightened, and the cross-section of the outer channel 600 is circular.
  • the proximal end of the conduit 3 communicates with the perfusate input part 20, so as to communicate the proximal end of the outer channel 600 with the perfusate input part 20.
  • the outer flow channel 600 is a high-pressure flow channel
  • the inner flow channel 800 is a low-pressure flow channel.
  • the perfusate penetrates through the wall of the drive shaft 300 and enters the inner flow channel 800 under the action of the pressure difference, and flows forward through the inner flow channel 800 until it enters the to the second discharge port 810 .
  • the proximal end of the drive shaft 300 is blocked proximally of the perfusate inlet 20 . In this way, the perfusate entering the drive shaft 300 is prevented from flowing proximally and causing leakage.
  • the perfusate input part 20 is the perfusate input port on the coupler 2 , and the perfusate input port is connected with an input channel.
  • the perfusate input port 21 communicates with the lumen of the catheter 3 through the input flow channel, and the drive shaft 300 passes through this part, and sealing measures are provided on the proximal side of the input flow channel (upstream of the power transmission direction) to prevent the perfusate from getting close to each other. side leaks.
  • the coupler 2 is connected to the proximal end of the catheter 3 , and there is a fluid channel between the catheter 3 and the drive shaft 300 ; the coupler 2 is also provided with a perfusate input part 21 communicating with the fluid channel.
  • the catheter pump also includes an irrigation channel that runs substantially through the entire working assembly. Specifically, the perfusion channel runs through the transmission link from the drive shaft 300 to the pump body 4 .
  • fluid can be injected into the perfusion channel.
  • the above-mentioned fluid is the perfusion fluid (Purge fluid) that needs to be perfused into the subject during the operation of the catheter pump.
  • Physiological saline, glucose solution, anticoagulant, or any combination of the above play a role in lubricating and cooling the transmission link.
  • the distal end of the coupler 20 is provided with a retaining sleeve 260 through which the catheter 3 passes, and the retaining sleeve 260 can further fix the catheter 3 .
  • the perfusate input part 20 includes a perfusion flow channel (participating in forming a perfusion channel) and a perfusion port 201 provided on the coupler 20 .
  • the proximal entrance of the perfusion channel is the perfusion port 201 provided on the coupler 20 .
  • the cavity inside the coupler 20 can be perfused with fluid, and the fluid lubricates and cools down the proximal end of the drive shaft 300 . Therefore, the perfusion channel lubricates and cools the transmission link from the starting point of the transmission link of the working component to ensure the effective work of the working component.
  • the present application is not limited to the embodiment in which the outer flow channel 600 communicates with the perfusate input part 20 .
  • the inner flow channel 800 communicates with the perfusate input part 20, and the perfusate in the inner flow channel 800 flows radially outward to the outer flow channel 600, specifically, the inner flow channel of the drive shaft 300 800 communicates with the extracorporeal perfusate input part 20, the proximal end of the drive shaft 300 is connected to the output shaft of the motor through the connecting shaft, the output shaft and the connecting shaft form a hollow structure, and the output shaft of the motor passes through its tail end to provide perfusion Liquid input interface.
  • the drive shaft 300 includes a first shaft 350 and a second shaft 355 connected, and the stiffness of the second shaft 355 is greater than that of the first shaft 350 .
  • the first shaft 350 is a flexible shaft, which can also be called a soft shaft, so as to facilitate the penetration into the blood vessel to adapt to the structure of the blood vessel for bending, so as to send the distal pump assembly to a desired position.
  • the second shaft 355 is a rigid shaft, which can also be referred to as a hard shaft or an impeller shaft. It cooperates with the proximal bearings 331, 332 and the distal bearing 4501 on both sides to provide stable support for the impeller 410, so that the impeller 410 is in the pump housing 363. The position achieves the desired stability.
  • the proximal end of the first shaft 350 passes through the catheter 3 and is connected with the output shaft of the motor through a connecting shaft.
  • the second shaft 355 is fixedly sheathed by the impeller 410 .
  • the impeller 410 has blades 411 and a hub 412 , the hub 412 is fixedly sleeved on the second shaft 355 and driven to rotate by the second shaft 355 .
  • connection position of the stent 404 and the catheter 3 is located near the second shaft 355 .
  • the proximal end of the stent 404 is provided with a connecting secondary tube 43, and the catheter 3 is connected to the connecting secondary tube 43, and the specific connection method can be thermal fusion or buckle connection.
  • the catheter 3 is connected to the secondary connecting tube 43 through the proximal bearing chamber 330 , a feasible way is to bond the distal end of the catheter 3 to the proximal bearing chamber 330 , and the connecting secondary tube 43 is snapped to the proximal bearing chamber 330 .
  • the second shaft 355 passing through the hub 412 is a hard shaft, which is not prone to bending deformation. Therefore, in order not to make the second shaft 355 with greater rigidity affect the bending performance of the working part of the front end of the blood pump (including the pump assembly and the front end catheter 3 part inserted into the human body), the proximal end of the second shaft 355 is located at the end of the bracket 404 The inside of the proximal end or the inside of the connecting secondary tube 43 , but does not protrude from the connecting secondary tube 43 . That is, the proximal end of the second shaft 355 is located in the secondary connection tube 43 and does not protrude from the secondary connection tube 43 .
  • the folded pump component is relatively rigid and generally cannot be bent. Then, during the intervention process, the bending of the pump assembly needs to be realized by the bending of the catheter 3 connected thereto.
  • the proximal end of the second shaft 355 is located inside the proximal end of the stent 404 or inside the connecting secondary tube 43, so that the proximal end of the second shaft 355 does not protrude from the connecting secondary tube 43 and enters the catheter 3 too much, Therefore, the rigidity of the catheter 3 will not increase due to the gain effect of the second shaft 355, which makes the distal part of the catheter 3 connected to the secondary tube 43 still maintain better flexibility, thereby ensuring the pump assembly during the intervention. cornering performance.
  • the distal end of the first shaft 350 and the proximal end of the second shaft 355 are connected by a plug-in method such as a non-circular cross-sectional structure, allowing relative axial movement between the first shaft 350 and the second shaft 355, and transmitting rotation .
  • a plug-in method such as a non-circular cross-sectional structure
  • the first shaft 350 has a rectangular female socket
  • the second shaft 355 has a rectangular male plug, and the two are plugged together to achieve a connection that allows relative movement in the axial direction and can transmit rotation.
  • the communication portion extends from the proximal end of the first shaft 350 to the distal end of the first shaft 350 .
  • the first shaft 350 is made of weaving, its wall is a liquid permeable structure, and the communication part is a weaving slit all over the wall of the first shaft 350 .
  • the first shaft 350 is a multi-layer braided structure, eg, a layer-by-layer wrapping of 2, 3, 4 or more layers.
  • the multiple braided layers of the first shaft 350 are nested layer by layer, and the braided layers are spiral braided. Among them, the helical directions of two adjacent braided layers are opposite.
  • the multi-layer braided structure is a roughly helical twisted structure, and the inner and outer braided layers are opposite in direction of rotation.
  • first shaft 350 By arranging the first shaft 350 with a braided and twisted structure with two inner and outer adjacent layers of braiding in opposite directions, a helical groove or protrusion is formed on the outer surface of the first shaft 350, and the spiral groove or helical protrusion has a helical groove.
  • the rotation direction of the drive shaft 300 is opposite to that of the driving shaft 300 to form a pump effect, pump the perfusate to the distal end, and prevent blood from entering at the distal end of the catheter 3 and prevent thrombus formation at the distal end of the catheter 3 .
  • the communication part extends around the circumference and the axial direction of the first shaft 350 and connects the outer flow channel 600 and the inner flow channel 800 through liquid penetration.
  • At least part of the wall of the drive shaft 300 located in the conduit 3 is a liquid permeable structure.
  • the first shaft 350 is a liquid-permeable structure as a whole, and the wall of the part of the first shaft 350 sheathed by the catheter 3 constitutes a communication part where the inner flow channel 800 and the outer flow channel 600 communicate. There is always liquid communication or liquid penetration from the inner flow channel 800 and the outer flow channel 600 extending to the connecting portion of the first shaft 350 and the second shaft 355 .
  • the outer wall of the first shaft 350 included in the driving shaft 300 is formed with a helical structure, which can be a helical protrusion or a helical groove, and the helical direction is opposite to that of the driving shaft 300 .
  • a helical structure which can be a helical protrusion or a helical groove, and the helical direction is opposite to that of the driving shaft 300 .
  • the helical structure is a left-handed thread.
  • the helical structure is a right-handed thread.
  • the perfusate first flows forward in the outer channel 600 , that is, inside the catheter 3 or outside the first shaft 350 .
  • a portion of the perfusate seeps into the first shaft 350 , that is, the inner channel 800 .
  • the pump effect formed by the helical structure on the outer wall of the first shaft 350 when rotating can generate a forward force on the perfusate in the outer channel 600 to ensure smooth flow of the perfusate and avoid congestion of the perfusate.
  • the inner wall of the first shaft 350 may also be formed with such a helical structure.
  • the helical structure formed by the outer wall and/or inner wall of the first shaft 350 may be composed of the above-mentioned helical braiding layer.
  • the braiding layer is generally helically braided from a single-strand material, and the cross-section of the single-strand material is roughly circular, so that spiral protrusions or grooves are naturally formed on the braided surface.
  • the protrusion is the outer contour of the single-strand material, and the groove is formed between the woven materials.
  • the helical direction of the innermost braided layer is opposite to the rotational direction of the first shaft 350 , so that a helical structure conforming to the above description can be formed on the inner wall of the first shaft 350 . That is, when viewed from the proximal end to the distal end, when the drive shaft 300 rotates clockwise, the helical structure on the innermost braiding layer is a left-handed thread. Or, in the case of counterclockwise rotation of the drive shaft 300, the helical structure on the innermost braided layer is a right-handed thread.
  • the helical directions of the innermost and outermost braided layers are the same.
  • the number of braided layers contained in the first shaft 350 should be an odd number greater than 1, for example, 3 or 5 layers.
  • the helical direction of the outermost braided layer is designed in the opposite direction to the rotation direction of the first shaft 350, so that the outermost helical braided layer tends to move due to the action of torque during rotation. Tighten tightly to avoid loosening of the outermost braid.
  • the diameter of the braid layer whose helical direction is opposite to the rotation direction of the first shaft 350 tends to become smaller. If all the helical braided layers of the first shaft 350 are opposite to the rotation direction of the first shaft 350 , the diameter of the first shaft 350 cannot be stably maintained as the working time prolongs.
  • the first shaft 350 includes a braided layer whose helical direction is the same as its rotating direction, and the diameter of the braided layer tends to increase due to torque during rotation, or tends to loosen.
  • the braiding layer whose helical direction is opposite to the rotation direction of the first shaft 350 exerts an inward compressive force on the inner braiding layer
  • the braiding layer whose helical direction is the same as the rotation direction of the first shaft 350 exerts an outward compressive force on the outer braiding layer. expansion force.
  • the diameter change or force action of adjacent braided layers can be offset at least partially, so that the diameter of the first shaft 350 can be stably maintained.
  • the stable maintenance of the diameter of the first shaft 350 is beneficial to the stable shape of the outer flow channel 600 , thereby making the flow rate and flow area of the perfusate stable.
  • the scheme of forming the helical structure by means of the helical braiding structure of the first shaft 350 described above is illustrative and cannot be construed as a unique limitation. That is, in other alternative embodiments, for example, the outer wall and/or inner wall of the first shaft 350 is a flat or smooth wall, and a spiral groove or protrusion is formed on the flat or smooth wall by machining. It is also feasible to form the above-mentioned helical structure in a manner of starting.
  • connection position between the distal end of the first shaft 350 and the proximal end of the second shaft 355 is located in the distal end of the catheter 3, and the two can be connected by any suitable method such as welding, and of course other transmission connection methods such as splines can also be used. It is only necessary for the two to be able to drive and rotate.
  • the second shaft 355 has an exposed portion 3556 whose wall surface is exposed in the bracket 404 , and at least part of the wall surface of the exposed portion 3556 is provided with a first helical structure 3558 .
  • the first helical structure 3558 is located at the far side of the hub 412 and may be a helical groove or a helical protrusion.
  • the direction of rotation of the first helical structure 3558 is the same as the direction of rotation of the second shaft 355 . Viewed from the direction of the proximal end to the distal end, in the case of the second shaft 355 rotating clockwise, the first helical structure 3558 is a right-handed thread, or, in the case of the second shaft 355 rotating counterclockwise, the first helical structure 3558 is a left-hand thread.
  • the first helical structure 3558 forms a pumping effect during rotation, which provides the blood with a driving force in the same direction as the impeller 410, pumps the blood in the pump casing 363, and prevents the blood from flowing in reverse and entering the distal bearing Chamber 6, to avoid hemolysis and thrombus formation.
  • the second shaft 355 has a first non-exposed portion 3555 sleeved within the hub 412 .
  • at least part of the wall surface of the first non-exposed portion 3555 is provided with a recessed structure 3554 .
  • the concave structure 3554 is disposed on the outer wall of the second shaft 355 and may have various forms, such as a groove structure, discretely distributed dotted grooves, a long groove structure, and the like.
  • the concave structure 3554 can increase the adhesive area and improve the connection strength between the hub 412 and the second shaft 355 .
  • the concave structure 3554 is a spiral groove structure, and forms a continuous spiral groove structure with the first spiral structure 3558 . That is to say, the continuous spiral groove structure extends from the inside of the hub 412 to the outside of the hub 412
  • the second shaft 355 has a second non-exposed portion 3557 sleeved in the distal bearing chamber 6 , and at least part of the wall surface of the second non-exposed portion 3557 is provided with a second helical structure 3559 .
  • the second helical structure 3559 can be a helical groove or a helical protrusion, and the helical direction is the same as the rotation direction of the second shaft 355 . Viewed from the proximal end to the distal end, when the second shaft 355 rotates clockwise, the second helical structure 3559 is a right-handed thread, or, when the second shaft 355 rotates counterclockwise, the second helical structure 3559 is a left-hand thread.
  • the second helical structure 3559 forms a pump effect during rotation, which provides the blood with a driving force in the same direction as the impeller 410, preventing the blood from flowing in reverse and entering the distal bearing chamber 6, and avoiding hemolysis and thrombus formation .
  • the concave structure 3554, the helical structure 3558 and the helical structure 3559 can form a continuous helical groove structure. That is, a continuous helical groove structure is distributed on the side wall surface of the distal end of the second shaft 355.
  • the part of the continuous helical structure in the hub 412 forms a concave structure 3554, and the part in the bracket 404 forms a helical structure 3558.
  • the part in the distal bearing chamber 6 forms a helical structure 3559 .
  • the continuous helical structure (3554, 3558, 3559) has achieved corresponding technical effects in three different positions, which will not be repeated here.
  • the continuous helical structure ( 3554 , 3558 , 3559 ) is turned in the same direction as the second shaft 355 is turned. Viewed from the proximal end to the distal end, when the rotation of the driving shaft 300 is clockwise, the continuous helical structure is right-handed, or when the rotation of the driving shaft 300 is counterclockwise, the helical structure is left-handed.
  • the continuous helical structure (3554, 3558, 3559) on the second shaft 355 has a start at the proximal end of the hub 412 and an end at the distal end (approximately the port position) of the second shaft 355, and proceeds along the direction of power transmission. Different segments are presented that are occluded, exposed, and occluded again.
  • the value range of the depth of the spiral groove is 0.05-0.2mm.
  • the communication part extends around the circumference and the axial direction of the first shaft 350 and connects the outer flow channel 600 and the inner flow channel 800 through liquid penetration.
  • At least part of the wall of the drive shaft 300 located in the conduit 3 is a liquid permeable structure.
  • the first shaft 350 is a liquid-permeable structure as a whole, and the wall of the part of the first shaft 350 sheathed by the catheter 3 constitutes a communication part where the inner flow channel 800 and the outer flow channel 600 communicate. There is always liquid communication or liquid penetration from the inner flow channel 800 and the outer flow channel 600 extending to the connecting portion of the first shaft 350 and the second shaft 355 .
  • the connecting portion of the first shaft 350 and the second shaft 355 is located at the proximal side of the proximal bearing chamber 340 , between the proximal bearing chamber 340 and the second shaft 355 to form a communication path connecting the outer flow channel 600 with the first outlet 608 .
  • the proximal bearing chamber 340 is located at the distal end of the catheter 3 , and is provided with a first proximal bearing 331 and a second proximal bearing 332 distal to the first proximal bearing 331 . In other embodiments, it is not excluded that there are one or more proximal bearings.
  • the proximal bearings 331 and 332 are sheathed on the second shaft 355 , and the first outlet 608 is located at the far side of the proximal bearing 332 .
  • the outer wall of the drive shaft 300 is provided with a stopper 356 that can move axially between the proximal bearings 331 and 332, and the stopper 356 is a stopper located on the outer wall of the drive shaft 300.
  • a stop flow gap is formed between the outer wall of the stopper 356 and the inner wall of the proximal bearing chamber 340 .
  • the first discharge port 605 is located distally of the second proximal bearing 332 .
  • the communication path includes the internal flow gap of the first proximal bearing 331 , the stop flow gap, and the internal flow gap of the second proximal bearing 332 .
  • the first proximal bearing 331 and the second proximal bearing 332 themselves have flow gaps that can be passed by fluid, and do not form a blockage for the passage of fluid.
  • a first fluid gap may also be formed between the first proximal bearing 331 and the outer wall of the second shaft 355, and a third fluid gap may be formed between the second proximal bearing 332 and the outer wall of the second shaft 355, which further facilitates fluid flow.
  • first space between the stopper 356 and the first proximal bearing 331 , and the first space communicates the stop flow gap with the first proximal bearing 331 .
  • second space between the stopper 356 and the second proximal bearing 332 , and the stop flow gap communicates with the second proximal bearing 332 .
  • a tortuous perfusate output path is constructed through the first proximal bearing 331, the stopper flow gap and the second proximal bearing 332 to slow down the flow rate and impact pressure of the perfusate, and avoid damage or other adverse effects caused by rapid entry into the subject.
  • the proximal bearing chamber 340 for installing the proximal bearings 331 , 332 can be replaced by other structures, such as the distal part of the catheter 3 or the connecting secondary tube 43 of the bracket 404 . Then in this embodiment, the proximal bearing chamber 340 can be eliminated, and the proximal bearings 331 , 332 are installed in the distal end of the catheter 3 or in the connecting secondary tube 43 .
  • the proximal bearing chamber 340 for installing the proximal bearings 331 , 332 , the distal portion of the catheter 3 or the connecting secondary tube 43 can constitute a proximal bearing installation component.
  • the proximal bearing installation part includes the proximal bearing chamber 340 , the distal portion of the catheter 3 or the connecting secondary tube 43 , and the present application is not limited solely to the additional distal bearing chamber 6 .
  • the distal end of the second shaft 355 is rotatably supported in the distal bearing chamber 6 , and the distal end of the bracket 404 is connected to the distal bearing chamber 6 .
  • the second discharge port 810 is located in the distal bearing chamber 6 , and the perfusate discharge port is formed between the proximal end of the distal bearing chamber 6 and the drive shaft 300 .
  • a flow gap is formed between the distal bearing 62 and the drive shaft 300 (second shaft 355).
  • the blocking member 550 is located between the distal end of the second shaft 355 and the proximal end of the atraumatic support member 5 .
  • the perfusion fluid in the inner flow channel 800 is discharged from the second discharge port 810 into the distal bearing chamber 6, and due to the presence of the blocking member 550, it can only flow in the reverse direction, and then flows through the distal bearing 62 to lubricate it, and then Then the perfusate is discharged from the distal bearing chamber 6 through the outlet of the perfusate, enters the bracket 404, and finally enters the human body.
  • the perfusate discharged from the perfusate discharge port can form a high-pressure zone within a certain range at the proximal end of the distal bearing chamber 6, thereby preventing blood from entering the distal bearing chamber 6 and preventing the formation of thrombus.
  • Occluder 550 is a flexible check valve, such as a check valve, provided with a resealable channel through which a guidewire can pass, and the resealable channel is closed after the guidewire threading is removed to maintain the occlusion in place state.
  • the flexible hemostatic valve can be made of blocking rubber or silicone.
  • the blocking member 550 can constitute an axial limit for the second shaft 355 , and limit the position far from the dead center of the axial movement of the blocking member 550 .
  • the stopper 356 when the stopper 356 is in contact with the second proximal end bearing 332, the distal end of the second shaft 355 is not in contact with the blocking member 550, and the two are spaced apart to avoid Axial movement of the second shaft 355 destroys the blocking member 550 .
  • no blocking member 500 may be provided between the second discharge port 810 and the atraumatic support member 500, and the inside of the distal bearing chamber 6 will be the second discharge port 810 communicates with hollow lumen 555 .
  • the distal port of the atraumatic support 500 constitutes a perfusate outlet.
  • the distal bearing 4051 can also form a perfusion fluid discharge path, and a perfusion fluid discharge port is formed on the proximal side of the distal bearing 4051.
  • the end port and the proximal side of the distal bearing 4051 are vented outward.
  • the perfusate flows out through the second discharge port 810 and enters the non-invasive support 500, and is discharged from the distal port of the non-invasive support 500 and the proximal side of the distal bearing 4051, while preventing blood from entering into the non-invasive support when the pump assembly is working.
  • the atraumatic support member 500 and the distal bearing chamber 6 are examples of the atraumatic support member 500 and the distal bearing chamber 6 .
  • the pump body 4 is folded with a sheath, and the specific folding scheme is to push the sheath forward and force the pump to be folded through axial movement.
  • the sheath exerts a huge axial force between the stent 404 and the catheter 3 .
  • This requires that the stent 404 and the catheter 3 must have a higher bonding strength. Otherwise, it is very easy for the sheath to push back the pump and break away from the catheter 3 .
  • the tortuous path through which the interventional procedure passes requires that the entire catheter 3 assembly has a better bend, including the connection between the bracket 404 and the catheter 3 should also have better bendability.
  • the proximal end of the stent 404 is provided with a connecting secondary tube 43 connected to the distal end of the catheter 3 .
  • the connection position between the stent 404 and the catheter 3 is located near the hard shaft 355 (second shaft 355 ), and the proximal end of the hard shaft 355 is located in the connecting secondary tube 43 and does not protrude from the connecting secondary tube 43 . In this way, improving the flexibility of the part of the connecting secondary tube 43 near the hard shaft 355 can improve the bending performance of the catheter 3 assembly.
  • the connecting secondary tube 43 located at the proximal end of the stent 404 is provided with a joint part penetrating through at least part of its wall thickness.
  • the joint portion presents a concave structure on the connecting secondary pipe 43 to form a receiving space.
  • the distal end of the catheter 3 is provided with a hot-melt and solidified joint material contained in the joint part.
  • a proximal bearing 330 supporting the drive shaft 300 is disposed inside the connecting secondary tube 43 , and the connecting secondary tube 43 is configured as a proximal bearing installation component.
  • the proximal bearing 330 is directly arranged in the connecting secondary tube 43, and is positioned by the positioning part provided on the connecting secondary tube 43, so that no additional proximal bearing chamber is required, which is beneficial to reduce the number of stacked layers at this part and improve the bending performance.
  • the connecting secondary tube 43 is sheathed outside the distal end of the catheter 3 .
  • An intermediate connecting sleeve 16 is sheathed on the outside of the connecting secondary pipe 43 .
  • the intermediate connecting sleeve 16 and the connecting secondary pipe 43 and the conduit 3 are in a separate structure.
  • the connecting secondary pipe 43 is connected to the conduit 3 through the additionally provided intermediate connecting sleeve 16 .
  • the bonding material is formed by solidifying after the intermediate connection sleeve 16 is melted.
  • the connecting sub-pipe 43 is provided with a joint that runs through at least part of its wall thickness. The joint is filled with a joint material that flows into and solidifies after being melted.
  • Part of the intermediate connecting sleeve 16 is located on the proximal side of the connecting secondary tube 43 and is fixedly sleeved outside the catheter 3 . Specifically, part of the intermediate connecting sleeve 16 is glued and sleeved on the outer wall of the conduit 3 after thermal melting, or part of the intermediate connecting sleeve 16 is glued to the outer wall of the conduit 3, or, the outer wall of the conduit 3 is provided with an accommodating part of the intermediate connecting sleeve 16 via The embedding groove formed by solidification after hot melting.
  • connection between the part of the intermediate connecting sleeve 16 and the conduit 3 may be through hot-melt connection or other connections, which are not particularly limited in this embodiment.
  • connection method between the intermediate connecting sleeve 16 and the catheter 3 can also refer to the connection method between the bonding material and the joint part, and will not be repeated here.
  • the bonding material is a structure in which part of the catheter 3 is formed by heat-melt solidification or thermocompression.
  • the bonding material is heated to soften the distal wall of the catheter 3 during thermocompression molding, and the softened wall of the catheter 3 is formed into a local convex deformation by the press tool, embedded inward into the joint, and the bonding material is formed after cooling and solidification.
  • the melting point of the bonding material is the same as or close to the melting point of the material of the conduit 3 .
  • the bonding material is the same material as the conduit 3 , or both the bonding material and the conduit 3 are resin materials.
  • the bonding material is similar to or the same as the main material of the catheter 3 .
  • the proximal end of the bracket 404 is provided with a first connecting portion 421, which is used for connecting the catheter 3.
  • the distal end 301 of the catheter 3 is provided with a second connecting portion 321 .
  • One of the first connecting portion 421 and the second connecting portion 321 is provided with a connecting protrusion 323 , and the other is provided with a limiting recess for engaging with the connecting protrusion 323 .
  • the limiting recess fixes the embedded connecting protrusion 323 at least in the axial upper limit. Further, the limiting recesses limit and fix the connecting protrusion 323 in the axial and circumferential directions. That is, the limiting recess is connected with the connection protrusion 323 , thereby realizing the connection between the catheter 3 and the bracket 404 .
  • the first connecting portion 421 and the connecting secondary pipe 43 are integrally formed, that is, the first connecting portion 421 is integrally formed on the connecting secondary pipe 43 .
  • the second connecting portion 321 is integrally formed with the catheter 3 , that is, the second connecting portion 321 is integrally formed at the distal end 301 of the catheter 3 .
  • the second connecting portion 321 is a locking protrusion (connecting protrusion 323 ) protruding radially inward.
  • the connection protrusion 323 is molded by hot-melt solidification.
  • the connecting protrusion 323 can also be formed by hot pressing.
  • the wall surface area of the first connecting portion 421 is smaller than the side area of a cylinder with the same axial length and diameter.
  • the limiting recess is a recessed structure provided on the connecting secondary pipe 43 .
  • the position-limiting recess is radially recessed, and then constitutes a female snap on one side of the axial direction to limit the connection protrusion 323 in the axial direction.
  • the concave structure is a through-hole structure, and may also be a groove structure.
  • the depression is a through hole through which the wall connecting the secondary pipe penetrates. Specifically, the limiting depression penetrates the wall connecting the secondary pipe radially.
  • the depression is the connection hole 435 .
  • the first connecting portion 421 has a plurality of connecting holes 435 arranged along the axial direction, and the plurality of connecting holes 435 are parallel to each other.
  • the wall of the proximal end of the connecting hole 435 in the axial direction constitutes a male buckle.
  • the secondary connecting pipe 43 is made of memory alloy, and a female hole (connecting hole) made of metal can be provided for the connecting protrusion 323 of the conduit 3 to be snapped in as a male buckle.
  • connection hole 435 is a long hole structure, and its length direction extends along the circumferential direction.
  • the central angle corresponding to the connecting hole 435 is greater than 180 degrees.
  • the circumferential two ends of the connection hole 435 are arranged opposite to each other at intervals.
  • the connecting hole 435 has a first hole end 4351 and a second hole end 4352 in the circumferential direction. The first hole end 4351 and the second hole end 4352 are arranged at intervals.
  • Two adjacent connecting holes 435 in the axial direction are at least partly staggered. Two adjacent connecting holes 435 in the axial direction are at least partially overlapped. In this way, on the basis of maintaining the structural strength of the first connecting portion 421 , the use of materials is reduced, thereby enabling better flexibility of the connecting portion.
  • the two adjacent connecting holes 435 are arranged in a staggered manner, so that the connecting part connecting the secondary tube 43 and the catheter 3 has better resistance to axial tensile damage, and prevents the sheath from disengaging the pump body 4 from the catheter 3 .
  • the hole spacer 437 between two adjacent connecting holes 435 .
  • the hole spacer 437 extends continuously in the circumferential direction, and separates the two connection holes 435 from each other, thereby forming a closed connection hole 435, that is, the connection hole 435 is a closed hole, and the hole wall is continuously extended to form a closed hole. circumferential long holes.
  • the axial width of the hole spacer 437 is not smaller than the axial width of the connecting hole 435 .
  • connection holes located on both axial sides of a connecting hole are aligned.
  • the connection hole 435a is aligned with the hole end of the connection hole 435b in the axial direction, and the space between the two connection holes 435a, 435b is centrally set relative to the connection hole 435c.
  • the length of the end spacer 436 in the circumferential direction is greater than the width of the connection hole 435 in the axial direction.
  • the circumferential length (length in the circumferential direction) of the end spacer 436 is smaller than the circumferential length of the connection hole 435 .
  • the projections of the end spacers 436 along the axial direction are all located in the adjacent connecting holes 435 .
  • the first hole end 4351 and the second hole end 4352 have a chamfered structure
  • the lengths of two adjacent connecting holes 435 may be equal or unequal. In this embodiment, the lengths of the plurality of connection holes 435 are equal, and two adjacent connection holes 435 are staggered to form a hole-like structure that is staggered on the connection secondary pipes 43 .
  • Two adjacent connecting holes 435 have overlapping portions along the axial direction. Wherein, the circumferential length of the overlapping portion 4355 is greater than the width of the connecting hole 435 in the axial direction. As shown in FIG. 23 and FIG. 24 , the connecting hole 435 has overlapping portions 4355 on both sides of the end spacer 436 in the circumferential direction, and the overlapping portions 4355 on both sides have a mirror-image symmetrical structure.
  • a connecting hole 435 is spaced between two adjacent end spacers 436 .
  • two adjacent connection holes 435 have overlapping portions 4355 in the circumferential direction, and of course may also have staggered portions.
  • the overlapped portions 4355 on both sides of the end spacer 436 are a first overlapped portion and a second overlapped portion, and the first and second overlapped portions are mutually mirror symmetrical structures.
  • the circumferential lengths of the end spacers 436 and the first overlapping portion or the second overlapping portion are substantially equal. In this embodiment, the total length of the end spacer 436 , the first overlapping portion and the second overlapping portion in the circumferential direction is approximately half of the circumference.
  • the connecting secondary tube at the proximal end of the stent 404 is provided with a plurality of connecting holes 435 , which can provide space for the stent 404 to avoid deformation and make the stent 404 more flexible.
  • first connection part 421 and the second connection part 321 are also fixed by bonding.
  • the second connecting portion 321 also has an adhesive surface that is bonded to the first connecting portion 421 .
  • the second connecting portion 321 forms an adhesive surface after being solidified by thermal melting.
  • the bonding structure for bonding the first connection part 421 and the second connection part 321 is formed by thermally melting the first connection part 421 .
  • the connecting secondary tube 43 at the proximal end of the stent 404 is provided with a plurality of connecting holes 435 , which are inserted into the clamping hole at the distal end 301 of the catheter 3 .
  • the material of the catheter 3 flows into the opening by hot-melt technology, so that the catheter 3 and the bracket 404 are fused together.
  • the connecting secondary pipe 43 of the bracket 404 is provided with a proximal bearing 330 or a proximal bearing chamber, and the connecting secondary pipe 43 of the bracket 404 or the proximal bearing chamber is provided with a proximal bearing 330 for the drive shaft 300 to pass through.
  • connection hole 435 can also be a spiral hole, extending helically at the proximal end of the connection secondary tube 43 .
  • the secondary connecting pipe 43 may be provided with a single helical connection hole, or a plurality of connection holes may extend in parallel and helically.
  • the connection hole is an axially extending long hole; a plurality of long holes are arranged along the circumferential direction.
  • the position-limiting depression is not limited to a hole-like structure.
  • the first connecting portion 421 is provided with a hook-like structure.
  • the proximate end of the hook-shaped structure, the hook edge and the protrusion of the second connecting part 321 are axially contacted and limited, and kept in engagement.
  • the hook structure formed by the hook edge of the first connecting part 421 and the protrusion of the second connecting part 321 prevents the stent 404 from being separated from the sheath tube, so that the stent 404 can be completely retracted. Fold into the sheath.
  • connection hole can also be an irregular hole, as long as it can connect the protrusion 323 structure to form an axial mechanical contact limit, so that the catheter 3 and the stent 404 form a more stable connection structure, and prevent the stent 404 from being folded and being blocked by the sheath. Push away to ensure that the pump body 4 is smoothly received into the sheath.
  • the distal end 301 of the catheter 3 and the proximal end of the stent 404 may also be connected through an intermediate connecting sleeve 16 .
  • the distal end 301 of the catheter 3 is connected with the intermediate connecting sleeve 16
  • the second connecting portion 321 is located on the intermediate connecting sleeve 16 .
  • the proximal end of the intermediate connecting sleeve 16 is fixedly sleeved on the distal end 301 of the catheter 3
  • the distal end 301 of the intermediate connecting sleeve 16 is fixedly sleeved on the proximal end of the bracket 404 .
  • the distal end 301 of the catheter 3 is provided with a connecting hole such as that described above, and correspondingly, the proximal end of the bracket 404 is provided with a connecting hole such as that described above, and the intermediate connecting sleeve 16 forms a protrusion embedded in the connecting hole by thermal melting , and connect the catheter 3 and the bracket 404 at the same time, so that the intermediate connecting sleeve 16 not only forms a mechanical hook structure with the distal end 301 of the catheter 3 , but also forms a mechanical hook structure with the proximal end of the bracket 404 .
  • the second connection part 321 is sleeved outside the first connection part 421, and the second connection part 321 is formed into a molten state by thermal melting, and the material of the conduit 3 in the molten state flows into the connection hole of the first connection part 421 to cool and solidify to form a connection protrusion. 323 to form a connection between the first connecting portion 421 and the second connecting portion 321 .
  • the second connecting part 321 still presents a sleeve structure as a whole in the heat-fused state, and the ring is covered outside the second connecting part 321 (connecting the proximal end of the secondary tube), and part of the material flows into the connecting hole to cool to form a connecting protrusion 323 , and the second connecting portion 321 will form an adhesive structure with the first connecting portion 421 after thermal melt cooling.
  • the distal end 301 of the catheter 3 is further provided with a third connecting portion 322 on the radial inner side of the first connecting portion 421 which is made of the same or similar material as the second connecting portion 321 .
  • the material of the conduit 3 produced by melting the second connection part 321 enters into the connection hole and contacts the third connection part 322 through the connection hole.
  • the third connection part 322 is located at the innermost side. With the same material or similar material as the second connection part 321, the melted catheter 3 material forms a firm bonding structure or an integrated structure with the third connection part 322 after cooling and solidification, and then passes through A closed annular connection structure is constructed to form a closed structure for the proximal end of the catheter 3 , which reduces the risk of prolapse in the radial direction when embedded in the connection hole, and further enhances the joint strength of the catheter 3 and the stent 404 . Specifically, the third connecting portion 322 is integrated with the catheter 3 and is formed at the distal end 301 of the catheter 3 .
  • the wall of the distal end 301 of the catheter 3 is provided with a (clamping wall) jack, the radially outer side of the jack is the second connecting portion 321, and the outer side of the jack is a second connecting portion 321.
  • the radial inner side is the third connecting portion 322 .
  • the insertion hole forms an insertion port on the end surface of the distal end 301 of the catheter 3, and the proximal end of the bracket 404 is inserted into the insertion hole from the insertion port.
  • the radial sides of the first connecting portion 421 are provided with a catheter 3 wall, and the outer tube wall 321 constitutes the second connecting portion 321, the inner tube wall 322 constitutes the third connecting portion 322, and the insertion hole is a clamping wall hole.
  • the second connection part 321 has a heat-melt protrusion (connection protrusion 323 ) protruding radially inward into the connection hole, and the inner end of the heat-melt protrusion is connected to the third connection part 322 .
  • the depth of the insertion hole is greater than the axial length of the first connection portion 421 , so that the entire number of connection holes enters the insertion hole.
  • the third connecting part 322 By providing the third connecting part 322, the structural damage of the second connecting part 321 due to heat fusion damage can be avoided.
  • the third connecting part 322 is located on the innermost side and cooperates with the second connecting part 321 to securely connect the proximal end of the bracket 404. .
  • An embodiment of the present disclosure provides a method for assembling the bracket 404 and the catheter 3 of the catheter pump.
  • the drive shaft 300 for driving the impeller 410 to rotate is passed through the conduit 3 .
  • the bracket 404 is used to support the expanded membrane 401 to form a rotating space for accommodating the impeller 410 .
  • the proximal end of the bracket 404 is provided with a connecting secondary tube 43 .
  • the connecting secondary pipe 43 is provided with a joint portion penetrating through at least part of its wall thickness.
  • the distal end of the catheter 3 is provided with a material portion.
  • the material part can be a tubular or sleeve-like structure with a flat surface, and after being melted, the material part is thermally melted and solidified to form the above-mentioned bonding material, the surface presents a concave-convex structure, and the joint with the concave structure The part forms an embedded fitting structure of at least the axial upper limit.
  • the assembly method includes: S10, covering the material part outside the joint part; S20, forming the flow material flowing into the joint part with the hot-melt material part; S30, solidifying the flow material to form a connection structure connecting the catheter 3 and the bracket 404 .
  • step S10 the material part covering the joint part can be covered outside the joint part by means of adhesive contact or peripheral sheathing, etc., so that the flow material formed in the subsequent hot melting can easily flow into the joint part, forming an embedded convex structure. connection structure.
  • step S30 natural cooling or low-temperature cooling may be used to solidify the flowing material.
  • the material part is naturally cooled to solidify the flowing material. That is, the connection structure connecting the conduit 3 and the bracket 404 is formed by natural cooling after the material part is thermally fused.
  • the material part covers the outside of the joint part, and the positions of the two parts are not mutually limited at least in the axial direction, and a connection structure connecting the two parts is formed by thermal melting and solidification.
  • connection structure reference may be made to the bonding materials described in other embodiments.
  • the material portion is integrally provided at the distal end of the catheter 3 .
  • the connection structure is a structure in which part of the conduit 3 is formed by heat-melting solidification or thermocompression. That is, the assembling method includes: S10', sheathing the distal end of the catheter 3 outside the connection secondary pipe 43; S20', melting the distal end of the catheter 3 to allow part of the material of the catheter 3 to flow into the joint; S30', solidifying and flowing into the joint The material of the part forms the connecting structure connecting the catheter 3 and the bracket 404.
  • the distal end of the catheter 3 is provided with a clamping wall insertion hole.
  • the distal end of the catheter 3 has an outer tube wall 321 (second connecting portion 321 ) radially outside the clamping wall insertion hole, and an inner tube wall 322 (third connecting portion 322 ) radially inside the clamping wall insertion hole.
  • the assembly method includes: S10", inserting the connecting secondary pipe 43 into the socket of the clamping wall so that the joint is located in the socket of the clamping wall; S20", melting the outer pipe wall to make part of the material of the conduit 3 flow into the joint; S30" 1.
  • the solidified material flowing into the junction forms a connecting structure connecting the catheter 3 and the bracket 404 .
  • the secondary connecting pipe 43 is provided with a proximal bearing chamber on the far side (front side) of the first connecting portion 421 .
  • the proximal bearing chamber is located between the first connecting portion 421 and the outlet section 42 .
  • a proximal bearing 330 is installed in the proximal bearing chamber.
  • the proximal bearing chamber is a circular sleeve structure.
  • a proximal bearing chamber is also provided in the connecting secondary pipe 43, and a proximal bearing 330 (first proximal bearing 331, second proximal bearing 332) is fixed in the proximal bearing chamber 340, so as to
  • the drive shaft 300 is rotatably supported.
  • the connecting secondary tube 43 is further provided with a positioning portion (connecting buckle 431 ) on the far side of the first connecting portion 421 .
  • the positioning part positions and fixes the proximal bearing 330 located in the connecting secondary tube 43 ; the proximal bearing 330 is sleeved outside the drive shaft 300 to support the drive shaft 300 in rotation.
  • the outer wall of the proximal bearing 330 is provided with a matching portion engaged with the positioning portion.
  • the positioning part and the matching part form a buckle structure.
  • the proximal bearing 330 is directly fixed in the connecting secondary tube 43 .
  • a connecting buckle 431 positioning part, male buckle
  • a card groove 336 fitting part, female buckle
  • the proximal bearing 330 is located in the connecting secondary tube 43 , and is buckled into the slot 336 on the outer wall of the proximal bearing 330 by the connecting buckle 431 as a male buckle to limit the axial position of the proximal bearing 330 .
  • proximal bearing 330 is fixed at the desired position at the proximal end of the bracket 404 (connecting the secondary tube) through interference fit, and the position of the proximal bearing is further limited by the connecting buckle 431 to avoid axial movement of the proximal bearing 330. bit.
  • a retaining ring 357 is fixed on the proximal side of the proximal bearing 330 inside the connecting secondary pipe 43 .
  • the retaining ring 357 is in contact with the distal end surface of the third connecting portion 322 to limit the position.
  • the distance between the retaining ring 357 and the drive shaft 300 is greater than the distance between the proximal bearing 330 and the drive shaft 300 .
  • the connecting secondary pipe 43 is provided with a clamping hole 432 , and the connecting buckle 431 is disposed in the clamping hole 432 and protrudes radially inward.
  • the first connecting portion 421 is located on the proximal side (rear side) of the connecting buckle 431 .
  • the connecting buckle 431 has a substantially rectangular structure, and correspondingly, the locking hole 432 also has a rectangular structure.
  • the distal end 301 of the connecting buckle is fixed on the secondary connecting pipe 43 , and the other sides are separated from the edge of the clamping hole, thereby allowing the connecting buckle 431 to move elastically to a certain extent in the radial direction.
  • the connecting hole 435 and the connecting buckle 431 are formed by cutting on the bracket 404 , or are integrally cast with the bracket 404 , which is not limited in this application. There is a certain distance between the first connecting portion 421 and the connecting buckle.
  • the distal end 301 of the catheter 3 is provided with a rotation support structure, and the rotation support structure includes at least one proximal end bearing 330 for the drive shaft 300 to pass through to support the drive shaft 300 in rotation.
  • the rotating support structure has a spaced limiting member and the rotating supporting structure. At least one of the stopper and the rotation support structure is a proximal bearing 330 .
  • the distal end 301 of the catheter 3 is fixed with a proximal bearing chamber 340 (also referred to as a proximal bearing sleeve), and the proximal bearing chamber 340 is opposite to the catheter 3 and the bracket 404
  • the connecting secondary tube of the bracket 404 is set outside the proximal bearing chamber 340, and the proximal bearing chamber 340 is provided with a first proximal bearing 331 as a limiter and a second proximal bearing as a rotating support structure 332.
  • the distal end 301 of the catheter 3 has a connecting end, the proximal bearing chamber 340 is sleeved on the connecting end, and the connecting secondary pipe is fixedly sleeved outside the proximal bearing chamber 340, that is, the proximal end of the proximal bearing chamber 340 is sleeved on the
  • the connection between the secondary tube and the connecting end of the catheter 3 is relatively fixed, and the proximal bearing chamber 340 provides rigid support for the proximal bearings (the first proximal bearing 331 and the second proximal bearing 332), facilitating the installation of the proximal bearings .
  • the connecting end is formed with a reduced diameter relative to the main body of the catheter 3, and there is a stopper step formed between the connecting end and the main body of the catheter 3, which can provide a stop limit when the secondary tube 43 and the proximal bearing chamber 340 are installed. Reminding that the installation is in place, it can also avoid protruding from the surface of the catheter 3 after installing the proximal bearing chamber 340 and connecting the secondary tube, which will adversely affect the blood flow and reduce the damage probability of the protrusion to the film 401 when it is folded.
  • the limiting member is a retaining ring 357 fixedly arranged at the distal end of the catheter 3 ; the rotating supporting member is a proximal bearing 330 .
  • the width of the gap between the retaining ring 357 and the drive shaft 300 is greater than the width of the gap between the rotating support (proximal bearing 330 ) and the drive shaft 300 .
  • the retaining ring 357 is located proximally of the proximal bearing 330 .
  • the connecting secondary tube 43 of the bracket 404 is connected to the proximal bearing chamber 340 through buckles, and the proximal bearing chamber 340 is connected to the catheter 3 through glue.
  • the outer wall surface of the proximal bearing chamber 340 has an elongated groove extending in the axial direction, and the elongated groove is aligned with the sensor wiring hole in the catheter 3 .
  • a stopper 356 is fixed on the outer wall of the drive shaft 300 .
  • the stopper 356 is located between the limiter and the rotation support structure.
  • the stopper 356 moves within an axial range defined by the limiter and the rotation support structure.
  • the stopper 356 is axially interposed between the limiter and the rotation support structure, and the axial distance between the limiter and the rotation support structure is the same as that of the stopper 356 in the axial direction. equal in length.
  • the distal end 301 of the stopper 356 is in contact with the rotating support structure for a limit, and the proximal end is in contact with the limiter for a limit.
  • the stopper 356 is clamped and limited by the limiter and the rotation support structure, so that the axial position of the second shaft 355 connected to the stopper 356 is limited.
  • the proximal end of the second shaft 355 can be prevented from being disengaged from the distal end 301 of the first shaft 350 .
  • the outer wall of the stopper 356 is spaced a certain distance from the inner wall of the proximal bearing chamber (the inner wall of the proximal bearing chamber 340 or the inner wall of the connecting secondary tube) to form a perfusate flow gap.
  • the distal end of the bracket 404 slides on the second shaft 355 together with the distal bearing 62 and the distal bearing chamber 6, so that the length of the bracket 404 becomes longer and enters in a reduced size. folded state.
  • the distal end 3551 of the second shaft 355 extends to the distal side of the distal bearing 62 for a certain distance in the radially unfolded state.
  • the distal end 3551 of the second shaft 355 is at a certain distance from the blocking member 550 to facilitate the outflow of perfusate.
  • the pump body 4 has a radially folded state and a radially expanded state.
  • the distal bearing 62 slides relative to the drive shaft and keeps supporting the drive shaft, and the axial length of the bracket 404 becomes longer to enter the folded state with reduced size, and The drive shaft cannot be disengaged from the distal bearing 62, so that the repeatable execution of folding and unfolding is ensured, so that the pump body 4 can be smoothly inserted into the body, and can be smoothly folded and removed from the body after the operation is completed.
  • the drive shaft includes a first shaft 350 with less rigidity and a second shaft 355 with greater rigidity. Proximal connection.
  • the impeller 410 is fixedly sleeved on the second shaft 355 .
  • the distal end of the bracket 404 slides along the drive shaft together with the distal bearing chamber 6 and the distal bearing 62 .
  • the distal end of the bracket 404 slides along the second shaft 355 together with the distal bearing chamber 6 and the distal bearing 62 .
  • the rigid second shaft 355 can provide sliding support for the bracket 404 , the distal bearing chamber 6 and the distal bearing 62 .
  • the distal end surface 3552 of the drive shaft is located at the distal side of the proximal end surface of the distal bearing 62 .
  • the distal end surface 3552 of the drive shaft is located distal to the distal end surface of the distal bearing 62 .
  • the distal end surface 3552 of the second shaft 355 is located at the far side of the proximal end surface of the distal bearing 62 .
  • the distal end surface 3552 of the second shaft is located distally of the distal end surface of the distal bearing 62 .
  • the distance between the distal end surface 3552 of the drive shaft and the proximal end surface of the distal bearing 62 is L1; The distance between them is L2, and L1 is greater than L2. More specifically, in the unfolded state, the distance between the distal end surface 3552 of the second shaft and the proximal end surface of the distal bearing 62 is L1; The distance between the proximal end surfaces of the bearings 62 is L2, and L1 is greater than L2.
  • the blocking member 550 can also constitute an axial limit for the second shaft 355 to limit the position far from the dead center of the axial movement of the blocking member 550 .
  • the stopper 356 in the above-mentioned embodiment exists, when the stopper 356 is in contact with the second proximal end bearing 332, the distal end of the second shaft 355 is not in contact with the blocking member 550. spaced apart so as to prevent the axial movement of the second shaft 355 from damaging the blocking member 550 .
  • the distal end surface 3552 of the second shaft 355 is at least on the far side of the proximal end surface of the distal bearing 62 to ensure that the second shaft 355 will never escape from the distal bearing 62 .
  • the distance between the distal end surface 3552 of the second shaft 355 and the proximal end surface 621 of the distal bearing 62 is greater than that of the distal end surface of the second shaft 355 in the radially collapsed state. 3552 and the distance between the proximal end face 621 of the distal bearing 62 .

Abstract

本公开提供一种用于对心脏发生功能衰竭时进行辅助的导管泵，能够明显减少血液损伤的不良事件。其中，一种导管泵，包括：马达；导管，近端连接至所述马达；驱动轴，被所述马达驱动；泵体，包括：连接至所述导管远端的泵壳、收纳在所述泵壳内的叶轮；所述泵壳包括：支架、部分覆盖所述支架的覆膜；近端轴承，设于所述支架的近端；远端轴承，设于所述支架的远端；其中，所述驱动轴包括：可转动的穿设在所述导管中的第一轴、与所述叶轮连接的第二轴；所述第二轴的刚度大于第一轴的刚度；所述第一轴的近端与所述马达的转动轴传动连接，远端与所述第二轴的近端连接；所述第二轴的近端和远端分别穿设在所述近端轴承和远端轴承中。

Description

导管泵 技术领域
本发明涉及医疗器械领域，特别地涉及一种心脏辅助用途设备，更特别地，涉及一种介入式导管泵及其泵体。
背景技术
心脏衰竭是一种威胁生命的疾病，一旦恶化至晚期，一年死亡率约为75％。鉴于晚期心脏衰竭的心脏供体有限，心室辅助设备技术已成为搭起受试者和移植手术之间的可行治疗或替代治疗选择。但是当前技术导致的不良事件仍然限制了心室辅助设备用于重症受试者的治疗。
在这些不良事件中与血液损伤的不良事件，例如溶血神经性事件、中风和泵内血栓形成，占20％的发生率，溶血和形成血栓主要归因于旋转式血泵中的过高生理应力和流动停滞。尽管可以通过液压设计优化来改善血液相容性，但对于带有血液浸没式轴承的旋转式血泵来说，旋转部件和固定部件之间的直接接触是不可避免的，很难对血液损伤的不良事件起到本质的改善作用。
发明内容
鉴于上述不足，本发明的一个目的在于提供一种用于对心脏发生功能衰竭时进行辅助的导管泵，以明显减少血液损伤的不良事件。
为达到上述目的，本发明采用如下技术方案：
一种导管泵，包括：
马达；
导管，近端连接至所述马达；
驱动轴，被所述马达驱动；
泵体，包括：连接至所述导管远端的泵壳、收纳在所述泵壳内的叶轮；所述泵壳包括：支架、部分覆盖所述支架的覆膜；
近端轴承，设于所述支架的近端；
远端轴承，设于所述支架的远端；
其中，所述驱动轴包括：可转动的穿设在所述导管中的第一轴、与所述叶轮连接的第二轴；所述第二轴的刚度大于第一轴的刚度；所述第一轴的近端与所述马达的转动轴传动连接，远端与所述第二轴的近端连接；所述第二轴的近端和远端分别穿设在所述近 端轴承和远端轴承中。
优选地，支架的近端设有近端轴承室；近端轴承在近端轴承室内支撑第二轴的近端。
优选地，所述支架的近端设有与所述导管远端连接的连接次管；所述连接次管构成所述近端轴承室，所述近端轴承内置于所述连接次管。
优选地，所述支架的近端设有连接次管；所述近端轴承室与所述导管的远端连接；所述近端轴承室固定套设在所述连接次管内。
优选地，所述连接次管与所述支架为一体结构。
优选地，支架的近端还设有与近端轴承轴向间隔设置的限位件；驱动轴上固定设有止挡件；止挡件位于所述近端轴承和限位件之间，被所述近端轴承和限位件轴向限位。
优选地，限位件为另一近端轴承；或者，限位件为固定设于近端轴承室内的挡圈。
优选地，所述限位件为另一近端轴承。此时，止挡件位于俩近端轴承之间。
优选地，所述限位件为固定设于所述近端轴承室内的挡圈；所述挡圈与所述驱动轴之间的间隙宽度大于所述近端轴承与所述驱动轴之间的间隙宽度。
优选地，所述挡圈位于所述近端轴承的近侧。
优选地，所述止挡件为固定套设在所述驱动轴上的止挡环。
优选地，所述止挡件的近端与所述限位件接触限位，并且，所述止挡件的远端与所述近端轴承接触限位。限位件与近端轴承将止挡件无间隙夹紧，如此第二轴被固定。
优选地，所述止挡件可轴向移动地设于所述近端轴承和限位件之间，所述近端轴承和限位件将所述止挡件的轴向移动范围限定。
优选地，所述第一轴为编织结构。
优选地，所述第一轴包括逐层套设的多个编织层；每层所述编织层为螺旋绕丝形成。
优选地，相邻两个编织层的旋向(螺旋绕丝的螺旋延伸方向)相反。
优选地，第一轴在其外壁上设有螺旋结构；螺旋结构的旋向与所述驱动轴的旋转方向相反。具体的，从近端向远端的方向观察，在第一轴顺时针旋转的情况下，所述螺旋结构为左旋螺纹，或者，在第一轴逆时针旋转的情况下，所述螺旋结构为右旋螺纹。
优选地，螺旋结构为螺旋凹槽或螺旋凸起。优选地，螺旋结构通过编织形成。
优选地，最外层的编织层的旋向与所述驱动轴的旋转方向相反。具体的，从近端向远端的方向观察，在驱动轴顺时针旋转的情况下，最外层的编织层的旋向为左旋螺旋结构，或者，在驱动轴逆时针旋转的情况下，最外层的编织层的旋向为右旋螺旋结构。
优选地，所述止挡件与近端轴承(第二近端轴承)接触限位时，轴连接部位于限位 件(第一近端轴承或者挡圈)的远端端面的近侧。此时，止挡件位于远死点位置。
优选地，第二轴的近端通过缩径形成所述连接部；连接部的远端具有缩径台阶；止挡件与近端轴承(第二近端轴承)接触限位时，缩径台阶位于限位件的远端端面的近侧。
优选地，止挡件与近端轴承(第二近端轴承)接触限位时，缩径台阶与第一轴的远端端面之间的轴向间距大于止挡件和限位件之间的轴向间距。
优选地，所述止挡件与所述限位件接触限位时，所述缩径台阶与第一轴的远端端面之间间隔一定距离。优选地，所述缩径台阶的径向厚度小于配接通道的导管壁的壁厚。
优选地，所述第一轴的远端的内壁通过扩径形成所述配接通道；所述配接通道的近端具有扩径台阶；所述扩径台阶的径向厚度大于所述轴连接部的壁厚。
优选地，所述止挡件与近端轴承(第二近端轴承)接触限位时，所述扩径台阶与所述连接部的近端端面之间的轴向间距大于所述止挡件和所述限位件之间的轴向间距。优选地，止挡件与限位件接触限位时，扩径台阶与连接部的近端端面之间间隔一定距离。
优选地，支架的远端连接有内置远端轴承的远端轴承室；泵体在展开状态与收折状态之间切换时，远端轴承室及远端轴承相对第二轴滑动并保持支撑第二轴。
优选地，所述支架的远端设有多个沿周向排布的连接支腿；多个所述连接支腿围绕在所述远端轴承室的周侧与所述远端轴承室连接。
优选地，远端轴承室的外壁设有供连接支腿嵌入的容纳槽；远端轴承室外固定套设有箍套，箍套套设在轴承轴套及所述连接支腿外将连接支腿限位在容纳槽内。
优选地，所述箍套为热缩管。
优选地，所述容纳槽包括多个沿轴向延伸的卡槽、以及连通多个所述卡槽的远端的环形槽；所述连接支腿包括嵌入到所述卡槽中的杆体以及嵌入到所述环形槽中的腿端。
优选地，所述腿端与所述杆体呈T形结构。
优选地，所述远端轴承室包括伸入段和束缚段；所述伸入段位于所述束缚段的近侧，所述伸入段的外径小于所述束缚段的外径，所述伸入段和所述束缚段之间设有变径台阶；所述容纳槽设于所述束缚段的外壁上；所述箍套固定套设在所述束缚段外；所述远端轴承内置于所述伸入段。
优选地，所述叶轮包括固定套设于第二轴上的轮毂、以及设于轮毂上的叶片。
优选地，所述轮毂胶粘于所述第二轴上。
优选地，第二轴具有壁面暴露在支架中的暴露部；暴露部的至少部分壁面上设有沿轴向螺旋延伸的第一螺旋结构；所述第一螺旋结构的旋向与所述第二轴的旋转方向相同。 也即，从近端向远端的方向观察，在第二轴顺时针旋转的情况下，所述第一螺旋结构为右旋螺纹，或者，在第二轴逆时针旋转的情况下，所述第一螺旋结构为左旋螺纹。
优选地，所述第一螺旋结构为螺旋槽或者螺旋凸起。
优选地，所述第一螺旋结构位于轮毂的远侧。
优选地，所述第二轴具有被套设在轮毂内的第一非暴露部；所述第一非暴露部的至少部分壁面上设有凹陷结构。优选地，凹陷结构为设于第一非暴露部的壁面上的螺旋槽。
优选地，所述螺旋槽自轮毂的远端连续延伸至所述轮毂的近端。
优选地，所述第二轴具有被套设在远端轴承室内的第二非暴露部，至少部分第二非暴露部的壁面上设有第二螺旋结构，所述第二螺旋结构的旋向与所述第二轴的旋转方向相同。也即，从近端向远端的方向观察，在第二轴顺时针旋转的情况下，所述第二螺旋结构为右旋螺纹，或者，在第二轴逆时针旋转的情况下，所述第二螺旋结构为左旋螺纹。
优选地，所述第二轴的壁面上设有螺旋槽；所述螺旋槽自轮毂的近端连续延伸至所述第二轴的远端；所述螺旋槽的旋向与所述第二轴的旋转方向相同。也即，从近端向远端的方向观察，在第二轴顺时针旋转的情况下，所述螺旋槽为右旋螺纹，或者，在第二轴逆时针旋转的情况下，所述螺旋槽为左旋螺纹。
一种导管泵，包括：
马达；
导管，近端连接至所述马达；
驱动轴，被所述马达驱动；
泵体，具有收折状态和展开状态，包括：连接至所述导管远端的泵壳、收纳在所述泵壳内并被所述驱动轴驱动的叶轮；
远端轴承室，连接至所述泵壳的远端，内置有远端轴承；
其中，所述驱动轴的远端穿过所述叶轮的轮毂并延伸至所述远端轴承中；
所述泵体在展开状态与收折状态之间切换时，所述远端轴承相对所述驱动轴滑动并保持支撑所述驱动轴。
优选地，所述驱动轴包括第一轴以及第二轴；所述第二轴的刚度大于所述第一轴的刚度；所述第一轴的近端与所述马达的转动轴传动连接；所述第一轴的远端与所述第二轴的近端连接；所述叶轮固定套设于所述第二轴上。
优选地，所述支架的远端连同所述远端轴承室及远端轴承沿着驱动轴滑动。具体的，所述支架的远端连同所述远端轴承室及远端轴承沿着第二轴滑动。
优选地，在收折状态下，驱动轴的远端端面位于所述远端轴承的近端端面的远侧。具体的，在收折状态下，第二轴的远端端面位于远端轴承的近端端面的远侧。
优选地，在展开状态下，驱动轴的远端端面位于远端轴承的远端端面的远侧。具体的，在展开状态下，第二轴的远端端面位于远端轴承的远端端面的远侧。
优选地，在展开状态下，驱动轴的远端端面与远端轴承的近端端面之间的距离为L1；在收折状态下，驱动轴的远端端面与远端轴承近端端面之间的距离为L2，L1大于L2。具体的，在展开状态下，第二轴的远端端面与所述远端轴承的近端端面之间的距离为L1；在收折状态下，第二轴的远端端面与远端轴承近端端面之间的距离为L2，L1大于L2。
优选地，所述远端轴承室的远端连接有无创支撑件。
优选地，所述远端轴承室内设有供导丝穿过的封堵件；所述封堵件能在所述导丝穿过前后维持所在位置的封堵状态。进一步地，所述远端轴承室内在所述驱动轴的远端和所述无创支撑件的近端之间还设有供导丝穿过的封堵件；所述封堵件能在所述导丝穿过前后维持所在位置的封堵状态。
优选地，所述无创支撑件的近端设有伸入所述远端轴承室的远端内的伸入部，所述伸入部与所述远端轴承室的远端相粘接。
优选地，所述伸入部的外壁和/或所述远端轴承室的远端的内壁设有容胶槽。
优选地，所述容胶槽为螺旋槽或者沿轴向延伸的直线槽或者沿周向延伸的弧线槽。
一种导管泵，包括：
马达；
导管，近端连接至所述马达；
驱动轴，被所述马达驱动；
泵体，包括：泵壳、收纳在所述泵壳内并被所述驱动轴驱动的叶轮；所述泵壳包括：支架、部分覆盖所述支架的覆膜；其中，所述支架的近端设有连接次管，所述连接次管上设有贯穿其至少部分壁厚的接合部，所述接合部中容纳有热熔后流入其内并固化的接合材料，所述接合材料设于所述导管远端。
一种导管泵，包括：
马达；
导管，近端连接至所述马达；
驱动轴，被所述马达驱动；
泵体，包括：泵壳、收纳在所述泵壳内并被所述驱动轴驱动的叶轮；所述泵壳包括： 支架、部分覆盖所述支架的覆膜；其中，所述支架的近端设有连接次管，所述连接次管上设有贯穿其至少部分壁厚的接合部，所述导管远端设有容纳在所述接合部中的热熔固化成型的接合材料。
优选地，所述连接次管套设在导管远端外部，所述连接次管的外部套设有中间连接套，所述接合材料为所述中间连接套热熔后固化形成。
优选地，部分所述中间连接套位于所述连接次管的近侧并固定套设在所述导管外。
优选地，部分所述中间连接套热熔后粘接套设于所述导管外壁上，或者，部分所述中间连接套胶粘于所述导管外壁上，或者，所述导管外壁设有容纳部分所述中间连接套经热熔后固化形成的嵌入凸起的嵌槽。
优选地，所述接合材料为部分所述导管经热熔固化成型或热压成型的结构。
优选地，所述接合材料的熔点与导管的材料的熔点相同或相近。
优选地，接合材料与导管的材质相同，或者，接合材料与导管均为树脂材料。
优选地，接合部包括开设于次管管壁上的限位凹陷，接合材料包括热熔固化成型的连接凸起；连接凸起通过卡入限位凹槽中将导管和支架至少轴向上固定。
优选地，连接次管的远端包括具有限位凹陷的第一连接部；导管的远端包括具有连接凸起的第二连接部；第二连接部套设于第一连接部外，连接凸起卡入限位凹槽中。
优选地，第二连接部通过热熔将部分导管材料流入限位凹陷后固化形成连接凸起。
优选地，所述第二连接部还具有与所述第一连接部相粘接的粘接面。
优选地，所述第二连接部通过热熔固化后形成所述粘接面。
优选地，所述限位凹陷在径向上将所述连接次管的壁贯通。
优选地，限位凹陷包括设于连接次管上将所述连接次管壁径向贯通的多个连接孔。
优选地，连接孔为沿周向延伸的长孔；多个连接孔沿连接次管的轴向平行排布。
优选地，相邻两个所述连接孔在轴向上至少部分相错开。
优选地，相邻两个所述连接孔在轴向上至少部分相重合。
优选地，相邻两个所述连接孔在轴向上具有重合部分；所述重合部分的周向长度大于所述连接孔的轴向宽度。
优选地，连接孔具有与邻近的连接孔沿轴向相重合的第一重合部分和第二重合部分；第一重合部分具有第一孔端，第二重合部分具有第二孔端；第一重合部分和第二重合部分的周向长度相等。
优选地，所述连接孔在周向上具有第一孔端和第二孔端；所述第一孔端和所述第二 孔端具有端间隔部；所述端间隔部的周向长度小于所在位置周长的一半。
优选地，所述连接孔在周向上具有第一孔端和第二孔端；所述第一孔端和所述第二孔端具有端间隔部；所述端间隔部的周向长度大于所述连接孔的轴向宽度。
优选地，相邻两个连接孔之间具有孔间隔部；孔间隔部的周向宽度小于连接孔的轴向宽度。优选地，位于一连接孔轴向两侧的连接孔在轴向上相对齐。
优选地，所述第一连接部的径向内侧还设有第三连接部；所述连接凸起穿过所述限位凹陷与所述第三连接部粘接或一体结构。
优选地，所述第三连接部与所述第二连接部材质相同。
优选地，所述第三连接部与所述导管为一体结构。
优选地，所述导管远端的导管壁上设有夹壁插孔；所述夹壁插孔的径向外侧管壁为所述第二连接部，所述夹壁插孔的径向内侧管壁为第三连接部；所述夹壁插孔在所述导管远端的端面上形成供所述第一连接部插入的插入口。
优选地，连接次管在第一连接部的远侧还设有定位部；定位部将位于连接次管内的近端轴承定位；近端轴承套设在驱动轴外，将驱动轴转动支撑；近端轴承的外壁上设有与定位部相接合的配合部；定位部和配合部形成卡扣结构。
优选地，所述定位部包括沿周向排布的多个沿径向向内凸出的公扣；所述配合部包括所述近端轴承的外壁上的被所述公扣卡入的卡槽。
优选地，所述连接次管的内部在所述近端轴承的近侧还固定有挡圈；所述挡圈与所述第三连接部的远端端面相接触限位；所述挡圈与所述驱动轴之间的间隔距离大于所述近端轴承和所述驱动轴之间的间隔距离。
优选地，所述连接次管内设有支撑所述驱动轴的近端轴承。
一种导管泵的支架与导管的装配方法，所述导管内用于穿设带动叶轮旋转的驱动轴，所述支架用于支撑展开覆膜形成容纳叶轮的旋转空间；所述支架的近端设有连接次管，所述连接次管上设有贯穿其至少部分壁厚的接合部，所述导管的远端设有材料部；其中，所述装配方法包括：将所述材料部覆盖于所述接合部外，热熔所述材料部形成流入所述接合部的流动材料，固化所述流动材料形成将所述导管和所述支架连接的连接结构。
优选地，自然冷却所述材料部以固化所述流动材料。
优选地，所述材料部一体设置在所述导管的远端；其中，所述装配方法包括：将所述导管的远端套设于所述连接次管外，热熔所述导管的远端使部分导管材料流入所述接合部，固化流入所述接合部的材料形成将所述导管和所述支架连接的连接结构。
优选地，导管的远端设有夹壁插孔；导管的远端在夹壁插孔的径向外侧具有外管壁，在夹壁插孔的径向内侧具有内管壁；其中，所述装配方法包括：将所述连接次管插入所述夹壁插孔以使所述接合部位于夹壁插孔内，热熔所述外管壁使部分导管材料流入所述接合部，固化流入所述接合部的材料形成将所述导管和所述支架连接的连接结构。
一种导管泵，包括：
马达；
导管，近端连接至所述马达；
驱动轴，被所述马达驱动；
泵体，包括：泵壳、收纳在所述泵壳内并被所述驱动轴驱动的叶轮；所述泵壳包括：支架、部分覆盖所述支架的覆膜；
远端轴承室，内置有远端轴承，所述驱动轴的远端穿设在所述远端轴承中；其中，所述支架近端与所述导管的远端连接，远端形成有多个间隔的连接支腿，多个所述连接支腿嵌设在所述远端轴承室的外壁的容纳槽中。
优选地，所述远端轴承室外固定套设有箍套；所述箍套套设在所述远端轴承室及所述连接支腿外将所述连接支腿限位在所述容纳槽内。
优选地，所述容纳槽包括多个沿轴向延伸的卡槽、以及连通多个所述卡槽的远端的环形槽；所述连接支腿包括嵌入到所述卡槽中的杆体以及嵌入到所述环形槽中的腿端。
优选地，的外径小于所述束缚段的外径，所述伸入段和所述束缚段之间设有变径台阶；所述容纳槽设于所述束缚段的外壁上；所述箍套固定套设在所述束缚段外；所述远端轴承内置于所述伸入段。
一种导管泵的泵体装配方法，所述泵体包括支架、设有叶轮的叶轮轴、远端轴承室；其中，所述支架的远端形成有多个间隔的连接支腿，所述远端轴承室开设有容纳槽；其中，所述泵体装配方法包括：径向打开多个所述连接支腿，将所述叶轮轴和远端轴承室自所述支架的远端向其近端穿设，将连接支腿放置于所述容纳槽中定位，在箍套套设在所述远端轴承室外将所述连接支腿限位在所述容纳槽中。
优选地，将叶轮轴的远端穿设于所述远端轴承室内；径向打开多个所述连接支腿后将叶轮轴和远端轴承室一同自所述支架的远端向近端移动穿设。
优选地，径向打开多个所述连接支腿，先将叶轮轴自所述支架的远端向其近端穿设，再将远端轴承室自所述支架的远端送入至被多个连接支腿围绕且被叶轮轴的远端插入。
优选地，径向打开多个所述连接支腿，将远端轴承室送入多个所述连接支腿内并将 容纳槽与所述连接支腿相对齐，放置所述连接支腿在所述容纳槽中定位。
优选地，将热缩管套设在远端轴承室外经热缩后形成所述箍套。
与现有技术相比，本发明具有如下有益效果：
本公开一个实施例中提供一种导管泵，该导管泵具有马达，近端通过耦合器与马达接合的导管，穿设在导管中的驱动轴，其近端与马达轴连接；以及泵体。其中泵体包括：泵壳、设在泵壳内并连接至驱动轴远端的叶轮；泵壳包括：近端与导管远端连接的支架、部分覆盖支架的覆膜；连接在支架的远端的无创支撑件。通过将导管泵的泵体介入到受试者心脏的期望位置，辅助心脏进行血液泵送，明显减少血液损伤的不良事件。
本公开一个实施例中提供一种导管泵，通过设置编织结构的第一轴，在第一轴上布满有编织间隙将第一轴的内外连通，进而同时形成灌注液流动的内外流道，实现灌注液的大面积流动，避免灌注压力过大。
并且，第一轴通过编织结构所形成的内外流道分别在叶轮的近侧和远侧流出，避免血液进入到导管内以及驱动轴内，稳定泵内血液流动，降低对泵效的影响以及血栓产生的风险。
本公开一个实施例提供的一种导管泵中，泵体在展开状态与收折状态之间切换时，远端轴承相对所述驱动轴滑动并保持支撑所述驱动轴，避免驱动轴在远端轴承内脱出，便于泵体的轴向上延伸收折。
本公开一个实施例中提供一种导管泵的驱动轴，在至少部分长度的驱动轴外表面和/或内表面(外壁和/或内壁)形成螺旋凹槽或螺旋凸起，该螺旋凹槽或凸起的旋向与驱动轴的旋转方向一致，以形成泵效应，将灌注液向远端泵送，并可在导管远端防止血液进入，避免在导管远端形成血栓。
本公开一个实施例提供的一种导管泵，在支架的近端设有连接次管，所述连接次管上设有贯穿其至少部分壁厚的接合部，所述接合部中容纳有热熔后流入其内并固化的接合材料，所述接合材料设于所述导管远端，热熔固化成型的接合材料将导管和支架形成至少轴向上的限位固定，借此实现支架和导管的机械连接，相较于胶粘形式的化学连接，连接强度更高。
进一步地，本公开一个实施例中提供一种导管与支架的连接方式，通过在支架和导管之间构建相配合的限位凹陷与连接凸起，进而形成机械的轴向限位及周向限位，借此实现支架和导管的机械连接，相较于胶粘形式的化学连接，连接强度更高。
并且，限位凹陷的使用，不仅能够节省支架和导管连接部位的接合材料，为形变提 升更多的形变空间，使连接部位具有较佳的柔性，而且还能够提升导管和支架的连接面积，使得导管和支架之间形成轴向的止挡或固定结构，从而至少提高导管与支架沿轴向的连接强度。
本公开一个实施例中提供一种远端轴承室与无创支撑件的连接方式，通过在远端轴承室的远端和/或无创支撑件的近端设置容胶槽，借此增大粘胶量和接合面积，进而提高两者的连接强度。
本公开一个实施例中提供一种泵体内的第二轴结构，第二轴至少在处于支架中暴露部分的外壁形成有螺旋槽或螺旋凸起的螺旋结构，该螺旋结构与驱动轴的旋转方向相同，以形成泵效应，将血液向泵壳中泵输，而防止血液反向进入远端轴承室，避免形成血栓。
本公开一个实施例中提供一种泵体内的第二轴结构，在第二轴处于轮毂腔内的部分的外壁形成有螺旋槽，通过设置螺旋槽，可增大第二轴与轮毂粘接的容胶量，提高叶轮与轮毂的接合强度。
本公开一个实施例中提供一种灌注液输入流道设计方式，其中，灌注液在导管与驱动轴之间的间隙(外流道)向前流动，由于驱动轴的第一轴为液体可渗透的结构。因此，灌注液一边向前流动，一边渗入第一轴的内流道中，在灌注液的作用下可以防止血液进入到远端轴承室或无创支撑件中，避免引起可能发生血栓等不良影响，同时对于支撑驱动轴的轴承进行润滑，保证轴承的平稳运转。
本公开一个实施例提供一种导管泵的泵体，覆膜在径向展开状态下不产生拉伸形变，覆膜具有较强的抗形变能力，进而在径向展开状态能够稳定约束并维持支撑构件的形状，保持泵间隙，使泵体保持较佳的泵效。
本公开一个实施例提供一种导管泵的支架远端的新型结构，在支架远端形成有分散的支腿结构，进而便于在支架远端送入其内部并安装叶轮及叶轮轴(第二轴)，为展开和收折的泵体提供了具备较佳实用性的制造组装的可靠方案。
附图说明
图1是本发明一个实施例提供的介入式导管泵结构示意图；
图2是图1的正视图；
图3是图1未设置覆膜的立体图；
图4是图3的正视图；
图5是图4的未设置覆膜的泵体放大图；
图6是图5的部分放大图；
图7是图3的未设置覆膜的泵体放大图；
图8是图2的泵体结构示意图；
图9是图8的部分剖面图；
图10是图8的立体图；
图11是图8的覆膜立体图；
图12是图11的正视图；
图13是本公开另一个实施例提供的介入式导管泵的泵体示意图；
图14是本公开的6组不同泵体在流体背压下的直径变化的曲线图；
图15是本公开一个实施例提供的泵体结构剖面图；
图16是图15的部分放大图；
图17是图15的部分放大图；
图18是图15的部分放大图；
图19是本公开一个实施例提供的泵体结构剖面图；
图20是图19的部分放大图；
图21是图19的部分放大图；
图22是本公开一个实施例提供的未设置覆膜的泵体结构剖面图；
图23是图22的支架立体示意图；
图24是图23的连接次管结构示意图；
图25是本公开一个实施例提供的支架结构示意图；
图26是图25的部分支撑网格放大示意图；
图27是图25的支架远端与远端轴承室配合示意图；
图28是本公开一个实施例提供的未设置覆膜的泵体结构剖面图；
图29是图28的第一轴和第二轴355连接结构放大示意图；
图30是图28的第二轴和远端轴承室连接结构放大示意图；
图31是图29的支架与导管的连接示意图。
具体实施方式
为了使本技术领域的人员更好地理解本发明中的技术方案，下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例，都应当属于 本发明保护的范围。
需要说明的是，当元件被称为“设于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的另一个元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中另一个元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
本发明所用术语“近”、“远”和“前”、“后”是相对于操纵导管泵的临床医生而言的。术语“近”、“后”是指相对靠近临床医生的部分，术语“远”、“前”则是指相对远离临床医生的部分。例如，体外部分在近端及后端，介入的体内部分在远端及前端。
本发明的导管泵以输出轴或连接轴、驱动轴300、第一轴350、第二轴355的延伸方向定义“轴向”或“轴向延伸方向”，驱动轴300包括第一轴350和第二轴355，驱动轴300的轴向是指驱动轴300调整为直线延伸时的轴向。本发明所用术语“内”“外”是相对轴向延伸的中心线而言的，相对靠近中心线的方向为“内”，相对远离中心线的方向为“外”。
需要理解的是，“近”、“远”、“后”、“前”、“内”、“外”、这些方位是为了方便描述而进行的定义。然而，导管泵可以在许多方向和位置使用，因此这些表达相对位置关系的术语并不是受限和绝对的。在本发明中，上述定义如果另有明确的规定和限定，它们应遵循上述明确的规定和限定。
在本发明中，除非另有明确的规定和限定，“相连”“连接”等术语应做广义理解，例如，可以是连接，也可以是可拆卸连接，还可以是可活动连接，或成一体；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
本发明实施例的导管泵，用于针对心脏功能衰竭进行辅助，可向心脏泵送血液，实现心脏的部分泵血功能。在适用于左心室辅助的场景中，导管泵将血液从左心室泵入主 动脉，为血液循环提供支持，减少受试者心脏的工作负荷，或者在心脏泵血能力不足时提供额外持续的泵血动力支持。
当然，导管泵也可以依托介入式手术将其按照期望介入到受试者的其他目标位置，例如右心室、血管、或者其他器官内部。
请参阅图1至图12，导管泵包括驱动组件1和工作组件。驱动组件1包括壳体以及收纳在壳体内并具有输出轴的马达。工作组件包括导管3、穿设在导管3中的驱动轴300、由驱动轴300驱动的泵体4。驱动组件1设于导管3的近端，通过耦合器2连接导管3，并通过穿设于导管3内的第一轴350连接泵体4。驱动组件1为工作组件提供动力，以驱动工作组件实现泵血功能。
泵体4可通过导管3被输送至心脏的期望位置例如左心室内泵送血液，包括具有血液进口403和血液出口402的泵壳363、收纳在泵壳363内的叶轮410。叶轮410用于为血液的流动提供动力，泵壳363至少包括限定血液流动通道的覆膜401。
泵体4具有介入构型以及工作构型。在泵体4对应介入构型下，泵壳363和叶轮410处于径向收折状态，以便泵体4以第一外径尺寸介入受试者的脉管系统和/或在脉管系统中输送。在泵体4对应工作构型下，泵壳363和叶轮410处于径向展开状态，以便泵体4以大于第一外径尺寸的第二外径尺寸在期望位置泵体4送血液。
泵体4包括径向收折状态和径向展开状态，泵壳363可操作地在径向收折状态与径向展开状态之间切换。相比于未受力状态，覆膜401在泵壳363处于径向展开状态下不发生拉伸形变。
如图9所示，叶轮410包括连接至驱动轴300远端的轮毂412以及支撑在轮毂412外壁的叶片411。在泵体4对应介入构型时，叶片411包裹在轮毂412外壁上，并至少部分地与泵壳363内壁接触。在泵体4对应工作构型时，叶片411自轮毂412径向向外延伸并与泵壳363内壁间隔，避免泵壳363影响叶片411转动，以及避免叶片411的旋转损坏泵壳363。
泵壳363还包括用于支撑展开覆膜401的支架404。支架404可以设于覆膜401内，或者设在覆膜401外，将覆膜401进行支撑。泵壳363在径向展开状态下，支架404与覆膜401内壁接触沿径向扩张将覆膜401支撑展开。其中，覆膜401在未受力状态下相比于覆膜401在泵壳363未受力的径向展开状态下不产生拉伸形变。
泵壳363未受力的径向展开状态下为叶轮410不旋转时的自然展开状态。
径向展开状态包括对应叶轮410不旋转时的自然展开状态。覆膜401发生拉伸变形 的临界点应力大于等于泵壳363处于自然展开状态时支架404对其施加的力。如此，在仅有支架404对覆膜401施加径向支撑展开作用力时，由于没有达到覆膜401拉伸变形临界力，进而在自然展开状态下，覆膜401并未发生拉伸形变。
径向展开状态还包括对应叶轮410旋转时的工作状态。为保证覆膜401的韧性，提供更稳定的泵间隙，稳定泵效，覆膜401发生拉伸变形的临界点应力大于等于泵体4处于最大工况时由于叶轮410的旋转而导致的血液背压对覆膜401施加的力。
泵体4的最大工况对应于叶轮410额定功率下的最大转速。此时，泵流量对应最大值，血液背压也处于最大值。本实施例中，血液背压的最大值仍然未超出覆膜401发生拉伸变形的临界点应力，进而在叶轮410旋转的工作状态，覆膜401仍然不会产生拉伸形变，以避免泵间隙变化，稳定泵效。
也就是，覆膜401本身的材料强度足以抵抗支架404的外扩张力，进而覆膜401在泵壳363由径向收折状态切换至自然展开状态时的周向拉伸形变量为0，不产生周向拉伸形变。
进一步地，覆膜401本身的材料强度足以抵抗由于叶轮410的旋转而导致的血液背压对其施加的力，进而覆膜401在泵壳363由自然展开状态切换至工作状态时的周向拉伸形变量为0。
需要明确的是，本发明中的覆膜401的拉伸形变，是指覆膜401发生圆周方向的长度变形。在受到径向作用力时，体现为周向长度(圆周长)变大。但是，在覆膜401本身存在褶皱的情况下，因支架404的膨胀作用而将褶皱展平并不属于对覆膜401的拉伸。
覆膜401的褶皱大多数情况下是由于收折而产生的。由于折叠鞘管的径向约束作用，覆膜401被强制压缩而发生折叠，进而造成褶皱的产生。当然，这并不能排除其他因素导致的覆膜401皱褶。例如，可能在制造时形成，或者放置时自身形变产生，亦或者测试时产生等等。褶皱可以为诸如折痕、(细微)皱纹的形式。
覆膜401的材质为TPU(热塑性聚氨酯弹性体橡胶)或者PEBAX材质或者PTFE(聚四氟乙烯)。较佳的，覆膜401采用诸如PEBAX的嵌段聚醚酰胺树脂材料。覆膜401在反复形变下没有机械性能的损失，并且抗疲劳，拥有良好的回弹和弹性回复性能以及精确的尺寸稳定性。进而在支架404的支撑下不产生拉伸形变，稳定保持泵间隙。
覆膜401借由自身材质承受并抵抗支架404的径向扩张力，在泵壳363处于自然展开状态时不产生拉伸形变，该拉伸形变为周向拉伸形变。
可以理解的，覆膜401在未受力状态下相比于自然展开状态下，内径或内横截面积 相同，并未发生改变。覆膜401在泵壳363未受力状态下为未被支架404支撑条件下所呈现的圆筒状结构。同样可以理解为，覆膜401的自然展开状态下相比于被支架404从内向外撑开状态下，并未产生拉伸形变，拉伸形变量为0。
自然展开状态是相较于叶轮410旋转驱动流体的工作状态而言的。在叶轮410旋转驱动血液流动的情况下，血液对覆膜401会产生一定的径向扩张作用力(流体背压)。
承接以上描述，泵体4包括适于在受试者脉管系统中输送的径向收折状态、对应叶轮410不旋转时的自然展开状态和对应叶轮410旋转时的工作状态。在泵体4由自然展开状态切换至工作状态的过程中，叶轮410的旋转引发的施加在覆膜401上的血液背压使得覆膜401的褶皱被至少部分的展平。
上述的直径增大率为覆膜401在泵壳363处于自然展开状态相比于工作状态下的直径变化率，该直径增大率取决于覆膜401褶皱的数量及起伏程度，进一步取决于覆膜401材质的柔韧性。
具体而言，覆膜401材质的柔韧性很大程度上决定褶皱的数量及起伏程度。也就是，覆膜401材质的柔韧性越差，可能导致覆膜401褶皱的数量越多、起伏程度越大，褶皱展平时，覆膜401直径的增大率越接近3％。相反，覆膜401材质的柔韧性越好，覆膜401褶皱的数量越少、起伏程度越小，褶皱展平时，覆膜401直径的增大率越偏离3％。
因此，在某些不可被明确排除的场景下，由于选取的覆膜401材质符合特别柔软的特征而导致其很少存在褶皱的情况下，褶皱的展平对覆膜401直径的增大率的贡献可能接近于0。
覆膜401为一体成型结构，可被支架404展开，覆膜401的远端开口与支架404远端未被覆膜401覆盖的区域共同构成泵壳363的血液进口403。覆膜401的远端还设有连接条19，连接条19的远端连接于远端轴承室6上。
覆膜401处于径向展开状态下，连接条19大致处于绷直拉伸状态。通过连接条19以及覆膜401的近端17的连接套16将覆膜401的远近端分别进行固定，进而覆膜401在轴向上处于整体平直状态，以尽量抹平覆膜401的褶皱，提供尽可能光滑的内壁。而众知的，光滑的内壁对泵的水力学效果是有利的。
当然在其他实施例中，覆膜401的远端18也可以连接支架404。例如，覆膜401的远端18内壁粘接在支架404的外壁上，随支架404一同收缩扩张。
泵壳363在自然展开状态下，支架404具有与覆膜401接触的接触支撑部。如图7、图9所示，支架404包括大致呈锥形的支架404近端121和支架404远端123、以及位 于支架404近端121和支架404远端123之间的大致呈圆柱形的支架404段122。其中，至少部分轴向长度的支架404段122构成接触支撑部。
覆膜401套设于支架404段122外，被支架404段122接触支撑进而构建形成稳定的圆筒形状的泵壳363。覆膜401的远端18(端面)不超出支架404段122。
在径向展开状态下，存在叶轮410旋转驱动血液流动的工作状态和叶轮410静止的自然展开状态。由于血液的状态不同(静止及流动)，对覆膜401产生作用力不同。进而，叶轮410旋转驱动血液流动状态下，不仅存在支架404对覆膜401的支撑力，还存在血液因被叶轮410驱动形成的对覆膜401的径向推动(流体背压)。
因此，相比于非工作状态(自然展开状态)，在叶轮410高转速(千转甚至万转每分钟以上)的工作状态下，覆膜401因褶皱被展平而使得覆膜401的周向存在一定程度的伸长。该伸长是由于褶皱被展平而导致的，但覆膜401本身并未发生周向的拉伸变形。
覆膜401在泵体4处于工作状态下的直径大于泵体4处于自然展开状态下的直径。该直径为覆膜401围构内部腔体的直径。在工作状态下，由于流体背压的存在，覆膜401的至少部分褶皱被展平，使得围构内部腔体的截面形状更趋圆形，覆膜401的内壁更趋光滑，进而使得覆膜401的直径(围构腔体的直径)增大。
在工作状态下，叶轮410的旋转引发的施加在覆膜401上的血液背压使得覆膜401的褶皱被至少部分的展平。在泵体4由自然展开状态切换至工作状态的过程中，叶轮410的旋转引发的施加在覆膜401上的血液背压使得覆膜401的褶皱被至少部分的展平。该褶皱的展平使得覆膜401的直径的增大率不超过3％，进一步不超过2％，甚至不超过1％。
该直径的增大率在图14中的6组覆膜401(其中，1#-A至3#-C代表不同覆膜401名称)在不同背压的直径变化情况可以看出。其中，每个曲线图中示出了两个压力端点值及一个大致中间压力下的覆膜401直径。从每个曲线图中可以看出，随着背压的增大，覆膜401的周向在进行一定程度的伸长，但直径的增加量都在0.1mm以内。
需要说明的是，由自然展开状态至工作状态转变过程中，覆膜401至少存在直径不增大的子过程。在测试过程中随着背压的增大，覆膜401的直径有时会存在一定压力范围增长下的保持不变甚至下降。
导致上述存在直径不增大的过程的原因在于，由于褶皱的存在，使得覆膜401处于自然展开状态下呈现类圆形但非严格圆形的截面形状。褶皱包括径向向内的凹陷，也有可能存在径向向外的凸起。如果选取的直径测量点为两个凸起点，则初始测出的直径较大，而在褶皱被展平后，凸起被拉平，进而导致虽然背压增大，直径却下降的现象。
当然，这也进一步地或间接地证明了，本发明中的覆膜401的周向伸长现象是由于褶皱展平而并非是拉伸形变产生。因为拉伸形变会导致直径持续性的增加，而不会出现不变和下降的现象。
在一个实施例中，在工作状态下，至少一部分接触支撑部(支架404段122)与覆膜401相隔开。覆膜401在流体背压作用下，部分褶皱进一步展平，内径增大至与接触支撑部相分离。而在覆膜401本身的强韧性作用下，限制了不产生拉伸形变。而褶皱进一步地展平使得覆膜401周向伸长，但该伸长率的变化小于3％。周向伸长变化较小，进而在工作状态下依然能维持叶轮410与覆膜401之间的间隔间隙，保持泵效的持续稳定。
泵壳363从径向收折状态转化到径向展开状态过程中，接触支撑部和覆膜401之间允许相对移动，覆膜401与诸如支架404段122的接触支撑部产生接触的部位允许改变。支架404与覆膜401的相对位置固定不发生改变。
接触支撑部与覆膜401之间仅为接触支撑，而无连接，进而在覆膜401展开过程中，接触支撑部与覆膜401之间形成一定程度相对运动，借此实现彼此的期望展开。并且，接触支撑部对覆膜401提供周向支撑力而不提供径向和周向的相对运动约束，允许覆膜401相对于接触支撑部产生径向或周向的相对运动，使得覆膜401在展开过程中与接触支撑部或支架404所接触的部位发生改变。
如图10至图13所示，覆膜401包括圆筒段110、设于圆筒段110的近端的近端锥形段111，圆筒段110的轴向长度大于近端锥形段111的长度，血液出口402从近端锥形段111延伸至圆筒段110。
近端锥形段111的近端设有连接套16，连接套16连接导管3的外壁，借此实现覆膜401远端18的连接。连接套16可以采用粘接、或者热熔、或者压接的方式与导管3连接。覆膜401与导管3的连接位置或者连接套16的位置位于近端轴承室340的近侧。
部分血液出口402位于近端锥形段111，另一部分血液出口402位于圆筒段110，多个血液出口402在圆周方向排布。位于圆筒段110的部分血液出口402输出的血液形成离心流动，进而多个血液出口402向外出流能够稳定泵体4位置，稳定血流。位于近端锥形段111的部分血液出口402输出的血液大致形成轴流流动，与圆筒段110的部分血液出口402共同保证血液出口402流量，避免流向损失。
为保持覆膜401前端的结构强度，保持形状结构的稳定，至少部分轴向长度的血液出口402在自远端向近端的方向上，周向宽度逐渐减小。
如图11、图12所示，位于近端锥形段111的部分血液出口402自远端向近端延伸 时其周向宽度逐渐减小，位于圆筒段110的另一部分血液出口402自远端向近端延伸时其周向宽度逐渐增大。如图13所示，在一个实施例中，沿自远端向近端延伸的方向，血液出口402周向宽度逐渐减小。
如图12所示，以位于近端锥形段111的部分血液出口402为后血液出口部21，位于圆筒段110的另一部分血液出口402为前血液出口部20。其中，血液出口402在近端锥形段111的部分的长度大于其在圆筒段110的部分的长度。即，后血液出口部21的长度大于前血液出口部20的长度。
至少部分(轴向)长度的前血液出口部20的周向宽度大于或等于后血液出口部21的最大周向宽度。在后血液出口部21中，血液出口402的任意轴向两个部位，位于下游的部位周向宽度小于或等于位于上游部位周向宽度。血液出口402的近端的周向宽度小于其远端的周向宽度。
在本实施例中，支架404或单个支架404为一体成型结构，支架404与覆膜401为分体结构，至少一部分支架404位于覆膜401内部并接触支撑覆膜401的内壁。
泵壳363在未受力的径向展开状态下，支架404被覆膜401径向约束而未完全展开。支架404为记忆合金材质，在失去鞘管的约束后支架404恢复形状而将覆膜401撑开，直至被覆膜401约束无法继续撑开。此时，支架404向覆膜401提供径向向外的支撑力，覆膜401依靠自身韧性抵抗支架404的形变，不产生拉伸形变，保持形状的稳定性。
泵体4的收折和展开过程如下：在将泵体4介入左心室的过程中，泵体4由于外部施加的径向约束力而处于径向约束状态(收折状态)。或者，泵头4仅在介入受试者脉管系统中的过程是收折的。在介入至左心室中后(以收折的形态在脉管系统中向前输送)，或者介入至受试者脉管系统中后(以展开的形态在脉管系统中向前输送)，撤去径向约束，支架404利用自身的记忆特性以及叶轮410的叶片411借助蓄能释放而自主扩张，所以泵体4自动地呈现其非约束形状(展开状态)。
反之，在泵体4完成工作需要从受试者体内撤出时，利用折叠鞘将泵体4收折，待泵体4完全撤出受试者体内，再撤除折叠鞘对泵体4的约束，使泵体4恢复至应力最小的自然状态，也就是展开状态。
需要说明的是，本发明的支架404并不局限于覆膜401中为单个支架404，还可以包括分散布置于轴向不同位置的多个支架404，以将覆膜401的不同部位进行支撑。例如，可以存在支撑覆膜401近端17的支架404，将血液出口402进行稳定支撑，维持血液出口402形状的稳定性，降低对血液流动的影响。
支架404为网格构造，其上的多网孔尤其是菱形网孔的设计便于支架404进行收折展开。叶轮410收容在支架404内，并位于覆膜401内。支架404支撑在覆膜401远端18，其远端或者锥形支架404远端123位于覆膜401的远端18外部，锥形支架404近端121和支架404段122位于覆膜401内。
叶轮410设于第二轴355上，第二轴355设于支架404内，远端可转动地支撑在远端轴承室6内。支架404为纺锤体构造，提供容纳叶轮410的支撑空间。支架404的近端和导管3的远端连接，覆膜401的近端17在支架404的近侧套设于导管3的外壁上。
导管3通过位于其远端的近端轴承室340连接支架404的近端17，近端轴承室340内设有对驱动轴300进行转动支撑的近端轴承331、332。远端轴承室6设于驱动轴300的远端，并通过远端轴承62对驱动轴300的远端转动支撑。支架404维持近端轴承室340和远端轴承室6的间距，借此为第二轴355提供稳定的转动支撑。
远端轴承室6的远端连接有无创支撑件5。无创支撑件5为一柔性管体结构，表现为端部呈圆弧状或卷绕状的柔性凸起，从而无创支撑件5以无创或无损伤的方式支撑在心室内壁上，将泵体4的血液进口403与心室内壁隔开，避免泵体4在工作过程中由于血液的反作用力而使得泵体4的吸入口贴合在心室内壁上，保证泵吸的有效面积。
无创支撑件5的中空管腔502的内径与导丝外径(直径)相等，或者稍大于导丝的外径。例如，无创支撑件5的中空管腔502的内径为导丝直径的1-1.2倍。中空管腔502的内径足够小(大约为0.2-0.9mm)，血液进入管腔的阻力较大，避免血液经无创支撑件5进入泵体4内，减少对血液的损伤，并有利于血液经血液进口403输入到泵体4内。
无创支撑件5的近端插入到远端轴承室6中，构成对第二轴355的远端限位。第二轴355的远端可滑动地伸入到远端轴承室6中，被可转动地支撑。无创支撑件5的近端端面在远端轴承室6中构成用于对第二轴355的远端限位的限位台阶。在泵体4沿着血管移动过弯时，适用于形成第二轴355相对于外套部件的轴向相对移动的活动余量。
无创支撑件5的近端与远端轴承室6的内壁之间可通过粘接固定。具体的，无创支撑件5的近端伸入远端轴承室6的远端内，与远端轴承室6的远端内壁粘接。
为提升无创支撑件5和远端轴承室6的连接强度，避免无创支撑件5与远端轴承室6发生脱离，无创支撑件5的近端外壁和/或远端轴承室6的内壁设有容胶槽。通过容胶槽提升二者之间的充胶量，借此提升二者的连接强度。
容胶槽设于无创支撑件5的近端外壁，亦或者设于远端轴承室6的内壁。容胶槽可以为多种形式，例如离散分布的点状凹槽、长槽结构或螺旋槽。示意性质地举例为，容 胶槽可以为沿轴向延伸的多个直线槽，多个直线槽沿周向平行排布。
在其他实施例中，无创支撑件5的近端为圆柱形，其侧壁上分布有凹陷结构，以增大胶粘接合面积，达到提高远端轴承室6和无创支撑件5之间连接强度的效果。凹陷结构可以为沟或槽，其具有诸如圆形槽、多边形槽、甚至不规则形状槽的形状。远端轴承室6的远端内壁也可以具有与无创支撑件5的近端相同的凹陷结构的构造，不作赘述。
远端轴承室6内设有止挡台阶。在无创支撑件5的近端插入到远端轴承室6内向近端移动时，无创支撑件5的近端端面接触到止挡台阶被限位。止挡台阶为远端轴承室6内部凸起结构或者变径形成。
在本实施例中，远端轴承室6内部为阶梯孔，止挡台阶为变径形成的变径台阶,阶梯孔的中间段的内径小于远近两侧的孔段内径,阶梯孔的近端内部的孔段用于安装远端轴承62,与之相背对的远端用于无创支撑件5的近端插入装配和限位。
远端轴承室6内设有可被导丝穿过的封堵件550，封堵件550位于止挡台阶和无创支撑件5的近端之间，并被夹设在两者之间。进而封堵件550被止挡台阶和无创支撑件5的近端向限位，保持在该位置，并将所在位置封堵并供导丝穿入穿出。
通过封堵件550将所在位置封堵，避免在泵送血液时血液经无创支撑件5进入到泵体4内部而影响血液泵入效果。
在本实施例中，泵体4是可收折的。出于减轻受试者痛苦和介入容易的角度，希望泵体4的尺寸小。而出于为受试者提供较强的辅助功能，希望泵体4的流量大，流量大一般要求泵体4的尺寸大。
通过设置可收折的泵体4，使得泵体4具有较小的收折尺寸和较大的展开尺寸，以兼顾在介入/输送过程中减轻受试者痛苦且介入容易，以及提供大流量这两方面的需求。
由上述，支架404的多网孔尤其是菱形网孔的设计可实现较佳的实现收折，同时借助镍钛合金的记忆特性实现展开。叶片411由柔弹性材料制成，在被收折时蓄能，在外界的约束撤除后，叶片411的蓄能释放，使叶片411展开。
泵体4是借助外界的约束实现收折，在约束撤除后，泵体4实现自展开。
在本实施例中，“收折状态”是指泵体4被径向约束的状态，也就是说，泵体4受到外界压力被径向压缩折叠成最小径向尺寸的状态。“展开状态”是指泵体4未被径向约束的状态，也就是说，支架404和叶轮410径向外侧展开成最大径向尺寸的状态。
上述的外界约束的施加，通过滑动套设在导管3外的折叠鞘管(未示出)完成。当折叠鞘管在导管3外向前移动时，可将泵体4整体收纳在其内，实现泵体4的强制收折。 当折叠鞘管向后移动时，泵体4受到的径向约束消失，泵体4自展开。
由上述，泵体4的收折是借助折叠鞘管施加的径向约束力实现的。而泵体4包含的叶轮410收纳在泵壳363内。因此，实质上，泵体4的收折过程是：折叠鞘管对泵壳363施加径向约束力，泵壳363径向压缩时，对叶轮410施加径向约束力。
也就是，泵壳363是直接在折叠鞘管的作用下被收折，而叶轮410却是直接在泵壳363的作用下被收折。而如上述，叶轮410具有弹性。因此，尽管处于收折状态，但叶轮410收折蓄能使其始终具有径向展开的趋势，进而叶轮410会与泵壳363内壁接触，并对泵壳363施加反作用力。
在折叠鞘管的约束撤除后，可折叠支架404在自身的记忆特性作用下，支撑弹性的覆膜401展开，直至被覆膜401约束无法继续张开，叶轮410在释放的蓄能作用下自展开。在展开状态下，叶轮410的外径小于泵壳363的内径。
这样，叶轮410的径向外端(也就是叶片411的叶尖)与泵壳363的内壁(具体为支架404内壁)之间保持间隔，该间隔为泵间隙。泵间隙的存在，使得叶轮410能无阻碍的旋转，而不发生碰壁。
此外，出于流体力学方面的考虑，泵间隙尺寸为较小的数值且被维持，是期望的。在本实施例中，叶轮410的外径略小于作为支架404的支架404内径，使得在满足叶轮410旋转不碰壁的情况下，泵间隙尽可能的小。
而泵间隙保持的主要实现手段是通过支架404提供的支撑强度以及覆膜401的抗拉伸形变性能，该支撑强度及覆膜401的韧性可抵抗流体(血液)的背压作用而不发生过量变形，进而保持泵壳363的形状稳定，则泵间隙也被稳定的保持。
支架404的多网孔设计结合记忆合金的材质便于收折展开。支架404包括大致呈圆柱状的主体段40、位于主体段40轴向两端的大致呈锥形的入口段41和出口段42。其中，主体段40、入口段41、出口段42上分布有网孔，主体段40的网孔面积小于入口段41和/或出口段42的网孔面积。
覆膜401与支架404过盈配合，覆膜401远端从支架404的主体段40开始延伸，支架404与覆膜401轴向部分重叠，覆膜401覆盖支架404大部分，仅入口段41露出形成血液进口403。覆膜401近端与导管3胶粘连接，血液出口402位于覆膜401近端。在自然展开状态下，主体段40的外壁在展开时与覆膜401内壁接触将覆膜401支撑展开。
主体段40的(至少一个)网孔具有沿轴向大致相对的两个第一顶点505、以及两对沿周向大致相对的第二顶点504。两对第二顶点504之间的间距大致相等，但小于两个 第一顶点505之间的间距。
主体段40的网孔的长轴方向与支架404的轴向一致，网孔可按照长轴方向拉长，实现支架404的径向收缩，可以较佳的适应轴向伸缩变形，完成支架404和覆膜401的可控平滑收缩，在体内完成期望操作后顺利完成收缩，进而便于移出体外。
主体段40的网孔的在轴向上的最大尺寸大于在其周向上的最大尺寸。在其他不规则多边形孔，或者最大尺寸为非顶点之间间距时，主体段40的网孔的周向最大尺寸为其轴向最大尺寸的1.2倍-3倍。提供周向尺寸的两个点大致沿周向相对，提供轴向尺寸的两个点大致沿轴向相对。
主体段40的网孔为多个支撑网孔50，支撑网孔50为封闭的多边形孔，以形成稳定的支撑结构，稳定泵间隙。支撑网孔50为至少两个边长不相等的多边形孔，多边形孔可以为不规则多边形孔，也可以为呈镜像对称结构的多边形孔，本申请不作限制。
例如，支撑网孔50为镜像对称结构网孔，其最小棱边的长度方向与轴向平行，包括相平行的两个第一边棱501、相平行的两个第二边棱502。第二顶点504位于第二边棱502的至少一个端点，第一顶点505位于第一边棱501的至少一个端点。
支撑网孔50可以为诸如菱形孔的四边形孔，也可以为六边形孔。
在为菱形网孔的实施例中，支撑网孔50具有两个轴向的第一顶点505，分别为第一边棱501和第二边棱502形成锯齿结构的前齿顶510a和后齿顶510b。两个第二顶点504在周向相对设置，分别第一边棱501和第二边棱502形成锯齿结构的左齿顶和右齿顶。
在为六边形孔的实施例中，支撑网孔50还包括平行于轴向的两个第三边棱503。一个第三边棱503连接在一个第一边棱501和第二边棱502之间，第一边棱501、第二边棱502、第三边棱503围构成封闭的六边形支撑网孔50。
通过第三边棱503增大支撑网孔50的轴向尺寸，使得支撑网孔50的轴向尺寸为主尺寸，进而在收入鞘管内时，可以沿轴向顺利收折，减小收折时的抵抗力。进一步地，第二边棱502的长度等于第一边棱501的长度，第三边棱503的长度小于第二边棱502的长度。第三边棱503为支撑网孔50的最小边棱，提供网孔的最小边长。
第三边棱503的轴向两个端点分别形成第二顶点504，第三边棱503的轴向的后端点与一第一边棱501共用，该共用端点形成一第二顶点504，第三边棱503的轴向的远端点与一第二边棱502共用，该共用端点形成另一第二顶点504。两个第三边棱503的周向间距为周向相对的两个第二顶点504的间距。第一边棱501和第二边棱502的共用端点形成第一顶点505。
第一边棱501、第二边棱502、第三边棱503中的至少一个边棱整体为直线形边棱，网孔的多个边棱围构成多边形网孔，边棱整体为直线型，其可以为如图11、图12所示的无弯曲的直线型。或者，边棱也可以为允许一定细微弯曲依然可以直观地视为多边形的直边，如图13所示的边棱。
如此在本申请中，多边形网孔的边棱在整体上为直线型构造即可。
第一边棱501的长度范围为1mm-2mm，第三边棱503的长度范围为0.15mm-0.35mm，第一边棱501和第三边棱503的长度比值范围为3：1至5:1。第一顶点505和第二顶点504分别设有第一和第二倒圆结构，使得支撑网孔50的孔边之间平滑过渡，构建稳定的支撑结构。第一倒圆结构的弧长大于第二倒圆结构的弧长。
值得注意的是，上述数值包括从下限值到上限值之间以一个单位递增的下值和上值的所有值，在任何下值和任何更高值之间存在至少两个单位的间隔即可。
举例来说，阐述的第一边棱501的长度范围为1mm-2mm，优选为1.1-1.9mm，更优选为1.2-1.8mm，进一步优选为1.3-1.7mm，目的是为说明上述未明确列举的诸如1.4mm、1.5mm、1.6mm等值。
如上述，以0.1为间隔单位的示例范围，并不能排除以适当的单位例如0.01、0.02、0.03、0.04、0.05等数值单位为间隔的增长。这些仅仅是想要明确表达的示例，可以认为在最低值和最高值之间列举的数值的所有可能组合都是以类似方式在该说明书明确地阐述了的。
除非另有说明，所有范围都包括端点以及端点之间的所有数字。与范围一起使用的“大约”或“近似”适合于该范围的两个端点。因而，“大约20到30”旨在覆盖“大约20到大约30”，至少包括指明的端点。
本文中出现的其他关于数值范围的限定说明，可参照上述描述，不再赘述。
多个支撑网孔50沿周向依次排布构成支撑孔环(50a、50b、50c)，多个支撑孔环沿轴向排布构成主体段40。如图26所示，沿周向，第一边棱501和第二边棱502交替排布形成呈锯齿结构的锯齿环520，两个轴向相邻锯齿环520相对形成一支撑孔环。
主体段4050具有沿轴向排布的三个支撑孔环50a、50b、50c。锯齿环520具有朝向入口段41的前齿顶510a以及朝向出口段42的后齿顶510b，多个锯齿环520沿周向排布，在相邻两个锯齿环520中一锯齿环520的前齿顶510a沿轴向与另一锯齿环520的后齿顶510b相对设置。
在本实施例中，一锯齿环520的前齿顶510a沿轴向与另一锯齿环520的后齿顶510b 通过一与轴向平行的第三边棱503连接(例如一体成型连接或焊接等连接方式)，构成一呈六边形形状的支撑网孔50。相应的，每个支撑孔环包括多个沿周向排布的六边形支撑网孔50。
在其他实施例中，一锯齿环520的前齿顶510a沿轴向与另一锯齿环520的后齿顶510b直接连接构成一呈菱形形状的支撑网孔50。相应的，每个支撑孔环包括多个沿周向排布的菱形支撑网孔50。
如图23、图25所示，入口段41位于主体段40的前侧，位于可折叠支架404的远端，入口段41的网孔在轴向两端之间的延伸长度大于支撑网孔50的轴向长度。
入口段41的网孔为过流网孔，供血液流入。入口段41的网孔的延伸长度为从网孔的前端向后端的延伸长度，并非在轴线上的径向投影长度。
本实施例中的支撑网孔50的轴向长度与其在轴线上的径向投影长度相等。
入口段41的网孔包括沿周向交替分布的第一过流网孔52a和第二过流网孔52b，第一过流网孔52a的长度小于第二过流网孔52b的长度。第一过流网孔52a为封闭孔，第二过流网孔52为非封闭孔。
入口段41的远端设有前连接部44，前连接部44呈分散结构或瓣体结构(分瓣结构)，其可以在径向上扩展，以方便叶轮410自远端装入支架404内。
前连接部44包括多个在周向分散的连接支腿45，连接支腿45呈T形结构，相邻两个连接支腿45之间具有支腿间隙，支腿间隙自前连接部44延伸至入口段41，进而入口段41同样呈分散结构或分瓣结构。
每个第一过流网孔52a构成一瓣体，入口段41在周向上具有多个相间隔的第一过流网孔52a，相邻两个第一过流网孔52a间隔一第二过滤网孔52b。连接支腿45在径向上向外扩展时拉动第一过流网孔52a(的边棱)，将入口段41一同径向张开，以方便叶轮410的装配。
连接支腿45的远端具有周向尺寸大于支腿杆体451的腿端452，连接支腿45可以卡入远端轴承室6的外壁上的卡槽602上，卡槽602的远端连通一环形槽603，连接支腿45的支腿杆体451卡入到卡槽602，其腿端452卡入环形槽603，并通过箍套61将分散的多个连接支腿45固定在远端轴承室6上。
远端轴承室6呈阶梯管状结构，具有伸入到支架404的入口段41内的伸入段605以及位于入口段41外部的束缚段606，伸入段605和束缚段606之间形成如图17所示的变径台阶607。伸入段605的外径小于束缚段606的外径，构建朝向近侧的变径台阶607。
在束缚段606的外壁上设有多个沿轴向延伸的卡槽602，多个卡槽602互相平行，且在周向上排布。较佳的，多个平行卡槽602在周向上均匀分布。
卡槽602的深度不超过变径台阶607的高度。较佳的，卡槽602的深度大致与变径台阶的(径向)凸出高度相等。如此，伸入段605方便支架404收折，使得支架404顺利收折进入鞘管。
连接支腿45的高度不超出卡槽602。即，连接支腿45的高度在卡槽602的深度以下，进而在连接支腿45卡入卡槽602中时，连接支腿45不超出束缚段606的壁面，减少额外凸起的产生。
卡槽602的远端通入环形容纳槽603中，支腿杆体451卡入到直线卡槽602中，腿端452卡入到环形槽603中。优选的，腿端452的侧面置于环形槽603中，为避免形成尖锐结构，腿端452的侧面为弧面，该弧面的弧度与束缚段606的外壁弧度相等，或者，该弧面的曲率半径与束缚段606的半径相等。
箍套61为圆筒结构套体，固定套设在束缚段606外，将连接支腿45束缚箍紧在束缚段606的卡槽602中，避免多个连接支腿45从卡槽602中弹出。
在一个实施例中，箍套61为热缩管经加热形成。具体而言，将连接支腿45嵌入到卡槽602及环形槽603中后，再将热缩管套接在远端轴承室6外，随后执行加热工序，热缩管径缩，将连接支腿45包裹在远端轴承室6外，形成箍套61。
远端轴承室6的远端设有球面结构或圆角结构，以方便在体内血管中无创介入。束缚段606的远端形成限位台阶，将箍套61的远端限位。
远端轴承62设在远端轴承室6的伸入段605内，避免第二轴355在轴向移动时从远端轴承62脱出，保持远端轴承62对第二轴355的转动支撑状态。第二轴355的远端伸出远端轴承62，位于远端轴承62的远侧。
在其他实施例中，箍套61与束缚段606之间可以通过螺纹连接固定。具体的，在束缚段606的外壁上可以设有螺纹，通过旋动箍套61实现箍套61的装卸。进一步地，箍套61和束缚段606之间还可以采用防转销钉进行固定，以避免二者之间存在相对转动。
泵体4的装配方法为：S1、径向打开多个连接支腿45；S2、将第二轴355和远端轴承室6自支架404的远端向其近端穿设；S3、将连接支腿45放置于远端轴承室6外壁的槽中定位；S4、在箍套61套设在远端轴承室6外将连接支腿45限位在槽中。
在步骤S1中，可以通过手工或者夹具夹持连接支腿45并向外拉动，使得多个连接支腿45径向张开，前连接套1644的前端口46(该前端口46为多个腿端452周向围构 形成)张大，便于叶轮410放入。
在连接支腿45径向打开过程中，连接支腿45会拉动入口段41上的第一过流网孔52a所构成一瓣体一同张开，便于叶轮410及第二轴355放入到支架404内。第二轴355向近端穿设直至第二轴355的近端穿设在近端轴承内停止。
在步骤S2中，第二轴355和远端轴承室6可以先后穿设，也可以同步(一同运动)穿设。在一较佳的实施例中，可以先将第二轴355与远端轴承室6装配，再一同移动穿设进入支架404内。具体的，先将第二轴355的远端穿设于远端轴承室6内，再径向打开多个连接支腿45后将第二轴355和远端轴承室6一同自支架404的远端向近端移动穿设。在该步骤中，第二轴355上固定套设有叶轮410。也即，在第二轴355的远端穿设进入远端轴承室6内之前，将叶轮410套设在第二轴355上，并向轮毂412和第二轴355之间打胶，胶水固化后将叶轮410固定在第二轴355上。
在另一实施例中，第二轴355和远端轴承室6先后穿设。具体的，在径向打开多个连接支腿45后，先将第二轴355自支架404的远端向其近端穿设，再将远端轴承室6自支架404的远端送入至被多个连接支腿45围绕且被第二轴355的远端插入。其中，在第二轴355的近端穿设在近端轴承内定位后，再装配远端轴承室6。
在该装配方法中，径向打开多个连接支腿45，将远端轴承室6送入多个连接支腿45内并将容纳槽与连接支腿45相对齐，放置连接支腿45在容纳槽中定位。在远端轴承室6送入到被多个连接支腿45围绕的位置时停止，将多个连接支腿45逐个收拢放置在容纳槽中。为避免连接支腿45在远端轴承室6的容纳槽中脱出，将热缩管套设在远端轴承室6外经热缩后形成箍套61。
承接上文描述，设在远端轴承室6内的封堵件550可供导丝穿引。在导丝撤出后，封堵件550恢复封堵状态。封堵件550可以为封堵橡胶或者硅胶材质，在导丝穿过封堵件550时，封堵件550与导丝贴合，维持封堵状态，而在导丝撤出后封堵件550复位将穿丝孔闭合，依然维持所在位置的封堵状态。
封堵件550位于远端轴承62的远侧，并且，位于第二轴355的远端的远侧。封堵件5和第二轴355的远端之间相间隔一定距离，提供第二轴355的轴向活动余量，以供第二轴355轴向移动。
第二过流网孔52b自入口段41延伸至前连接部44，直至在前连接部44的端部形成敞口523，两个腿端452之间形成该敞口523。部分第二过流网孔52b位于入口段41，部分第二过流网孔52b位于前连接部44。两个连接支腿45之间的间隙构成位于前连接 部44的部分第二过流网孔52b，在安装时被远端轴承室6的外壁凸起所填充。
第一过流网孔52a自前齿顶510a朝向交汇点延伸时其周向宽度逐渐减小，前交汇点525或第一过流网孔52a不超出入口段41和连接次管43的过渡部位。第二过流网孔52b包括周向宽度在轴向上延伸保持不变的前侧区段521和周向宽度在轴向上朝远离主体段40方向延伸逐渐变小的后侧区段522。其中，前侧区段521位于前连接部44。
在如图25所示的实施例中，后侧区段522在轴向上延伸时其周向宽度大致不变。第二过流网孔52b的位于前齿顶510a和交汇点之间的区段(后侧区段522)的周向宽度在轴向的不同位置上的变化率小于10％。后侧区段522的周向宽度大于或等于前侧区段521的周向宽度，后侧区段522和前侧区域之间具有一过渡位置，该过渡收窄位置大致位于入口段41和前连接部44的过渡位置。
具体的，入口段41包括多个自前齿顶510a向前连接部44延伸的前拉伸棱条528；相邻两个前拉伸棱条528远离主体段40的一端相汇合形成一前交汇点525；多个前交汇点525一一对应地连接至或延伸至连接支腿45。前拉伸棱条528的数量与一锯齿环520的前齿顶510a的数量相等，且为连接支腿45的数量的2倍。
出口段42与入口段41大致相似，不同的是第三过流网孔51a和第四过流网孔51b均为封闭孔。其中，出口段42位于可折叠支架404的近端。出口段42的网孔在轴向两端之间的延伸长度大于支撑网孔50的轴向长度。
出口段42的网孔包括沿周向交替分布的第三过流网孔51a和第四过流网孔51b，第三过流网孔51a和第四过流网孔51b的形状或面积不同，第三过流网孔51a的长度小于第四过流网孔51b的长度。
出口段42的近端设有连接次管43，连接次管43通过热熔或胶粘的方式固定在导管3或近端轴承室上，实现支架404的近端固定。连接次管43上可以设有卡孔431，供导管3或近端轴承室340的外壁卡扣扣合。
第四过流网孔51b自出口段42延伸至连接次管43，并在连接次管43形成封闭孔端。部分第四过流网孔512位于出口段42，部分第四过流网孔511位于连接次管43。第四过流网孔51b向后端延伸未超过连接次管43上的卡孔431。
出口段42包括多个自后齿顶510b向后延伸的后拉伸棱条518，相邻两个后拉伸棱条518在近端汇合形成一后交汇点。多个后交汇点一一对应地连接至或如图25所示延伸至后间隔条，相邻两个后间隔条之间构成位于连接次管43的部分第四过流网孔511。后拉伸棱条518的数量与一锯齿环520的后齿顶510b的数量相等，且为连接支腿45或后 间隔条的数量的2倍。
第三过流网孔51a自后齿顶510b朝向后交汇点延伸时其周向宽度逐渐减小，后交汇点或第二过流网孔52b不超出出口段42和连接次管43的过渡部位。位于连接次管43的部分第四过流网孔51b的周向宽度在轴向上保持不变，第四过流网孔51b的位于后齿顶510b和后交汇点之间的区段的周向宽度在轴向不同位置上的变化率小于10％。
图23中的支架404与图25中的支架404的网格不同，出口段42的后拉伸棱条518向后侧延伸未进入连接次管43。相应的，第三过流网孔51a、第四过流网孔51b基本分布于支架404的出口段42，向近端延伸未超出出口段42和连接次管43的过渡部位。
驱动轴300的外壁和导管3的内壁之间形成外流道600，驱动轴300内设有与其共同延伸的内流道800。外流道600在导管3的远端设有第一排出口608，内流道800在驱动轴300的远端设有第二排出口810。
为减缓进入体内的灌注液流速，适宜被受试者接受，内流道800的远端设有扩散段820，扩散段820的端口为第二排出口810。扩散段820呈喇叭孔形状，自其近端向远端延伸时横截面积逐渐增大。
如图1所示，外流道600和内流道800中的至少一个与灌注液输入部20连通，通过灌注液输入部20向外流道600和内流道800输入灌注液。
驱动轴300的壁上设有将内流道800和外流道600相连通的连通部，外流道600和内流道800通过驱动轴300的壁相间隔，通过连通部相连通。
通过构建共同向远端输送灌注液的外流道600和内流道800，实现灌注液体的多通道输送，并且该动力传递组件中灌注液输入部20与外流道600和内流道800中的一个相连通，可以简化输入结构，便于制造，在输入到其中一个流道中时通过连通部增大灌注液的流通面积，降低灌注压力，避免因灌注压力过大而产生的不良影响，并且又能保证灌注流量，保障介入手术的正常顺利进行。
连通部包括在导管3内的可被液体渗透通过的至少部分长度的驱动轴300的壁。外流道600自导管3的近端延伸至导管3的远端，内流道800自驱动轴300的近端延伸至驱动轴300的远端，外流道600和内流道800均为连续流道。外流道600的横截面大致为(圆)环形结构。内流道800的截面形状可以为圆形也可以为多边形，甚至不规则形状。在本实施例中，内流道800的截面形状为圆形，在导管3伸直状态下导管3和驱动轴300大致为同轴设置，外流道600的截面为圆环形状。
在本实施例中，导管3的近端与灌注液输入部20相连通，以将外流道600的近端与 灌注液输入部20相连通。外流道600为高压流道，内流道800为低压流道，灌注液在压差作用下穿过驱动轴300的壁渗透进入到内流道800中，经内流道800向前流动直至进入到第二排出口810。驱动轴300的近端在灌注液输入部20的近侧被封堵。如此，避免驱动轴300内进入的灌注液向近侧流动而产生泄漏。
灌注液输入部20为耦合器2上的灌注液输入口，灌注液输入口连通有输入流道。灌注液输入口21通过输入流道与导管3的管腔相连通，驱动轴300穿过该部位，并在输入流道的近侧(动力传递方向的上游)设置密封措施，避免灌注液相近侧泄漏。
耦合器2连接导管3的近端，导管3和驱动轴300之间具有液体流道；耦合器2上还设有与液体流道相连通的灌注液输入部21。
导管泵在工作时，相对旋转的部件之间，例如输出轴与驱动轴300、驱动轴300与导管33之间会产生热量，热量的聚集会加剧这些部件的磨损，降低使用寿命。因此，有必要措施进行热管理。
有鉴于此，导管泵还包括基本贯穿整个工作组件的灌注通道。具体的，灌注通道贯穿驱动轴300至泵体4的传动链路。在导管泵工作时，灌注通道内可注入流体，上述所指流体为导管泵运行过程中需灌注至受试者内的灌注液(Purge液)，该灌注液例如为维持受试者机体的注入生理盐水、葡萄糖溶液、抗凝剂，或者上述任意的组合，对传动链路起到润滑和降温的作用。
耦合器20的远端设有供导管3穿过的保持套260，该保持套260可对导管3进一步起到固定的作用。灌注液输入部20包括设在耦合器20上灌注流道(参与形成灌注通道)以及灌注口201。
具体的，灌注通道的近端入口为设在耦合器20上的灌注口201。耦合器20内部的腔内可灌注流体，流体对驱动轴300的近端进行润滑及降温。因此，灌注通道从工作组件传动链路的起点开始对传动链路进行润滑及降温，保证工作组件的有效工作。
本申请并不局限于外流道600与灌注液输入部20相连通的实施例。在一个可行实施例中，内流道800与灌注液输入部20相连通，内流道800中的灌注液沿径向向外流动至外流道600中，具体的，驱动轴300的内流道800与体外灌注液输入部20相连通，驱动轴300的近端通过连接轴与马达的输出轴连接，输出轴及连接轴构成为中空结构，马达的输出轴从其尾端穿出，提供灌注液输入接口。
如图28或图29所示，驱动轴300包括连接的第一轴350和第二轴355，第二轴355的刚度大于第一轴350的刚度。第一轴350为柔性轴，也可以称为软轴，以方便穿入血 管适应血管构造进行弯曲，将远端的泵组件送入期望位置。第二轴355为刚性轴，也可以称为硬轴、叶轮轴，配合两侧的近端轴承331、332和远端轴承4501，为叶轮410提供稳定支撑，使叶轮410在泵壳363中的位置实现期望的稳定。
第一轴350的近端穿出导管3，并通过连接轴与马达的输出轴连接。第二轴355用于被叶轮410固定套设。叶轮410具有叶片411及轮毂412，轮毂412固定套设在第二轴355上，被第二轴355带动旋转。
支架404与导管3的连接位置位于第二轴355的近侧。支架404近端设有连接次管43，导管3与连接次管43连接，具体连接方式可以为热熔或卡扣连接。或者，导管3通过近端轴承室330与连接次管43连接，可行的方式为导管3远端与近端轴承室330粘接，连接次管43与近端轴承室330卡扣连接。
如上文描述，为了向叶轮410提供足够的强度支撑，使其在泵壳363内位置稳定的被保持，穿过轮毂412的第二轴355为硬轴，不易发生弯曲变形。因此，为了不使刚度较大的第二轴355影响血泵前端的工作部分(包括泵组件以及介入到人体内的前端导管3部分)的弯曲性能，第二轴355的近端位于支架404的近端的内部或者连接次管43的内部，但不伸出连接次管43。也即，第二轴355的近端位于连接次管43内且不伸出连接次管43。
在泵组件以收折方式介入的场景中，收折后的泵组件刚性较大，一般不能弯曲。那么，在介入过程中，泵组件的过弯需要依靠与之相连的导管3的弯曲来实现。通过上述设计，第二轴355的近端位于支架404的近端的内部或者连接次管43的内部，使得第二轴355的近端不伸出连接次管43而过多的进入导管3，因此导管3的刚度不会因为得到第二轴355的增益作用而变大，这就使得导管3与连接次管43连接的远端部分依然保持较佳的弯曲性，进而保证介入过程中泵组件的过弯性能。
第一轴350的远端和第二轴355的近端通过诸如非圆形截面结构的插接的方式连接，第一轴350和第二轴355之间允许轴向相对移动，并将转动传递。例如，第一轴350具有矩形母插口，第二轴355具有矩形公插头，通过二者对插实现二者的允许轴向相对移动且可传递转动的连接。
连通部自第一轴350的近端延伸至第一轴350的远端。第一轴350为编织制成，其壁为液体可渗透结构，连通部为遍布于第一轴350壁上的编织缝隙。第一轴350为多层编织结构，例如，2层、3层、4层或更多层的逐层包裹。
第一轴350的多个编织层为逐层套设关系，编织层为螺旋编织。其中，相邻两个编 织层的螺旋方向相反。多层编织结构为大致为螺旋状的拧绕结构，内外相邻两层编织层的旋向相反。
通过设置具有内外相邻两层编织层的旋向相反的编织拧绕结构的第一轴350，在第一轴350的外表形成螺旋凹槽或凸起，该螺旋凹槽或螺旋凸起的旋向与驱动轴300的旋转方向相反，以形成泵效应，将灌注液向远端泵送，并可以在导管3的远端防止血液进入，避免在导管3的远端形成血栓。
连通部遍布第一轴350的周向和轴向，通过液体渗透方式将外流道600和内流道800连通，至少部分位于导管3内的驱动轴300的壁为液体可渗透结构。第一轴350整体为液体可渗透结构，第一轴350被导管3套设的部分的壁构成为内流道800和外流道600连通的连通部。内流道800和外流道600延伸至第一轴350和第二轴355的连接部位一直存在液体交流或液体渗透。
驱动轴300包含的第一轴350外壁形成有螺旋结构，螺旋结构可以为螺旋凸起，也可以为螺旋凹槽，其螺旋方向有驱动轴300的旋转方向相反。从近端向远端的方向观察，在驱动轴300顺时针旋转的情况下，螺旋结构为左旋螺纹。或者，在驱动轴300逆时针旋转的情况下，螺旋结构为右旋螺纹。
在本实施例中，灌注液首先在外流道600也就是导管3内或第一轴350外向前流动。在流动过程中，一部分灌注液渗进第一轴350内也就是内流道800。第一轴350外壁的螺旋结构在旋转时形成的泵效应，可对外流道600中的灌注液产生向前的力，保证灌注液流动通畅，避免灌注液拥堵。
出于同样的目的，为给内流道800中的灌注液提供持续向前流动的动力，第一轴350内壁也可以形成有这样的螺旋结构。
第一轴350外壁和/或内壁形成的螺旋结构，可由上述的螺旋编织层构成。编织层一般由单股材料螺旋编织而成，该单股材料截面大致呈圆形，从而在编织面天然形成螺旋状的凸起或凹槽。其中，凸起为单股材料的外轮廓，凹槽形成在编织后的材料之间。
因此，为达到上述的在第一轴350的外壁形成符合上述描述的螺旋结构，在第一轴350采用螺旋编织构造的情况下，只需使最外层的编织层的螺旋方向与第一轴350的旋转方向相反即可。
同样的，最内层的编织层的螺旋方向与第一轴350的旋转方向相反，可实现在第一轴350的内壁形成符合上述描述的螺旋结构。也即，从近端向远端的方向观察，在驱动轴300顺时针旋转的情况下，最内层的编织层上的螺旋结构为左旋螺纹。或者，在驱动 轴300逆时针旋转的情况下，最内层的编织层上的螺旋结构为右旋螺纹。
由此，最内层和最外层的编织层的螺旋方向相同。在上文阐述相邻编织层的螺旋方向相反的情况下，第一轴350包含的编织层的层数应为大于1的奇数，例如3层或5层。
进一步地，由于第一轴350需要传递扭矩，通过其最外的编织层的螺旋方向与第一轴350旋转方向相反的结构设计，使得最外的螺旋编织层在旋转过程中由于扭矩作用而趋于拧紧，避免最外的编织层松散。
由此，在旋转过程中，螺旋方向与第一轴350旋转方向相反的编织层的直径趋于变小。如果第一轴350的所有螺旋编织层均与第一轴350旋转方向相反，那么随着工作时间的延长，第一轴350的直径不能被稳定的维持。
如上文描述，第一轴350中存在螺旋方向相反的相邻两个编织层。也就说，第一轴350包含螺旋方向与其旋转方向相同的编织层，该编织层旋转过程中由于扭矩作用而趋于直径增大，或者趋于松散。
那么，螺旋方向与第一轴350旋转方向相反的编织层对内侧的编织层施加向内的压缩力，而螺旋方向与第一轴350旋转方向相同的编织层对外侧的编织层施加向外的扩张力。借此，相邻的编织层的直径变化或力作用至少部分程度上得以抵偿，进而使第一轴350的直径得到稳定的保持。
第一轴350的直径的稳定保持，对外流道600的形状稳定是有利的，进而使得灌注液的流速和过流面积稳定。
上文阐述的借助第一轴350的螺旋编织构造来形成螺旋结构的方案是示意性的，并不能构成唯一性的限制。也就是，在其他可替换的实施例中，例如，第一轴350的外壁和/或内壁为平整或光滑的壁，在该平整或光滑的壁上通过机加工形成螺旋形的凹槽或凸起的方式形成上述螺旋结构，也是可行的。
第一轴350的远端和第二轴355的近端的连接位置位于导管3远端内，两者可通过任意合适的方式例如焊接实现连接，当然也可以通过其他诸如花键等传动连接方式相连接，只需二者能够传动转动即可。
如图18所示，第二轴355具有壁面暴露在支架404中的暴露部3556，至少部分暴露部3556的壁面上设有第一螺旋结构3558。第一螺旋结构3558位于轮毂412的远侧，可以为螺旋槽或者螺旋凸起。
第一螺旋结构3558的旋向与第二轴355的旋转方向相同。从近端向远端的方向观察，在第二轴355顺时针旋转的情况下，第一螺旋结构3558为右旋螺纹，或者，在第二轴 355逆时针旋转的情况下，第一螺旋结构3558为左旋螺纹。第一螺旋结构3558在转动过程中形成泵效应，该泵效应为血液提供与叶轮410相同方向的驱动力，将血液在泵壳363内泵送，进而防止血液反向流动而进入到远端轴承室6，避免溶血和形成血栓。
第二轴355具有被套设在轮毂412内的第一非暴露部3555。为提升第二轴355和叶轮410的连接强度，避免叶轮410与第二轴355发生脱离问题，至少部分第一非暴露部3555的壁面上设有凹陷结构3554。
凹陷结构3554设于第二轴355的外壁上，可以具有多种形式，例如沟槽结构、离散分布的点状凹槽、长槽结构等。凹陷结构3554可增大胶粘面积，提高轮毂412与第二轴355的连接强度。
在一个实施例中，凹陷结构3554为螺旋槽结构，与第一螺旋结构3558构成连续的螺旋槽结构。也就是说，该连续的螺旋槽结构从轮毂412内延伸至轮毂412外
第二轴355具有被套设在远端轴承室6内的第二非暴露部3557，至少部分第二非暴露部3557的壁面上设有第二螺旋结构3559。第二螺旋结构3559可以为螺旋槽或者螺旋凸起，螺旋方向与第二轴355的旋转方向相同。从近端向远端的方向观察，在第二轴355顺时针旋转的情况下，第二螺旋结构3559为右旋螺纹，或者，在第二轴355逆时针旋转的情况下，第二螺旋结构3559为左旋螺纹。
同样的，第二螺旋结构3559在转动过程中形成泵效应，该泵效应为血液提供与叶轮410相同方向的驱动力，防止血液反向流动而进入到远端轴承室6，避免溶血和形成血栓。
凹陷结构3554、螺旋结构3558以及螺旋结构3559可以构成连续的螺旋槽结构。也即，第二轴355的远端的侧壁面上分布有连续的螺旋槽结构，该连续的螺旋结构在轮毂412内的部分构成凹陷结构3554，在支架404内的部分构成螺旋结构3558，在远端轴承室6内的部分构成螺旋结构3559。
如上述，该连续的螺旋结构(3554、3558、3559)在三个不同的位置，均取得相应的技术效果，不再赘述。
该连续的螺旋结构(3554、3558、3559)的旋向与第二轴355的旋转方向相同。从近端向远端观察，驱动轴300的旋转为顺时针转动时，该连续的螺旋结构为右旋，或驱动轴300的旋转为逆时针转动时，螺旋结构为左旋。
第二轴355上的该连续的螺旋结构(3554、3558、3559)具有起始于轮毂412近端的始端以及位于第二轴355远端(大致端口位置)的止端，进而沿动力传递方向呈现被遮挡、暴露、再被遮挡的不同区段。螺旋槽的深度的取值范围为0.05-0.2mm。
连通部遍布第一轴350的周向和轴向，通过液体渗透方式将外流道600和内流道800相连通，至少部分位于导管3内的驱动轴300的壁为液体可渗透结构。第一轴350整体为液体可渗透结构，第一轴350被导管3套设的部分的壁构成为内流道800和外流道600相连通的连通部。内流道800和外流道600延伸至第一轴350和第二轴355的连接部位一直存在液体交流或液体渗透。
第一轴350和第二轴355的连接部位位于近端轴承室340的近侧近端轴承室340和第二轴355之间形成将外流道600和第一排出口608相连通的连通路径。
近端轴承室340位于导管3的远端，内设有第一近端轴承331和位于第一近端轴承331远侧的第二近端轴承332。在其他实施例中，并不排斥近端轴承为一个或者更多个。近端轴承331、332套设于第二轴355外，第一排出口608位于近端轴承332的远侧。
如图19、图20所示，驱动轴300的外壁设有可轴向活动地位于近端轴承331、332之间的止挡件356，止挡件356为设在驱动轴300外壁上的止挡环，或者为设在驱动轴300外壁上的诸如凸块的止挡凸起。
止挡件356的外壁和近端轴承室340的内壁之间构成止挡流动间隙。第一排出口605位于第二近端轴承332的远侧。连通路径包括第一近端轴承331内部流动缝隙、止挡流动间隙、以及第二近端轴承332内部流动缝隙。其中，第一近端轴承331、第二近端轴承332自身具有可被流体穿过的流动缝隙，并不对流体穿过形成封堵。
当然，第一近端轴承331与第二轴355外壁之间也可以构成第一流动间隙，第二近端轴承332与第二轴355外壁之间构成第三流动间隙，进一步方便流体流过。
止挡件356和第一近端轴承331之间具有第一间隔空间，第一间隔空间将止挡流动间隙和第一近端轴承331相连通。止挡件356和第二近端轴承332之间具有第二间隔空间，止挡流动间隙和第二近端轴承332相连通。
通过第一近端轴承331、止挡流动间隙及第二近端轴承332构建曲折的灌注液输出路径，减缓灌注液流速和冲击压力，避免快速进入到受试者内造成损伤或其他不良影响。
在一些其他实施例中，用于安装近端轴承331、332的近端轴承室340可由其他结构来替换，例如导管3远端部分或者支架404的连接次管43。则在该实施例中，近端轴承室340可以被取消，近端轴承331、332安装在导管3远端内或连接次管43内。
因此，用于安装近端轴承331、332的近端轴承室340、导管3远端部分或者连接次管43可构成近端轴承安装部件。或者，该近端轴承安装部件包含近端轴承室340、导管3远端部分或者连接次管43，本申请并不以额外设置的远端轴承室6作唯一的限制。
第二轴355的远端可转动地支撑于远端轴承室6内，支架404的远端连接远端轴承室6。第二排出口810位于远端轴承室6内，远端轴承室6的近端和驱动轴300之间构成灌注液排出口。远端轴承62和驱动轴300(第二轴355)之间形成流动间隙。
如图17所示，封堵件550位于第二轴355的远端和无创支撑件5的近端之间。这样，内流道800中的灌注液从第二排出口810排出进入远端轴承室6，由于封堵件550的存在只能反向流动，进而流经远端轴承62对其进行润滑，然后再从灌注液排出口排出远端轴承室6，进入支架404，并最终进入人体。从而，从灌注液排出口排出的灌注液可在远端轴承室6近端形成一定范围内的高压区，从而拒止血液进入远端轴承室6，防止血栓的形成。
封堵件550为诸如止回阀的柔性止回阀，设有可供导丝穿过的可再密封通道，可再密封通道在导丝穿设移除后闭合，以维持所在位置的封堵状态。柔性止血阀可以为封堵橡胶或者硅胶材质，在导丝穿过可再密封通道时，柔性止血阀与导丝贴合，维持封堵状态，而在导丝撤出后柔性止血阀复位将穿丝孔闭合，依然维持所在位置的封堵状态。
封堵件550可构成对第二轴355的轴向限位，将封堵件550的轴向移动的远死点位置限定。当然，在上述止挡件356存在的情况下，止挡件356在与第二近端轴承332接触时，第二轴355的远端与封堵件550并不接触，二者间隔，以避免第二轴355的轴向移动对封堵件550产生破坏。
如图1、图21、图22所示，在某些实施例中，第二排出口810和无创支撑件500之间可不设置封堵件500，远端轴承室6的内部将第二排出口810与中空管腔555连通。无创支撑件500的远端端口构成灌注液排出口。此时，由于灌注液压力较高，远端轴承4051同样可以构成灌注液排出路径，在远端轴承4051的近侧形成灌注液排出口，此时，灌注液可以同时在无创支撑件500的远端端口以及远端轴承4051的近侧向外排出。
灌注液经第二排出口810流出后进入到无创支撑件500中，并在无创支撑件500的远端端口以及远端轴承4051的近侧排出，同时可以避免在泵组件工作状态下血液进入到无创支撑件500以及远端轴承室6中。
承接上文描述，泵体4采用鞘进行收折，具体收折方案是鞘向前推，通过轴向的运动强制收折泵。这样，鞘对支架404与导管3之间施加极大的轴向力。这就要求支架404与导管3之间必须具有较高的接合强度。否则，极容易出现鞘将泵顶开与导管3脱离。
另一方面，介入过程所通过的弯曲的路径要求整个导管3组件具有较佳的弯曲，这其中就包括支架404与导管3连接处也应具有较佳的弯曲性。
承接上文描述，支架404近端设有连接导管3远端的连接次管43。在本实施例中，支架404与导管3的连接位置位于硬轴355(第二轴355)的近侧，硬轴355的近端位于连接次管43内且不伸出连接次管43。如此，提升连接次管43位于硬轴355近侧的部分的柔韧性可以提升导管3组件的过弯性能。
如图29、图31所示，位于支架404近端的连接次管43上设有贯穿其至少部分壁厚的接合部。接合部在连接次管43上呈现凹陷结构以形成容纳空间。导管3远端设有容纳在接合部中的热熔固化成型的接合材料。
在本实施例中，连接次管43内设有支撑驱动轴300的近端轴承330，连接次管43构成为近端轴承安装部件。近端轴承330直接设在连接次管43内，被连接次管43上设置的定位部承定位，进而无需额外设置近端轴承室，有利于减少该部位的叠置层数，提升弯曲性能。
在一个可行的实施例中，连接次管43套设在导管3远端外部。连接次管43的外部套设有中间连接套16。中间连接套16与连接次管43、导管3为分体结构。通过额外设置的中间连接套16将连接次管43和导管3连接。接合材料为中间连接套16热熔后固化形成。连接次管43上设有贯穿其至少部分壁厚的接合部，接合部中容纳有热熔后流入其内并固化的接合材料，接合材料设于导管3远端，由中间连接套16提供。
部分中间连接套16位于连接次管43的近侧并固定套设在导管3外。具体的，部分中间连接套16热熔后粘接套设于导管3外壁上，或者，部分中间连接套16胶粘于导管3外壁上，或者，导管3外壁设有容纳部分中间连接套16经热熔后固化形成的嵌入凸起的嵌槽。
在本实施例中，该部分中间连接套16与导管3通过可以采用热熔连接或其他连接，本实施例并不作特别的限制。当然，中间连接套16与导管3的连接方式还可以参照接合材料与接合部的连接方式，此处不再赘述。
继续参照图28、图29、图31所示的实施例。在本实施例中，接合材料为部分导管3经热熔固化成型或热压成型的结构。接合材料在热压成型时通过加热软化导管3远端管壁，并通过压具将导管3软化的管壁形成局部凸起形变，向内嵌入到接合部中，待冷却固化后形成接合材料。
接合材料的熔点与导管3的材料的熔点相同或相近。接合材料与导管3的材质相同，或者，接合材料与导管3均为树脂材料。接合材料与导管3的主要材料相近或相同。
为在提高导管3与支架404之间的接合强度，又不损失导管3组件的弯曲性能，支 架404的近端设有第一连接部421，连接部用于连接导管3。导管3的远端301设有第二连接部321。第一连接部421和第二连接部321之一设有连接凸起323，另一设有与连接凸起323进行嵌入配合的限位凹陷。限位凹陷将所嵌入的连接凸起323至少轴向上限位固定。进一步地，限位凹陷对连接凸起323进行轴向及周向上的限位固定。也即，限位凹陷与连接凸起323连接，借此实现导管3和支架404的连接。
第一连接部421与连接次管43为一体成型结构，也即，第一连接部421一体成型于连接次管43上。第二连接部321与导管3为一体成型结构，也即，第二连接部321一体成型于导管3的远端301。第二连接部321为在径向上向内凸起的卡扣凸起(连接凸起323)。连接凸起323通过热熔固化成型。另外，连接凸起323也可以通过热压成型。
第一连接部421的壁面面积小于相同轴向长度及直径下的圆柱的侧面积。在本实施例中，限位凹陷为设于连接次管43上的凹陷结构。限位凹陷通过径向下凹，进而在轴向的一侧构成母扣，对连接凸起323进行轴向限位。
凹陷结构为透孔结构，也可以为凹槽结构。在本实施例中，凹陷为将连接次管的壁穿透的透孔，具体的，限位凹陷沿径向将连接次管的壁贯通。该凹陷为连接孔435。第一连接部421具有多个连接孔435，多个连接孔435沿轴向排布，并且，多个连接孔435互相平行。连接孔435在轴向上的近端孔壁的构成公扣。连接次管43为记忆合金材质，进而可以提供金属材质的母孔(连接孔)，供导管3的连接凸起323作为公扣卡入。
连接孔435为长孔结构，其长度方向为沿圆周方向延伸。连接孔435所对应的圆心角大于180度。连接孔435的周向的两端间隔相对设置。连接孔435在周向上具有第一孔端4351和第二孔端4352。第一孔端4351和第二孔端4352相间隔设置。
在轴向上相邻两个连接孔435至少部分相错开设置。在轴向上相邻两个连接孔435至少部分相重合设置。如此，使得第一连接部421保持自身结构强度的基础上，减少材料的使用，进而使得连接部位具有更佳的柔性。相邻两个连接孔435相错开设置，使得连接次管43和导管3的连接部位具有较佳的抗轴向拉伸破坏能力，避免鞘管将泵体4与导管3脱开。
相邻两个连接孔435之间具有孔间隔部437。其中，孔间隔部437在圆周方向连续延伸，将两个连接孔435相间隔，互不相通，进而构成封闭的连接孔435，也即，连接孔435为封闭孔，孔壁连续延伸构建成封闭的周向长孔。孔间隔部437的轴向宽度不小于连接孔435的轴向宽度。
位于一连接孔轴向两侧的连接孔相对齐设置，如图24所示，连接孔435a与连接孔 435b之间具有连接孔435c，其中，连接孔435c与连接孔435a、连接孔435b相错开设置，连接孔435a与连接孔435b的孔端在轴向上相对齐，两个连接孔435a、435b之间的间隔部相对于连接孔435c居中设置。
第一孔端4351和第二孔端4352之间具有端间隔部436。端间隔部436在圆周方向的长度大于连接孔435在轴向的宽度。端间隔部436的周向长度(在圆周方向的长度)小于连接孔435的周向长度。端间隔部436沿轴向的投影全部位于邻近的连接孔435。第一孔端4351和第二孔端4352具有倒角结构，
相邻两个连接孔435的长度可以相等，也可以不等。在本实施例中，多个连接孔435的长度均相等，相邻两个连接孔435错开设置，形成交错设于连接次管43上的孔状结构。
相邻两个连接孔435沿轴向具有相重合的部分。其中，重合部分4355的周向长度大于连接孔435在轴向上的宽度。如图23、图24所示，连接孔435在端间隔部436的周向两侧均具有重合部分4355，两侧重合部分4355呈镜像对称结构。
相邻两个端间隔部436之间间隔一连接孔435。在沿轴向延伸实施例中，相邻两个连接孔435具有在周向上的重合部分4355，当然也可以具有错开部分。端间隔部436两侧的重合部分4355为第一重合部分和第二重合部分，第一和第二重合部分互为镜像对称结构。端间隔部436和第一重合部分或第二重合部分的周向长度大致相等。在本实施例中，端间隔部436、第一重合部分和第二重合部分在周向的总长度大致为一半周长。
支架404近端的连接次管设置多个连接孔435，一方面能够为支架404提供形变避让空间，使支架404具有较佳的柔性。另一方面，便于使熔融的导管3材料进入连接孔435，增大导管3与支架404的接合面积，使导管3与支架404之间形成沿轴向的止挡或固定结构，从而至少提高导管3与支架404沿轴向的连接强度。
进一步地，第一连接部421和第二连接部321之间还通过粘接固定。第二连接部321还具有与第一连接部421相粘接的粘接面。第二连接部321通过热熔固化后形成粘接面。将第一连接部421和第二连接部321粘接的粘接结构通过对第一连接部421热熔形成。
具体的，支架404近端的连接次管43设有多个连接孔435，插入导管3远端301的夹壁插孔中。通过热熔技术，使导管3材料流入开口中，使导管3与支架404融合为一体。支架404的连接次管43中设有近端轴承330或者设置近端轴承室，支架404的连接次管43或者近端轴承室中设有近端轴承330，供驱动轴300穿过。
在其他实施例中，连接孔435也可以为螺旋孔，在连接次管43的近端螺旋延伸。当然，连接次管43上可以设有单个螺旋连接孔，也可以为多个连接孔平行螺旋延伸。或者， 连接孔为轴向延伸的长孔；多个长孔沿圆周方向排布。
限位凹陷也并不局限于为孔状结构，在一个可行的实施例中，第一连接部421设有钩状结构，该钩状结构具有一大致周向延伸的勾边，勾边位于钩状结构的近端，该勾边与第二连接部321的凸起进行轴向的接触限位，保持接合。在支架404被鞘管向远端推挤时，第一连接部421的勾边与第二连接部321的凸起形成的钩挂结构，避免支架404与鞘管脱离，使得支架404能够完成收折进入鞘管中。
另外，也可以为不同形状的孔在连接次管壁上分布。连接孔也可以为不规则形孔，只需能够连接凸起323结构，构成轴向机械接触限位，使得导管3和支架404形成更稳定的连接结构，避免支架404无法收折而被鞘管推挤脱离，保证泵体4顺利收入鞘管中。
在一个可行的实施例中，导管3的远端301和支架404的近端还可以通过中间连接套16进行连接。其中，导管3的远端301连接有中间连接套16，第二连接部321位于中间连接套16上。中间连接套16的近端固定套设在导管3的远端301上，中间连接套16的远端301固定套设在支架404的近端上。其中，导管3的远端301设有诸如上述描述的连接孔，相应的，支架404的近端设有诸如上述描述的连接孔，中间连接套16通过热熔形成嵌入到连接孔中的凸起，同时将导管3和支架404连接，如此，中间连接套16不仅与导管3的远端301形成机械挂钩结构，同样与支架404的近端形成机械挂钩结构。
第二连接部321套设在第一连接部421外，通过热熔将第二连接部321形成熔融状态，熔融状态的导管3材料流入第一连接部421的连接孔中冷却固化后形成连接凸起323，形成第一连接部421和第二连接部321连接。当然，第二连接部321在热熔状态下依然整体呈现管套结构，环套在第二连接部321(连接次管的近端)外，部分材料流入到连接孔中冷却形成连接凸起323，并且，第二连接部321在热熔冷却后与第一连接部421还会形成粘接结构。
依靠导管3自身进行热熔形成机械钩挂结构以及化学粘接结构，无需额外设置其他连接结构，进而不仅能够提升导管3和支架404之间的结合强度，又不损失导管3组件的弯曲性能，还能增强连接部位的弯曲性能。
进一步的，导管3的远端301在第一连接部421的径向内侧还设有与第二连接部321材质相同或相近的第三连接部322。第二连接部321熔融产生的导管3材料进入到连接孔中，并穿过连接孔与第三连接部322接触。
第三连接部322位于最内侧，通过与第二连接部321相同材质或相近材质，熔融的导管3材料在冷却固化后与第三连接部322形成牢固的粘接构造或者形成一体结构，进 而通过构建封闭的环形连接构造，形成将导管3的近端封闭结构，降低嵌入到连接孔中的沿径向脱出的风险，进一步增强了导管3和支架404的接合强度。具体的，第三连接部322与导管3为一体结构，其形成于导管3的远端301。
为实现导管3的远端301和支架404的近端连接，导管3的远端301管壁上设有(夹壁)插孔，插孔的径向外侧为第二连接部321，插孔的径向内侧为第三连接部322。插孔在导管3远端301的端面上形成插入口，支架404的近端自插入口中插入到插孔中，在第一连接部421的径向两侧均设有导管3壁，外管壁321构成为第二连接部321，内管壁322构成为第三连接部322，进而插孔为一夹壁孔。第二连接部321具有在径向向内凸起进入到连接孔中的热熔凸起(连接凸起323)，热熔凸起的内端连接第三连接部322。插孔的深度大于第一连接部421的轴向长度，使得全部数量的连接孔进入到插孔中。
通过设置第三连接部322，可避免第二连接部321因热熔损坏而产生的结构损伤，第三连接部322位于最内侧，与第二连接部321相配合将支架404的近端牢固连接。
本公开一个实施例中提供一种导管泵的支架404与导管3的装配方法。导管3内用于穿设带动叶轮410旋转的驱动轴300。支架404用于支撑展开覆膜401形成容纳叶轮410的旋转空间。支架404的近端设有连接次管43。连接次管43上设有贯穿其至少部分壁厚的接合部。导管3的远端设有材料部。
在该装配方法中的支架404及导管3可以参考本公开其他实施例中的描述，重复之处不再赘述。需要说明的是，在采用该装配方法之前材料部可以为表面平整的管状或套状结构，而在经过热熔之后材料部热熔固化形成上述接合材料，表面呈现凹凸结构，与凹陷结构的接合部形成嵌入式的至少轴向上限位的配合结构。
装配方法包括：S10、将材料部覆盖于接合部外；S20、热熔材料部形成流入接合部的流动材料；S30、固化流动材料形成将导管3和支架404连接的连接结构。
在步骤S10中，材料部覆盖于接合部可以通过贴合接触或者外围套设等方式覆盖在接合部外，以在后续的热熔中形成的流动材料便于流入接合部内，形成嵌入凸起构造的连接结构。
在步骤S30中，固化流动材料的方式可以采用自然冷却或者低温冷却，在本实施例中，自然冷却材料部以固化流动材料。也即，在将材料部热熔后通过自然冷却形成将导管3和支架404连接的连接结构。而在步骤S10中，材料部覆盖于接合部外，二者位置至少在轴向上并无互相限位，通过热熔固化形成将二者连接的连接结构。该连接结构具体可以参考其他实施例中所描述的接合材料。
材料部一体设置在导管3的远端。连接结构为部分导管3经热熔固化成型或热压成型的结构。也即，装配方法包括：S10’、将导管3的远端套设于连接次管43外；S20’、热熔导管3的远端使部分导管3材料流入接合部；S30’、固化流入接合部的材料形成将导管3和支架404连接的连接结构。
进一步地，如图29、图31所示，导管3的远端设有夹壁插孔。导管3的远端在夹壁插孔的径向外侧具有外管壁321(第二连接部321)，在夹壁插孔的径向内侧具有内管壁322(第三连接部322)。
相应的，装配方法包括：S10”、将连接次管43插入夹壁插孔以使接合部位于夹壁插孔内；S20”、热熔外管壁使部分导管3材料流入接合部；S30”、固化流入接合部的材料形成将导管3和支架404连接的连接结构。
如图28、图29所示，连接次管43在第一连接部421的远侧(前侧)设有近端轴承室。近端轴承室位于第一连接部421和出口段42之间。近端轴承330安装在该近端轴承室。近端轴承室为圆形套体结构。在一个可行实施例中，连接次管43内还设有近端轴承室，近端轴承室340内固定有近端轴承330(第一近端轴承331、第二近端轴承332)，以将驱动轴300进行转动支撑。
在本实施例中，连接次管43在第一连接部421的远侧还设有定位部(连接扣431)。定位部将位于连接次管43内的近端轴承330定位固定；近端轴承330套设在驱动轴300外，将驱动轴300转动支撑。近端轴承330的外壁上设有与定位部相接合的配合部。定位部和配合部形成卡扣结构。
具体的，近端轴承330直接固定在连接次管43内。在连接次管43的第一连接部421的远侧(前侧)设有连接扣431(定位部，公扣)，近端轴承330的外壁上设有卡槽336(配合部，母扣)。近端轴承330位于连接次管43内，并被连接扣431作为公扣扣入到近端轴承330的外壁的卡槽336内，将近端轴承330轴向限位。
当然，近端轴承330通过过盈配合固定在支架404近端(连接次管)的期望位置，并通过连接扣431进一步将近端轴承的位置限制，避免近端轴承330发生轴向窜动移位。
如图27所示，连接次管43的内部在近端轴承330的近侧还固定有挡圈357。挡圈357与第三连接部322的远端端面相接触限位。挡圈357与驱动轴300之间的间隔距离大于近端轴承330和驱动轴300之间的间隔距离。
连接次管43设有卡孔432，连接扣431设在卡孔432中，并沿径向向内凸出。第一连接部421位于连接扣431的近侧(后侧)。在第一连接部421插入到导管3近端的插 孔中时，其插入深度不没入连接扣431，连接扣431位于插孔外。在导管3和支架404相对插时，连接次管43的近端端面接触到插孔的孔底而停止继续插入，插孔的孔底可以形成对导管3和支架404对插的轴向限位。连接扣431大致为矩形结构，相应的，卡孔432同样为矩形结构。连接扣的远端301固定在连接次管43上，其他侧边与卡孔的孔边脱离间隔，进而允许连接扣431在径向上一定程度的弹性移动。
连接孔435及连接扣431为在支架404上切割形成，或者，与支架404一体铸造成型，本申请中并不作限制。第一连接部421和连接扣之间相间隔一定距离。
导管3的远端301设有旋转支撑结构，旋转支撑结构包括至少一个近端轴承330，以供驱动轴300穿过，对驱动轴300进行转动支撑。其中，旋转支撑结构具有相间隔的限位件和旋转支撑结构。限位件和旋转支撑结构中的至少一个为近端轴承330。
在一个可行的实施例中，如图16所示，导管3的远端301固定有近端轴承室340(也可以称为近端轴承套)，近端轴承室340相对于导管3及支架404为独立部件，支架404的连接次管套设在近端轴承室340外，近端轴承室340内设有作为限位件的第一近端轴承331以及作为旋转支撑结构的第二近端轴承332。导管3的远端301具有连接端，近端轴承室340套设在该连接端上，连接次管固定套设在近端轴承室340外，也即近端轴承室340的近端套设在连接次管和导管3的连接端之间，三者相对固定，近端轴承室340为近端轴承(第一近端轴承331和第二近端轴承332)提供刚性支撑，便于近端轴承安装。该连接端相对于导管3主体缩径形成，连接端与导管3主体之间具有缩径形成的止挡台阶，进而在连接次管43和近端轴承室340安装时能够提供止挡限位，提醒安装到位，还能够避免在安装近端轴承室340和连接次管后凸出于导管3表面，对于血液流动形成不良影响，且降低凸起对覆膜401收折状态下的损伤几率。
在诸如图28、图29所示的实施例中，限位件为固定设于导管3远端的挡圈357；转动支撑件为近端轴承330。挡圈357与驱动轴300之间的间隙宽度大于转动支撑件(近端轴承330)与驱动轴300之间的间隙宽度。挡圈357位于近端轴承330的近侧。
支架404的连接次管43通过卡扣与近端轴承室340相连，近端轴承室340通过胶粘与导管3连接。近端轴承室340外壁表面具有沿轴向延伸的长形凹槽，该长形凹槽与导管3内的传感器走线孔相对齐。
限位件和旋转支撑结构相间隔设置。在驱动轴300的外壁上固定有止挡件356。止挡件356位于限位件和旋转支撑结构之间。止挡件356在借由限位件和旋转支撑结构所限定的轴向范围内移动。
在一个可行的实施例中，止挡件356被轴向夹设在限位件和旋转支撑结构之间，限位件和旋转支撑结构之间的轴向间距与止挡件356在轴向的长度相等。止挡件356的远端301与旋转支撑结构接触限位，近端与限位件接触限位。通过限位件和旋转支撑结构将止挡件356夹紧限位，使得止挡件356所连接的第二轴355的轴向位置被限定。
通过设置止挡件356，可以避免第二轴355的近端从第一轴350的远端301中脱离。止挡件356的外侧壁与近端轴承室的内壁(近端轴承室340的内壁或者连接次管的内壁)间隔一定距离，构成灌注液流动间隙。
泵体4从径向展开状态到径向收折状态，支架404的远端连同远端轴承62及远端轴承室6在第二轴355上滑动，使得支架404长度变长，以缩小尺寸进入折叠状态。
为避免在收折过程中，第二轴355远端3551从远端轴承62中滑脱，在径向展开状态下，第二轴355远端3551延伸至远端轴承62远侧一段距离。较佳的，在径向展开状态下，第二轴355远端3551距离封堵件550一定距离，以便于灌注液的流出。
具体的，泵体4具有径向收折状态和径向展开状态。泵体4在径向展开状态与径向收折状态之间切换时，远端轴承62相对驱动轴滑动并保持支撑驱动轴，通过支架404轴向长度变长，以缩小尺寸进入折叠状态，并且驱动轴无法从远端轴承62脱出，保证收折和展开的可重复执行，以便泵体4顺利介入体内，并在手术完毕后顺利收折从体内移出。
承接上文描述，驱动轴包括刚度较小的第一轴350和刚度较大的第二轴355，第一轴350的近端与马达1的转动轴传动连接，远端与第二轴355的近端连接。叶轮410固定套设于第二轴355上。支架404的远端连同远端轴承室6及远端轴承62沿着驱动轴滑动。具体的，支架404的远端连同远端轴承室6及远端轴承62沿着第二轴355滑动。刚性的第二轴355能够为支架404、远端轴承室6及远端轴承62提供滑动支撑。
在收折状态下，驱动轴的远端端面3552位于远端轴承62的近端端面的远侧。在展开状态下，驱动轴的远端端面3552位于远端轴承62的远端端面的远侧。具体的，在收折状态下，第二轴355的远端端面3552位于远端轴承62的近端端面的远侧。在展开状态下，第二轴的远端端面3552位于远端轴承62的远端端面的远侧。
在泵体4的展开状态切换至收折状态过程中，驱动轴伸入的远端轴承室6的长度逐渐降低。在泵体4的收折状态切换至展开状态过程中，驱动轴伸入的远端轴承室6的长度逐渐增大。
在展开状态下，驱动轴的远端端面3552与远端轴承62的近端端面之间的距离为L1；在收折状态下，驱动轴的远端端面3552与远端轴承62的近端端面之间的距离为L2，L1 大于L2。更具体的，在展开状态下，第二轴的远端端面3552与远端轴承62的近端端面之间的距离为L1；在收折状态下，第二轴的远端端面3552与远端轴承62近端端面之间的距离为L2，L1大于L2。
如图30所示，(柔性)封堵件550和第二轴355的远端之间相间隔一定距离，第二轴355远端3551和封堵件550之间形成有间隔间隙560，如此可以提供第二轴355的轴向活动余量，以供第二轴355轴向移动。并且，封堵件550还可以构成对第二轴355的轴向限位，将封堵件550的轴向移动的远死点位置限定。
当然，在上述实施例中的止挡件356存在的情况下，止挡件356在与第二近端轴承332接触时，第二轴355的远端与封堵件550并不接触，二者相间隔，以避免第二轴355的轴向移动破坏封堵件550。
在径向收折状态下，第二轴355的远端端面3552至少处于远端轴承62近端端面的远侧，以保证第二轴355始终不会从远端轴承62中脱出。或者，在径向展开状态下，第二轴355的远端端面3552与远端轴承62的近端端面621之间的距离，大于在径向收折状态下，第二轴355的远端端面3552与远端轴承62的近端端面621之间的距离。
应该理解，以上描述是为了进行图示说明而不是为了进行限制。通过阅读上述描述，在所提供的示例之外的许多实施方式和许多应用对本领域技术人员来说都将是显而易见的。因此，本教导的范围不应该参照上述描述来确定，而是应该参照所附权利要求以及这些权利要求所拥有的等价物的全部范围来确定。出于全面之目的，所有文章和参考包括专利申请和公告的公开都通过参考结合在本文中。在前述权利要求中省略这里公开的主题的任何方面并不是为了放弃该主体内容，也不应该认为发明人没有将该主题考虑为所公开的发明主题的一部分。

Claims (67)

  1. 一种导管泵，包括：
    马达；
    导管，近端连接至所述马达；
    驱动轴，被所述马达驱动；
    泵体，包括：连接至所述导管远端的泵壳、收纳在所述泵壳内的叶轮；所述泵壳包括：支架、部分覆盖所述支架的覆膜；
    近端轴承，设于所述支架的近端；
    远端轴承，设于所述支架的远端；
    其中，所述驱动轴包括：可转动的穿设在所述导管中的第一轴、与所述叶轮连接的第二轴；所述第二轴的刚度大于第一轴的刚度；
    所述第一轴的近端与所述马达的转动轴传动连接，远端与所述第二轴的近端连接；所述第二轴的近端和远端分别穿设在所述近端轴承和远端轴承中。
  2. 如权利要求1所述的导管泵，其中，所述支架的近端设有近端轴承室；所述近端轴承在所述近端轴承室内支撑所述第二轴的近端。
  3. 如权利要求2所述的导管泵，其中，所述支架的近端设有与所述导管远端连接的连接次管；所述连接次管构成所述近端轴承室，所述近端轴承内置于所述连接次管。
  4. 如权利要求2所述的导管泵，其中，所述支架的近端设有连接次管；所述近端轴承室与所述导管的远端连接；所述近端轴承室设在所述连接次管内。
  5. 如权利要求2所述的导管泵，其中，所述支架的近端设有与所述近端轴承轴向间隔设置的限位件，所述驱动轴上设有位于所述近端轴承与所述位件之间的止挡件。
  6. 如权利要求5所述的导管泵，其中，所述限位件为另一近端轴承；或者，所述限位件为设于所述近端轴承室内的挡圈。
  7. 如权利要求5所述的导管泵，其中，所述止挡件的近端与所述限位件接触限位，远端与所述近端轴承接触限位。
  8. 如权利要求5所述的导管泵，其中，所述止挡件可轴向移动地设于所述近端轴承和限位件之间，所述近端轴承和限位件将所述止挡件的轴向移动范围限定。
  9. 如权利要求1所述的导管泵，其中，所述第二轴具有壁面暴露在所述支架中的暴露部，所述暴露部的至少部分壁面上设有沿轴向螺旋延伸的第一螺旋结构，从近端向远端的方向观察，在第二轴顺时针旋转的情况下，所述第一螺旋结构为右旋螺纹，或者， 在第二轴逆时针旋转的情况下，所述第一螺旋结构为左旋螺纹。
  10. 如权利要求9所述的导管泵，其中，所述第一螺旋结构位于轮毂的远侧。
  11. 如权利要求1所述的导管泵，其中，所述第二轴具有被套设在轮毂内的第一非暴露部，所述第一非暴露部的至少部分壁面上设有凹陷结构。
  12. 如权利要求11所述的导管泵，其中，所述凹陷结构为设于所述第一非暴露部的壁面上的螺旋槽。
  13. 如权利要求12所述的导管泵，其中，所述螺旋槽自所述轮毂的远端连续延伸至所述轮毂的近端。
  14. 如权利要求1所述的导管泵，其中，所述第二轴具有被套设在远端轴承室内的第二非暴露部，至少部分第二非暴露部的壁面上设有第二螺旋结构；从近端向远端的方向观察，在第二轴顺时针旋转的情况下，所述第二螺旋结构为右旋螺纹，或者，在第二轴逆时针旋转的情况下，所述第二螺旋结构为左旋螺纹。
  15. 如权利要求14所述的导管泵，其中，所述第二轴的壁面上设有螺旋槽；所述螺旋槽自所述轮毂的近端连续延伸至所述第二轴的远端；从近端向远端的方向观察，在第二轴顺时针旋转的情况下，所述螺旋槽为右旋螺纹，或者，在第二轴逆时针旋转的情况下，所述螺旋槽为左旋螺纹。
  16. 如权利要求1所述的导管泵，其中，所述第一轴为编织结构，包括逐层套设的多个编织层；每层所述编织层为螺旋绕丝形成，相邻两个编织层的螺旋绕丝的旋向相反。
  17. 如权利要求1所述的导管泵，其中，从近端向远端的方向观察，在驱动轴顺时针旋转的情况下，最外层的编织层的旋向为左旋螺旋结构，或者，在驱动轴逆时针旋转的情况下，最外层的编织层的旋向为右旋螺旋结构。
  18. 一种导管泵，包括：
    马达；
    导管，近端连接至所述马达；
    驱动轴，被所述马达驱动；
    泵体，具有收折状态和展开状态，包括：连接至所述导管远端的泵壳、收纳在所述泵壳内并被所述驱动轴驱动的叶轮；
    远端轴承室，连接至所述泵壳的远端，内置有远端轴承；
    其中，所述驱动轴的远端穿过所述叶轮的轮毂并延伸至所述远端轴承中；
    所述泵体在展开状态与收折状态之间切换时，所述远端轴承相对所述驱动轴滑动并 保持支撑所述驱动轴。
  19. 如权利要求18所述的导管泵，其中，所述泵体在展开状态与收折状态之间切换时，所述支架的远端连同所述远端轴承室及远端轴承沿着所述驱动轴滑动。
  20. 如权利要求18所述的导管泵，其中，在收折状态下，所述驱动轴的远端端面位于所述远端轴承的近端端面的远侧。
  21. 如权利要求18所述的导管泵，其中，在展开状态下，所述驱动轴的远端端面与所述远端轴承的近端端面之间的距离为L1；在收折状态下，所述驱动轴的远端端面与所述远端轴承近端端面之间的距离为L2，其中，L1大于L2。
  22. 如权利要求18所述的导管泵，其中，所述远端轴承室内设有供导丝穿过的封堵件；所述封堵件能在所述导丝穿过前后维持所在位置的封堵状态。
  23. 如权利要求18所述的导管泵，其中，所述远端轴承室的远端连接有无创支撑件，所述无创支撑件的近端伸入所述远端轴承室的远端内，所述无创支撑件的近端与所述远端轴承室的远端内壁粘接。
  24. 如权利要求24所述的导管泵，其中，所述无创支撑件的近端外壁和/或所述远端轴承室的远端内壁设有容胶槽。
  25. 一种导管泵，包括：
    马达；
    导管，近端连接至所述马达；
    驱动轴，被所述马达驱动；
    泵体，包括：泵壳、收纳在所述泵壳内并被所述驱动轴驱动的叶轮；所述泵壳包括：支架、部分覆盖所述支架的覆膜；
    其中，所述支架的近端设有连接次管，所述连接次管上设有贯穿其至少部分壁厚的接合部，所述接合部中容纳有热熔后流入其内并固化的接合材料，所述接合材料设于所述导管远端。
  26. 一种导管泵，包括：
    马达；
    导管，近端连接至所述马达；
    驱动轴，被所述马达驱动；
    泵体，包括：泵壳、收纳在所述泵壳内并被所述驱动轴驱动的叶轮；所述泵壳包括：支架、部分覆盖所述支架的覆膜；
    其中，所述支架的近端设有连接次管，所述连接次管上设有贯穿其至少部分壁厚的接合部，所述导管远端设有容纳在所述接合部中的热熔固化成型的接合材料。
  27. 如权利要求25或26所述的导管泵，其中，所述连接次管套设在导管远端外部，所述连接次管的外部套设有中间连接套，所述接合材料为所述中间连接套热熔后固化形成。
  28. 如权利要求27所述的导管泵，其中，部分所述中间连接套位于所述连接次管的近侧并固定套设在所述导管外。
  29. 如权利要求28所述的导管泵，其中，部分所述中间连接套热熔后粘接套设于所述导管外壁上，或者，部分所述中间连接套胶粘于所述导管外壁上，或者，所述导管外壁设有容纳部分所述中间连接套经热熔后固化形成的嵌入凸起的嵌槽。
  30. 如权利要求25或26所述的导管泵，其中，所述接合材料为部分所述导管经热熔固化成型的结构。
  31. 如权利要求25或26所述的导管泵，其中，所述接合材料的熔点与导管的材料的熔点相同或相近。
  32. 如权利要求25或26所述的导管泵，其中，所述接合材料与所述导管的材质相同，或者，所述接合材料与所述导管均为树脂材料。
  33. 如权利要求25或26所述的导管泵，其中，所述接合部包括开设于所述次管管壁上的限位凹陷，所述接合材料包括热熔固化成型的连接凸起；所述连接凸起通过卡入所述限位凹槽中将所述导管和所述支架至少轴向上固定。
  34. 如权利要求33所述的导管泵，其中，所述连接次管的远端包括具有所述限位凹陷的第一连接部；所述导管的远端包括具有所述连接凸起的第二连接部；所述第二连接部套设于所述第一连接部外，所述连接凸起卡入所述限位凹槽中。
  35. 如权利要求34所述的导管泵，其中，所述第二连接部通过热熔将部分导管材料流入所述限位凹陷后固化形成所述连接凸起。
  36. 如权利要求34所述的导管泵，其中，所述第二连接部还具有与所述第一连接部相粘接的粘接面。
  37. 如权利要求36所述的导管泵，其中，所述第二连接部通过热熔固化后形成所述粘接面。
  38. 如权利要求34所述的导管泵，其中，所述限位凹陷在径向上将所述连接次管的壁贯通。
  39. 如权利要求38所述的导管泵，其中，所述限位凹陷包括设于所述连接次管上将所述连接次管壁径向贯通的多个连接孔。
  40. 如权利要求39所述的导管泵，其中，所述连接孔为沿周向延伸的长孔；多个所述连接孔沿所述连接次管的轴向平行排布。
  41. 如权利要求39或40所述的导管泵，其中，相邻两个所述连接孔在轴向上至少部分相错开或重合。
  42. 如权利要求41所述的导管泵，其中，相邻两个所述连接孔在轴向上具有重合部分；所述重合部分的周向长度大于所述连接孔的轴向宽度。
  43. 如权利要求41所述的导管泵，其中，所述连接孔具有与邻近的连接孔沿轴向相重合的第一重合部分和第二重合部分；所述第一重合部分具有第一孔端，所述第二重合部分具有第二孔端；所述第一重合部分和第二重合部分的周向长度相等。
  44. 如权利要求41所述的导管泵，其中，所述连接孔在周向上具有第一孔端和第二孔端；所述第一孔端和所述第二孔端具有端间隔部；所述端间隔部的周向长度小于所在位置周长的一半；或者，所述端间隔部的周向长度大于所述连接孔的轴向宽度。
  45. 如权利要求40所述的导管泵，其中，相邻两个连接孔之间具有孔间隔部；所述孔间隔部的周向宽度小于所述连接孔的轴向宽度。
  46. 如权利要求40所述的导管泵，其中，位于一连接孔轴向两侧的连接孔在轴向上相对齐。
  47. 如权利要求34所述的导管泵，其中，所述第一连接部的径向内侧还设有第三连接部；所述连接凸起穿过所述限位凹陷与所述第三连接部粘接或一体结构。
  48. 如权利要求47所述的导管泵，其中，所述第三连接部与所述第二连接部材质相同。
  49. 如权利要求47所述的导管泵，其中，所述第三连接部与所述导管为一体结构。
  50. 如权利要求49所述的导管泵，其中，所述导管远端的导管壁上设有夹壁插孔；所述夹壁插孔的径向外侧管壁为所述第二连接部，所述夹壁插孔的径向内侧管壁为第三连接部；所述夹壁插孔在所述导管远端的端面上形成供所述第一连接部插入的插入口。
  51. 如权利要求50所述的导管泵，其中，所述连接次管在所述第一连接部的远侧还设有定位部；所述定位部将位于所述连接次管内的近端轴承定位；所述近端轴承套设在所述驱动轴外，将所述驱动轴转动支撑；所述近端轴承的外壁上设有与所述定位部相接合的配合部；所述定位部和所述配合部形成卡扣结构。
  52. 如权利要求51所述的导管泵，其中，所述定位部包括沿周向排布的多个沿径向向内凸出的公扣；所述配合部包括所述近端轴承的外壁上的被所述公扣卡入的卡槽。
  53. 如权利要求51所述的导管泵，其中，所述连接次管的内部在所述近端轴承的近侧还固定有挡圈；所述挡圈与所述第三连接部的远端端面相接触限位；所述挡圈与所述驱动轴之间的间隔距离大于所述近端轴承和所述驱动轴之间的间隔距离。
  54. 一种导管泵的支架与导管的装配方法，所述导管内用于穿设带动叶轮旋转的驱动轴，所述支架用于支撑展开覆膜形成容纳叶轮的旋转空间；所述支架的近端设有连接次管，所述连接次管上设有贯穿其至少部分壁厚的接合部，所述导管的远端设有材料部；
    其中，所述装配方法包括：将所述材料部覆盖于所述接合部外，热熔所述材料部形成流入所述接合部的流动材料，固化所述流动材料形成将所述导管和所述支架连接的连接结构。
  55. 如权利要求54所述的装配方法，其中，自然冷却所述材料部以固化所述流动材料。
  56. 如权利要求54所述的装配方法，其中，所述材料部一体设在所述导管的远端；
    其中，所述装配方法包括：将所述导管的远端套设于所述连接次管外，热熔所述导管的远端使部分导管材料流入所述接合部，固化流入所述接合部的材料形成将所述导管和所述支架连接的连接结构。
  57. 如权利要求54所述的装配方法，其中，所述导管的远端设有夹壁插孔；所述导管的远端在所述夹壁插孔的径向外侧具有外管壁，在所述夹壁插孔的径向内侧具有内管壁；
    其中，所述装配方法包括：将所述连接次管插入所述夹壁插孔以使所述接合部位于夹壁插孔内，热熔所述外管壁使部分导管材料流入所述接合部，固化流入所述接合部的材料形成将所述导管和所述支架连接的连接结构。
  58. 一种导管泵，包括：
    马达；
    导管，近端连接至所述马达；
    驱动轴，被所述马达驱动；
    泵体，包括：泵壳、收纳在所述泵壳内并被所述驱动轴驱动的叶轮；所述泵壳包括：支架、部分覆盖所述支架的覆膜；
    远端轴承室，内置有远端轴承，所述驱动轴的远端穿设在所述远端轴承中；
    其中，所述支架近端与所述导管的远端连接，远端形成有多个间隔的连接支腿，多个所述连接支腿嵌设在所述远端轴承室的外壁的容纳槽中。
  59. 如权利要求58所述的导管泵，其中，所述远端轴承室外固定套设有箍套；所述箍套套设在所述远端轴承室及所述连接支腿外将所述连接支腿限位在所述容纳槽内。
  60. 如权利要求58所述的导管泵，其中，所述容纳槽包括多个沿轴向延伸的卡槽、以及连通多个所述卡槽的远端的环形槽；所述连接支腿包括嵌入到所述卡槽中的杆体以及嵌入到所述环形槽中的腿端。
  61. 如权利要求60所述的导管泵，其中，所述腿端与所述杆体呈T形结构。
  62. 如权利要求58所述的导管泵，其中，所述远端轴承室包括伸入段和束缚段；所述伸入段位于所述束缚段的近侧，所述伸入段的外径小于所述束缚段的外径，所述伸入段和所述束缚段之间设有变径台阶；所述容纳槽设于所述束缚段的外壁上；所述箍套固定套设在所述束缚段外；所述远端轴承内置于所述伸入段。
  63. 一种导管泵的泵体装配方法，所述泵体包括支架、设有叶轮的叶轮轴、远端轴承室；其中，所述支架的远端形成有多个间隔的连接支腿，所述远端轴承室开设有容纳槽；其中，所述泵体装配方法包括：径向打开多个所述连接支腿，将所述叶轮轴和远端轴承室自所述支架的远端向其近端穿设，将连接支腿放置于所述容纳槽中定位，在箍套套设在所述远端轴承室外将所述连接支腿限位在所述容纳槽中。
  64. 如权利要求63所述的泵体装配方法，其中，将叶轮轴的远端穿设于所述远端轴承室内；径向打开多个所述连接支腿后将叶轮轴和远端轴承室一同自所述支架的远端向近端移动穿设。
  65. 如权利要求63所述的泵体装配方法，其中，径向打开多个所述连接支腿，先将所述叶轮轴自所述支架的远端向其近端穿设，再将所述远端轴承室自所述支架的远端送入至被多个所述连接支腿围绕且被叶轮轴的远端插入。
  66. 如权利要求63所述的泵体装配方法，其中，径向打开多个所述连接支腿，将远端轴承室送入多个所述连接支腿内并将容纳槽与所述连接支腿相对齐，放置所述连接支腿在所述容纳槽中定位。
  67. 如权利要求63所述的泵体装配方法，其中，将热缩管套设在远端轴承室外经热缩后形成所述箍套。
PCT/CN2021/127377 2021-10-29 2021-10-29 导管泵 WO2023070515A1 (zh)

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CN202111574903.7A CN114225213B (zh) 2021-10-29 2021-12-21 导管泵
CN202220416000.XU CN217960999U (zh) 2021-10-29 2022-02-25 导管泵及其泵壳
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